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    Clinical Trial Results:
    PROTEAse inhibitor (DRV/rtv) in mono- or triple therapy in suppressed HIV-1 infected subjects

    Summary
    EudraCT number
    2011-001635-23
    Trial protocol
    BE   GB   IE   DE   ES   AT   HU   DK   IT   SE   PL  
    Global end of trial date
    18 Mar 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    09 Mar 2016
    First version publication date
    09 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TMC114IFD3003
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01448707
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Cilag International N.V.
    Sponsor organisation address
    Turnhoutseweg 30, Beerse, Belgium, 2340
    Public contact
    Clinical Registry Group , Janssen Cilag International N.V., ClinicaltrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group , Janssen Cilag International N.V., ClinicaltrialsEU@its.jnj.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
    25 Jun 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Mar 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to demonstrate the non-inferiority in terms of the percentage of participants who have plasma human immunodeficiency type 1 (HIV-1) ribonucleic acid (RNA) levels less than (<) 50 copies/milliliters (mL) after 48 weeks of follow-up after switching to darunavir/ritonavir (DRV/rtv) monotherapy versus triple therapy containing DRV/rtv along with 2 nucleoside analogues [Food and Drug Administration (FDA) Snapshot method].
    Protection of trial subjects
    Safety evaluations for this study included the monitoring of adverse events (AEs); laboratory tests (hematology, biochemistry, urinalysis, serum pregnancy test and hepatitis serology); vital sign measurements and physical examinations. An Independent data monitoring committee was involved for the safety evaluation.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    26 Jan 2012
    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
    Spain: 40
    Country: Number of subjects enrolled
    Sweden: 7
    Country: Number of subjects enrolled
    Switzerland: 15
    Country: Number of subjects enrolled
    United Kingdom: 36
    Country: Number of subjects enrolled
    Austria: 10
    Country: Number of subjects enrolled
    Belgium: 15
    Country: Number of subjects enrolled
    Denmark: 15
    Country: Number of subjects enrolled
    France: 28
    Country: Number of subjects enrolled
    Germany: 22
    Country: Number of subjects enrolled
    Hungary: 8
    Country: Number of subjects enrolled
    Ireland: 8
    Country: Number of subjects enrolled
    Israel: 10
    Country: Number of subjects enrolled
    Italy: 46
    Country: Number of subjects enrolled
    Poland: 13
    Worldwide total number of subjects
    273
    EEA total number of subjects
    248
    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)
    261
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    274 participants were randomized in to the study treatment with 1:1 ratio. One randomized participant was not treated.

    Pre-assignment
    Screening details
    The study consisted of a screening period up to 6 weeks, a 4-week run-in phase (Baseline 1), and a 96 week treatment period (which starts at Baseline 2), followed by a 30- to 35-day follow-up period.

    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
    DRV/rtv MONO
    Arm description
    Participants received 2 tablets of Darunavir (DRV) 400 milligram (mg) and 1 tablet of ritonavir (rtv) 100 mg within 30 minutes after a meal.
    Arm type
    Experimental

    Investigational medicinal product name
    Darunavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 2 tablets of DRV 400 mg within 30 minutes after a meal.

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 1 tablet of rtv 100 mg within 30 minutes after a meal.

    Arm title
    DRV/rtv + 2NRTIs
    Arm description
    Participants received 2 tablets of DRV 400 mg and 1 tablet of rtv 100 mg within 30 minutes after a meal in combination with 2 nucleoside reverse transcriptase inhibitor (N[t]RTIs), an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).
    Arm type
    Experimental

    Investigational medicinal product name
    Darunavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 2 tablets of DRV 400 mg within 30 minutes after a meal in combination with 2 N[t]RTIs.

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 1 tablet of rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs.

    Investigational medicinal product name
    Abacavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 2 tablets of DRV 400 mg and 1 tablet of rtv 100 mg within 30 minutes after a meal in combination with abacavir.

    Investigational medicinal product name
    lamivudine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 2 tablets of DRV 400 mg and 1 tablet of rtv 100 mg within 30 minutes after a meal in combination with lamivudine.

    Investigational medicinal product name
    Zidovudine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 2 tablets of DRV 400 mg and 1 tablet of rtv 100 mg within 30 minutes after a meal in combination with zidovudine.

