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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to Methotrexate Therapy (FLEX M)

    Summary
    EudraCT number
    		 2010-022205-17
    Trial protocol
    		 HU   LT   BG   PL  
    Global end of trial date
    21 Jan 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    H9B-MC-BCDM
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01198002
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 11352
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center , Indianapolis, IN, United States, 46285
    Public contact
    Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-CTLilly,
    Scientific contact
    Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-285-4559,
    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
    21 Jan 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jan 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis while on a background treatment of methotrexate. This study is comprised of 3 periods: Period 1: 52-week blinded treatment Period 2: additional 48-week unblinded treatment Period 3: 48-week post-treatment follow-up
    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
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Dec 2010
    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
    United States: 167
    Country: Number of subjects enrolled
    Taiwan: 31
    Country: Number of subjects enrolled
    Slovakia: 11
    Country: Number of subjects enrolled
    Ukraine: 68
    Country: Number of subjects enrolled
    Lithuania: 20
    Country: Number of subjects enrolled
    Russian Federation: 72
    Country: Number of subjects enrolled
    Colombia: 51
    Country: Number of subjects enrolled
    Sri Lanka: 5
    Country: Number of subjects enrolled
    India: 14
    Country: Number of subjects enrolled
    Hungary: 25
    Country: Number of subjects enrolled
    Mexico: 64
    Country: Number of subjects enrolled
    Argentina: 50
    Country: Number of subjects enrolled
    Malaysia: 8
    Country: Number of subjects enrolled
    Brazil: 41
    Country: Number of subjects enrolled
    Poland: 100
    Country: Number of subjects enrolled
    Croatia: 2
    Country: Number of subjects enrolled
    Romania: 4
    Country: Number of subjects enrolled
    South Africa: 48
    Country: Number of subjects enrolled
    Bulgaria: 32
    Country: Number of subjects enrolled
    Japan: 158
    Country: Number of subjects enrolled
    New Zealand: 2
    Country: Number of subjects enrolled
    Korea, Republic of: 68
    Worldwide total number of subjects
    1041
    EEA total number of subjects
    194
    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)
    900
    From 65 to 84 years
    141
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Study had a blinded Treatment Period 1 (Weeks 0-52), a non-blinded Treatment Period 2 (Weeks 52-100) and a post-treatment follow-up (24-48 weeks in length). All participants were assessed for nonresponse at Week 16 with non-responders (NR) defined as participants with <20% improvement from baseline in both tender and swollen joint counts.

    Period 1
    Period 1 title
    Treatment Period 1 (Weeks 0-52)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 120 mg LY2127399
    Arm description
    		 Treatment Period 1 (Weeks 0-52): A loading dose of 240 milligrams (mg) (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered subcutaneously (SC) every 4 weeks (Q4W). For blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks (Q2W). At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2. At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    120 mg LY2127399
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Treatment Period 1 (Weeks 0-52): A loading dose of 240 milligrams (mg) (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered subcutaneously (SC) every 4 weeks (Q4W). For blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks (Q2W). At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2. At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.

    Arm title
    		 90 mg LY2127399
    Arm description
    		 Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2. At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    90 mg LY2127399
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.

    Arm title
    		 Placebo
    Arm description
    		 Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2. At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.

    Number of subjects in period 1
    		120 mg LY2127399 90 mg LY2127399 Placebo
    Started
    345
    347
    349
    Received at Least 1 Dose of Study Drug
    345
    345
    348
    Week 16 NR
    58 [1]
    62 [2]
    90
    Post-Treatment Follow-Up Population
    293
    303
    307
    Completed
    70
    73
    80
    Not completed
    275
    274
    269
         Adverse event, serious fatal
    2
    -
    1
         Consent withdrawn by subject
    16
    21
    12
         Physician decision
    1
    2
    2
         Adverse event, non-fatal
    18
    11
    11
         Sponsor Decision
    213
    216
    224
         Lost to follow-up
    -
    2
    -
         Entry Criteria Not Met
    1
    3
    3
         Lack of efficacy
    10
    9
    6
         Protocol deviation
    14
    10
    10
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: All participants were assessed for nonresponse at Week 16 with non-responders (NR) defined as participants with <20% improvement from baseline in both tender and swollen joint counts.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: All participants were assessed for nonresponse at Week 16 with non-responders (NR) defined as participants with <20% improvement from baseline in both tender and swollen joint counts.
    Period 2
    Period 2 title
    Treatment Period 2 (Weeks 52-100)
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 120 mg LY2127399
    Arm description
    		 Treatment Period 1 (Weeks 0-52): A loading dose of 240 milligrams (mg) (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered subcutaneously (SC) every 4 weeks (Q4W). For blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks (Q2W). At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2. At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    120 mg LY2127399
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Treatment Period 1 (Weeks 0-52): A loading dose of 240 milligrams (mg) (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered subcutaneously (SC) every 4 weeks (Q4W). For blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks (Q2W). At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2. At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.

    Arm title
    		 90 mg LY2127399
    Arm description
    		 Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2. At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    90 mg LY2127399
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.

    Arm title
    		 Placebo
    Arm description
    		 Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2. At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2.

    Number of subjects in period 2
    		120 mg LY2127399 90 mg LY2127399 Placebo
    Started
    70
    73
    80
    Completed
    1
    0
    2
    Not completed
    69
    73
    78
         Physician decision
    1
    -
    1
         Adverse event, non-fatal
    2
    -
    1
         Sponsor Decision
    62
    70
    75
         Lost to follow-up
    -
    2
    -
         Entry Criteria Not Met
    1
    -
    -
         Lack of efficacy
    3
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    120 mg LY2127399
    Reporting group description
    		 Treatment Period 1 (Weeks 0-52): A loading dose of 240 milligrams (mg) (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered subcutaneously (SC) every 4 weeks (Q4W). For blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks (Q2W). At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2. At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.

    Reporting group title
    90 mg LY2127399
    Reporting group description
    		 Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2. At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.

    Reporting group title
    Placebo
    Reporting group description
    		 Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2. At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.

    Reporting group values
    		 120 mg LY2127399 90 mg LY2127399 Placebo Total
    Number of subjects
    		 345 347 349 1041
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 290 311 299 900
        From 65-84 years
    		 55 36 50 141
        85 years and over
    		 0 0 0 0
    Gender, Male/Female
    Units:
        Male
    		 51 56 57 164
        Female
    		 294 291 292 877
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 20 18 15 53
        Asian
    		 100 102 101 303
        Native Hawaiian or Other Pacific Islander
    		 0 1 0 1
        Black or African American
    		 22 19 22 63
        White
    		 191 197 200 588
        More than once Race
    		 9 7 7 23
        Unknown or Not Reported
    		 3 3 4 10
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 63 67 61 191
        Not Hispanic or Latino
    		 140 131 140 411
        Unknown or Not Reported
    		 142 149 148 439

    End points

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    End points reporting groups
    Reporting group title
    120 mg LY2127399
    Reporting group description
    		 Treatment Period 1 (Weeks 0-52): A loading dose of 240 milligrams (mg) (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered subcutaneously (SC) every 4 weeks (Q4W). For blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks (Q2W). At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2. At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.

    Reporting group title
    90 mg LY2127399
    Reporting group description
    		 Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2. At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.

    Reporting group title
    Placebo
    Reporting group description
    		 Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2. At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.
    Reporting group title
    120 mg LY2127399
    Reporting group description
    		 Treatment Period 1 (Weeks 0-52): A loading dose of 240 milligrams (mg) (2 injections of 120 mg) of LY2127399, followed by maintenance dosing of 120 mg of LY2127399 administered subcutaneously (SC) every 4 weeks (Q4W). For blinding purposes, participants alternated injections of LY2127399 and injections of placebo every 2 weeks (Q2W). At Week 16, responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2. At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.

    Reporting group title
    90 mg LY2127399
    Reporting group description
    		 Treatment Period 1 (Weeks 0-52): A loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by maintenance dosing of 90 mg of LY2127399 administered SC Q2W. At Week 16, responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, Week 16 responders received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2. At Week 16, NR received 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.

    Reporting group title
    Placebo
    Reporting group description
    		 Treatment Period 1 (Weeks 0-52): A loading dose of 2 injections of placebo, followed by maintenance dosing of 1 injection of placebo administered SC Q2W. At Week 16, responders received 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the Treatment Period 1. Treatment Period 2 (Weeks 52-100): At Week 52, responders were randomized to receive either 2 injections of 120 mg of LY2127399, followed by 120 mg of LY2127399 Q4W for the rest of the Treatment Period 2 or 2 injections of 90 mg of LY2127399, followed by 90 mg of LY2127399 Q2W for the rest of the Treatment Period 2. At Week 16, NR received a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.

    Subject analysis set title
    PK subset
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Population PK subset of all participants who received LY2127399.

    Primary: Percentage of participants with American College of Rheumatology 20% response (ACR20) at Week 24

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    End point title
    		 Percentage of participants with American College of Rheumatology 20% response (ACR20) at Week 24
    End point description
    ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responder: had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). Percentage of participants achieving ACR20 response=(number of ACR20 responders) / (number of participants treated) * 100. All NR at Week 16 as well as all participants who discontinued study treatment at any time for any reason were defined as NR starting at that time-point and going forward, including Week 24 endpoint. All randomized participants with evaluable ACR20 responder data.
    End point type
    Primary
    End point timeframe
    Baseline through 24 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    330 [1]
    332 [2]
    335 [3]
    Units: percentage of participants
        number (not applicable)
    29.7
    32.8
    25.1
    Notes
    [1] - All randomized participants with evaluable ACR20 responder data.
    [2] - All randomized participants with evaluable ACR20 responder data.
    [3] - All randomized participants with evaluable ACR20 responder data.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    120 mg LY2127399 v 90 mg LY2127399 v Placebo
    Number of subjects included in analysis
    997
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 > 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Change from baseline to Week 52 in van der Heijde modified Total Sharp Score (mTSS)

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    End point title
    		 Change from baseline to Week 52 in van der Heijde modified Total Sharp Score (mTSS)
    End point description
    The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range = 0 to 220 for 44 joints) and narrowing scores (range = 0 to 168 for 42 joints) were added to obtain the mTSS (range = 0 [normal] to 388 [maximal disease]). Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline as a covariate.
    End point type
    Primary
    End point timeframe
    Baseline, 52 Weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    295 [4]
    304 [5]
    306 [6]
    Units: units on a scale
        least squares mean (standard error)
    1.43 ( 0.27 )
    0.84 ( 0.27 )
    1.57 ( 0.27 )
    Notes
    [4] - All randomized participants with evaluable mTSS data.
    [5] - All randomized participants with evaluable mTSS data.
    [6] - All randomized participants with evaluable mTSS data.
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    120 mg LY2127399 v 90 mg LY2127399 v Placebo
    Number of subjects included in analysis
    905
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 > 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Change from baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI)

