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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs)

    Summary
    EudraCT number
    		 2020-005303-39
    Trial protocol
    		 ES   DE   SK   NL   CZ   PL   GR   IT  
    Global end of trial date
    04 Aug 2023

    Results information
    Results version number
    		 v2(current)
    This version publication date
    08 Nov 2024
    First version publication date
    11 Aug 2024
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Clarifying edits to unit of measure for outcome measure 10

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    M20-466
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04888585
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6 4UB
    Public contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Aug 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Aug 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. This study aimed to evaluate how safe and effective ABBV-154 is in subjects treated for moderately to severely active RA. Adverse events and change in the disease activity were assessed. ABBV-154 is an investigational drug being evaluated for the treatment of RA. Approximately 425 subjects 18-75 years of age with moderate to severe RA were enrolled in the study at approximately 270 sites worldwide. Subjects attended regular visits during the study at a hospital or clinic. The effect of the treatment was checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.
    Protection of trial subjects
    Subjects read and understood the information provided about the study and gave written permission.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Jun 2021
    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
    Canada: 4
    Country: Number of subjects enrolled
    Germany: 15
    Country: Number of subjects enrolled
    Greece: 3
    Country: Number of subjects enrolled
    Hungary: 42
    Country: Number of subjects enrolled
    Israel: 12
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Japan: 66
    Country: Number of subjects enrolled
    Poland: 22
    Country: Number of subjects enrolled
    Puerto Rico: 8
    Country: Number of subjects enrolled
    Russian Federation: 6
    Country: Number of subjects enrolled
    Slovakia: 13
    Country: Number of subjects enrolled
    Spain: 19
    Country: Number of subjects enrolled
    Taiwan: 1
    Country: Number of subjects enrolled
    United States: 232
    Country: Number of subjects enrolled
    Czechia: 25
    Worldwide total number of subjects
    473
    EEA total number of subjects
    144
    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)
    337
    From 65 to 84 years
    136
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 473 participants (All Randomized Population) were enrolled in the study. The ITT Population (N=472) included all participants who were randomized and received at least 1 dose of study drug. One randomized participant was not treated and thus not included in the ITT Population.

    Pre-assignment
    Screening details
    		 After a 12 week placebo-controlled period, subjects in the Placebo group were re-randomized to ABBV-154 at 2 different doses SC every other week, while others remained on their previous dose. There was a planned double-blind long term extension (LTE) of 66 weeks and a LTE 2 of 104 weeks. The study was terminated before any subjects entered LTE 2.

    Period 1
    Period 1 title
    Placebo-Controlled Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Subjects were randomized to 5 treatment groups in a 1:1:1:1:1 ratio to receive blinded ABBV-154 at a dose of 40 mg, 150 mg, or 340 mg, subcutaneously (SC) every other week (EOW); 340 mg SC E4W; or placebo SC EOW for 12 weeks.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Period 1 (Placebo-Controlled Period) Placebo
    Arm description
    		 Subjects in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection

    Arm title
    		 Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
    Arm description
    		 Subjects in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ABBV-154
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous Injection

    Arm title
    		 Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
    Arm description
    		 Subjects in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period. One randomized subject in this arm was ineligible and did not receive treatment. This subject was not included in the ITT population.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ABBV-154
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous Injection

    Arm title
    		 Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
    Arm description
    		 Subjects in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ABBV-154
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous Injection

    Arm title
    		 Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
    Arm description
    		 Subjects in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ABBV-154
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous Injection

    Number of subjects in period 1 [1]
    		Period 1 (Placebo-Controlled Period) Placebo Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
    Started
    96
    98
    94
    90
    94
    Completed
    92
    93
    86
    85
    89
    Not completed
    4
    5
    8
    5
    5
         Consent withdrawn by subject
    -
    1
    4
    3
    3
         Other
    4
    4
    3
    2
    1
         Lost to follow-up
    -
    -
    1
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: One randomized subject was ineligible and did not receive treatment. This subject was was not included in the ITT population.
    Period 2
    Period 2 title
    Long-Term Extension Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Period 2 (Extension Period) Placebo to ABBV-154 150 mg EOW
    Arm description
    		 Subjects in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized in 1:1 ratio to receive ABBV-154 150 mg or 340 mg respectively SC EOW for 66 weeks in the long term extension (LTE) period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ABBV-154
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous Injection

    Arm title
    		 Period 2 (Extension Period) Placebo to ABBV-154 340 mg EOW
    Arm description
    		 Subjects in this group received placebo SC EOW for 12 weeks in the placebo-controlled period and were re-randomized in 1:1 ratio to receive ABBV-154 150 mg or 340 mg respectively SC EOW for 66 weeks in the LTE period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ABBV-154
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous Injection

    Arm title
    		 Period 2 (Extension Period) ABBV-154 40 mg EOW
    Arm description
    		 Subjects in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ABBV-154
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous Injection

    Arm title
    		 Period 2 (Extension Period) ABBV-154 150 mg EOW
    Arm description
    		 Subjects in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ABBV-154
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous Injection

    Arm title
    		 Period 2 (Extension Period) ABBV-154 340 mg EOW
    Arm description
    		 Subjects in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ABBV-154
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous Injection

    Arm title
    		 Period 2 (Extension Period) ABBV-154 340 mg E4W
    Arm description
    		 Subjects in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ABBV-154
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous Injection

    Number of subjects in period 2 [2]
    		Period 2 (Extension Period) Placebo to ABBV-154 150 mg EOW Period 2 (Extension Period) Placebo to ABBV-154 340 mg EOW Period 2 (Extension Period) ABBV-154 40 mg EOW Period 2 (Extension Period) ABBV-154 150 mg EOW Period 2 (Extension Period) ABBV-154 340 mg EOW Period 2 (Extension Period) ABBV-154 340 mg E4W
    Started
    45
    46
    93
    86
    85
    89
    Completed
    0
    0
    0
    0
    0
    0
    Not completed
    45
    46
    93
    86
    85
    89
         Consent withdrawn by subject
    5
    5
    8
    8
    8
    11
         Other
    3
    1
    4
    5
    5
    3
         Death
    -
    -
    1
    -
    -
    3
         Study terminated by sponsor
    37
    36
    78
    71
    71
    72
         Lost to follow-up
    -
    4
    2
    2
    1
    -
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: One subject from Period 1 Placebo group did not enter Period 2.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Period 1 (Placebo-Controlled Period) Placebo
    Reporting group description
    		 Subjects in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.