    Investigational medicinal product name
    Tenofovir Disoproxil Fumarate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 2 tablets of DRV 400 mg and 1 tablet of rtv 100 mg within 30 minutes after a meal in combination with tenofovir disoproxil fumarate.

    Investigational medicinal product name
    Emtricitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 2 tablets of DRV 400 mg and 1 tablet of rtv 100 mg within 30 minutes after a meal in combination with emtricitabine.

    Number of subjects in period 1
    DRV/rtv MONO DRV/rtv + 2NRTIs
    Started
    137
    136
    Completed
    119
    118
    Not completed
    18
    18
         Withdrawal By Subject
    6
    7
         Other
    7
    4
         Adverse Event
    3
    1
         Lost to follow-up
    2
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DRV/rtv MONO
    Reporting group description
    Participants received 2 tablets of Darunavir (DRV) 400 milligram (mg) and 1 tablet of ritonavir (rtv) 100 mg within 30 minutes after a meal.

    Reporting group title
    DRV/rtv + 2NRTIs
    Reporting group description
    Participants received 2 tablets of DRV 400 mg and 1 tablet of rtv 100 mg within 30 minutes after a meal in combination with 2 nucleoside reverse transcriptase inhibitor (N[t]RTIs), an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).

    Reporting group values
    DRV/rtv MONO DRV/rtv + 2NRTIs Total
    Number of subjects
    137 136 273
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    131 130 261
        From 65 to 84 years
    6 6 12
        85 years and over
    0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    44.6 ± 11.21 43.1 ± 10.41 -
    Title for Gender
    Units: subjects
        Female
    26 21 47
        Male
    111 115 226

    End points

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    End points reporting groups
    Reporting group title
    DRV/rtv MONO
    Reporting group description
    Participants received 2 tablets of Darunavir (DRV) 400 milligram (mg) and 1 tablet of ritonavir (rtv) 100 mg within 30 minutes after a meal.

    Reporting group title
    DRV/rtv + 2NRTIs
    Reporting group description
    Participants received 2 tablets of DRV 400 mg and 1 tablet of rtv 100 mg within 30 minutes after a meal in combination with 2 nucleoside reverse transcriptase inhibitor (N[t]RTIs), an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).

    Subject analysis set title
    DRV/rtv MONO
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Intention-to-treat (ITT) analysis set included all participants who were randomized and who took at least one dose of study medication in the Treatment phase, regardless of their compliance with the protocol.

    Subject analysis set title
    DRV/rtv + 2NRTIs
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    ITT analysis set included all participants who were randomized and who took at least one dose of study medication in the Treatment phase, regardless of their compliance with the protocol.

    Primary: Virologic Response (Food drug and administration [FDA] Snapshot, Switch = Failure)

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    End point title
    Virologic Response (Food drug and administration [FDA] Snapshot, Switch = Failure)
    End point description
    The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels less than (<) 50 copies/milliliters [mL] after 48 weeks of follow-up after switching to DRV/ritonavir (rtv) monotherapy versus triple therapy containing DRV/rtv.
    End point type
    Primary
    End point timeframe
    Week 48
    End point values
    DRV/rtv MONO DRV/rtv + 2NRTIs
    Number of subjects analysed
    137 [1]
    136 [2]
    Units: percentage of participants
        number (not applicable)
    87
    95
    Notes
    [1] - ITT Population
    [2] - ITT Population
    Statistical analysis title
    Statistical Analysis
    Comparison groups
    DRV/rtv + 2NRTIs v DRV/rtv MONO
    Number of subjects included in analysis
    273
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [3]
    P-value
    = 0.2331
    Method
    Mixed models analysis
    Parameter type
    Non-Linear mixed model
    Point estimate
    -7.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -14.64
         upper limit
    -1.19
    Notes
    [3] - Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%).

