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    Clinical Trial Results:
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa

    Summary
    EudraCT number
    2020-001981-13
    Trial protocol
    FR  
    Global end of trial date
    16 Aug 2023

    Results information
    Results version number
    v1(current)
    This version publication date
    30 Aug 2024
    First version publication date
    30 Aug 2024
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    INCB 54707-204
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Incyte Corporation
    Sponsor organisation address
    1801 Augustine Cutoff Drive, Wilmington, United States, 19803
    Public contact
    Study Director, Incyte Corporation, 1 8554633463, medinfo@incyte.com
    Scientific contact
    Study Director, Incyte Corporation, 1 8554633463, medinfo@incyte.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
    16 Aug 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Aug 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study was conducted to evaluate the efficacy and safety of INCB054707 in participants with hidradenitis suppurativa over a 16-week Placebo-Controlled Treatment Period followed by a 36-week Open-Label Extension Period. All eligible participants were invited to continue treatment for an additional 48-week Long-Term Extension Period (also open label).
    Protection of trial subjects
    This study was to be performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and conducted in adherence to the study Protocol, applicable Good Clinical Practices, and applicable laws and country-specific regulations in which the study was conducted.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    25 Aug 2020
    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
    Canada: 10
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    Spain: 9
    Country: Number of subjects enrolled
    Poland: 19
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    United States: 161
    Worldwide total number of subjects
    209
    EEA total number of subjects
    38
    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)
    205
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 209 participants were enrolled at 36 study centers: 26 in North America and 10 in Europe.

    Period 1
    Period 1 title
    16-Week Placebo-Controlled Period
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants received oral placebo once daily (QD) for 16 weeks in the Placebo-controlled Treatment Period.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    matching placebo taken once daily

    Arm title
    Povorcitinib 15 mg
    Arm description
    Participants received oral povorcitinib 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.
    Arm type
    Experimental

    Investigational medicinal product name
    povorcitinib
    Investigational medicinal product code
    INCB054707
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One 15-mg tablet taken once daily

    Arm title
    Povorcitinib 45 mg
    Arm description
    Participants received oral povorcitinib 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
    Arm type
    Experimental

    Investigational medicinal product name
    povorcitinib
    Investigational medicinal product code
    INCB054707
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Three 15-mg tablets taken once daily

    Arm title
    Povorcitinib 75 mg
    Arm description
    Participants received oral povorcitinib 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
    Arm type
    Experimental

    Investigational medicinal product name
    povorcitinib
    Investigational medicinal product code
    INCB054707
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Five 15-mg tablets taken once daily

    Number of subjects in period 1
    Placebo Povorcitinib 15 mg Povorcitinib 45 mg Povorcitinib 75 mg
    Started
    52
    52
    52
    53
    Completed
    48
    47
    45
    51
    Not completed
    4
    5
    7
    2
         Consent withdrawn by subject
    1
    3
    4
    1
         Adverse event, non-fatal
    2
    -
    1
    -
         Lost to follow-up
    1
    1
    2
    1
         Protocol deviation
    -
    1
    -
    -
    Period 2
    Period 2 title
    36-Week Open-Label Extension Period
    Is this the baseline period?
    No
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo to povorcitinib 75 mg
    Arm description
    Participants received oral placebo once daily (QD) for 16 weeks in the Placebo-controlled Treatment Period. At Week 16, eligible participants who opted to enter the 36-week Open-Label Extension (OLE) Period received povorcitinib 75 milligrams (mg) QD.
    Arm type
    Experimental

    Investigational medicinal product name
    povorcitinib
    Investigational medicinal product code
    INCB054707
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Five 15-mg tablets taken once daily

    Arm title
    Povorcitinib 15 mg to 75 mg
    Arm description
    Participants received oral povorcitinib 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period. At Week 16, eligible participants who opted to enter the 36-week Open-Label Extension Period received povorcitinib 75 mg QD.
    Arm type
    Experimental

    Investigational medicinal product name
    povorcitinib
    Investigational medicinal product code
    INCB054707
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Five 15-mg tablets taken once daily

    Arm title
    Povorcitinib 45 mg to 75 mg
    Arm description
    Participants received oral povorcitinib 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period. At Week 16, eligible participants who opted to enter the 36-week Open-Label Extension Period received povorcitinib 75 mg QD.
    Arm type
    Experimental

    Investigational medicinal product name
    povorcitinib
    Investigational medicinal product code
    INCB054707
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Five 15-mg tablets taken once daily

    Arm title
    Povorcitinib 75 mg
    Arm description
    Participants received oral povorcitinib 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period. At Week 16, eligible participants who opted to enter the 36-week Open-Label Extension Period received povorcitinib 75 mg QD.
    Arm type
    Experimental

    Investigational medicinal product name
    povorcitinib
    Investigational medicinal product code
    INCB054707
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Five 15-mg tablets taken once daily

    Number of subjects in period 2 [1]
    Placebo to povorcitinib 75 mg Povorcitinib 15 mg to 75 mg Povorcitinib 45 mg to 75 mg Povorcitinib 75 mg
    Started
    43
    44
    42
    46
    Completed
    26
    32
    30
    31
    Not completed
    17
    12
    12
    15
         Consent withdrawn by subject
    11
    5
    2
    3
         Non-compliance with Study Drug
    1
    -
    -
    -
         Physician decision
    -
    2
    -
    1
         Adverse event, non-fatal
    1
    3
    -
    4
         Pregnancy
    2
    -
    -
    -
         Lost to follow-up
    1
    2
    7
    5
         Sponsor Request
    -
    -
    1
    -
         Lack of Efficacy/Depression and Facial Acne
    1
    -
    -
    -
         Lack of efficacy
    -
    -
    1
    2
         Protocol deviation
    -
    -
    1
    -
    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: Not all participants who completed the Placebo-Controlled Period decided to continue to the Open-Label Extension Period.
    Period 3
    Period 3 title
    48-Week Long-Term Extension Period
    Is this the baseline period?
    No
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Povorcitinib 45 mg
    Arm description
    At the completion of the Open-Label Extension (OLE) Period, all eligible participants had the option to continue treatment for an additional 48 weeks. Participants received povorcitinib 45 mg QD during the Long-Term Extension (LTE) Period based on the number of hidradenitis suppurativa (HS) lesions they had at each study visit. In some cases, the study doctor had the opportunity to choose a dose that was different from 45 mg or 75 mg.
    Arm type
    Experimental

    Investigational medicinal product name
    povorcitinib
    Investigational medicinal product code
    INCB054707
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Three 15-mg tablets taken once daily

