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    Clinical Trial Results:
    An Open-Label, Phase 3 Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Coinfected With Genotype 1 Hepatitis C Virus and Human Immunodeficiency Virus Type 1(HCV/HIV-1)

    Summary
    EudraCT number
    		 2011-002668-25
    Trial protocol
    		 DE   ES  
    Global end of trial date
    04 Feb 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jun 2016
    First version publication date
    07 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VX11-950-115
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01467479
    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
    04 Feb 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of the study was to evaluate the antiviral efficacy of response-guided dosing of telaprevir, peginterferon alfa-2a (Peg-IFN-alfa-2a), and ribavarin during 24 or 48-week treatment in subjects co-infected with human immunodeficiency virus (HIV) and Hepatitis C Virus (HCV), who were treatment-naive for HCV or received prior HCV treatment with Peg-IFN-alfa-2a and ribavirin and experienced viral relapse.
    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
    28 Dec 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 16
    Country: Number of subjects enrolled
    United States: 144
    Country: Number of subjects enrolled
    Germany: 7
    Country: Number of subjects enrolled
    Spain: 15
    Worldwide total number of subjects
    182
    EEA total number of subjects
    22
    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)
    179
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study included Treatment-Naïve (no prior hepatitis C virus [HCV] therapy); Prior Relapser (prior HCV treatment with Peg-IFN/RBV and experienced viral relapse); and Prior Null/Partial Responder (prior HCV treatment with Peg-IFN/RBV and had null/partial response) subjects.

    Pre-assignment
    Screening details
    		 Total 55, 69, and 61 subjects were enrolled in “T/PR + HAART Regimen (ATV/r-Based)”, “T/PR + HAART Regimen (EFV-Based)” and “T/PR + HAART Regimen (RAL-Based)” arms, respectively of which 54, 69, and 59 subjects were treated. Results were reported as per HAART treatment and also separately as per prior response, unless otherwise specified.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 T/PR + HAART Regimen (ATV/r-Based)
    Arm description
    		 Subjects who were receiving atazanavir/ritonavir (ATV/r) based Highly Active Antiretroviral Therapy (HAART) at baseline, received Telaprevir (T) 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Subjects continued their HAART, as per standard practice and investigator discretion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    VX-950
    Other name
    Incivek
    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
    Ribavirin
    Investigational medicinal product code
    Other name
    Copegus®, RBV
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin (RBV) tablet twice daily at a dose of 800 mg/day for 24 or 48 weeks.

    Investigational medicinal product name
    Pegylated Interferon Alfa-2a
    Investigational medicinal product code
    Other name
    Pegasys®, Peg-IFN-Alfa-2a
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection.

    Investigational medicinal product name
    Atazanavir/ritonavir (ATV/r)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet, Capsule, soft, Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Atazanavir/ritonavir (ATV/r) based HAART as per standard practice.

    Arm title
    		 T/PR + HAART Regimen (EFV-Based)
    Arm description
    		 Subjects who were receiving efavirenz (EFV) based HAART at baseline, received Telaprevir 1125 mg tablet three times a day 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 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Subjects continued their HAART, as per standard practice and investigator discretion.
    Arm type
    		 Experimental

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

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Copegus®, RBV
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin tablet twice daily at a dose of 800 mg/day for 24 or 48 weeks.

    Investigational medicinal product name
    Pegylated Interferon Alfa-2a
    Investigational medicinal product code
    Other name
    Pegasys®, Peg-IFN-Alfa-2a
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Pegylated interferon alfa 2a 180 mcg/week subcutaneous injection.

    Investigational medicinal product name
    Efavirenz (EFV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Efavirenz based HAART as per standard practice.

    Arm title
    		 T/PR + HAART Regimen (RAL-Based)
    Arm description
    		 Subjects who were receiving raltegravir (RAL) based HAART at baseline, 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 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Subjects continued their HAART, as per standard practice and investigator discretion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    VX-950
    Other name
    Incivek
    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
    Ribavirin
    Investigational medicinal product code
    Other name
    Copegus®, RBV
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin tablet twice daily at a dose of 800 mg/day for 24 or 48 weeks.

    Investigational medicinal product name
    Pegylated Interferon Alfa-2a
    Investigational medicinal product code
    Other name
    Pegasys®, Peg-IFN-Alfa-2a
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection.

    Investigational medicinal product name
    Raltegravir (RAL)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules for oral suspension, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Raltegravir based HAART as per standard practice.

    Number of subjects in period 1
    		T/PR + HAART Regimen (ATV/r-Based) T/PR + HAART Regimen (EFV-Based) T/PR + HAART Regimen (RAL-Based)
    Started
    54
    69
    59
    Completed
    46
    52
    45
    Not completed
    8
    17
    14
         Consent withdrawn by subject
    3
    7
    7
         Adverse Event
    1
    2
    -
         Death
    -
    -
    1
         Unspecified
    1
    -
    -
         Study Terminated by Sponsor
    1
    3
    3
         Lost to follow-up
    2
    5
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    T/PR + HAART Regimen (ATV/r-Based)
    Reporting group description
    		 Subjects who were receiving atazanavir/ritonavir (ATV/r) based Highly Active Antiretroviral Therapy (HAART) at baseline, received Telaprevir (T) 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Subjects continued their HAART, as per standard practice and investigator discretion.

