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    Clinical Trial Results:
    A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of the Co-Administration of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) With Sofosbuvir (SOF) With or Without Ribavirin (RBV) in Subjects With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection or Genotype 3 HCV Infection With or Without Cirrhosis.

    Summary
    EudraCT number
    		 2014-003147-35
    Trial protocol
    		 GB  
    Global end of trial date
    14 Jul 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jul 2018
    First version publication date
    12 Jul 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    M14-567
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02292719
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6-4UB
    Public contact
    Global Medical Services, AbbVie, 001 800-633-9110, eu-clinical-trials@abbvie.com
    Scientific contact
    Mariem Charafeddine, AbbVie, mariem.charafeddine@abbvie.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Jul 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jul 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the safety and efficacy of Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) with sofosbuvir (SOF) with or without ribavirin (RBV) in adults with Genotype 2 Chronic Hepatitis C Virus (HCV) infection or Genotype 3 HCV infection with or without Cirrhosis.
    Protection of trial subjects
    Prior to the initiation of any screening or study-specific procedures, the investigator or his or her representative explained the nature of the study to the subject or his or her representative and answered all questions regarding this study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Dec 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 19
    Country: Number of subjects enrolled
    New Zealand: 13
    Country: Number of subjects enrolled
    Canada: 22
    Country: Number of subjects enrolled
    United Kingdom: 16
    Worldwide total number of subjects
    70
    EEA total number of subjects
    16
    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)
    66
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All subjects who received at least 1 dose of study drug were included in the intent-to-treat (ITT) population; the safety population is the same as the ITT population.

    Pre-assignment
    Screening details
    		 The study included a 35-day screening period.

    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
    		 Arm A (genotype [GT]3, noncirrhotic)
    Arm description
    		 Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    Sovaldi
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Sofosbuvir (SOF) 400 mg QD for 12 weeks

    Investigational medicinal product name
    Ombitasvir/paritaprevir/ritonavir
    Investigational medicinal product code
    Other name
    ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir, ritonavir also known as Norvir, VIEKIRAX combination tablets, TECHNIVIE
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) for 12 weeks.

    Arm title
    		 Arm B (GT3, noncirrhotic)
    Arm description
    		 Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) (25/150/100) mg QD with sofosbuvir (SOF) (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ombitasvir/paritaprevir/ritonavir
    Investigational medicinal product code
    Other name
    ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir, ritonavir also known as Norvir, VIEKIRAX combination tablets, TECHNIVIE
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) for 12 weeks.

    Investigational medicinal product name
    Ribavirin (RBV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    Sovaldi
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Sofosbuvir 400 mg QD for 12 weeks.

    Arm title
    		 Arm C (GT2, Noncirrhotic)
    Arm description
    		 Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) (25/150/100) mg QD with sofosbuvir (SOF) (400 mg QD) and ribavirin (RBV; weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ombitasvir/paritaprevir/ritonavir
    Investigational medicinal product code
    Other name
    ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir, ritonavir also known as Norvir, VIEKIRAX combination tablets, TECHNIVIE
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) for 8 weeks.

    Investigational medicinal product name
    Ribavirin (RBV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV weight- based 1,000 mg or 1,200 mg daily divided BID for 8 weeks.

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    Sovaldi
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Sofosbuvir 400 mg QD for 8 weeks.

    Arm title
    		 Arm D (GT2, Noncirrhotic)
    Arm description
    		 Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) (25/150/100) mg QD with sofosbuvir (SOF) (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ombitasvir/paritaprevir/ritonavir
    Investigational medicinal product code
    Other name
    ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir, ritonavir also known as Norvir, VIEKIRAX combination tablets, TECHNIVIE
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) for 6 weeks.

    Investigational medicinal product name
    Ribavirin (RBV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV weight- based 1,000 mg or 1,200 mg daily divided BID for 6 weeks.

    Investigational medicinal product name
    Sofosbuvir (SOF)
    Investigational medicinal product code
    Other name
    Sovaldi
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    SOF 400 mg QD for 6 weeks

    Arm title
    		 Arm E (GT3, Cirrhotic)
    Arm description
    		 Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) (25/150/100) mg QD with sofosbuvir (SOF) (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ombitasvir/paritaprevir/ritonavir
    Investigational medicinal product code
    Other name
    ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir, ritonavir also known as Norvir, VIEKIRAX combination tablets, TECHNIVIE
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) for 12 weeks.

    Investigational medicinal product name
    Ribavirin (RBV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    Sovaldi
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Sofosbuvir 400 mg QD for 12 weeks.

    Arm title
    		 Arm F (GT3, Noncirrhotic)
    Arm description
    		 Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) (25/150/100) mg QD and Sofosbuvir (SOF) (400 mg QD) for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ombitasvir/paritaprevir/ritonavir
    Investigational medicinal product code
    Other name
    ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir, ritonavir also known as Norvir, VIEKIRAX combination tablets, TECHNIVIE
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) for 12 weeks.

