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    Clinical Trial Results:
    A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE)

    Summary
    EudraCT number
    		 2017-005028-11
    Trial protocol
    		 GB   CZ   DE   AT   HU   PL   BE   ES   GR   NL   HR   IT   RO  
    Global end of trial date
    01 Apr 2022

    Results information
    Results version number
    		 v2(current)
    This version publication date
    29 May 2023
    First version publication date
    16 Apr 2023
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    As per ct.gov PRS comments, revising the unit of measure for 3 outcomes in EudraCT draft to be consistent with ct.gov results.

    Trial information

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    Trial identification
    Sponsor protocol code
    I4V-MC-JAIM
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03843125
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 16832
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Apr 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Apr 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The reason for this long term study is to see how safe and effective the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE) who have completed the final treatment visit of study I4V-MC-JAHZ (NCT03616912) or study I4V-MC-JAIA (NCT03616964).
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Sep 2019
    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
    Argentina: 73
    Country: Number of subjects enrolled
    Australia: 17
    Country: Number of subjects enrolled
    Brazil: 60
    Country: Number of subjects enrolled
    Chile: 27
    Country: Number of subjects enrolled
    China: 51
    Country: Number of subjects enrolled
    Colombia: 39
    Country: Number of subjects enrolled
    India: 65
    Country: Number of subjects enrolled
    Israel: 6
    Country: Number of subjects enrolled
    Japan: 24
    Country: Number of subjects enrolled
    Korea, Republic of: 18
    Country: Number of subjects enrolled
    Mexico: 112
    Country: Number of subjects enrolled
    Philippines: 33
    Country: Number of subjects enrolled
    South Africa: 34
    Country: Number of subjects enrolled
    Taiwan: 30
    Country: Number of subjects enrolled
    United States: 192
    Country: Number of subjects enrolled
    Serbia: 43
    Country: Number of subjects enrolled
    Austria: 2
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    Croatia: 6
    Country: Number of subjects enrolled
    Czechia: 28
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 29
    Country: Number of subjects enrolled
    Greece: 15
    Country: Number of subjects enrolled
    Hungary: 39
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    Netherlands: 2
    Country: Number of subjects enrolled
    Poland: 79
    Country: Number of subjects enrolled
    Romania: 24
    Country: Number of subjects enrolled
    Spain: 21
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    Switzerland: 2
    Country: Number of subjects enrolled
    Russian Federation: 57
    Worldwide total number of subjects
    1147
    EEA total number of subjects
    254
    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)
    1088
    From 65 to 84 years
    59
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants who completed originating study [I4V-MC-JAHZ (NCT03616912) or Study I4V-MC-JAIA (NCT03616964)] were enrolled in this study. Safety population included all participants who received at least one dose of study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit.

    Pre-assignment
    Screening details
    		 Participants who were randomized to placebo during originating Study I4V-MC-JAHZ (NCT03616912) or Study I4V-MC-JAIA (NCT03616964) were randomized 1:1 to receive baricitinib 4-milligrams (mg) or baricitinib 2-mg once daily (QD), administered orally.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 2 milligrams (mg) Baricitinib
    Arm description
    		 Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    Other name
    LY3009104
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received one 2 mg Baricitinib tablet administered orally every day (QD).

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received one placebo tablet matching 4 mg Baricitinib administered orally QD.

    Arm title
    		 4 mg Baricitinib
    Arm description
    		 Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    Other name
    LY3009104
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received one 2 mg Baricitinib tablet administered orally QD.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received one placebo tablet matching 2 mg Baricitinib administered orally QD.

    Arm title
    		 Placebo to 2 mg Baricitinib
    Arm description
    		 Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    Other name
    LY3009104
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received one 2 mg Baricitinib tablet administered orally QD.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received one placebo tablet matching 4 mg Baricitinib administered orally QD.

    Arm title
    		 Placebo to 4 mg Baricitinib
    Arm description
    		 Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    Other name
    LY3009104
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received one 4 mg Baricitinib tablet administered orally QD.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received one placebo tablet matching 2 mg Baricitinib administered orally QD.

