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    Clinical Trial Results:
    A Phase IIb Multi-Center, Randomised, Open Label Study to Assess the Efficacy and Safety of Sequential Treatment with GSK3228836 followed by Pegylated Interferon Alpha 2a in Participants with Chronic Hepatitis B Virus (B-Together)

    Summary
    EudraCT number
    		 2020-002979-35
    Trial protocol
    		 GB   PL   IT  
    Global end of trial date
    17 Feb 2023

    Results information
    Results version number
    		 v1
    This version publication date
    06 Mar 2024
    First version publication date
    06 Mar 2024
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    209348
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04676724
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND: 122685
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford,Middlesex, United Kingdom, TW8 9GS
    Public contact
    GlaxoSmithKline, GSK Response Center, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.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
    06 Apr 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Feb 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Efficacy: To investigate the efficacy of two different durations of GSK3228836 followed by up to 24 weeks of PegIFN therapy in participants with CHB on stable NA therapy.
    Protection of trial subjects
    None
    Background therapy
    		 Participants were to continue their stable nucleos(t)ide analogue (NA) therapy for the duration of the study.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Jan 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    China: 15
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Japan: 13
    Country: Number of subjects enrolled
    Korea, Republic of: 18
    Country: Number of subjects enrolled
    Poland: 5
    Country: Number of subjects enrolled
    Russian Federation: 27
    Country: Number of subjects enrolled
    South Africa: 1
    Country: Number of subjects enrolled
    Spain: 11
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    United States: 9
    Worldwide total number of subjects
    108
    EEA total number of subjects
    21
    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)
    103
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants who were on stable NA therapy randomized 1:1 to receive 300 mg/wk GSK3228836 for 24 wks+ PegIFN 180 mcg/wk 24 weeks, on-treatment until wk 48 and off-treatment from Week 48-72 in Arm1 & 300 mg/wk GSK3228836 for 12wks + PegIFN 180 mcg/wk for 24wks, on-treatment until wk 36 and off-treatment follow-up from Weeks 36 to 60 and 72 in arm2.

    Pre-assignment
    Screening details
    		 There were 108 participants enrolled in this study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GSK3228836 300 mg (24 weeks) + PegIFN 180 mcg (24 weeks)
    Arm description
    		 Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK3228836 and PegINF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    GSK3228836 300mg once a week for 24 weeks, plus a loading dose of GSK3228836 300mg on Day 4 and 11.

    Investigational medicinal product name
    PegIFN
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PegIFN180 180 mcg once a week up to 24 weeks.

    Arm title
    		 GSK3228836 300 mg (12 weeks) + PegIFN 180 mcg (24 weeks)
    Arm description
    		 Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PegIFN
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PegIFN180 180 mcg once a week up to 24 weeks.

    Investigational medicinal product name
    GSK3228836 and PegINF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    GSK3228836 300mg once a week for 12 weeks, plus a loading dose of GSK3228836 300mg on Day 4 and 11.

    Number of subjects in period 1
    		GSK3228836 300 mg (24 weeks) + PegIFN 180 mcg (24 weeks) GSK3228836 300 mg (12 weeks) + PegIFN 180 mcg (24 weeks)
    Started
    55
    53
    Completed
    49
    50
    Not completed
    6
    3
         Consent withdrawn by subject
    3
    2
         Physician decision
    -
    1
         Adverse event, non-fatal
    2
    -
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK3228836 300 mg (24 weeks) + PegIFN 180 mcg (24 weeks)
    Reporting group description
    		 Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.

    Reporting group title
    GSK3228836 300 mg (12 weeks) + PegIFN 180 mcg (24 weeks)
    Reporting group description
    		 Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.

    Reporting group values
    		 GSK3228836 300 mg (24 weeks) + PegIFN 180 mcg (24 weeks) GSK3228836 300 mg (12 weeks) + PegIFN 180 mcg (24 weeks) Total
    Number of subjects
    		 55 53 108
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 50 53 103
        From 65-84 years
    		 5 0 5
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.5 ( 10.73 ) 45.5 ( 9.35 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 11 20 31
        Male
    		 44 33 77
    Race/Ethnicity, Customized
    Units: Subjects
        ASIAN
    		 30 26 56
        BLACK OR AFRICAN AMERICAN
    		 3 3 6
        WHITE
    		 22 24 46
        American Indian or Alaska Native
    		 0 0 0
        Mixed Race
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    GSK3228836 300 mg (24 weeks) + PegIFN 180 mcg (24 weeks)
    Reporting group description
    		 Participants on stable NA therapy received 300mg/week GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.

    Reporting group title
    GSK3228836 300 mg (12 weeks) + PegIFN 180 mcg (24 weeks)
    Reporting group description
    		 Participants on stable NA therapy received 300mg/week GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 mcg/week up to 24 weeks.

    Primary: Treatment Arm 1 - Percentage of participants achieving sustained virologic response (SVR) for 24 weeks after end of treatment

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    End point title
    		 Treatment Arm 1 - Percentage of participants achieving sustained virologic response (SVR) for 24 weeks after end of treatment [1] [2]
    End point description
    Sustained virologic response is defined as undetectable levels of Hepatitis B surface antigen (HBsAg) and Hepatitis-B virus deoxy-ribonucleic acid (HBV DNA) on treatment. The SVR was a composite endpoint defined as HBsAg and HBV DNA levels were less than (<) Lower limit of quantitation (LLOQ) at the planned end of sequential treatment of GSK3228836 and PegIFN treatment which is sustained for 24 weeks post-GSK3228836 and PegIFN treatment in the absence of any rescue medication. Intent to Treat (ITT) Set that included all randomized participants. Percentage values are rounded-off.
    End point type
    Primary
    End point timeframe
    Up to 24 weeks off treatment (Study Weeks 48 to 72)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (24 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    55 [3]
    Units: Percentage of Participants
    9
    Notes
    [3] - Intent to Treat (ITT) Set
    No statistical analyses for this end point

    Primary: Treatment Arm 2 - Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks After End of Treatment

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    End point title
    		 Treatment Arm 2 - Percentage of Participants Achieving Sustained Virologic Response (SVR) for 24 Weeks After End of Treatment [4] [5]
    End point description
    Sustained virologic response is defined as undetectable levels of Hepatitis B surface antigen (HBsAg) and Hepatitis-B virus deoxy-ribonucleic acid (HBV DNA) on treatment. The SVR was a composite endpoint defined as HBsAg and HBV DNA levels were less than (<) Lower limit of quantitation (LLOQ) at the planned end of sequential treatment of GSK3228836 and PegIFN treatment which is sustained for 24 weeks post-GSK3228836 and PegIFN treatment in the absence of any rescue medication. Intent to Treat (ITT) Set that included all randomized participants. Percentage values are rounded-off.
    End point type
    Primary
    End point timeframe
    Up to 24 weeks off treatment (Study Weeks 36 to 60)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (12 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    53 [6]
    Units: Percentage of Participants
    15
    Notes
    [6] - Intent to Treat (ITT) Set
    No statistical analyses for this end point