    Secondary: Virologic Response (Food drug and administration [FDA] Snapshot, Switch = Failure)

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    End point title
    Virologic Response (Food drug and administration [FDA] Snapshot, Switch = Failure)
    End point description
    The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/milliliters [mL] after 96 weeks of follow-up after switching to DRV/ritonavir (rtv) monotherapy versus triple therapy containing DRV/rtv.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    DRV/rtv MONO DRV/rtv + 2NRTIs
    Number of subjects analysed
    137 [4]
    136 [5]
    Units: percentage of participants
        number (not applicable)
    75.2
    85.3
    Notes
    [4] - ITT Population
    [5] - ITT Population
    Statistical analysis title
    Statistical Analysis
    Comparison groups
    DRV/rtv MONO v DRV/rtv + 2NRTIs
    Number of subjects included in analysis
    273
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [6]
    P-value
    = 0.6933
    Method
    Mixed models analysis
    Parameter type
    Non-Linear mixed model
    Point estimate
    -10.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -19.5
         upper limit
    -0.73
    Notes
    [6] - Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%).

    Secondary: Virologic Response (FDA Snapshot, Switch included)

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    End point title
    Virologic Response (FDA Snapshot, Switch included)
    End point description
    The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/mL after 48 and 96 weeks of follow-up after switching to DRV/ritonavir(rtv) monotherapy versus triple therapy containing DRV/rtv.
    End point type
    Secondary
    End point timeframe
    Week 48 and 96
    End point values
    DRV/rtv MONO DRV/rtv + 2NRTIs
    Number of subjects analysed
    137 [7]
    136 [8]
    Units: percentage
    number (not applicable)
        Week 48
    93
    96.5
        Week 96
    89.3
    89.9
    Notes
    [7] - ITT Population
    [8] - ITT Population
    Statistical analysis title
    Statistical Analysis Week 48
    Comparison groups
    DRV/rtv MONO v DRV/rtv + 2NRTIs
    Number of subjects included in analysis
    273
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [9]
    P-value
    = 0.0016
    Method
    Mixed models analysis
    Parameter type
    non-linear mixed model
    Point estimate
    -3.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.77
         upper limit
    1.72
    Notes
    [9] - Week 48: Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%).
    Statistical analysis title
    Statistical Analysis Week 96
    Comparison groups
    DRV/rtv MONO v DRV/rtv + 2NRTIs
    Number of subjects included in analysis
    273
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [10]
    P-value
    = 0.0022
    Method
    Mixed models analysis
    Parameter type
    Non-linear mixed model
    Point estimate
    -0.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.89
         upper limit
    6.58
    Notes
    [10] - Week 96: Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%).

    Secondary: Change From Baseline in Global Neurocognitive Performance z Score

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    End point title
    Change From Baseline in Global Neurocognitive Performance z Score
    End point description
    Change in neurocognitive function of DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks. Neurocognitive function was measured by Hopkins Verbal Learning Test (verbal learning and memory), Colour Trail Test (psychomotor speed and cognitive flexibility) and Grooved Pegboard Test (psychomotor speed and fine motor function). Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48 and 96
    End point values
    DRV/rtv MONO DRV/rtv + 2NRTIs
    Number of subjects analysed
    137 [11]
    136 [12]
    Units: units on a scale
    arithmetic mean (standard error)
        Change at Week 48
    0.39 ± 0.048
    0.42 ± 0.057
        Change at Week 96
    0.63 ± 0.06
    0.57 ± 0.057
    Notes
    [11] - ITT Population
    [12] - ITT Population
    No statistical analyses for this end point

    Secondary: Time to Loss of Virologic Response

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    End point title
    Time to Loss of Virologic Response
    End point description
    Time to loss of virologic response (<50 copies/mL, FDA Snapshot switch = failure) measured over time. Here 99999 signifies "Not Available (NA)", because the event occurred in less than 50 percent of the participants.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 48 or early withdrawal
    End point values
    DRV/rtv MONO DRV/rtv + 2NRTIs
    Number of subjects analysed
    137 [13]
    136 [14]
    Units: days
        median (full range (min-max))
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    Notes
    [13] - ITT Population
    [14] - ITT Population
    No statistical analyses for this end point

    Secondary: Number of Participants Reporting Treatment-Emergent Phenotypic Drug Resistance