    Reporting group title
    T/PR + HAART Regimen (EFV-Based)
    Reporting group description
    		 Subjects who were receiving efavirenz (EFV) based HAART at baseline, received Telaprevir 1125 mg tablet three times a day 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 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Subjects continued their HAART, as per standard practice and investigator discretion.

    Reporting group title
    T/PR + HAART Regimen (RAL-Based)
    Reporting group description
    		 Subjects who were receiving raltegravir (RAL) based HAART at baseline, 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 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Subjects continued their HAART, as per standard practice and investigator discretion.

    Reporting group values
    		 T/PR + HAART Regimen (ATV/r-Based) T/PR + HAART Regimen (EFV-Based) T/PR + HAART Regimen (RAL-Based) Total
    Number of subjects
    		 54 69 59 182
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50.4 ± 8.81 49.6 ± 8.84 48.4 ± 9.58 -
    Gender categorical
    Units: Subjects
        Female
    		 6 9 15 30
        Male
    		 48 60 44 152

    End points

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    End points reporting groups
    Reporting group title
    T/PR + HAART Regimen (ATV/r-Based)
    Reporting group description
    		 Subjects who were receiving atazanavir/ritonavir (ATV/r) based Highly Active Antiretroviral Therapy (HAART) at baseline, received Telaprevir (T) 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Subjects continued their HAART, as per standard practice and investigator discretion.

    Reporting group title
    T/PR + HAART Regimen (EFV-Based)
    Reporting group description
    		 Subjects who were receiving efavirenz (EFV) based HAART at baseline, received Telaprevir 1125 mg tablet three times a day 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 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Subjects continued their HAART, as per standard practice and investigator discretion.

    Reporting group title
    T/PR + HAART Regimen (RAL-Based)
    Reporting group description
    		 Subjects who were receiving raltegravir (RAL) based HAART at baseline, 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 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Subjects continued their HAART, as per standard practice and investigator discretion.

    Subject analysis set title
    T/PR + HAART Regimen
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects who were receiving either ATV/r based HAART or EFV based HAART or RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily or 1125 mg three times a day 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 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Subjects continued their respective HAART, as per standard practice and investigator discretion.

    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]
    End point description
    SVR 12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 12 weeks after last planned dose of study drug. The plasma hepatitis C virus ribonucleic acid (HCV RNA) level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL). Analysis was carried out on safety set defined as all subjects who received at least 1 dose of study drug. Here, n = subjects evaluable for specified category for each arm, respectively.
    End point type
    Primary
    End point timeframe
    12 weeks after last planned dose of study drug (up to Week 60)
    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.
    End point values
    		 T/PR + HAART Regimen (ATV/r-Based) T/PR + HAART Regimen (EFV-Based) T/PR + HAART Regimen (RAL-Based)
    Number of subjects analysed
    54
    69
    59
    Units: Percentage of Subjects
    number (not applicable)
        Treatment Naïve (n= 24, 39, 31)
    66.7
    59
    61.3
        Prior Relapser (n=8, 11, 4)
    75
    54.5
    100
        Prior Null Responder (n= 15, 11, 15)
    40
    36.4
    40
        Prior Partial Responder (n= 7, 8, 9)
    14.3
    87.5
    55.6
        Total (n= 54, 69, 59)
    53.7
    58
    57.6
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Subjects With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR 24)
    End point description
    SVR 24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 24 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). Analysis was carried out on safety set defined as all subjects who received at least 1 dose of study drug. Here number of subjects analyzed = subjects evaluable for this measure and n = subjects evaluable for specified categories, for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    24 weeks after last planned dose of study drug (up to Week 72)
    End point values
    		 T/PR + HAART Regimen (ATV/r-Based) T/PR + HAART Regimen (EFV-Based) T/PR + HAART Regimen (RAL-Based)
    Number of subjects analysed
    53
    66
    56
    Units: Percentage of Subjects
    number (not applicable)
        Treatment Naïve (n= 23, 38, 29)
    65.2
    57.9
    51.7
        Prior Relapser (n=8, 11, 4)
    75
    54.5
    100
        Prior Null Responder (n= 15, 9, 14)
    33.3
    22.2
    35.7
        Prior Partial Responder (n= 7, 8, 9)
    14.3
    75
    55.6
        Total (n= 53, 66, 56)
    50.9
    54.5
    51.8
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Subjects With Rapid Viral Response (RVR)
    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. RVR was defined as undetectable HCV RNA (<lower limit of quantification) 4 weeks after the start of study treatment. Analysis was carried out on safety set defined as all subjects who received at least 1 dose of study drug. Here, n = subjects evaluable for specified category for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 T/PR + HAART Regimen (ATV/r-Based) T/PR + HAART Regimen (EFV-Based) T/PR + HAART Regimen (RAL-Based)
    Number of subjects analysed
    54
    69
    59
    Units: Percentage of Subjects
    number (not applicable)
        Treatment Naïve (n= 24, 39, 31)
    50
    53.8
    74.2
        Prior Relapser (n=8, 11, 4)
    62.5
    72.7
    100
        Prior Null Responder (n= 15, 11, 15)
    26.7
    54.5
    53.3
        Prior Partial Responder (n= 7, 8, 9)
    42.9
    50
    44.4
        Total (n= 54, 69, 59)
    44.4
    56.5
    66.1
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Subjects With Extended Rapid Viral Response (eRVR)
    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. eRVR was defined as undetectable HCV RNA (<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment. Analysis was carried out on safety set defined as all subjects who received at least 1 dose of study drug. Here, n = subjects evaluable for specified category for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Week 4, Week 12
    End point values
    		 T/PR + HAART Regimen (ATV/r-Based) T/PR + HAART Regimen (EFV-Based) T/PR + HAART Regimen (RAL-Based)
    Number of subjects analysed
    54
    69
    59
    Units: Percentage of Subjects
    number (not applicable)
        Treatment Naïve (n= 24, 39, 31)
    50
    53.8
    61.3
        Prior Relapser (n=8, 11, 4)
    62.5
    72.7
    100
        Prior Null Responder (n= 15, 11, 15)
    26.7
    54.5
    53.3
        Prior Partial Responder (n= 7, 8, 9)
    14.3
    50
    44.4
        Total (n= 54, 69, 59)
    40.7
    56.5
    59.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Undetectable HCV RNA at End of Treatment (EOT)