    Arm title
    Povorcitinib 75 mg
    Arm description
    At the completion of the OLE Period, all eligible participants had the option to continue treatment for an additional 48 weeks. Participants received povorcitinib 75 mg QD during the LTE Period based on the number of HS lesions they had at each study visit. In some cases, the study doctor had the opportunity to choose a dose that was different from 45 mg or 75 mg.
    Arm type
    Experimental

    Investigational medicinal product name
    povorcitinib
    Investigational medicinal product code
    INCB054707
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Five 15-mg tablets taken once daily

    Number of subjects in period 3 [2]
    Povorcitinib 45 mg Povorcitinib 75 mg
    Started
    45
    52
    Completed
    33
    33
    Not completed
    12
    19
         Site Closure
    3
    3
         Adverse event, serious fatal
    -
    1
         Consent withdrawn by subject
    5
    3
         Received Rescue for Lesions
    -
    1
         Adverse event, non-fatal
    -
    5
         Lost to follow-up
    4
    2
         Sponsor Request
    -
    4
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all participants who completed the Open-Label Extension Period decided to continue to the Long-Term Extension Period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received oral placebo once daily (QD) for 16 weeks in the Placebo-controlled Treatment Period.

    Reporting group title
    Povorcitinib 15 mg
    Reporting group description
    Participants received oral povorcitinib 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.

    Reporting group title
    Povorcitinib 45 mg
    Reporting group description
    Participants received oral povorcitinib 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.

    Reporting group title
    Povorcitinib 75 mg
    Reporting group description
    Participants received oral povorcitinib 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.

    Reporting group values
    Placebo Povorcitinib 15 mg Povorcitinib 45 mg Povorcitinib 75 mg Total
    Number of subjects
    52 52 52 53 209
    Age Categorical
    Units: Subjects
        In utero
    0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0
        Children (2-11 years)
    0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0
        Adults (18-64 years)
    51 51 51 52 205
        From 65-84 years
    1 1 1 1 4
        85 years and over
    0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    35.2 ( 9.96 ) 38.2 ( 10.85 ) 37.3 ( 12.51 ) 37.5 ( 10.83 ) -
    Gender Categorical
    Units: Subjects
        Female
    43 37 39 39 158
        Male
    9 15 13 14 51
    Race
    Units: Subjects
        White/Caucasian
    40 36 35 36 147
        Black/African American
    10 13 12 16 51
        Asian
    1 2 2 1 6
        American Indian/Alaska Native
    0 0 1 0 1
        Captured as Other
    1 1 2 0 4
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    10 5 7 6 28
        Not Hispanic or Latino
    41 47 44 47 179
        Unknown
    1 0 0 0 1
        Captured as Other
    0 0 1 0 1
    Mean abscess and inflammatory nodule (AN) count
    Units: abscesses and inflammatory nodules
        arithmetic mean (standard deviation)
    11.2 ( 5.85 ) 11.8 ( 7.10 ) 12.9 ( 12.34 ) 10.6 ( 7.24 ) -
    Mean abscess, inflammatory nodule (IN), and draining fistula (DF) (ANF) count
    Units: abscesses, INs, and DFs
        arithmetic mean (standard deviation)
    13.6 ( 6.36 ) 14.1 ( 10.08 ) 15.1 ( 13.51 ) 12.2 ( 8.94 ) -
    Mean International Hidradenitis Suppurativa Severity Score System (IHS4) score
    The IHS4 is a composite, dynamic score and validated tool used to determine Hidradenitis Suppurativa severity. It employs a weighted scale using the number of inflammatory nodules, the number of abscesses, and the number of draining tunnels (fistulas or sinuses), with respective weight factors of 1, 2, and 4. Scores: mild=0-3; moderate=4-10; severe ≥11.
    Units: scores on a scale
        arithmetic mean (standard deviation)
    22.9 ( 17.02 ) 22.4 ( 23.24 ) 23.5 ( 22.79 ) 18.9 ( 17.25 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received oral placebo once daily (QD) for 16 weeks in the Placebo-controlled Treatment Period.

    Reporting group title
    Povorcitinib 15 mg
    Reporting group description
    Participants received oral povorcitinib 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period.

    Reporting group title
    Povorcitinib 45 mg
    Reporting group description
    Participants received oral povorcitinib 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period.

    Reporting group title
    Povorcitinib 75 mg
    Reporting group description
    Participants received oral povorcitinib 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period.
    Reporting group title
    Placebo to povorcitinib 75 mg
    Reporting group description
    Participants received oral placebo once daily (QD) for 16 weeks in the Placebo-controlled Treatment Period. At Week 16, eligible participants who opted to enter the 36-week Open-Label Extension (OLE) Period received povorcitinib 75 milligrams (mg) QD.

    Reporting group title
    Povorcitinib 15 mg to 75 mg
    Reporting group description
    Participants received oral povorcitinib 15 milligrams (mg) QD for 16 weeks in the Placebo-controlled Treatment Period. At Week 16, eligible participants who opted to enter the 36-week Open-Label Extension Period received povorcitinib 75 mg QD.

    Reporting group title
    Povorcitinib 45 mg to 75 mg
    Reporting group description
    Participants received oral povorcitinib 45 mg QD for 16 weeks in the Placebo-controlled Treatment Period. At Week 16, eligible participants who opted to enter the 36-week Open-Label Extension Period received povorcitinib 75 mg QD.

    Reporting group title
    Povorcitinib 75 mg
    Reporting group description
    Participants received oral povorcitinib 75 mg QD for 16 weeks in the Placebo-controlled Treatment Period. At Week 16, eligible participants who opted to enter the 36-week Open-Label Extension Period received povorcitinib 75 mg QD.
    Reporting group title
    Povorcitinib 45 mg
    Reporting group description
    At the completion of the Open-Label Extension (OLE) Period, all eligible participants had the option to continue treatment for an additional 48 weeks. Participants received povorcitinib 45 mg QD during the Long-Term Extension (LTE) Period based on the number of hidradenitis suppurativa (HS) lesions they had at each study visit. In some cases, the study doctor had the opportunity to choose a dose that was different from 45 mg or 75 mg.

    Reporting group title
    Povorcitinib 75 mg
    Reporting group description
    At the completion of the OLE Period, all eligible participants had the option to continue treatment for an additional 48 weeks. Participants received povorcitinib 75 mg QD during the LTE Period based on the number of HS lesions they had at each study visit. In some cases, the study doctor had the opportunity to choose a dose that was different from 45 mg or 75 mg.