    Secondary: Treatment Arm 1: Percentage of participants achieving HBsAg and HBV DNA < lower limit of quantitation (LLOQ)

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    End point title
    		 Treatment Arm 1: Percentage of participants achieving HBsAg and HBV DNA < lower limit of quantitation (LLOQ) [7]
    End point description
    Percentage of participants achieving HBsAg and HBV DNA <LLOQ were reported. Intent to Treat (ITT) Set that included all randomized participants. Percentage values are rounded-off.
    End point type
    Secondary
    End point timeframe
    End of treatment (up to 48 weeks) and up to 24 weeks off treatment (OTT) follow-up (FUP) (Study Weeks 48 to 72)
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (24 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    49 [8]
    Units: Percentage of Participants
        End of treatment (up to 48 weeks) n=38
    15
        Up to 24 weeks OTT FUP (Study Weeks 48 to 72) n=49
    13
    Notes
    [8] - Intent to Treat (ITT) Set
    No statistical analyses for this end point

    Secondary: Treatment Arm 1: Percentage of Participants with Categorical Changes from Baseline in HBsAg Values

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    End point title
    		 Treatment Arm 1: Percentage of Participants with Categorical Changes from Baseline in HBsAg Values [9]
    End point description
    Participants who achieved a decline in HBsAg values from baseline were reported. Participants were categorized in the following categorical HBsAg decline of <0.5, greater than or equal to (>=) 0.5, >=1, >=1.5, and >=3 log10 international units per milliliter (IU/mL). The 'HBsAg < LLOQ' category is derived based on Absolute/raw HBsAg result. The HBsAg decline categories are based on change from baseline values. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. Percentage values are rounded-off.
    End point type
    Secondary
    End point timeframe
    Baseline, End of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (24 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    49 [10]
    Units: Percentage of Participants
        HBsAg <LLOQ- EOT up to 48 weeks, n=36
    18
        HBsAg<LLOQ- 24 Wk OTT (Wks 48 to 72) n=49
    13
        HBsAg decline <0.5- EOT up to 48 weeks, n=36
    24
        HBsAg decline <0.5- 24 Wk OTT (Wks 48 to 72) n=49
    45
        HBsAg decline ≥0.5- EOT up to 48 weeks, n=36
    42
        HBsAg decline ≥0.5-24 Wk OTT (Wks 48 to 72) n=49
    44
        HBsAg decline ≥1- EOT up to 48 weeks, n=36
    33
        HBsAg decline ≥1- 24 Wk OTT (Wks 48 to 72) n=49
    36
        HBsAg decline ≥1.5- EOT up to 48 weeks, n=36
    27
        HBsAg decline ≥1.5- 24 Wk OTT (Wks 48 to 72) n=49
    36
        HBsAg decline ≥3, EOT up to 48 weeks, n=36
    20
        HBsAg decline ≥3- 24 Wk OTT (Wks 48 to 72) n=49
    27
    Notes
    [10] - Intent to Treat (ITT) Set
    No statistical analyses for this end point

    Secondary: Treatment Arm 2: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ)

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    End point title
    		 Treatment Arm 2: Percentage of Participants Achieving HBsAg and HBV DNA < Lower Limit of Quantitation (LLOQ) [11]
    End point description
    Percentage of participants achieving HBsAg and HBV DNA <LLOQ were reported. Intent to Treat (ITT) Set that included all randomized participants. Percentage values are rounded-off.
    End point type
    Secondary
    End point timeframe
    End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (12 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    50 [12]
    Units: Percentage of Participants
        End of treatment (up to 48 weeks) n=36
    15
        Up to 24 weeks OTT FUP (Study Weeks 36 to 60) n=50
    17
        Up to 36 weeks OTT FUP (Study Weeks 36 to 72) n=50
    15
    Notes
    [12] - Intent to Treat (ITT) Set
    No statistical analyses for this end point

    Secondary: Treatment Arm 2: Percentage of Participants with Categorical Changes from Baseline in HBsAg Values

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    End point title
    		 Treatment Arm 2: Percentage of Participants with Categorical Changes from Baseline in HBsAg Values [13]
    End point description
    Participants who achieved a decline in HBsAg values from baseline were reported. Participants were categorized in the following categorical HBsAg decline of <0.5, greater than or equal to (>=) 0.5, >=1, >=1.5, and >=3 log10 international units per milliliter (IU/mL). The 'HBsAg < LLOQ' category is derived based on Absolute/raw HBsAg result. The HBsAg decline categories are based on change from baseline values. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
    End point type
    Secondary
    End point timeframe
    Baseline, End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60) and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (12 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    50 [14]
    Units: Percentage of Participants
        HBsAg <LLOQ- EOT up to 36 weeks, n=36
    15
        HBsAg<LLOQ-24 Wk OTT (Wks 36 to 60) n=50
    17
        HBsAg<LLOQ-36 Wk OTT (Wks 36 to 72) n=50
    15
        HBsAg decline <0.5-EOT up to 36 weeks, n=36
    26
        HBsAg decline <0.5- 24 Wk OTT (Wks 36 to 60) n=50
    42
        HBsAg decline <0.5- 36 Wk OTT (Wks 36 to 72) n=50
    43
        HBsAg decline ≥0.5-EOT up to 36 weeks, n=36
    42
        HBsAg decline ≥0.5- 24 Wk OTT (Wks 36 to 60) n=50
    51
        HBsAg decline ≥0.5- 36 Wk OTT (Wks 36 to 72) n=50
    47
        HBsAg decline ≥1- EOT up to 36 weeks, n=36
    34
        HBsAg decline ≥1-24 Wk OTT (Wks 36 to 60) n=50
    34
        HBsAg decline ≥1- 36 Wk OTT (Wks 36 to 72) n=50
    32
        HBsAg decline ≥1.5- EOT up to 36 weeks, n=36
    28
        HBsAg decline ≥1.5- 24 Wk OTT ( Wks 36 to 60) n=50
    23
        HBsAg decline ≥1.5- 36 Wk OTT (Wks 36 to 72) n=50
    19
        HBsAg decline ≥3 -EOT up to 36 weeks, n=36
    15
        HBsAg decline ≥3- 24 Wk OTT ( Wks 36 to 60) n=50
    17
        HBsAg decline ≥3- 36 Wk OTT (Wks 36 to 72) n=50
    17
    Notes
    [14] - ITT set
    No statistical analyses for this end point

    Secondary: Treatment Arm 1: Percentage of Participants with Alanine Aminotransferase (ALT) Normalization

