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    Clinical Trial Results:
    A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected with Chronic HCV who have Advanced Liver Disease or are Post-Liver Transplant

    Summary
    EudraCT number
    		 2013-002802-30
    Trial protocol
    		 BE   GB   DE   IT   AT   NL   ES  
    Global end of trial date
    27 Aug 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jul 2016
    First version publication date
    03 Jul 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-337-0124
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02010255
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, United States, 94404
    Public contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.com
    Scientific contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.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
    27 Aug 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Aug 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study was to evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV) infection. CPT = Child-Pugh-Turcotte; FCH = fibrosing cholestatic hepatitis
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Jan 2014
    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
    Netherlands: 8
    Country: Number of subjects enrolled
    Spain: 52
    Country: Number of subjects enrolled
    United Kingdom: 36
    Country: Number of subjects enrolled
    Austria: 23
    Country: Number of subjects enrolled
    Belgium: 16
    Country: Number of subjects enrolled
    France: 32
    Country: Number of subjects enrolled
    Germany: 28
    Country: Number of subjects enrolled
    Italy: 23
    Country: Number of subjects enrolled
    Canada: 49
    Country: Number of subjects enrolled
    Australia: 27
    Country: Number of subjects enrolled
    Switzerland: 23
    Country: Number of subjects enrolled
    New Zealand: 16
    Worldwide total number of subjects
    333
    EEA total number of subjects
    218
    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)
    267
    From 65 to 84 years
    66
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Europe, Canada, Australia, and New Zealand. The first participant was screened on 14 January 2014. The last study visit occurred on 27 August 2015.

    Pre-assignment
    Screening details
    		 Cohort A: decompensated cirrhosis [advanced liver disease], no prior liver transplant; Cohort B: post-liver transplant, with or without cirrhosis. Group assignment within cohorts was based on severity of liver impairment at screening (or presence of disease for FCH groups). Randomization was 1:1 within groups to 12 or 24 weeks of treatment.

    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
    		 Cohort A, Group 1 (12 wk): CPT Class B (7-9)
    Arm description
    		 LDV/SOF+RBV for 12 weeks in participants with CPT Class B (CPT score 7-9)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    Harvoni®, GS-5885/GS-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LDV/SOF (90/400 mg) FDC tablet administered orally once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV tablets (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) administered orally in a divided daily dose

    Arm title
    		 Cohort A, Group 1 (24 wk): CPT Class B (7-9)
    Arm description
    		 LDV/SOF+RBV tablets for 24 weeks in participants with CPT Class B (CPT score 7-9)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    Harvoni®, GS-5885/GS-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LDV/SOF (90/400 mg) FDC tablet administered orally once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV tablets (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) administered orally in a divided daily dose

    Arm title
    		 Cohort A, Group 2 (12 wk): CPT Class C (10-12)
    Arm description
    		 LDV/SOF+RBV for 12 weeks in participants with CPT Class C (CPT score 10-12)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    Harvoni®, GS-5885/GS-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LDV/SOF (90/400 mg) FDC tablet administered orally once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV tablets (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) administered orally in a divided daily dose

    Arm title
    		 Cohort A, Group 2 (24 wk): CPT Class C (10-12)
    Arm description
    		 LDV/SOF+RBV tablets for 24 weeks in participants with CPT Class C (CPT score 10-12)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    Harvoni®, GS-5885/GS-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LDV/SOF (90/400 mg) FDC tablet administered orally once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV tablets (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) administered orally in a divided daily dose

    Arm title
    		 Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
    Arm description
    		 LDV/SOF+RBV tablets for 12 weeks in participants with Fibrosis Stage F0-F3
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    Harvoni®, GS-5885/GS-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LDV/SOF (90/400 mg) FDC tablet administered orally once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV tablets (weight-based dosing: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) administered orally in a divided daily dose

    Arm title
    		 Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
    Arm description
    		 LDV/SOF+RBV 24 weeks in participants with Fibrosis Stage F0-F3
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    Harvoni®, GS-5885/GS-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LDV/SOF (90/400 mg) FDC tablet administered orally once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV tablets (weight-based dosing: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) administered orally in a divided daily dose

    Arm title
    		 Cohort B, Group 4 (12 wk): CPT Class A (5-6)
    Arm description
    		 LDV/SOF+RBV tablets for 12 weeks in participants with CPT Class A (CPT score 5-6)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    Harvoni®, GS-5885/GS-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LDV/SOF (90/400 mg) FDC tablet administered orally once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV tablets (weight-based dosing: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) administered orally in a divided daily dose

    Arm title
    		 Cohort B, Group 4 (24 wk): CPT Class A (5-6)
    Arm description
    		 LDV/SOF+RBV for 24 weeks in participants with CPT Class A (CPT score 5-6)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    Harvoni®, GS-5885/GS-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LDV/SOF (90/400 mg) FDC tablet administered orally once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV tablets (weight-based dosing: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) administered orally in a divided daily dose

    Arm title
    		 Cohort B, Group 5 (12 wk): CPT Class B (7-9)
    Arm description
    		 LDV/SOF+RBV tablets for 12 weeks in participants with CPT Class B (CPT score 7-9)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    Harvoni®, GS-5885/GS-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LDV/SOF (90/400 mg) FDC tablet administered orally once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV tablets (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) administered orally in a divided daily dose

    Arm title
    		 Cohort B, Group 5 (24 wk): CPT Class B (7-9)
    Arm description
    		 LDV/SOF+RBV tablets for 24 weeks in participants with CPT Class B (CPT score 7-9)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    Harvoni®, GS-5885/GS-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LDV/SOF (90/400 mg) FDC tablet administered orally once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV tablets (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) administered orally in a divided daily dose

    Arm title
    		 Cohort B, Group 6 (12 wk): CPT Class C (10-12)
    Arm description
    		 LDV/SOF+RBV tablets for 12 weeks in participants with CPT Class C (CPT score 10-12)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    Harvoni®, GS-5885/GS-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LDV/SOF (90/400 mg) FDC tablet administered orally once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV tablets (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) administered orally in a divided daily dose

    Arm title
    		 Cohort B, Group 6 (24 wk): CPT Class C (10-12)
    Arm description
    		 LDV/SOF+RBV tablets for 24 weeks in participants with CPT Class C (CPT score 10-12)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    Harvoni®, GS-5885/GS-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LDV/SOF (90/400 mg) FDC tablet administered orally once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV tablets (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) administered orally in a divided daily dose

    Arm title
    		 Cohort B, Group 7 (12 wk): FCH
    Arm description
    		 LDV/SOF+RBV tablets for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    Harvoni®, GS-5885/GS-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LDV/SOF (90/400 mg) FDC tablet administered orally once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV tablets (weight-based dosing: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) administered orally in a divided daily dose

    Arm title
    		 Cohort B, Group 7 (24 wk): FCH
    Arm description
    		 LDV/SOF+RBV tablets for 24 weeks in participants with FCH
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ledipasvir/sofosbuvir
    Investigational medicinal product code
    Other name
    Harvoni®, GS-5885/GS-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LDV/SOF (90/400 mg) FDC tablet administered orally once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV tablets (weight-based dosing: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) administered orally in a divided daily dose

    Number of subjects in period 1
    		Cohort A, Group 1 (12 wk): CPT Class B (7-9) Cohort A, Group 1 (24 wk): CPT Class B (7-9) Cohort A, Group 2 (12 wk): CPT Class C (10-12) Cohort A, Group 2 (24 wk): CPT Class C (10-12) Cohort B, Group 3 (12 wk): F0-F3 Fibrosis Cohort B, Group 3 (24 wk): F0-F3 Fibrosis Cohort B, Group 4 (12 wk): CPT Class A (5-6) Cohort B, Group 4 (24 wk): CPT Class A (5-6) Cohort B, Group 5 (12 wk): CPT Class B (7-9) Cohort B, Group 5 (24 wk): CPT Class B (7-9) Cohort B, Group 6 (12 wk): CPT Class C (10-12) Cohort B, Group 6 (24 wk): CPT Class C (10-12) Cohort B, Group 7 (12 wk): FCH Cohort B, Group 7 (24 wk): FCH
    Started
    28
    28
    25
    26
    52
    49
    34
    33
    22
    23
    3
    5
    3
    2
    Completed
    22
    26
    18
    20
    48
    49
    33
    32
    21
    23
    1
    4
    3
    2
    Not completed
    6
    2
    7
    6
    4
    0
    1
    1
    1
    0
    2
    1
    0
    0
         Withdrew Consent
    1
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Adverse event, non-fatal
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Death
    -
    1
    4
    4
    2
    -
    1
    1
    1
    -
    1
    1
    -
    -
         Lost to follow-up
    -
    -
    1
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Lack of efficacy
    4
    1
    2
    1
    1
    -
    -
    -
    -
    -
    1
    -
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Cohort A, Group 1 (12 wk): CPT Class B (7-9)
    Reporting group description
    		 LDV/SOF+RBV for 12 weeks in participants with CPT Class B (CPT score 7-9)

    Reporting group title
    Cohort A, Group 1 (24 wk): CPT Class B (7-9)
    Reporting group description
    		 LDV/SOF+RBV tablets for 24 weeks in participants with CPT Class B (CPT score 7-9)

    Reporting group title
    Cohort A, Group 2 (12 wk): CPT Class C (10-12)
    Reporting group description
    		 LDV/SOF+RBV for 12 weeks in participants with CPT Class C (CPT score 10-12)

    Reporting group title
    Cohort A, Group 2 (24 wk): CPT Class C (10-12)
    Reporting group description
    		 LDV/SOF+RBV tablets for 24 weeks in participants with CPT Class C (CPT score 10-12)

    Reporting group title
    Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
    Reporting group description
    		 LDV/SOF+RBV tablets for 12 weeks in participants with Fibrosis Stage F0-F3

    Reporting group title
    Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
    Reporting group description
    		 LDV/SOF+RBV 24 weeks in participants with Fibrosis Stage F0-F3

    Reporting group title
    Cohort B, Group 4 (12 wk): CPT Class A (5-6)
    Reporting group description
    		 LDV/SOF+RBV tablets for 12 weeks in participants with CPT Class A (CPT score 5-6)

    Reporting group title
    Cohort B, Group 4 (24 wk): CPT Class A (5-6)
    Reporting group description
    		 LDV/SOF+RBV for 24 weeks in participants with CPT Class A (CPT score 5-6)

    Reporting group title
    Cohort B, Group 5 (12 wk): CPT Class B (7-9)
    Reporting group description
    		 LDV/SOF+RBV tablets for 12 weeks in participants with CPT Class B (CPT score 7-9)

    Reporting group title
    Cohort B, Group 5 (24 wk): CPT Class B (7-9)
    Reporting group description
    		 LDV/SOF+RBV tablets for 24 weeks in participants with CPT Class B (CPT score 7-9)

    Reporting group title
    Cohort B, Group 6 (12 wk): CPT Class C (10-12)
    Reporting group description
    		 LDV/SOF+RBV tablets for 12 weeks in participants with CPT Class C (CPT score 10-12)