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    End point title
    		 Percentage of Subjects With Undetectable HCV RNA at End of Treatment (EOT)
    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. Percentage of subjects with undetectable HCV RNA (<lower limit of quantification) at EOT (up to Week 48) was reported. Data for this outcome was not planned to be reported by prior response. Analysis was carried out on full analysis set (FAS) population defined as all subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    EOT (up to Week 48)
    End point values
    		 T/PR + HAART Regimen (ATV/r-Based) T/PR + HAART Regimen (EFV-Based) T/PR + HAART Regimen (RAL-Based)
    Number of subjects analysed
    54
    69
    59
    Units: Percentage of Subjects
        number (not applicable)
    55.6
    63.8
    61
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
    End point description
    AE: any untoward medical occurrence in a subject during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. SAE (subset of AE): 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. Analysis was carried out on safety set defined as all subjects who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    		 T/PR + HAART Regimen (ATV/r-Based) T/PR + HAART Regimen (EFV-Based) T/PR + HAART Regimen (RAL-Based)
    Number of subjects analysed
    54
    69
    59
    Units: Percentage of Subjects
    number (not applicable)
        AEs
    100
    95.7
    94.9
        SAEs
    13
    11.6
    15.3
    No statistical analyses for this end point

    Secondary: Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg)

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    End point title
    		 Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg)
    End point description
    Cmax, Cmin, and Cavg were reported for atazanavir (ATV), efavirenz (EFV), raltegravir (RAL), and telaprevir. Analysis was carried out on FAS population defined as all subjects who received at least 1 dose of study drug. Here, n = subjects evaluable for specified category for each arm, respectively. Value 99999 represents data not available as no subject was evaluable for this parameter from the specified reporting group.
    End point type
    Secondary
    End point timeframe
    Day -14 to Day -1 and Week 1 for ATV, EFV, and RAL; Week 1 for telaprevir
    End point values
    		 T/PR + HAART Regimen (ATV/r-Based) T/PR + HAART Regimen (EFV-Based) T/PR + HAART Regimen (RAL-Based)
    Number of subjects analysed
    54
    69
    59
    Units: nanogram per milliliter (ng/mL)
    arithmetic mean (standard deviation)
        ATV: Day -14 to Day -1, Cmax(n=46, 0, 0)
    2870 ± 1580
    99999 ± 99999
    99999 ± 99999
        ATV: Day -14 to Day -1, Cmin(n=46, 0, 0)
    991 ± 635
    99999 ± 99999
    99999 ± 99999
        ATV: Day -14 to Day -1, Cavg(n=41, 0, 0)
    1100 ± 647
    99999 ± 99999
    99999 ± 99999
        ATV: Week 1, Cmax (n=42, 0, 0)
    2820 ± 1570
    99999 ± 99999
    99999 ± 99999
        ATV: Week 1, Cmin (n=42, 0, 0)
    1280 ± 636
    99999 ± 99999
    99999 ± 99999
        ATV: Week 1, Cavg (n=30, 0, 0)
    1320 ± 685
    99999 ± 99999
    99999 ± 99999
        EFV: Day -14 to Day -1, Cmax(n=0, 60, 0)
    99999 ± 99999
    3800 ± 2600
    99999 ± 99999
        EFV: Day -14 to Day -1, Cmin(n=0, 60, 0)
    99999 ± 99999
    2560 ± 1900
    99999 ± 99999
        EFV: Day -14 to Day -1, Cavg(n=0, 51, 0)
    99999 ± 99999
    2150 ± 1680
    99999 ± 99999
        EFV: Week 1, Cmax (n=0, 51, 0)
    99999 ± 99999
    3340 ± 2450
    99999 ± 99999
        EFV: Week 1, Cmin (n=0, 51, 0)
    99999 ± 99999
    2290 ± 1880
    99999 ± 99999
        EFV: Week 1, Cavg (n=0, 47, 0)
    99999 ± 99999
    1920 ± 1400
    99999 ± 99999
        RAL: Day -14 to Day -1, Cmax(n=0, 0, 52)
    99999 ± 99999
    99999 ± 99999
    1900 ± 1880
        RAL: Day -14 to Day -1, Cmin(n=0, 0, 52)
    99999 ± 99999
    99999 ± 99999
    196 ± 198
        RAL: Day -14 to Day -1, Cavg(n=0, 0, 35)
    99999 ± 99999
    99999 ± 99999
    483 ± 429
        RAL: Week 1, Cmax (n=0, 0, 49)
    99999 ± 99999
    99999 ± 99999
    2320 ± 1970
        RAL: Week 1, Cmin (n=0, 0, 49)
    99999 ± 99999
    99999 ± 99999
    281 ± 435
        RAL: Week 1, Cavg (n=0, 0, 34)
    99999 ± 99999
    99999 ± 99999
    643 ± 539
        Telaprevir: Week 1, Cmax(n=49, 59, 54)
    3160 ± 1180
    3780 ± 1670
    3470 ± 868
        Telaprevir: Week 1, Cmin(n=49, 59, 54)
    1650 ± 863
    1750 ± 961
    1840 ± 741
        Telaprevir: Week 1, Cavg(n=30, 32, 26)
    2320 ± 907
    2430 ± 1290
    2520 ± 643
    No statistical analyses for this end point