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    End point title
    		 Treatment Arm 1: Percentage of Participants with Alanine Aminotransferase (ALT) Normalization [15]
    End point description
    The ALT normalization (ALT <=upper limit of normal [ULN]) over time in absence of rescue medication in participants with baseline ALT>ULN over time. Participants who achieved ALT normalization were reported. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
    End point type
    Secondary
    End point timeframe
    At baseline, end of treatment (up to 48 weeks) and up to 24 weeks off treatment follow-up (study week 48 to week 72)
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (24 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    55 [16]
    Units: Percentage of Participants
        ALT>ULN, at Baseline n=55
    7
        End of Treatment (up to 48 weeks) n=4
    0
        Up to 24 weeks OTT FUP (Study Weeks 48 to 72) n=4
    4
    Notes
    [16] - ITT set
    No statistical analyses for this end point

    Secondary: Treatment Arm 1: Absolute values of HBe Antibody Levels

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    End point title
    		 Treatment Arm 1: Absolute values of HBe Antibody Levels [17]
    End point description
    Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive participants. The unit of measure is Log10 International Units Per Milliliter (IU/mL). Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
    End point type
    Secondary
    End point timeframe
    At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
    Notes
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (24 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    14 [18]
    Units: Log10 IU/mL
    arithmetic mean (standard deviation)
        At Baseline n=14
    0.52 ( 1.117 )
        End of Treatment (up to 48 weeks) n=9
    -0.89 ( 0.509 )
        Up to 24 weeks OTT FUP (study week 48 to 72) n=13
    -0.46 ( 0.793 )
    Notes
    [18] - ITT set
    No statistical analyses for this end point

    Secondary: Treatment Arm 2: Absolute values of HBe antibody levels

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    End point title
    		 Treatment Arm 2: Absolute values of HBe antibody levels [19]
    End point description
    Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive participants. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
    End point type
    Secondary
    End point timeframe
    At baseline, End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (12 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    14 [20]
    Units: Log10 IU/mL
    arithmetic mean (standard deviation)
        At Baseline n=14
    0.69 ( 0.943 )
        End of Treatment (up to 36 weeks) n=9
    -0.05 ( 0.897 )
        Up to 24 weeks OTT FUP (study week 36 to 60) n=12
    0.03 ( 0.834 )
        36 weeks OTT FUP (Study Weeks 36 to week 72) n=13
    0.01 ( 0.724 )
    Notes
    [20] - ITT set
    No statistical analyses for this end point

    Secondary: Treatment Arm 2: Percentage of Participants with Alanine Aminotransferase (ALT) Normalization

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    End point title
    		 Treatment Arm 2: Percentage of Participants with Alanine Aminotransferase (ALT) Normalization [21]
    End point description
    The ALT normalization (ALT <=upper limit of normal [ULN]) over time in absence of rescue medication in participants with baseline ALT>ULN and ALT data at that visit. Participants who achieved ALT normalization were reported. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
    End point type
    Secondary
    End point timeframe
    At baseline, End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (12 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    53 [22]
    Units: Percentage of Participants
        ALT>ULN, at Baseline n=53
    19
        End of Treatment (up to 36 weeks) n=7
    2
        Up to 24 weeks OTT FUP (Study Weeks 36 to 60) n=9
    9
        Up to 36 weeks OTT FUP (Study Weeks 36 to 72) n=9
    11
    Notes
    [22] - ITT set
    No statistical analyses for this end point

    Secondary: Treatment Arm 2: Mean Change from Baseline in HBe antibody levels

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    End point title
    		 Treatment Arm 2: Mean Change from Baseline in HBe antibody levels [23]
    End point description
    Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive participants. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
    End point type
    Secondary
    End point timeframe
    At baseline, End of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
    Notes
    [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (12 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    13 [24]
    Units: Log10 IU/mL
    arithmetic mean (standard deviation)
        End of Treatment (up to 36 weeks) n=9
    -0.52 ( 0.598 )
        Up to 24 weeks OTT FUP (study week 36 to 60) n=12
    -0.58 ( 0.766 )
        Up to 36 weeks OTT FUP (study week 36 to 72) n=13
    -0.65 ( 0.787 )
    Notes
    [24] - ITT set
    No statistical analyses for this end point

    Secondary: Treatment Arm 1: Mean Change from Baseline in HBe antibody levels

    		 Close Top of page
    End point title
    		 Treatment Arm 1: Mean Change from Baseline in HBe antibody levels [25]
    End point description
    Blood samples were collected to assess HBe antibody levels and results reported are for baseline HBeAg positive participants. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
    End point type
    Secondary
    End point timeframe
    At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
    Notes
    [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (24 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    13 [26]
    Units: Log10 IU/mL
    arithmetic mean (standard deviation)
        End of Treatment (up to 48 weeks) n=9
    -1.04 ( 1.133 )
        Up to 24 weeks OTT FUP (study week 48 to 72)- n=13
    -0.81 ( 1.044 )
    Notes
    [26] - ITT set
    No statistical analyses for this end point

    Secondary: Treatment Arm 1: Absolute values of HBsAg levels

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    End point title
    		 Treatment Arm 1: Absolute values of HBsAg levels [27]
    End point description
    Blood samples were collected from participants to assess HBsAg over time at indicated time points. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. The unit of measure is log10 International Units Per Milliliter (IU/mL).
    End point type
    Secondary
    End point timeframe
    At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
    Notes
    [27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (24 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    54 [28]
    Units: Log10 IU/mL
    arithmetic mean (standard deviation)
        At Baseline n=55
    3.34 ( 0.555 )
        End of Treatment (up to 48 weeks) n=36
    1.52 ( 2.071 )
        Up to 24 weeks OTT FUP (study week 48 to 72) n=49
    1.72 ( 2.043 )
    Notes
    [28] - ITT set
    No statistical analyses for this end point

    Secondary: Treatment Arm 2: Absolute values of HBsAg levels

    		 Close Top of page
    End point title
    		 Treatment Arm 2: Absolute values of HBsAg levels [29]
    End point description
    Blood samples were collected from participants to assess HBsAg over time at indicated time points. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. The unit of measure is log10 International Units Per Milliliter (IU/mL).
    End point type
    Secondary
    End point timeframe
    At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
    Notes
    [29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (12 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    53 [30]
    Units: Log10 IU/mL
    arithmetic mean (standard deviation)
        At Baseline n=53
    3.32 ( 0.622 )
        End of Treatment (up to 36 weeks) n=36
    1.70 ( 0.491 )
        Up to 24 weeks OTT FUP (study week 36 to 60) n=49
    2.12 ( 1.897 )
        Up to 36 weeks OTT FUP (study week 36 to 72) n=48
    2.12 ( 1.830 )
    Notes
    [30] - ITT set
    No statistical analyses for this end point

    Secondary: Treatment Arm 1: Mean Change from Baseline in HBsAg levels

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    End point title
    		 Treatment Arm 1: Mean Change from Baseline in HBsAg levels [31]
    End point description
    Blood samples were collected to assess HBsAg change from baselines levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
    End point type
    Secondary
    End point timeframe
    At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
    Notes
    [31] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (24 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    49 [32]
    Units: Log10 IU/mL
    arithmetic mean (standard deviation)
        End of Treatment (up to 48 weeks) n=36
    -1.76 ( 1.726 )
        Up to 24 weeks OTT FUP (study week 48 to 72) n=49
    -1.58 ( 1.722 )
    Notes
    [32] - ITT set
    No statistical analyses for this end point