    Reporting group title
    Cohort B, Group 6 (24 wk): CPT Class C (10-12)
    Reporting group description
    		 LDV/SOF+RBV tablets for 24 weeks in participants with CPT Class C (CPT score 10-12)

    Reporting group title
    Cohort B, Group 7 (12 wk): FCH
    Reporting group description
    		 LDV/SOF+RBV tablets for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)

    Reporting group title
    Cohort B, Group 7 (24 wk): FCH
    Reporting group description
    		 LDV/SOF+RBV tablets for 24 weeks in participants with FCH

    Reporting group values
    		 Cohort A, Group 1 (12 wk): CPT Class B (7-9) Cohort A, Group 1 (24 wk): CPT Class B (7-9) Cohort A, Group 2 (12 wk): CPT Class C (10-12) Cohort A, Group 2 (24 wk): CPT Class C (10-12) Cohort B, Group 3 (12 wk): F0-F3 Fibrosis Cohort B, Group 3 (24 wk): F0-F3 Fibrosis Cohort B, Group 4 (12 wk): CPT Class A (5-6) Cohort B, Group 4 (24 wk): CPT Class A (5-6) Cohort B, Group 5 (12 wk): CPT Class B (7-9) Cohort B, Group 5 (24 wk): CPT Class B (7-9) Cohort B, Group 6 (12 wk): CPT Class C (10-12) Cohort B, Group 6 (24 wk): CPT Class C (10-12) Cohort B, Group 7 (12 wk): FCH Cohort B, Group 7 (24 wk): FCH Total
    Number of subjects
    		 28 28 25 26 52 49 34 33 22 23 3 5 3 2 333
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55 ± 9.9 56 ± 8.6 58 ± 8.1 54 ± 10.7 58 ± 7.9 59 ± 6.9 57 ± 7.2 62 ± 7.5 58 ± 8 60 ± 10.2 62 ± 4.6 62 ± 9.2 58 ± 2.6 53 ± 2.8 -
    Gender categorical
    Units: Subjects
        Female
    		 5 9 10 6 11 10 6 7 7 8 1 0 1 1 82
        Male
    		 23 19 15 20 41 39 28 26 15 15 2 5 2 1 251
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 6 6 3 8 4 8 5 7 3 4 1 2 0 0 57
        Not Hispanic or Latino
    		 22 22 22 18 48 41 29 26 19 19 2 3 3 2 276
        Unknown or not reported
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
    Race
    Units: Subjects
        Black or African American
    		 1 0 1 1 1 0 0 0 0 1 0 0 0 0 5
        White
    		 25 28 23 25 50 47 33 30 21 21 3 5 2 1 314
        Asian
    		 0 0 0 0 0 1 0 3 0 1 0 0 1 1 7
        Native Hawaiian or Pacific Islander
    		 1 0 0 0 0 0 1 0 0 0 0 0 0 0 2
        Other
    		 1 0 1 0 1 1 0 0 1 0 0 0 0 0 5
    HCV RNA Category
    Units: Subjects
        < 800,000 IU/mL
    		 11 14 16 17 12 5 9 5 5 9 2 0 0 1 106
        ≥ 800,000 IU/mL
    		 17 14 9 9 40 44 25 28 17 14 1 5 3 1 227
    HCV Genotype
    Units: Subjects
        Genotype 1a
    		 13 12 13 12 27 29 14 13 11 13 1 1 2 2 163
        Genotype 1b
    		 12 13 11 11 18 15 16 15 9 7 1 4 1 0 133
        Genotype 4
    		 3 3 1 3 7 5 4 5 2 3 1 0 0 0 37
    IL28b Status
    The CC, CT, and TT alleles are different forms of the IL28b gene.
    Units: Subjects
        CC
    		 6 9 7 4 9 10 3 7 3 5 0 3 0 1 67
        CT
    		 18 10 10 15 31 25 23 21 12 11 2 2 3 1 184
        TT
    		 4 9 8 7 12 14 8 5 7 7 1 0 0 0 82
    Cirrhosis Status
    Units: Subjects
        No
    		 0 0 0 0 52 49 0 0 0 0 0 0 3 2 106
        Yes
    		 28 28 25 26 0 0 34 33 22 23 3 5 0 0 227
    HCV RNA
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    		 6 ± 0.49 5.9 ± 0.56 5.6 ± 0.58 5.7 ± 0.44 6.4 ± 0.72 6.5 ± 0.44 6.3 ± 0.58 6.5 ± 0.55 6.1 ± 0.78 6.2 ± 0.85 6 ± 0.49 6.5 ± 0.5 7.3 ± 0.72 6 ± 0.41 -

    End points

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    End points reporting groups
    Reporting group title
    Cohort A, Group 1 (12 wk): CPT Class B (7-9)
    Reporting group description
    		 LDV/SOF+RBV for 12 weeks in participants with CPT Class B (CPT score 7-9)

    Reporting group title
    Cohort A, Group 1 (24 wk): CPT Class B (7-9)
    Reporting group description
    		 LDV/SOF+RBV tablets for 24 weeks in participants with CPT Class B (CPT score 7-9)

    Reporting group title
    Cohort A, Group 2 (12 wk): CPT Class C (10-12)
    Reporting group description
    		 LDV/SOF+RBV for 12 weeks in participants with CPT Class C (CPT score 10-12)

    Reporting group title
    Cohort A, Group 2 (24 wk): CPT Class C (10-12)
    Reporting group description
    		 LDV/SOF+RBV tablets for 24 weeks in participants with CPT Class C (CPT score 10-12)

    Reporting group title
    Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
    Reporting group description
    		 LDV/SOF+RBV tablets for 12 weeks in participants with Fibrosis Stage F0-F3

    Reporting group title
    Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
    Reporting group description
    		 LDV/SOF+RBV 24 weeks in participants with Fibrosis Stage F0-F3

    Reporting group title
    Cohort B, Group 4 (12 wk): CPT Class A (5-6)
    Reporting group description
    		 LDV/SOF+RBV tablets for 12 weeks in participants with CPT Class A (CPT score 5-6)

    Reporting group title
    Cohort B, Group 4 (24 wk): CPT Class A (5-6)
    Reporting group description
    		 LDV/SOF+RBV for 24 weeks in participants with CPT Class A (CPT score 5-6)

    Reporting group title
    Cohort B, Group 5 (12 wk): CPT Class B (7-9)
    Reporting group description
    		 LDV/SOF+RBV tablets for 12 weeks in participants with CPT Class B (CPT score 7-9)

    Reporting group title
    Cohort B, Group 5 (24 wk): CPT Class B (7-9)
    Reporting group description
    		 LDV/SOF+RBV tablets for 24 weeks in participants with CPT Class B (CPT score 7-9)

    Reporting group title
    Cohort B, Group 6 (12 wk): CPT Class C (10-12)
    Reporting group description
    		 LDV/SOF+RBV tablets for 12 weeks in participants with CPT Class C (CPT score 10-12)

    Reporting group title
    Cohort B, Group 6 (24 wk): CPT Class C (10-12)
    Reporting group description
    		 LDV/SOF+RBV tablets for 24 weeks in participants with CPT Class C (CPT score 10-12)

    Reporting group title
    Cohort B, Group 7 (12 wk): FCH
    Reporting group description
    		 LDV/SOF+RBV tablets for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)

    Reporting group title
    Cohort B, Group 7 (24 wk): FCH
    Reporting group description
    		 LDV/SOF+RBV tablets for 24 weeks in participants with FCH

    Subject analysis set title
    All LDV/SOF+RBV (pTVR)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Includes participants who had a liver transplant while on study if their last observed HCV RNA measurement prior to transplant was < LLOQ. Participants who received a transplant from an HCV-infected donor were excluded from analysis.

    Subject analysis set title
    Cohort A: Baseline CPT Class B (12 wk)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.

    Subject analysis set title
    Cohort A: Baseline CPT Class B (24 wk)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.

    Subject analysis set title
    Cohort A: Baseline CPT Class C (12 wk)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.

    Subject analysis set title
    Cohort A: Baseline CPT Class C (24 wk)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.

    Subject analysis set title
    Cohort B: Baseline CPT Class A (12 wk)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.

    Subject analysis set title
    Cohort B: Baseline CPT Class A (24 wk)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.

    Subject analysis set title
    Cohort B: Baseline CPT Class B (12 wk)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.

    Subject analysis set title
    Cohort B: Baseline CPT Class B (24 wk)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.

    Subject analysis set title
    Cohort B: Baseline CPT Class C (12 wk)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.

    Subject analysis set title
    Cohort B: Baseline CPT Class C (24 wk)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Includes participants in Cohort B (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.

    Primary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

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    End point title
    		 Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [1]
    End point description
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. Full Analysis Set: participants who were randomized and received at least one dose of study drug. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 12 visit were not included in the analysis.
    End point type
    Primary
    End point timeframe
    Posttreatment Week 12
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned or performed.
    End point values
    		 Cohort A, Group 1 (12 wk): CPT Class B (7-9) Cohort A, Group 1 (24 wk): CPT Class B (7-9) Cohort A, Group 2 (12 wk): CPT Class C (10-12) Cohort A, Group 2 (24 wk): CPT Class C (10-12) Cohort B, Group 3 (12 wk): F0-F3 Fibrosis Cohort B, Group 3 (24 wk): F0-F3 Fibrosis Cohort B, Group 4 (12 wk): CPT Class A (5-6) Cohort B, Group 4 (24 wk): CPT Class A (5-6) Cohort B, Group 5 (12 wk): CPT Class B (7-9) Cohort B, Group 5 (24 wk): CPT Class B (7-9) Cohort B, Group 6 (12 wk): CPT Class C (10-12) Cohort B, Group 6 (24 wk): CPT Class C (10-12) Cohort B, Group 7 (12 wk): FCH Cohort B, Group 7 (24 wk): FCH
    Number of subjects analysed
    26
    25
    21
    25
    52
    49
    34
    33
    22
    23
    3
    5
    3
    2
    Units: percentage of participants
        number (not applicable)
    84.6
    96
    81
    76
    94.2
    100
    97.1
    97
    95.5
    100
    33.3
    80
    100
    100
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event

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    End point title
    		 Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event [2]
    End point description
    Safety Analysis Set: participants who were randomized and received at least one dose of study drug
    End point type
    Primary
    End point timeframe
    Up to 24 weeks
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned or performed.
    End point values
    		 Cohort A, Group 1 (12 wk): CPT Class B (7-9) Cohort A, Group 1 (24 wk): CPT Class B (7-9) Cohort A, Group 2 (12 wk): CPT Class C (10-12) Cohort A, Group 2 (24 wk): CPT Class C (10-12) Cohort B, Group 3 (12 wk): F0-F3 Fibrosis Cohort B, Group 3 (24 wk): F0-F3 Fibrosis Cohort B, Group 4 (12 wk): CPT Class A (5-6) Cohort B, Group 4 (24 wk): CPT Class A (5-6) Cohort B, Group 5 (12 wk): CPT Class B (7-9) Cohort B, Group 5 (24 wk): CPT Class B (7-9) Cohort B, Group 6 (12 wk): CPT Class C (10-12) Cohort B, Group 6 (24 wk): CPT Class C (10-12) Cohort B, Group 7 (12 wk): FCH Cohort B, Group 7 (24 wk): FCH
    Number of subjects analysed
    28
    28
    25
    26
    52
    49
    34
    33
    22
    23
    3
    5
    3
    2
    Units: percentage of participants
    number (not applicable)
        Discontinued LDV/SOF
    3.6
    3.6
    0
    7.7
    1.9
    0
    0
    3
    0
    0
    0
    20
    0
    0
        Discontinued Any Study Drug
    3.6
    7.1
    16
    23.1
    5.8
    6.1
    0
    15.2
    18.2
    17.4
    33.3
    20
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2)