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    End point title
    Number of Participants Reporting Treatment-Emergent Phenotypic Drug Resistance
    End point description
    The loss of treatment options of DRV/rtv monotherapy versus triple therapy containing DRV/rtv at Weeks 48 and 96, as defined by treatment-emergent phenotypic drug resistance. Drug resistance is classified as: 1) Confirmed HIV RNA >= 400 copies/mL, 2) Post-baseline phenotypic data and 3) Phenotypic resistance to any of the drug classes (NRTI, NNRTI, or PI).
    End point type
    Secondary
    End point timeframe
    At Weeks 48 and 96
    End point values
    DRV/rtv MONO DRV/rtv + 2NRTIs
    Number of subjects analysed
    137 [15]
    136 [16]
    Units: participants
    number (not applicable)
        Confirmed HIV RNA >= 400 copies/mL
    1
    2
        Post-baseline phenotypic data
    2
    1
        Phenotypic resistance to any of the drug classes
    0
    0
    Notes
    [15] - ITT Population
    [16] - ITT Population
    No statistical analyses for this end point

    Secondary: Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results

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    End point title
    Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results
    End point description
    The viral genotype of participants treated with DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks. Genotypic resistance (number of resistance mutations) at any time point when a participant had a confirmed plasma VL >400 copies/mL after randomization was performed per treatment group for the ITT population. Results were summarized based on individual treatment received: Darunavir resistance mutations, non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations, nucleoside reverse transcriptase inhibitor (NRTI) mutations, protease inhibitor (PI) resistance mutations, PR mutations, RT mutations, extended NNRTI mutations, primary PI mutations.
    End point type
    Secondary
    End point timeframe
    Over 48 and 96 Weeks
    End point values
    DRV/rtv MONO DRV/rtv + 2NRTIs
    Number of subjects analysed
    137 [17]
    136 [18]
    Units: participants
    number (not applicable)
        Participans with HIV RNA >= 400 copies/mL
    1
    2
        Number of 0 Darunavir resistance mutations
    2
    1
        Number of 0 NNRTI mutations
    2
    0
        Number of 1 NNRTI mutations
    0
    1
        Number of 1 PI resistance mutations
    1
    0
        Number of 5 PI resistance mutations
    0
    1
        Number of 6 PI resistance mutations
    1
    0
        Number of 11 PR mutations
    0
    1
        Number of 15 PR mutations
    1
    0
        Number of 7 PR mutations
    1
    0
        Number of 14 RT mutations
    1
    0
        Number of 16 RT mutations
    0
    1
        Number of 33 RT mutations
    1
    0
        Number of extended 0 NNRTI mutations
    2
    0
        Number of extended 1 NNRTI mutations
    0
    1
        Number of primary 0 PI mutations
    2
    1
        Number of participants with no mutations
    0
    0
    Notes
    [17] - ITT Population
    [18] - ITT Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 96 weeks
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    DRV/rtv MONO
    Reporting group description
    Participants received 2 tablets of Darunavir (DRV) 400 milligram (mg) and 1 tablet of ritonavir (rtv) 100 mg within 30 minutes after a meal.

    Reporting group title
    DRV/rtv + 2NRTIs
    Reporting group description
    Participants received 2 tablets of DRV 400 mg and 1 tablet of rtv 100 mg within 30 minutes after a meal in combination with 2 nucleoside reverse transcriptase inhibitor (N[t]RTIs), an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).