    Secondary: Treatment Arm 2: Mean Change from Baseline in HBsAg levels

    		 Close Top of page
    End point title
    		 Treatment Arm 2: Mean Change from Baseline in HBsAg levels [33]
    End point description
    Blood samples were collected to assess HBsAg change from baselines levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
    End point type
    Secondary
    End point timeframe
    At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
    Notes
    [33] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (12 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    49 [34]
    Units: Log10 IU/mL
    arithmetic mean (standard deviation)
        End of Treatment (up to 36 weeks) n=36
    -1.54 ( 1.567 )
        Up to 24 weeks OTT FUP (study week 36 to 60) n=49
    -1.20 ( 1.458 )
        Up to 36 weeks OTT FUP (study week 36 to 72) n=48
    -1.20 ( 1.460 )
    Notes
    [34] - ITT set
    No statistical analyses for this end point

    Secondary: Treatment Arm 1: Absolute values of HBV DNA levels

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    End point title
    		 Treatment Arm 1: Absolute values of HBV DNA levels [35]
    End point description
    Blood samples were collected to assess HBV DNA levels. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
    End point type
    Secondary
    End point timeframe
    At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
    Notes
    [35] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (24 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    55 [36]
    Units: Log10 IU/mL
    arithmetic mean (standard deviation)
        At Baseline n=55
    0.64 ( 0.796 )
        End of Treatment (up to 48 weeks) n=35
    0.97 ( 0.629 )
        Up to 24 weeks OTT FUP (study week 48 to 72) n=47
    0.17 ( 0.438 )
    Notes
    [36] - ITT set
    No statistical analyses for this end point

    Secondary: Treatment Arm 2: Absolute values of HBV DNA levels

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    End point title
    		 Treatment Arm 2: Absolute values of HBV DNA levels [37]
    End point description
    Blood samples were collected to assess HBV DNA levels. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
    End point type
    Secondary
    End point timeframe
    At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
    Notes
    [37] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (12 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    53 [38]
    Units: Log10 IU/mL
    arithmetic mean (standard deviation)
        At Baseline n=53
    0.57 ( 0.687 )
        End of treatment (up to 36 weeks) n=35
    0.70 ( 0.700 )
        Up to 24 weeks OTT FUP (study week 36 to 60) n=49
    0.34 ( 0.579 )
        Up to 36 weeks OTT FUP (study week 36 to 72) n=48
    0.35 ( 0.587 )
    Notes
    [38] - ITT set
    No statistical analyses for this end point

    Secondary: Treatment Arm 1: Mean Change from Baseline in HBV DNA Levels

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    End point title
    		 Treatment Arm 1: Mean Change from Baseline in HBV DNA Levels [39]
    End point description
    Blood samples were collected to assess HBV DNA levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
    End point type
    Secondary
    End point timeframe
    At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
    Notes
    [39] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (24 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    47 [40]
    Units: Log10 IU/mL
    arithmetic mean (standard deviation)
        End of treatment (up to 48 weeks) n=35
    0.40 ( 0.945 )
        Up to 24 weeks OTT FUP (study week 48 to 72) n=47
    -0.39 ( 0.727 )
    Notes
    [40] - ITT set
    No statistical analyses for this end point

    Secondary: Treatment Arm 1: Absolute values of Hepatitis B virus e-antigen (HBeAg) levels

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    End point title
    		 Treatment Arm 1: Absolute values of Hepatitis B virus e-antigen (HBeAg) levels [41]
    End point description
    Blood samples were collected to assess HBeAg levels. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
    End point type
    Secondary
    End point timeframe
    At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
    Notes
    [41] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (24 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    55 [42]
    Units: Log10 IU/mL
    arithmetic mean (standard deviation)
        At Baseline, n=55
    14.221 ( 69.3438 )
        End of Treatment (up to 48 weeks) n=10
    0.250 ( 0.4193 )
        Up to 24 weeks OTT FUP (study week 48 to 72) n=15
    1.197 ( 2.4945 )
    Notes
    [42] - ITT set
    No statistical analyses for this end point

    Secondary: Treatment Arm 2: Mean Change from Baseline in HBV DNA Levels

    		 Close Top of page
    End point title
    		 Treatment Arm 2: Mean Change from Baseline in HBV DNA Levels [43]
    End point description
    Blood samples were collected to assess HBV DNA levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
    End point type
    Secondary
    End point timeframe
    At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
    Notes
    [43] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (12 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    49 [44]
    Units: Log10 IU/mL
    arithmetic mean (standard deviation)
        End of Treatment (up to 36 weeks) n=35
    0.21 ( 0.925 )
        Up to 24 weeks OTT FUP (study week 36 to 60) n=49
    -0.21 ( 0.876 )
        up to 36 weeks OTT FUP (study week 36 to 72) n=48
    -0.22 ( 0.754 )
    Notes
    [44] - ITT set
    No statistical analyses for this end point

    Secondary: Treatment Arm 2: Absolute values of Hepatitis B virus e-antigen (HBeAg) levels

    		 Close Top of page
    End point title
    		 Treatment Arm 2: Absolute values of Hepatitis B virus e-antigen (HBeAg) levels [45]
    End point description
    Blood samples were collected to assess HBeAg levels. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
    End point type
    Secondary
    End point timeframe
    At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
    Notes
    [45] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (12 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    53 [46]
    Units: Log10 IU/mL
    arithmetic mean (standard deviation)
        At Baseline, n=53
    8.510 ( 42.1588 )
        End of Treatment (up to 36 weeks) n=12
    3.008 ( 6.2682 )
        Up to 24 weeks OTT FUP (study week 36 to 60) n=14
    3.410 ( 6.0421 )
        Up to 36 weeks OTT FUP (study week 36 to 72) n=15
    2.797 ( 4.8973 )
    Notes
    [46] - ITT set
    No statistical analyses for this end point

    Secondary: Treatment Arm 1: Mean Change from Baseline in HBeAg Levels

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    End point title
    		 Treatment Arm 1: Mean Change from Baseline in HBeAg Levels [47]
    End point description
    Blood samples were collected to assess HBeAg levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
    End point type
    Secondary
    End point timeframe
    At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
    Notes
    [47] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (24 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    15 [48]
    Units: Log10 IU/mL
    arithmetic mean (standard deviation)
        End of Treatment (up to 48 weeks) n=10
    -21.774 ( 65.4276 )
        Up to 24 weeks OTT FUP (study week 48 to 72) n=15
    -19.482 ( 55.1948 )
    Notes
    [48] - ITT set
    No statistical analyses for this end point