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    End point title
    		 Change from baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI)
    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 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
    End point type
    Primary
    End point timeframe
    Baseline, 24 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    329 [7]
    329 [8]
    328 [9]
    Units: units on a scale
        least squares mean (standard error)
    -0.26 ( 0.03 )
    -0.30 ( 0.03 )
    -0.20 ( 0.03 )
    Notes
    [7] - All randomized participants with evaluable HAQ-DI data.
    [8] - All randomized participants with evaluable HAQ-DI data.
    [9] - All randomized participants with evaluable HAQ-DI data.
    Statistical analysis title
    		 Stats analysis 2
    Comparison groups
    120 mg LY2127399 v 90 mg LY2127399 v Placebo
    Number of subjects included in analysis
    986
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 > 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Change from baseline in Disease Activity Score based on 28 joint count and C-Reactive Protein Level (DAS28-CRP)

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    End point title
    		 Change from baseline in Disease Activity Score based on 28 joint count and C-Reactive Protein Level (DAS28-CRP)
    End point description
    Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP [milligrams per liter (mg/L)], and participant's global assessment of disease activity using visual analog scale (VAS) (participant global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity and remission is DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
    End point type
    Secondary
    End point timeframe
    Baseline, 24 weeks and 52 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    328 [10]
    327 [11]
    328 [12]
    Units: units on a scale
    least squares mean (standard error)
        Week 24
    -1.02 ( 0.07 )
    -1.00 ( 0.07 )
    -0.78 ( 0.07 )
        Week 52
    -1.07 ( 0.07 )
    -1.00 ( 0.07 )
    -0.80 ( 0.07 )
    Notes
    [10] - All randomized participants with evaluable DAS28-CRP data
    [11] - All randomized participants with evaluable DAS28-CRP data
    [12] - All randomized participants with evaluable DAS28-CRP data
    No statistical analyses for this end point

    Secondary: Percentage of participants with American College of Rheumatology 50% (ACR50) and 70% (ACR70) response

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    End point title
    		 Percentage of participants with American College of Rheumatology 50% (ACR50) and 70% (ACR70) response
    End point description
    ACR Responder Index: Composite of clinical, laboratory, and functional measures of RA. ACR50 Responder: had ≥50% improvement from baseline in both 68 tender joint (TJ) and 66 swollen joint (SJ) counts and ≥50% improvement in at least 3 of 5 criteria: participant's (Pt's) and physician's global assessment of disease activity, HAQ-DI (measured Pts' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of Pt achieving ACR50 response=(number (No.) of ACR50 responders) / (No. of Pts treated) * 100. ACR70 Responder: had ≥70% improvement from baseline in both TJ and SJ counts and ≥70% improvement in at least 3 of same 5 criteria for ACR50. Percentage of Pts achieving ACR70 response= (No. of ACR70 responders) / (No. of Pts treated) * 100. All NR at Week 16 as well as all Pts who discontinued study treatment at any time for any reason were defined as NR starting at that time-point and going forward, including Weeks 24 and 52 endpoints.
    End point type
    Secondary
    End point timeframe
    Baseline through 24 weeks and 52 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    330 [13]
    332 [14]
    335 [15]
    Units: percentage of participants
    number (not applicable)
        ACR50- Week 24
    10.6
    11.1
    10.1
        ACR50- Week52
    4.2
    3.0
    4.8
        ACR70- Week 24
    3.9
    3.0
    1.8
        ACR70- Week 52
    1.5
    1.2
    1.8
    Notes
    [13] - All randomized participants with evaluable ACR50 or ACR70 responder data.
    [14] - All randomized participants with evaluable ACR50 or ACR70 responder data.
    [15] - All randomized participants with evaluable ACR50 or ACR70 responder data.
    No statistical analyses for this end point

    Secondary: Change from baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey domain scores and summary scores

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    End point title
    		 Change from baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey domain scores and summary scores
    End point description
    SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, 2 component scores (CS), physical CS (PCS) and mental CS (MCS). Domain scores were calculated by summing each item for each domain and transforming scores into a 0-100 scale. Higher scores indicated better health status. If < 50% of the questions within a domain were answered, raw scores were not calculated. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. Both PCS and MCS range from 0-100. Higher score indicated better mental or physical health. LS means were calculated using ANCOVA with treatment, region as fixed factors and baseline as a covariate.
    End point type
    Secondary
    End point timeframe
    Baseline, 24 weeks and 52 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    320 [16]
    322 [17]
    323 [18]
    Units: units on a scale
    least squares mean (standard error)
        Physical functioning - Week 24 (n=320, 322, 323)
    2.70 ( 0.48 )
    3.16 ( 0.47 )
    2.06 ( 0.47 )
        Physical functioning - Week 52 (n=320, 322, 323)
    2.15 ( 0.50 )
    3.22 ( 0.49 )
    1.82 ( 0.49 )
        Bodily pain - Week 24 (n=319, 322, 323)
    4.07 ( 0.46 )
    4.08 ( 0.45 )
    2.52 ( 0.45 )
        Bodily pain - Week 52 (n=319, 322, 323)
    3.77 ( 0.47 )
    4.48 ( 0.46 )
    2.32 ( 0.46 )
        RL - physical problems - Week 24 (n=320, 322, 323)
    2.77 ( 0.46 )
    3.64 ( 0.46 )
    1.99 ( 0.45 )
        RL - physical problems - Week 52 (n=320, 322, 323)
    3.01 ( 0.47 )
    3.79 ( 0.46 )
    1.82 ( 0.46 )
        RL - emotional problems- Week 24 (n=319, 322, 323)
    3.20 ( 0.60 )
    4.81 ( 0.59 )
    2.91 ( 0.59 )
        RL - emotional problems- Week 52 (n=319, 322, 323)
    2.84 ( 0.61 )
    4.34 ( 0.59 )
    2.56 ( 0.59 )
        GH Perception - Week 24 (n=319, 322, 323)
    2.60 ( 0.41 )
    3.72 ( 0.40 )
    2.54 ( 0.40 )
        GH Perception - Week 52 (n=319, 322, 323)
    2.89 ( 0.42 )
    3.41 ( 0.41 )
    2.18 ( 0.41 )
        Mental Health - Week 24 (n=319, 322, 323)
    3.39 ( 0.53 )
    4.47 ( 0.53 )
    3.28 ( 0.52 )
        Mental Health - Week 52 (n=319, 322, 323)
    3.01 ( 0.55 )
    4.37 ( 0.54 )
    3.10 ( 0.54 )
        Social function - Week 24 (n=319, 322, 323)
    3.25 ( 0.53 )
    4.18 ( 0.52 )
    2.79 ( 0.52 )
        Social function - Week 52 (n=319, 322, 323)
    3.04 ( 0.53 )
    3.99 ( 0.52 )
    2.87 ( 0.52 )
        Vitality - Week 24 (n=319, 322, 323)
    3.43 ( 0.50 )
    4.41 ( 0.49 )
    2.99 ( 0.48 )
        Vitality - Week 52 (n=319, 322, 323)
    3.10 ( 0.51 )
    3.96 ( 0.50 )
    3.02 ( 0.49 )
        PCS - Week 24 (n=319, 322, 323)
    2.80 ( 0.43 )
    3.08 ( 0.43 )
    1.76 ( 0.42 )
        PCS - Week 52 (n=319, 322, 323)
    2.79 ( 0.44 )
    3.30 ( 0.43 )
    1.55 ( 0.43 )
        MCS - Week 24 (n=319, 322, 323)
    3.34 ( 0.56 )
    4.74 ( 0.55 )
    3.33 ( 0.55 )
        MCS - Week 52 (n=319, 322, 323)
    2.98 ( 0.57 )
    4.27 ( 0.56 )
    3.22 ( 0.56 )
    Notes
    [16] - All randomized participants with evaluable SF-36 domain and summary scores.
    [17] - All randomized participants with evaluable SF-36 domain and summary scores.
    [18] - All randomized participants with evaluable SF-36 domain and summary scores.
    No statistical analyses for this end point

    Secondary: Percentage of participants with DAS28-CRP Based European League Against Rheumatism (EULAR) response

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    End point title
    		 Percentage of participants with DAS28-CRP Based European League Against Rheumatism (EULAR) response
    End point description
    EULAR Responder index based on 28 joint counts categorizes clinical response based on improvement since baseline in DAS28-CRP. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. High disease activity: DAS28-CRP >5.1, low disease activity: DAS28-CRP <3.2, and remission: DAS28-CRP <2.6. Participants are categorized as EULAR responders or NR based on improvement of DAS28-CRP scores from baseline. EULAR DAS28-CRP responder index defines a good (absolute: <3.2 or >1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2 improvement from baseline), or no response (absolute: >5.1 or <0.6 improvement from baseline). Percentage of participants with DAS28-CRP based EULAR response =(number of participants with specific response) / (number of participants analyzed in the group) * 100.
    End point type
    Secondary
    End point timeframe
    Baseline through 24 weeks and 52 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    328 [19]
    327 [20]
    328 [21]
    Units: percentage of participants
    number (not applicable)
        Week 24- Good
    17.7
    16.2
    14.3
        Week 24 - Moderate
    41.5
    38.5
    30.8
        Week 24 - No Response
    40.9
    45.3
    54.9
        Week 52 - Good
    18.6
    14.7
    15.9
        Week 52 - Moderate
    37.5
    39.1
    29.0
        Week 52 - No Response
    43.9
    46.2
    55.2
    Notes
    [19] - All randomized participants with evaluable EULAR response data
    [20] - All randomized participants with evaluable EULAR response data
    [21] - All randomized participants with evaluable EULAR response data
    No statistical analyses for this end point

    Secondary: Change from baseline in Brief Fatigue Inventory (BFI) individual items and impact score

