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    Clinical Trial Results:
    A Phase 3b Study of 2 Treatment Durations of Telaprevir, Peg-IFN (Pegasys®), and Ribavirin (Copegus®) in Treatment-Naive and Prior Relapser Subjects With Genotype 1 Chronic Hepatitis C and IL28B CC Genotype

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    2011-001323-21
    Trial protocol
    DE   AT   PL  
    Global end of trial date
    13 Jan 2014

    Results information
    Results version number
    v2(current)
    This version publication date
    13 Jul 2016
    First version publication date
    07 Aug 2015
    Other versions
    v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Update required to address issues related to the EudraCT System bug, that necessitated the review and Quality check of results posting and to ensure data accuracy

    Trial information

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    Trial identification
    Sponsor protocol code
    VX11-950-114
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01459913
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Vertex Pharmaceuticals Incorporated
    Sponsor organisation address
    50 Northern Avenue, Boston, Massachusetts, United States, 02210-1862
    Public contact
    Medical Monitor, Vertex Pharmaceuticals Incorporated, 1 617-341-6777, medicalinfo@vrtx.com
    Scientific contact
    Medical Monitor, Vertex Pharmaceuticals Incorporated, 1 617-341-6777, medicalinfo@vrtx.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
    24 Feb 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jan 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of a 12-week regimen of telaprevir, pegylated interferon (Peg-IFN), and ribavirin (RBV) in treatment-naive and prior relapser subjects with genotype 1 chronic hepatitis C (CHC) and interleukin-28B (IL28B) CC genotype
    Protection of trial subjects
    The study was conducted in accordance with the ethical principles stated in the Declaration of Helsinki and the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice (GCP).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    11 Nov 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 25
    Country: Number of subjects enrolled
    Germany: 11
    Country: Number of subjects enrolled
    Canada: 28
    Country: Number of subjects enrolled
    Poland: 19
    Country: Number of subjects enrolled
    Israel: 18
    Country: Number of subjects enrolled
    United States: 138
    Worldwide total number of subjects
    239
    EEA total number of subjects
    55
    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)
    228
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Subjects received telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a)/ ribavirin (RBV). Planned duration of telaprevir treatment was 12 weeks. Minimum planned duration of Peg-IFN-alfa-2a/RBV treatment was 12 weeks; however, was dependent on virologic response during initial 12 weeks of telaprevir plus Peg-IFN-alfa-2a/RBV.

    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
    Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)
    Arm description
    Telaprevir 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met rapid viral response (RVR, undetectable Hepatitis C Virus [HCV] Ribonucleic Acid [RNA] at Week 4) criteria, were randomized in this group, as planned, and did not receive any further treatment.
    Arm type
    Experimental

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    VX-950
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Telaprevir 1125 milligram (mg) tablet twice daily for 12 weeks.

    Investigational medicinal product name
    Pegylated interferon alfa 2a
    Investigational medicinal product code
    Other name
    Pegasys ®, Peg-INF
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week).

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Copegus ®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin (RBV) tablet twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 12 weeks.

    Arm title
    Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
    Arm description
    Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
    Arm type
    Experimental

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    VX-950
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Telaprevir 1125 mg tablet twice daily for 12 weeks.

    Investigational medicinal product name
    Peg-IFN-alfa-2a
    Investigational medicinal product code
    Other name
    Pegasys ®, Peg-INF
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Peg-IFN-alfa-2a 180 mcg/week.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Copegus ®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV tablet twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.

    Arm title
    Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)
    Arm description
    Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
    Arm type
    Experimental

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    VX-950
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Telaprevir 1125 mg tablet twice daily for 12 weeks.

    Investigational medicinal product name
    Pegylated interferon alfa 2a
    Investigational medicinal product code
    Other name
    Pegasys ®, Peg-INF
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Peg-IFN-alfa-2a 180 mcg/week .

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Copegus ®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV tablet twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.

    Arm title
    Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
    Arm description
    Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
    Arm type
    Experimental

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    VX-950
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Telaprevir 1125 mg tablet twice daily for 12 weeks.

    Investigational medicinal product name
    Pegylated interferon alfa 2a
    Investigational medicinal product code
    Other name
    Pegasys ®, Peg-INF
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Peg-IFN-alfa-2a 180 mcg/week.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Copegus ®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV tablet twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.

    Number of subjects in period 1
    Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
    Started
    106
    52
    19
    62
    Completed
    65
    32
    6
    29
    Not completed
    41
    20
    13
    33
         Study Terminated by Sponsor
    30
    15
    9
    11
         Death
    -
    -
    -
    1
         Non- Compliance
    -
    -
    -
    3
         Physician decision
    -
    1
    -
    -
         Unspecified
    -
    -
    3
    1
         Consent withdrawn by subject
    4
    -
    -
    5
         Adverse Event
    -
    -
    -
    3
         Did Not Meet Inclusion Criteria
    -
    -
    -
    1
         Lost to follow-up
    7
    4
    1
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)
    Reporting group description
    Telaprevir 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met rapid viral response (RVR, undetectable Hepatitis C Virus [HCV] Ribonucleic Acid [RNA] at Week 4) criteria, were randomized in this group, as planned, and did not receive any further treatment.

