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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Crohn's Disease (CD): AIM-CD

    Summary
    EudraCT number
    		 2021-002869-18
    Trial protocol
    		 ES   DE   BE   IT   GR   NL   CZ   BG   SK   HU  
    Global end of trial date
    20 Jul 2023

    Results information
    Results version number
    		 v1
    This version publication date
    02 Aug 2024
    First version publication date
    02 Aug 2024
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    M20-371
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05068284
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6 4UB
    Public contact
    Global Medical Services, AbbVie, Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    Global Medical Services, AbbVie, Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Jul 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jul 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    ABBV-154 is an investigational drug being evaluated for the treatment of Crohn's disease (CD). In the induction period, there is a 1 in 5 chance that participants will be assigned to placebo. Depending on the dose received in the induction period, there is a 1 in 2 or 1 in 3 chance that participants will be assigned to placebo in the maintenance period. Around 265 participants 18-75 yrs of age with moderately to severely active CD will be enrolled in the study at approximately 200 sites worldwide. The study is comprised of a 12-week double-blind, placebo-controlled induction period, followed by either a 12-week double-blind re-induction period for non-responders or a 40-week double-blind placebo-controlled maintenance period for responders. In the maintenance period, responders will be randomized to receive subcutaneous placebo or ABBV-154 in 2 different doses every other week. Participants in the placebo group who are initial responders will receive ABBV-154 in the maintenance period.
    Protection of trial subjects
    The investigator or his/her representative will explain the nature of the study to the subject, the benefits and risks anticipated from participation in the study, and answer all questions regarding this study. Prior to any study-related screening procedures being performed on the subject or any medications being discontinued by the subject in order to participate in this study, the informed consent statement will be reviewed, signed, and dated by the subject, the person who administered the informed consent, and any other signatories according to local requirements. A copy of the signed informed consent will be given to the subject and the original will be placed in the subject's medical record. An entry must also be made in the subject's dated source documents to confirm that informed consent was obtained prior to any study-related procedures and that the subject received a signed copy.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Jan 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 7
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    Bulgaria: 1
    Country: Number of subjects enrolled
    Canada: 3
    Country: Number of subjects enrolled
    France: 5
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Greece: 3
    Country: Number of subjects enrolled
    Israel: 3
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Japan: 20
    Country: Number of subjects enrolled
    Netherlands: 4
    Country: Number of subjects enrolled
    New Zealand: 2
    Country: Number of subjects enrolled
    Poland: 2
    Country: Number of subjects enrolled
    Slovakia: 6
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Taiwan: 1
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    United States: 30
    Worldwide total number of subjects
    106
    EEA total number of subjects
    39
    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)
    100
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Randomized into 5 Grps for 12 Wks (Induction Period [IP]). At Wk 12, subjects were categorized as responders or non-responders. Responders were re-randomized into a 40-Wk Maintenance Period (MP). Non-responders were re-randomized into the 12-Wk Re-IP. At Wk 12 of the Re-IP, those achieving clinical/endoscopic response were re-randomized into MP.

    Pre-assignment
    Screening details
    		 The N=24 non-responders were re-randomized into the 12-Wk Re-Induction Period as follows: ABBV-154 300mg IV, 230mg SC EOW N=12 started of which N=9 completed, N=1 study terminated by sponsor, N=2 lack of efficacy; ABBV-154 600mg IV, 530mg SC EOW N=12 started of which N=6 completed, N=2 adverse event, non-fatal, N=4 study terminated by sponsor.

    Period 1
    Period 1 title
    Double-Blind Induction (12 weeks)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received Placebo Intravenous (IV) during Week (Wk) 0, followed by Placebo Subcutaneous (SC) Every Other Week (EOW) until Week 12.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion, Solution for solution for injection
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Participants received Placebo Intravenous (IV) during Week (Wk) 0, followed by Placebo Subcutaneous (SC)Every Other Week (EOW) until Week 12.

    Arm title
    		 ABBV-154 150mg IV, 80mg SC EOW
    Arm description
    		 Participants received a loading dose of 150mg IV of ABBV-154 during Wk 0, followed by ABBV-154 80mg SC during Wk 2 and EOW until Week 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABBV-154
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion, Solution for solution for injection
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Participants received a loading dose of 150mg IV of ABBV-154 during Wk 0, followed by ABBV-154 80mg SC during Wk 2 and EOW until Week 12.

    Arm title
    		 ABBV-154 300mg IV, 230mg SC EOW
    Arm description
    		 Participants received 300mg IV of ABBV-154 during Wk 0, followed by ABBV-154 230mg SC during Wk 2 and EOW until Week 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABBV-154
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion, Solution for solution for injection
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Participants received 300mg IV of ABBV-154 during Wk 0, followed by ABBV-154 230mg SC during Wk 2 and EOW until Week 12.