    Number of subjects in period 1
    		2 milligrams (mg) Baricitinib 4 mg Baricitinib Placebo to 2 mg Baricitinib Placebo to 4 mg Baricitinib
    Started
    388
    379
    189
    191
    Safety Population
    388
    378
    189
    191
    Completed
    0
    0
    0
    0
    Not completed
    388
    379
    189
    191
         Adverse event, serious fatal
    -
    6
    2
    -
         Consent withdrawn by subject
    23
    12
    6
    9
         Adverse event, non-fatal
    17
    13
    5
    9
         Due to Epidemic/Pandemic
    1
    -
    -
    -
         Unknown
    12
    14
    3
    4
         Study Terminated by Sponsor
    318
    318
    163
    163
         Lost to follow-up
    3
    4
    -
    2
         Missing data
    -
    1
    1
    -
         Lack of efficacy
    14
    11
    9
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    2 milligrams (mg) Baricitinib
    Reporting group description
    		 Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).

    Reporting group title
    4 mg Baricitinib
    Reporting group description
    		 Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.

    Reporting group title
    Placebo to 2 mg Baricitinib
    Reporting group description
    		 Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.

    Reporting group title
    Placebo to 4 mg Baricitinib
    Reporting group description
    		 Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.

    Reporting group values
    		 2 milligrams (mg) Baricitinib 4 mg Baricitinib Placebo to 2 mg Baricitinib Placebo to 4 mg Baricitinib Total
    Number of subjects
    		 388 379 189 191 1147
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 43.8 ± 12.68 43.8 ± 12.03 43.8 ± 11.85 43.5 ± 13.22 -
    Gender categorical
    Units: Subjects
        Female
    		 361 357 181 176 1075
        Male
    		 27 22 8 15 72
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 21 16 13 11 61
        Asian
    		 79 77 44 41 241
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 32 36 19 19 106
        White
    		 249 241 109 115 714
        More than one race
    		 3 2 2 2 9
        Unknown or Not Reported
    		 4 7 2 3 16
    Region of Enrollment
    Units: Subjects
        United States
    		 66 68 28 30 192
        Czechia
    		 7 9 7 5 28
        Russia
    		 19 16 11 11 57
        Greece
    		 8 4 0 3 15
        South Korea
    		 7 7 2 2 18
        Netherlands
    		 1 1 0 0 2
        Austria
    		 1 1 0 0 2
        China
    		 17 18 10 6 51
        Poland
    		 27 28 11 13 79
        Brazil
    		 17 19 14 10 60
        France
    		 0 1 0 1 2
        Serbia
    		 18 15 3 7 43
        Chile
    		 12 7 4 4 27
        Croatia
    		 3 1 1 1 6
        Colombia
    		 11 13 8 7 39
        Argentina
    		 21 23 13 16 73
        Romania
    		 11 6 3 4 24
        Hungary
    		 16 13 5 5 39
        Japan
    		 6 9 4 5 24
        Philippines
    		 13 8 5 7 33
        United Kingdom
    		 3 3 3 1 10
        Switzerland
    		 0 0 2 0 2
        India
    		 20 20 13 12 65
        Spain
    		 3 9 6 3 21
        Belgium
    		 1 1 1 0 3
        Taiwan
    		 8 10 5 7 30
        Italy
    		 2 0 1 1 4
        Mexico
    		 40 40 15 17 112
        South Africa
    		 13 9 6 6 34
        Israel
    		 3 3 0 0 6
        Australia
    		 5 6 4 2 17
        Germany
    		 9 11 4 5 29

    End points

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    End points reporting groups
    Reporting group title
    2 milligrams (mg) Baricitinib
    Reporting group description
    		 Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).

    Reporting group title
    4 mg Baricitinib
    Reporting group description
    		 Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.

    Reporting group title
    Placebo to 2 mg Baricitinib
    Reporting group description
    		 Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.

    Reporting group title
    Placebo to 4 mg Baricitinib
    Reporting group description
    		 Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.