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    End point title
    		 Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2)
    End point description
    Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2). Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 2 visit were not included in the analysis.
    End point type
    Secondary
    End point timeframe
    Posttreatment Week 2
    End point values
    		 Cohort A, Group 1 (12 wk): CPT Class B (7-9) Cohort A, Group 1 (24 wk): CPT Class B (7-9) Cohort A, Group 2 (12 wk): CPT Class C (10-12) Cohort A, Group 2 (24 wk): CPT Class C (10-12) Cohort B, Group 3 (12 wk): F0-F3 Fibrosis Cohort B, Group 3 (24 wk): F0-F3 Fibrosis Cohort B, Group 4 (12 wk): CPT Class A (5-6) Cohort B, Group 4 (24 wk): CPT Class A (5-6) Cohort B, Group 5 (12 wk): CPT Class B (7-9) Cohort B, Group 5 (24 wk): CPT Class B (7-9) Cohort B, Group 6 (12 wk): CPT Class C (10-12) Cohort B, Group 6 (24 wk): CPT Class C (10-12) Cohort B, Group 7 (12 wk): FCH Cohort B, Group 7 (24 wk): FCH
    Number of subjects analysed
    26
    26
    23
    25
    52
    49
    34
    33
    22
    23
    3
    5
    3
    2
    Units: percentage of participants
        number (not applicable)
    96.2
    100
    91.3
    80
    98.1
    100
    100
    97
    95.5
    100
    100
    80
    100
    100
    No statistical analyses for this end point

    Secondary: Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)

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    End point title
    		 Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)
    End point description
    SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 4 visit were not included in the analysis.
    End point type
    Secondary
    End point timeframe
    Posttreatment Week 4
    End point values
    		 Cohort A, Group 1 (12 wk): CPT Class B (7-9) Cohort A, Group 1 (24 wk): CPT Class B (7-9) Cohort A, Group 2 (12 wk): CPT Class C (10-12) Cohort A, Group 2 (24 wk): CPT Class C (10-12) Cohort B, Group 3 (12 wk): F0-F3 Fibrosis Cohort B, Group 3 (24 wk): F0-F3 Fibrosis Cohort B, Group 4 (12 wk): CPT Class A (5-6) Cohort B, Group 4 (24 wk): CPT Class A (5-6) Cohort B, Group 5 (12 wk): CPT Class B (7-9) Cohort B, Group 5 (24 wk): CPT Class B (7-9) Cohort B, Group 6 (12 wk): CPT Class C (10-12) Cohort B, Group 6 (24 wk): CPT Class C (10-12) Cohort B, Group 7 (12 wk): FCH Cohort B, Group 7 (24 wk): FCH
    Number of subjects analysed
    26
    26
    22
    25
    52
    49
    34
    33
    22
    23
    3
    5
    3
    2
    Units: percentage of participants
        number (not applicable)
    88.5
    100
    90.9
    80
    94.2
    100
    97.1
    97
    95.5
    100
    100
    80
    100
    100
    No statistical analyses for this end point

    Secondary: Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8)

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    End point title
    		 Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8)
    End point description
    SVR8 was defined as HCV RNA < LLOQ at 8 weeks after stopping study treatment. Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 8 visit were not included in the analysis.
    End point type
    Secondary
    End point timeframe
    Posttreatment Week 8
    End point values
    		 Cohort A, Group 1 (12 wk): CPT Class B (7-9) Cohort A, Group 1 (24 wk): CPT Class B (7-9) Cohort A, Group 2 (12 wk): CPT Class C (10-12) Cohort A, Group 2 (24 wk): CPT Class C (10-12) Cohort B, Group 3 (12 wk): F0-F3 Fibrosis Cohort B, Group 3 (24 wk): F0-F3 Fibrosis Cohort B, Group 4 (12 wk): CPT Class A (5-6) Cohort B, Group 4 (24 wk): CPT Class A (5-6) Cohort B, Group 5 (12 wk): CPT Class B (7-9) Cohort B, Group 5 (24 wk): CPT Class B (7-9) Cohort B, Group 6 (12 wk): CPT Class C (10-12) Cohort B, Group 6 (24 wk): CPT Class C (10-12) Cohort B, Group 7 (12 wk): FCH Cohort B, Group 7 (24 wk): FCH
    Number of subjects analysed
    26
    26
    22
    25
    52
    49
    34
    33
    22
    23
    3
    5
    3
    2
    Units: percentage of participants
        number (not applicable)
    84.6
    96.2
    81.8
    80
    94.2
    100
    97.1
    97
    95.5
    100
    33.3
    80
    100
    100
    No statistical analyses for this end point

    Secondary: Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24)

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    End point title
    		 Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24)
    End point description
    SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. Full Analysis Set. Participants in Cohort A and 1 participant in Cohort B who received a liver transplant prior to the lower bound of the Posttreatment Week 24 visit were not included in the analysis.
    End point type
    Secondary
    End point timeframe
    Posttreatment Week 24
    End point values
    		 Cohort A, Group 1 (12 wk): CPT Class B (7-9) Cohort A, Group 1 (24 wk): CPT Class B (7-9) Cohort A, Group 2 (12 wk): CPT Class C (10-12) Cohort A, Group 2 (24 wk): CPT Class C (10-12) Cohort B, Group 3 (12 wk): F0-F3 Fibrosis Cohort B, Group 3 (24 wk): F0-F3 Fibrosis Cohort B, Group 4 (12 wk): CPT Class A (5-6) Cohort B, Group 4 (24 wk): CPT Class A (5-6) Cohort B, Group 5 (12 wk): CPT Class B (7-9) Cohort B, Group 5 (24 wk): CPT Class B (7-9) Cohort B, Group 6 (12 wk): CPT Class C (10-12) Cohort B, Group 6 (24 wk): CPT Class C (10-12) Cohort B, Group 7 (12 wk): FCH Cohort B, Group 7 (24 wk): FCH
    Number of subjects analysed
    25
    25
    20
    25
    52
    49
    34
    33
    22
    22
    3
    5
    3
    2
    Units: percentage of participants
        number (not applicable)
    84
    96
    80
    76
    94.2
    100
    97.1
    97
    95.5
    100
    33.3
    80
    100
    100
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Virologic Failure

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    End point title
    		 Percentage of Participants With Virologic Failure
    End point description
    Virologic failure was defined as either on-treatment virologic failure or virologic relapse. On-treatment virologic failure = either breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ on 2 consecutive measurements while on treatment), or rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment). Virologic relapse = confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. Full Analysis Set. Participants were excluded from the analysis if they received a liver transplant while on study (with HCV RNA <LLOQ at transplant) prior to lower bound of Posttreatment Week 12 visit window.
    End point type
    Secondary
    End point timeframe
    Up to Posttreatment Week 24
    End point values
    		 Cohort A, Group 1 (12 wk): CPT Class B (7-9) Cohort A, Group 1 (24 wk): CPT Class B (7-9) Cohort A, Group 2 (12 wk): CPT Class C (10-12) Cohort A, Group 2 (24 wk): CPT Class C (10-12) Cohort B, Group 3 (12 wk): F0-F3 Fibrosis Cohort B, Group 3 (24 wk): F0-F3 Fibrosis Cohort B, Group 4 (12 wk): CPT Class A (5-6) Cohort B, Group 4 (24 wk): CPT Class A (5-6) Cohort B, Group 5 (12 wk): CPT Class B (7-9) Cohort B, Group 5 (24 wk): CPT Class B (7-9) Cohort B, Group 6 (12 wk): CPT Class C (10-12) Cohort B, Group 6 (24 wk): CPT Class C (10-12) Cohort B, Group 7 (12 wk): FCH Cohort B, Group 7 (24 wk): FCH
    Number of subjects analysed
    26
    25
    21
    25
    52
    49
    34
    33
    22
    23
    3
    5
    3
    2
    Units: percentage of participants
        number (not applicable)
    15.4
    4
    9.5
    4
    1.9
    0
    0
    0
    0
    0
    33.3
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12

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    End point title
    		 Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12
    End point description
    pTVR was defined as HCV RNA < LLOQ at Week 12 after transplant. All participants in the analysis are presented in a single group, regardless of randomization group assignment. Participants who had a liver transplant while on study were analyzed if their last observed HCV RNA measurement prior to transplant was < LLOQ. Participants who received a transplant from an HCV-infected donor were excluded from the analysis.
    End point type
    Secondary
    End point timeframe
    Posttransplant Week 12
    End point values
    		 All LDV/SOF+RBV (pTVR)
    Number of subjects analysed
    10
    Units: percentage of participants
        number (not applicable)
    100
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HCV RNA < LLOQ at Week 1

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    End point title
    		 Percentage of Participants With HCV RNA < LLOQ at Week 1
    End point description
    Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Week 1
    End point values
    		 Cohort A, Group 1 (12 wk): CPT Class B (7-9) Cohort A, Group 1 (24 wk): CPT Class B (7-9) Cohort A, Group 2 (12 wk): CPT Class C (10-12) Cohort A, Group 2 (24 wk): CPT Class C (10-12) Cohort B, Group 3 (12 wk): F0-F3 Fibrosis Cohort B, Group 3 (24 wk): F0-F3 Fibrosis Cohort B, Group 4 (12 wk): CPT Class A (5-6) Cohort B, Group 4 (24 wk): CPT Class A (5-6) Cohort B, Group 5 (12 wk): CPT Class B (7-9) Cohort B, Group 5 (24 wk): CPT Class B (7-9) Cohort B, Group 6 (12 wk): CPT Class C (10-12) Cohort B, Group 6 (24 wk): CPT Class C (10-12) Cohort B, Group 7 (12 wk): FCH Cohort B, Group 7 (24 wk): FCH
    Number of subjects analysed
    26
    27
    25
    26
    52
    49
    34
    33
    22
    23
    3
    5
    3
    2
    Units: percentage of participants
        number (not applicable)
    3.8
    3.7
    12
    3.8
    9.6
    6.1
    5.9
    3
    0
    8.7
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HCV RNA < LLOQ at Week 2