    Secondary: Treatment Arm 1: Absolute values of HBs antibody levels

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    End point title
    		 Treatment Arm 1: Absolute values of HBs antibody levels [49]
    End point description
    Blood samples were collected to assess HBs antibody levels. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
    End point type
    Secondary
    End point timeframe
    At baseline, end of treatment (up to 48 weeks) and up to 24 weeks off treatment follow-up (study week 48 to week 72)
    Notes
    [49] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (24 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    54 [50]
    Units: Log10 IU/L
    arithmetic mean (standard deviation)
        At Baseline, n=54
    0.62 ( 0.271 )
        End of Treatment (up to 48 weeks), n=36
    1.06 ( 0.903 )
        Up to 24 weeks OTT FUP (Study Weeks 48 to 72) n=49
    0.82 ( 0.718 )
    Notes
    [50] - ITT set
    No statistical analyses for this end point

    Secondary: Treatment Arm 2: Absolute values of HBs Antibody Levels

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    End point title
    		 Treatment Arm 2: Absolute values of HBs Antibody Levels [51]
    End point description
    Blood samples were collected to assess HBs antibody levels. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
    End point type
    Secondary
    End point timeframe
    At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
    Notes
    [51] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (12 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    53 [52]
    Units: Log10 IU/L
    arithmetic mean (standard deviation)
        At Baseline, n=53
    0.69 ( 0.204 )
        End of Treatment (up to 36 weeks) n=35
    0.87 ( 0.491 )
        Up to 24 weeks OTT FUP (Study Weeks 36 to 60) n=49
    0.80 ( 0.521 )
        Up to 36 weeks OTT FUP (Study Weeks 36 to 72) n=49
    0.76 ( 0.481 )
    Notes
    [52] - ITT set
    No statistical analyses for this end point

    Secondary: Treatment Arm 2: Mean Change from Baseline in HBeAg Levels

    		 Close Top of page
    End point title
    		 Treatment Arm 2: Mean Change from Baseline in HBeAg Levels [53]
    End point description
    Blood samples were collected to assess HBeAg levels. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
    End point type
    Secondary
    End point timeframe
    At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
    Notes
    [53] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (12 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    15 [54]
    Units: Log10 IU/mL
    arithmetic mean (standard deviation)
        End of Treatment (up to 36 weeks) n=12
    -5.270 ( 8.8942 )
        Up to 24 weeks OTT FUP (study week 36 to 60) n=14
    -26.384 ( 80.2108 )
        Up to 36 weeks OTT FUP (study week 36 to 72) n=15
    -26.345 ( 77.2836 )
    Notes
    [54] - ITT set
    No statistical analyses for this end point

    Secondary: Treatment Arm 2: Mean Change from Baseline in HBs antibody levels

    		 Close Top of page
    End point title
    		 Treatment Arm 2: Mean Change from Baseline in HBs antibody levels [55]
    End point description
    Blood samples were collected to assess HBs antibody levels over time. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
    End point type
    Secondary
    End point timeframe
    At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
    Notes
    [55] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (12 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    49 [56]
    Units: Log10 IU/L
    arithmetic mean (standard deviation)
        End of Treatment (up to 36 weeks) n=35
    0.18 ( 0.450 )
        Up to 24 weeks OTT FUP (Study Weeks 36 to 60) n=49
    0.09 ( 0.487 )
        Up to 36 weeks OTT FUP (Study Weeks 36 to 72) n=49
    0.05 ( 0.453 )
    Notes
    [56] - ITT set
    No statistical analyses for this end point

    Secondary: Treatment Arm 1: Mean Change from Baseline in HBs antibody levels

    		 Close Top of page
    End point title
    		 Treatment Arm 1: Mean Change from Baseline in HBs antibody levels [57]
    End point description
    Blood samples were collected to assess HBs antibody levels over time. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
    End point type
    Secondary
    End point timeframe
    At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
    Notes
    [57] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (24 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    48 [58]
    Units: Log10 IU/L
    arithmetic mean (standard deviation)
        End of treatment (up to 48 weeks) n=35
    0.42 ( 0.934 )
        Up to 24 weeks OTT FUP (Study Weeks 48 to 72) n=48
    0.18 ( 0.757 )
    Notes
    [58] - ITT set
    No statistical analyses for this end point

    Secondary: Treatment Arm 1: Absolute values of ALT

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    End point title
    		 Treatment Arm 1: Absolute values of ALT [59]
    End point description
    Mean values over time for ALT are reported here. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
    End point type
    Secondary
    End point timeframe
    At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
    Notes
    [59] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (24 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    55 [60]
    Units: International units per Liter (IU/L)
    arithmetic mean (standard deviation)
        At Baseline, n=55
    22.7 ( 13.97 )
        End of Treatment (up to 48 weeks) n=36
    53.1 ( 60.61 )
        Up to 24 weeks OTT FUP (Study Weeks 48 to 72) n=49
    19.2 ( 9.77 )
    Notes
    [60] - ITT set
    No statistical analyses for this end point

    Secondary: Treatment Arm 1: Change from Baseline in ALT

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    End point title
    		 Treatment Arm 1: Change from Baseline in ALT [61]
    End point description
    Blood samples were collected to assess ALT values. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
    End point type
    Secondary
    End point timeframe
    At baseline, end of treatment (up to 48 weeks), and up to 24 weeks off treatment follow-up (Study Weeks 48 to 72)
    Notes
    [61] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (24 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    49 [62]
    Units: IU/L
    arithmetic mean (standard deviation)
        End of Treatment (up to 48 weeks) n=36
    27.6 ( 56.05 )
        Up to 24 weeks OTT FUP (study week 48 to 72) n=49
    -3.8 ( 9.86 )
    Notes
    [62] - ITT set
    No statistical analyses for this end point

    Secondary: Treatment Arm 2: Absolute values of ALT

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    End point title
    		 Treatment Arm 2: Absolute values of ALT [63]
    End point description
    Mean values over time for ALT are reported here. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
    End point type
    Secondary
    End point timeframe
    At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
    Notes
    [63] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (12 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    53 [64]
    Units: IU/L
    arithmetic mean (standard deviation)
        At Baseline, n=53
    26.9 ( 19.16 )
        End of treatment (up to 36 weeks), n=35
    55.3 ( 46.60 )
        Up to 24 weeks OTT FUP (Study Weeks 36 to 60) n=49
    22.1 ( 13.30 )
        Up to 36 weeks OTT FUP (Study Weeks 36 to 72) n=48
    23.5 ( 15.61 )
    Notes
    [64] - ITT set
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Sustained Virologic Response (SVR) up to 24 weeks off-treatment for Comparision of Efficacy Between Different Treatment Durations