    Primary: Mean change from Baseline in abscess and inflammatory nodule (AN) count at Week 16

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    End point title
    Mean change from Baseline in abscess and inflammatory nodule (AN) count at Week 16
    End point description
    Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The mixed model repeated measure (MMRM) included the fixed effects of treatment group (placebo and povorcitinib 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured. Analysis was conducted in members of the Intent-to-Treat (ITT) Population: all randomized participants. Treatment groups for this population were defined according to the treatment assignment at randomization.
    End point type
    Primary
    End point timeframe
    Baseline; Week 16
    End point values
    Placebo Povorcitinib 15 mg Povorcitinib 45 mg Povorcitinib 75 mg
    Number of subjects analysed
    43 [1]
    45 [2]
    43 [3]
    46 [4]
    Units: abscesses and inflammatory nodules
        least squares mean (standard error)
    -2.5 ( 0.88 )
    -5.2 ( 0.86 )
    -6.9 ( 0.88 )
    -6.3 ( 0.85 )
    Notes
    [1] - Only participants with available data were analyzed.
    [2] - Only participants with available data were analyzed.
    [3] - Only participants with available data were analyzed.
    [4] - Only participants with available data were analyzed.
    Statistical analysis title
    Placebo versus povorcitinib 15 mg
    Comparison groups
    Placebo v Povorcitinib 15 mg
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0277
    Method
    MMRM
    Parameter type
    Least squares mean (LSM) difference
    Point estimate
    -2.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.2
         upper limit
    -0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.23
    Statistical analysis title
    Placebo versus povorcitinib 45 mg
    Comparison groups
    Placebo v Povorcitinib 45 mg
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0006
    Method
    MMRM
    Parameter type
    LSM difference
    Point estimate
    -4.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.8
         upper limit
    -1.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.25
    Statistical analysis title
    Placebo verus povorcitinib 75 mg
    Comparison groups
    Placebo v Povorcitinib 75 mg
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0021
    Method
    MMRM
    Parameter type
    LSM difference
    Point estimate
    -3.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.2
         upper limit
    -1.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.22

    Secondary: Percentage of participants who achieved a hidradenitis suppurativa clinical response (HiSCR) at Week 16

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    End point title
    Percentage of participants who achieved a hidradenitis suppurativa clinical response (HiSCR) at Week 16
    End point description
    HiSCR, the key secondary endpoint, was defined as at least a 50% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas. 95% confidence interval (CI) was based on the Clopper-Pearson exact method. Missing post-Baseline values were imputed as nonresponders.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 16
    End point values
    Placebo Povorcitinib 15 mg Povorcitinib 45 mg Povorcitinib 75 mg
    Number of subjects analysed
    52 [5]
    52 [6]
    52 [7]
    53 [8]
    Units: percentage of participants
        number (confidence interval 95%)
    28.8 (17.1 to 43.1)
    48.1 (34.0 to 62.4)
    44.2 (30.5 to 58.7)
    45.3 (31.6 to 59.6)
    Notes
    [5] - ITT Population
    [6] - ITT Population
    [7] - ITT Population
    [8] - ITT Population
    Statistical analysis title
    Placebo versus povorcitinib 15 mg
    Comparison groups
    Placebo v Povorcitinib 15 mg
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    superiority [9]
    P-value
    = 0.0445
    Method
    Wald test
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1
         upper limit
    5.3
    Notes
    [9] - Logistic regression model with treatment group and stratification factors (disease severity and geographical region).
    Statistical analysis title
    Placebo verus povorcitinib 75 mg
    Comparison groups
    Placebo v Povorcitinib 75 mg
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    superiority [10]
    P-value
    = 0.0829
    Method
    Wald test
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.9
         upper limit
    4.7
    Notes
    [10] - Logistic regression model with treatment group and stratification factors (disease severity and geographical region).
    Statistical analysis title
    Placebo versus povorcitinib 45 mg
    Comparison groups
    Placebo v Povorcitinib 45 mg
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    superiority [11]
    P-value
    = 0.0998
    Method
    Wald test
    Parameter type
    Odds ratio (OR)
    Point estimate
    2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.9
         upper limit
    4.6
    Notes
    [11] - Logistic regression model with treatment group and stratification factors (disease severity and geographical region).

    Secondary: Percentage of participants who achieved a HiSCR at Weeks 2 through 12

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    End point title
    Percentage of participants who achieved a HiSCR at Weeks 2 through 12
    End point description
    HiSCR was defined as at least a 50% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas. 95% CI was based on the Clopper-Pearson exact method. Missing post-Baseline values were imputed as nonresponders.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 2, 4, 6, 8, and 12
    End point values
    Placebo Povorcitinib 15 mg Povorcitinib 45 mg Povorcitinib 75 mg
    Number of subjects analysed
    52 [12]
    52 [13]
    52 [14]
    53 [15]
    Units: percentage of participants
    number (confidence interval 95%)
        Week 2
    15.4 (6.9 to 28.1)
    25.0 (14.0 to 38.9)
    34.6 (22.0 to 49.1)
    34.0 (21.5 to 48.3)
        Week 4
    25.0 (14.0 to 38.9)
    36.5 (23.6 to 51.0)
    44.2 (30.5 to 58.7)
    49.1 (35.1 to 63.2)
        Week 6
    17.3 (8.2 to 30.3)
    32.7 (20.3 to 47.1)
    48.1 (34.0 to 62.4)
    52.8 (38.6 to 66.7)
        Week 8
    28.8 (17.1 to 43.1)
    36.5 (23.6 to 51.0)
    44.2 (30.5 to 58.7)
    52.8 (38.6 to 66.7)
        Week 12
    30.8 (18.7 to 45.1)
    42.3 (28.7 to 56.8)
    48.1 (34.0 to 62.4)
    58.5 (44.1 to 71.9)
    Notes
    [12] - ITT Population
    [13] - ITT Population
    [14] - ITT Population
    [15] - ITT Population
    No statistical analyses for this end point

    Secondary: Percentage of participants who achieved HiSCR75 from Weeks 2 to 16

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    End point title
    Percentage of participants who achieved HiSCR75 from Weeks 2 to 16
    End point description
    HiSCR75 was defined as at least a 75% decrease from Baseline in AN count with no increase in the number of abscesses or draining fistulas. 95% CI was based on the Clopper-Pearson exact method. Missing post-Baseline values were imputed as nonresponders.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 2, 4, 6, 8, 12, and 16
    End point values
    Placebo Povorcitinib 15 mg Povorcitinib 45 mg Povorcitinib 75 mg
    Number of subjects analysed
    52 [16]
    52 [17]
    52 [18]
    53 [19]
    Units: percentage of participants
    number (confidence interval 95%)
        Week 2
    1.9 (0.0 to 10.3)
    9.6 (3.2 to 21.0)
    13.5 (5.6 to 25.8)
    18.9 (9.4 to 32.0)
        Week 4
    7.7 (2.1 to 18.5)
    15.4 (6.9 to 28.1)
    21.2 (11.1 to 34.7)
    15.1 (6.7 to 27.6)
        Week 6
    9.6 (3.2 to 21.0)
    17.3 (8.2 to 30.3)
    28.8 (17.1 to 43.1)
    24.5 (13.8 to 38.3)
        Week 8
    19.2 (9.6 to 32.5)
    23.1 (12.5 to 36.8)
    30.8 (18.7 to 45.1)
    35.8 (23.1 to 50.2)
        Week 12
    19.2 (9.6 to 32.5)
    26.9 (15.6 to 41.0)
    32.7 (20.3 to 47.1)
    39.6 (26.5 to 54.0)
        Week 16
    17.3 (8.2 to 30.3)
    30.8 (18.7 to 45.1)
    28.8 (17.1 to 43.1)
    30.2 (18.3 to 44.3)
    Notes
    [16] - ITT Population
    [17] - ITT Population
    [18] - ITT Population
    [19] - ITT Population
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in the severity of the disease, as assessed by the International Hidradenitis Suppurativa Severity Score System (IHS4) score, from Weeks 2 to 16