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    Sovaldi
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Sofosbuvir (SOF) 400 mg QD for 12 weeks

    Number of subjects in period 1
    		Arm A (genotype [GT]3, noncirrhotic) Arm B (GT3, noncirrhotic) Arm C (GT2, Noncirrhotic) Arm D (GT2, Noncirrhotic) Arm E (GT3, Cirrhotic) Arm F (GT3, Noncirrhotic)
    Started
    9
    11
    10
    9
    21
    10
    Completed
    9
    11
    9
    8
    20
    10
    Not completed
    0
    0
    1
    1
    1
    0
         Consent withdrawn by subject
    -
    -
    -
    1
    1
    -
         Subject enrolled in new study.
    -
    -
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A (genotype [GT]3, noncirrhotic)
    Reporting group description
    		 Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.

    Reporting group title
    Arm B (GT3, noncirrhotic)
    Reporting group description
    		 Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) (25/150/100) mg QD with sofosbuvir (SOF) (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.

    Reporting group title
    Arm C (GT2, Noncirrhotic)
    Reporting group description
    		 Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) (25/150/100) mg QD with sofosbuvir (SOF) (400 mg QD) and ribavirin (RBV; weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.

    Reporting group title
    Arm D (GT2, Noncirrhotic)
    Reporting group description
    		 Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) (25/150/100) mg QD with sofosbuvir (SOF) (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks.

    Reporting group title
    Arm E (GT3, Cirrhotic)
    Reporting group description
    		 Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) (25/150/100) mg QD with sofosbuvir (SOF) (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks.

    Reporting group title
    Arm F (GT3, Noncirrhotic)
    Reporting group description
    		 Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) (25/150/100) mg QD and Sofosbuvir (SOF) (400 mg QD) for 12 weeks.

    Reporting group values
    		 Arm A (genotype [GT]3, noncirrhotic) Arm B (GT3, noncirrhotic) Arm C (GT2, Noncirrhotic) Arm D (GT2, Noncirrhotic) Arm E (GT3, Cirrhotic) Arm F (GT3, Noncirrhotic) Total
    Number of subjects
    		 9 11 10 9 21 10 70
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 52.1 ± 9.17 53.5 ± 8.26 56.6 ± 6.70 61.6 ± 5.90 53.8 ± 6.56 48.9 ± 7.52 -
    Gender categorical
    Units: Subjects
        Female
    		 4 4 5 3 9 2 27
        Male
    		 5 7 5 6 12 8 43

    End points

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    End points reporting groups
    Reporting group title
    Arm A (genotype [GT]3, noncirrhotic)
    Reporting group description
    		 Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks.

    Reporting group title
    Arm B (GT3, noncirrhotic)
    Reporting group description
    		 Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) (25/150/100) mg QD with sofosbuvir (SOF) (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.

    Reporting group title
    Arm C (GT2, Noncirrhotic)
    Reporting group description
    		 Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) (25/150/100) mg QD with sofosbuvir (SOF) (400 mg QD) and ribavirin (RBV; weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks.

    Reporting group title
    Arm D (GT2, Noncirrhotic)
    Reporting group description
    		 Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) (25/150/100) mg QD with sofosbuvir (SOF) (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks.

    Reporting group title
    Arm E (GT3, Cirrhotic)
    Reporting group description
    		 Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) (25/150/100) mg QD with sofosbuvir (SOF) (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks.

    Reporting group title
    Arm F (GT3, Noncirrhotic)
    Reporting group description
    		 Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) (25/150/100) mg QD and Sofosbuvir (SOF) (400 mg QD) for 12 weeks.

    Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

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    End point title
    		 Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [1]
    End point description
    SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.
    End point type
    Primary
    End point timeframe
    12 weeks after the last actual dose of study drug
    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: Descriptive data are summarized for this end point per protocol.
    End point values
    		 Arm A (genotype [GT]3, noncirrhotic) Arm B (GT3, noncirrhotic) Arm C (GT2, Noncirrhotic) Arm D (GT2, Noncirrhotic) Arm E (GT3, Cirrhotic) Arm F (GT3, Noncirrhotic)
    Number of subjects analysed
    9
    11
    10
    9
    21
    10
    Units: percentage of participants
        number (confidence interval 95%)
    100 (70.1 to 100)
    90.9 (62.3 to 98.4)
    90.0 (59.6 to 98.2)
    44.4 (18.9 to 73.3)
    100 (84.5 to 100)
    100 (72.2 to 100)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With On-treatment Virologic Failure