    Reporting group title
    Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
    Reporting group description
    		 Subjects in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.

    Reporting group title
    Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
    Reporting group description
    		 Subjects in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period. One randomized subject in this arm was ineligible and did not receive treatment. This subject was not included in the ITT population.

    Reporting group title
    Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
    Reporting group description
    		 Subjects in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.

    Reporting group title
    Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
    Reporting group description
    		 Subjects in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.

    Reporting group values
    		 Period 1 (Placebo-Controlled Period) Placebo Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W Total
    Number of subjects
    		 96 98 94 90 94 472
    Age categorical
    Units: Subjects
        < 40
    		 6 7 5 6 9 33
        40–65
    		 60 68 65 55 55 303
        >=65
    		 30 23 24 29 30 136
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.8 ( 11.28 ) 56.2 ( 10.17 ) 56.8 ( 9.91 ) 59.5 ( 10.72 ) 57.9 ( 10.70 ) -
    Gender categorical
    Units: Subjects
        Female
    		 80 76 73 70 74 373
        Male
    		 16 22 21 20 20 99

    End points

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    End points reporting groups
    Reporting group title
    Period 1 (Placebo-Controlled Period) Placebo
    Reporting group description
    		 Subjects in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.

    Reporting group title
    Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
    Reporting group description
    		 Subjects in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.

    Reporting group title
    Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
    Reporting group description
    		 Subjects in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period. One randomized subject in this arm was ineligible and did not receive treatment. This subject was not included in the ITT population.

    Reporting group title
    Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
    Reporting group description
    		 Subjects in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.

    Reporting group title
    Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
    Reporting group description
    		 Subjects in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.
    Reporting group title
    Period 2 (Extension Period) Placebo to ABBV-154 150 mg EOW
    Reporting group description
    		 Subjects in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized in 1:1 ratio to receive ABBV-154 150 mg or 340 mg respectively SC EOW for 66 weeks in the long term extension (LTE) period.

    Reporting group title
    Period 2 (Extension Period) Placebo to ABBV-154 340 mg EOW
    Reporting group description
    		 Subjects in this group received placebo SC EOW for 12 weeks in the placebo-controlled period and were re-randomized in 1:1 ratio to receive ABBV-154 150 mg or 340 mg respectively SC EOW for 66 weeks in the LTE period.

    Reporting group title
    Period 2 (Extension Period) ABBV-154 40 mg EOW
    Reporting group description
    		 Subjects in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.

    Reporting group title
    Period 2 (Extension Period) ABBV-154 150 mg EOW
    Reporting group description
    		 Subjects in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.

    Reporting group title
    Period 2 (Extension Period) ABBV-154 340 mg EOW
    Reporting group description
    		 Subjects in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.

    Reporting group title
    Period 2 (Extension Period) ABBV-154 340 mg E4W
    Reporting group description
    		 Subjects in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.

    Primary: Achievement of 50% Improvement as Measured by American College of Rheumatology Response Criteria (ACR50) at Week 12

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    End point title
    		 Achievement of 50% Improvement as Measured by American College of Rheumatology Response Criteria (ACR50) at Week 12
    End point description
    Subjects who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria: ≥ 50% improvement in 68-tender joint count; ≥ 50% improvement in 66-swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters: - Physician's Global Assessment of Disease Activity (NRS) - Patient's Global Assessment of Disease Activity (NRS) - Patient's Assessment of Pain (NRS) - Health Assessment Questionnaire - Disability Index (HAQ-DI) - High-sensitivity C-reactive protein (hsCRP).
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 Period 1 (Placebo-Controlled Period) Placebo Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
    Number of subjects analysed
    96 [1]
    98 [2]
    94 [3]
    90 [4]
    94 [5]
    Units: percentage of subjects
        number (confidence interval 95%)
    6.3 (1.4 to 11.1)
    25.5 (16.9 to 34.1)
    33.3 (23.7 to 42.9)
    44.4 (34.2 to 54.7)
    30.9 (21.5 to 40.2)
    Notes
    [1] - ITT analysis set subjects were included (N=472)
    [2] - ITT analysis set subjects were included (N=472)
    [3] - ITT analysis set subjects were included (N=472)
    [4] - ITT analysis set subjects were included (N=472)
    [5] - ITT analysis set subjects were included (N=472)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    21.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.5
         upper limit
    		 31
    Notes
    [6] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [7]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    26.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 16.5
         upper limit
    		 36.7
    Notes
    [7] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [8]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    37.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 27.4
         upper limit
    		 48.1
    Notes
    [8] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [9]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    23.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 13.8
         upper limit
    		 32.6
    Notes
    [9] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.