    Reporting group title
    Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
    Reporting group description
    Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.

    Reporting group title
    Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)
    Reporting group description
    Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.

    Reporting group title
    Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
    Reporting group description
    Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.

    Reporting group values
    Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized) Total
    Number of subjects
    106 52 19 62 239
    Age categorical
    Units: Subjects
    Age continuous
    Number subjects analysed for this parameter are 106, 52, 19 and 61 respectively.
    Units: years
        arithmetic mean (standard deviation)
    46.1 ± 12.82 44.8 ± 12.89 54.4 ± 8.7 49.8 ± 10.56 -
    Gender categorical
    Units: Subjects
        Female
    39 16 11 29 95
        Male
    67 36 8 33 144

    End points

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    End points reporting groups
    Reporting group title
    Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)
    Reporting group description
    Telaprevir 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met rapid viral response (RVR, undetectable Hepatitis C Virus [HCV] Ribonucleic Acid [RNA] at Week 4) criteria, were randomized in this group, as planned, and did not receive any further treatment.

    Reporting group title
    Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
    Reporting group description
    Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.

    Reporting group title
    Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)
    Reporting group description
    Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.

    Reporting group title
    Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
    Reporting group description
    Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.

    Subject analysis set title
    Telaprevir+Peg-IFN-alfa-2a, RBV (Total)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All subjects who received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, up to 48 weeks.

    Primary: Percentage of Subjects With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)

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    End point title
    Percentage of Subjects With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12) [1] [2]
    End point description
    SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 12 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. Full Analysis (FA) Set was used.
    End point type
    Primary
    End point timeframe
    12 weeks after last planned dose of study drug (up to Week 36)
    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 inferential statistics was planned for this study.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.
    End point values
    Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
    Number of subjects analysed
    106
    52
    Units: Percentage of Subjects
        number (not applicable)
    88.7
    96.2
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)

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    End point title
    Percentage of Subjects With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4) [3]
    End point description
    SVR4 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 4 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. FA Set was used.
    End point type
    Secondary
    End point timeframe
    4 weeks after last planned dose of study drug (up to Week 28)
    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: This endpoint was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.
    End point values
    Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
    Number of subjects analysed
    106
    52
    Units: Percentage of Subjects
        number (not applicable)
    89.6
    98.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)

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    End point title
    Percentage of Subjects With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24) [4]
    End point description
    SVR24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 24 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. FA Set was used.
    End point type
    Secondary
    End point timeframe
    24 weeks after last planned dose of study drug (up to Week 48)
    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: This endpoint was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.
    End point values
    Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
    Number of subjects analysed
    106
    52
    Units: Percentage of Subjects
        number (not applicable)
    85.8
    92.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Sustained Viral Response at Week 72 (SVR72)

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    End point title
    Percentage of Subjects With Sustained Viral Response at Week 72 (SVR72) [5]
    End point description
    SVR72 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 72. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. FA Set was used. Here number of subjects analyzed = subjects who were evaluable for this measure. Subjects who did not have the SVR72 assessment because they discontinued the study due to ‘Study Terminated by the Sponsor’ are excluded from this analysis.
    End point type
    Secondary
    End point timeframe
    Week 72
    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: This endpoint was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.
    End point values
    Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
    Number of subjects analysed
    76
    37
    Units: Percentage of Subjects
        number (not applicable)
    72.4
    86.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Viral Relapse

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    End point title
    Percentage of Subjects With Viral Relapse [6]
    End point description
    Viral relapse was defined as having detectable HCV RNA during antiviral follow-up in subjects who had HCV RNA less than (<) lower limit of quantification (LLOQ) at end of treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The LLOQ was 25 IU/mL and the lower limit of detection was 10 IU/mL. FA Set was used.
    End point type
    Secondary
    End point timeframe
    After last dose of study drug up to 4 weeks (up to Week 28), 12 weeks (up to Week 36), 24 weeks (up to Week 48) antiviral follow-up
    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: This endpoint was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.
    End point values
    Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
    Number of subjects analysed
    106
    52
    Units: Percentage of Subjects
    number (not applicable)
        4 Weeks
    1.9
    0
        12 Weeks
    7.5
    0
        24 Weeks
    10.4
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With On-Treatment Virologic Failure

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    End point title
    Percentage of Subjects With On-Treatment Virologic Failure
    End point description
    On-treatment virologic failure was defined as subjects who met futility (as per investigator discretion) or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). This outcome was planned to be assessed in all reporting groups and results were to be reported for total arm as well. FA Set was used.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 48
    End point values
    Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized) Telaprevir+Peg-IFN-alfa-2a, RBV (Total)
    Number of subjects analysed
    106
    52
    19
    61
    238
    Units: Percentage of Subjects
        number (not applicable)
    0
    0
    0
    3.3
    0.8
    No statistical analyses for this end point