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    End point title
    		 Percentage of Participants With HCV RNA < LLOQ at Week 2
    End point description
    Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    		 Cohort A, Group 1 (12 wk): CPT Class B (7-9) Cohort A, Group 1 (24 wk): CPT Class B (7-9) Cohort A, Group 2 (12 wk): CPT Class C (10-12) Cohort A, Group 2 (24 wk): CPT Class C (10-12) Cohort B, Group 3 (12 wk): F0-F3 Fibrosis Cohort B, Group 3 (24 wk): F0-F3 Fibrosis Cohort B, Group 4 (12 wk): CPT Class A (5-6) Cohort B, Group 4 (24 wk): CPT Class A (5-6) Cohort B, Group 5 (12 wk): CPT Class B (7-9) Cohort B, Group 5 (24 wk): CPT Class B (7-9) Cohort B, Group 6 (12 wk): CPT Class C (10-12) Cohort B, Group 6 (24 wk): CPT Class C (10-12) Cohort B, Group 7 (12 wk): FCH Cohort B, Group 7 (24 wk): FCH
    Number of subjects analysed
    26
    27
    25
    26
    52
    49
    34
    33
    22
    23
    3
    5
    3
    2
    Units: percentage of participants
        number (not applicable)
    26.9
    37
    40
    38.5
    48.1
    44.9
    26.5
    21.2
    31.8
    30.4
    0
    0
    33.3
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HCV RNA < LLOQ at Week 4

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    End point title
    		 Percentage of Participants With HCV RNA < LLOQ at Week 4
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Cohort A, Group 1 (12 wk): CPT Class B (7-9) Cohort A, Group 1 (24 wk): CPT Class B (7-9) Cohort A, Group 2 (12 wk): CPT Class C (10-12) Cohort A, Group 2 (24 wk): CPT Class C (10-12) Cohort B, Group 3 (12 wk): F0-F3 Fibrosis Cohort B, Group 3 (24 wk): F0-F3 Fibrosis Cohort B, Group 4 (12 wk): CPT Class A (5-6) Cohort B, Group 4 (24 wk): CPT Class A (5-6) Cohort B, Group 5 (12 wk): CPT Class B (7-9) Cohort B, Group 5 (24 wk): CPT Class B (7-9) Cohort B, Group 6 (12 wk): CPT Class C (10-12) Cohort B, Group 6 (24 wk): CPT Class C (10-12) Cohort B, Group 7 (12 wk): FCH Cohort B, Group 7 (24 wk): FCH
    Number of subjects analysed
    26
    27
    25
    26
    52
    49
    34
    33
    22
    23
    3
    4
    3
    2
    Units: percentage of participants
        number (not applicable)
    76.9
    81.5
    80
    84.6
    84.6
    91.8
    67.6
    81.8
    72.7
    82.6
    100
    25
    100
    100
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HCV RNA < LLOQ at Week 6

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    End point title
    		 Percentage of Participants With HCV RNA < LLOQ at Week 6
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Cohort A, Group 1 (12 wk): CPT Class B (7-9) Cohort A, Group 1 (24 wk): CPT Class B (7-9) Cohort A, Group 2 (12 wk): CPT Class C (10-12) Cohort A, Group 2 (24 wk): CPT Class C (10-12) Cohort B, Group 3 (12 wk): F0-F3 Fibrosis Cohort B, Group 3 (24 wk): F0-F3 Fibrosis Cohort B, Group 4 (12 wk): CPT Class A (5-6) Cohort B, Group 4 (24 wk): CPT Class A (5-6) Cohort B, Group 5 (12 wk): CPT Class B (7-9) Cohort B, Group 5 (24 wk): CPT Class B (7-9) Cohort B, Group 6 (12 wk): CPT Class C (10-12) Cohort B, Group 6 (24 wk): CPT Class C (10-12) Cohort B, Group 7 (12 wk): FCH Cohort B, Group 7 (24 wk): FCH
    Number of subjects analysed
    26
    27
    24
    25
    52
    49
    34
    33
    22
    23
    3
    4
    3
    2
    Units: percentage of participants
        number (not applicable)
    100
    100
    91.7
    100
    98.1
    100
    100
    97
    100
    100
    100
    100
    100
    100
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HCV RNA < LLOQ at Week 8

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    End point title
    		 Percentage of Participants With HCV RNA < LLOQ at Week 8
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Cohort A, Group 1 (12 wk): CPT Class B (7-9) Cohort A, Group 1 (24 wk): CPT Class B (7-9) Cohort A, Group 2 (12 wk): CPT Class C (10-12) Cohort A, Group 2 (24 wk): CPT Class C (10-12) Cohort B, Group 3 (12 wk): F0-F3 Fibrosis Cohort B, Group 3 (24 wk): F0-F3 Fibrosis Cohort B, Group 4 (12 wk): CPT Class A (5-6) Cohort B, Group 4 (24 wk): CPT Class A (5-6) Cohort B, Group 5 (12 wk): CPT Class B (7-9) Cohort B, Group 5 (24 wk): CPT Class B (7-9) Cohort B, Group 6 (12 wk): CPT Class C (10-12) Cohort B, Group 6 (24 wk): CPT Class C (10-12) Cohort B, Group 7 (12 wk): FCH Cohort B, Group 7 (24 wk): FCH
    Number of subjects analysed
    26
    27
    24
    25
    52
    49
    34
    32
    22
    23
    3
    4
    3
    2
    Units: percentage of participants
        number (not applicable)
    100
    100
    100
    96
    100
    100
    100
    96.9
    100
    100
    100
    100
    100
    100
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HCV RNA < LLOQ at Week 12

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    End point title
    		 Percentage of Participants With HCV RNA < LLOQ at Week 12
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Cohort A, Group 1 (12 wk): CPT Class B (7-9) Cohort A, Group 1 (24 wk): CPT Class B (7-9) Cohort A, Group 2 (12 wk): CPT Class C (10-12) Cohort A, Group 2 (24 wk): CPT Class C (10-12) Cohort B, Group 3 (12 wk): F0-F3 Fibrosis Cohort B, Group 3 (24 wk): F0-F3 Fibrosis Cohort B, Group 4 (12 wk): CPT Class A (5-6) Cohort B, Group 4 (24 wk): CPT Class A (5-6) Cohort B, Group 5 (12 wk): CPT Class B (7-9) Cohort B, Group 5 (24 wk): CPT Class B (7-9) Cohort B, Group 6 (12 wk): CPT Class C (10-12) Cohort B, Group 6 (24 wk): CPT Class C (10-12) Cohort B, Group 7 (12 wk): FCH Cohort B, Group 7 (24 wk): FCH
    Number of subjects analysed
    26
    27
    24
    24
    51
    49
    34
    32
    22
    23
    3
    4
    3
    2
    Units: percentage of participants
        number (not applicable)
    100
    100
    100
    100
    100
    100
    100
    100
    95.5
    100
    100
    100
    100
    100
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HCV RNA < LLOQ at Week 16

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    End point title
    		 Percentage of Participants With HCV RNA < LLOQ at Week 16 [3]
    End point description
    Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.
    End point type
    Secondary
    End point timeframe
    Week 16
    Notes
    [3] - 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: 12-week treatment groups (did not collect data past Week 12) are not presented in this table.
    End point values
    		 Cohort A, Group 1 (24 wk): CPT Class B (7-9) Cohort A, Group 2 (24 wk): CPT Class C (10-12) Cohort B, Group 3 (24 wk): F0-F3 Fibrosis Cohort B, Group 4 (24 wk): CPT Class A (5-6) Cohort B, Group 5 (24 wk): CPT Class B (7-9) Cohort B, Group 6 (24 wk): CPT Class C (10-12) Cohort B, Group 7 (24 wk): FCH
    Number of subjects analysed
    26
    22
    49
    32
    23
    4
    2
    Units: percentage of participants
        number (not applicable)
    100
    100
    100
    100
    100
    100
    100
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HCV RNA < LLOQ at Week 20

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    End point title
    		 Percentage of Participants With HCV RNA < LLOQ at Week 20 [4]
    End point description
    Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.
    End point type
    Secondary
    End point timeframe
    Week 20
    Notes
    [4] - 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: 12-week treatment groups (did not collect data past Week 12) are not presented in this table.
    End point values
    		 Cohort A, Group 1 (24 wk): CPT Class B (7-9) Cohort A, Group 2 (24 wk): CPT Class C (10-12) Cohort B, Group 3 (24 wk): F0-F3 Fibrosis Cohort B, Group 4 (24 wk): CPT Class A (5-6) Cohort B, Group 5 (24 wk): CPT Class B (7-9) Cohort B, Group 6 (24 wk): CPT Class C (10-12) Cohort B, Group 7 (24 wk): FCH
    Number of subjects analysed
    26
    21
    49
    32
    23
    4
    2
    Units: percentage of participants
        number (not applicable)
    100
    100
    100
    100
    100
    100
    100
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HCV RNA < LLOQ at Week 24

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    End point title
    		 Percentage of Participants With HCV RNA < LLOQ at Week 24 [5]
    End point description
    Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [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: 12-week treatment groups (did not collect data past Week 12) are not presented in this table.
    End point values
    		 Cohort A, Group 1 (24 wk): CPT Class B (7-9) Cohort A, Group 2 (24 wk): CPT Class C (10-12) Cohort B, Group 3 (24 wk): F0-F3 Fibrosis Cohort B, Group 4 (24 wk): CPT Class A (5-6) Cohort B, Group 5 (24 wk): CPT Class B (7-9) Cohort B, Group 6 (24 wk): CPT Class C (10-12) Cohort B, Group 7 (24 wk): FCH
    Number of subjects analysed
    25
    21
    49
    32
    23
    4
    2
    Units: percentage of participants
        number (not applicable)
    100
    100
    100
    100
    100
    100
    100
    No statistical analyses for this end point

    Secondary: HCV RNA and Change From Baseline at Week 1

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    End point title
    		 HCV RNA and Change From Baseline at Week 1
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 1
    End point values
    		 Cohort A, Group 1 (12 wk): CPT Class B (7-9) Cohort A, Group 1 (24 wk): CPT Class B (7-9) Cohort A, Group 2 (12 wk): CPT Class C (10-12) Cohort A, Group 2 (24 wk): CPT Class C (10-12) Cohort B, Group 3 (12 wk): F0-F3 Fibrosis Cohort B, Group 3 (24 wk): F0-F3 Fibrosis Cohort B, Group 4 (12 wk): CPT Class A (5-6) Cohort B, Group 4 (24 wk): CPT Class A (5-6) Cohort B, Group 5 (12 wk): CPT Class B (7-9) Cohort B, Group 5 (24 wk): CPT Class B (7-9) Cohort B, Group 6 (12 wk): CPT Class C (10-12) Cohort B, Group 6 (24 wk): CPT Class C (10-12) Cohort B, Group 7 (12 wk): FCH Cohort B, Group 7 (24 wk): FCH
    Number of subjects analysed
    26
    27
    24
    25
    52
    49
    34
    33
    22
    23
    3
    5
    3
    2
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Week 1
    2.44 ± 0.665
    2.47 ± 0.696
    2.32 ± 0.868
    2.5 ± 0.645
    2.38 ± 0.716
    2.38 ± 0.653
    2.64 ± 0.784
    2.81 ± 0.729
    2.63 ± 0.78
    2.75 ± 0.888
    2.97 ± 0.229
    3.73 ± 0.434
    2.91 ± 0.825
    2.28 ± 0.62
        Change at Week 1
    -3.6 ± 0.535
    -3.39 ± 0.634
    -3.28 ± 0.735
    -3.2 ± 0.61
    -3.98 ± 0.611
    -4.12 ± 0.538
    -3.7 ± 0.489
    -3.65 ± 0.562
    -3.5 ± 0.666
    -3.44 ± 0.789
    -3.06 ± 0.645
    -2.74 ± 0.446
    -4.4 ± 0.503
    -3.76 ± 0.213
    No statistical analyses for this end point