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    End point title
    		 Change from baseline in Brief Fatigue Inventory (BFI) individual items and impact score
    End point description
    The BFI is a brief participant-reported questionnaire for the rapid assessment of fatigue severity and the impact of fatigue on daily functioning in the past 24 hours. The BFI contains 10 items; however, Item 1 is not included in the scoring of the scale as it asks about usual fatigue over the past week with the participant answering 'yes' or 'no'. The remaining 9 items assess fatigue severity (3 items) and impact of fatigue on daily functioning (6 items) using an 11-point numeric scale, with 0=no fatigue and 10=fatigue as bad as you can imagine. The fatigue impact subscale score is the average of the non-missing responses to 6 items: general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. If more than 3 items within the fatigue impact subscale were not answered by a participant, the subscale is set to missing. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
    End point type
    Secondary
    End point timeframe
    Baseline, 24 weeks and 52 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    320 [22]
    322 [23]
    323 [24]
    Units: units on a scale
    least squares mean (standard error)
        Fatigue-Now - Week 24 (n=320, 322, 323)
    -0.86 ( 0.14 )
    -1.12 ( 0.13 )
    -0.61 ( 0.13 )
        Fatigue-Now - Week 52 (n=320, 322, 323)
    -0.79 ( 0.14 )
    -1.01 ( 0.13 )
    -0.56 ( 0.13 )
        Fatigue-Usual - Week 24 (n=320, 322, 323)
    -0.93 ( 0.13 )
    -1.06 ( 0.13 )
    -0.61 ( 0.13 )
        Fatigue-Usual - Week 52 (n=320, 322, 323)
    -0.91 ( 0.14 )
    -0.97 ( 0.13 )
    -0.66 ( 0.13 )
        Fatigue-Worst - Week 24 (n=320, 322, 323)
    -0.98 ( 0.14 )
    -1.22 ( 0.14 )
    -0.71 ( 0.14 )
        Fatigue-Worst - Week 52 (n=320, 322, 323)
    -1.22 ( 0.15 )
    -1.19 ( 0.14 )
    -0.81 ( 0.14 )
        General Activity - Week 24 (n=320, 322, 323)
    -0.93 ( 0.14 )
    -1.09 ( 0.13 )
    -0.61 ( 0.13 )
        General Activity - Week 52 (n=320, 322, 323
    -1.03 ( 0.14 )
    -1.07 ( 0.13 )
    -0.61 ( 0.13 )
        Mood - Week 24 (n=320, 322, 323)
    -0.67 ( 0.14 )
    -1.01 ( 0.14 )
    -0.47 ( 0.14 )
        Mood - Week 52 (n=320, 322, 323)
    -0.86 ( 0.14 )
    -0.82 ( 0.14 )
    -0.53 ( 0.14 )
        Walking Ability - Week 24 (n=320, 322, 323)
    -0.92 ( 0.15 )
    -1.02 ( 0.14 )
    -0.44 ( 0.14 )
        Walking Ability - Week 52 (n=320, 322, 323)
    -0.88 ( 0.14 )
    -0.98 ( 0.14 )
    -0.45 ( 0.14 )
        Normal Work - Week 24 (n=320, 322, 322)
    -0.78 ( 0.14 )
    -1.07 ( 0.14 )
    -0.48 ( 0.14 )
        Normal Work - Week 52 (n=320, 322, 323)
    -0.88 ( 0.14 )
    -1.00 ( 0.14 )
    -0.52 ( 0.14 )
        Relations with Other - Week 24 (n=320, 322, 322)
    -0.39 ( 0.14 )
    -0.64 ( 0.14 )
    -0.13 ( 0.14 )
        Relations with Other - Week 52 (n=320, 322, 323)
    -0.47 ( 0.14 )
    -0.46 ( 0.14 )
    -0.16 ( 0.14 )
        Enjoyment of Life - Week 24 (n=320, 322, 322)
    -0.58 ( 0.15 )
    -0.82 ( 0.15 )
    -0.36 ( 0.14 )
        Enjoyment of Life - Week 52 (n=320, 322, 323)
    -0.66 ( 0.15 )
    -0.74 ( 0.14 )
    -0.46 ( 0.14 )
        Fatigue Impact Subscale- Week 24(n=320, 322, 323)
    -0.71 ( 0.13 )
    -0.93 ( 0.13 )
    -0.42 ( 0.23 )
        Fatigue Impact Subscale- Week 52 (n=320, 322, 323)
    -0.80 ( 0.13 )
    -0.83 ( 0.13 )
    -0.46 ( 0.13 )
    Notes
    [22] - All randomized participants with evaluable BFI data.
    [23] - All randomized participants with evaluable BFI data.
    [24] - All randomized participants with evaluable BFI data.
    No statistical analyses for this end point

    Secondary: Change from baseline in Brief Pain Inventory Short Form (BPI-SF) individual items and interference scores

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    End point title
    		 Change from baseline in Brief Pain Inventory Short Form (BPI-SF) individual items and interference scores
    End point description
    The BPI-SF is a self-reported scale that measures the severity of pain based on the worst pain, least pain, average pain experienced during the past 24-hours and pain based on the pain right now with scores ranging from 0 (no pain) to 10 (pain as severe as you can imagine). Pain interference score is the average of the responses in past 24-hours to 7 items: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life [each item scored from 0 (does not interfere) to 10 (completely interferes)]. If more than 3 items of the Pain Interference Score are not answered by a participant, the score were set to missing. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
    End point type
    Secondary
    End point timeframe
    Baseline, 24 weeks and 52 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    320 [25]
    322 [26]
    323 [27]
    Units: units on a scale
    least squares mean (standard error)
        Pain- Worst- Week 24
    -1.1 ( 0.1 )
    -1.1 ( 0.1 )
    -0.7 ( 0.1 )
        Pain-Worst- Week 52
    -1.1 ( 0.1 )
    -1.3 ( 0.1 )
    -0.8 ( 0.1 )
        Pain-Least- Week 24
    -0.3 ( 0.1 )
    -0.6 ( 0.1 )
    -0.1 ( 0.1 )
        Pain-Least - Week 52
    -0.3 ( 0.1 )
    -0.6 ( 0.1 )
    -0.1 ( 0.1 )
        Pain-Average - Week 24
    -0.8 ( 0.1 )
    -0.9 ( 0.1 )
    -0.3 ( 0.1 )
        Pain-Average - Week 52
    -0.7 ( 0.1 )
    -1.0 ( 0.1 )
    -0.3 ( 0.1 )
        Pain-Now - Week 24
    -1.1 ( 0.1 )
    -1.2 ( 0.1 )
    -0.5 ( 0.1 )
        Pain-Now - Week 52
    -1.0 ( 0.1 )
    -1.3 ( 0.1 )
    -0.5 ( 0.1 )
        General Activity - Week 24
    -1.0 ( 0.1 )
    -1.0 ( 0.1 )
    -0.6 ( 0.1 )
        General Activity - Week 52
    -1.0 ( 0.1 )
    -1.3 ( 0.1 )
    -0.8 ( 0.1 )
        Mood - Week 24
    -0.9 ( 0.1 )
    -1.0 ( 0.1 )
    -0.6 ( 0.1 )
        Mood - Week 52
    -1.0 ( 0.1 )
    -1.1 ( 0.1 )
    -0.7 ( 0.1 )
        Walking Ability - Week 24
    -0.9 ( 0.1 )
    -1.2 ( 0.1 )
    -0.5 ( 0.1 )
        Walking Ability - Week 52
    -0.8 ( 0.1 )
    -1.1 ( 0.1 )
    -0.6 ( 0.1 )
        Relations with Other - Week 24
    -0.5 ( 0.1 )
    -0.6 ( 0.1 )
    -0.6 ( 0.1 )
        Relations with Other - Week 52
    -0.5 ( 0.1 )
    -0.5 ( 0.1 )
    -0.3 ( 0.1 )
        Sleep - Week 24
    -1.0 ( 0.1 )
    -1.1 ( 0.1 )
    -0.4 ( 0.1 )
        Sleep - Week 52
    -0.9 ( 0.1 )
    -0.6 ( 0.1 )
    -0.5 ( 0.1 )
        Enjoyment of Life - Week 24
    -0.8 ( 0.1 )
    -1.2 ( 0.1 )
    -0.5 ( 0.1 )
        Enjoyment of Life - Week 52
    -0.9 ( 0.1 )
    -1.1 ( 0.1 )
    -0.5 ( 0.1 )
        Pain Interference Score - Week 24
    -0.89 ( 0.12 )
    -1.02 ( 0.12 )
    -0.50 ( 0.12 )
        Pain Interference Score - Week 52
    -0.85 ( 0.12 )
    -1.00 ( 0.12 )
    -0.58 ( 0.12 )
    Notes
    [25] - All randomized participants with evaluable BPI-SF scores.
    [26] - All randomized participants with evaluable BPI-SF scores.
    [27] - All randomized participants with evaluable BPI-SF scores.
    No statistical analyses for this end point

    Secondary: Change from baseline in duration of morning stiffness (minutes)

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    End point title
    		 Change from baseline in duration of morning stiffness (minutes)
    End point description
    The Investigator asks participants about the duration of their morning stiffness (in minutes) in and around the joints and records the duration. The Investigator should ask the participants about duration of morning stiffness on the day prior to the study visit to capture actual symptoms. If morning stiffness duration is longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
    End point type
    Secondary
    End point timeframe
    Baseline, 24 weeks and 52 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    307 [28]
    319 [29]
    314 [30]
    Units: minutes
    least squares mean (standard error)
        Week 24 (n=306, 318, 313)
    -41.2 ( 5.0 )
    -32.0 ( 4.8 )
    -34.5 ( 4.9 )
        Week 52 (n= 307, 319, 314)
    -41.4 ( 5.2 )
    -31.2 ( 5.0 )
    -37.3 ( 5.1 )
    Notes
    [28] - All randomized participants with evaluable morning stiffness data.
    [29] - All randomized participants with evaluable morning stiffness data.
    [30] - All randomized participants with evaluable morning stiffness data.
    No statistical analyses for this end point

    Secondary: Percentage of participants with change from baseline in mTSS less than or equal to (≤) 0

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    End point title
    		 Percentage of participants with change from baseline in mTSS less than or equal to (≤) 0
    End point description
    The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range = 0 [normal] to 388 [maximal disease]). Percentage of participants = (number of participants with mTSS ≤0 at Week 24) / (total number of participants analyzed in the group) * 100.
    End point type
    Secondary
    End point timeframe
    Baseline through 24 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    295 [31]
    304 [32]
    306 [33]
    Units: percentage of participants
        number (not applicable)
    61.0
    61.8
    56.2
    Notes
    [31] - All randomized participants with evaluable mTSS data.
    [32] - All randomized participants with evaluable mTSS data.
    [33] - All randomized participants with evaluable mTSS data.
    No statistical analyses for this end point