    Secondary: Number of Subjects With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region

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    End point title
    		 Number of Subjects With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region
    End point description
    Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA >=1000 IU/mL). Results of this outcome measure were to be reported for overall subjects instead of by HAART treatment. Analysis was carried out on FAS population defined as all subjects who received at least 1 dose of study drug. Here number of subjects analyzed = subjects who were evaluable for this measure and n = subjects evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    Baseline, follow-up (Week 96)
    End point values
    		 T/PR + HAART Regimen
    Number of subjects analysed
    180
    Units: subjects
        Baseline (n = 180)
    2
        Follow-up (n = 26)
    11
    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 52
    Adverse event reporting additional description
    Adverse events were planned to be reported as per HAART treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    T/PR + HAART Regimen (ATV/r-Based)
    Reporting group description
    		 Subjects who were receiving atazanavir/ritonavir (ATV/r) based Highly Active Antiretroviral Therapy (HAART) at baseline, received Telaprevir (T)1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Subjects continued their HAART, as per standard practice and investigator discretion.

    Reporting group title
    T/PR + HAART Regimen (EFV-Based)
    Reporting group description
    		 Subjects who were receiving efavirenz (EFV) based HAART at baseline, received Telaprevir 1125 mg tablet three times a day 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 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Subjects continued their HAART, as per standard practice and investigator discretion.

    Reporting group title
    T/PR + HAART Regimen (RAL-Based)
    Reporting group description
    		 Subjects who were receiving raltegravir (RAL) based HAART at baseline, 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 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Subjects continued their HAART, as per standard practice and investigator discretion.