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    End point title
    		 Percentage of Participants With On-treatment Virologic Failure
    End point description
    On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment for 12-week and 8-week treatment or at least 26 days of treatments for 6-week treatment.
    End point type
    Secondary
    End point timeframe
    Up to Week 12
    End point values
    		 Arm A (genotype [GT]3, noncirrhotic) Arm B (GT3, noncirrhotic) Arm C (GT2, Noncirrhotic) Arm D (GT2, Noncirrhotic) Arm E (GT3, Cirrhotic) Arm F (GT3, Noncirrhotic)
    Number of subjects analysed
    9
    11
    10
    9
    21
    10
    Units: percentage of particip
        number (confidence interval 95%)
    0 (0.0 to 29.9)
    0 (0.0 to 25.9)
    0 (0.0 to 27.8)
    0 (0.0 to 29.9)
    0 (0.0 to 15.5)
    0 (0.0 to 27.8)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Post-treatment Relapse

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    End point title
    		 Percentage of Participants With Post-treatment Relapse
    End point description
    Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
    End point type
    Secondary
    End point timeframe
    Up to 12 weeks after the last actual dose of active study drug
    End point values
    		 Arm A (genotype [GT]3, noncirrhotic) Arm B (GT3, noncirrhotic) Arm C (GT2, Noncirrhotic) Arm D (GT2, Noncirrhotic) Arm E (GT3, Cirrhotic) Arm F (GT3, Noncirrhotic)
    Number of subjects analysed
    9
    10
    10
    9
    21
    10
    Units: percentage of participants
        number (confidence interval 95%)
    0 (0.0 to 29.9)
    0 (0.0 to 27.8)
    10.0 (1.8 to 40.4)
    55.6 (26.7 to 81.1)
    0 (0.0 to 15.5)
    0 (0.0 to 27.8)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).
    Adverse event reporting additional description
    TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Arm A (genotype [GT]3, noncirrhotic)
    Reporting group description
    		 Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) 25/150/100 mg once daily (QD) and sofosbuvir (SOF) 400 mg QD for 12 weeks

    Reporting group title
    Arm B (GT3, noncirrhotic)
    Reporting group description
    		 Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) (25/150/100) mg QD with sofosbuvir (SOF) (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided twice daily [BID]) for 12 weeks.

    Reporting group title
    Arm C (GT2, Noncirrhotic)
    Reporting group description
    		 Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) (25/150/100) mg QD with sofosbuvir (SOF) (400 mg QD) and ribavirin (RBV; weight- based 1,000 mg or 1,200 mg daily divided BID) for 8 weeks

    Reporting group title
    Arm D (GT2, Noncirrhotic)
    Reporting group description
    		 Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) (25/150/100) mg QD with sofosbuvir (SOF) (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided BID) for 6 weeks

    Reporting group title
    E (GT3, Cirrhotic)
    Reporting group description
    		 Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) (25/150/100) mg QD with sofosbuvir (SOF) (400 mg QD) and ribavirin (RBV; weight-based 1,000 mg or 1,200 mg daily divided BID) for 12 weeks

    Reporting group title
    Arm F (GT3, Noncirrhotic)
    Reporting group description
    		 Ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) (25/150/100) mg QD and sofosbuvir (SOF) (400 mg QD) for 12 weeks