    Secondary: Number of Subjects With Rapid Viral Response (RVR)

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    End point title
    Number of Subjects With Rapid Viral Response (RVR) [7]
    End point description
    The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment. FA Set was used.
    End point type
    Secondary
    End point timeframe
    Week 4
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.
    End point values
    Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
    Number of subjects analysed
    106
    52
    Units: Subjects
    106
    52
    No statistical analyses for this end point

    Secondary: Number of Subjects With Extended Rapid Viral Response (eRVR)

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    End point title
    Number of Subjects With Extended Rapid Viral Response (eRVR) [8]
    End point description
    The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both 4 weeks and 12 weeks after the start of study treatment. FA Set was used.
    End point type
    Secondary
    End point timeframe
    Week 4 and Week 12
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be assessed only in “Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)” and “Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)” reporting groups.
    End point values
    Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
    Number of subjects analysed
    106
    52
    Units: Subjects
    105
    51
    No statistical analyses for this end point

    Secondary: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
    End point description
    AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents administered during the course of the study. Safety set included all subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 48
    End point values
    Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
    Number of subjects analysed
    106
    52
    19
    62
    Units: Subjects
        AEs
    104
    51
    19
    61
        SAEs
    5
    4
    3
    13
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Week 48
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)
    Reporting group description
    Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.

    Reporting group title
    Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)
    Reporting group description
    Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.

    Reporting group title
    Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)
    Reporting group description
    Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.

    Reporting group title
    Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
    Reporting group description
    Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.