    Secondary: Change From Baseline in Disease Activity Score (DAS) 28 (CRP) at Week 12

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    End point title
    		 Change From Baseline in Disease Activity Score (DAS) 28 (CRP) at Week 12
    End point description
    The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Period 1 (Placebo-Controlled Period) Placebo Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
    Number of subjects analysed
    93 [10]
    95 [11]
    90 [12]
    86 [13]
    94 [14]
    Units: Units on a scale
        least squares mean (confidence interval 95%)
    -1.08 (-1.35 to -0.82)
    -1.59 (-1.85 to -1.33)
    -2.09 (-2.37 to -1.82)
    -2.51 (-2.78 to -2.23)
    -1.71 (-1.96 to -1.45)
    Notes
    [10] - ITT population subjects with non-missing baseline and at least one post-baseline value were included
    [11] - ITT population subjects with non-missing baseline and at least one post-baseline value were included
    [12] - ITT population subjects with non-missing baseline and at least one post-baseline value were included
    [13] - ITT population subjects with non-missing baseline and at least one post-baseline value were included
    [14] - ITT population subjects with non-missing baseline and at least one post-baseline value were included
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007 [15]
    Method
    		 Mixed Model for Repeated Measures
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -0.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.87
         upper limit
    		 -0.14
    Notes
    [15] - MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [16]
    Method
    		 Mixed Model for Repeated Measures
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.38
         upper limit
    		 -0.64
    Notes
    [16] - MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
    Number of subjects included in analysis
    179
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [17]
    Method
    		 Mixed Model for Repeated Measures
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -1.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 -1.05
    Notes
    [17] - MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
    Number of subjects included in analysis
    187
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [18]
    Method
    		 Mixed Model for Repeated Measures
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -0.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.99
         upper limit
    		 -0.26
    Notes
    [18] - MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.

    Secondary: Change in Clinical Disease Activity Index (CDAI) at Week 12

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    End point title
    		 Change in Clinical Disease Activity Index (CDAI) at Week 12
    End point description
    CDAI is a composite index for assessing disease activity based on the sum of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and Physician's Global Assessment of Disease Activity (NRS). The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Period 1 (Placebo-Controlled Period) Placebo Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
    Number of subjects analysed
    92 [19]
    91 [20]
    88 [21]
    86 [22]
    93 [23]
    Units: Units on a scale
        least squares mean (confidence interval 95%)
    -14.21 (-16.81 to -11.60)
    -18.77 (-21.41 to -16.13)
    -22.21 (-24.94 to -19.48)
    -25.62 (-28.31 to -22.93)
    -19.50 (-22.06 to -16.94)
    Notes
    [19] - ITT population subjects with non-missing baseline and at least one post-baseline value were included
    [20] - ITT population subjects with non-missing baseline and at least one post-baseline value were included
    [21] - ITT population subjects with non-missing baseline and at least one post-baseline value were included
    [22] - ITT population subjects with non-missing baseline and at least one post-baseline value were included
    [23] - ITT population subjects with non-missing baseline and at least one post-baseline value were included
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.014 [24]
    Method
    		 Mixed Model for Repeated Measures
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -4.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.21
         upper limit
    		 -0.92
    Notes
    [24] - MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [25]
    Method
    		 Mixed Model for Repeated Measures
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -8.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.7
         upper limit
    		 -4.31
    Notes
    [25] - MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [26]
    Method
    		 Mixed Model for Repeated Measures
    Parameter type
    		 Least Squares (LS) Mean Difference
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.1
         upper limit
    		 -7.73
    Notes
    [26] - MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004 [27]
    Method
    		 Mixed Model for Repeated Measures
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -5.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.89
         upper limit
    		 -1.69
    Notes
    [27] - MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.

    Secondary: Percentage of Subjects Achieving American College of Rheumatology 20% (ACR20) Response at Week 12

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    End point title
    		 Percentage of Subjects Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
    End point description
    Subjects who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria: ≥ 20% improvement in 68-tender joint count; ≥ 20% improvement in 66-swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: - Physician's Global Assessment of Disease Activity (NRS) - Patient's Global Assessment of Disease Activity (NRS) - Patient's Assessment of Pain (NRS) - Health Assessment Questionnaire - Disability Index (HAQ-DI) - High-sensitivity C-reactive protein (hsCRP).
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Period 1 (Placebo-Controlled Period) Placebo Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
    Number of subjects analysed
    96 [28]
    98 [29]
    94 [30]
    90 [31]
    94 [32]
    Units: Percentage of subjects
        number (confidence interval 95%)
    28.1 (19.1 to 37.1)
    52.7 (42.7 to 62.7)
    59.3 (49.3 to 69.2)
    74.4 (65.4 to 83.5)
    54.3 (44.2 to 64.3)
    Notes
    [28] - ITT analysis set participants were included (N=472)
    [29] - ITT analysis set participants were included (N=472)
    [30] - ITT analysis set participants were included (N=472)
    [31] - ITT analysis set participants were included (N=472)
    [32] - ITT analysis set participants were included (N=472)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [33]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    24.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.1
         upper limit
    		 37.3
    Notes
    [33] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [34]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    30.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 17.4
         upper limit
    		 42.9
    Notes
    [34] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [35]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    45.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 33.5
         upper limit
    		 57.4
    Notes
    [35] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [36]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    24.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.9
         upper limit
    		 37.3
    Notes
    [36] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.

    Secondary: Percentage of Subjects Achieving American College of Rheumatology 70% (ACR70) Response at Week 12

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    End point title
    		 Percentage of Subjects Achieving American College of Rheumatology 70% (ACR70) Response at Week 12
    End point description
    Subjects who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria: ≥ 70% improvement in 68-tender joint count; ≥ 70% improvement in 66-swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters: - Physician's Global Assessment of Disease Activity (NRS) - Patient's Global Assessment of Disease Activity (NRS) - Patient's Assessment of Pain (NRS) - Health Assessment Questionnaire - Disability Index (HAQ-DI) - High-sensitivity C-reactive protein (hsCRP).
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Period 1 (Placebo-Controlled Period) Placebo Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
    Number of subjects analysed
    96 [37]
    98 [38]
    94 [39]
    90 [40]
    94 [41]
    Units: Percentage of subjects
        number (confidence interval 95%)
    3.1 (0.0 to 6.6)
    9.2 (3.5 to 14.9)
    12.8 (6.1 to 19.6)
    13.3 (6.3 to 20.4)
    4.3 (0.2 to 8.3)
    Notes
    [37] - ITT analysis set subjects were included (N=472)
    [38] - ITT analysis set subjects were included (N=472)
    [39] - ITT analysis set subjects were included (N=472)
    [40] - ITT analysis set subjects were included (N=472)
    [41] - ITT analysis set subjects were included (N=472)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.031 [42]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    6.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 12.4
    Notes
    [42] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007 [43]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    9.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.7
         upper limit
    		 17
    Notes
    [43] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004 [44]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    10.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.6
         upper limit
    		 18.2
    Notes
    [44] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.709 [45]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 5.9
    Notes
    [45] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.