    Secondary: Percentage of participants with Major Clinical Response (MCR) during 52 weeks

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    End point title
    		 Percentage of participants with Major Clinical Response (MCR) during 52 weeks
    End point description
    Zero participants were analyzed due to early termination of the study and statistical analysis plan (SAP) amendment.
    End point type
    Secondary
    End point timeframe
    Baseline through 52 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    0 [34]
    0 [35]
    0 [36]
    Units: Participants
        number (not applicable)
    Notes
    [34] - Zero participants were analyzed.
    [35] - Zero participants were analyzed.
    [36] - Zero participants were analyzed.
    No statistical analyses for this end point

    Secondary: Change from baseline to week 52 in B cell subset counts

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    End point title
    		 Change from baseline to week 52 in B cell subset counts
    End point description
    B cell subset counts are: cluster designation (CD)19+ B cell counts, Immature/transitional [CD19+immunoglobulin D (IgD)-CD27-], Mature naïve (CD19+IgD+CD27-), Non-switched memory (CD19+IgD+CD27+) and Memory (CD19+IgD-CD27+). A positive or negative change indicated an increase or decrease, respectively in B cell count. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
    End point type
    Secondary
    End point timeframe
    Baseline, 52 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    326 [37]
    333 [38]
    339 [39]
    Units: cells/microliter (cells/µL)
    least squares mean (standard error)
        CD19+ (n=326, 333, 339)
    -57.1 ( 4.9 )
    -60.9 ( 4.9 )
    0.7 ( 4.8 )
        CD19+IgD-CD27- (n=321, 330, 336)
    -3.1 ( 0.7 )
    -3.9 ( 0.07 )
    0.2 ( 0.7 )
        CD19+IgD+CD27- (n=321, 330, 336)
    -89.4 ( 3.3 )
    -92.4 ( 3.3 )
    -3.5 ( 3.2 )
        CD19+IgD+CD27+ (n=321, 330, 336)
    9.5 ( 1.0 )
    8.9 ( 1.0 )
    1.0 ( 1.0 )
        CD19+IgD-CD27+ (n=321, 330, 336)
    19.7 ( 1.9 )
    20.6 ( 1.8 )
    3.2 ( 1.8 )
    Notes
    [37] - All randomized participants with evaluable B cell subset counts data
    [38] - All randomized participants with evaluable B cell subset counts data
    [39] - All randomized participants with evaluable B cell subset counts data
    No statistical analyses for this end point

    Secondary: Population Pharmacokinetics (PK): Constant Clearance

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    End point title
    		 Population Pharmacokinetics (PK): Constant Clearance
    End point description
    Population estimate of constant clearance as determined by population PK analysis. A 2-compartment model was used in PK modeling. Constant clearance is the PK parameter which describes the linear elimination of LY2127399 from serum.
    End point type
    Secondary
    End point timeframe
    Baseline through 52 weeks
    End point values
    		 PK subset
    Number of subjects analysed
    825 [40]
    Units: milliliter per hour (mL/h)
        arithmetic mean (confidence interval 95%)
    3.60 (3.46 to 3.73)
    Notes
    [40] - All randomized participants who received at least 1 dose LY2127399 with evaluable PK data
    No statistical analyses for this end point

    Secondary: Percentage of participants developing anti-LY2127399 antibodies

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    End point title
    		 Percentage of participants developing anti-LY2127399 antibodies
    End point description
    Participants with treatment-emergent anti-drug antibodies (ADA) were participants who had any sample from baseline up to and through Week 24 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Percentage of participants with ADA=(number of participants with treatment-emergent ADA) / (number of participants assessed) * 100.
    End point type
    Secondary
    End point timeframe
    Baseline through 52 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    344 [41]
    344 [42]
    347 [43]
    Units: percentage of participants
        number (not applicable)
    3.8
    1.5
    4.9
    Notes
    [41] - All randomized participants who received 1 dose of study drug evaluable ADA baseline & postbaseline
    [42] - All randomized participants who received 1 dose of study drug evaluable ADA baseline & postbaseline
    [43] - All randomized participants who received 1 dose of study drug evaluable ADA baseline & postbaseline
    No statistical analyses for this end point

    Secondary: Percentage of participants with No structural progression at Week 52

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    End point title
    		 Percentage of participants with No structural progression at Week 52
    End point description
    No structural progression is defined as the change in mTSS from baseline ≤0. The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range=0 [normal] to 388 [maximal disease]). Percentage of participants=(number of participants with mTSS ≤0 at Week 52) / (total number of participants analyzed in the group) * 100.
    End point type
    Secondary
    End point timeframe
    Baseline through 52 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    295 [44]
    304 [45]
    306 [46]
    Units: percentage of participants
        number (not applicable)
    55.6
    57.6
    53.9
    Notes
    [44] - All randomized participants with evaluable mTSS data.
    [45] - All randomized participants with evaluable mTSS data.
    [46] - All randomized participants with evaluable mTSS data.
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 24 in mTSS

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    End point title
    		 Change from baseline to Week 24 in mTSS
    End point description
    The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range=0 [normal] to 388 [maximal disease]). LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
    End point type
    Secondary
    End point timeframe
    Baseline, 24 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    295 [47]
    304 [48]
    306 [49]
    Units: units on a scale
        least squares mean (standard error)
    0.63 ( 0.14 )
    0.45 ( 0.14 )
    0.82 ( 0.14 )
    Notes
    [47] - All randomized participants with evaluable mTSS data.
    [48] - All randomized participants with evaluable mTSS data.
    [49] - All randomized participants with evaluable mTSS data.
    No statistical analyses for this end point

    Secondary: Change from baseline in serum immunoglobulin (Ig) levels

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    End point title
    		 Change from baseline in serum immunoglobulin (Ig) levels
    End point description
    Immunoglobulins (Ig), or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin G (IgG), immunoglobulin A (IgA), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in Ig levels. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
    End point type
    Secondary
    End point timeframe
    Baseline, 52 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    342 [50]
    342 [51]
    347 [52]
    Units: grams/liter (g/L)
    least squares mean (standard error)
        IgA
    -0.380 ( 0.028 )
    -0.382 ( 0.028 )
    -0.009 ( 0.028 )
        IgG
    -1.375 ( 0.096 )
    -1.235 ( 0.097 )
    -0.176 ( 0.096 )
        IgM
    -0.235 ( 0.016 )
    -0.274 ( 0.016 )
    -0.032 ( 0.016 )
    Notes
    [50] - All randomized participants with evaluable serum Ig data.
    [51] - All randomized participants with evaluable serum Ig data.
    [52] - All randomized participants with evaluable serum Ig data.
    No statistical analyses for this end point

    Secondary: Change from baseline in joint space narrowing score and bone erosions score (components of mTSS)

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    End point title
    		 Change from baseline in joint space narrowing score and bone erosions score (components of mTSS)
    End point description
    The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range=0 to 220 for 44 joints) and narrowing scores (range=0 to 168 for 42 joints) were added to obtain the mTSS (range=0 [normal] to 388 [maximal disease]). LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
    End point type
    Secondary
    End point timeframe
    Baseline, 24 weeks and 52 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    295 [53]
    304 [54]
    306 [55]
    Units: units on a scale
    least squares mean (standard error)
        Joint Space Narrowing - Week 24
    0.22 ( 0.09 )
    0.19 ( 0.09 )
    0.34 ( 0.09 )
        Joint Space Narrowing - Week 52
    0.56 ( 0.16 )
    0.35 ( 0.16 )
    0.61 ( 0.16 )
        Bone Erosions - Week 24
    0.40 ( 0.09 )
    0.26 ( 0.08 )
    0.48 ( 0.08 )
        Bone Erosions - Week 52
    0.86 ( 0.17 )
    0.49 ( 0.17 )
    0.96 ( 0.17 )
    Notes
    [53] - All randomized participants with evaluable mTSS data.
    [54] - All randomized participants with evaluable mTSS data.
    [55] - All randomized participants with evaluable mTSS data.
    No statistical analyses for this end point

    Secondary: American College of Rheumatology Percent Improvement (ACR-N)

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    End point title
    		 American College of Rheumatology Percent Improvement (ACR-N)
    End point description
    ACR-N is a continuous measure of clinical, laboratory, and functional outcomes in RA that characterizes percentage (%) of improvement in disease activity from baseline based on ACR core set. This index was calculated as minimum of either a) % change in TJ count, b) % change in SJ count, or c) the median % change of remaining 5 ACR core criteria: If ≥3 components of the 5 ACR core criteria were missing, then c) was set to missing; if any of 3 components a), b), or c) were missing, then ACR-N was set to missing. Percentage of improvement was truncated to range of -100 to 100 to minimize impact of outliers (greater values indicate greater % improvement) and negative scores indicate a decline. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline DAS28-CRP as a covariate.
    End point type
    Secondary
    End point timeframe
    Baseline through 24 weeks and 52 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    329 [56]
    326 [57]
    327 [58]
    Units: percentage of improvement
    least squares mean (standard error)
        Week 24
    2.0 ( 2.5 )
    2.1 ( 2.5 )
    -6.9 ( 2.5 )
        Week 52
    2.9 ( 2.5 )
    0.3 ( 2.5 )
    -7.3 ( 2.5 )
    Notes
    [56] - All randomized participants with evaluable ACR-N data.
    [57] - All randomized participants with evaluable ACR-N data.
    [58] - All randomized participants with evaluable ACR-N data.
    No statistical analyses for this end point

    Secondary: Change from baseline in Tender Joint Count (68 joint count)

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    End point title
    		 Change from baseline in Tender Joint Count (68 joint count)
    End point description
    Tender joint count is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
    End point type
    Secondary
    End point timeframe
    Baseline, 24 weeks and 52 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    329 [59]
    329 [60]
    334 [61]
    Units: joint counts
    least squares mean (standard error)
        Week 24
    -7.41 ( 0.72 )
    -7.88 ( 0.72 )
    -6.40 ( 0.72 )
        Week 52
    -7.88 ( 0.73 )
    -8.09 ( 0.73 )
    -5.72 ( 0.73 )
    Notes
    [59] - All randomized participants with evaluable tender joint count data.
    [60] - All randomized participants with evaluable tender joint count data.
    [61] - All randomized participants with evaluable tender joint count data.
    No statistical analyses for this end point