    Secondary: HCV RNA and Change From Baseline at Week 2

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    End point title
    		 HCV RNA and Change From Baseline at Week 2
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 2
    End point values
    		 Cohort A, Group 1 (12 wk): CPT Class B (7-9) Cohort A, Group 1 (24 wk): CPT Class B (7-9) Cohort A, Group 2 (12 wk): CPT Class C (10-12) Cohort A, Group 2 (24 wk): CPT Class C (10-12) Cohort B, Group 3 (12 wk): F0-F3 Fibrosis Cohort B, Group 3 (24 wk): F0-F3 Fibrosis Cohort B, Group 4 (12 wk): CPT Class A (5-6) Cohort B, Group 4 (24 wk): CPT Class A (5-6) Cohort B, Group 5 (12 wk): CPT Class B (7-9) Cohort B, Group 5 (24 wk): CPT Class B (7-9) Cohort B, Group 6 (12 wk): CPT Class C (10-12) Cohort B, Group 6 (24 wk): CPT Class C (10-12) Cohort B, Group 7 (12 wk): FCH Cohort B, Group 7 (24 wk): FCH
    Number of subjects analysed
    26
    27
    25
    26
    52
    48
    33
    33
    22
    23
    3
    5
    3
    2
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Week 2
    1.76 ± 0.668
    1.7 ± 0.579
    1.71 ± 0.625
    1.72 ± 0.573
    1.62 ± 0.604
    1.49 ± 0.477
    1.92 ± 0.839
    1.97 ± 0.607
    1.86 ± 0.607
    2 ± 0.718
    2.08 ± 0.378
    2.81 ± 0.709
    1.85 ± 0.731
    1.65 ± 0.122
        Change at Week 2
    -4.29 ± 0.534
    -4.17 ± 0.538
    -3.92 ± 0.61
    -3.99 ± 0.566
    -4.74 ± 0.733
    -5 ± 0.522
    -4.42 ± 0.729
    -4.48 ± 0.583
    -4.26 ± 0.708
    -4.2 ± 0.764
    -3.95 ± 0.796
    -3.66 ± 0.601
    -5.46 ± 0.756
    -4.38 ± 0.285
    No statistical analyses for this end point

    Secondary: HCV RNA and Change From Baseline at Week 4

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    End point title
    		 HCV RNA and Change From Baseline at Week 4
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 4
    End point values
    		 Cohort A, Group 1 (12 wk): CPT Class B (7-9) Cohort A, Group 1 (24 wk): CPT Class B (7-9) Cohort A, Group 2 (12 wk): CPT Class C (10-12) Cohort A, Group 2 (24 wk): CPT Class C (10-12) Cohort B, Group 3 (12 wk): F0-F3 Fibrosis Cohort B, Group 3 (24 wk): F0-F3 Fibrosis Cohort B, Group 4 (12 wk): CPT Class A (5-6) Cohort B, Group 4 (24 wk): CPT Class A (5-6) Cohort B, Group 5 (12 wk): CPT Class B (7-9) Cohort B, Group 5 (24 wk): CPT Class B (7-9) Cohort B, Group 6 (12 wk): CPT Class C (10-12) Cohort B, Group 6 (24 wk): CPT Class C (10-12) Cohort B, Group 7 (12 wk): FCH Cohort B, Group 7 (24 wk): FCH
    Number of subjects analysed
    26
    27
    24
    25
    52
    49
    34
    32
    22
    23
    3
    4
    3
    2
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Week 4
    1.26 ± 0.257
    1.2 ± 0.148
    1.23 ± 0.205
    1.18 ± 0.147
    1.23 ± 0.247
    1.18 ± 0.129
    1.29 ± 0.301
    1.21 ± 0.154
    1.25 ± 0.199
    1.32 ± 0.408
    1.15 ± 0
    1.56 ± 0.585
    1.15 ± 0
    1.15 ± 0
        Change at Week 4
    -4.78 ± 0.43
    -4.66 ± 0.518
    -4.45 ± 0.521
    -4.52 ± 0.492
    -5.13 ± 0.721
    -5.32 ± 0.453
    -5.05 ± 0.526
    -5.25 ± 0.518
    -4.88 ± 0.762
    -4.87 ± 0.816
    -4.89 ± 0.49
    -4.91 ± 0.24
    -6.16 ± 0.725
    -4.89 ± 0.407
    No statistical analyses for this end point

    Secondary: HCV RNA and Change From Baseline at Week 6

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    End point title
    		 HCV RNA and Change From Baseline at Week 6
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 6
    End point values
    		 Cohort A, Group 1 (12 wk): CPT Class B (7-9) Cohort A, Group 1 (24 wk): CPT Class B (7-9) Cohort A, Group 2 (12 wk): CPT Class C (10-12) Cohort A, Group 2 (24 wk): CPT Class C (10-12) Cohort B, Group 3 (12 wk): F0-F3 Fibrosis Cohort B, Group 3 (24 wk): F0-F3 Fibrosis Cohort B, Group 4 (12 wk): CPT Class A (5-6) Cohort B, Group 4 (24 wk): CPT Class A (5-6) Cohort B, Group 5 (12 wk): CPT Class B (7-9) Cohort B, Group 5 (24 wk): CPT Class B (7-9) Cohort B, Group 6 (12 wk): CPT Class C (10-12) Cohort B, Group 6 (24 wk): CPT Class C (10-12) Cohort B, Group 7 (12 wk): FCH Cohort B, Group 7 (24 wk): FCH
    Number of subjects analysed
    26
    27
    23
    25
    51
    49
    34
    32
    22
    23
    3
    4
    3
    2
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Week 6
    1.15 ± 0
    1.15 ± 0
    1.17 ± 0.102
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
        Change at Week 6
    -4.9 ± 0.487
    -4.72 ± 0.535
    -4.51 ± 0.527
    -4.56 ± 0.445
    -5.21 ± 0.728
    -5.35 ± 0.436
    -5.19 ± 0.577
    -5.31 ± 0.557
    -4.98 ± 0.779
    -5.05 ± 0.851
    -4.89 ± 0.49
    -5.33 ± 0.574
    -6.16 ± 0.725
    -4.89 ± 0.407
    No statistical analyses for this end point

    Secondary: HCV RNA and Change From Baseline at Week 8

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    End point title
    		 HCV RNA and Change From Baseline at Week 8
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 8
    End point values
    		 Cohort A, Group 1 (12 wk): CPT Class B (7-9) Cohort A, Group 1 (24 wk): CPT Class B (7-9) Cohort A, Group 2 (12 wk): CPT Class C (10-12) Cohort A, Group 2 (24 wk): CPT Class C (10-12) Cohort B, Group 3 (12 wk): F0-F3 Fibrosis Cohort B, Group 3 (24 wk): F0-F3 Fibrosis Cohort B, Group 4 (12 wk): CPT Class A (5-6) Cohort B, Group 4 (24 wk): CPT Class A (5-6) Cohort B, Group 5 (12 wk): CPT Class B (7-9) Cohort B, Group 5 (24 wk): CPT Class B (7-9) Cohort B, Group 6 (12 wk): CPT Class C (10-12) Cohort B, Group 6 (24 wk): CPT Class C (10-12) Cohort B, Group 7 (12 wk): FCH Cohort B, Group 7 (24 wk): FCH
    Number of subjects analysed
    26
    27
    24
    24
    52
    49
    34
    31
    22
    23
    3
    4
    3
    2
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Week 8
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
        Change at Week 8
    -4.9 ± 0.487
    -4.72 ± 0.535
    -4.53 ± 0.534
    -4.6 ± 0.393
    -5.21 ± 0.722
    -5.35 ± 0.436
    -5.19 ± 0.577
    -5.31 ± 0.565
    -4.98 ± 0.779
    -5.05 ± 0.851
    -4.89 ± 0.49
    -5.33 ± 0.574
    -6.16 ± 0.725
    -4.89 ± 0.407
    No statistical analyses for this end point

    Secondary: HCV RNA and Change From Baseline at Week 12

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    End point title
    		 HCV RNA and Change From Baseline at Week 12
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 12
    End point values
    		 Cohort A, Group 1 (12 wk): CPT Class B (7-9) Cohort A, Group 1 (24 wk): CPT Class B (7-9) Cohort A, Group 2 (12 wk): CPT Class C (10-12) Cohort A, Group 2 (24 wk): CPT Class C (10-12) Cohort B, Group 3 (12 wk): F0-F3 Fibrosis Cohort B, Group 3 (24 wk): F0-F3 Fibrosis Cohort B, Group 4 (12 wk): CPT Class A (5-6) Cohort B, Group 4 (24 wk): CPT Class A (5-6) Cohort B, Group 5 (12 wk): CPT Class B (7-9) Cohort B, Group 5 (24 wk): CPT Class B (7-9) Cohort B, Group 6 (12 wk): CPT Class C (10-12) Cohort B, Group 6 (24 wk): CPT Class C (10-12) Cohort B, Group 7 (12 wk): FCH Cohort B, Group 7 (24 wk): FCH
    Number of subjects analysed
    26
    27
    24
    24
    51
    49
    34
    32
    21
    23
    3
    4
    3
    2
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Week 12
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
    1.15 ± 0
        Change at Week 12
    -4.9 ± 0.487
    -4.72 ± 0.535
    -4.53 ± 0.534
    -4.6 ± 0.393
    -5.21 ± 0.729
    -5.35 ± 0.436
    -5.19 ± 0.577
    -5.3 ± 0.556
    -4.98 ± 0.798
    -5.05 ± 0.851
    -4.89 ± 0.49
    -5.33 ± 0.574
    -6.16 ± 0.725
    -4.89 ± 0.407
    No statistical analyses for this end point