    Secondary: Percentage of Subjects Achieving Low Disease Activity (LDA) Defined by DAS28 (CRP) <= 3.2 at Week 12

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    End point title
    		 Percentage of Subjects Achieving Low Disease Activity (LDA) Defined by DAS28 (CRP) <= 3.2 at Week 12
    End point description
    Low disease activity (LDA) was defined as a DAS28 score less than or equal to 3.2. The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS) and Physician's Global Assessment of Disease Activity (NRS), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Period 1 (Placebo-Controlled Period) Placebo Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
    Number of subjects analysed
    96 [46]
    98 [47]
    94 [48]
    90 [49]
    94 [50]
    Units: Percentage of subjects
        number (confidence interval 95%)
    20.8 (12.7 to 29.0)
    38.9 (29.2 to 48.6)
    48.2 (38.0 to 58.3)
    53.3 (43.0 to 63.6)
    45.7 (35.7 to 55.8)
    Notes
    [46] - ITT analysis set participants were included (N=472)
    [47] - ITT analysis set participants were included (N=472)
    [48] - ITT analysis set participants were included (N=472)
    [49] - ITT analysis set participants were included (N=472)
    [50] - ITT analysis set participants were included (N=472)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006 [51]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    16.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.9
         upper limit
    		 28.9
    Notes
    [51] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [52]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    25.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 13.5
         upper limit
    		 38.1
    Notes
    [52] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [53]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    31.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18.9
         upper limit
    		 44.2
    Notes
    [53] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [54]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    23.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11
         upper limit
    		 35.4
    Notes
    [54] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.

    Secondary: Percentage of Subjects Achieving LDA Defined by CDAI <= 10 at Week 12

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    End point title
    		 Percentage of Subjects Achieving LDA Defined by CDAI <= 10 at Week 12
    End point description
    Low disease activity based on CDAI is defined as a CDAI score less than or equal to 10. CDAI is a composite index for assessing disease activity based on the sum of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and Physician's Global Assessment of Disease Activity (NRS). The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Period 1 (Placebo-Controlled Period) Placebo Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
    Number of subjects analysed
    96 [55]
    98 [56]
    94 [57]
    90 [58]
    94 [59]
    Units: Percentage of subjects
        number (confidence interval 95%)
    21.9 (13.6 to 30.1)
    36.8 (27.3 to 46.4)
    46.1 (36.0 to 56.2)
    46.7 (36.4 to 57.0)
    36.2 (26.5 to 45.9)
    Notes
    [55] - ITT analysis set subjects were included (N=472)
    [56] - ITT analysis set subjects were included (N=472)
    [57] - ITT analysis set subjects were included (N=472)
    [58] - ITT analysis set subjects were included (N=472)
    [59] - ITT analysis set subjects were included (N=472)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.022 [60]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    14.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2
         upper limit
    		 26.2
    Notes
    [60] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [61]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    22.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10
         upper limit
    		 35.5
    Notes
    [61] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [62]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    24.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.6
         upper limit
    		 37
    Notes
    [62] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W v Period 1 (Placebo-Controlled Period) Placebo
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.042 [63]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    12.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 24.7
    Notes
    [63] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.

    Secondary: Percentage of Subjects Achieving Clinical Remission (CR) Defined by DAS28 (CRP) < 2.6 at Week 12

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    End point title
    		 Percentage of Subjects Achieving Clinical Remission (CR) Defined by DAS28 (CRP) < 2.6 at Week 12
    End point description
    Clinical remission was defined as a DAS28 (CRP) score less than 2.6. The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Period 1 (Placebo-Controlled Period) Placebo Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
    Number of subjects analysed
    96 [64]
    98 [65]
    94 [66]
    90 [67]
    94 [68]
    Units: Percentage of subjects
        number (confidence interval 95%)
    12.5 (5.9 to 19.1)
    18.4 (10.7 to 26.1)
    33.0 (23.5 to 42.6)
    37.8 (27.8 to 47.8)
    27.7 (18.6 to 36.7)
    Notes
    [64] - ITT analysis set subjects were included (N=472)
    [65] - ITT analysis set subjects were included (N=472)
    [66] - ITT analysis set subjects were included (N=472)
    [67] - ITT analysis set subjects were included (N=472)
    [68] - ITT analysis set subjects were included (N=472)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.296 [69]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    5.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.4
         upper limit
    		 14.6
    Notes
    [69] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [70]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    19.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.7
         upper limit
    		 30.2
    Notes
    [70] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [71]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    25.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 14.3
         upper limit
    		 36.7
    Notes
    [71] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007 [72]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    14.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.8
         upper limit
    		 24.5
    Notes
    [72] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.

    Secondary: Percentage of Subjects Achieving CR Defined by CDAI <= 2.8 at Week 12

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    End point title
    		 Percentage of Subjects Achieving CR Defined by CDAI <= 2.8 at Week 12
    End point description
    Clinical Remission was defined by CDAI as a score less than or equal to 2.8. CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and Physician's Global Assessment of Disease Activity (NRS). The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Period 1 (Placebo-Controlled Period) Placebo Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
    Number of subjects analysed
    96
    98
    94
    90
    94
    Units: Percentage of subjects
        number (confidence interval 95%)
    2.1 (0.0 to 4.9)
    9.2 (3.5 to 14.9)
    4.3 (0.2 to 8.3)
    4.4 (0.2 to 8.7)
    3.2 (0.0 to 6.7)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.017 [73]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    7.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.3
         upper limit
    		 13
    Notes
    [73] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.424 [74]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 6.8
    Notes
    [74] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.303 [75]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3
         upper limit
    		 7.5
    Notes
    [75] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
    Number of subjects included in analysis
    190
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.551 [76]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Response Rate Difference
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.9
         upper limit
    		 5.4
    Notes
    [76] - Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.