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    End point title
    Mean change from Baseline in the severity of the disease, as assessed by the International Hidradenitis Suppurativa Severity Score System (IHS4) score, from Weeks 2 to 16
    End point description
    Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The IHS4 is a composite, dynamic score and validated tool used to determine Hidradenitis Suppurativa severity. It employs a weighted scale using the number of inflammatory nodules, the number of abscesses, and the number of draining tunnels (fistulas or sinuses), with respective weight factors of 1, 2, and 4. Scores: mild=0-3; moderate=4-10; severe ≥11. MMRM included the fixed effects of treatment group (placebo and povorcitinib 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 2, 4, 6, 8, 12, and 16
    End point values
    Placebo Povorcitinib 15 mg Povorcitinib 45 mg Povorcitinib 75 mg
    Number of subjects analysed
    52 [20]
    52 [21]
    52 [22]
    53 [23]
    Units: scores on a scale
    least squares mean (standard error)
        Week 2, n=47, 51, 48, 52
    -2.4 ( 1.17 )
    -3.8 ( 1.13 )
    -6.7 ( 1.16 )
    -6.1 ( 1.12 )
        Week 4, n=49, 50, 50, 52
    -2.1 ( 1.52 )
    -3.9 ( 1.49 )
    -9.3 ( 1.51 )
    -9.3 ( 1.47 )
        Week 6, n=45, 47, 48, 49
    -3.1 ( 1.77 )
    -4.7 ( 1.73 )
    -10.7 ( 1.75 )
    -10.6 ( 1.71 )
        Week 8, n=45, 50, 47, 51
    -3.0 ( 1.85 )
    -4.0 ( 1.79 )
    -11.8 ( 1.83 )
    -10.7 ( 1.78 )
        Week 12, n=45, 45, 45, 49
    -3.1 ( 1.80 )
    -5.5 ( 1.76 )
    -11.8 ( 1.79 )
    -11.9 ( 1.73 )
        Week 16, n=43, 45, 43, 36
    -3.1 ( 1.96 )
    -5.6 ( 1.92 )
    -11.0 ( 1.96 )
    -12.1 ( 1.90 )
    Notes
    [20] - ITT Population. Only participants with available data were analyzed.
    [21] - ITT Population. Only participants with available data were analyzed.
    [22] - ITT Population. Only participants with available data were analyzed.
    [23] - ITT Population. Only participants with available data were analyzed.
    No statistical analyses for this end point

    Secondary: Percentage of participants who achieved AN50, AN75, AN90, and AN100 from Weeks 2 to 16

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    End point title
    Percentage of participants who achieved AN50, AN75, AN90, and AN100 from Weeks 2 to 16
    End point description
    AN50, AN75, AN90, and AN100 were defined as at least a 50%, 75%, 90%, and 100% decrease, respectively, from Baseline in AN count. 95% CI was based on the Clopper-Pearson exact method. Missing post-Baseline values were imputed as nonresponders.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 2, 4, 6, 8, 12, and 16
    End point values
    Placebo Povorcitinib 15 mg Povorcitinib 45 mg Povorcitinib 75 mg
    Number of subjects analysed
    52 [24]
    52 [25]
    52 [26]
    53 [27]
    Units: percentage of participants
    number (confidence interval 95%)
        AN50, Week 2
    15.4 (6.9 to 28.1)
    25.0 (14.0 to 38.9)
    34.6 (22.0 to 49.1)
    39.6 (26.5 to 54.0)
        AN50, Week 4
    30.8 (18.7 to 45.1)
    44.2 (30.5 to 58.7)
    46.2 (32.2 to 60.5)
    58.5 (44.1 to 71.9)
        AN50, Week 6
    32.7 (20.3 to 47.1)
    46.2 (32.2 to 60.5)
    51.9 (37.6 to 66.0)
    56.6 (42.3 to 70.2)
        AN50, Week 8
    36.5 (23.6 to 51.0)
    55.8 (41.3 to 69.5)
    53.8 (39.5 to 67.8)
    54.7 (40.4 to 68.4)
        AN50, Week 12
    44.2 (30.5 to 58.7)
    51.9 (37.6 to 66.0)
    55.8 (41.3 to 69.5)
    62.3 (47.9 to 75.2)
        AN50, Week 16
    36.5 (23.6 to 51.0)
    55.8 (41.3 to 69.5)
    57.7 (43.2 to 71.3)
    52.8 (38.6 to 66.7)
        AN75, Week 2
    1.9 (0.0 to 10.3)
    9.6 (3.2 to 21.0)
    13.5 (5.6 to 25.8)
    20.8 (10.8 to 34.1)
        AN75, Week 4
    7.7 (2.1 to 18.5)
    15.4 (6.9 to 28.1)
    23.1 (12.5 to 36.8)
    18.9 (9.4 to 32.0)
        AN75, Week 6
    13.5 (5.6 to 25.8)
    25.0 (14.0 to 38.9)
    32.7 (20.3 to 47.1)
    26.4 (15.3 to 40.3)
        AN75, Week 8
    21.2 (11.1 to 34.7)
    28.8 (17.1 to 43.1)
    32.7 (20.3 to 47.1)
    37.7 (24.8 to 52.1)
        AN75, Week 12
    23.1 (12.5 to 36.8)
    32.7 (20.3 to 47.1)
    36.5 (23.6 to 51.0)
    39.6 (26.5 to 54.0)
        AN75, Week 16
    17.3 (8.2 to 30.3)
    36.5 (23.6 to 51.0)
    36.5 (23.6 to 51.0)
    34.0 (21.5 to 48.3)
        AN90, Week 2
    0.0 (0.0 to 6.8)
    3.8 (0.5 to 13.2)
    1.9 (0.0 to 10.3)
    11.3 (4.3 to 23.0)
        AN90, Week 4
    0.0 (0.0 to 6.8)
    5.8 (1.2 to 15.9)
    7.7 (2.1 to 18.5)
    5.7 (1.2 to 15.7)
        AN90, Week 6
    5.8 (1.2 to 15.9)
    5.8 (1.2 to 15.9)
    11.5 (4.4 to 23.4)
    9.4 (3.1 to 20.7)
        AN90, Week 8
    5.8 (1.2 to 15.9)
    15.4 (6.9 to 28.1)
    19.2 (9.6 to 32.5)
    18.9 (9.4 to 32.0)
        AN90, Week 12
    5.8 (1.2 to 15.9)
    17.3 (8.2 to 30.3)
    13.5 (5.6 to 25.8)
    20.8 (10.8 to 34.1)
        AN90, Week 16
    3.8 (0.5 to 13.2)
    17.3 (8.2 to 30.3)
    19.2 (9.6 to 32.5)
    18.9 (9.4 to 32.0)
        AN100, Week 2
    0.0 (0.0 to 6.8)
    3.8 (0.5 to 13.2)
    1.9 (0.0 to 10.3)
    7.5 (2.1 to 18.2)
        AN100, Week 4
    0.0 (0.0 to 6.8)
    3.8 (0.5 to 13.2)
    5.8 (1.2 to 15.9)
    5.7 (1.2 to 15.7)
        AN100, Week 6
    0.0 (0.0 to 6.8)
    3.8 (0.5 to 13.2)
    7.7 (2.1 to 18.5)
    9.4 (3.1 to 20.7)
        AN100, Week 8
    3.8 (0.5 to 13.2)
    13.5 (5.6 to 25.8)
    11.5 (4.4 to 23.4)
    17.0 (8.1 to 29.8)
        AN100, Week 12
    3.8 (0.5 to 13.2)
    13.5 (5.6 to 25.8)
    11.5 (4.4 to 23.4)
    18.9 (9.4 to 32.0)
        AN100, Week 16
    3.8 (0.5 to 13.2)
    15.4 (6.9 to 28.1)
    11.5 (4.4 to 23.4)
    17.0 (8.1 to 29.8)
    Notes
    [24] - ITT Population
    [25] - ITT Population
    [26] - ITT Population
    [27] - ITT Population
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in AN count at Weeks 2 to 12