    Serious adverse events
    Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 106 (4.72%)
    4 / 52 (7.69%)
    3 / 19 (15.79%)
    13 / 62 (20.97%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 106 (1.89%)
    3 / 52 (5.77%)
    2 / 19 (10.53%)
    7 / 62 (11.29%)
         occurrences causally related to treatment / all
    3 / 3
    3 / 3
    2 / 2
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis microscopic
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis chronic
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Drug reaction with eosinophilia and systemic symptoms
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    3 / 62 (4.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess oral
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Perirectal abscess
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    104 / 106 (98.11%)
    51 / 52 (98.08%)
    19 / 19 (100.00%)
    61 / 62 (98.39%)
    Vascular disorders
    Pallor
         subjects affected / exposed
    2 / 106 (1.89%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    2
    0
    0
    1
    Circulatory collapse
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    0
    0
    0
    2
    Hot flush
         subjects affected / exposed
    2 / 106 (1.89%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Hypertension
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Hypotension
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    0
    0
    0
    2
    Orthostatic hypotension
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    1
    0
    0
    1
    Haematoma
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Orthostatic hypertension
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Peripheral coldness
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vascular pain
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant melanoma
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Melanocytic naevus
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 106 (0.00%)
    4 / 52 (7.69%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    4
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    55 / 106 (51.89%)
    25 / 52 (48.08%)
    12 / 19 (63.16%)
    26 / 62 (41.94%)
         occurrences all number
    59
    25
    13
    29
    Pyrexia
         subjects affected / exposed
    26 / 106 (24.53%)
    13 / 52 (25.00%)
    4 / 19 (21.05%)
    15 / 62 (24.19%)
         occurrences all number
    28
    14
    4
    15
    Influenza like illness
         subjects affected / exposed
    28 / 106 (26.42%)
    10 / 52 (19.23%)
    8 / 19 (42.11%)
    9 / 62 (14.52%)
         occurrences all number
    29
    10
    8
    9
    Asthenia
         subjects affected / exposed
    14 / 106 (13.21%)
    8 / 52 (15.38%)
    3 / 19 (15.79%)
    13 / 62 (20.97%)
         occurrences all number
    14
    9
    3
    16
    Irritability
         subjects affected / exposed
    9 / 106 (8.49%)
    7 / 52 (13.46%)
    2 / 19 (10.53%)
    9 / 62 (14.52%)
         occurrences all number
    9
    8
    2
    9
    Chills
         subjects affected / exposed
    6 / 106 (5.66%)
    6 / 52 (11.54%)
    0 / 19 (0.00%)
    9 / 62 (14.52%)
         occurrences all number
    6
    6
    0
    9
    Injection site erythema
         subjects affected / exposed
    5 / 106 (4.72%)
    4 / 52 (7.69%)
    0 / 19 (0.00%)
    3 / 62 (4.84%)
         occurrences all number
    5
    4
    0
    3
    Pain
         subjects affected / exposed
    5 / 106 (4.72%)
    3 / 52 (5.77%)
    1 / 19 (5.26%)
    3 / 62 (4.84%)
         occurrences all number
    5
    3
    1
    3
    Malaise
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    1 / 19 (5.26%)
    5 / 62 (8.06%)
         occurrences all number
    0
    1
    1
    5
    Oedema peripheral
         subjects affected / exposed
    1 / 106 (0.94%)
    4 / 52 (7.69%)
    1 / 19 (5.26%)
    1 / 62 (1.61%)
         occurrences all number
    1
    4
    1
    1
    Injection site reaction
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    4 / 62 (6.45%)
         occurrences all number
    1
    1
    0
    4
    Chest pain
         subjects affected / exposed
    2 / 106 (1.89%)
    2 / 52 (3.85%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    2
    2
    1
    0
    Injection site rash
         subjects affected / exposed
    1 / 106 (0.94%)
    2 / 52 (3.85%)
    0 / 19 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    1
    2
    0
    2
    Chest discomfort
         subjects affected / exposed
    0 / 106 (0.00%)
    4 / 52 (7.69%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    4
    0
    0
    Injection site pruritus
         subjects affected / exposed
    1 / 106 (0.94%)
    2 / 52 (3.85%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Local swelling
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    1
    1
    0
    1
    Thirst
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    1 / 19 (5.26%)
    1 / 62 (1.61%)
         occurrences all number
    1
    0
    1
    1
    Feeling abnormal
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Injection site bruising
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    0
    1
    Enanthema
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Feeling cold
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Feeling hot
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injection site pain
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Temperature intolerance
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    22 / 106 (20.75%)
    11 / 52 (21.15%)
    6 / 19 (31.58%)
    12 / 62 (19.35%)
         occurrences all number
    22
    12
    6
    12
    Depression
         subjects affected / exposed
    12 / 106 (11.32%)
    8 / 52 (15.38%)
    4 / 19 (21.05%)
    10 / 62 (16.13%)
         occurrences all number
    12
    8
    4
    10
    Anxiety
         subjects affected / exposed
    6 / 106 (5.66%)
    2 / 52 (3.85%)
    2 / 19 (10.53%)
    3 / 62 (4.84%)
         occurrences all number
    6
    2
    2
    3
    Depressed mood
         subjects affected / exposed
    4 / 106 (3.77%)
    2 / 52 (3.85%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    4
    2
    0
    0
    Mood swings
         subjects affected / exposed
    2 / 106 (1.89%)
    2 / 52 (3.85%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    2
    2
    0
    1
    Affect lability
         subjects affected / exposed
    2 / 106 (1.89%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    2
    1
    0
    1
    Agitation
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    1
    0
    0
    2
    Anger
         subjects affected / exposed
    1 / 106 (0.94%)
    2 / 52 (3.85%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Mood altered
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    1
    0
    0
    2
    Sleep disorder
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    1
    0
    0
    2
    Apathy
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Drug dependence
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Emotional disorder
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Initial insomnia
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    1
    0
    0
    1
    Nervousness
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Restlessness
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Aggression
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Confusional state
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Disorientation