    Arm title
    		 ABBV-154 600mg IV, 530mg SC EOW
    Arm description
    		 Participants received 600mg IV of ABBV-154 during Wk 0, followed by ABBV-154 530mg SC during Wk 2 and EOW until Week 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABBV-154
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion, Solution for solution for injection
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Participants received 600mg IV of ABBV-154 during Wk 0, followed by ABBV-154 530mg SC during Wk 2 and EOW until Week 12.

    Arm title
    		 ABBV-154 600mg IV, 530mg SC E4W
    Arm description
    		 Participants received 600mg IV of ABBV-154 during Wk 0, followed by ABBV-154 530mg SC during Wk 4; every 4 weeks (E4W).
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABBV-154
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion, Solution for solution for injection
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Participants received 600mg IV of ABBV-154 during Wk 0, followed by ABBV-154 530mg SC during Wk 4; every 4 weeks (E4W).

    Number of subjects in period 1
    		Placebo ABBV-154 150mg IV, 80mg SC EOW ABBV-154 300mg IV, 230mg SC EOW ABBV-154 600mg IV, 530mg SC EOW ABBV-154 600mg IV, 530mg SC E4W
    Started
    21
    20
    22
    20
    23
    Completed
    12
    15
    12
    15
    12
    Not completed
    9
    5
    10
    5
    11
         Consent withdrawn by subject
    2
    3
    -
    -
    -
         Adverse event, non-fatal
    -
    -
    3
    -
    -
         Study terminated by sponsor
    7
    2
    6
    5
    10
         Lack of efficacy
    -
    -
    1
    -
    1
    Period 2
    Period 2 title
    Double-Blind Maintenance (40 Weeks)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 During the Maintenance Period, participants received Placebo SC, EOW for 40 weeks. No IV was administered during the Maintenance Period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    During the Maintenance Period, participants received Placebo SC, EOW for 40 weeks.

    Arm title
    		 ABBV-154 80mg SC EOW
    Arm description
    		 During the Maintenance Period, participants received ABBV-154 80mg SC only. No IV was administered during the Maintenance Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABBV-154
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    During the Maintenance Period, participants received ABBV-154 80mg SC only.

    Arm title
    		 ABBV-154 230mg SC EOW
    Arm description
    		 During the Maintenance Period, participants received ABBV-154 230mg SC only. No IV was administered during the Maintenance Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABBV-154
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    During the Maintenance Period, participants received ABBV-154 230mg SC only.

    Arm title
    		 ABBV-154 80mg SC EOW, Non-Randomized
    Arm description
    		 During the Maintenance Period, placebo responders received ABBV-154 80mg SC only. No IV was administered during the Maintenance Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABBV-154
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    During the Maintenance Period, placebo responders received ABBV-154 80mg SC only.

    Number of subjects in period 2 [1]
    		Placebo ABBV-154 80mg SC EOW ABBV-154 230mg SC EOW ABBV-154 80mg SC EOW, Non-Randomized
    Started
    18
    14
    13
    4
    Completed
    0
    1
    0
    0
    Not completed
    18
    13
    13
    4
         Lack of efficacy w/o receiving ABBV-154 rescue
    1
    -
    -
    -
         Study terminated by sponsor after ABBV-154 rescue
    8
    3
    1
    -
         AE w/o receiving ABBV-154 rescue
    1
    -
    1
    -
         WD by subject w/o receiving ABBV-154 rescue
    1
    -
    -
    -
         Not specified
    -
    -
    -
    1
         Lack of efficacy after receiving ABBV-154 rescue
    1
    -
    -
    -
         Study terminated by sponsor w/o ABBV-154 rescue
    6
    10
    11
    3
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Randomized into 5 Grps for 12 Wks (Induction Period [IP]). At Wk 12, subjects were categorized as responders or non-responders. Responders were re-randomized into a 40-Wk Maintenance Period (MP). Non-responders were re-randomized into the 12-Wk Re-IP. At Wk 12 of the Re-IP, those achieving clinical/endoscopic response were re-randomized into MP.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received Placebo Intravenous (IV) during Week (Wk) 0, followed by Placebo Subcutaneous (SC) Every Other Week (EOW) until Week 12.

    Reporting group title
    ABBV-154 150mg IV, 80mg SC EOW
    Reporting group description
    		 Participants received a loading dose of 150mg IV of ABBV-154 during Wk 0, followed by ABBV-154 80mg SC during Wk 2 and EOW until Week 12.

    Reporting group title
    ABBV-154 300mg IV, 230mg SC EOW
    Reporting group description
    		 Participants received 300mg IV of ABBV-154 during Wk 0, followed by ABBV-154 230mg SC during Wk 2 and EOW until Week 12.