    Secondary: Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score

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    End point title
    		 Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score [6]
    End point description
    Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease. Full Analysis Set. Participants with cirrhosis were analyzed if they had measurements at both baseline and Posttreatment Week 4. Only groups with cirrhotic participants are presented.
    End point type
    Secondary
    End point timeframe
    Baseline to Posttreatment Week 4
    Notes
    [6] - 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: Only groups with cirrhotic participants are presented.
    End point values
    		 Cohort A, Group 1 (12 wk): CPT Class B (7-9) Cohort A, Group 1 (24 wk): CPT Class B (7-9) Cohort A, Group 2 (12 wk): CPT Class C (10-12) Cohort A, Group 2 (24 wk): CPT Class C (10-12) Cohort B, Group 4 (12 wk): CPT Class A (5-6) Cohort B, Group 4 (24 wk): CPT Class A (5-6) Cohort B, Group 5 (12 wk): CPT Class B (7-9) Cohort B, Group 5 (24 wk): CPT Class B (7-9) Cohort B, Group 6 (12 wk): CPT Class C (10-12) Cohort B, Group 6 (24 wk): CPT Class C (10-12)
    Number of subjects analysed
    24
    22
    21
    20
    32
    32
    21
    23
    2
    4
    Units: percentage of participants
    number (not applicable)
        Decrease
    70.8
    77.3
    81
    70
    28.1
    62.5
    66.7
    65.2
    50
    75
        No Change
    12.5
    9.1
    14.3
    5
    31.3
    18.8
    14.3
    17.4
    50
    0
        Increase
    16.7
    13.6
    4.8
    25
    40.6
    18.8
    19
    17.4
    0
    25
    No statistical analyses for this end point

    Secondary: Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score

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    End point title
    		 Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score
    End point description
    CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for entry into the study was 12); higher scores/increased scores indicate greater severity of disease. Groups are arranged by cohort, then by duration of treatment, then by CPT class at baseline. Full Analysis Set. Cirrhotic participants were analyzed if they had measurements at both baseline and Posttreatment Week 4. Only groups with cirrhotic participants are presented.
    End point type
    Secondary
    End point timeframe
    Baseline to Posttreatment Week 4
    End point values
    		 Cohort A: Baseline CPT Class B (12 wk) Cohort A: Baseline CPT Class B (24 wk) Cohort A: Baseline CPT Class C (12 wk) Cohort A: Baseline CPT Class C (24 wk) Cohort B: Baseline CPT Class A (12 wk) Cohort B: Baseline CPT Class A (24 wk) Cohort B: Baseline CPT Class B (12 wk) Cohort B: Baseline CPT Class B (24 wk) Cohort B: Baseline CPT Class C (12 wk) Cohort B: Baseline CPT Class C (24 wk)
    Number of subjects analysed
    28
    23
    17
    19
    35
    34
    18
    20
    2
    5
    Units: percentage of participants
    number (not applicable)
        Decrease
    64.3
    87
    82.4
    73.7
    28.6
    23.5
    61.1
    85
    100
    80
        No Change
    28.6
    13
    11.8
    26.3
    68.6
    61.8
    33.3
    10
    0
    20
        Increase
    7.1
    0
    5.9
    0
    2.9
    14.7
    5.6
    5
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 24 weeks on treatment plus 30 days
    Adverse event reporting additional description
    Safety Analysis Set: participants who were enrolled and received at least one dose of study drug
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Cohort A, Group 1 (12 wk): CPT Class B (7-9)
    Reporting group description
    		 LDV/SOF+RBV for 12 weeks in participants with CPT Class B (CPT score 7-9)

    Reporting group title
    Cohort A, Group 1 (24 wk): CPT Class B (7-9)
    Reporting group description
    		 LDV/SOF+RBV tablets for 24 weeks in participants with CPT Class B (CPT score 7-9)

    Reporting group title
    Cohort A, Group 2 (12 wk): CPT Class C (10-12)
    Reporting group description
    		 LDV/SOF+RBV for 12 weeks in participants with CPT Class C (CPT score 10-12)

    Reporting group title
    Cohort A, Group 2 (24 wk): CPT Class C (10-12)
    Reporting group description
    		 LDV/SOF+RBV tablets for 24 weeks in participants with CPT Class C (CPT score 10-12)

    Reporting group title
    Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
    Reporting group description
    		 LDV/SOF+RBV tablets for 12 weeks in participants with Fibrosis Stage F0-F3

    Reporting group title
    Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
    Reporting group description
    		 LDV/SOF+RBV 24 weeks in participants with Fibrosis Stage F0-F3

    Reporting group title
    Cohort B, Group 4 (12 wk): CPT Class A (5-6)
    Reporting group description
    		 LDV/SOF+RBV tablets for 12 weeks in participants with CPT Class A (CPT score 5-6)

    Reporting group title
    Cohort B, Group 4 (24 wk): CPT Class A (5-6)
    Reporting group description
    		 LDV/SOF+RBV for 24 weeks in participants with CPT Class A (CPT score 5-6)

    Reporting group title
    Cohort B, Group 5 (12 wk): CPT Class B (7-9)
    Reporting group description
    		 LDV/SOF+RBV tablets for 12 weeks in participants with CPT Class B (CPT score 7-9)

    Reporting group title
    Cohort B, Group 5 (24 wk): CPT Class B (7-9)
    Reporting group description
    		 LDV/SOF+RBV tablets for 24 weeks in participants with CPT Class B (CPT score 7-9)

    Reporting group title
    Cohort B, Group 6 (12 wk): CPT Class C (10-12)
    Reporting group description
    		 LDV/SOF+RBV tablets for 12 weeks in participants with CPT Class C (CPT score 10-12)

    Reporting group title
    Cohort B, Group 6 (24 wk): CPT Class C (10-12)
    Reporting group description
    		 LDV/SOF+RBV tablets for 24 weeks in participants with CPT Class C (CPT score 10-12)

    Reporting group title
    Cohort B, Group 7 (12 wk): FCH
    Reporting group description
    		 LDV/SOF+RBV tablets for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)

    Reporting group title
    Cohort B, Group 7 (24 wk): FCH
    Reporting group description
    		 LDV/SOF+RBV tablets for 24 weeks in participants with FCH