    Secondary: Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) to Week 12

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    End point title
    		 Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) to Week 12
    End point description
    The Health Assessment Questionnaire - Disability Index is a participant-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from Baseline in the overall score indicates improvement.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Period 1 (Placebo-Controlled Period) Placebo Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
    Number of subjects analysed
    94
    95
    90
    86
    94
    Units: units on a scale
        least squares mean (confidence interval 95%)
    -0.08 (-0.19 to 0.03)
    -0.26 (-0.36 to -0.15)
    -0.33 (-0.45 to -0.22)
    -0.41 (-0.52 to -0.29)
    -0.29 (-0.39 to -0.18)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
    Number of subjects included in analysis
    189
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.022 [77]
    Method
    		 Mixed Model for Repeated Measures
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -0.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.33
         upper limit
    		 -0.03
    Notes
    [77] - MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001 [78]
    Method
    		 Mixed Model for Repeated Measures
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.41
         upper limit
    		 -0.1
    Notes
    [78] - MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [79]
    Method
    		 Mixed Model for Repeated Measures
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -0.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.48
         upper limit
    		 -0.17
    Notes
    [79] - MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    Period 1 (Placebo-Controlled Period) Placebo v Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007 [80]
    Method
    		 Mixed Model for Repeated Measures
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -0.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.36
         upper limit
    		 -0.06
    Notes
    [80] - MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality and adverse event tables include events reported from enrollment to end of study.
    Adverse event reporting additional description
    Median time subjects were followed was 85 days for all groups in Period 1. For each LTE group, the median time subjects were followed was 412 days (Placebo-ABBV-154 150mg); 389 days (Placebo-ABBV-154 340mg); 390 days (ABBV-154 40mg EOW); 402.5 days (ABBV-154 150mg EOW), 404 days (ABBV-154 340mg EOW), and 380 days (ABBV-154 340mg E4W), respectively.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Period 1 (Placebo-Controlled Period) Placebo
    Reporting group description
    		 Subjects in this group received placebo subcutaneously (SC) every other week (EOW) for 12 weeks in the placebo-controlled period and were re-randomized at 1:1 ratio to receive ABBV-154 150 mg or 340 mg SC EOW for 66 weeks in the long term extension (LTE) period.

    Reporting group title
    Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW
    Reporting group description
    		 Subjects in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period. One subject experienced an AE in Period 1 that was ongoing and resulted in death in Period 2.

    Reporting group title
    Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW
    Reporting group description
    		 Subjects in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.

    Reporting group title
    Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW
    Reporting group description
    		 Subjects in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.

    Reporting group title
    Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W
    Reporting group description
    		 Subjects in this group received 340 mg of ABBV-154 SC every 4 weeks (E4W) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.

    Reporting group title
    Period 2 (Extension Period) Placebo to ABBV-154 150mg EOW
    Reporting group description
    		 Subjects in this group received placebo SC EOW for 12 weeks in the placebo-controlled period and then received ABBV-154 150mg SC EOW for 66 weeks in the LTE period.

    Reporting group title
    Period 2 (Extension Period) Placebo to ABBV-154 340mg EOW
    Reporting group description
    		 Subjects in this group received placebo SC EOW for 12 weeks in the placebo-controlled period and then received ABBV-154 340mg SC EOW for 66 weeks in the LTE period.

    Reporting group title
    Period 2 (Extension Period) ABBV-154 40 mg EOW
    Reporting group description
    		 Subjects in this group received 40 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.

    Reporting group title
    Period 2 (Extension Period) ABBV-154 150 mg EOW
    Reporting group description
    		 Subjects in this group received 150 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.

    Reporting group title
    Period 2 (Extension Period) ABBV-154 340 mg EOW
    Reporting group description
    		 Subjects in this group received 340 mg of ABBV-154 SC EOW for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.

    Reporting group title
    Period 2 (Extension Period) ABBV-154 340 mg E4W
    Reporting group description
    		 Subjects in this group received 340 mg of ABBV-154 SC E4W for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period.