    Reporting group title
    ABBV-154 600mg IV, 530mg SC EOW
    Reporting group description
    		 Participants received 600mg IV of ABBV-154 during Wk 0, followed by ABBV-154 530mg SC during Wk 2 and EOW until Week 12.

    Reporting group title
    ABBV-154 600mg IV, 530mg SC E4W
    Reporting group description
    		 Participants received 600mg IV of ABBV-154 during Wk 0, followed by ABBV-154 530mg SC during Wk 4; every 4 weeks (E4W).

    Reporting group values
    		 Placebo ABBV-154 150mg IV, 80mg SC EOW ABBV-154 300mg IV, 230mg SC EOW ABBV-154 600mg IV, 530mg SC EOW ABBV-154 600mg IV, 530mg SC E4W Total
    Number of subjects
    		 21 20 22 20 23 106
    Age categorical
    Units: Subjects
        ≥ 18 - < 40 years
    		 14 11 10 8 12 55
        ≥ 40 - < 65 years
    		 6 8 11 11 9 45
        ≥ 65 years
    		 1 1 1 1 2 6
    Age continuous
    Double-Blind Induction Phase
    Units: years
        arithmetic mean (standard deviation)
    		 38.8 ( 13.23 ) 41.7 ( 14.27 ) 39.6 ( 12.23 ) 43.1 ( 14.37 ) 42.0 ( 14.20 ) -
    Gender categorical
    Double-Blind Induction Phase
    Units: Subjects
        Female
    		 8 8 8 9 10 43
        Male
    		 13 12 14 11 13 63
    Ethnicity (NIH/OMB)
    Double-Blind Induction Phase
    Units: Subjects
        Hispanic or Latino
    		 0 0 1 0 0 1
        Not Hispanic or Latino
    		 21 20 21 20 23 105
        Unknown or Not Reported
    		 0 0 0 0 0 0
    Race (NIH/OMB)
    Double-Blind Induction Phase
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0 0
        Asian
    		 4 5 4 5 4 22
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0
        Black or African American
    		 0 0 0 1 2 3
        White
    		 17 15 17 14 17 80
        More than one race
    		 0 0 1 0 0 1
        Unknown or Not Reported
    		 0 0 0 0 0 0
    Baseline Simple Endoscopic Score for Crohn's Disease (SES-CD) for ITT1 (all enrolled)
    Double-Blind Induction Phase. Measure Description: ITT1 population; all enrolled. Note: Percentages calculated on non-missing values.
    Units: Simplified Endoscopic Score for CD
        arithmetic mean (standard deviation)
    		 14.86 ( 8.928 ) 13.53 ( 6.816 ) 16.73 ( 10.533 ) 16.13 ( 6.472 ) 14.65 ( 6.748 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received Placebo Intravenous (IV) during Week (Wk) 0, followed by Placebo Subcutaneous (SC) Every Other Week (EOW) until Week 12.

    Reporting group title
    ABBV-154 150mg IV, 80mg SC EOW
    Reporting group description
    		 Participants received a loading dose of 150mg IV of ABBV-154 during Wk 0, followed by ABBV-154 80mg SC during Wk 2 and EOW until Week 12.

    Reporting group title
    ABBV-154 300mg IV, 230mg SC EOW
    Reporting group description
    		 Participants received 300mg IV of ABBV-154 during Wk 0, followed by ABBV-154 230mg SC during Wk 2 and EOW until Week 12.

    Reporting group title
    ABBV-154 600mg IV, 530mg SC EOW
    Reporting group description
    		 Participants received 600mg IV of ABBV-154 during Wk 0, followed by ABBV-154 530mg SC during Wk 2 and EOW until Week 12.

    Reporting group title
    ABBV-154 600mg IV, 530mg SC E4W
    Reporting group description
    		 Participants received 600mg IV of ABBV-154 during Wk 0, followed by ABBV-154 530mg SC during Wk 4; every 4 weeks (E4W).
    Reporting group title
    Placebo
    Reporting group description
    		 During the Maintenance Period, participants received Placebo SC, EOW for 40 weeks. No IV was administered during the Maintenance Period.

    Reporting group title
    ABBV-154 80mg SC EOW
    Reporting group description
    		 During the Maintenance Period, participants received ABBV-154 80mg SC only. No IV was administered during the Maintenance Period.

    Reporting group title
    ABBV-154 230mg SC EOW
    Reporting group description
    		 During the Maintenance Period, participants received ABBV-154 230mg SC only. No IV was administered during the Maintenance Period.

    Reporting group title
    ABBV-154 80mg SC EOW, Non-Randomized
    Reporting group description
    		 During the Maintenance Period, placebo responders received ABBV-154 80mg SC only. No IV was administered during the Maintenance Period.