    Serious adverse events
    		 Cohort A, Group 1 (12 wk): CPT Class B (7-9) Cohort A, Group 1 (24 wk): CPT Class B (7-9) Cohort A, Group 2 (12 wk): CPT Class C (10-12) Cohort A, Group 2 (24 wk): CPT Class C (10-12) Cohort B, Group 3 (12 wk): F0-F3 Fibrosis Cohort B, Group 3 (24 wk): F0-F3 Fibrosis Cohort B, Group 4 (12 wk): CPT Class A (5-6) Cohort B, Group 4 (24 wk): CPT Class A (5-6) Cohort B, Group 5 (12 wk): CPT Class B (7-9) Cohort B, Group 5 (24 wk): CPT Class B (7-9) Cohort B, Group 6 (12 wk): CPT Class C (10-12) Cohort B, Group 6 (24 wk): CPT Class C (10-12) Cohort B, Group 7 (12 wk): FCH Cohort B, Group 7 (24 wk): FCH
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 28 (10.71%)
    6 / 28 (21.43%)
    13 / 25 (52.00%)
    10 / 26 (38.46%)
    9 / 52 (17.31%)
    5 / 49 (10.20%)
    3 / 34 (8.82%)
    7 / 33 (21.21%)
    5 / 22 (22.73%)
    6 / 23 (26.09%)
    3 / 3 (100.00%)
    2 / 5 (40.00%)
    2 / 3 (66.67%)
    1 / 2 (50.00%)
         number of deaths (all causes)
    1
    1
    5
    4
    2
    0
    1
    1
    1
    0
    1
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    1 / 26 (3.85%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    1 / 52 (1.92%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    1 / 23 (4.35%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    1 / 52 (1.92%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jugular vein thrombosis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device dislocation
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    1 / 52 (1.92%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Liver transplant rejection
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    1 / 52 (1.92%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    1 / 26 (3.85%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Aspiration
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    1 / 52 (1.92%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydrothorax
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasal polyps
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    1 / 34 (2.94%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia postoperative
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    1 / 52 (1.92%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    1 / 23 (4.35%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    1 / 23 (4.35%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    1 / 26 (3.85%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Left ventricle outflow tract obstruction
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    1 / 52 (1.92%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    1 / 52 (1.92%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    1 / 26 (3.85%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac septal hypertrophy
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    1 / 34 (2.94%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Hepatic encephalopathy
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    2 / 25 (8.00%)
    2 / 26 (7.69%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    0 / 22 (0.00%)
    1 / 23 (4.35%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    1 / 52 (1.92%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    3 / 33 (9.09%)
    0 / 22 (0.00%)
    2 / 23 (8.70%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    2 / 3
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    1 / 23 (4.35%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    1 / 49 (2.04%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    1 / 26 (3.85%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal varices haemorrhage
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    1 / 26 (3.85%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    1 / 49 (2.04%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric varices haemorrhage
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    1 / 49 (2.04%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic erosive gastritis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incarcerated umbilical hernia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    1 / 23 (4.35%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    1 / 26 (3.85%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Localised intraabdominal fluid collection
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    1 / 23 (4.35%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophagitis haemorrhagic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    1 / 26 (3.85%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    1 / 34 (2.94%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal haemorrhage
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    1 / 23 (4.35%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    1 / 49 (2.04%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    1 / 52 (1.92%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Portal vein thrombosis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    2 / 25 (8.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatorenal syndrome
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    1 / 26 (3.85%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal impairment
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Calculus ureteric
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis haemorrhagic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    1 / 34 (2.94%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    1 / 52 (1.92%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure acute
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteochondritis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    1 / 25 (4.00%)
    1 / 26 (3.85%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    1 / 26 (3.85%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocarditis staphylococcal
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    1 / 49 (2.04%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemophilus infection
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Labyrinthitis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    1 / 52 (1.92%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritoneal tuberculosis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis bacterial
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    1 / 26 (3.85%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection bacterial
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    1 / 49 (2.04%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    1 / 49 (2.04%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Streptococcal sepsis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    1 / 52 (1.92%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fluid retention
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    1 / 52 (1.92%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    1 / 26 (3.85%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort A, Group 1 (12 wk): CPT Class B (7-9) Cohort A, Group 1 (24 wk): CPT Class B (7-9) Cohort A, Group 2 (12 wk): CPT Class C (10-12) Cohort A, Group 2 (24 wk): CPT Class C (10-12) Cohort B, Group 3 (12 wk): F0-F3 Fibrosis Cohort B, Group 3 (24 wk): F0-F3 Fibrosis Cohort B, Group 4 (12 wk): CPT Class A (5-6) Cohort B, Group 4 (24 wk): CPT Class A (5-6) Cohort B, Group 5 (12 wk): CPT Class B (7-9) Cohort B, Group 5 (24 wk): CPT Class B (7-9) Cohort B, Group 6 (12 wk): CPT Class C (10-12) Cohort B, Group 6 (24 wk): CPT Class C (10-12) Cohort B, Group 7 (12 wk): FCH Cohort B, Group 7 (24 wk): FCH
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 28 (89.29%)
    25 / 28 (89.29%)
    23 / 25 (92.00%)
    23 / 26 (88.46%)
    49 / 52 (94.23%)
    48 / 49 (97.96%)
    27 / 34 (79.41%)
    30 / 33 (90.91%)
    20 / 22 (90.91%)
    20 / 23 (86.96%)
    3 / 3 (100.00%)
    5 / 5 (100.00%)
    3 / 3 (100.00%)
    2 / 2 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign pancreatic neoplasm
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    2 / 52 (3.85%)
    1 / 49 (2.04%)
    1 / 34 (2.94%)
    0 / 33 (0.00%)
    2 / 22 (9.09%)
    1 / 23 (4.35%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    0
    0
    2
    1
    1
    0
    2
    1
    0
    0
    0
    1
    Haematoma
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    3 / 49 (6.12%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    Hot flush
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    1 / 49 (2.04%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    Flushing
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    10 / 28 (35.71%)
    9 / 28 (32.14%)
    5 / 25 (20.00%)
    8 / 26 (30.77%)
    22 / 52 (42.31%)
    20 / 49 (40.82%)
    8 / 34 (23.53%)
    11 / 33 (33.33%)
    7 / 22 (31.82%)
    9 / 23 (39.13%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    1 / 2 (50.00%)
         occurrences all number
    10
    10
    6
    8
    22
    21
    9
    11
    8
    9
    1
    1
    1
    1
    Asthenia
         subjects affected / exposed
    2 / 28 (7.14%)
    2 / 28 (7.14%)
    3 / 25 (12.00%)
    4 / 26 (15.38%)
    4 / 52 (7.69%)
    4 / 49 (8.16%)
    5 / 34 (14.71%)
    7 / 33 (21.21%)
    1 / 22 (4.55%)
    4 / 23 (17.39%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    2
    3
    4
    4
    4
    5
    9
    1
    4
    1
    1
    0
    0
    Oedema peripheral
         subjects affected / exposed
    2 / 28 (7.14%)
    2 / 28 (7.14%)
    1 / 25 (4.00%)
    7 / 26 (26.92%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    3 / 34 (8.82%)
    2 / 33 (6.06%)
    2 / 22 (9.09%)
    2 / 23 (8.70%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    1 / 2 (50.00%)
         occurrences all number
    2
    2
    1
    7
    0
    0
    3
    3
    3
    3
    0
    0
    1
    1
    Pyrexia
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 28 (7.14%)
    4 / 25 (16.00%)
    3 / 26 (11.54%)
    1 / 52 (1.92%)
    2 / 49 (4.08%)
    1 / 34 (2.94%)
    2 / 33 (6.06%)
    1 / 22 (4.55%)
    2 / 23 (8.70%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    3
    5
    3
    1
    2
    1
    3
    1
    2
    1
    0
    0
    0
    Chest pain
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    2 / 49 (4.08%)
    2 / 34 (5.88%)
    2 / 33 (6.06%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    2
    2
    3
    0
    0
    0
    0
    0
    0
    Oedema
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    3 / 26 (11.54%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    1 / 34 (2.94%)
    1 / 33 (3.03%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    1
    3
    0
    0
    1
    1
    1
    0
    0
    0
    0
    0
    Feeling abnormal
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    2 / 49 (4.08%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    1
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    1
    Influenza like illness
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 28 (3.57%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    1 / 52 (1.92%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    1
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Peripheral swelling
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    1 / 52 (1.92%)
    1 / 49 (2.04%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Social circumstances
    Eczema
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    1 / 52 (1.92%)
    6 / 49 (12.24%)
    0 / 34 (0.00%)
    3 / 33 (9.09%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    6
    0
    3
    0
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    Gynaecomastia
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    2 / 23 (8.70%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 28 (7.14%)
    4 / 28 (14.29%)
    4 / 25 (16.00%)
    4 / 26 (15.38%)
    5 / 52 (9.62%)
    8 / 49 (16.33%)
    4 / 34 (11.76%)
    7 / 33 (21.21%)
    3 / 22 (13.64%)
    4 / 23 (17.39%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    4
    4
    4
    6
    10
    4
    7
    3
    5
    0
    0
    0
    0
    Dyspnoea
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    3 / 25 (12.00%)
    3 / 26 (11.54%)
    9 / 52 (17.31%)
    4 / 49 (8.16%)
    5 / 34 (14.71%)
    3 / 33 (9.09%)
    2 / 22 (9.09%)
    1 / 23 (4.35%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    4
    4
    10
    4
    5
    4
    2
    1
    0
    0
    0
    0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 25 (0.00%)
    2 / 26 (7.69%)
    5 / 52 (9.62%)
    3 / 49 (6.12%)
    1 / 34 (2.94%)
    2 / 33 (6.06%)
    1 / 22 (4.55%)
    1 / 23 (4.35%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    0
    2
    5
    3
    1
    2
    1
    1
    0
    0
    0
    1
    Pleural effusion
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    2 / 25 (8.00%)
    1 / 26 (3.85%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    2 / 22 (9.09%)
    1 / 23 (4.35%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    2
    2
    0
    0
    0
    1
    2
    1
    0
    0
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    1 / 26 (3.85%)
    0 / 52 (0.00%)
    1 / 49 (2.04%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    0 / 22 (0.00%)
    2 / 23 (8.70%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    1
    0
    1
    0
    2
    0
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    3 / 49 (6.12%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    4
    0
    1
    0
    0
    0
    0
    0
    0
    Productive cough
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    1 / 49 (2.04%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    1 / 22 (4.55%)
    1 / 23 (4.35%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    1
    0
    0
    1
    1
    0
    0
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 28 (3.57%)
    4 / 28 (14.29%)
    4 / 25 (16.00%)
    4 / 26 (15.38%)
    8 / 52 (15.38%)
    10 / 49 (20.41%)
    4 / 34 (11.76%)
    3 / 33 (9.09%)
    2 / 22 (9.09%)
    4 / 23 (17.39%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    1 / 2 (50.00%)
         occurrences all number
    1
    4
    4
    5
    8
    10
    4
    5
    2
    4
    1
    0
    1
    1
    Irritability
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 28 (3.57%)
    1 / 25 (4.00%)
    1 / 26 (3.85%)
    2 / 52 (3.85%)
    3 / 49 (6.12%)
    2 / 34 (5.88%)
    3 / 33 (9.09%)
    0 / 22 (0.00%)
    2 / 23 (8.70%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
         occurrences all number
    2
    1
    1
    1
    2
    3
    2
    3
    0
    2
    0
    0
    1
    0
    Sleep disorder
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    1 / 26 (3.85%)
    4 / 52 (7.69%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    1 / 22 (4.55%)
    1 / 23 (4.35%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    1
    1
    5
    0
    0
    0
    1
    1
    0
    0
    0
    0
    Anxiety
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    1 / 26 (3.85%)
    2 / 52 (3.85%)
    1 / 49 (2.04%)
    1 / 34 (2.94%)
    1 / 33 (3.03%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    0
    1
    2
    1
    1
    1
    1
    0
    0
    0
    0
    1
    Depression
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 25 (0.00%)
    1 / 26 (3.85%)
    1 / 52 (1.92%)
    1 / 49 (2.04%)
    1 / 34 (2.94%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    2 / 23 (8.70%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    1
    1
    1
    1
    0
    0
    2
    0
    0
    1
    0
    Agitation
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    2 / 25 (8.00%)
    0 / 26 (0.00%)
    1 / 52 (1.92%)
    1 / 49 (2.04%)
    2 / 34 (5.88%)
    3 / 33 (9.09%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    2
    0
    1
    1
    2
    3
    1
    0
    0
    0
    0
    0
    Blood sodium decreased
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    2 / 25 (8.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 28 (7.14%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    1 / 49 (2.04%)
    1 / 34 (2.94%)