    Serious adverse events
    		 T/PR + HAART Regimen (ATV/r-Based) T/PR + HAART Regimen (EFV-Based) T/PR + HAART Regimen (RAL-Based)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 54 (12.96%)
    8 / 69 (11.59%)
    9 / 59 (15.25%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea exertional
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Clavicle fracture
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 54 (0.00%)
    3 / 69 (4.35%)
    4 / 59 (6.78%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 69 (1.45%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinopathy
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mallory-Weiss syndrome
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin lesion
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal cyst
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure acute
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Basedow's disease
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Flank pain
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psoas abscess
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 T/PR + HAART Regimen (ATV/r-Based) T/PR + HAART Regimen (EFV-Based) T/PR + HAART Regimen (RAL-Based)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    54 / 54 (100.00%)
    66 / 69 (95.65%)
    56 / 59 (94.92%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    1
    Flushing
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Peripheral coldness
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Thrombosis
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    26 / 54 (48.15%)
    36 / 69 (52.17%)
    30 / 59 (50.85%)
         occurrences all number
    32
    43
    34
    Influenza like illness
         subjects affected / exposed
    5 / 54 (9.26%)
    8 / 69 (11.59%)
    8 / 59 (13.56%)
         occurrences all number
    5
    9
    8
    Pyrexia
         subjects affected / exposed
    9 / 54 (16.67%)
    5 / 69 (7.25%)
    7 / 59 (11.86%)
         occurrences all number
    10
    5
    7
    Chills
         subjects affected / exposed
    8 / 54 (14.81%)
    6 / 69 (8.70%)
    4 / 59 (6.78%)
         occurrences all number
    8
    6
    5
    Asthenia
         subjects affected / exposed
    6 / 54 (11.11%)
    2 / 69 (2.90%)
    9 / 59 (15.25%)
         occurrences all number
    6
    2
    9
    Injection site reaction
         subjects affected / exposed
    1 / 54 (1.85%)
    9 / 69 (13.04%)
    4 / 59 (6.78%)
         occurrences all number
    1
    9
    4
    Irritability
         subjects affected / exposed
    2 / 54 (3.70%)
    5 / 69 (7.25%)
    7 / 59 (11.86%)
         occurrences all number
    2
    6
    8
    Pain
         subjects affected / exposed
    6 / 54 (11.11%)
    2 / 69 (2.90%)
    6 / 59 (10.17%)
         occurrences all number
    6
    2
    6
    Injection site erythema
         subjects affected / exposed
    0 / 54 (0.00%)
    3 / 69 (4.35%)
    2 / 59 (3.39%)
         occurrences all number
    0
    5
    2
    Malaise
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 69 (2.90%)
    2 / 59 (3.39%)
         occurrences all number
    0
    3
    2
    Injection site bruising
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 69 (2.90%)
    1 / 59 (1.69%)
         occurrences all number
    0
    2
    1
    Injection site rash
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    2 / 59 (3.39%)
         occurrences all number
    0
    1
    2
    Crying
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    1
    Feeling hot
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 69 (2.90%)
    0 / 59 (0.00%)
         occurrences all number
    0
    2
    0
    Thirst
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    1
    0
    1
    Chest discomfort
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Chest pain
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Cyst
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Feeling abnormal
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Gait disturbance
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Injection site pruritus
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Local swelling
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Localised oedema
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Sluggishness
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Temperature intolerance
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Xerosis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    1
    1
    0
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Genital hypoaesthesia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    2
    0
    Haematospermia
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Menstruation irregular
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Sexual dysfunction
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Testicular pain
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    4 / 54 (7.41%)
    5 / 69 (7.25%)
    5 / 59 (8.47%)
         occurrences all number
    4
    5
    5
    Cough
         subjects affected / exposed
    4 / 54 (7.41%)
    6 / 69 (8.70%)
    0 / 59 (0.00%)
         occurrences all number
    4
    6
    0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 54 (0.00%)
    4 / 69 (5.80%)
    2 / 59 (3.39%)
         occurrences all number
    0
    4
    2
    Epistaxis
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 69 (2.90%)
    2 / 59 (3.39%)
         occurrences all number
    0
    2
    2
    Oropharyngeal pain
         subjects affected / exposed
    2 / 54 (3.70%)
    2 / 69 (2.90%)
    0 / 59 (0.00%)
         occurrences all number
    2
    2
    0
    Wheezing
         subjects affected / exposed
    0 / 54 (0.00%)
    3 / 69 (4.35%)
    1 / 59 (1.69%)
         occurrences all number
    0
    3
    1
    Respiratory tract congestion
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 69 (2.90%)
    0 / 59 (0.00%)
         occurrences all number
    1
    2
    0
    Rhinorrhoea
         subjects affected / exposed
    2 / 54 (3.70%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    2
    1
    0
    Nasal congestion
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    1
    Sneezing
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    1
    Dry throat
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Hiccups
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Increased viscosity of nasal secretion
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Oropharyngeal plaque
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Pharyngeal oedema
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Productive cough
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Sinus congestion
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Throat irritation
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Throat tightness
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    9 / 54 (16.67%)
    14 / 69 (20.29%)
    14 / 59 (23.73%)
         occurrences all number
    9
    15
    16
    Depression
         subjects affected / exposed
    5 / 54 (9.26%)
    7 / 69 (10.14%)
    4 / 59 (6.78%)
         occurrences all number
    6
    8
    4
    Mood swings
         subjects affected / exposed
    2 / 54 (3.70%)
    5 / 69 (7.25%)
    3 / 59 (5.08%)
         occurrences all number
    2
    5
    3
    Anxiety
         subjects affected / exposed
    3 / 54 (5.56%)
    3 / 69 (4.35%)
    2 / 59 (3.39%)
         occurrences all number
    3
    3
    2
    Sleep disorder
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 69 (2.90%)
    1 / 59 (1.69%)
         occurrences all number
    1
    2
    1
    Abnormal dreams
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    2 / 59 (3.39%)
         occurrences all number
    0
    0
    3
    Affect lability
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    1
    0
    1
    Anger
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    1
    0
    1
    Restlessness
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    1
    1
    0
    Anxiety disorder
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Bipolar disorder
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Bruxism
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Depressed mood
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Hallucination
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Libido decreased
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Mood altered
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Panic disorder
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Stress
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Suicidal ideation