    Secondary: Change from baseline in Swollen Joint Count (66 joint count)

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    End point title
    		 Change from baseline in Swollen Joint Count (66 joint count)
    End point description
    Swollen joint count is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
    End point type
    Secondary
    End point timeframe
    Baseline, 24 weeks and 52 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    329 [62]
    329 [63]
    334 [64]
    Units: joint counts
    least squares mean (standard error)
        Week 24
    -5.38 ( 0.49 )
    -5.64 ( 0.49 )
    -4.61 ( 0.49 )
        Week 52
    -6.10 ( 0.49 )
    -5.53 ( 0.49 )
    -4.67 ( 0.49 )
    Notes
    [62] - All randomized participants with evaluable swollen joint count data.
    [63] - All randomized participants with evaluable swollen joint count data.
    [64] - All randomized participants with evaluable swollen joint count data.
    No statistical analyses for this end point

    Secondary: Change from baseline in Participant's Assessment of Pain [Visual Analog Scale (VAS)]

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    End point title
    		 Change from baseline in Participant's Assessment of Pain [Visual Analog Scale (VAS)]
    End point description
    Participant's assessment of their current arthritis pain using VAS ranged from 0 millimeters (mm) (no pain) to 100 mm (worst possible pain). A decrease in pain score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
    End point type
    Secondary
    End point timeframe
    Baseline, 24 weeks and 52 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    329 [65]
    327 [66]
    328 [67]
    Units: mm
    least squares mean (standard error)
        Week 24
    -13.2 ( 1.2 )
    -14.6 ( 1.2 )
    -9.0 ( 1.2 )
        Week 52
    -13.6 ( 1.2 )
    -14.6 ( 1.2 )
    -8.7 ( 1.2 )
    Notes
    [65] - All randomized participants with evaluable participant's assessment of pain data.
    [66] - All randomized participants with evaluable participant's assessment of pain data.
    [67] - All randomized participants with evaluable participant's assessment of pain data.
    No statistical analyses for this end point

    Secondary: Change from baseline in Participant's Global Assessment of Disease Activity (VAS)

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    End point title
    		 Change from baseline in Participant's Global Assessment of Disease Activity (VAS)
    End point description
    Participant's assessment of their current arthritis disease activity using VAS ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
    End point type
    Secondary
    End point timeframe
    Baseline, 24 weeks and 52 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    329 [68]
    327 [69]
    328 [70]
    Units: mm
    least squares mean (standard error)
        Week 24
    -13.6 ( 1.2 )
    -14.6 ( 1.2 )
    -9.0 ( 1.2 )
        Week 52
    -13.2 ( 1.2 )
    -14.6 ( 1.2 )
    -8.7 ( 1.2 )
    Notes
    [68] - All randomized participants with evaluable participant's assessment of pain data.
    [69] - All randomized participants with evaluable participant's assessment of pain data.
    [70] - All randomized participants with evaluable participant's assessment of pain data.
    No statistical analyses for this end point

    Secondary: Change from baseline in Physician's Global Assessment of Disease Activity (VAS)

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    End point title
    		 Change from baseline in Physician's Global Assessment of Disease Activity (VAS)
    End point description
    Physician's assessment of the participant's current arthritis disease activity using VAS ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
    End point type
    Secondary
    End point timeframe
    Baseline, 24 weeks and 52 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    321 [71]
    315 [72]
    314 [73]
    Units: mm
    least squares mean (standard error)
        Week 24
    -20.7 ( 1.3 )
    -22.0 ( 1.3 )
    -17.2 ( 1.3 )
        Week 52
    -20.4 ( 1.3 )
    -20.6 ( 1.3 )
    -17.8 ( 1.3 )
    Notes
    [71] - All randomized participants with evaluable physician's global assessment of disease activity data.
    [72] - All randomized participants with evaluable physician's global assessment of disease activity data.
    [73] - All randomized participants with evaluable physician's global assessment of disease activity data.
    No statistical analyses for this end point

    Secondary: Change from baseline to Week 52 in HAQ-DI

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    End point title
    		 Change from baseline to Week 52 in HAQ-DI
    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 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
    End point type
    Secondary
    End point timeframe
    Baseline, 52 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    329 [74]
    327 [75]
    328 [76]
    Units: units on a scale
        least squares mean (standard error)
    -0.24 ( 0.03 )
    -0.30 ( 0.03 )
    -0.18 ( 0.03 )
    Notes
    [74] - All randomized participants with evaluable HAQ-DI data.
    [75] - All randomized participants with evaluable HAQ-DI data.
    [76] - All randomized participants with evaluable HAQ-DI data.
    No statistical analyses for this end point

    Secondary: Change from baseline to week 52 in absolute B cell counts

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    End point title
    		 Change from baseline to week 52 in absolute B cell counts
    End point description
    Cell-surface marker cluster designation (CD) 3 negative, CD20 positive (CD3-CD20+) defines total mature B cells. B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. A positive or negative change indicated an increase or decrease, respectively in B cell count. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
    End point type
    Secondary
    End point timeframe
    Baseline, 52 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    343 [77]
    344 [78]
    348 [79]
    Units: cells/microliter (cells/µL)
        least squares mean (standard error)
    -56.5 ( 4.5 )
    -58.6 ( 4.5 )
    -6.8 ( 4.5 )
    Notes
    [77] - All randomized participants with evaluable B cell subset counts data.
    [78] - All randomized participants with evaluable B cell subset counts data
    [79] - All randomized participants with evaluable B cell subset counts data
    No statistical analyses for this end point

    Secondary: Time to ACR20 response

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    End point title
    		 Time to ACR20 response
    End point description
    ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responder: had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. The Kaplan-Meier was used to estimate time to ACR20 response over the Treatment Period (52 weeks). Time to ACR20 response = (Date of the first post-baseline visit during the Treatment Period meeting ACR20 response criteria - Date of first injection of study treatment + 1) / 7. Week 16 NR are counted as responders if they responded prior to Week 16. Otherwise, they are censored at the date of the Week 16 injection. All participants ongoing at Week 52 and had not yet responded are censored at the date of the Week 52 visit.
    End point type
    Secondary
    End point timeframe
    Baseline through 52 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    327 [80]
    327 [81]
    329 [82]
    Units: weeks
        median (confidence interval 95%)
    16.1 (12.1 to 16.4)
    16.1 (12.3 to 20.0)
    20.1 (16.4 to 24.7)
    Notes
    [80] - All randomized participants with evaluable ACR20 responder data.
    [81] - All randomized participants with evaluable ACR20 responder data.
    [82] - All randomized participants with evaluable ACR20 responder data.
    No statistical analyses for this end point

    Secondary: Percentage of participants with ACR20 at Week 52

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    End point title
    		 Percentage of participants with ACR20 at Week 52
    End point description
    ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responder: had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of participants achieving ACR20 response=(number of ACR20 responders) /( number of participants treated) * 100. All NR at Week 16 as well as all participants who discontinued study treatment at any time for any reason were defined as NR starting at that time-point and going forward, including Week 52 endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline through 52 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    330 [83]
    332 [84]
    335 [85]
    Units: percentage of participants
        number (not applicable)
    7.9
    9.6
    10.7
    Notes
    [83] - All randomized participants with evaluable ACR20 responder data.
    [84] - All randomized participants with evaluable ACR20 responder data.
    [85] - All randomized participants with evaluable ACR20 responder data.
    No statistical analyses for this end point

    Secondary: Change from baseline in CRP

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    End point title
    		 Change from baseline in CRP
    End point description
    CRP is an indicator of inflammation. A negative change indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.
    End point type
    Secondary
    End point timeframe
    Baseline, 24 weeks and 52 weeks
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    329 [86]
    328 [87]
    334 [88]
    Units: milligrams/liter (mg/L)
    least squares mean (standard error)
        Week 24
    -3.30 ( 0.83 )
    -2.03 ( 0.84 )
    -0.54 ( 0.83 )
        Week 52
    -1.72 ( 0.96 )
    -2.04 ( 0.97 )
    -0.40 ( 0.96 )
    Notes
    [86] - All randomized participants with evaluable CRP data.
    [87] - All randomized participants with evaluable CRP data.
    [88] - All randomized participants with evaluable CRP data.
    No statistical analyses for this end point

    Other pre-specified: Number of participants who died during post-Treatment follow-Up period

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    End point title
    		 Number of participants who died during post-Treatment follow-Up period
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Discontinuation from study treatment up to 48 weeks during follow-up period
    End point values
    		 120 mg LY2127399 90 mg LY2127399 Placebo
    Number of subjects analysed
    293 [89]
    303 [90]
    307 [91]
    Units: participants
        number (not applicable)
    0
    1
    2
    Notes
    [89] - All randomized participants who received study drug and entered follow up period.
    [90] - All randomized participants who received study drug and entered follow up period.
    [91] - All randomized participants who received study drug and entered follow up period.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    H9B-MC-BCDM
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    LY 120 mg Q4W, Randomized Treatment Period 1
    Reporting group description
    		 -

    Reporting group title
    LY 90 mg Q2W, Randomized Treatment Period 1
    Reporting group description
    		 -

    Reporting group title
    Placebo, Randomized Treatment Period 1
    Reporting group description
    		 -

    Reporting group title
    LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Rescue Period
    Reporting group description
    		 -

    Reporting group title
    LY 90 mg Q2W, Rescue Period
    Reporting group description
    		 -

    Reporting group title
    Placebo to LY 90 mg Q2W (Week 16), Rescue Period
    Reporting group description
    		 -

    Reporting group title
    LY 120 mg Q4W, Treatment Period 2
    Reporting group description
    		 -

    Reporting group title
    LY 90 mg Q2W, Treatment Period 2
    Reporting group description
    		 -

    Reporting group title
    Placebo to LY 120 mg Q4W (Week 52), Treatment Period 2
    Reporting group description
    		 -

    Reporting group title
    Placebo to LY 90 mg Q2W (Week 52), Treatment Period 2
    Reporting group description
    		 -

    Reporting group title
    LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Treatment Period 2
    Reporting group description
    		 -

    Reporting group title
    Placebo to LY 90 mg Q2W (Week 16), Treatment Period 2
    Reporting group description
    		 -

    Reporting group title
    LY 120 mg Q4W, Follow-up Period
    Reporting group description
    		 -

    Reporting group title
    LY 90 mg Q2W, Follow-up Period
    Reporting group description
    		 -