    Primary: Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    		 Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) [1]
    End point description
    Percentage of participants with TEAEs. A treatment-emergent AE (TEAE) is defined as an event that first occurred or worsened in severity after the first dose of study treatment in Study JAIM and on or prior to the last visit date during the analysis period. The analysis period is defined as the treatment period plus up to 30 days off-drug follow-up time. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. Analysis population description (APD): All participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Week 134
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis were not planned for this outcome measure.
    End point values
    		 2 milligrams (mg) Baricitinib 4 mg Baricitinib Placebo to 2 mg Baricitinib Placebo to 4 mg Baricitinib
    Number of subjects analysed
    388
    378
    189
    191
    Units: Percentage of Participants
        number (not applicable)
    61.9
    68.8
    65.1
    64.4
    No statistical analyses for this end point

    Primary: Percentage of Participants with Adverse Events of Special Interest (AESIs)

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    End point title
    		 Percentage of Participants with Adverse Events of Special Interest (AESIs) [2]
    End point description
    Percentage of Participants with AESIs. AESI consisted of infections, positively adjudicated arterial thromboembolic events (ATE), positively adjudicated venous thromboembolic events (VTE), positively adjudicated major adverse cardiovascular events (MACE), other positively adjudicated cardiovascular events, death, anaphylactic reactions, hypersensitivity, angioedema, and malignancies. APD: All participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Week 134
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis were not planned for this outcome measure.
    End point values
    		 2 milligrams (mg) Baricitinib 4 mg Baricitinib Placebo to 2 mg Baricitinib Placebo to 4 mg Baricitinib
    Number of subjects analysed
    388
    378
    189
    191
    Units: Percentage of participants
    number (not applicable)
        Infections
    38.4
    42.1
    36.5
    35.1
        Positively adjudicated ATE
    0.3
    0.8
    0.5
    0.5
        Positively adjudicated VTE
    0.3
    1.1
    0.5
    0.5
        Positively adjudicated MACE
    0.3
    0.8
    0.5
    0.5
        Other positively adjudicated cardiovascular events
    0.3
    0.8
    0
    0.5
        Death
    0
    1.6
    1.1
    0
        Anaphylactic reactions
    3.6
    4.2
    5.8
    3.1
        Hypersensitivity
    3.6
    4.2
    5.8
    3.1
        Angioedema
    1.3
    0.8
    1.6
    0
        Malignancies
    0.5
    0.3
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Participants with Serious Adverse Events (SAEs)

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    End point title
    		 Percentage of Participants with Serious Adverse Events (SAEs) [3]
    End point description
    Percentage of participants with SAEs. An SAE is any AE from this study that results in one of the following outcomes: Death; Initial or prolonged inpatient hospitalization; A life-threatening experience (that is, immediate risk of dying); Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important medical events that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the definition above. APD: All participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Week 134
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis were not planned for this outcome measure.
    End point values
    		 2 milligrams (mg) Baricitinib 4 mg Baricitinib Placebo to 2 mg Baricitinib Placebo to 4 mg Baricitinib
    Number of subjects analysed
    388
    378
    189
    191
    Units: Percentage of Participants
        number (not applicable)
    11.1
    13.5
    11.1
    11.5
    No statistical analyses for this end point

    Primary: Percentage of Participants with Temporary Investigational Product Interruptions

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    End point title
    		 Percentage of Participants with Temporary Investigational Product Interruptions [4]
    End point description
    Percentage of participants with temporary investigational product interruptions. APD: All participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Week 134
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis were not planned for this outcome measure.
    End point values
    		 2 milligrams (mg) Baricitinib 4 mg Baricitinib Placebo to 2 mg Baricitinib Placebo to 4 mg Baricitinib
    Number of subjects analysed
    388
    378
    189
    191
    Units: Percentage of Participants
        number (not applicable)
    19.1
    24.6
    18.5
    23.6
    No statistical analyses for this end point

    Primary: Percentage of Participants with Permanent Investigational Product Discontinuations

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    End point title
    		 Percentage of Participants with Permanent Investigational Product Discontinuations [5]
    End point description
    Percentage of participants with permanent investigational product discontinuations. APD: All participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Week 134
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis were not planned for this outcome measure.
    End point values
    		 2 milligrams (mg) Baricitinib 4 mg Baricitinib Placebo to 2 mg Baricitinib Placebo to 4 mg Baricitinib
    Number of subjects analysed
    388
    378
    189
    191
    Units: Percentage of Participants
        number (not applicable)
    5.2
    5.8
    4.2
    5.8
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response