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Weight decreased
         subjects affected / exposed
    3 / 54 (5.56%)
    6 / 69 (8.70%)
    1 / 59 (1.69%)
         occurrences all number
    3
    6
    1
    Neutrophil count decreased
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 69 (1.45%)
    3 / 59 (5.08%)
         occurrences all number
    1
    1
    3
    Blood uric acid increased
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 69 (1.45%)
    2 / 59 (3.39%)
         occurrences all number
    1
    1
    3
    CD4 lymphocytes decreased
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    2 / 59 (3.39%)
         occurrences all number
    0
    1
    2
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 69 (2.90%)
    1 / 59 (1.69%)
         occurrences all number
    0
    2
    1
    Blood bilirubin increased
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    2
    0
    2
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Blood creatine increased
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Blood glucose increased
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    2
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Blood triglycerides increased
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Creatinine renal clearance decreased
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Electrocardiogram abnormal
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Eosinophil count increased
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Glomerular filtration rate decreased
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Haematocrit decreased
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    International normalised ratio increased
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Lipase increased
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Liver function test abnormal
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Neutrophil count increased
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Prothrombin time prolonged
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Reticulocyte count decreased
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    2
    0
    Weight increased
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    2
    Contusion
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Excoriation
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Fall
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Joint dislocation
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Joint injury
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Laceration
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Ligament sprain
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Transfusion reaction
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Congenital, familial and genetic disorders
    Colour blindness
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    3 / 59 (5.08%)
         occurrences all number
    0
    0
    4
    Tachycardia
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 69 (2.90%)
    0 / 59 (0.00%)
         occurrences all number
    0
    2
    0
    Atrioventricular block first degree
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Bundle branch block left
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Mitral valve incompetence
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Sinus tachycardia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Tricuspid valve incompetence
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    15 / 54 (27.78%)
    17 / 69 (24.64%)
    20 / 59 (33.90%)
         occurrences all number
    17
    18
    23
    Dizziness
         subjects affected / exposed
    6 / 54 (11.11%)
    6 / 69 (8.70%)
    6 / 59 (10.17%)
         occurrences all number
    7
    6
    7
    Dysgeusia
         subjects affected / exposed
    2 / 54 (3.70%)
    10 / 69 (14.49%)
    5 / 59 (8.47%)
         occurrences all number
    2
    10
    5
    Disturbance in attention
         subjects affected / exposed
    0 / 54 (0.00%)
    4 / 69 (5.80%)
    4 / 59 (6.78%)
         occurrences all number
    0
    4
    4
    Paraesthesia
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    5 / 59 (8.47%)
         occurrences all number
    1
    0
    5
    Hypoaesthesia
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    4 / 59 (6.78%)
         occurrences all number
    0
    0
    5
    Dizziness postural
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    2
    0
    1
    Syncope
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 69 (2.90%)
    1 / 59 (1.69%)
         occurrences all number
    0
    5
    1
    Hypersomnia
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    1
    0
    1
    Memory impairment
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    1
    Migraine
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    1
    1
    0
    Neuropathy peripheral
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    1
    Somnolence
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    1
    Tremor
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    2
    0
    0
    Ageusia
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Allodynia
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Amnesia
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Burning sensation
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Head discomfort
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperaesthesia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    2
    0
    Lethargy
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Parosmia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Presyncope
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Sciatica
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Sensory disturbance
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    15 / 54 (27.78%)
    21 / 69 (30.43%)
    16 / 59 (27.12%)
         occurrences all number
    17
    23
    20
    Neutropenia
         subjects affected / exposed
    10 / 54 (18.52%)
    15 / 69 (21.74%)
    4 / 59 (6.78%)
         occurrences all number
    13
    23
    6
    Thrombocytopenia
         subjects affected / exposed
    1 / 54 (1.85%)
    5 / 69 (7.25%)
    0 / 59 (0.00%)
         occurrences all number
    1
    6
    0
    Lymphadenopathy
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 69 (2.90%)
    0 / 59 (0.00%)
         occurrences all number
    1
    2
    0
    Pancytopenia
         subjects affected / exposed
    3 / 54 (5.56%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    3
    0
    0
    Haemolytic anaemia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Lymph node pain
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Lymphoid tissue hyperplasia
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Lymphopenia
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Ear pruritus
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperacusis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Photophobia
         subjects affected / exposed
    2 / 54 (3.70%)
    1 / 69 (1.45%)
    1 / 59 (1.69%)
         occurrences all number
    2
    1
    1
    Vision blurred
         subjects affected / exposed
    2 / 54 (3.70%)
    1 / 69 (1.45%)
    1 / 59 (1.69%)
         occurrences all number
    2
    1
    1
    Dry eye
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    1
    0
    1
    Ocular hyperaemia
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 69 (2.90%)
    0 / 59 (0.00%)
         occurrences all number
    0
    2
    0
    Visual impairment
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    1
    Abnormal sensation in eye
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Blepharitis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Eye discharge
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Eye inflammation
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Eye pruritus
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Hypermetropia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Lacrimation increased
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Ocular icterus
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    23 / 54 (42.59%)
    22 / 69 (31.88%)
    19 / 59 (32.20%)
         occurrences all number
    27
    26
    23
    Diarrhoea
         subjects affected / exposed
    13 / 54 (24.07%)
    21 / 69 (30.43%)
    6 / 59 (10.17%)
         occurrences all number
    14
    22
    6
    Vomiting
         subjects affected / exposed
    10 / 54 (18.52%)
    11 / 69 (15.94%)
    11 / 59 (18.64%)
         occurrences all number
    10
    14
    15