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    End point title
    Mean change from Baseline in AN count at Weeks 2 to 12
    End point description
    Change from Baseline was calculated as the post-Baseline value minus the Baseline value. MMRM included the fixed effects of treatment group (placebo and povorcitinib 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 2, 4, 6, 8, and 12
    End point values
    Placebo Povorcitinib 15 mg Povorcitinib 45 mg Povorcitinib 75 mg
    Number of subjects analysed
    52 [28]
    52 [29]
    52 [30]
    53 [31]
    Units: abscesses and inflammatory nodules
    least squares mean (standard error)
        Week 2, n=47, 51, 48, 52
    -1.7 ( 0.69 )
    -2.7 ( 0.66 )
    -3.4 ( 0.69 )
    -4.0 ( 0.66 )
        Week 4, n=49, 50, 50, 52
    -3.0 ( 0.71 )
    -3.6 ( 0.70 )
    -4.8 ( 0.71 )
    -5.3 ( 0.69 )
        Week 6, n=45, 47, 48, 49
    -2.7 ( 0.77 )
    -4.8 ( 0.76 )
    -5.3 ( 0.77 )
    -6.2 ( 0.75 )
        Week 8, n=45, 50, 47, 51
    -2.7 ( 0.82 )
    -4.7 ( 0.79 )
    -6.4 ( 0.82 )
    -5.7 ( 0.79 )
        Week 12, n=45, 45, 45, 49
    -2.8 ( 0.84 )
    -5.0 ( 0.82 )
    -6.7 ( 0.84 )
    -6.5 ( 0.81 )
    Notes
    [28] - ITT Population. Only participants with available data were analyzed.
    [29] - ITT Population. Only participants with available data were analyzed.
    [30] - ITT Population. Only participants with available data were analyzed.
    [31] - ITT Population. Only participants with available data were analyzed.
    No statistical analyses for this end point

    Secondary: Percentage of participants with a total AN count of 0 to 2 from Weeks 2 to 16

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    End point title
    Percentage of participants with a total AN count of 0 to 2 from Weeks 2 to 16
    End point description
    Total AN count was assessed throughout the study.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, 8, 12, and 16
    End point values
    Placebo Povorcitinib 15 mg Povorcitinib 45 mg Povorcitinib 75 mg
    Number of subjects analysed
    52 [32]
    52 [33]
    52 [34]
    53 [35]
    Units: percentage of participants
    number (not applicable)
        Week 2, n=47, 51, 48, 52
    4.3
    9.8
    16.7
    23.1
        Week 4, n=49, 50, 50, 52
    14.3
    20.0
    20.0
    23.1
        Week 6, n=45, 47, 48, 49
    13.3
    19.1
    31.3
    38.8
        Week 8, n=45, 50, 47, 51
    28.9
    30.0
    38.3
    41.2
        Week 12, n=45, 45, 45, 49
    28.9
    33.3
    46.7
    38.8
        Week 16, n=43, 45, 43, 46
    25.6
    44.4
    51.2
    37.0
    Notes
    [32] - ITT Population. Only participants with available data were analyzed.
    [33] - ITT Population. Only participants with available data were analyzed.
    [34] - ITT Population. Only participants with available data were analyzed.
    [35] - ITT Population, Only participants with available data were analyzed.
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in draining fistula count from Weeks 2 to 16

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    End point title
    Mean change from Baseline in draining fistula count from Weeks 2 to 16
    End point description
    Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 2, 4, 6, 8, 12, and 16
    End point values
    Placebo Povorcitinib 15 mg Povorcitinib 45 mg Povorcitinib 75 mg
    Number of subjects analysed
    52 [36]
    52 [37]
    52 [38]
    53 [39]
    Units: draining fistulas
    arithmetic mean (standard deviation)
        Baseline, n=52, 52, 52, 53
    2.4 ( 3.97 )
    2.3 ( 4.44 )
    2.2 ( 4.04 )
    1.6 ( 2.85 )
        Change from Baseline at Week 2, n=47, 51, 48, 52
    -0.2 ( 1.23 )
    -0.2 ( 1.01 )
    -0.6 ( 1.62 )
    -0.2 ( 1.30 )
        Change from Baseline at Week 4, n=49, 50, 50, 52
    0.0 ( 1.80 )
    0.0 ( 1.11 )
    -0.8 ( 2.59 )
    -0.6 ( 2.44 )
        Change from Baseline at Week 6, n=45, 47, 48, 49
    -0.2 ( 2.14 )
    0.1 ( 1.85 )
    -1.0 ( 2.95 )
    -0.8 ( 2.62 )
        Change from Baseline at Week 8, n=45, 50, 47, 51
    -0.2 ( 2.46 )
    0.2 ( 2.10 )
    -1.1 ( 2.82 )
    -0.8 ( 2.70 )
        Change from Baseline at Week 12, n=45, 45, 45, 49
    -0.3 ( 2.17 )
    0.0 ( 2.71 )
    -1.0 ( 2.87 )
    -1.0 ( 2.61 )
        Change from Baseline at Week 16, n=43, 45, 43, 46
    -0.3 ( 2.05 )
    0.1 ( 3.25 )
    -0.8 ( 3.20 )
    -1.1 ( 2.57 )
    Notes
    [36] - ITT Population. Only participants with available data were analyzed.
    [37] - ITT Population. Only participants with available data were analyzed.
    [38] - ITT Population. Only participants with available data were analyzed.
    [39] - ITT Population. Only participants with available data were analyzed.
    No statistical analyses for this end point