    Serious adverse events
    DRV/rtv MONO DRV/rtv + 2NRTIs
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 137 (13.14%)
    14 / 136 (10.29%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Surgical and medical procedures
    Gastrectomy
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillectomy
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital Warts
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bowen's Disease
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Cancer
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diffuse Large B-Cell Lymphoma
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion Spontaneous
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tenderness
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcoholism
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Substance Abuse
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Facial Bones Fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laceration
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar Vertebral Fracture
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal Injury
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Lumbar Puncture Syndrome
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius Fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac Arrest
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Nasal Obstruction
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Encephalomyelitis
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Central Nervous System Lesion
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lethargy
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Stroke
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic Neuritis
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal Fistula
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal Failure
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus Urinary
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Retention
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Excessive Granulation Tissue
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Ulcer
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash Pruritic
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Rhabdomyolysis
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Infections and infestations
    Abscess
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus Infection
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Viral
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin Abscess
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis B
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis C
         subjects affected / exposed
    2 / 137 (1.46%)
    0 / 136 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis Bacterial
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shigella Infection
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    DRV/rtv MONO DRV/rtv + 2NRTIs
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    110 / 137 (80.29%)
    106 / 136 (77.94%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 137 (0.00%)
    2 / 136 (1.47%)
         occurrences all number
    0
    2
    Hypertension
         subjects affected / exposed
    1 / 137 (0.73%)
    2 / 136 (1.47%)
         occurrences all number
    1
    2
    Venous Thrombosis
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anal Neoplasm
         subjects affected / exposed
    2 / 137 (1.46%)
    0 / 136 (0.00%)
         occurrences all number
    2
    0
    Anogenital Warts
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Basal Cell Carcinoma
         subjects affected / exposed
    0 / 137 (0.00%)
    2 / 136 (1.47%)
         occurrences all number
    0
    2
    Colon Adenoma
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Fibroma
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Gastrointestinal Neoplasm
         subjects affected / exposed
    1 / 137 (0.73%)
    2 / 136 (1.47%)
         occurrences all number
    1
    2
    Lipoma
         subjects affected / exposed
    1 / 137 (0.73%)
    2 / 136 (1.47%)
         occurrences all number
    1
    2
    Lymphoma
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Melanocytic Naevus
         subjects affected / exposed
    2 / 137 (1.46%)
    0 / 136 (0.00%)
         occurrences all number
    2
    0
    Skin Papilloma
         subjects affected / exposed
    2 / 137 (1.46%)
    1 / 136 (0.74%)
         occurrences all number
    2
    1
    Uterine Leiomyoma
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Seasonal Allergy
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    1 / 137 (0.73%)
    2 / 136 (1.47%)
         occurrences all number
    1
    2
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 137 (0.73%)
    5 / 136 (3.68%)
         occurrences all number
    1
    5
    Chest Discomfort
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Chest Pain
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Cyst
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Facial Pain
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    7 / 137 (5.11%)
    7 / 136 (5.15%)
         occurrences all number
    7
    7
    Influenza Like Illness
         subjects affected / exposed
    6 / 137 (4.38%)
    6 / 136 (4.41%)
         occurrences all number
    6
    6
    Local Swelling
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Malaise
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Non-Cardiac Chest Pain
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Oedema Peripheral
         subjects affected / exposed
    0 / 137 (0.00%)
    3 / 136 (2.21%)
         occurrences all number
    0
    3
    Pain
         subjects affected / exposed
    4 / 137 (2.92%)
    1 / 136 (0.74%)
         occurrences all number
    8
    1
    Polyp
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    4 / 137 (2.92%)
    7 / 136 (5.15%)
         occurrences all number
    4
    8
    Spinal Pain
         subjects affected / exposed
    2 / 137 (1.46%)
    0 / 136 (0.00%)
         occurrences all number
    2
    0
    Swelling
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Tenderness
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    2
    Ulcer
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Abnormal Behaviour
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Anhedonia
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Anxiety
         subjects affected / exposed
    2 / 137 (1.46%)
    3 / 136 (2.21%)
         occurrences all number
    3
    3
    Borderline Personality Disorder
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Depressed Mood
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Depression
         subjects affected / exposed
    4 / 137 (2.92%)
    7 / 136 (5.15%)
         occurrences all number
    4
    7
    Middle Insomnia
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    6 / 137 (4.38%)