    Serious adverse events
    		 Period 1 (Placebo-Controlled Period) Placebo Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W Period 2 (Extension Period) Placebo to ABBV-154 150mg EOW Period 2 (Extension Period) Placebo to ABBV-154 340mg EOW Period 2 (Extension Period) ABBV-154 40 mg EOW Period 2 (Extension Period) ABBV-154 150 mg EOW Period 2 (Extension Period) ABBV-154 340 mg EOW Period 2 (Extension Period) ABBV-154 340 mg E4W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 96 (2.08%)
    4 / 98 (4.08%)
    6 / 95 (6.32%)
    5 / 90 (5.56%)
    3 / 94 (3.19%)
    3 / 45 (6.67%)
    6 / 46 (13.04%)
    7 / 91 (7.69%)
    8 / 86 (9.30%)
    10 / 84 (11.90%)
    9 / 89 (10.11%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    3
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    ADENOCARCINOMA OF COLON
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    1 / 95 (1.05%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    BREAST CANCER
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 91 (1.10%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    GLIOBLASTOMA
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 91 (1.10%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 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
    HEPATOCELLULAR CARCINOMA
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    1 / 84 (1.19%)
    0 / 89 (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 / 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
    Vascular disorders
    AORTIC STENOSIS
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    1 / 89 (1.12%)
         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 / 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
    General disorders and administration site conditions
    MULTIPLE ORGAN DYSFUNCTION SYNDROME
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    1 / 95 (1.05%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    Immune system disorders
    ANAPHYLACTIC REACTION
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    1 / 90 (1.11%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    Reproductive system and breast disorders
    UTERINE POLYP
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    1 / 89 (1.12%)
         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 / 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
    Respiratory, thoracic and mediastinal disorders
    ACUTE RESPIRATORY FAILURE
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    1 / 86 (1.16%)
    0 / 84 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    PNEUMONITIS
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    Psychiatric disorders
    CONFUSIONAL STATE
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    1 / 90 (1.11%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    DEPRESSION
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    1 / 86 (1.16%)
    0 / 84 (0.00%)
    0 / 89 (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 / 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
    Injury, poisoning and procedural complications
    ANKLE FRACTURE
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    PATELLA FRACTURE
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 91 (1.10%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    LIMB FRACTURE
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 91 (1.10%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    SKIN LACERATION
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 91 (1.10%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    SPINAL COMPRESSION FRACTURE
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 98 (1.02%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    1 / 84 (1.19%)
    0 / 89 (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 / 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
    SYNOVIAL RUPTURE
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    1 / 95 (1.05%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    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
    TENDON INJURY
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 91 (1.10%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    Cardiac disorders
    ACUTE CORONARY SYNDROME
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    1 / 89 (1.12%)
         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
    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
    ATRIAL FIBRILLATION
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 91 (1.10%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    BRADYCARDIA
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    1 / 84 (1.19%)
    0 / 89 (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 / 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
    CARDIAC FAILURE CONGESTIVE
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    1 / 89 (1.12%)
         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 / 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 / 1
    CORONARY ARTERY DISEASE
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    1 / 84 (1.19%)
    1 / 89 (1.12%)
         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 / 1
    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
    MYOCARDIAL INFARCTION
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 98 (1.02%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    Nervous system disorders
    CEREBRAL ISCHAEMIA
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    1 / 89 (1.12%)
         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 / 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 / 1
    METABOLIC ENCEPHALOPATHY
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    1 / 89 (1.12%)
         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 / 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
    SEIZURE
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 91 (1.10%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    STROKE IN EVOLUTION
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    1 / 95 (1.05%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    SUBARACHNOID HAEMORRHAGE
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    1 / 45 (2.22%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    SYNCOPE
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    1 / 94 (1.06%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    1 / 86 (1.16%)
    0 / 84 (0.00%)
    0 / 89 (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 / 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
    Eye disorders
    RETINAL DETACHMENT
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    1 / 84 (1.19%)
    0 / 89 (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 / 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
    Gastrointestinal disorders
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    1 / 86 (1.16%)
    0 / 84 (0.00%)
    0 / 89 (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 / 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
    COLITIS
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    1 / 89 (1.12%)
         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 / 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
    FOOD POISONING
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    1 / 95 (1.05%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    GASTRITIS
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    1 / 45 (2.22%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    HAEMATOCHEZIA
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    1 / 89 (1.12%)
         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 / 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
    INCARCERATED INGUINAL HERNIA
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 91 (1.10%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    LARGE INTESTINE POLYP
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    Hepatobiliary disorders