    2 / 33 (6.06%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    1
    1
    2
    0
    0
    0
    0
    0
    0
    Fall
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    4 / 33 (12.12%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    4
    0
    0
    1
    0
    0
    0
    Muscle strain
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 28 (28.57%)
    7 / 28 (25.00%)
    7 / 25 (28.00%)
    2 / 26 (7.69%)
    12 / 52 (23.08%)
    14 / 49 (28.57%)
    6 / 34 (17.65%)
    9 / 33 (27.27%)
    2 / 22 (9.09%)
    7 / 23 (30.43%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    1 / 2 (50.00%)
         occurrences all number
    9
    9
    8
    2
    13
    15
    6
    9
    2
    8
    0
    1
    1
    1
    Dizziness
         subjects affected / exposed
    4 / 28 (14.29%)
    3 / 28 (10.71%)
    1 / 25 (4.00%)
    2 / 26 (7.69%)
    7 / 52 (13.46%)
    5 / 49 (10.20%)
    3 / 34 (8.82%)
    1 / 33 (3.03%)
    2 / 22 (9.09%)
    2 / 23 (8.70%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
         occurrences all number
    4
    3
    1
    2
    8
    5
    3
    1
    2
    2
    0
    0
    1
    0
    Lethargy
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 28 (0.00%)
    3 / 25 (12.00%)
    3 / 26 (11.54%)
    1 / 52 (1.92%)
    3 / 49 (6.12%)
    1 / 34 (2.94%)
    3 / 33 (9.09%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    3
    4
    1
    4
    1
    4
    1
    0
    0
    0
    0
    0
    Hepatic encephalopathy
         subjects affected / exposed
    0 / 28 (0.00%)
    11 / 28 (39.29%)
    2 / 25 (8.00%)
    4 / 26 (15.38%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    1 / 23 (4.35%)
    2 / 3 (66.67%)
    2 / 5 (40.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    2
    5
    0
    0
    0
    0
    0
    1
    3
    2
    0
    0
    Tremor
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    1 / 26 (3.85%)
    0 / 52 (0.00%)
    4 / 49 (8.16%)
    1 / 34 (2.94%)
    1 / 33 (3.03%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    5
    1
    1
    1
    0
    0
    0
    0
    0
    Somnolence
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    2 / 23 (8.70%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Syncope
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    1 / 49 (2.04%)
    1 / 34 (2.94%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 28 (3.57%)
    3 / 28 (10.71%)
    5 / 25 (20.00%)
    8 / 26 (30.77%)
    21 / 52 (40.38%)
    27 / 49 (55.10%)
    10 / 34 (29.41%)
    15 / 33 (45.45%)
    6 / 22 (27.27%)
    12 / 23 (52.17%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    2 / 3 (66.67%)
    1 / 2 (50.00%)
         occurrences all number
    1
    3
    6
    12
    22
    31
    10
    15
    6
    14
    1
    1
    2
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 28 (0.00%)
    3 / 28 (10.71%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    1 / 52 (1.92%)
    0 / 49 (0.00%)
    1 / 34 (2.94%)
    1 / 33 (3.03%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    1
    0
    0
    1
    1
    0
    1
    Eyelid cyst
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    2 / 26 (7.69%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Ocular icterus
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    1 / 49 (2.04%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    Pterygium
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 28 (17.86%)
    6 / 28 (21.43%)
    3 / 25 (12.00%)
    3 / 26 (11.54%)
    12 / 52 (23.08%)
    11 / 49 (22.45%)
    5 / 34 (14.71%)
    1 / 33 (3.03%)
    2 / 22 (9.09%)
    3 / 23 (13.04%)
    1 / 3 (33.33%)
    2 / 5 (40.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
         occurrences all number
    8
    7
    4
    5
    14
    14
    5
    13
    2
    8
    1
    2
    1
    0
    Nausea
         subjects affected / exposed
    6 / 28 (21.43%)
    4 / 28 (14.29%)
    4 / 25 (16.00%)
    5 / 26 (19.23%)
    13 / 52 (25.00%)
    6 / 49 (12.24%)
    5 / 34 (14.71%)
    10 / 33 (30.30%)
    6 / 22 (27.27%)
    3 / 23 (13.04%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    1 / 2 (50.00%)
         occurrences all number
    6
    4
    4
    5
    14
    6
    5
    12
    6
    3
    0
    0
    1
    1
    Vomiting
         subjects affected / exposed
    2 / 28 (7.14%)
    2 / 28 (7.14%)
    6 / 25 (24.00%)
    3 / 26 (11.54%)
    5 / 52 (9.62%)
    3 / 49 (6.12%)
    4 / 34 (11.76%)
    4 / 33 (12.12%)
    3 / 22 (13.64%)
    4 / 23 (17.39%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    1 / 2 (50.00%)
         occurrences all number
    3
    2
    9
    3
    11
    3
    4
    5
    3
    5
    0
    0
    1
    1
    Abdominal pain
         subjects affected / exposed
    2 / 28 (7.14%)
    3 / 28 (10.71%)
    3 / 25 (12.00%)
    1 / 26 (3.85%)
    4 / 52 (7.69%)
    5 / 49 (10.20%)
    3 / 34 (8.82%)
    4 / 33 (12.12%)
    1 / 22 (4.55%)
    2 / 23 (8.70%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    3
    4
    1
    4
    5
    3
    4
    1
    2
    1
    1
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 28 (0.00%)
    3 / 28 (10.71%)
    0 / 25 (0.00%)
    1 / 26 (3.85%)
    5 / 52 (9.62%)
    4 / 49 (8.16%)
    1 / 34 (2.94%)
    4 / 33 (12.12%)
    0 / 22 (0.00%)
    2 / 23 (8.70%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    3
    0
    1
    5
    4
    1
    4
    0
    2
    0
    0
    0
    0
    Constipation
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    3 / 25 (12.00%)
    1 / 26 (3.85%)
    2 / 52 (3.85%)
    5 / 49 (10.20%)
    2 / 34 (5.88%)
    2 / 33 (6.06%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    3
    1
    2
    5
    2
    2
    2
    0
    1
    0
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 28 (7.14%)
    3 / 25 (12.00%)
    0 / 26 (0.00%)
    2 / 52 (3.85%)
    4 / 49 (8.16%)
    3 / 34 (8.82%)
    1 / 33 (3.03%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    4
    0
    2
    4
    3
    1
    1
    0
    0
    0
    0
    0
    Ascites
         subjects affected / exposed
    0 / 28 (0.00%)
    3 / 28 (10.71%)
    1 / 25 (4.00%)
    1 / 26 (3.85%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    3 / 33 (9.09%)
    1 / 22 (4.55%)
    2 / 23 (8.70%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    3
    1
    1
    0
    0
    0
    3
    1
    2
    1
    0
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 28 (3.57%)
    1 / 25 (4.00%)
    1 / 26 (3.85%)
    1 / 52 (1.92%)
    0 / 49 (0.00%)
    1 / 34 (2.94%)
    1 / 33 (3.03%)
    2 / 22 (9.09%)
    0 / 23 (0.00%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    1
    1
    1
    1
    1
    0
    1
    1
    2
    0
    1
    1
    0
    1
    Abdominal discomfort
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    2 / 26 (7.69%)
    2 / 52 (3.85%)
    1 / 49 (2.04%)
    2 / 34 (5.88%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    0
    2
    2
    1
    2
    0
    0
    0
    0
    0
    0
    1
    Abdominal distension
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 28 (3.57%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    2 / 49 (4.08%)
    1 / 34 (2.94%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    2 / 23 (8.70%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    2
    1
    0
    0
    3
    0
    0
    0
    0
    Dry mouth
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    1 / 34 (2.94%)
    2 / 33 (6.06%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    2
    1
    0
    0
    0
    0
    0
    Gastritis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    2 / 49 (4.08%)
    0 / 34 (0.00%)
    2 / 33 (6.06%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    2
    0
    0
    0
    0
    0
    0
    Flatulence
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 28 (7.14%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Abdominal pain lower
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    1 / 26 (3.85%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Gait disturbance
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    1 / 26 (3.85%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 28 (7.14%)
    1 / 25 (4.00%)
    1 / 26 (3.85%)
    2 / 52 (3.85%)
    2 / 49 (4.08%)
    3 / 34 (8.82%)
    1 / 33 (3.03%)
    0 / 22 (0.00%)
    1 / 23 (4.35%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    1
    1
    2
    2
    3
    1
    0
    1
    1
    0
    0
    0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    2 / 26 (7.69%)
    0 / 52 (0.00%)
    1 / 49 (2.04%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    5 / 28 (17.86%)
    8 / 28 (28.57%)
    3 / 25 (12.00%)
    4 / 26 (15.38%)
    5 / 52 (9.62%)
    6 / 49 (12.24%)
    4 / 34 (11.76%)
    7 / 33 (21.21%)
    2 / 22 (9.09%)
    2 / 23 (8.70%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
         occurrences all number
    5
    9
    3
    5
    8
    6
    4
    8
    2
    2
    0
    0
    1
    0
    Rash
         subjects affected / exposed
    0 / 28 (0.00%)
    4 / 28 (14.29%)
    2 / 25 (8.00%)
    2 / 26 (7.69%)
    4 / 52 (7.69%)
    3 / 49 (6.12%)
    4 / 34 (11.76%)
    1 / 33 (3.03%)
    2 / 22 (9.09%)
    1 / 23 (4.35%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
         occurrences all number
    0
    4
    2
    2
    4
    4
    4
    1
    2
    1
    0
    0
    1
    0
    Dry skin
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 28 (3.57%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    2 / 52 (3.85%)
    3 / 49 (6.12%)
    0 / 34 (0.00%)
    2 / 33 (6.06%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    1
    0
    2
    3
    0
    2
    0
    0
    0
    0
    0
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    2 / 22 (9.09%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    2 / 28 (7.14%)
    5 / 28 (17.86%)
    5 / 25 (20.00%)
    4 / 26 (15.38%)
    2 / 52 (3.85%)
    3 / 49 (6.12%)
    1 / 34 (2.94%)
    3 / 33 (9.09%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    5
    5
    4
    2
    3
    2
    3
    0
    0
    0
    0
    0
    0
    Back pain
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 28 (7.14%)
    2 / 25 (8.00%)
    1 / 26 (3.85%)
    5 / 52 (9.62%)
    4 / 49 (8.16%)
    2 / 34 (5.88%)
    3 / 33 (9.09%)
    2 / 22 (9.09%)
    1 / 23 (4.35%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    2
    2
    1
    5
    4
    2
    3
    2
    1
    1
    0
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    1 / 25 (4.00%)
    2 / 26 (7.69%)
    5 / 52 (9.62%)
    4 / 49 (8.16%)
    0 / 34 (0.00%)
    4 / 33 (12.12%)
    1 / 22 (4.55%)
    1 / 23 (4.35%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    1
    2
    5
    5
    0
    4
    1
    1
    0
    0
    0
    0
    Arthralgia
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 28 (7.14%)
    1 / 25 (4.00%)
    1 / 26 (3.85%)
    2 / 52 (3.85%)
    1 / 49 (2.04%)
    1 / 34 (2.94%)
    4 / 33 (12.12%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    2
    1
    1
    2
    1
    1
    5
    0
    0
    0
    0
    0
    0
    Pain in extremity
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 28 (3.57%)
    1 / 25 (4.00%)
    2 / 26 (7.69%)
    1 / 52 (1.92%)
    3 / 49 (6.12%)
    0 / 34 (0.00%)
    2 / 33 (6.06%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    1
    1
    1
    2
    1
    3
    0
    2
    1
    0
    0
    0
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    1 / 52 (1.92%)
    2 / 49 (4.08%)
    0 / 34 (0.00%)
    2 / 33 (6.06%)
    0 / 22 (0.00%)
    1 / 23 (4.35%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    0
    0
    1
    2
    0
    2
    0
    1
    0
    0
    0
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    3 / 52 (5.77%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    3
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Flank pain
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Joint swelling
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    2 / 33 (6.06%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Osteopenia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    4 / 52 (7.69%)
    5 / 49 (10.20%)
    2 / 34 (5.88%)
    5 / 33 (15.15%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    1
    0
    4
    6
    2
    5
    1
    0
    0
    2
    0
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 28 (3.57%)
    3 / 25 (12.00%)
    2 / 26 (7.69%)
    2 / 52 (3.85%)
    1 / 49 (2.04%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    5
    2
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Influenza
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 28 (7.14%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    4 / 49 (8.16%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    4
    0
    0
    1
    0
    0
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    2 / 25 (8.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    4 / 49 (8.16%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    4
    0
    0
    0
    0
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    1 / 49 (2.04%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Herpes zoster
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    1 / 49 (2.04%)
    2 / 34 (5.88%)
    1 / 33 (3.03%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    2
    1
    0
    0
    0
    0
    0
    0
    Tooth infection
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 25 (0.00%)
    2 / 26 (7.69%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Pharyngitis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    Puncture site infection
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 28 (3.57%)
    4 / 25 (16.00%)
    1 / 26 (3.85%)
    2 / 52 (3.85%)
    5 / 49 (10.20%)
    3 / 34 (8.82%)
    4 / 33 (12.12%)
    2 / 22 (9.09%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    4
    1
    2
    5
    3
    4
    2
    0
    0
    0
    0
    0
    Hyponatraemia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    2 / 25 (8.00%)
    4 / 26 (15.38%)
    1 / 52 (1.92%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    2
    4
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Hyperkalaemia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    2 / 26 (7.69%)
    1 / 52 (1.92%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    2
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Hypoglycaemia
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    1 / 49 (2.04%)
    2 / 34 (5.88%)
    1 / 33 (3.03%)
    0 / 22 (0.00%)
    1 / 23 (4.35%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    2
    1
    0
    1
    0
    0
    0
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    1 / 25 (4.00%)
    3 / 26 (11.54%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    1
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Diabetes mellitus
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 25 (4.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    1 / 22 (4.55%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    Gout
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 25 (0.00%)
    0 / 26 (0.00%)
    0 / 52 (0.00%)
    0 / 49 (0.00%)
    0 / 34 (0.00%)
    2 / 33 (6.06%)
    0 / 22 (0.00%)
    0 / 23 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jan 2014
    1) An equivalent study conducted in the US (GS-US-337-0123) showed that Cohort B, Group 7 was challenging to enroll based on the current exclusion requirements for hematology and chemistry parameters; specifically alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase ≥ 10 × the upper limit of normal (ULN). These parameters were no longer used to determine eligibility for Group 7. In addition, the stopping rules for individual subjects were clarified for Cohort B, Group 7; 2) Clarification was added for RBV dose reductions for renal impairment; 3) Clarification was added that the Ampliprep® assay was used for HCV RNA quantitation and used plasma instead of serum.

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

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