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Libido decreased
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Loss of libido
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Personality disorder
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Suicide attempt
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Reproductive system and breast disorders
    Menorrhagia
         subjects affected / exposed
    2 / 106 (1.89%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Metrorrhagia
         subjects affected / exposed
    0 / 106 (0.00%)
    2 / 52 (3.85%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Amenorrhoea
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Erectile dysfunction
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Menstrual disorder
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pruritus genital
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Scrotal erythema
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Scrotal pain
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    1
    0
    0
    1
    Laceration
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Scratch
         subjects affected / exposed
    2 / 106 (1.89%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Arthropod bite
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Excoriation
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Procedural pain
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Investigations
    Weight decreased
         subjects affected / exposed
    8 / 106 (7.55%)
    2 / 52 (3.85%)
    2 / 19 (10.53%)
    4 / 62 (6.45%)
         occurrences all number
    8
    2
    2
    4
    Lymphocyte count decreased
         subjects affected / exposed
    3 / 106 (2.83%)
    1 / 52 (1.92%)
    1 / 19 (5.26%)
    1 / 62 (1.61%)
         occurrences all number
    3
    1
    2
    1
    Blood uric acid increased
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    3 / 62 (4.84%)
         occurrences all number
    1
    0
    0
    3
    Blood pressure increased
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    1 / 19 (5.26%)
    1 / 62 (1.61%)
         occurrences all number
    1
    0
    1
    1
    Haemoglobin decreased
         subjects affected / exposed
    2 / 106 (1.89%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    2
    0
    0
    1
    Platelet count decreased
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    2 / 19 (10.53%)
    0 / 62 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Amylase increased
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    0
    1
    Blood potassium decreased
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    0
    1
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Blood urine present
         subjects affected / exposed
    2 / 106 (1.89%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    0
    1
    Transaminases increased
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    1
    0
    0
    White blood cell count decreased
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Blood calcium decreased
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood creatinine increased
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Body temperature increased
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Electrocardiogram ST-T change
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eosinophil count increased
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Haematocrit decreased
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Haemoglobin increased
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    2
    Lipase increased
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Liver function test abnormal
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Red blood cell count decreased
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Respiratory rate increased
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    3 / 106 (2.83%)
    1 / 52 (1.92%)
    2 / 19 (10.53%)
    2 / 62 (3.23%)
         occurrences all number
    3
    1
    2
    2
    Tachycardia
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    3 / 62 (4.84%)
         occurrences all number
    0
    1
    0
    3
    Arrhythmia
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    supraventricular Atrial fibrillation
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Sinus bradycardia
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Supraventricular extrasystoles
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    42 / 106 (39.62%)
    22 / 52 (42.31%)
    10 / 19 (52.63%)
    20 / 62 (32.26%)
         occurrences all number
    46
    25
    14
    23
    Neutropenia
         subjects affected / exposed
    5 / 106 (4.72%)
    4 / 52 (7.69%)
    4 / 19 (21.05%)
    1 / 62 (1.61%)
         occurrences all number
    6
    4
    5
    2
    Leukopenia
         subjects affected / exposed
    1 / 106 (0.94%)
    2 / 52 (3.85%)
    0 / 19 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    1
    2
    0
    2
    Lymphopenia
         subjects affected / exposed
    2 / 106 (1.89%)
    1 / 52 (1.92%)
    1 / 19 (5.26%)
    1 / 62 (1.61%)
         occurrences all number
    2
    1
    1
    1
    Thrombocytopenia
         subjects affected / exposed
    3 / 106 (2.83%)
    0 / 52 (0.00%)
    1 / 19 (5.26%)
    1 / 62 (1.61%)
         occurrences all number
    3
    0
    1
    1
    Lymphadenopathy
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Increased tendency to bruise
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pancytopenia
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    18 / 106 (16.98%)
    11 / 52 (21.15%)
    5 / 19 (26.32%)
    9 / 62 (14.52%)
         occurrences all number
    19
    12
    5
    13
    Cough
         subjects affected / exposed
    9 / 106 (8.49%)
    5 / 52 (9.62%)
    0 / 19 (0.00%)
    9 / 62 (14.52%)
         occurrences all number
    9
    5
    0
    11
    Oropharyngeal pain
         subjects affected / exposed
    7 / 106 (6.60%)
    1 / 52 (1.92%)
    1 / 19 (5.26%)
    2 / 62 (3.23%)
         occurrences all number
    7
    1
    1
    2
    Dyspnoea exertional
         subjects affected / exposed
    5 / 106 (4.72%)
    0 / 52 (0.00%)
    1 / 19 (5.26%)
    3 / 62 (4.84%)
         occurrences all number
    5
    0
    1
    3
    Epistaxis
         subjects affected / exposed
    3 / 106 (2.83%)
    1 / 52 (1.92%)
    1 / 19 (5.26%)
    3 / 62 (4.84%)
         occurrences all number
    3
    1
    1
    3
    Nasal congestion
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    2 / 19 (10.53%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 52 (1.92%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Productive cough
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Respiratory tract congestion
         subjects affected / exposed
    2 / 106 (1.89%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Sinus congestion
         subjects affected / exposed
    2 / 106 (1.89%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Sneezing
         subjects affected / exposed
    2 / 106 (1.89%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Dysphonia
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hiccups
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Nasal discomfort
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nasal disorder
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nasal dryness