    Serious adverse events
    		 Arm A (genotype [GT]3, noncirrhotic) Arm B (GT3, noncirrhotic) Arm C (GT2, Noncirrhotic) Arm D (GT2, Noncirrhotic) E (GT3, Cirrhotic) Arm F (GT3, Noncirrhotic)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    2 / 21 (9.52%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 21 (4.76%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 21 (4.76%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm A (genotype [GT]3, noncirrhotic) Arm B (GT3, noncirrhotic) Arm C (GT2, Noncirrhotic) Arm D (GT2, Noncirrhotic) E (GT3, Cirrhotic) Arm F (GT3, Noncirrhotic)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 9 (88.89%)
    10 / 11 (90.91%)
    10 / 10 (100.00%)
    9 / 9 (100.00%)
    20 / 21 (95.24%)
    8 / 10 (80.00%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Peripheral artery stenosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 21 (4.76%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    Energy increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Fatigue
         subjects affected / exposed
    3 / 9 (33.33%)
    3 / 11 (27.27%)
    3 / 10 (30.00%)
    6 / 9 (66.67%)
    10 / 21 (47.62%)
    4 / 10 (40.00%)
         occurrences all number
    3
    3
    4
    9
    13
    4
    Feeling abnormal
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    2 / 21 (9.52%)
    2 / 10 (20.00%)
         occurrences all number
    0
    0
    1
    0
    2
    2
    Influenza like illness
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Malaise
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Pain
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 21 (4.76%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Nipple pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    cough
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 21 (4.76%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    0
    0
    1
    1
    Dyspnoea
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 11 (27.27%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    3
    0
    1
    0
    0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    2 / 21 (9.52%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    Epistaxis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 21 (4.76%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    0
    0
    1
    1
    Respiratory tract congestion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Upper respiratory tract congestion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Anxiety
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 21 (4.76%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    2
    1
    depressed mood
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    0
    Depression
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    1 / 21 (4.76%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Disorientation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Hallucination
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Insomnia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    2 / 10 (20.00%)
    0 / 9 (0.00%)
    5 / 21 (23.81%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    2
    0
    5
    1
    Irritability
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    1 / 9 (11.11%)
    1 / 21 (4.76%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    1
    1
    1
    1
    Mood swings
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Sleep disorder
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    1 / 21 (4.76%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    1
    1
    Tearfulness
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Withdrawal syndrome
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    1 / 21 (4.76%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    International normalised ratio decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Back injury
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Contusion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    1 / 21 (4.76%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    1
    1
    Muscle strain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    1 / 21 (4.76%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Nervous system disorders
    Disturbance in attention
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 21 (4.76%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Dizziness
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    2 / 9 (22.22%)
    4 / 21 (19.05%)
    2 / 10 (20.00%)
         occurrences all number
    2
    1
    1
    3
    4
    2
    Dysgeusia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Head discomfort
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Headache
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 11 (18.18%)
    6 / 10 (60.00%)
    3 / 9 (33.33%)
    9 / 21 (42.86%)
    2 / 10 (20.00%)
         occurrences all number
    1
    2
    8
    4
    9
    2
    Hypoaesthesia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Intercostal neuralgia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Memory impairment
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Paraesthesia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Poor quality sleep
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Ear and labyrinth disorders
    Hypoacusis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Vision blurred
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 21 (4.76%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    0
    0
    1
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    1 / 9 (11.11%)
    1 / 21 (4.76%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    1
    1
    1
    1
    Abdominal distension
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    1 / 9 (11.11%)
    1 / 21 (4.76%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    1
    1
    1
    abdominal pain upper
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    2 / 21 (9.52%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    3
    0
    Constipation
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    3 / 9 (33.33%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    1
    3
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    3 / 10 (30.00%)
    2 / 9 (22.22%)
    2 / 21 (9.52%)
    3 / 10 (30.00%)
         occurrences all number
    0
    1
    3
    2
    3
    3
    Dry mouth
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    0
    0
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    3 / 9 (33.33%)
    1 / 21 (4.76%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    1
    3
    1
    0
    Flatulence
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 21 (4.76%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Mouth ulceration
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 21 (4.76%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    Nausea
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    3 / 10 (30.00%)
    0 / 9 (0.00%)
    6 / 21 (28.57%)
    3 / 10 (30.00%)
         occurrences all number
    0
    1
    3
    0
    10
    3
    Stomatitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Vomiting
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 21 (4.76%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    1 / 21 (4.76%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    1
    0
    1
    1
    Eczema
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 21 (4.76%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    Ingrowing nail
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    2 / 10 (20.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    Night sweats
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Pruritus
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 11 (18.18%)
    0 / 10 (0.00%)
    2 / 9 (22.22%)
    7 / 21 (33.33%)
    1 / 10 (10.00%)
         occurrences all number
    1
    3
    0
    2
    7
    1
    Pruritus allergic
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Pruritus generalised
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    2 / 21 (9.52%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    2
    1
    Psoriasis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Rash
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    4 / 21 (19.05%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    0
    0
    4
    1
    Rash erythematous
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    2 / 21 (9.52%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    Rash pruritic
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    3 / 21 (14.29%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    Skin odour abnormal
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Skin ulcer
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Renal and urinary disorders
    Chromaturia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    1 / 21 (4.76%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    Micturition urgency
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Pollakiuria
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Urine odour abnormal
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    1 / 9 (11.11%)
    1 / 21 (4.76%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    1
    1
    1
    Back pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    2 / 9 (22.22%)
    4 / 21 (19.05%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    2
    4
    0
    Joint swelling
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Muscle spasms
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    2 / 9 (22.22%)
    1 / 21 (4.76%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    2
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    3 / 21 (14.29%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    4
    0
    Neck pain
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Plantar fasciitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Infections and infestations
    Ear infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    2 / 21 (9.52%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Genital herpes
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    herpes zoster
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Paronychia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    2
    0
    2
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 9 (11.11%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    4 / 10 (40.00%)
    0 / 9 (0.00%)
    5 / 21 (23.81%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    4
    0
    5
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    3 / 21 (14.29%)
    2 / 10 (20.00%)
         occurrences all number
    1
    0
    0
    0
    3
    2
    Polydipsia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 9 (0.00%)
    0 / 21 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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