    5 / 136 (3.68%)
         occurrences all number
    6
    5
    Nervousness
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Nightmare
         subjects affected / exposed
    0 / 137 (0.00%)
    2 / 136 (1.47%)
         occurrences all number
    0
    2
    Panic Attack
         subjects affected / exposed
    0 / 137 (0.00%)
    2 / 136 (1.47%)
         occurrences all number
    0
    2
    Sleep Disorder
         subjects affected / exposed
    0 / 137 (0.00%)
    2 / 136 (1.47%)
         occurrences all number
    0
    2
    Stress
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Social Phobia
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Substance Abuse
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Balanitis
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Breast Mass
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Erectile Dysfunction
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Gynaecomastia
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Metrorrhagia
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Orchitis Noninfective
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Sexual Dysfunction
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Uterine Fibrosis
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Arthropod Bite
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Arthropod Sting
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Contusion
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    2
    Face Injury
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Foot Fracture
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Joint Injury
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Ligament Injury
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Ligament Rupture
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Muscle Strain
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    2
    0
    Ligament Sprain
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Nerve Injury
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Post Lumbar Puncture Syndrome
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Radius Fracture
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Procedural Pain
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Skin Injury
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Spinal Fracture
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Traumatic Haematoma
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Wrist Fracture
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    2
    1
    Amylase Increased
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    2
    0
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Blood Cholesterol Increased
         subjects affected / exposed
    6 / 137 (4.38%)
    2 / 136 (1.47%)
         occurrences all number
    7
    2
    Blood Alkaline Phosphatase Increased
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Blood Creatine Phosphokinase Increased
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Blood Creatinine Increased
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Blood Folate Decreased
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Blood Potassium Decreased
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Blood Thyroid Stimulating Hormone Increased
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Blood Pressure Diastolic Increased
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Body Temperature Increased
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Bone Density Decreased
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    C-Reactive Protein Increased
         subjects affected / exposed
    0 / 137 (0.00%)
    3 / 136 (2.21%)
         occurrences all number
    0
    3
    Glomerular Filtration Rate Decreased
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Haemoglobin Decreased
         subjects affected / exposed
    0 / 137 (0.00%)
    2 / 136 (1.47%)
         occurrences all number
    0
    2
    Hepatic Enzyme Increased
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Lipase Increased
         subjects affected / exposed
    2 / 137 (1.46%)
    0 / 136 (0.00%)
         occurrences all number
    4
    0
    Platelet Count Decreased
         subjects affected / exposed
    0 / 137 (0.00%)
    2 / 136 (1.47%)
         occurrences all number
    0
    2
    Prostatic Specific Antigen Increased
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Red Blood Cell Sedimentation Rate Decreased
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Transaminases Increased
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Urine Colour Abnormal
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Urine Output Decreased
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Weight Decreased
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Weight Increased
         subjects affected / exposed
    2 / 137 (1.46%)
    0 / 136 (0.00%)
         occurrences all number
    2
    0
    Cardiac disorders
    Atrial Fibrillation
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Bundle Branch Block Right
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Cardiovascular Insufficiency
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Palpitations
         subjects affected / exposed
    1 / 137 (0.73%)
    2 / 136 (1.47%)
         occurrences all number
    1
    5
    Sinus Bradycardia
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchial Hyperreactivity
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Bronchitis Chronic
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Cough
         subjects affected / exposed
    8 / 137 (5.84%)
    8 / 136 (5.88%)
         occurrences all number
    8
    8
    Dyspnoea
         subjects affected / exposed
    2 / 137 (1.46%)
    0 / 136 (0.00%)
         occurrences all number
    2
    0
    Dyspnoea Exertional
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Epistaxis
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Nasal Congestion
         subjects affected / exposed
    2 / 137 (1.46%)
    1 / 136 (0.74%)
         occurrences all number
    2
    1
    Oropharyngeal Pain
         subjects affected / exposed
    4 / 137 (2.92%)
    2 / 136 (1.47%)
         occurrences all number
    4
    2
    Respiratory Tract Irritation
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Rhinitis Allergic
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Sleep Apnoea Syndrome
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Tonsillar Hypertrophy
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Upper Respiratory Tract Inflammation
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Wheezing
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Agranulocytosis
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Anaemia
         subjects affected / exposed
    1 / 137 (0.73%)
    2 / 136 (1.47%)
         occurrences all number
    1
    2