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nasal inflammation
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nasal mucosal disorder
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Oropharyngeal discomfort
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Painful respiration
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Paranasal sinus discomfort
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pharyngeal oedema
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rales
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiration abnormal
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    30 / 106 (28.30%)
    16 / 52 (30.77%)
    5 / 19 (26.32%)
    17 / 62 (27.42%)
         occurrences all number
    30
    16
    5
    17
    Dizziness
         subjects affected / exposed
    17 / 106 (16.04%)
    6 / 52 (11.54%)
    6 / 19 (31.58%)
    14 / 62 (22.58%)
         occurrences all number
    18
    8
    6
    15
    Dysgeusia
         subjects affected / exposed
    13 / 106 (12.26%)
    2 / 52 (3.85%)
    2 / 19 (10.53%)
    5 / 62 (8.06%)
         occurrences all number
    13
    2
    2
    5
    Hypoaesthesia
         subjects affected / exposed
    2 / 106 (1.89%)
    5 / 52 (9.62%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    4
    6
    0
    1
    Migraine
         subjects affected / exposed
    2 / 106 (1.89%)
    3 / 52 (5.77%)
    1 / 19 (5.26%)
    1 / 62 (1.61%)
         occurrences all number
    2
    3
    1
    1
    Disturbance in attention
         subjects affected / exposed
    3 / 106 (2.83%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    3
    1
    0
    1
    Memory impairment
         subjects affected / exposed
    3 / 106 (2.83%)
    2 / 52 (3.85%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    3
    2
    0
    0
    Hyperaesthesia
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 52 (1.92%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Paraesthesia
         subjects affected / exposed
    2 / 106 (1.89%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    3
    1
    0
    0
    Somnolence
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    1
    0
    0
    2
    Lethargy
         subjects affected / exposed
    2 / 106 (1.89%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Syncope
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    0
    1
    Burning sensation
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cognitive disorder
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dizziness exertional
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Drooling
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Mental impairment
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Parosmia
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Sciatica
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Tremor
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    8 / 106 (7.55%)
    2 / 52 (3.85%)
    3 / 19 (15.79%)
    2 / 62 (3.23%)
         occurrences all number
    8
    3
    3
    2
    Dry eye
         subjects affected / exposed
    4 / 106 (3.77%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    4 / 62 (6.45%)
         occurrences all number
    4
    0
    0
    4
    Eye pruritus
         subjects affected / exposed
    3 / 106 (2.83%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    3
    0
    0
    1
    Ocular hyperaemia
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    1
    0
    0
    2
    Visual impairment
         subjects affected / exposed
    0 / 106 (0.00%)
    2 / 52 (3.85%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    2
    0
    1
    Diplopia
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    1
    0
    0
    1
    Eye irritation
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    0
    1
    Eye pain
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    1
    0
    0
    1
    Retinal exudates
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    1
    0
    0
    1
    Abnormal sensation in eye
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eye haemorrhage
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Eyelid oedema
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Ocular discomfort
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Periorbital oedema
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Retinal haemorrhage
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Retinopathy
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vitreous floaters
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    photophobia
         subjects affected / exposed
    6 / 106 (5.66%)
    3 / 52 (5.77%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    6
    3
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    4 / 106 (3.77%)
    2 / 52 (3.85%)
    0 / 19 (0.00%)
    4 / 62 (6.45%)
         occurrences all number
    4
    2
    0
    4
    Tinnitus
         subjects affected / exposed
    2 / 106 (1.89%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    2
    1
    0
    2
    Ear pruritus
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Ear discomfort
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ear pain
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hyperacusis
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hypoacusis
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Otorrhoea
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    49 / 106 (46.23%)
    19 / 52 (36.54%)
    13 / 19 (68.42%)
    33 / 62 (53.23%)
         occurrences all number
    51
    22
    15
    37
    Diarrhoea
         subjects affected / exposed
    19 / 106 (17.92%)
    6 / 52 (11.54%)
    6 / 19 (31.58%)
    11 / 62 (17.74%)
         occurrences all number
    21
    6
    6
    11
    Vomiting
         subjects affected / exposed
    17 / 106 (16.04%)
    6 / 52 (11.54%)
    6 / 19 (31.58%)
    11 / 62 (17.74%)
         occurrences all number
    18
    7
    6
    15
    Anorectal discomfort
         subjects affected / exposed
    22 / 106 (20.75%)
    9 / 52 (17.31%)
    3 / 19 (15.79%)
    5 / 62 (8.06%)
         occurrences all number
    22
    9
    3
    5
    Anal pruritus
         subjects affected / exposed
    10 / 106 (9.43%)
    8 / 52 (15.38%)
    3 / 19 (15.79%)
    4 / 62 (6.45%)
         occurrences all number
    11
    10
    3
    4
    Haemorrhoids
         subjects affected / exposed
    8 / 106 (7.55%)
    4 / 52 (7.69%)
    1 / 19 (5.26%)
    6 / 62 (9.68%)
         occurrences all number
    8
    4
    1
    6
    Dry mouth
         subjects affected / exposed
    5 / 106 (4.72%)
    3 / 52 (5.77%)
    3 / 19 (15.79%)
    7 / 62 (11.29%)
         occurrences all number
    5
    3
    3
    7
    Dyspepsia
         subjects affected / exposed
    9 / 106 (8.49%)
    2 / 52 (3.85%)
    1 / 19 (5.26%)
    3 / 62 (4.84%)
         occurrences all number
    9
    2
    1
    5
    Proctalgia
         subjects affected / exposed
    5 / 106 (4.72%)
    4 / 52 (7.69%)
    0 / 19 (0.00%)
    3 / 62 (4.84%)
         occurrences all number
    5
    4
    0
    3
    Constipation
         subjects affected / exposed
    4 / 106 (3.77%)
    1 / 52 (1.92%)
    3 / 19 (15.79%)
    3 / 62 (4.84%)
         occurrences all number
    4
    1
    3
    3
    Abdominal pain upper
         subjects affected / exposed
    3 / 106 (2.83%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    5 / 62 (8.06%)
         occurrences all number
    3
    0
    0
    6
    Abdominal pain