    Primary: Percentage of Participants Achieving Endoscopic Response per Simple Endoscopic Score for Crohn's Disease (SES-CD)

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    End point title
    		 Percentage of Participants Achieving Endoscopic Response per Simple Endoscopic Score for Crohn's Disease (SES-CD)
    End point description
    The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline). Analysis Population Description: ITT1 Population - All enrolled.
    End point type
    Primary
    End point timeframe
    Induction Period Week 12
    End point values
    		 Placebo ABBV-154 150mg IV, 80mg SC EOW ABBV-154 300mg IV, 230mg SC EOW ABBV-154 600mg IV, 530mg SC EOW ABBV-154 600mg IV, 530mg SC E4W
    Number of subjects analysed
    11
    14
    12
    14
    11
    Units: percentage of participants
        number (not applicable)
    0
    7.1
    33.3
    28.6
    27.3
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Risk difference = (ABBV-154 - placebo)
    Comparison groups
    Placebo v ABBV-154 150mg IV, 80mg SC EOW
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    7.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.3
         upper limit
    		 20.6
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Risk difference = (ABBV-154 - placebo)
    Comparison groups
    Placebo v ABBV-154 300mg IV, 230mg SC EOW
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    33.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.7
         upper limit
    		 60
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Risk difference = (ABBV-154 - placebo)
    Comparison groups
    Placebo v ABBV-154 600mg IV, 530mg SC EOW
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    28.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.9
         upper limit
    		 52.2
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    Risk difference = (ABBV-154 - placebo)
    Comparison groups
    Placebo v ABBV-154 600mg IV, 530mg SC E4W
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    27.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 53.6

    Secondary: Percentage of Participants Achieving Clinical Remission per SF/AP

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    End point title
    		 Percentage of Participants Achieving Clinical Remission per SF/AP
    End point description
    Clinical remission is defined as average daily liquid or very soft SF <= 2.8 and not worse than Baseline and average daily AP score <= 1 and not worse than Baseline. Data were not collected for this outcome due to early termination of the study.
    End point type
    Secondary
    End point timeframe
    Week 40 in the Maintenance Period
    End point values
    		 Placebo ABBV-154 80mg SC EOW ABBV-154 230mg SC EOW
    Number of subjects analysed
    0 [1]
    0 [2]
    0 [3]
    Units: Overall Number of Participants Analyzed
    Notes
    [1] - Data were not collected for this Outcome Measure due to early termination of the study.
    [2] - Data were not collected for this Outcome Measure due to early termination of the study.
    [3] - Data were not collected for this Outcome Measure due to early termination of the study.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Endoscopic Response per SES-CD

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    End point title
    		 Percentage of Participants Achieving Endoscopic Response per SES-CD
    End point description
    The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline). Data were not collected for this outcome due to early termination of the study.
    End point type
    Secondary
    End point timeframe
    Week 40 in the Maintenance Period
    End point values
    		 Placebo ABBV-154 80mg SC EOW ABBV-154 230mg SC EOW
    Number of subjects analysed
    0 [4]
    0 [5]
    0 [6]
    Units: Overall Number of Participants Analyzed
    Notes
    [4] - No data displayed because Outcome Measure has zero total participants analyzed.
    [5] - No data displayed because Outcome Measure has zero total participants analyzed.
    [6] - No data displayed because Outcome Measure has zero total participants analyzed.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Clinical Remission per CDAI

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    End point title
    		 Percentage of Participants Achieving Clinical Remission per CDAI
    End point description
    The CDAI consists of 8 components; 6 are based on participant diary entries, participant interviews, and physical examinations, and 2 are based on laboratory analysis, and measurement of body weight and height. Clinical remission is defined as CDAI < 150. Data were not collected for this outcome due to early termination of the study.
    End point type
    Secondary
    End point timeframe
    Week 40 in the Maintenance Period
    End point values
    		 Placebo ABBV-154 80mg SC EOW ABBV-154 230mg SC EOW
    Number of subjects analysed
    0 [7]
    0 [8]
    0 [9]
    Units: Overall Number of Participants Analyzed
    Notes
    [7] - Data were not collected for this Outcome Measure due to early termination of the study.
    [8] - Data were not collected for this Outcome Measure due to early termination of the study.
    [9] - Data were not collected for this Outcome Measure due to early termination of the study.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI)