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    End point title
    		 Percentage of Participants Achieving Sustained Virologic Response (SVR) up to 24 weeks off-treatment for Comparision of Efficacy Between Different Treatment Durations
    End point description
    Sustained virologic response is defined as undetectable levels of HBsAg and Hepatitis-B virus deoxy-ribonucleic acid (HBV DNA) on treatment. The SVR was a composite endpoint defined as Hepatitis B surface antigen (HBsAg) and Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) levels were less than (<) Lower limit of quantitation (LLOQ) at the planned end of GSK3228836 treatment which is sustained for 24 weeks post-GSK3228836 treatment in the absence of rescue medication. The point estimate for the difference in SVR and its respective credible interval (CI) were evaluated at 24 weeks off of planned treatment for both arms. The comparison of efficacy is between treatment durations and timepoint corresponds to Week 72 in Arm 1 and Week 60 in Arm 2. 95% CI refers here as credible interval. Intent to Treat (ITT) Set that included all randomized participants.
    End point type
    Secondary
    End point timeframe
    Up to 24 weeks off treatment (Treatment Arm 1: Study Weeks 48 to 72 and Treatment Arm 2: Study Weeks 36 to 60)
    End point values
    		 GSK3228836 300 mg (24 weeks) + PegIFN 180 mcg (24 weeks) GSK3228836 300 mg (12 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    55
    53
    Units: Percentage of participants
    9
    15
    Statistical analysis title
    		 Treatment Arm 1 Versus Treatment Arm 2
    Comparison groups
    GSK3228836 300 mg (24 weeks) + PegIFN 180 mcg (24 weeks) v GSK3228836 300 mg (12 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 other [65]
    Method
    Parameter type
    		 Difference in SVR Rate
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29
         upper limit
    		 11
    Notes
    [65] - The point estimate of SVR and its 95% highest posterior density Credible Interval (CI) are estimated from a Bayesian model that incorporates the analysis stratification factors and treatment arm.

    Secondary: Treatment Arm 2 - Median Time to ALT normalization in absence of rescue medication for 24 Weeks Off Treatment

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    End point title
    		 Treatment Arm 2 - Median Time to ALT normalization in absence of rescue medication for 24 Weeks Off Treatment [66]
    End point description
    Time to ALT normalization in absence of rescue medication were measured in participants having Baseline ALT>ULN. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
    End point type
    Secondary
    End point timeframe
    Up to 24 weeks off treatment (Study Weeks 36 to 60)
    Notes
    [66] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (12 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    10 [67]
    Units: Weeks
        median (confidence interval 95%)
    4.1 (1.1 to 47.1)
    Notes
    [67] - Intent to Treat (ITT) Set
    No statistical analyses for this end point

    Secondary: Treatment Arm 1 - Median Time to ALT normalization in absence of rescue medication for 24 Weeks Off Treatment

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    End point title
    		 Treatment Arm 1 - Median Time to ALT normalization in absence of rescue medication for 24 Weeks Off Treatment [68]
    End point description
    Time to ALT normalization in absence of rescue medication were measured in participants having Baseline ALT>ULN. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. The estimate for Median Time to Event (Weeks) is 99999 (non-estimable-NE) for Arm 1 because the survival curve did not reach below 0.5 at the last timepoint. The corresponding 95% CI's upper limit is 99999 (non-estimable-NE) because the number of events in Arm 1 was too small to provide an estimate.
    End point type
    Secondary
    End point timeframe
    Up to 24 weeks off treatment (Study Week 48 to72)
    Notes
    [68] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (24 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    4 [69]
    Units: Weeks
        median (confidence interval 95%)
    99999 (6.3 to 99999)
    Notes
    [69] - ITT Set
    No statistical analyses for this end point

    Secondary: Treatment Arm 2: Change from Baseline in ALT

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    End point title
    		 Treatment Arm 2: Change from Baseline in ALT [70]
    End point description
    Blood samples were collected to assess ALT values. Change from Baseline was defined as value at the indicated time point minus Baseline value. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Intent-to-Treat Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
    End point type
    Secondary
    End point timeframe
    At baseline, end of treatment (up to 36 weeks), up to 24 weeks off treatment follow-up (Study Weeks 36 to 60), and up to 36 weeks off treatment follow-up (Study Weeks 36 to 72)
    Notes
    [70] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was descriptive, hence no statistical analysis to report.
    End point values
    		 GSK3228836 300 mg (12 weeks) + PegIFN 180 mcg (24 weeks)
    Number of subjects analysed
    49 [71]
    Units: IU/L
    arithmetic mean (standard deviation)
        End of treatment (up to 36 weeks), n=35
    27.8 ( 40.55 )
        Up to 24 weeks OTT FUP (Study Weeks36 to 60) n=49
    -4.3 ( 17.50 )
        Up to 36 weeks OTT FUP (Study Weeks36 to 72) n=48
    -3.1 ( 18.65 )
    Notes
    [71] - ITT set
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 72
    Adverse event reporting additional description
    All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    GSK3228836 (24 weeks) + PegIFN (24 weeks)
    Reporting group description
    		 Participants on stable NA therapy received 300mg GSK3228836 for 24 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.

    Reporting group title
    GSK3228836 (12 weeks) + PegIFN (24 weeks)
    Reporting group description
    		 Participants on stable NA therapy received 300mg GSK3228836 for 12 weeks (plus a loading dose on Day 4 and 11), followed by PegIFN 180 microgram per week (mcg/week) up to 24 weeks.