    Secondary: Mean change from Baseline in abscess, inflammatory nodule (IN), and draining fistula (DF) (ANF) count from Weeks 2 to 16

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    End point title
    Mean change from Baseline in abscess, inflammatory nodule (IN), and draining fistula (DF) (ANF) count from Weeks 2 to 16
    End point description
    Change from Baseline was calculated as the post-Baseline value minus the Baseline value. MMRM included the fixed effects of treatment group (placebo and povorcitinib 15, 45, and 75 mg), stratification factors (disease severity [Hurley Stage I, II, and III] and geographical region [North America and outside of North America]), visit (Weeks 2, 4, 6, 8, 12, and 16), treatment by visit interaction, and covariates of Baseline measurement and Baseline measurement by visit interaction. The variance-covariance matrix of the within-participant errors in MMRM are modeled as unstructured.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 2, 4, 6, 8, 12, and 16
    End point values
    Placebo Povorcitinib 15 mg Povorcitinib 45 mg Povorcitinib 75 mg
    Number of subjects analysed
    52 [40]
    52 [41]
    52 [42]
    53 [43]
    Units: abscesses, INs, and DFs
    least squares mean (standard error)
        Week 2, n=47, 51, 48, 52
    -1.8 ( 0.74 )
    -2.9 ( 0.72 )
    -4.0 ( 0.74 )
    -4.4 ( 0.71 )
        Week 4, n=49, 50, 50, 52
    -2.7 ( 0.83 )
    -3.5 ( 0.82 )
    -5.7 ( 0.82 )
    -6.2 ( 0.80 )
        Week 6, n=45, 47, 48, 49
    -2.6 ( 0.92 )
    -4.7 ( 0.90 )
    -6.4 ( 0.92 )
    -7.1 ( 0.89 )
        Week 8, n=45, 50, 47, 51
    -2.6 ( 0.96 )
    -4.4 ( 0.93 )
    -7.5 ( 0.96 )
    -6.8 ( 0.92 )
        Week 12, n=45, 45, 45, 49
    -2.7 ( 0.99 )
    -5.0 ( 0.97 )
    -7.7 ( 0.98 )
    -7.6 ( 0.95 )
        Week 16, n=43, 45, 43, 46
    -2.4 ( 1.06 )
    -5.1 ( 1.03 )
    -7.7 ( 1.05 )
    -7.6 ( 1.02 )
    Notes
    [40] - ITT Population. Only participants with available data were analyzed.
    [41] - ITT Population. Only participants with available data were analyzed.
    [42] - ITT Population. Only participants with available data were analyzed.
    [43] - ITT Population. Only participants with available data were analyzed.
    No statistical analyses for this end point

    Secondary: Placebo-Controlled Period: Number of participants with treatment-emergent adverse events (TEAEs)

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    End point title
    Placebo-Controlled Period: Number of participants with treatment-emergent adverse events (TEAEs)
    End point description
    An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. Analysis was conducted in members of the Safety Population, defined as all participants who received at least 1 dose of povorcitinib or placebo during the Placebo-controlled Period.
    End point type
    Secondary
    End point timeframe
    up to Week 16
    End point values
    Placebo Povorcitinib 15 mg Povorcitinib 45 mg Povorcitinib 75 mg
    Number of subjects analysed
    52 [44]
    52 [45]
    52 [46]
    53 [47]
    Units: participants
    34
    31
    30
    32
    Notes
    [44] - Safety Population
    [45] - Safety Population
    [46] - Safety Population
    [47] - Safety Population
    No statistical analyses for this end point

    Secondary: Open-Label Extension Period: Number of participants with TEAEs

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    End point title
    Open-Label Extension Period: Number of participants with TEAEs
    End point description
    An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. Analysis was conducted in members of the Open-Label Evaluable (OLE) Population, defined as all participants who received at least 1 dose of povorcitinib 75 mg during the OLE Period.
    End point type
    Secondary
    End point timeframe
    Week 17 to Week 52
    End point values
    Placebo to povorcitinib 75 mg Povorcitinib 15 mg to 75 mg Povorcitinib 45 mg to 75 mg Povorcitinib 75 mg
    Number of subjects analysed
    43 [48]
    44 [49]
    42 [50]
    46 [51]
    Units: participants
    32
    35
    35
    33
    Notes
    [48] - OLE Population
    [49] - OLE Population
    [50] - OLE Population
    [51] - OLE Population
    No statistical analyses for this end point

    Secondary: Long-Term Extension Period: Number of participants with TEAEs

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    End point title
    Long-Term Extension Period: Number of participants with TEAEs
    End point description
    An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. Analysis was conducted in members of the Long-Term Evaluable (LTE) Population, defined as all participants who received at least 1 dose of povorcitinib during the LTE Period.
    End point type
    Secondary
    End point timeframe
    Week 53 to Week 100
    End point values
    Povorcitinib 45 mg Povorcitinib 75 mg
    Number of subjects analysed
    45 [52]
    52 [53]
    Units: participants
    25
    39
    Notes
    [52] - LTE Population
    [53] - LTE Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    up to Week 100
    Adverse event reporting additional description
    Treatment-emergent adverse events (TEAEs), defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug until the end of the safety follow-up, have been reported.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    26
    Reporting groups
    Reporting group title
    PC Pd: Placebo/OLE Pd: Povo 75 mg/LTE Pd: Povo ≤45 mg
    Reporting group description
    Participants who took placebo during the 16-week Placebo-controlled (PC) Period (Pd), took povorcitinib (povo) 75 milligrams (mg) during the 36-week Open-Label Extension (OLE) Period, and took povorcitinib ≤45 mg at the beginning of the 48-week Long-term Extension (LTE) Period