    Anorectal discomfort
         subjects affected / exposed
    6 / 54 (11.11%)
    11 / 69 (15.94%)
    9 / 59 (15.25%)
         occurrences all number
    6
    11
    10
    Anal pruritus
         subjects affected / exposed
    4 / 54 (7.41%)
    10 / 69 (14.49%)
    6 / 59 (10.17%)
         occurrences all number
    4
    10
    6
    Haemorrhoids
         subjects affected / exposed
    2 / 54 (3.70%)
    11 / 69 (15.94%)
    2 / 59 (3.39%)
         occurrences all number
    2
    11
    3
    Dry mouth
         subjects affected / exposed
    4 / 54 (7.41%)
    1 / 69 (1.45%)
    5 / 59 (8.47%)
         occurrences all number
    4
    1
    5
    Constipation
         subjects affected / exposed
    2 / 54 (3.70%)
    5 / 69 (7.25%)
    1 / 59 (1.69%)
         occurrences all number
    2
    5
    1
    Abdominal pain
         subjects affected / exposed
    2 / 54 (3.70%)
    4 / 69 (5.80%)
    1 / 59 (1.69%)
         occurrences all number
    2
    4
    1
    Cheilitis
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 69 (2.90%)
    3 / 59 (5.08%)
         occurrences all number
    1
    2
    3
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 54 (3.70%)
    2 / 69 (2.90%)
    2 / 59 (3.39%)
         occurrences all number
    2
    2
    2
    Aphthous stomatitis
         subjects affected / exposed
    2 / 54 (3.70%)
    2 / 69 (2.90%)
    1 / 59 (1.69%)
         occurrences all number
    2
    2
    1
    Dyspepsia
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 69 (2.90%)
    3 / 59 (5.08%)
         occurrences all number
    0
    2
    3
    Abdominal pain upper
         subjects affected / exposed
    0 / 54 (0.00%)
    4 / 69 (5.80%)
    0 / 59 (0.00%)
         occurrences all number
    0
    4
    0
    Proctalgia
         subjects affected / exposed
    0 / 54 (0.00%)
    3 / 69 (4.35%)
    1 / 59 (1.69%)
         occurrences all number
    0
    3
    1
    Rectal haemorrhage
         subjects affected / exposed
    1 / 54 (1.85%)
    3 / 69 (4.35%)
    0 / 59 (0.00%)
         occurrences all number
    1
    3
    0
    Flatulence
         subjects affected / exposed
    2 / 54 (3.70%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    2
    1
    0
    Oral pain
         subjects affected / exposed
    0 / 54 (0.00%)
    3 / 69 (4.35%)
    0 / 59 (0.00%)
         occurrences all number
    0
    4
    0
    Abdominal discomfort
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    1
    0
    1
    Anal ulcer
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    1
    Gastritis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    2
    0
    1
    Gingival pain
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 69 (2.90%)
    0 / 59 (0.00%)
         occurrences all number
    0
    3
    0
    Glossodynia
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 69 (2.90%)
    0 / 59 (0.00%)
         occurrences all number
    0
    2
    0
    Haematochezia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    1
    Loose tooth
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    1
    Toothache
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    1
    1
    0
    Abdominal distension
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Abnormal faeces
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Anal fissure
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Anorectal disorder
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Chapped lips
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Dental caries
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Dysphagia
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Eructation
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Faeces discoloured
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Faeces hard
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Frequent bowel movements
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Gastrointestinal tract irritation
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Gingival bleeding
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Lip dry
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Mouth ulceration
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Odynophagia
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Oesophageal pain
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Oral discomfort
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Oral mucosal erythema
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Palatal disorder
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Rectal fissure
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Retching
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Sensitivity of teeth
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Stomatitis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Tongue disorder
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Tongue eruption
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    3 / 54 (5.56%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    3
    0
    1
    Cholelithiasis
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    22 / 54 (40.74%)
    21 / 69 (30.43%)
    18 / 59 (30.51%)
         occurrences all number
    25
    22
    20
    Rash
         subjects affected / exposed
    16 / 54 (29.63%)
    20 / 69 (28.99%)
    11 / 59 (18.64%)
         occurrences all number
    23
    25
    15
    Alopecia
         subjects affected / exposed
    1 / 54 (1.85%)
    4 / 69 (5.80%)
    2 / 59 (3.39%)
         occurrences all number
    1
    4
    2
    Dry skin
         subjects affected / exposed
    2 / 54 (3.70%)
    3 / 69 (4.35%)
    2 / 59 (3.39%)
         occurrences all number
    2
    3
    2
    Pruritus generalised
         subjects affected / exposed
    2 / 54 (3.70%)
    1 / 69 (1.45%)
    4 / 59 (6.78%)
         occurrences all number
    2
    1
    4
    Rash pruritic
         subjects affected / exposed
    2 / 54 (3.70%)
    3 / 69 (4.35%)
    2 / 59 (3.39%)
         occurrences all number
    2
    4
    2
    Eczema
         subjects affected / exposed
    2 / 54 (3.70%)
    2 / 69 (2.90%)
    1 / 59 (1.69%)
         occurrences all number
    2
    2
    2
    Rash papular
         subjects affected / exposed
    2 / 54 (3.70%)
    2 / 69 (2.90%)
    1 / 59 (1.69%)
         occurrences all number
    2
    2
    1
    Night sweats
         subjects affected / exposed
    3 / 54 (5.56%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    3
    1
    0
    Rash erythematous
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 69 (1.45%)
    2 / 59 (3.39%)
         occurrences all number
    1
    1
    2
    Rash maculo-papular
         subjects affected / exposed
    2 / 54 (3.70%)
    1 / 69 (1.45%)
    1 / 59 (1.69%)
         occurrences all number
    2
    1
    1
    Erythema
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 69 (2.90%)
    0 / 59 (0.00%)
         occurrences all number
    1
    2
    0
    Acne
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    2 / 59 (3.39%)
         occurrences all number
    0
    0
    3
    Dermatitis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    1
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    2 / 59 (3.39%)
         occurrences all number
    0
    0
    2
    Macule
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    1
    0
    1
    Photosensitivity reaction
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    2
    0
    0
    Rash morbilliform
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    2 / 59 (3.39%)
         occurrences all number
    0
    0
    2
    Skin fissures
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    2 / 59 (3.39%)
         occurrences all number
    0
    0
    2
    Angioedema
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Cold sweat
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Dermatitis acneiform
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Dermatitis contact
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Dermatosis
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Erythema multiforme
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Nail disorder
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Neurodermatitis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Pigmentation disorder
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    2
    0
    Psoriasis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Rash generalised
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Seborrhoea
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Skin disorder
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Skin exfoliation