    Serious adverse events
    		 GSK3228836 (24 weeks) + PegIFN (24 weeks) GSK3228836 (12 weeks) + PegIFN (24 weeks)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 55 (10.91%)
    2 / 53 (3.77%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung adenocarcinoma
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Chest injury
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Spinal stenosis
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 GSK3228836 (24 weeks) + PegIFN (24 weeks) GSK3228836 (12 weeks) + PegIFN (24 weeks)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    52 / 55 (94.55%)
    50 / 53 (94.34%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Melanocytic naevus
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Uterine leiomyoma
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Varicose vein
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    5 / 55 (9.09%)
    10 / 53 (18.87%)
         occurrences all number
    8
    21
    Chills
         subjects affected / exposed
    3 / 55 (5.45%)
    1 / 53 (1.89%)
         occurrences all number
    5
    2
    Discomfort
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Facial pain
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    9 / 55 (16.36%)
    5 / 53 (9.43%)
         occurrences all number
    19
    8
    Influenza like illness
         subjects affected / exposed
    12 / 55 (21.82%)
    8 / 53 (15.09%)
         occurrences all number
    14
    12
    Malaise
         subjects affected / exposed
    7 / 55 (12.73%)
    3 / 53 (5.66%)
         occurrences all number
    11
    3
    Pain
         subjects affected / exposed
    2 / 55 (3.64%)
    2 / 53 (3.77%)
         occurrences all number
    7
    2
    Pyrexia
         subjects affected / exposed
    17 / 55 (30.91%)
    14 / 53 (26.42%)
         occurrences all number
    25
    19
    Vaccination site pain
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Injection site pain
         subjects affected / exposed
    7 / 55 (12.73%)
    11 / 53 (20.75%)
         occurrences all number
    56
    102
    Injection site erythema
         subjects affected / exposed
    20 / 55 (36.36%)
    22 / 53 (41.51%)
         occurrences all number
    112
    208
    Injection site pruritus
         subjects affected / exposed
    10 / 55 (18.18%)
    11 / 53 (20.75%)
         occurrences all number
    36
    118
    Injection site induration
         subjects affected / exposed
    7 / 55 (12.73%)
    3 / 53 (5.66%)
         occurrences all number
    9
    17
    Injection site discolouration
         subjects affected / exposed
    5 / 55 (9.09%)
    3 / 53 (5.66%)
         occurrences all number
    17
    12
    Injection site swelling
         subjects affected / exposed
    2 / 55 (3.64%)
    5 / 53 (9.43%)
         occurrences all number
    8
    32
    Injection site bruising
         subjects affected / exposed
    2 / 55 (3.64%)
    4 / 53 (7.55%)
         occurrences all number
    13
    7
    Injection site haematoma
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Injection site discomfort
         subjects affected / exposed
    1 / 55 (1.82%)
    2 / 53 (3.77%)
         occurrences all number
    38
    5
    Injection site haemorrhage
         subjects affected / exposed
    2 / 55 (3.64%)
    1 / 53 (1.89%)
         occurrences all number
    4
    1
    Injection site nodule
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Injection site anaesthesia
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    2
    0
    Injection site warmth
         subjects affected / exposed
    1 / 55 (1.82%)
    3 / 53 (5.66%)
         occurrences all number
    44
    77
    Reproductive system and breast disorders
    Pruritus genital
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Prostatitis
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    2
    0
    Pelvic pain
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    2
    Heavy menstrual bleeding
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    2
    0
    Erectile dysfunction
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Dysmenorrhoea
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Breast swelling
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract inflammation
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Throat irritation
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Pleural effusion
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    2 / 55 (3.64%)
    1 / 53 (1.89%)
         occurrences all number
    2
    2
    Nasal obstruction
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Laryngeal discomfort
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Epistaxis
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Dyspnoea exertional
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Dyspnoea
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Dry throat
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Cough
         subjects affected / exposed
    1 / 55 (1.82%)
    2 / 53 (3.77%)
         occurrences all number
    1
    3
    Psychiatric disorders
    Sleep disorder
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Nervousness
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Mood altered
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Libido decreased
         subjects affected / exposed
    1 / 55 (1.82%)
    2 / 53 (3.77%)
         occurrences all number
    1
    2
    Irritability
         subjects affected / exposed
    1 / 55 (1.82%)
    3 / 53 (5.66%)
         occurrences all number
    1
    4
    Insomnia
         subjects affected / exposed
    1 / 55 (1.82%)
    4 / 53 (7.55%)
         occurrences all number
    1
    6
    Hyposomnia
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Depression
         subjects affected / exposed
    2 / 55 (3.64%)
    2 / 53 (3.77%)
         occurrences all number
    2
    2
    Depressed mood
         subjects affected / exposed
    2 / 55 (3.64%)
    1 / 53 (1.89%)
         occurrences all number
    2
    1
    Anxiety
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    2 / 55 (3.64%)
    2 / 53 (3.77%)
         occurrences all number
    3
    6
    Alanine aminotransferase increased
         subjects affected / exposed
    23 / 55 (41.82%)
    6 / 53 (11.32%)
         occurrences all number
    36
    9
    Antineutrophil cytoplasmic antibody increased
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 53 (1.89%)
         occurrences all number
    1
    2
    Antineutrophil cytoplasmic antibody positive
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    4
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    16 / 55 (29.09%)
    6 / 53 (11.32%)
         occurrences all number
    21
    6
    Bilirubin conjugated increased
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Blood creatinine increased
         subjects affected / exposed
    2 / 55 (3.64%)
    2 / 53 (3.77%)
         occurrences all number
    2
    2
    Blood phosphorus decreased
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Blood pressure increased
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Blood thyroid stimulating hormone decreased
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Body temperature increased
         subjects affected / exposed
    3 / 55 (5.45%)
    4 / 53 (7.55%)
         occurrences all number
    3
    8
    C-reactive protein increased
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Complement factor C3 decreased
         subjects affected / exposed
    7 / 55 (12.73%)
    3 / 53 (5.66%)
         occurrences all number
    9
    3
    Complement factor C4 decreased
         subjects affected / exposed
    8 / 55 (14.55%)
    2 / 53 (3.77%)
         occurrences all number
    11
    2
    Complement fragment Bb increased
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Creatinine renal clearance decreased
         subjects affected / exposed
    6 / 55 (10.91%)
    4 / 53 (7.55%)
         occurrences all number
    35
    24
    Creatinine renal clearance increased
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Glomerular filtration rate decreased
         subjects affected / exposed
    2 / 55 (3.64%)
    1 / 53 (1.89%)
         occurrences all number
    2
    2
    Haemoglobin decreased
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    2
    Hepatitis B DNA increased
         subjects affected / exposed
    2 / 55 (3.64%)
    0 / 53 (0.00%)
         occurrences all number
    2
    0
    Monocyte chemotactic protein-1 increased
         subjects affected / exposed
    2 / 55 (3.64%)
    0 / 53 (0.00%)
         occurrences all number
    2
    0
    Neutrophil count decreased
         subjects affected / exposed
    14 / 55 (25.45%)
    8 / 53 (15.09%)
         occurrences all number
    22
    12
    Platelet count decreased
         subjects affected / exposed
    10 / 55 (18.18%)
    5 / 53 (9.43%)
         occurrences all number
    13
    5
    Red blood cell count decreased
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Transaminases increased
         subjects affected / exposed
    0 / 55 (0.00%)
    2 / 53 (3.77%)
         occurrences all number
    0
    5
    Weight decreased
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    White blood cell count decreased
         subjects affected / exposed
    8 / 55 (14.55%)
    4 / 53 (7.55%)
         occurrences all number
    14
    7
    Thyroxine increased
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Head injury
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Joint injury
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Ligament sprain
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Lip injury
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Muscle strain
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Wound complication
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Bundle branch block left
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Sinus bradycardia
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Sinus tachycardia
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    2
    0
    Tachycardia
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    2
    0
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Tremor
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    11
    0
    Tension headache
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    8
    Somnolence
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Sensory disturbance
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Presyncope