    Reporting group title
    Placebo to LY 120 mg Q4W (Week 52), Follow-up Period
    Reporting group description
    		 -

    Reporting group title
    Placebo to LY 90 mg Q2W (Week 52), Follow-up Period
    Reporting group description
    		 -

    Reporting group title
    LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Follow-up Period
    Reporting group description
    		 -

    Reporting group title
    Placebo to LY 90 mg Q2W (Week 16), Follow-up Period
    Reporting group description
    		 -

    Reporting group title
    Placebo, Follow-up Period
    Reporting group description
    		 -

    Serious adverse events
    		 LY 120 mg Q4W, Randomized Treatment Period 1 LY 90 mg Q2W, Randomized Treatment Period 1 Placebo, Randomized Treatment Period 1 LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Rescue Period LY 90 mg Q2W, Rescue Period Placebo to LY 90 mg Q2W (Week 16), Rescue Period LY 120 mg Q4W, Treatment Period 2 LY 90 mg Q2W, Treatment Period 2 Placebo to LY 120 mg Q4W (Week 52), Treatment Period 2 Placebo to LY 90 mg Q2W (Week 52), Treatment Period 2 LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Treatment Period 2 Placebo to LY 90 mg Q2W (Week 16), Treatment Period 2 LY 120 mg Q4W, Follow-up Period LY 90 mg Q2W, Follow-up Period Placebo to LY 120 mg Q4W (Week 52), Follow-up Period Placebo to LY 90 mg Q2W (Week 52), Follow-up Period LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Follow-up Period Placebo to LY 90 mg Q2W (Week 16), Follow-up Period Placebo, Follow-up Period
    Total subjects affected by serious adverse events
         subjects affected / exposed
    19 / 345 (5.51%)
    17 / 345 (4.93%)
    17 / 348 (4.89%)
    3 / 58 (5.17%)
    3 / 62 (4.84%)
    2 / 90 (2.22%)
    1 / 57 (1.75%)
    1 / 73 (1.37%)
    2 / 27 (7.41%)
    1 / 31 (3.23%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    8 / 241 (3.32%)
    11 / 303 (3.63%)
    1 / 27 (3.70%)
    1 / 27 (3.70%)
    4 / 52 (7.69%)
    4 / 85 (4.71%)
    12 / 168 (7.14%)
         number of deaths (all causes)
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    1
         number of deaths resulting from adverse events
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    b-cell lymphoma stage i
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    basal cell carcinoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bladder transitional cell carcinoma stage iii
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    1 / 31 (3.23%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    breast cancer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    1 / 168 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cervix carcinoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [1]
    0 / 294 (0.00%)
    1 / 289 (0.35%)
    0 / 291 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intraductal proliferative breast lesion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    1 / 241 (0.41%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    metastatic gastric cancer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    1 / 241 (0.41%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ovarian cancer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [2]
    0 / 294 (0.00%)
    1 / 289 (0.35%)
    0 / 291 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    rectal adenocarcinoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    squamous cell carcinoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    1 / 168 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    uterine leiomyoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [3]
    1 / 294 (0.34%)
    0 / 289 (0.00%)
    0 / 291 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    deep vein thrombosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hypotension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    1 / 85 (1.18%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    peripheral ischaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    death
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    1 / 85 (1.18%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    device dislocation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    1 / 90 (1.11%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    non-cardiac chest pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    1 / 348 (0.29%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pyrexia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    1 / 241 (0.41%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    drug hypersensitivity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 345 (0.29%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    menorrhagia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [4]
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 211 (0.00%)
    1 / 255 (0.39%)
    0 / 22 (0.00%)
    0 / 24 (0.00%)
    0 / 40 (0.00%)
    0 / 66 (0.00%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    vaginal haemorrhage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [5]
    1 / 294 (0.34%)
    0 / 289 (0.00%)
    0 / 291 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    acute pulmonary oedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    1 / 168 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    chronic respiratory failure
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    1 / 348 (0.29%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    interstitial lung disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 345 (0.29%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    2 / 303 (0.66%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lung disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    1 / 168 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    nasal septum deviation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 345 (0.29%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    obliterative bronchiolitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pulmonary embolism
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    depression
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    1 / 348 (0.29%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    mental status changes
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    1 / 85 (1.18%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    stress
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    1 / 58 (1.72%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    suicide attempt
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    1 / 58 (1.72%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    femoral neck fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    1 / 241 (0.41%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    femur fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    1 / 345 (0.29%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    2 / 27 (7.41%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    foot fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    head injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 345 (0.29%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    joint dislocation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 345 (0.29%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    joint injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    1 / 62 (1.61%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    multiple injuries
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 345 (0.29%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pubis fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    1 / 348 (0.29%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    radius fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    1 / 348 (0.29%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    spinal compression fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 345 (0.29%)
    1 / 348 (0.29%)
    1 / 58 (1.72%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    synovial rupture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    tendon rupture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    2 / 345 (0.58%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    acute myocardial infarction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    1 / 168 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    arrhythmia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    atrial fibrillation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    1 / 168 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cardiac failure chronic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    1 / 348 (0.29%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cardiogenic shock
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    1 / 348 (0.29%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    congestive cardiomyopathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    1 / 168 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    coronary artery insufficiency
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    1 / 348 (0.29%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    myocardial infarction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 345 (0.00%)
    2 / 348 (0.57%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sick sinus syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    1 / 62 (1.61%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    cerebral atrophy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    1 / 85 (1.18%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cerebral small vessel ischaemic disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    1 / 85 (1.18%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cerebrovascular accident
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    1 / 85 (1.18%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    convulsion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    1 / 85 (1.18%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    encephalopathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    1 / 85 (1.18%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    headache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 345 (0.29%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hemiparesis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    1 / 85 (1.18%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lumbar radiculopathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    presyncope
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    radiculitis lumbosacral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 345 (0.29%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    syncope
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 345 (0.29%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    transient ischaemic attack
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    1 / 85 (1.18%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    iron deficiency anaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    1 / 73 (1.37%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pancytopenia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    1 / 241 (0.41%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    ulcerative keratitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    gastric haemorrhage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastric ulcer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    1 / 348 (0.29%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hiatus hernia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    mechanical ileus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    1 / 241 (0.41%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    nausea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 345 (0.29%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pancreatitis acute
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    1 / 345 (0.29%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pancreatitis chronic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 345 (0.29%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    vomiting
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 345 (0.29%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    cholecystitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    1 / 348 (0.29%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cholelithiasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    1 / 348 (0.29%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    calculus ureteric
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    1 / 58 (1.72%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    nephrolithiasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 345 (0.29%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    renal failure acute
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    1 / 85 (1.18%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    1 / 168 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    foot deformity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 345 (0.29%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    monarthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    1 / 348 (0.29%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    osteoarthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    1 / 345 (0.29%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    1 / 85 (1.18%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    rheumatoid arthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    1 / 345 (0.29%)
    4 / 348 (1.15%)
    1 / 58 (1.72%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    1 / 241 (0.41%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    3 / 168 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    1 / 4
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    spinal column stenosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    1 / 241 (0.41%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    spondylolisthesis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    1 / 348 (0.29%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    bronchitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cellulitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    1 / 57 (1.75%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    device related infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    0 / 85 (0.00%)
    1 / 168 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    diverticulitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    enteritis infectious
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastroenteritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    1 / 62 (1.61%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    1 / 168 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    herpes zoster
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 345 (0.58%)
    1 / 345 (0.29%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    infective tenosynovitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    1 / 168 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    influenza
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    1 / 241 (0.41%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    peritonitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    1 / 90 (1.11%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    1 / 85 (1.18%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    post procedural infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    1 / 85 (1.18%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pseudomembranous colitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    1 / 348 (0.29%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pyelonephritis acute