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    End point title
    		 Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response
    End point description
    SRI-4 response defined as 1)greater than or equal to 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score 2)no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and 3)no worsening in Physician Global Assessment (PGA) of Disease Activity (worsening defined as an increase of >=0.3 from baseline on a 0-3 visual analogue scale). SLEDAI-2K assessment consists of 24 items with total score of 0(no symptoms) to 105 (presence of all defined symptoms) with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms,or laboratory parameters related to Systemic Lupus Erythematosus (SLE),divided into 9 organ systems. For each organ system A=severe disease,B=moderate disease,C=mild stable disease,D=inactive,but previously active,E=inactive and never affected. PGA assesses disease activity on a visual analogue scale from 0 to 3 (1=mild, 2=moderate, 3=severe).
    End point type
    Secondary
    End point timeframe
    Week 134 APD: All randomized participants who had SLEDAI-2K score of >=4 at baseline.
    End point values
    		 2 milligrams (mg) Baricitinib 4 mg Baricitinib Placebo to 2 mg Baricitinib Placebo to 4 mg Baricitinib
    Number of subjects analysed
    388
    379
    129
    131
    Units: Percentage of participants
        number (not applicable)
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS)

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    End point title
    		 Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS)
    End point description
    Percentage of participants achieving a LLDAS. The LLDAS is a composite measure designed to identify patients achieving a state of low disease activity. The LLDAS response criteria were: (1) SLEDAI-2K <=4, with no activity in major organ systems (CNS, vascular, renal, cardiorespiratory and constitutional); where "no activity" is defined as all items of SLEDAI-2K within these major organ systems equal to 0. (2) no new features of lupus disease activity compared to previous occurred visit, where the "new feature" is defined as any of the SLEDAI-2K 24 items changed from 0 to greater than 0; (3) PGA (scale 0-3), <=1; (4) current prednisolone (or equivalent) dose <=7.5 mg daily. APD: All participants who received at least one dose of study drug and had SLEDAI-2K score of >=4 at baseline. Due to early termination of the study, this population consisted of participants who completed Week 48 treatment, or discontinued treatment prior to Week 48 (but not due to study termination).
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 2 milligrams (mg) Baricitinib 4 mg Baricitinib Placebo to 2 mg Baricitinib Placebo to 4 mg Baricitinib
    Number of subjects analysed
    289
    261
    98
    100
    Units: Percentage of participants
        number (not applicable)
    29.8
    33.0
    19.4
    26.0
    No statistical analyses for this end point

    Secondary: Change from Baseline in Prednisone Dose

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    End point title
    		 Change from Baseline in Prednisone Dose
    End point description
    Change from baseline in prednisone dose. APD: Due to early termination of the study, this population consisted of participants who completed Week 48 treatment, or discontinued treatment prior to Week 48 (but not due to study termination). Participants having values for this outcome were included.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 48
    End point values
    		 2 milligrams (mg) Baricitinib 4 mg Baricitinib Placebo to 2 mg Baricitinib Placebo to 4 mg Baricitinib
    Number of subjects analysed
    235
    225
    115
    121
    Units: milligrams (mg)
        least squares mean (standard error)
    2.35 ± 0.305
    2.27 ± 0.316
    1.68 ± 0.426
    1.00 ± 0.419
    No statistical analyses for this end point

    Secondary: Annualized Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index Flare Rate

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    End point title
    		 Annualized Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index Flare Rate
    End point description
    The SELENA-SLEDAI tool is a cumulative and weighted index used to assess disease activity across 24 different disease descriptors in patients with lupus. A patient's SELENA-SLEDAI total score is the sum of all marked lupus related descriptors (seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, vasculitis, arthritis, myositis, urinary casts, hematuria, proteinuria, pyuria, new rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, increased DNA binding, fever, thrombocytopenia, leukopenia). A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity. The annualized flare rate is calculated as the number of flares divided by the flare exposure time in days multiplied with 365.25. Participants having values for this outcome were included.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 48 APD: Due to early termination of the study, this population consisted of participants who completed Week 48 treatment, or discontinued treatment prior to Week 48 (but not due to study termination).
    End point values
    		 2 milligrams (mg) Baricitinib 4 mg Baricitinib Placebo to 2 mg Baricitinib Placebo to 4 mg Baricitinib
    Number of subjects analysed
    289
    261
    136
    143
    Units: flares per year
        number (not applicable)
    0.978
    0.926
    0.894
    0.746
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Total Activity Score ≥10 at Baseline with ≥50% Reduction in CLASI Total Activity Score