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Muscle contractions involuntary
         subjects affected / exposed
    2 / 55 (3.64%)
    1 / 53 (1.89%)
         occurrences all number
    2
    3
    Migraine
         subjects affected / exposed
    1 / 55 (1.82%)
    2 / 53 (3.77%)
         occurrences all number
    1
    2
    Hypoaesthesia
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    3
    0
    Headache
         subjects affected / exposed
    7 / 55 (12.73%)
    12 / 53 (22.64%)
         occurrences all number
    29
    25
    Dizziness
         subjects affected / exposed
    3 / 55 (5.45%)
    4 / 53 (7.55%)
         occurrences all number
    4
    4
    Blood and lymphatic system disorders
    Agranulocytosis
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Coagulopathy
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Leukopenia
         subjects affected / exposed
    10 / 55 (18.18%)
    7 / 53 (13.21%)
         occurrences all number
    18
    10
    Neutropenia
         subjects affected / exposed
    10 / 55 (18.18%)
    12 / 53 (22.64%)
         occurrences all number
    25
    21
    Neutrophilia
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Pancytopenia
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Thrombocytopenia
         subjects affected / exposed
    14 / 55 (25.45%)
    11 / 53 (20.75%)
         occurrences all number
    20
    16
    Anaemia
         subjects affected / exposed
    3 / 55 (5.45%)
    1 / 53 (1.89%)
         occurrences all number
    3
    3
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 53 (1.89%)
         occurrences all number
    2
    1
    Ear pruritus
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Tinnitus
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Dry eye
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Iridocyclitis
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Meibomian gland dysfunction
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Visual impairment
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Vitreous floaters
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Xerophthalmia
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Eye pain
         subjects affected / exposed
    0 / 55 (0.00%)
    2 / 53 (3.77%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Abdominal discomfort
         subjects affected / exposed
    2 / 55 (3.64%)
    1 / 53 (1.89%)
         occurrences all number
    2
    1
    Abdominal distension
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Abdominal pain
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 53 (1.89%)
         occurrences all number
    12
    1
    Abdominal pain upper
         subjects affected / exposed
    4 / 55 (7.27%)
    4 / 53 (7.55%)
         occurrences all number
    8
    4
    Abdominal tenderness
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Anal blister
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Aphthous ulcer
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Colitis
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    0 / 55 (0.00%)
    4 / 53 (7.55%)
         occurrences all number
    0
    5
    Diarrhoea
         subjects affected / exposed
    3 / 55 (5.45%)
    6 / 53 (11.32%)
         occurrences all number
    3
    6
    Dry mouth
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Dyspepsia
         subjects affected / exposed
    2 / 55 (3.64%)
    4 / 53 (7.55%)
         occurrences all number
    3
    4
    Gastritis
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Gingival bleeding
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Hypoaesthesia oral
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Malocclusion
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    8 / 55 (14.55%)
    6 / 53 (11.32%)
         occurrences all number
    14
    6
    Oral mucosal blistering
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Proctalgia
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Toothache
         subjects affected / exposed
    2 / 55 (3.64%)
    3 / 53 (5.66%)
         occurrences all number
    3
    4
    Vomiting
         subjects affected / exposed
    2 / 55 (3.64%)
    2 / 53 (3.77%)
         occurrences all number
    3
    2
    Gingival pain
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    3 / 55 (5.45%)
    2 / 53 (3.77%)
         occurrences all number
    5
    2
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    3 / 55 (5.45%)
    2 / 53 (3.77%)
         occurrences all number
    5
    2
    Rash macular
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Rash papular
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Skin discolouration
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    7
    0
    Skin lesion
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Urticaria
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Alopecia
         subjects affected / exposed
    3 / 55 (5.45%)
    6 / 53 (11.32%)
         occurrences all number
    3
    6
    Angioedema
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Dermatitis
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    2
    Dermatitis allergic
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Dermatitis contact
         subjects affected / exposed
    0 / 55 (0.00%)
    2 / 53 (3.77%)
         occurrences all number
    0
    2
    Dry skin
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Ecchymosis
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Eczema
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Erythema
         subjects affected / exposed
    2 / 55 (3.64%)
    3 / 53 (5.66%)
         occurrences all number
    3
    3
    Erythema multiforme
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Nail ridging
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Petechiae
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Pruritus
         subjects affected / exposed
    5 / 55 (9.09%)
    2 / 53 (3.77%)
         occurrences all number
    5
    5
    Psoriasis
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    2
    Purpura
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Diabetic nephropathy
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Chronic kidney disease
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Renal impairment
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Pollakiuria
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Haematuria
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Dysuria
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Hypothyroidism
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Temporomandibular joint syndrome
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Arthralgia
         subjects affected / exposed
    4 / 55 (7.27%)
    9 / 53 (16.98%)
         occurrences all number
    5
    13
    Arthritis
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Back pain
         subjects affected / exposed
    3 / 55 (5.45%)
    4 / 53 (7.55%)
         occurrences all number
    9
    5
    Flank pain
         subjects affected / exposed
    2 / 55 (3.64%)
    0 / 53 (0.00%)
         occurrences all number
    2
    0
    Hip deformity
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Limb discomfort
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 55 (0.00%)
    2 / 53 (3.77%)
         occurrences all number
    0
    4
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Myalgia
         subjects affected / exposed
    6 / 55 (10.91%)
    12 / 53 (22.64%)
         occurrences all number
    9
    25
    Neck pain
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 53 (1.89%)
         occurrences all number
    1
    7
    Osteoporosis
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    1 / 55 (1.82%)
    2 / 53 (3.77%)
         occurrences all number
    2
    3
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    Spinal pain
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    2
    Infections and infestations
    Folliculitis
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Acute sinusitis
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    COVID-19
         subjects affected / exposed
    15 / 55 (27.27%)
    5 / 53 (9.43%)
         occurrences all number
    15
    5
    Chlamydial infection
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Cystitis
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Gingivitis
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Herpes dermatitis
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    2
    Hordeolum
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Influenza
         subjects affected / exposed
    0 / 55 (0.00%)
    2 / 53 (3.77%)
         occurrences all number
    0
    3
    Laryngitis
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Localised infection
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 55 (3.64%)
    5 / 53 (9.43%)
         occurrences all number
    2
    7
    Oral herpes
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    2
    Otitis media
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Pneumonia
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Pulmonary tuberculosis
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Respiratory tract infection viral
         subjects affected / exposed
    2 / 55 (3.64%)
    4 / 53 (7.55%)
         occurrences all number
    2
    5
    Sinusitis
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Tonsillitis
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 55 (5.45%)
    0 / 53 (0.00%)
         occurrences all number
    4
    0
    Viral infection
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Gonorrhoea
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Cell death
         subjects affected / exposed
    2 / 55 (3.64%)
    0 / 53 (0.00%)
         occurrences all number
    2
    0
    Decreased appetite
         subjects affected / exposed
    7 / 55 (12.73%)
    4 / 53 (7.55%)
         occurrences all number
    7
    4
    Gout
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Oct 2020
    Original Protocol
    24 Sep 2021
    Protocol Amendment 01: This amendment is considered to be non-substantial based on the criteria set forth in Article 10(a) of Directive 2001/20/Ethics Committee (EC) of the European Parliament and the Council of the European Union because it neither significantly impacts the safety or physical/mental integrity of participants nor the scientific value of the study.

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

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