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    1 / 241 (0.41%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pyelonephritis chronic
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 345 (0.29%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sepsis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 345 (0.00%)
    1 / 348 (0.29%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    urinary tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    diabetes mellitus inadequate control
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been 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: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been 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: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been 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: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been 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: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 LY 120 mg Q4W, Randomized Treatment Period 1 LY 90 mg Q2W, Randomized Treatment Period 1 Placebo, Randomized Treatment Period 1 LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Rescue Period LY 90 mg Q2W, Rescue Period Placebo to LY 90 mg Q2W (Week 16), Rescue Period LY 120 mg Q4W, Treatment Period 2 LY 90 mg Q2W, Treatment Period 2 Placebo to LY 120 mg Q4W (Week 52), Treatment Period 2 Placebo to LY 90 mg Q2W (Week 52), Treatment Period 2 LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Treatment Period 2 Placebo to LY 90 mg Q2W (Week 16), Treatment Period 2 LY 120 mg Q4W, Follow-up Period LY 90 mg Q2W, Follow-up Period Placebo to LY 120 mg Q4W (Week 52), Follow-up Period Placebo to LY 90 mg Q2W (Week 52), Follow-up Period LY 120 mg Q4W to LY 90 mg Q2W (Week 16), Follow-up Period Placebo to LY 90 mg Q2W (Week 16), Follow-up Period Placebo, Follow-up Period
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    137 / 345 (39.71%)
    117 / 345 (33.91%)
    129 / 348 (37.07%)
    22 / 58 (37.93%)
    25 / 62 (40.32%)
    20 / 90 (22.22%)
    22 / 57 (38.60%)
    20 / 73 (27.40%)
    7 / 27 (25.93%)
    4 / 31 (12.90%)
    7 / 13 (53.85%)
    9 / 22 (40.91%)
    43 / 241 (17.84%)
    39 / 303 (12.87%)
    6 / 27 (22.22%)
    9 / 27 (33.33%)
    10 / 52 (19.23%)
    10 / 85 (11.76%)
    26 / 168 (15.48%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    neuroma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    1 / 90 (1.11%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    ovarian germ cell teratoma benign
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [6]
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 211 (0.00%)
    0 / 255 (0.00%)
    0 / 22 (0.00%)
    1 / 24 (4.17%)
    0 / 40 (0.00%)
    0 / 66 (0.00%)
    0 / 146 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    uterine leiomyoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [7]
    1 / 294 (0.34%)
    1 / 289 (0.35%)
    0 / 291 (0.00%)
    1 / 44 (2.27%)
    0 / 57 (0.00%)
    0 / 69 (0.00%)
    1 / 51 (1.96%)
    1 / 62 (1.61%)
    0 / 22 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
    0 / 19 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Vascular disorders
    haematoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    2 / 57 (3.51%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hypertension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    12 / 345 (3.48%)
    3 / 345 (0.87%)
    7 / 348 (2.01%)
    2 / 58 (3.45%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    2 / 57 (3.51%)
    2 / 73 (2.74%)
    1 / 27 (3.70%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    1 / 241 (0.41%)
    2 / 303 (0.66%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    1 / 168 (0.60%)
         occurrences all number
    13
    3
    7
    2
    0
    0
    2
    2
    1
    0
    0
    0
    1
    2
    0
    1
    0
    0
    1
    hypotension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    2 / 345 (0.58%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    1 / 27 (3.70%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    injection site erythema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 345 (1.16%)
    4 / 345 (1.16%)
    1 / 348 (0.29%)
    0 / 58 (0.00%)
    2 / 62 (3.23%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    5
    5
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    malaise
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 345 (0.00%)
    2 / 348 (0.57%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    oedema peripheral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 345 (0.87%)
    1 / 345 (0.29%)
    3 / 348 (0.86%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    1 / 85 (1.18%)
    1 / 168 (0.60%)
         occurrences all number
    3
    1
    3
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    pyrexia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 345 (0.87%)
    3 / 345 (0.87%)
    1 / 348 (0.29%)
    1 / 58 (1.72%)
    0 / 62 (0.00%)
    1 / 90 (1.11%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    2 / 303 (0.66%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    3
    3
    1
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    3
    0
    1
    0
    0
    0
    Reproductive system and breast disorders
    benign prostatic hyperplasia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [8]
    0 / 51 (0.00%)
    1 / 56 (1.79%)
    0 / 57 (0.00%)
    0 / 14 (0.00%)
    1 / 5 (20.00%)
    0 / 21 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 30 (0.00%)
    1 / 48 (2.08%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 12 (0.00%)
    0 / 19 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    metrorrhagia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [9]
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    1 / 44 (2.27%)
    0 / 57 (0.00%)
    0 / 69 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    uterine prolapse
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [10]
    1 / 294 (0.34%)
    0 / 289 (0.00%)
    0 / 291 (0.00%)
    1 / 44 (2.27%)
    0 / 57 (0.00%)
    0 / 69 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    asthma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    cough
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 345 (2.03%)
    3 / 345 (0.87%)
    5 / 348 (1.44%)
    1 / 58 (1.72%)
    0 / 62 (0.00%)
    2 / 90 (2.22%)
    1 / 57 (1.75%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    3 / 241 (1.24%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    1 / 85 (1.18%)
    0 / 168 (0.00%)
         occurrences all number
    8
    3
    5
    1
    0
    2
    1
    0
    0
    0
    0
    0
    3
    0
    0
    0
    0
    1
    0
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 345 (0.87%)
    1 / 345 (0.29%)
    1 / 348 (0.29%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    1 / 90 (1.11%)
    0 / 57 (0.00%)
    2 / 73 (2.74%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    1 / 241 (0.41%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    1 / 168 (0.60%)
         occurrences all number
    3
    1
    1
    0
    0
    1
    0
    2
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    1
    depression
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 345 (0.58%)
    1 / 345 (0.29%)
    1 / 348 (0.29%)
    0 / 58 (0.00%)
    2 / 62 (3.23%)
    1 / 90 (1.11%)
    0 / 57 (0.00%)
    3 / 73 (4.11%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    0 / 241 (0.00%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    2
    1
    1
    0
    2
    1
    0
    3
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    insomnia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 345 (2.03%)
    3 / 345 (0.87%)
    3 / 348 (0.86%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    1 / 90 (1.11%)
    2 / 57 (3.51%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    7
    3
    3
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 345 (1.16%)
    2 / 345 (0.58%)
    6 / 348 (1.72%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    1 / 241 (0.41%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    4
    2
    6
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    1
    0
    0
    0
    0
    0
    blood alkaline phosphatase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    1 / 348 (0.29%)
    1 / 58 (1.72%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    blood glucose increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 345 (0.58%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    1 / 58 (1.72%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    1 / 13 (7.69%)
    0 / 22 (0.00%)
    1 / 241 (0.41%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    2
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    blood potassium decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    1 / 73 (1.37%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    gamma-glutamyltransferase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    2 / 345 (0.58%)
    1 / 348 (0.29%)
    2 / 58 (3.45%)
    1 / 62 (1.61%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    1 / 31 (3.23%)
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    0 / 241 (0.00%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    0
    2
    1
    2
    1
    0
    0
    0
    0
    1
    0
    1
    0
    1
    0
    0
    0
    0
    0
    haemoglobin decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 345 (0.58%)
    0 / 345 (0.00%)
    1 / 348 (0.29%)
    1 / 58 (1.72%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    1 / 13 (7.69%)
    0 / 22 (0.00%)
    1 / 241 (0.41%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    2
    0
    1
    1
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    liver function test abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    1 / 58 (1.72%)
    1 / 62 (1.61%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    1 / 13 (7.69%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    1
    0
    0
    1
    1
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    1
    0
    0
    white blood cell count decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 345 (0.29%)
    1 / 348 (0.29%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    1 / 73 (1.37%)
    1 / 27 (3.70%)
    0 / 31 (0.00%)
    1 / 13 (7.69%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    1
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    contusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 345 (0.87%)
    1 / 345 (0.29%)
    4 / 348 (1.15%)
    0 / 58 (0.00%)
    1 / 62 (1.61%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    2 / 73 (2.74%)
    0 / 27 (0.00%)
    1 / 31 (3.23%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    1 / 168 (0.60%)
         occurrences all number
    3
    1
    4
    0
    1
    0
    0
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    ligament sprain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 345 (0.58%)
    1 / 345 (0.29%)
    2 / 348 (0.57%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    2 / 57 (3.51%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    1 / 241 (0.41%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    2
    1
    2
    0
    0
    0
    2
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    muscle strain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    1 / 90 (1.11%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    radius fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    tendon injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    1 / 58 (1.72%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    1 / 13 (7.69%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Cardiac disorders
    tachycardia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 345 (0.58%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    1 / 90 (1.11%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Nervous system disorders
    carpal tunnel syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 345 (0.58%)
    0 / 345 (0.00%)
    2 / 348 (0.57%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    1 / 90 (1.11%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    2
    0
    3
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    dizziness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 345 (1.16%)
    6 / 345 (1.74%)
    5 / 348 (1.44%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    2 / 57 (3.51%)
    1 / 73 (1.37%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    1 / 85 (1.18%)
    0 / 168 (0.00%)
         occurrences all number
    4
    6
    5
    0
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    headache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 345 (2.03%)
    6 / 345 (1.74%)
    3 / 348 (0.86%)
    1 / 58 (1.72%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    1 / 73 (1.37%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    2 / 241 (0.83%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    2 / 85 (2.35%)
    1 / 168 (0.60%)
         occurrences all number
    10
    6
    3
    1
    0
    0
    0
    1
    0
    0
    0
    0
    2
    1
    0
    0
    0
    2
    1
    hypoaesthesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    2 / 348 (0.57%)
    1 / 58 (1.72%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    1 / 73 (1.37%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    1 / 13 (7.69%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    0
    0
    2
    1
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    migraine
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    2 / 345 (0.58%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    1 / 62 (1.61%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    2 / 73 (2.74%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    1
    2
    0
    0
    1
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    paraesthesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 345 (0.00%)
    1 / 348 (0.29%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    1 / 57 (1.75%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    8 / 345 (2.32%)
    6 / 345 (1.74%)
    11 / 348 (3.16%)
    1 / 58 (1.72%)
    0 / 62 (0.00%)
    5 / 90 (5.56%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    1 / 27 (3.70%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    1 / 241 (0.41%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    8
    6
    11
    1
    0
    5
    0
    0
    1
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    leukocytosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    1 / 58 (1.72%)
    1 / 62 (1.61%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    1 / 27 (3.70%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    1
    0
    0
    1
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    lymphopenia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 345 (1.45%)
    1 / 345 (0.29%)
    2 / 348 (0.57%)
    1 / 58 (1.72%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    2 / 241 (0.83%)
    1 / 303 (0.33%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    6
    2
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    1
    0
    0
    0