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    End point title
    		 Percentage of Participants with Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Total Activity Score ≥10 at Baseline with ≥50% Reduction in CLASI Total Activity Score
    End point description
    The CLASI is a single-page tool that separately quantifies disease activity and damage. For the activity score, points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. The total score represents the sum of the individual scores and ranges from 0 to 70. Higher scores are awarded for more severe manifestations. APD: All participants with CLASI Total Activity Score >= 10 at baseline. Due to early termination of the study, this population consisted of participants who completed Week 48 treatment, or discontinued treatment prior to Week 48 (but not due to study termination).
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 2 milligrams (mg) Baricitinib 4 mg Baricitinib Placebo to 2 mg Baricitinib Placebo to 4 mg Baricitinib
    Number of subjects analysed
    59
    50
    5
    5
    Units: Percentage of participants
        number (not applicable)
    55.9
    64.0
    60.0
    20.0
    No statistical analyses for this end point

    Secondary: Change from Baseline in Tender Joint Count

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    End point title
    		 Change from Baseline in Tender Joint Count
    End point description
    The number of tender and painful joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. The joints are assessed and classified as tender or not tender. LS mean was calculated using Mixed Model Repeated Measures (MMRM) analysis with treatment, baseline disease activity (total SLEDAI-2K <10; >=10), baseline corticosteroid dose (<10 mg/day; >=10 mg/day prednisone or equivalent), region (North America, Central/South America/Mexico, Europe, Asia and Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 48 APD: This population consisted of participants who completed Week 48 treatment, or discontinued treatment prior to Week 48 (but not due to study termination). Participants having values for this outcome were included.
    End point values
    		 2 milligrams (mg) Baricitinib 4 mg Baricitinib Placebo to 2 mg Baricitinib Placebo to 4 mg Baricitinib
    Number of subjects analysed
    230
    217
    113
    119
    Units: tender joints
        least squares mean (standard error)
    -5.68 ± 0.281
    -5.85 ± 0.292
    -3.62 ± 0.383
    -3.73 ± 0.376
    No statistical analyses for this end point

    Secondary: Change from Baseline in Swollen Joint Count

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    End point title
    		 Change from Baseline in Swollen Joint Count
    End point description
    The number of swollen joints is determined by examination of 28 joints (14 on each side) which include: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. The joints are assessed and classified as swollen or not swollen. LS mean was calculated using MMRM analysis with treatment, baseline disease activity (total SLEDAI-2K <10; >=10), baseline corticosteroid dose (<10 mg/day; >=10 mg/day prednisone or equivalent), region (North America, Central/South America/Mexico, Europe, Asia and Rest of World), visit (as categorical variable), baseline value, treatment-by-visit interaction, and baseline value-by-visit interaction. APD: This population consisted of participants who completed Week 48 treatment, or discontinued treatment prior to Week 48 (but not due to study termination). Participants having values for this outcome were included.
    End point type
    Secondary
    End point timeframe
    Baseline trough Week 48
    End point values
    		 2 milligrams (mg) Baricitinib 4 mg Baricitinib Placebo to 2 mg Baricitinib Placebo to 4 mg Baricitinib
    Number of subjects analysed
    230
    217
    113
    119
    Units: swollen joints
        least squares mean (standard error)
    -4.03 ± 0.191
    -4.01 ± 0.196
    -3.19 ± 0.264
    -2.94 ± 0.257
    No statistical analyses for this end point

    Secondary: Change from Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Total Score

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    End point title
    		 Change from Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Total Score
    End point description
    The SLICC/ACR damage index is a validated instrument to assess damage, defined as irreversible impairment, continuously persistent for 6 months (ascertained by clinical assessment), occurring since the onset of lupus, and it is based on a weighted scoring system. This index records damage occurring in participants with SLE regardless of cause, with demonstrated content, face, criterion, and discriminant validity. A score of 0 indicates no damage. Total maximum score is 47 and increasing score indicates increasing disease severity. APD: Due to early termination of the study, this population consisted of participants who completed Week 48 treatment, or discontinued treatment prior to Week 48 (but not due to study termination). Participants having values for this outcome were included.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 48
    End point values
    		 2 milligrams (mg) Baricitinib 4 mg Baricitinib Placebo to 2 mg Baricitinib Placebo to 4 mg Baricitinib
    Number of subjects analysed
    235
    226
    115
    121
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -0.03 ± 0.569
    -0.04 ± 0.544
    -0.04 ± 0.754
    -0.06 ± 0.505
    No statistical analyses for this end point