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    End point title
    		 Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI)
    End point description
    The CDAI consists of 8 components; 6 are based on participant diary entries, participant interviews, and physical examinations, and 2 are based on laboratory analysis, and measurement of body weight and height. Clinical remission is defined as CDAI < 150. Analysis Population Description: ITT1 Population - All enrolled.
    End point type
    Secondary
    End point timeframe
    Induction Period Week 12
    End point values
    		 Placebo ABBV-154 150mg IV, 80mg SC EOW ABBV-154 300mg IV, 230mg SC EOW ABBV-154 600mg IV, 530mg SC EOW ABBV-154 600mg IV, 530mg SC E4W
    Number of subjects analysed
    12
    14
    13
    14
    10
    Units: percentage of participants
        number (not applicable)
    16.7
    28.6
    46.2
    35.7
    40
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v ABBV-154 150mg IV, 80mg SC EOW
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [10]
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    11.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.8
         upper limit
    		 43.6
    Notes
    [10] - Risk difference = (ABBV-154 - placebo)
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v ABBV-154 300mg IV, 230mg SC EOW
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [11]
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    29.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.8
         upper limit
    		 63.8
    Notes
    [11] - Risk difference = (ABBV-154 - placebo)
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Risk difference = (ABBV-154 - placebo)
    Comparison groups
    Placebo v ABBV-154 600mg IV, 530mg SC EOW
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.7
         upper limit
    		 51.8
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    Risk difference = (ABBV-154 - placebo)
    Comparison groups
    Placebo v ABBV-154 600mg IV, 530mg SC E4W
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    23.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.6
         upper limit
    		 60.3

    Secondary: Percentage of Participants Achieving Clinical Remission per Average Daily Liquid or Very Soft Stool Frequency (SF) andAverage Daily Abdominal Pain (AP) Score (SF/AP)

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    End point title
    		 Percentage of Participants Achieving Clinical Remission per Average Daily Liquid or Very Soft Stool Frequency (SF) andAverage Daily Abdominal Pain (AP) Score (SF/AP)
    End point description
    Clinical remission is defined as average daily liquid or very soft SF <= 2.8 and not worse than Baseline and average daily AP score <= 1 and not worse than Baseline. Analysis Population Description: ITT1 - All enrolled.
    End point type
    Secondary
    End point timeframe
    Induction Period Week 12
    End point values
    		 Placebo ABBV-154 150mg IV, 80mg SC EOW ABBV-154 300mg IV, 230mg SC EOW ABBV-154 600mg IV, 530mg SC EOW ABBV-154 600mg IV, 530mg SC E4W
    Number of subjects analysed
    13
    15
    13
    15
    11
    Units: percentage of participants
        number (not applicable)
    15.4
    26.7
    53.8
    40
    54.5
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v ABBV-154 150mg IV, 80mg SC EOW
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [12]
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    11.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.5
         upper limit
    		 41
    Notes
    [12] - Risk difference = (ABBV-154 - placebo)
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Risk difference = (ABBV-154 - placebo)
    Comparison groups
    Placebo v ABBV-154 300mg IV, 230mg SC EOW
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    38.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5
         upper limit
    		 71.9
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Risk difference = (ABBV-154 - placebo)
    Comparison groups
    Placebo v ABBV-154 600mg IV, 530mg SC EOW
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    24.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7
         upper limit
    		 56.2
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    Risk difference = (ABBV-154 - placebo)
    Comparison groups
    Placebo v ABBV-154 600mg IV, 530mg SC E4W
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    39.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.8
         upper limit
    		 74.5

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality were reported from enrollment to study termination, median time on follow up was 85 days(d) for Placebo and ABBV-154 150 IV/80 SC; 87.5d for ABBV-154 300 IV/230 SC; 86d for ABBV-154 600IV/530 SC; and 84d for ABBV-154 600 IV/530 SC E4W.
    Adverse event reporting additional description
    Treatment-emergent and serious AE were collected from first dose until 70d after last dose; mean duration on study drug was 12 weeks for each group.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    IP_Pbo
    Reporting group description
    		 Participants received Placebo Intravenous (IV) during Week (Wk) 0, followed by Placebo Subcutaneous (SC)Every Other Week (EOW) until Week 12

    Reporting group title
    P_ABBV-154_150mg_IV_80mg_SC_EOW
    Reporting group description
    		 Participants received 150mg IV of ABBV-154 during Wk 0, followed by ABBV-154 80mg SC during Wk 2 and EOW until Week 12

    Reporting group title
    IP_ABBV-154_600mg_IV_530mg_SC_E4W
    Reporting group description
    		 Participants received 600mg IV of ABBV-154 during Wk 0, followed by ABBV-154 530mg SC during Wk 4 and Wk 8; every 4 weeks (E4W)

    Reporting group title
    IP_Pbo_ReIP_ABBV-154_300mg_IV_230mg_SC_EOW
    Reporting group description
    		 Following Induction Period (IP): Non-responding, Placebo-dosed Participants were re-induced (ReIP) with ABBV-154 300mg IV (Wk 12), followed by 230mg SC (Wk 14) and EOW until Wk 24

    Reporting group title
    Rescue_ABBV-154_600mg_IV_230_mg_SC_EOW
    Reporting group description
    		 During MP: Inadequate-Responding, Placebo or ABBV-154-dosed Participants received ABBV-154 600mg IV followed by 230mg SC Rescue Therapy