         subjects affected / exposed
    3 / 106 (2.83%)
    2 / 52 (3.85%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    3
    2
    0
    1
    Aphthous stomatitis
         subjects affected / exposed
    2 / 106 (1.89%)
    2 / 52 (3.85%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    2
    2
    0
    1
    Cheilitis
         subjects affected / exposed
    2 / 106 (1.89%)
    2 / 52 (3.85%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Flatulence
         subjects affected / exposed
    3 / 106 (2.83%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    3
    0
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    4 / 62 (6.45%)
         occurrences all number
    0
    0
    0
    4
    Haematochezia
         subjects affected / exposed
    2 / 106 (1.89%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    2
    1
    0
    1
    Rectal haemorrhage
         subjects affected / exposed
    0 / 106 (0.00%)
    2 / 52 (3.85%)
    1 / 19 (5.26%)
    1 / 62 (1.61%)
         occurrences all number
    0
    2
    1
    1
    Stomatitis
         subjects affected / exposed
    2 / 106 (1.89%)
    1 / 52 (1.92%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Abdominal discomfort
         subjects affected / exposed
    3 / 106 (2.83%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Abdominal distension
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    0
    1
    0
    2
    Gingival bleeding
         subjects affected / exposed
    2 / 106 (1.89%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    2
    0
    0
    1
    Toothache
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 52 (1.92%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Anal haemorrhage
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Epigastric discomfort
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    2
    0
    0
    1
    Glossodynia
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    0
    1
    Oral pain
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    1
    0
    0
    1
    Proctitis
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Retching
         subjects affected / exposed
    2 / 106 (1.89%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Abdominal pain lower
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Abdominal tenderness
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Anal fissure
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ascites
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Bowel movement irregularity
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Duodenal ulcer
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Eructation
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Faeces pale
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Frequent bowel movements
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal motility disorder
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gingival pain
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Glossitis
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hyperchlorhydria
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Lip dry
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Lip pain
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Oral discomfort
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Oral disorder
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Perianal erythema
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Sensitivity of teeth
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Steatorrhoea
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Swollen tongue
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tongue coated
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tongue disorder
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Tooth impacted
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Periportal oedema
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Dysuria
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    44 / 106 (41.51%)
    17 / 52 (32.69%)
    8 / 19 (42.11%)
    24 / 62 (38.71%)
         occurrences all number
    52
    18
    11
    25
    Rash
         subjects affected / exposed
    31 / 106 (29.25%)
    15 / 52 (28.85%)
    9 / 19 (47.37%)
    13 / 62 (20.97%)
         occurrences all number
    38
    22
    16
    17
    Alopecia
         subjects affected / exposed
    13 / 106 (12.26%)
    11 / 52 (21.15%)
    4 / 19 (21.05%)
    7 / 62 (11.29%)
         occurrences all number
    13
    11
    4
    7
    Dry skin
         subjects affected / exposed
    11 / 106 (10.38%)
    11 / 52 (21.15%)
    6 / 19 (31.58%)
    4 / 62 (6.45%)
         occurrences all number
    11
    11
    6
    4
    Pruritus generalised
         subjects affected / exposed
    4 / 106 (3.77%)
    3 / 52 (5.77%)
    3 / 19 (15.79%)
    3 / 62 (4.84%)
         occurrences all number
    4
    3
    5
    3
    Rash maculo-papular
         subjects affected / exposed
    5 / 106 (4.72%)
    2 / 52 (3.85%)
    3 / 19 (15.79%)
    3 / 62 (4.84%)
         occurrences all number
    9
    2
    4
    4
    Rash papular
         subjects affected / exposed
    5 / 106 (4.72%)
    1 / 52 (1.92%)
    4 / 19 (21.05%)
    3 / 62 (4.84%)
         occurrences all number
    5
    2
    7
    3
    Rash erythematous
         subjects affected / exposed
    4 / 106 (3.77%)
    1 / 52 (1.92%)
    2 / 19 (10.53%)
    4 / 62 (6.45%)
         occurrences all number
    6
    1
    3
    4
    Rash pruritic
         subjects affected / exposed
    2 / 106 (1.89%)
    2 / 52 (3.85%)
    2 / 19 (10.53%)
    1 / 62 (1.61%)
         occurrences all number
    2
    4
    3
    2
    Dermatitis
         subjects affected / exposed
    1 / 106 (0.94%)
    2 / 52 (3.85%)
    0 / 19 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    1
    2
    0
    2
    Rash generalised
         subjects affected / exposed
    1 / 106 (0.94%)
    2 / 52 (3.85%)
    1 / 19 (5.26%)
    1 / 62 (1.61%)
         occurrences all number
    2
    2
    1
    1
    Swelling face
         subjects affected / exposed
    2 / 106 (1.89%)
    0 / 52 (0.00%)
    2 / 19 (10.53%)
    1 / 62 (1.61%)
         occurrences all number
    2
    0
    2
    1
    Erythema
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 52 (1.92%)
    1 / 19 (5.26%)
    1 / 62 (1.61%)
         occurrences all number
    1
    1
    1
    2
    Night sweats
         subjects affected / exposed
    2 / 106 (1.89%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    2
    1
    0
    1
    Psoriasis
         subjects affected / exposed
    2 / 106 (1.89%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    2
    0
    0
    2
    Eczema
         subjects affected / exposed
    2 / 106 (1.89%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    3
    1
    0
    0
    Rash macular
         subjects affected / exposed
    2 / 106 (1.89%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    4
    1
    0
    0
    Skin irritation
         subjects affected / exposed
    2 / 106 (1.89%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    2
    0
    0
    1
    Urticaria
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 52 (1.92%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Drug eruption
         subjects affected / exposed
    2 / 106 (1.89%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Blister
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dermatitis acneiform
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Drug reaction with eosinophilia and systemic symptoms