    Secondary: Change from Baseline in Worst Pain Numeric Rating Scale (NRS)

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    End point title
    		 Change from Baseline in Worst Pain Numeric Rating Scale (NRS)
    End point description
    Change from baseline in Worst Pain NRS. It is assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". Overall severity of a patient's pain is indicated by selecting the number that best describes the worst level of pain during the past 7 days. APD: Due to early termination of the study, this population consisted of participants who completed Week 48 treatment, or discontinued treatment prior to Week 48 (but not due to study termination). Participants having values for this outcome were included.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 48
    End point values
    		 2 milligrams (mg) Baricitinib 4 mg Baricitinib Placebo to 2 mg Baricitinib Placebo to 4 mg Baricitinib
    Number of subjects analysed
    220
    207
    111
    118
    Units: Score on a scale
        least squares mean (standard error)
    -0.96 ± 0.167
    -1.23 ± 0.173
    -0.55 ± 0.222
    -0.83 ± 0.218
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline through Study Completion (Up to 134 Weeks)
    Adverse event reporting additional description
    All participants who received at least one dose of study drug in Study JAIM and who did not discontinue from the study for the reason of Lost to Follow-up at the first post baseline visit (Safety Population). Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    2 mg Baricitinib
    Reporting group description
    		 Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.

    Reporting group title
    4 mg Baricitinib
    Reporting group description
    		 Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.

    Reporting group title
    Placebo to 2 mg Baricitinib
    Reporting group description
    		 Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.

    Reporting group title
    Placebo to 4 mg Baricitinib
    Reporting group description
    		 Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.