    Reporting group title
    IP_ABBV-154_ReIP_ABBV-154_300mg_IV_230mg_SC_EOW
    Reporting group description
    		 Participants received 300mg IV of ABBV-154 during Wk 0, followed by ABBV-154 230mg SC during Wk 2 and EOW until Week 12

    Reporting group title
    IP_ABBV-154_ReIP_ABBV-154_600mg_IV_530mg_SC_EOW
    Reporting group description
    		 Participants received 600mg IV of ABBV-154 during Wk 0, followed by ABBV-154 530mg SC during Wk 2 and EOW until Week 12

    Reporting group title
    MP_Rand_Pbo
    Reporting group description
    		 Following IP: Responding, ABBV-154-dosed Participants received Placebo SC EOW during the maintenance period (MP) of 40 weeks

    Reporting group title
    MP_Rand_ABBV-154_80mg_SC_EOW
    Reporting group description
    		 Following IP: Responding, ABBV-154-dosed Participants received ABBV-154 80mg SC EOW during the maintenance period (MP) of 40 weeks

    Reporting group title
    MP_Rand_ABBV-154_230mg_SC_EOW
    Reporting group description
    		 Following IP: Responding, ABBV-154-dosed Participants received ABBV-154 230mg SC EOW during the maintenance period (MP) of 40 weeks

    Reporting group title
    MP_Non-Rand_ABBV-154_80mg_SC_EOW
    Reporting group description
    		 Following IP: Responding, Placebo-dosed Participants received ABBV-154 80mg SC EOW during the maintenance period (MP) of 40 weeks

    Reporting group title
    IP_ABBV-154_600mg_IV_530mg_SC_EOW
    Reporting group description
    		 Following IP: Non-responding, Placebo-dosed Participants were ReIP with ABBV-154 600mg IV (Wk 12), followed by 530mg SC (Wk 14) and EOW until Wk 24

    Reporting group title
    IP_ABBV-154_300mg_IV_230mg_SC_EOW
    Reporting group description
    		 Following IP: Non-responding, ABBV-154-dosed Participants were ReIP with ABBV-154 300mg IV (Wk 12), followed by 230mg SC (Wk 14) and EOW until Wk 24

    Reporting group title
    IP_Pbo_ReIP_ABBV-154_600mg_IV_530mg_SC_EOW
    Reporting group description
    		 Following IP: Non-responding, ABBV-154-dosed Participants were ReIP with ABBV-154 600mg IV (Wk 12), followed by 530mg SC (Wk 14) and EOW until Wk 24