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hair growth abnormal
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hair texture abnormal
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Onychoclasis
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pain of skin
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Photosensitivity reaction
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Purpura
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rash follicular
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rash vesicular
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Scab
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Seborrhoea
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin burning sensation
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Skin exfoliation
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Skin fragility
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin lesion
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Stasis dermatitis
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Telangiectasia
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    9 / 106 (8.49%)
    7 / 52 (13.46%)
    2 / 19 (10.53%)
    8 / 62 (12.90%)
         occurrences all number
    12
    7
    3
    10
    Myalgia
         subjects affected / exposed
    6 / 106 (5.66%)
    7 / 52 (13.46%)
    0 / 19 (0.00%)
    11 / 62 (17.74%)
         occurrences all number
    6
    7
    0
    12
    Back pain
         subjects affected / exposed
    6 / 106 (5.66%)
    2 / 52 (3.85%)
    0 / 19 (0.00%)
    4 / 62 (6.45%)
         occurrences all number
    6
    2
    0
    4
    Muscle spasms
         subjects affected / exposed
    3 / 106 (2.83%)
    4 / 52 (7.69%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    3
    5
    0
    1
    Pain in extremity
         subjects affected / exposed
    2 / 106 (1.89%)
    2 / 52 (3.85%)
    1 / 19 (5.26%)
    3 / 62 (4.84%)
         occurrences all number
    3
    2
    2
    3
    Joint swelling
         subjects affected / exposed
    1 / 106 (0.94%)
    2 / 52 (3.85%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    1
    2
    0
    2
    Muscular weakness
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 52 (1.92%)
    2 / 19 (10.53%)
    0 / 62 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Musculoskeletal pain
         subjects affected / exposed
    2 / 106 (1.89%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    2
    1
    0
    1
    Bone pain
         subjects affected / exposed
    2 / 106 (1.89%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    2
    0
    0
    1
    Neck pain
         subjects affected / exposed
    3 / 106 (2.83%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    4
    0
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Costochondritis
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Joint stiffness
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal discomfort
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Plantar fasciitis
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Spinal pain
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    0
    0
    0
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    21 / 106 (19.81%)
    6 / 52 (11.54%)
    4 / 19 (21.05%)
    10 / 62 (16.13%)
         occurrences all number
    21
    7
    4
    12
    Dehydration
         subjects affected / exposed
    3 / 106 (2.83%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    2 / 62 (3.23%)
         occurrences all number
    3
    1
    0
    3
    Hyponatraemia
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    1
    0
    0
    1
    Abnormal loss of weight
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gout
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hyperuricaemia
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypocalcaemia
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Hypokalaemia
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Hypomagnesaemia
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    5 / 106 (4.72%)
    1 / 52 (1.92%)
    2 / 19 (10.53%)
    3 / 62 (4.84%)
         occurrences all number
    6
    1
    3
    4
    Nasopharyngitis
         subjects affected / exposed
    2 / 106 (1.89%)
    1 / 52 (1.92%)
    1 / 19 (5.26%)
    2 / 62 (3.23%)
         occurrences all number
    2
    1
    1
    2
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 106 (0.00%)
    3 / 52 (5.77%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    0
    3
    1
    0
    Cellulitis
         subjects affected / exposed
    0 / 106 (0.00%)
    3 / 52 (5.77%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Ear infection
         subjects affected / exposed
    1 / 106 (0.94%)
    2 / 52 (3.85%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Oral herpes
         subjects affected / exposed
    3 / 106 (2.83%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Cystitis
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    2
    0
    0
    1
    Influenza
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Pneumonia
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    0
    1
    Sinusitis
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    1
    0
    0
    3
    Skin infection
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    1
    0
    0
    1
    Tooth abscess
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    1
    0
    1
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Bronchitis
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Candida infection
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Dermatitis infected
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Folliculitis
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Genital herpes
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gingivitis
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Herpes pharyngitis
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    1 / 19 (5.26%)
    0 / 62 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Parotitis
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rash pustular
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Scrotal abscess
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Tinea cruris
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 52 (0.00%)
    0 / 19 (0.00%)
    1 / 62 (1.61%)
         occurrences all number
    0
    0
    0
    1
    Tooth infection
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 52 (1.92%)
    0 / 19 (0.00%)
    0 / 62 (0.00%)
         occurrences all number
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Aug 2011
    Following FDA recommendation, changed study design to randomized study of 2 treatment regimens. Subjects who have rapid viral response (RVR) and no permanent discontinuation of any study drug will be randomized 2:1 to T12/PR12 or T12/PR24 group. To reflect study design changes, title was changed to specify 2 treatment durations and include subjects with prior relapse. Revised the text for sample size and power, to account for the additional treatment arm. Added allowance for 2 interim analyses.

    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.
    The study was terminated early at the primary efficacy endpoint (SVR12), by the sponsor on 13 January 2014 due to a decision to modify the drug development plan.
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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