    CHOLANGITIS ACUTE
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    1 / 95 (1.05%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    Musculoskeletal and connective tissue disorders
    EXOSTOSIS
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 91 (1.10%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    RHEUMATOID ARTHRITIS
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    1 / 84 (1.19%)
    0 / 89 (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 / 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
    SYNOVIAL CYST
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    1 / 86 (1.16%)
    0 / 84 (0.00%)
    0 / 89 (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 / 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
    SYNOVITIS
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    2 / 86 (2.33%)
    0 / 84 (0.00%)
    0 / 89 (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 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    TENOSYNOVITIS
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    1 / 86 (1.16%)
    0 / 84 (0.00%)
    0 / 89 (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 / 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
    Infections and infestations
    BRONCHITIS
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    BACTERAEMIA
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    1 / 89 (1.12%)
         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 / 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
    COVID-19
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 98 (1.02%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    1 / 94 (1.06%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    1 / 84 (1.19%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    1 / 1
    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
    CELLULITIS
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    1 / 84 (1.19%)
    0 / 89 (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
         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
    COVID-19 PNEUMONIA
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 98 (1.02%)
    0 / 95 (0.00%)
    1 / 90 (1.11%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DIVERTICULITIS
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    INFECTIOUS MONONUCLEOSIS
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    1 / 84 (1.19%)
    0 / 89 (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
         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
    HERPES ZOSTER
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    1 / 84 (1.19%)
    0 / 89 (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
         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
    LARYNGITIS
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    NEUROLOGICAL INFECTION
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    1 / 90 (1.11%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    OPPORTUNISTIC INFECTION
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    1 / 86 (1.16%)
    0 / 84 (0.00%)
    0 / 89 (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 / 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
    OSTEOMYELITIS
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    1 / 86 (1.16%)
    0 / 84 (0.00%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 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
    PNEUMOCYSTIS JIROVECII PNEUMONIA
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    1 / 90 (1.11%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    PNEUMONIA
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    1 / 94 (1.06%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    0 / 91 (0.00%)
    1 / 86 (1.16%)
    1 / 84 (1.19%)
    2 / 89 (2.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    1 / 1
    0 / 2
    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
    POSTOPERATIVE WOUND INFECTION
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 91 (1.10%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 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
    PYELONEPHRITIS
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    1 / 45 (2.22%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    1 / 89 (1.12%)
         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
    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
    Q FEVER
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    1 / 45 (2.22%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    SEPSIS
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    1 / 95 (1.05%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    2 / 89 (2.25%)
         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 / 2
         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
    STAPHYLOCOCCAL INFECTION
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    1 / 95 (1.05%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    SINUSITIS
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    1 / 84 (1.19%)
    0 / 89 (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 / 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
    URINARY TRACT INFECTION
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    1 / 84 (1.19%)
    0 / 89 (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 / 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
    WOUND INFECTION STAPHYLOCOCCAL
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    1 / 91 (1.10%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 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
    Metabolism and nutrition disorders
    HYPOGLYCAEMIA
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 98 (1.02%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    0 / 86 (0.00%)
    0 / 84 (0.00%)
    0 / 89 (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
         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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Period 1 (Placebo-Controlled Period) Placebo Period 1 (Placebo-Controlled Period) ABBV-154 40 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 150 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg EOW Period 1 (Placebo-Controlled Period) ABBV-154 340 mg E4W Period 2 (Extension Period) Placebo to ABBV-154 150mg EOW Period 2 (Extension Period) Placebo to ABBV-154 340mg EOW Period 2 (Extension Period) ABBV-154 40 mg EOW Period 2 (Extension Period) ABBV-154 150 mg EOW Period 2 (Extension Period) ABBV-154 340 mg EOW Period 2 (Extension Period) ABBV-154 340 mg E4W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 96 (26.04%)
    43 / 98 (43.88%)
    26 / 95 (27.37%)
    26 / 90 (28.89%)
    27 / 94 (28.72%)
    31 / 45 (68.89%)
    25 / 46 (54.35%)
    54 / 91 (59.34%)
    56 / 86 (65.12%)
    52 / 84 (61.90%)
    47 / 89 (52.81%)
    Injury, poisoning and procedural complications
    CONTUSION
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    3 / 95 (3.16%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    1 / 46 (2.17%)
    2 / 91 (2.20%)
    5 / 86 (5.81%)
    3 / 84 (3.57%)
    1 / 89 (1.12%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    1
    2
    5
    3
    1
    FALL
         subjects affected / exposed
    1 / 96 (1.04%)
    1 / 98 (1.02%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    6 / 91 (6.59%)
    2 / 86 (2.33%)
    0 / 84 (0.00%)
    0 / 89 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    6
    2
    0
    0
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    2 / 95 (2.11%)
    2 / 90 (2.22%)
    1 / 94 (1.06%)
    1 / 45 (2.22%)
    1 / 46 (2.17%)
    4 / 91 (4.40%)
    3 / 86 (3.49%)
    4 / 84 (4.76%)
    5 / 89 (5.62%)
         occurrences all number
    0
    0
    2
    2
    1
    1
    1
    4
    3
    4
    5
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    3 / 96 (3.13%)
    4 / 98 (4.08%)
    3 / 95 (3.16%)
    4 / 90 (4.44%)