    Serious adverse events
    		 IP_Pbo P_ABBV-154_150mg_IV_80mg_SC_EOW IP_ABBV-154_600mg_IV_530mg_SC_E4W IP_Pbo_ReIP_ABBV-154_300mg_IV_230mg_SC_EOW Rescue_ABBV-154_600mg_IV_230_mg_SC_EOW IP_ABBV-154_ReIP_ABBV-154_300mg_IV_230mg_SC_EOW IP_ABBV-154_ReIP_ABBV-154_600mg_IV_530mg_SC_EOW MP_Rand_Pbo MP_Rand_ABBV-154_80mg_SC_EOW MP_Rand_ABBV-154_230mg_SC_EOW MP_Non-Rand_ABBV-154_80mg_SC_EOW IP_ABBV-154_600mg_IV_530mg_SC_EOW IP_ABBV-154_300mg_IV_230mg_SC_EOW IP_Pbo_ReIP_ABBV-154_600mg_IV_530mg_SC_EOW
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 21 (14.29%)
    3 / 20 (15.00%)
    2 / 23 (8.70%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
    1 / 8 (12.50%)
    2 / 8 (25.00%)
    3 / 18 (16.67%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    2 / 22 (9.09%)
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    INFLAMMATION
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    INFUSION RELATED HYPERSENSITIVITY REACTION
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SERUM SICKNESS
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    CROHN'S DISEASE
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    1 / 23 (4.35%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    1 / 18 (5.56%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SMALL INTESTINAL OBSTRUCTION
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    FEMALE GENITAL TRACT FISTULA
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    ANAL ABSCESS
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ABDOMINAL ABSCESS
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    APPENDICITIS
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COLONIC ABSCESS
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    FOCAL PERITONITIS
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    INFECTION
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    INFECTIOUS PLEURAL EFFUSION
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    URINARY TRACT INFECTION
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 23 (4.35%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    HYPOKALAEMIA
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 IP_Pbo P_ABBV-154_150mg_IV_80mg_SC_EOW IP_ABBV-154_600mg_IV_530mg_SC_E4W IP_Pbo_ReIP_ABBV-154_300mg_IV_230mg_SC_EOW Rescue_ABBV-154_600mg_IV_230_mg_SC_EOW IP_ABBV-154_ReIP_ABBV-154_300mg_IV_230mg_SC_EOW IP_ABBV-154_ReIP_ABBV-154_600mg_IV_530mg_SC_EOW MP_Rand_Pbo MP_Rand_ABBV-154_80mg_SC_EOW MP_Rand_ABBV-154_230mg_SC_EOW MP_Non-Rand_ABBV-154_80mg_SC_EOW IP_ABBV-154_600mg_IV_530mg_SC_EOW IP_ABBV-154_300mg_IV_230mg_SC_EOW IP_Pbo_ReIP_ABBV-154_600mg_IV_530mg_SC_EOW
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 21 (33.33%)
    12 / 20 (60.00%)
    13 / 23 (56.52%)
    4 / 4 (100.00%)
    8 / 14 (57.14%)
    5 / 8 (62.50%)
    4 / 8 (50.00%)
    9 / 18 (50.00%)
    10 / 14 (71.43%)
    8 / 13 (61.54%)
    2 / 4 (50.00%)
    14 / 20 (70.00%)
    10 / 22 (45.45%)
    1 / 4 (25.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    SKIN PAPILLOMA
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Vascular disorders
    DEEP VEIN THROMBOSIS
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    HOT FLUSH
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    1 / 8 (12.50%)
    1 / 8 (12.50%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    1
    0
    0
    0
    0
    1
    0
    0
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 23 (4.35%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    2 / 18 (11.11%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    CHEST PAIN
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    INJECTION SITE ERYTHEMA
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    1
    0
    1
    0
    0
    0
    0
    INJECTION SITE DRYNESS
         subjects affected / exposed
    0 / 21 (0.00%)
    2 / 20 (10.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    INJECTION SITE BRUISING
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    INFLUENZA LIKE ILLNESS
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 23 (8.70%)
    1 / 4 (25.00%)
    0 / 14 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    2
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    FEELING ABNORMAL
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    FATIGUE
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 23 (4.35%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    1 / 14 (7.14%)
    1 / 13 (7.69%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    1
    0
    0
    1
    1
    0
    0
    0
    0
    INJECTION SITE EXFOLIATION
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    PAIN
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 23 (8.70%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    OEDEMA PERIPHERAL
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    1 / 20 (5.00%)
    1 / 22 (4.55%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    1
    0
    INJECTION SITE SWELLING
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    INJECTION SITE RASH
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 23 (4.35%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 4 (0.00%)
    2 / 20 (10.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    4
    0
    0
    INJECTION SITE PRURITUS
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    INJECTION SITE INDENTATION
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    PYREXIA
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    2 / 22 (9.09%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    2
    0
    Immune system disorders
    SEASONAL ALLERGY
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    INFUSION RELATED HYPERSENSITIVITY REACTION
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    2 / 8 (25.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    HYPERSENSITIVITY
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    PROSTATOMEGALY
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    1 / 4 (25.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    CERVICAL DYSPLASIA
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    DYSPHONIA
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 23 (4.35%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    COUGH
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 23 (8.70%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    NASAL CONGESTION
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 23 (8.70%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 23 (8.70%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Psychiatric disorders
    INSOMNIA
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    1 / 14 (7.14%)
    1 / 13 (7.69%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    DEPRESSED MOOD
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    AGITATION
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    WEIGHT INCREASED
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    3 / 23 (13.04%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    WEIGHT DECREASED
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    LIVER FUNCTION TEST ABNORMAL
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    FAECAL CALPROTECTIN INCREASED
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    BLOOD CREATINE PHOSPHOKINASE INCREASED
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    1 / 23 (4.35%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    ASPARTATE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    TOOTH FRACTURE
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    PROCEDURAL PAIN
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    FALL
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Nervous system disorders
    DIZZINESS
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 23 (4.35%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    MIGRAINE
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    HEADACHE
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    5 / 23 (21.74%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    2 / 20 (10.00%)
    1 / 22 (4.55%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    5
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    0
    OPHTHALMIC MIGRAINE
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    SYNCOPE
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Blood and lymphatic system disorders
    LYMPHOPENIA
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 20 (5.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    LYMPHADENOPATHY
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 23 (4.35%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    LEUKOCYTOSIS
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Eye disorders
    VISION BLURRED
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    1 / 23 (4.35%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    ABDOMINAL DISTENSION
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    ABDOMINAL PAIN