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Skin hypopigmentation
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Skin lesion
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Skin mass
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    1
    0
    1
    Pyuria
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 69 (2.90%)
    0 / 59 (0.00%)
         occurrences all number
    0
    2
    0
    Enuresis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Haematuria
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Nephropathy
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Nocturia
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Pollakiuria
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Polyuria
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Renal failure acute
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary incontinence
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    2
    0
    1
    Hypogonadism
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    2
    0
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    8 / 54 (14.81%)
    9 / 69 (13.04%)
    9 / 59 (15.25%)
         occurrences all number
    8
    9
    9
    Arthralgia
         subjects affected / exposed
    5 / 54 (9.26%)
    5 / 69 (7.25%)
    3 / 59 (5.08%)
         occurrences all number
    5
    6
    3
    Back pain
         subjects affected / exposed
    5 / 54 (9.26%)
    3 / 69 (4.35%)
    1 / 59 (1.69%)
         occurrences all number
    6
    3
    1
    Pain in extremity
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 69 (2.90%)
    3 / 59 (5.08%)
         occurrences all number
    1
    3
    3
    Bone pain
         subjects affected / exposed
    2 / 54 (3.70%)
    1 / 69 (1.45%)
    1 / 59 (1.69%)
         occurrences all number
    2
    2
    1
    Muscle spasms
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 69 (1.45%)
    1 / 59 (1.69%)
         occurrences all number
    1
    1
    1
    Neck pain
         subjects affected / exposed
    2 / 54 (3.70%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    2
    2
    0
    Flank pain
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Joint stiffness
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Joint swelling
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Muscle haemorrhage
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    2
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Osteopenia
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Osteoporosis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Pain in jaw
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 69 (1.45%)
    5 / 59 (8.47%)
         occurrences all number
    1
    1
    7
    Folliculitis
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 69 (1.45%)
    2 / 59 (3.39%)
         occurrences all number
    1
    1
    2
    Influenza
         subjects affected / exposed
    3 / 54 (5.56%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    3
    1
    0
    Sinusitis
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 69 (2.90%)
    1 / 59 (1.69%)
         occurrences all number
    2
    2
    1
    Bronchitis
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 69 (1.45%)
    1 / 59 (1.69%)
         occurrences all number
    1
    1
    1
    Oral candidiasis
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    2
    0
    1
    Pharyngitis
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 69 (2.90%)
    1 / 59 (1.69%)
         occurrences all number
    0
    2
    2
    Tooth infection
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    2 / 59 (3.39%)
         occurrences all number
    0
    1
    2
    Urinary tract infection
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 69 (1.45%)
    1 / 59 (1.69%)
         occurrences all number
    1
    1
    2
    Cellulitis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    1
    0
    1
    Hordeolum
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    1 / 59 (1.69%)
         occurrences all number
    0
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    2 / 59 (3.39%)
         occurrences all number
    0
    0
    2
    Onychomycosis
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    1
    1
    0
    Otitis media
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    2
    0
    0
    Pneumonia
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    1
    1
    0
    Abscess jaw
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Abscess limb
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Abscess soft tissue
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Body tinea
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Candida infection
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    2
    0
    Cardiac valve vegetation
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Eye infection
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Furuncle
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Gingivitis
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Injection site pustule
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Mycoplasma infection
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Oral herpes
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Otitis externa
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Rhinitis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    2
    0
    0
    Sepsis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Staphylococcal skin infection
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    0
    Tinea cruris
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Tooth abscess
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Urethritis chlamydial
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Urethritis gonococcal
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    8 / 54 (14.81%)
    11 / 69 (15.94%)
    8 / 59 (13.56%)
         occurrences all number
    9
    12
    8
    Hypokalaemia
         subjects affected / exposed
    1 / 54 (1.85%)
    6 / 69 (8.70%)
    4 / 59 (6.78%)
         occurrences all number
    1
    6
    4
    Dehydration
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    2 / 59 (3.39%)
         occurrences all number
    0
    4
    2
    Diabetes mellitus
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 69 (2.90%)
    0 / 59 (0.00%)
         occurrences all number
    0
    2
    0
    Hypophosphataemia
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    1
    1
    0
    Abnormal loss of weight
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Acidosis
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Gout
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperamylasaemia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperlipasaemia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperuricaemia
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 69 (1.45%)
    0 / 59 (0.00%)
         occurrences all number
    0
    1
    0
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 69 (0.00%)
    1 / 59 (1.69%)
         occurrences all number
    0
    0
    1
    Hyponatraemia
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 69 (0.00%)
    0 / 59 (0.00%)
         occurrences all number
    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
    09 Sep 2011
    Made several changes to the schedule of assessments. Revised inclusion and exclusion criteria. Included specification that one of the IDMC reviews will occur when 10 prior null responder subjects receiving non-EFV HAART regimen reached Week 4. Included RAL in predefined HAART medications for PK evaluations. Included dose modifications based on CD4 counts and HIV RNA results.
    22 Dec 2011
    Modified timing of serial PK samples. Provided further detail regarding undetectable HCV RNA results (LLOQ and LOD). Modified exclusion for participation in any concurrent research study- observational studies that include blood draws are permitted. Included instruction regarding repeat testing and confirmation of HCV RNA results. Included clarification reference to DAIDS for grading the intensity of certain clinical events and laboratory abnormalities. Included reference to Investigator’s Brochure for prohibited antihistamines.

    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.
    It was decided by Sponsor on 13 January 2014 to terminate the study early at the primary efficacy endpoint (SVR12) as part of a decision to modify the drug development plan. Eligible subjects completed virologic follow-up after termination.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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