    2 / 94 (2.13%)
    2 / 45 (4.44%)
    1 / 46 (2.17%)
    3 / 91 (3.30%)
    5 / 86 (5.81%)
    3 / 84 (3.57%)
    1 / 89 (1.12%)
         occurrences all number
    3
    4
    3
    4
    2
    2
    1
    3
    5
    5
    1
    General disorders and administration site conditions
    INJECTION SITE DISCOLOURATION
         subjects affected / exposed
    0 / 96 (0.00%)
    3 / 98 (3.06%)
    1 / 95 (1.05%)
    4 / 90 (4.44%)
    1 / 94 (1.06%)
    4 / 45 (8.89%)
    3 / 46 (6.52%)
    2 / 91 (2.20%)
    5 / 86 (5.81%)
    3 / 84 (3.57%)
    3 / 89 (3.37%)
         occurrences all number
    0
    4
    2
    4
    1
    5
    5
    2
    5
    3
    3
    INJECTION SITE BRUISING
         subjects affected / exposed
    2 / 96 (2.08%)
    3 / 98 (3.06%)
    0 / 95 (0.00%)
    1 / 90 (1.11%)
    1 / 94 (1.06%)
    0 / 45 (0.00%)
    5 / 46 (10.87%)
    2 / 91 (2.20%)
    2 / 86 (2.33%)
    2 / 84 (2.38%)
    6 / 89 (6.74%)
         occurrences all number
    2
    4
    0
    1
    1
    0
    13
    3
    4
    2
    6
    INJECTION SITE ERYTHEMA
         subjects affected / exposed
    1 / 96 (1.04%)
    3 / 98 (3.06%)
    1 / 95 (1.05%)
    3 / 90 (3.33%)
    6 / 94 (6.38%)
    2 / 45 (4.44%)
    3 / 46 (6.52%)
    7 / 91 (7.69%)
    3 / 86 (3.49%)
    5 / 84 (5.95%)
    5 / 89 (5.62%)
         occurrences all number
    3
    7
    1
    6
    7
    3
    9
    35
    14
    8
    8
    OEDEMA PERIPHERAL
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    0 / 91 (0.00%)
    3 / 86 (3.49%)
    7 / 84 (8.33%)
    0 / 89 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    3
    7
    0
    PYREXIA
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    1 / 95 (1.05%)
    2 / 90 (2.22%)
    0 / 94 (0.00%)
    2 / 45 (4.44%)
    1 / 46 (2.17%)
    6 / 91 (6.59%)
    3 / 86 (3.49%)
    3 / 84 (3.57%)
    0 / 89 (0.00%)
         occurrences all number
    0
    0
    1
    2
    0
    2
    1
    6
    3
    3
    0
    Gastrointestinal disorders
    NAUSEA
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    1 / 90 (1.11%)
    3 / 94 (3.19%)
    0 / 45 (0.00%)
    2 / 46 (4.35%)
    2 / 91 (2.20%)
    5 / 86 (5.81%)
    1 / 84 (1.19%)
    2 / 89 (2.25%)
         occurrences all number
    1
    0
    0
    1
    3
    0
    2
    2
    7
    1
    2
    DIARRHOEA
         subjects affected / exposed
    1 / 96 (1.04%)
    2 / 98 (2.04%)
    3 / 95 (3.16%)
    2 / 90 (2.22%)
    0 / 94 (0.00%)
    2 / 45 (4.44%)
    0 / 46 (0.00%)
    3 / 91 (3.30%)
    5 / 86 (5.81%)
    2 / 84 (2.38%)
    2 / 89 (2.25%)
         occurrences all number
    1
    2
    5
    2
    0
    2
    0
    4
    6
    2
    2
    Skin and subcutaneous tissue disorders
    RASH
         subjects affected / exposed
    0 / 96 (0.00%)
    2 / 98 (2.04%)
    3 / 95 (3.16%)
    2 / 90 (2.22%)
    2 / 94 (2.13%)
    0 / 45 (0.00%)
    3 / 46 (6.52%)
    4 / 91 (4.40%)
    4 / 86 (4.65%)
    3 / 84 (3.57%)
    0 / 89 (0.00%)
         occurrences all number
    0
    2
    5
    2
    2
    0
    3
    4
    9
    3
    0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    0 / 96 (0.00%)
    2 / 98 (2.04%)
    1 / 95 (1.05%)
    1 / 90 (1.11%)
    0 / 94 (0.00%)
    1 / 45 (2.22%)
    1 / 46 (2.17%)
    6 / 91 (6.59%)
    3 / 86 (3.49%)
    1 / 84 (1.19%)
    1 / 89 (1.12%)
         occurrences all number
    0
    2
    1
    1
    0
    1
    1
    8
    3
    1
    1
    BACK PAIN
         subjects affected / exposed
    2 / 96 (2.08%)
    3 / 98 (3.06%)
    0 / 95 (0.00%)
    2 / 90 (2.22%)
    1 / 94 (1.06%)
    1 / 45 (2.22%)
    0 / 46 (0.00%)
    3 / 91 (3.30%)
    8 / 86 (9.30%)
    3 / 84 (3.57%)
    2 / 89 (2.25%)
         occurrences all number
    2
    4
    0
    2
    1
    1
    0
    3
    8
    3
    2
    RHEUMATOID ARTHRITIS
         subjects affected / exposed
    7 / 96 (7.29%)
    5 / 98 (5.10%)
    2 / 95 (2.11%)
    1 / 90 (1.11%)
    2 / 94 (2.13%)
    5 / 45 (11.11%)
    4 / 46 (8.70%)
    10 / 91 (10.99%)
    11 / 86 (12.79%)
    5 / 84 (5.95%)
    8 / 89 (8.99%)
         occurrences all number
    8
    6
    2
    1
    2
    6
    6
    12
    14
    5
    10
    Infections and infestations
    BRONCHITIS
         subjects affected / exposed
    2 / 96 (2.08%)
    2 / 98 (2.04%)
    1 / 95 (1.05%)
    1 / 90 (1.11%)
    0 / 94 (0.00%)
    2 / 45 (4.44%)
    0 / 46 (0.00%)
    6 / 91 (6.59%)
    2 / 86 (2.33%)
    2 / 84 (2.38%)
    6 / 89 (6.74%)
         occurrences all number
    2
    2
    1
    1
    0
    2
    0
    6
    2
    2
    6
    COVID-19
         subjects affected / exposed
    1 / 96 (1.04%)
    13 / 98 (13.27%)
    5 / 95 (5.26%)
    2 / 90 (2.22%)
    7 / 94 (7.45%)
    12 / 45 (26.67%)
    8 / 46 (17.39%)
    15 / 91 (16.48%)
    15 / 86 (17.44%)
    17 / 84 (20.24%)
    16 / 89 (17.98%)
         occurrences all number
    1
    13
    5
    2
    7
    12
    8
    17
    16
    18
    17
    INFLUENZA
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 98 (1.02%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    5 / 45 (11.11%)
    1 / 46 (2.17%)
    1 / 91 (1.10%)
    3 / 86 (3.49%)
    3 / 84 (3.57%)
    4 / 89 (4.49%)
         occurrences all number
    0
    1
    0
    0
    0
    6
    1
    1
    3
    3
    6
    NASOPHARYNGITIS
         subjects affected / exposed
    2 / 96 (2.08%)
    2 / 98 (2.04%)
    4 / 95 (4.21%)
    1 / 90 (1.11%)
    3 / 94 (3.19%)
    4 / 45 (8.89%)
    4 / 46 (8.70%)
    9 / 91 (9.89%)
    11 / 86 (12.79%)
    6 / 84 (7.14%)
    11 / 89 (12.36%)
         occurrences all number
    2
    2
    5
    1
    3
    4
    4
    11
    13
    6
    15
    PHARYNGITIS
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 98 (0.00%)
    0 / 95 (0.00%)
    0 / 90 (0.00%)
    0 / 94 (0.00%)
    0 / 45 (0.00%)
    0 / 46 (0.00%)
    5 / 91 (5.49%)
    3 / 86 (3.49%)
    3 / 84 (3.57%)
    1 / 89 (1.12%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    6
    3
    3
    1
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    1 / 96 (1.04%)
    3 / 98 (3.06%)
    0 / 95 (0.00%)
    4 / 90 (4.44%)
    4 / 94 (4.26%)
    9 / 45 (20.00%)
    5 / 46 (10.87%)
    6 / 91 (6.59%)
    8 / 86 (9.30%)
    12 / 84 (14.29%)
    7 / 89 (7.87%)
         occurrences all number
    1
    3
    0
    5
    4
    11
    5
    6
    10
    13
    7
    URINARY TRACT INFECTION
         subjects affected / exposed
    3 / 96 (3.13%)
    5 / 98 (5.10%)
    1 / 95 (1.05%)
    2 / 90 (2.22%)
    0 / 94 (0.00%)
    8 / 45 (17.78%)
    5 / 46 (10.87%)
    3 / 91 (3.30%)
    6 / 86 (6.98%)
    8 / 84 (9.52%)
    5 / 89 (5.62%)
         occurrences all number
    3
    5
    1
    2
    0
    10
    10
    3
    8
    10
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Apr 2022
    Protocol Version 2.0 Typographical corrections or edits were made for consistency. In addition, updates and clarifications were made to study procedures, including but not limited to the following: • Added a 104-week LTE Period 2 and renamed the originally planned double-blind LTE period "Double-Blind, Long-term Extension Period 1" • Updated wording to clarify when unblinding would occur • Updated/clarified eligibility criteria related to b/tsDMARDs • Changed the definition of ITT population from all randomized subjects to all subjects who were randomized and received at least 1 dose of study drug • Updates/clarifications to Objectives, Hypotheses, and Estimands • The Optional Synovial Biopsy Substudy was removed as it was determined it will not be possible to enroll enough subjects into the Substudy to achieve scientific goals • Added 70-Day Follow-up Period to the description of the overall study design • Clarified primary and final analysis timing • Clarified that subjects previously on placebo will be re-randomized • Updates/clarifications made to the section on requirements for contraception, breastfeeding, and pregnancy

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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