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    1 / 23 (4.35%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    CONSTIPATION
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 23 (8.70%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    APHTHOUS ULCER
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 23 (4.35%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    CROHN'S DISEASE
         subjects affected / exposed
    1 / 21 (4.76%)
    4 / 20 (20.00%)
    2 / 23 (8.70%)
    0 / 4 (0.00%)
    2 / 14 (14.29%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    3 / 14 (21.43%)
    0 / 13 (0.00%)
    2 / 4 (50.00%)
    0 / 20 (0.00%)
    2 / 22 (9.09%)
    0 / 4 (0.00%)
         occurrences all number
    1
    4
    2
    0
    2
    0
    0
    1
    4
    0
    2
    0
    2
    0
    HAEMATOCHEZIA
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 4 (25.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    DIARRHOEA
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    DENTAL CARIES
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    HAEMORRHOIDS THROMBOSED
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    NAUSEA
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    1 / 14 (7.14%)
    1 / 13 (7.69%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    1
    1
    0
    0
    0
    0
    PROCTALGIA
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    VOMITING
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    RECTAL HAEMORRHAGE
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hepatobiliary disorders
    LIVER DISORDER
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    DERMATITIS CONTACT
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    1 / 4 (25.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    DERMATITIS ACNEIFORM
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    DERMATITIS
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    ALOPECIA
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    2 / 20 (10.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    ACNE
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 23 (4.35%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    2 / 20 (10.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    DERMATITIS PSORIASIFORM
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    ECCHYMOSIS
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    ERYTHROSIS
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    HYPERHIDROSIS
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    LICHENOID KERATOSIS
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    NIGHT SWEATS
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    PRURITUS
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    2 / 18 (11.11%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    1
    0
    PSORIASIS
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    RASH
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    1 / 4 (25.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    RASH VESICULAR
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    SKIN LESION
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Renal and urinary disorders
    RENAL COLIC
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    URINARY RETENTION
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Endocrine disorders
    CUSHING'S SYNDROME
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 20 (5.00%)
    2 / 23 (8.70%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    2
    0
    0
    1
    0
    1
    1
    0
    0
    0
    1
    0
    TENDON PAIN
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    1 / 4 (25.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    MUSCULOSKELETAL CHEST PAIN
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 23 (8.70%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    MUSCLE SPASMS
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    JOINT SWELLING
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    BACK PAIN
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 20 (0.00%)
    1 / 23 (4.35%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    2 / 13 (15.38%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    0
    0
    0
    2
    0
    0
    1
    0
    Infections and infestations
    BRONCHITIS VIRAL
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    ANAL ABSCESS
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    CELLULITIS
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    CONJUNCTIVITIS
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    COVID-19
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 23 (4.35%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    2 / 14 (14.29%)
    2 / 13 (15.38%)
    1 / 4 (25.00%)
    2 / 20 (10.00%)
    1 / 22 (4.55%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    1
    0
    1
    2
    2
    1
    2
    1
    0
    CRYPTOSPORIDIOSIS INFECTION
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    CYSTITIS
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    ESCHERICHIA INFECTION
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    GASTROENTERITIS
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    GINGIVITIS
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    INFLUENZA
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    NASOPHARYNGITIS
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 23 (4.35%)
    0 / 4 (0.00%)
    1 / 14 (7.14%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    3 / 20 (15.00%)
    1 / 22 (4.55%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    1
    0
    1
    0
    0
    0
    4
    1
    0
    ORAL CANDIDIASIS
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    ORAL HERPES
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    PARONYCHIA
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    PHARYNGITIS
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    PNEUMONIA
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    RASH PUSTULAR
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    RECTAL ABSCESS
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    SALMONELLOSIS
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    SINUSITIS
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    SUBCUTANEOUS ABSCESS
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    TINEA INFECTION
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 4 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    URINARY TRACT INFECTION
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    2 / 20 (10.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    VIRAEMIA
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    1 / 23 (4.35%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    1 / 13 (7.69%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    DEHYDRATION
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 23 (4.35%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    IRON DEFICIENCY
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    INCREASED APPETITE
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    1 / 23 (4.35%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    HYPOPHOSPHATAEMIA
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 18 (0.00%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    HYPOKALAEMIA
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    1 / 14 (7.14%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    HYPOALBUMINAEMIA
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 23 (0.00%)
    0 / 4 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 18 (5.56%)
    0 / 14 (0.00%)
    0 / 13 (0.00%)
    0 / 4 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Oct 2021
    Version 2.0, Global Amendment updated eligibility criterion and corrected typographical errors.
    18 May 2022
    Version 3.0, Global Amendment updated synopsis errors, specified terminology for ITT1 populations, clarified efficacy endpoints and planned assessments, clarified Rescue Therapy options, updated eligibility criterion, specified duration of contraception requirements and females of child-bearing potential, changed time period for prohibited medications, updated appendices language.
    20 Dec 2022
    Version 4.0, Global Amendment updated synopsis, investigational plan, key eligibility criteria, added to prohibited medications list, updated language to outline information security policies, updated protocol signatories.

    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.
    AbbVie has decided to discontinue further subject enrollment in the M20-371 (ABBV-154) study. This decision is not based on a safety or an efficacy signal; rather this decision was made because of a change in AbbVie’s development.
    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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