    Serious adverse events
    		 2 mg Baricitinib 4 mg Baricitinib Placebo to 2 mg Baricitinib Placebo to 4 mg Baricitinib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    43 / 388 (11.08%)
    53 / 378 (14.02%)
    21 / 189 (11.11%)
    22 / 191 (11.52%)
         number of deaths (all causes)
    0
    6
    2
    0
         number of deaths resulting from adverse events
    0
    6
    2
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    colon adenoma
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    extranodal marginal zone b-cell lymphoma (malt type)
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    her2 positive breast cancer
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    invasive ductal breast carcinoma
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lung adenocarcinoma
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    metastases to liver
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    non-hodgkin's lymphoma
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    squamous cell carcinoma
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    squamous cell carcinoma of skin
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    uterine leiomyoma
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed [1]
    0 / 361 (0.00%)
    0 / 356 (0.00%)
    1 / 181 (0.55%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    accelerated hypertension
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    aortic stenosis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    deep vein thrombosis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    embolism arterial
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    jugular vein thrombosis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    raynaud's phenomenon
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    cervical conisation
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed [2]
    0 / 361 (0.00%)
    0 / 356 (0.00%)
    1 / 181 (0.55%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cholecystectomy
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    fasciotomy
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    abortion spontaneous
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed [3]
    0 / 361 (0.00%)
    1 / 356 (0.28%)
    0 / 181 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    pain
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pyrexia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    anaphylactic reaction
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    cervical dysplasia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed [4]
    2 / 361 (0.55%)
    1 / 356 (0.28%)
    0 / 181 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    endometriosis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed [5]
    0 / 361 (0.00%)
    1 / 356 (0.28%)
    0 / 181 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    acute respiratory distress syndrome
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    dysphonia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pleural effusion
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    2 / 388 (0.52%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pleurisy
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pulmonary embolism
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    2 / 378 (0.53%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pulmonary hypertension
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    acute psychosis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    depression suicidal
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hallucination
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    suicide attempt
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    biopsy
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    clostridium test positive
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    herpes simplex test positive
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    international normalised ratio increased
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    hand fracture
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ligament rupture
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    radius fracture
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    road traffic accident
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    upper limb fracture
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    wrist fracture
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    acute myocardial infarction
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    angina unstable
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    atrial fibrillation
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    atrial flutter
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cardiac failure congestive
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cardio-respiratory arrest
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    myocardial infarction
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pericardial effusion
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    2 / 388 (0.52%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    autoimmune neuropathy
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    central nervous system lupus
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cerebral infarction
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cerebral ischaemia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cognitive disorder
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hypoaesthesia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ischaemic stroke
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    seizure
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    syncope
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    immune thrombocytopenia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    scleritis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    colitis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    diarrhoea
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    dysphagia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    erosive oesophagitis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    small intestinal obstruction
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    vomiting
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    2 / 388 (0.52%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    bile duct stone
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cholecystitis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cholecystitis chronic
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cholelithiasis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    2 / 191 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    immune-mediated hepatic disorder
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    rosacea
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    stevens-johnson syndrome
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    acute kidney injury
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    calculus urinary
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    glomerulonephritis membranous
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lupus nephritis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    nephrolithiasis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    proteinuria
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    renal impairment
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    urinary incontinence
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    arthritis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    2 / 191 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    back pain
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    compartment syndrome
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    joint instability
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    musculoskeletal chest pain
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    osteoarthritis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    osteonecrosis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    3 / 189 (1.59%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pain in extremity
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    systemic lupus erythematosus
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    2 / 388 (0.52%)
    5 / 378 (1.32%)
    1 / 189 (0.53%)
    3 / 191 (1.57%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    1 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    tendon sheath disorder
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    acinetobacter sepsis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    appendicitis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    arthritis bacterial
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    atypical pneumonia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bronchitis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    covid-19
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    7 / 378 (1.85%)
    3 / 189 (1.59%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 7
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 2
    1 / 1
    0 / 0
    covid-19 pneumonia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    5 / 388 (1.29%)
    5 / 378 (1.32%)
    0 / 189 (0.00%)
    3 / 191 (1.57%)
         occurrences causally related to treatment / all
    1 / 5
    1 / 5
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    cellulitis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    2 / 378 (0.53%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cystitis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cytomegalovirus infection reactivation
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    endocarditis bacterial
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    escherichia pyelonephritis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    3 / 191 (1.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    escherichia urinary tract infection
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastroenteritis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastroenteritis salmonella
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastroenteritis viral
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    herpes zoster
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    herpes zoster meningitis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    infection
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    influenza
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lower respiratory tract infection
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lower respiratory tract infection bacterial
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    meningitis bacterial
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    osteomyelitis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    4 / 388 (1.03%)
    1 / 378 (0.26%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonia parainfluenzae viral
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonia viral
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    post procedural infection
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pulmonary tuberculosis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pyelonephritis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pyelonephritis acute
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    1 / 189 (0.53%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    renal abscess
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sinusitis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    tubo-ovarian abscess
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed [6]
    1 / 361 (0.28%)
    0 / 356 (0.00%)
    0 / 181 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    urinary tract infection
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    2 / 378 (0.53%)
    1 / 189 (0.53%)
    2 / 191 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    3 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 388 (0.00%)
    1 / 378 (0.26%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    dehydration
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hypomagnesaemia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 388 (0.26%)
    0 / 378 (0.00%)
    0 / 189 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly..
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly..
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 2 mg Baricitinib 4 mg Baricitinib Placebo to 2 mg Baricitinib Placebo to 4 mg Baricitinib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    54 / 388 (13.92%)
    54 / 378 (14.29%)
    35 / 189 (18.52%)
    29 / 191 (15.18%)
    Infections and infestations
    covid-19
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    35 / 388 (9.02%)
    32 / 378 (8.47%)
    21 / 189 (11.11%)
    23 / 191 (12.04%)
         occurrences all number
    35
    33
    22
    25
    urinary tract infection
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    20 / 388 (5.15%)
    22 / 378 (5.82%)
    17 / 189 (8.99%)
    7 / 191 (3.66%)
         occurrences all number
    28
    27
    19
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Nov 2019
    - Removed secondary endpoints due to categorical nature not appropriate for long term study; - Information about study visits were updated; - Updated information about inclusion criteria, packaging and labelling, timing of doses, and blinding for better clarity; - Updated text related to temporary interruption of investigational product, efficacy and safety analyses, adverse events for better clarity.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    This study was terminated due to insufficient evidence to support a positive benefit: risk profile. Safety findings were consistent with previously published OLUMIANT data.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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