    0
    Eye disorders
    cataract
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 345 (0.58%)
    2 / 345 (0.58%)
    1 / 348 (0.29%)
    0 / 58 (0.00%)
    2 / 62 (3.23%)
    0 / 90 (0.00%)
    1 / 57 (1.75%)
    3 / 73 (4.11%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    1 / 241 (0.41%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    1 / 168 (0.60%)
         occurrences all number
    2
    2
    1
    0
    3
    0
    1
    3
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    abdominal pain upper
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 345 (0.58%)
    2 / 345 (0.58%)
    1 / 348 (0.29%)
    1 / 58 (1.72%)
    0 / 62 (0.00%)
    1 / 90 (1.11%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    2 / 52 (3.85%)
    0 / 85 (0.00%)
    1 / 168 (0.60%)
         occurrences all number
    2
    2
    1
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    2
    0
    1
    constipation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 345 (1.16%)
    3 / 345 (0.87%)
    6 / 348 (1.72%)
    0 / 58 (0.00%)
    1 / 62 (1.61%)
    0 / 90 (0.00%)
    3 / 57 (5.26%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    1 / 31 (3.23%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    3 / 241 (1.24%)
    2 / 303 (0.66%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    4
    3
    6
    0
    1
    0
    3
    0
    0
    1
    0
    0
    3
    2
    0
    0
    0
    0
    0
    diarrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 345 (2.03%)
    9 / 345 (2.61%)
    5 / 348 (1.44%)
    1 / 58 (1.72%)
    1 / 62 (1.61%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    3 / 241 (1.24%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    1 / 168 (0.60%)
         occurrences all number
    7
    9
    6
    1
    1
    0
    0
    0
    0
    0
    0
    0
    3
    1
    0
    0
    0
    0
    1
    dyspepsia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 345 (0.87%)
    1 / 345 (0.29%)
    2 / 348 (0.57%)
    2 / 58 (3.45%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    1 / 85 (1.18%)
    0 / 168 (0.00%)
         occurrences all number
    3
    1
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 345 (0.58%)
    1 / 345 (0.29%)
    5 / 348 (1.44%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    1 / 57 (1.75%)
    0 / 73 (0.00%)
    1 / 27 (3.70%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    2 / 241 (0.83%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    1 / 168 (0.60%)
         occurrences all number
    2
    1
    5
    0
    0
    0
    1
    0
    1
    0
    0
    0
    2
    1
    0
    0
    0
    0
    1
    nausea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 345 (2.03%)
    7 / 345 (2.03%)
    3 / 348 (0.86%)
    2 / 58 (3.45%)
    1 / 62 (1.61%)
    1 / 90 (1.11%)
    1 / 57 (1.75%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    1 / 241 (0.41%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    0 / 85 (0.00%)
    3 / 168 (1.79%)
         occurrences all number
    7
    11
    3
    2
    1
    1
    1
    0
    0
    0
    0
    1
    1
    1
    0
    0
    1
    0
    3
    stomatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 345 (0.87%)
    0 / 345 (0.00%)
    1 / 348 (0.29%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    1 / 27 (3.70%)
    1 / 31 (3.23%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    1 / 241 (0.41%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    1 / 168 (0.60%)
         occurrences all number
    4
    0
    1
    0
    0
    0
    0
    0
    1
    1
    0
    0
    1
    0
    0
    0
    0
    0
    1
    Hepatobiliary disorders
    hepatic function abnormal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 345 (0.87%)
    1 / 345 (0.29%)
    2 / 348 (0.57%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    3
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    alopecia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    3 / 345 (0.87%)
    1 / 348 (0.29%)
    0 / 58 (0.00%)
    1 / 62 (1.61%)
    0 / 90 (0.00%)
    1 / 57 (1.75%)
    2 / 73 (2.74%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    1
    3
    1
    0
    1
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    rash
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 345 (1.74%)
    3 / 345 (0.87%)
    5 / 348 (1.44%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    2 / 57 (3.51%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    1 / 241 (0.41%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    6
    3
    6
    0
    0
    0
    2
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Renal and urinary disorders
    pollakiuria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    1 / 58 (1.72%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    1 / 241 (0.41%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    1 / 168 (0.60%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    1
    0
    0
    1
    stress urinary incontinence
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 345 (1.74%)
    9 / 345 (2.61%)
    7 / 348 (2.01%)
    2 / 58 (3.45%)
    0 / 62 (0.00%)
    1 / 90 (1.11%)
    1 / 57 (1.75%)
    2 / 73 (2.74%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    2 / 241 (0.83%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    1 / 85 (1.18%)
    0 / 168 (0.00%)
         occurrences all number
    9
    10
    7
    8
    0
    1
    1
    2
    0
    0
    0
    1
    2
    0
    0
    0
    0
    1
    0
    back pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    10 / 345 (2.90%)
    6 / 345 (1.74%)
    5 / 348 (1.44%)
    1 / 58 (1.72%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    2 / 57 (3.51%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    1 / 241 (0.41%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    2 / 52 (3.85%)
    1 / 85 (1.18%)
    0 / 168 (0.00%)
         occurrences all number
    10
    6
    5
    1
    0
    0
    2
    0
    0
    0
    0
    0
    1
    0
    0
    0
    2
    1
    0
    bunion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    1 / 348 (0.29%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    1 / 85 (1.18%)
    0 / 168 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
    foot deformity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    1 / 345 (0.29%)
    1 / 348 (0.29%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    1 / 57 (1.75%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    osteoarthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 345 (0.87%)
    0 / 345 (0.00%)
    1 / 348 (0.29%)
    2 / 58 (3.45%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    3
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    pain in extremity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 345 (1.16%)
    1 / 345 (0.29%)
    3 / 348 (0.86%)
    2 / 58 (3.45%)
    1 / 62 (1.61%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    1 / 73 (1.37%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    5
    1
    3
    3
    1
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    rheumatoid arthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    12 / 345 (3.48%)
    19 / 345 (5.51%)
    15 / 348 (4.31%)
    3 / 58 (5.17%)
    5 / 62 (8.06%)
    0 / 90 (0.00%)
    5 / 57 (8.77%)
    3 / 73 (4.11%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    2 / 13 (15.38%)
    0 / 22 (0.00%)
    5 / 241 (2.07%)
    4 / 303 (1.32%)
    0 / 27 (0.00%)
    2 / 27 (7.41%)
    1 / 52 (1.92%)
    0 / 85 (0.00%)
    3 / 168 (1.79%)
         occurrences all number
    14
    20
    18
    3
    5
    0
    5
    3
    0
    0
    2
    0
    5
    4
    0
    2
    1
    0
    3
    tenosynovitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    1 / 345 (0.29%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Infections and infestations
    bronchitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    8 / 345 (2.32%)
    8 / 345 (2.32%)
    11 / 348 (3.16%)
    1 / 58 (1.72%)
    3 / 62 (4.84%)
    1 / 90 (1.11%)
    1 / 57 (1.75%)
    1 / 73 (1.37%)
    1 / 27 (3.70%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    1 / 241 (0.41%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    1 / 168 (0.60%)
         occurrences all number
    8
    8
    11
    1
    3
    1
    1
    1
    1
    0
    0
    0
    1
    1
    0
    0
    0
    0
    1
    candidiasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    1 / 27 (3.70%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    cellulitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    1 / 345 (0.29%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    1 / 90 (1.11%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    1 / 27 (3.70%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    0 / 241 (0.00%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    1
    0
    0
    1
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    cystitis bacterial
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    1 / 27 (3.70%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    herpes zoster
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    2 / 345 (0.58%)
    2 / 348 (0.57%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    1 / 90 (1.11%)
    2 / 57 (3.51%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    2 / 241 (0.83%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    1
    2
    2
    0
    0
    1
    2
    0
    0
    0
    0
    1
    2
    1
    0
    0
    0
    0
    0
    influenza
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    2 / 345 (0.58%)
    8 / 348 (2.30%)
    0 / 58 (0.00%)
    1 / 62 (1.61%)
    1 / 90 (1.11%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    1 / 241 (0.41%)
    2 / 303 (0.66%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    2 / 168 (1.19%)
         occurrences all number
    1
    2
    8
    0
    1
    1
    0
    0
    0
    0
    0
    0
    1
    2
    1
    0
    0
    0
    2
    nasopharyngitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    20 / 345 (5.80%)
    15 / 345 (4.35%)
    25 / 348 (7.18%)
    2 / 58 (3.45%)
    3 / 62 (4.84%)
    2 / 90 (2.22%)
    1 / 57 (1.75%)
    3 / 73 (4.11%)
    1 / 27 (3.70%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    7 / 241 (2.90%)
    7 / 303 (2.31%)
    0 / 27 (0.00%)
    3 / 27 (11.11%)
    1 / 52 (1.92%)
    0 / 85 (0.00%)
    5 / 168 (2.98%)
         occurrences all number
    25
    22
    34
    2
    4
    2
    1
    3
    1
    0
    0
    0
    8
    9
    0
    3
    1
    0
    5
    onychomycosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    1 / 13 (7.69%)
    0 / 22 (0.00%)
    1 / 241 (0.41%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    pharyngitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 345 (2.03%)
    4 / 345 (1.16%)
    5 / 348 (1.44%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    1 / 90 (1.11%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    7
    4
    5
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    pulpitis dental
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    1 / 27 (3.70%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    18 / 345 (5.22%)
    20 / 345 (5.80%)
    18 / 348 (5.17%)
    0 / 58 (0.00%)
    1 / 62 (1.61%)
    2 / 90 (2.22%)
    1 / 57 (1.75%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    4 / 241 (1.66%)
    4 / 303 (1.32%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    2 / 85 (2.35%)
    5 / 168 (2.98%)
         occurrences all number
    21
    21
    20
    0
    1
    2
    1
    0
    0
    0
    0
    1
    4
    5
    0
    0
    0
    2
    5
    upper respiratory tract infection bacterial
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    1 / 348 (0.29%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    urinary tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    10 / 345 (2.90%)
    6 / 345 (1.74%)
    5 / 348 (1.44%)
    1 / 58 (1.72%)
    1 / 62 (1.61%)
    1 / 90 (1.11%)
    1 / 57 (1.75%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    1 / 31 (3.23%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    2 / 241 (0.83%)
    3 / 303 (0.99%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    1 / 85 (1.18%)
    2 / 168 (1.19%)
         occurrences all number
    12
    8
    6
    1
    1
    1
    1
    0
    0
    1
    0
    0
    2
    3
    0
    0
    0
    1
    2
    viral infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    2 / 348 (0.57%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    1 / 27 (3.70%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    vulvovaginitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [11]
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    1 / 44 (2.27%)
    0 / 57 (0.00%)
    0 / 69 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    diabetes mellitus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    1 / 345 (0.29%)
    1 / 348 (0.29%)
    1 / 58 (1.72%)
    1 / 62 (1.61%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    1 / 27 (3.70%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    1
    1
    1
    1
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    hypercholesterolaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    0 / 345 (0.00%)
    1 / 348 (0.29%)
    0 / 58 (0.00%)
    1 / 62 (1.61%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    1 / 27 (3.70%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    1 / 168 (0.60%)
         occurrences all number
    1
    0
    1
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    hyperglycaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 345 (0.29%)
    1 / 345 (0.29%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    1 / 27 (3.70%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hyperlipidaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    1 / 58 (1.72%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    1 / 13 (7.69%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    1 / 303 (0.33%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    1 / 52 (1.92%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    1
    0
    0
    hypoalbuminaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    2 / 58 (3.45%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hyponatraemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    0 / 345 (0.00%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    0 / 62 (0.00%)
    0 / 90 (0.00%)
    0 / 57 (0.00%)
    0 / 73 (0.00%)
    1 / 27 (3.70%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    type 2 diabetes mellitus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 345 (1.16%)
    0 / 345 (0.00%)
    0 / 348 (0.00%)
    0 / 58 (0.00%)
    1 / 62 (1.61%)
    1 / 90 (1.11%)
    0 / 57 (0.00%)
    1 / 73 (1.37%)
    0 / 27 (0.00%)
    0 / 31 (0.00%)
    0 / 13 (0.00%)
    2 / 22 (9.09%)
    0 / 241 (0.00%)
    0 / 303 (0.00%)
    0 / 27 (0.00%)
    0 / 27 (0.00%)
    0 / 52 (0.00%)
    0 / 85 (0.00%)
    0 / 168 (0.00%)
         occurrences all number
    4
    0
    0
    0
    2
    1
    0
    2
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Notes
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    This study has been terminated not based on safety concerns, but due to insufficient efficacy. Early termination led to lower than expected enrollment and was responsible for the large number of discontinuation reason as Sponsor Decision.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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