    Reporting group title
    PC Pd: Placebo/OLE Pd: Povo 75 mg/LTE Pd: Povo ≥60 mg
    Reporting group description
    Participants who took placebo during the 16-week PC Period, took povorcitinib 75 mg during the 36-week OLE Period, and took povorcitinib ≥60 mg at the beginning of the 48-week LTE Period

    Reporting group title
    PC Pd: Povo 15 mg/OLE Pd: Povo 75 mg/LTE Pd: Povo ≤45 mg
    Reporting group description
    Participants who took povorcitinib 15 mg during the 16-week PC Period, took povorcitinib 75 mg during the 36-week OLE Period, and took povorcitinib ≤45 mg at the beginning of the 48-week LTE Period

    Reporting group title
    PC Pd: Povo 15 mg/OLE Pd: Povo 75 mg/LTE Pd: Povo ≥60 mg
    Reporting group description
    Participants who took povorcitinib 15 mg during the 16-week PC Period, took povorcitinib 75 mg during the 36-week OLE Period, and took povorcitinib ≥60 mg at the beginning of the 48-week LTE Period

    Reporting group title
    PC Pd: Povo 45 mg/OLE Pd: Povo 75 mg/LTE Pd: Povo ≤45 mg
    Reporting group description
    Participants who took povorcitinib 45 mg during the 16-week PC Period, took povorcitinib 75 mg during the 36-week OLE Period, and took povorcitinib ≤45 mg at the beginning of the 48-week LTE Period

    Reporting group title
    PC Pd: Povo 45 mg/OLE Pd: Povo 75 mg/LTE Pd: Povo ≥60 mg
    Reporting group description
    Participants who took povorcitinib 45 mg during the 16-week PC Period, took povorcitinib 75 mg during the 36-week OLE Period, and took povorcitinib ≥60 mg at the beginning of the 48-week LTE Period

    Reporting group title
    PC Pd: Povo 75 mg/OLE Pd: Povo 75 mg/LTE Pd: Povo ≤45 mg
    Reporting group description
    Participants who took povorcitinib 75 mg during the 16-week PC Period, took povorcitinib 75 mg during the 36-week OLE Period, and took povorcitinib ≤45 mg at the beginning of the 48-week LTE Period

    Reporting group title
    PC Pd: Povo 75 mg/OLE Pd: Povo 75 mg/LTE Pd: Povo ≥60 mg
    Reporting group description
    Participants who took povorcitinib 75 mg during the 16-week PC Period, took povorcitinib 75 mg during the 36-week OLE Period, and took povorcitinib ≥60 mg at the beginning of the 48-week LTE Period

    Reporting group title
    PC Period: Placebo/OLE Period: Placebo to Povorcitinib 75 mg
    Reporting group description
    Participants who took placebo during the 16-week PC Period, took povorcitinib 75 mg during the 36-week OLE Period, and did not enter the 48-week LTE Period

    Reporting group title
    PC Pd: Povorcitinib 15 mg/OLE Pd: Povorcitinib 15 mg to 75 mg
    Reporting group description
    Participants who took povorcitinib 15 mg during the 16-week PC Period, took povorcitinib 75 mg during the 36-week OLE Period, and did not enter the 48-week LTE Period

    Reporting group title
    PC Pd: Povorcitinib 45 mg/OLE Pd: Povorcitinib 45 mg to 75 mg
    Reporting group description
    Participants who took povorcitinib 45 mg during the 16-week PC Period, took povorcitinib 75 mg during the 36-week OLE Period, and did not enter the 48-week LTE Period

    Reporting group title
    PC Period: Povorcitinib 75 mg/OLE Period: Povorcitinib 75 mg
    Reporting group description
    Participants who took povorcitinib 75 mg during the 16-week PC Period, took povorcitinib 75 mg during the 36-week OLE Period, and did not enter the 48-week LTE Period

    Reporting group title
    PC Period: Placebo
    Reporting group description
    Participants who took placebo during the 16-week PC Period, and did not enter the 36-week OLE Period

    Reporting group title
    PC Period: Povorcitinib 15 mg
    Reporting group description
    Participants who took povorcitinib 15 mg during the 16-week PC Period, and did not enter the 36-week OLE Period

    Reporting group title
    PC Period: Povorcitinib 45 mg
    Reporting group description
    Participants who took povorcitinib 45 mg during the 16-week PC Period, and did not enter the 36-week OLE Period

    Reporting group title
    PC Period: Povorcitinib 75 mg
    Reporting group description
    Participants who took povorcitinib 75 mg during the 16-week PC Period, and did not enter the 36-week OLE Period

    Serious adverse events
    PC Pd: Placebo/OLE Pd: Povo 75 mg/LTE Pd: Povo ≤45 mg PC Pd: Placebo/OLE Pd: Povo 75 mg/LTE Pd: Povo ≥60 mg PC Pd: Povo 15 mg/OLE Pd: Povo 75 mg/LTE Pd: Povo ≤45 mg PC Pd: Povo 15 mg/OLE Pd: Povo 75 mg/LTE Pd: Povo ≥60 mg PC Pd: Povo 45 mg/OLE Pd: Povo 75 mg/LTE Pd: Povo ≤45 mg PC Pd: Povo 45 mg/OLE Pd: Povo 75 mg/LTE Pd: Povo ≥60 mg PC Pd: Povo 75 mg/OLE Pd: Povo 75 mg/LTE Pd: Povo ≤45 mg PC Pd: Povo 75 mg/OLE Pd: Povo 75 mg/LTE Pd: Povo ≥60 mg PC Period: Placebo/OLE Period: Placebo to Povorcitinib 75 mg PC Pd: Povorcitinib 15 mg/OLE Pd: Povorcitinib 15 mg to 75 mg PC Pd: Povorcitinib 45 mg/OLE Pd: Povorcitinib 45 mg to 75 mg PC Period: Povorcitinib 75 mg/OLE Period: Povorcitinib 75 mg PC Period: Placebo PC Period: Povorcitinib 15 mg PC Period: Povorcitinib 45 mg PC Period: Povorcitinib 75 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    4 / 16 (25.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    3 / 21 (14.29%)
    3 / 20 (15.00%)
    1 / 15 (6.67%)
    4 / 22 (18.18%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung adenocarcinoma stage IV
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastatic neoplasm
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (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
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (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
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Interstitial lung disease
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Hidradenitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (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
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (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
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Perirectal abscess
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    PC Pd: Placebo/OLE Pd: Povo 75 mg/LTE Pd: Povo ≤45 mg PC Pd: Placebo/OLE Pd: Povo 75 mg/LTE Pd: Povo ≥60 mg PC Pd: Povo 15 mg/OLE Pd: Povo 75 mg/LTE Pd: Povo ≤45 mg PC Pd: Povo 15 mg/OLE Pd: Povo 75 mg/LTE Pd: Povo ≥60 mg PC Pd: Povo 45 mg/OLE Pd: Povo 75 mg/LTE Pd: Povo ≤45 mg PC Pd: Povo 45 mg/OLE Pd: Povo 75 mg/LTE Pd: Povo ≥60 mg PC Pd: Povo 75 mg/OLE Pd: Povo 75 mg/LTE Pd: Povo ≤45 mg PC Pd: Povo 75 mg/OLE Pd: Povo 75 mg/LTE Pd: Povo ≥60 mg PC Period: Placebo/OLE Period: Placebo to Povorcitinib 75 mg PC Pd: Povorcitinib 15 mg/OLE Pd: Povorcitinib 15 mg to 75 mg PC Pd: Povorcitinib 45 mg/OLE Pd: Povorcitinib 45 mg to 75 mg PC Period: Povorcitinib 75 mg/OLE Period: Povorcitinib 75 mg PC Period: Placebo PC Period: Povorcitinib 15 mg PC Period: Povorcitinib 45 mg PC Period: Povorcitinib 75 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 9 (88.89%)
    13 / 13 (100.00%)
    10 / 12 (83.33%)
    12 / 12 (100.00%)
    9 / 11 (81.82%)
    16 / 16 (100.00%)
    10 / 13 (76.92%)
    10 / 11 (90.91%)
    16 / 21 (76.19%)
    17 / 20 (85.00%)
    15 / 15 (100.00%)
    15 / 22 (68.18%)
    7 / 9 (77.78%)
    7 / 8 (87.50%)
    4 / 8 (50.00%)
    5 / 7 (71.43%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cervix neoplasm
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Fibroadenoma of breast
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Skin papilloma
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Vascular disorders
    Essential hypertension
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Haematoma
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hypertension
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    2 / 11 (18.18%)
    2 / 21 (9.52%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    2
    2
    2
    0
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Drug withdrawal syndrome
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Fatigue
         subjects affected / exposed
    2 / 9 (22.22%)
    3 / 13 (23.08%)
    2 / 12 (16.67%)
    2 / 12 (16.67%)
    1 / 11 (9.09%)
    2 / 16 (12.50%)
    1 / 13 (7.69%)
    2 / 11 (18.18%)
    2 / 21 (9.52%)
    2 / 20 (10.00%)
    2 / 15 (13.33%)
    4 / 22 (18.18%)
    1 / 9 (11.11%)
    1 / 8 (12.50%)
    2 / 8 (25.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    4
    2
    2
    1
    2
    1
    2
    2
    2
    2
    4
    1
    1
    2
    0
    Feeling abnormal
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Influenza like illness
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Malaise
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Nodule
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Oedema
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    1
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Swelling
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Vaccination site pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Xerosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Immune system disorders
    Mite allergy
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Seasonal allergy
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    Abnormal uterine bleeding
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Adenomyosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Amenorrhoea
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Breast enlargement
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Dysmenorrhoea
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Erectile dysfunction
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Genital ulceration
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Haemorrhagic ovarian cyst
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Heavy menstrual bleeding
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    2
    0
    Menstruation irregular
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    2 / 21 (9.52%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Ovarian cyst
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    2 / 11 (18.18%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    1
    0
    Pelvic pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Uterine polyp
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Cough
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    1 / 11 (9.09%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    1 / 8 (12.50%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    1
    0
    0
    0
    0
    0
    1
    0
    0
    Dyspnoea
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Emphysema
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Obstructive sleep apnoea syndrome
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Pharyngeal erythema
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Productive cough
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Sinus congestion
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Throat irritation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Attention deficit hyperactivity disorder
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Bipolar disorder
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    2 / 13 (15.38%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Depression
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    3 / 15 (20.00%)
    2 / 22 (9.09%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    3
    2
    1
    0
    0
    0
    Depressive symptom
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Generalised anxiety disorder
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Insomnia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    2 / 21 (9.52%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    2
    1
    0
    1
    0
    0
    0
    0
    Panic attack
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Tachyphrenia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 21 (4.76%)
    1 / 20 (5.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    1
    1
    1
    0
    0
    0
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    2 / 15 (13.33%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    0
    Blood cholesterol increased
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    1
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    Blood glucose increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood creatinine increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    3 / 12 (25.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    3 / 16 (18.75%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    1 / 21 (4.76%)
    1 / 20 (5.00%)
    2 / 15 (13.33%)
    2 / 22 (9.09%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    3
    0
    0
    4
    1
    0
    1
    1
    2
    3
    0
    0
    0
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood testosterone increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    1
    0
    0
    0
    0
    0
    Blood oestrogen decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood triglycerides increased
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    C-reactive protein increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Crystal urine present
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Electrocardiogram abnormal
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    2
    0
    0
    0
    0
    0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 16 (6.25%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    0
    1
    0
    0
    0
    Heart rate increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Human papilloma virus test positive
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Platelet count decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    1
    0
    3
    1
    0
    1
    0
    0
    0
    0
    0
    SARS-CoV-2 test positive
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    2 / 11 (18.18%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Transaminases increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    2 / 22 (9.09%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Urine analysis abnormal
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    White blood cell count decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Arteriovenous fistula site haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Breast injury
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Burns second degree
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Contusion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    2
    0
    2
    1
    0
    0
    1
    0
    Eye injury
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Fall
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Ligament sprain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 21 (4.76%)
    1 / 20 (5.00%)
    1 / 15 (6.67%)
    1 / 22 (4.55%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    1
    1
    0
    0
    0
    0
    Muscle strain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    2 / 22 (9.09%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    2
    0
    0
    0
    0
    Neck injury
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Procedural pain
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Rib fracture
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Road traffic accident
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Sunburn
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    Thermal burn
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Wound
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Bundle branch block right
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Mitral valve incompetence
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Pulmonary valve incompetence
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Tachycardia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Tricuspid valve incompetence
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 11 (9.09%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Cerebral disorder
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 15 (6.67%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Dizziness
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    2 / 8 (25.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
    Dysgeusia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Headache
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 13 (23.08%)
    3 / 12 (25.00%)
    1 / 12 (8.33%)
    1 / 11 (9.09%)
    1 / 16 (6.25%)
    1 / 13 (7.69%)
    1 / 11 (9.09%)
    3 / 21 (14.29%)
    4 / 20 (20.00%)
    2 / 15 (13.33%)
    2 / 22 (9.09%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    4
    5
    1
    1
    1
    1
    1
    3
    7
    2
    2
    1
    0
    0
    1
    Memory impairment
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Migraine
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    1 / 8 (12.50%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Sciatica
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 15 (0.00%)
    0 / 22 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Small fibre neuropathy