    Iron Deficiency Anaemia
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Lymphadenopathy
         subjects affected / exposed
    1 / 137 (0.73%)
    2 / 136 (1.47%)
         occurrences all number
    1
    2
    Neutropenia
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Thrombocytopenia
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Anosmia
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Carpal Tunnel Syndrome
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Cervicobrachial Syndrome
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Cognitive Disorder
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Disturbance In Attention
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Dizziness
         subjects affected / exposed
    2 / 137 (1.46%)
    3 / 136 (2.21%)
         occurrences all number
    2
    3
    Headache
         subjects affected / exposed
    8 / 137 (5.84%)
    9 / 136 (6.62%)
         occurrences all number
    9
    11
    Hypoaesthesia
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Lethargy
         subjects affected / exposed
    0 / 137 (0.00%)
    2 / 136 (1.47%)
         occurrences all number
    0
    4
    Memory Impairment
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Migraine
         subjects affected / exposed
    1 / 137 (0.73%)
    2 / 136 (1.47%)
         occurrences all number
    1
    2
    Myelopathy
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Neuropathy Peripheral
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Paraesthesia
         subjects affected / exposed
    1 / 137 (0.73%)
    3 / 136 (2.21%)
         occurrences all number
    1
    3
    Parkinson's Disease
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Polyneuropathy
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Sciatica
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Syncope
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Somnolence
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Trigeminal Neuralgia
         subjects affected / exposed
    0 / 137 (0.00%)
    2 / 136 (1.47%)
         occurrences all number
    0
    2
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis
         subjects affected / exposed
    3 / 137 (2.19%)
    2 / 136 (1.47%)
         occurrences all number
    3
    3
    Dry Eye
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    2
    1
    Optic Neuropathy
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Photophobia
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Visual Acuity Reduced
         subjects affected / exposed
    1 / 137 (0.73%)
    2 / 136 (1.47%)
         occurrences all number
    1
    2
    Visual Impairment
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Ear and labyrinth disorders
    Cerumen Impaction
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Vertigo
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal Discomfort
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Abdominal Distension
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Abdominal Pain
         subjects affected / exposed
    5 / 137 (3.65%)
    0 / 136 (0.00%)
         occurrences all number
    5
    0
    Abdominal Pain Upper
         subjects affected / exposed
    2 / 137 (1.46%)
    4 / 136 (2.94%)
         occurrences all number
    2
    4
    Abnormal Faeces
         subjects affected / exposed
    0 / 137 (0.00%)
    2 / 136 (1.47%)
         occurrences all number
    0
    2
    Anal Inflammation
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Anal Ulcer
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Aphthous Stomatitis
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    2
    0
    Bowel Movement Irregularity
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Cheilitis
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    3 / 137 (2.19%)
    6 / 136 (4.41%)
         occurrences all number
    3
    7
    Diarrhoea
         subjects affected / exposed
    18 / 137 (13.14%)
    10 / 136 (7.35%)
         occurrences all number
    18
    10
    Dry Mouth
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Dyspepsia
         subjects affected / exposed
    1 / 137 (0.73%)
    4 / 136 (2.94%)
         occurrences all number
    2
    5
    Faeces Hard
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Flatulence
         subjects affected / exposed
    1 / 137 (0.73%)
    2 / 136 (1.47%)
         occurrences all number
    1
    2
    Gastritis
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    2
    Gastritis Erosive
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Gingivitis
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Glossodynia
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Haematochezia
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    2
    Haemorrhoidal Haemorrhage
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Haemorrhoids
         subjects affected / exposed
    4 / 137 (2.92%)
    6 / 136 (4.41%)
         occurrences all number
    4
    7
    Inguinal Hernia
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Mouth Ulceration
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    1 / 137 (0.73%)
    2 / 136 (1.47%)
         occurrences all number
    1
    2
    Oral Discomfort
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Oral Disorder
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Pancreatitis
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Parotid Gland Enlargement
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Proctitis
         subjects affected / exposed
    0 / 137 (0.00%)
    4 / 136 (2.94%)
         occurrences all number
    0
    5
    Rectal Discharge
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Rectal Polyp
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Rectal Ulcer
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    2
    0
    Reflux Gastritis
         subjects affected / exposed
    2 / 137 (1.46%)
    0 / 136 (0.00%)
         occurrences all number
    2
    0
    Salivary Gland Calculus
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Tooth Discolouration
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Tooth Loss
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Toothache
         subjects affected / exposed
    0 / 137 (0.00%)
    2 / 136 (1.47%)
         occurrences all number
    0
    2
    Varices Oesophageal
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 137 (0.73%)
    3 / 136 (2.21%)
         occurrences all number
    1
    3
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 137 (0.00%)
    2 / 136 (1.47%)
         occurrences all number
    0
    2
    Haematuria
         subjects affected / exposed
    2 / 137 (1.46%)
    2 / 136 (1.47%)
         occurrences all number
    2
    2
    Micturition Urgency
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Nephrolithiasis
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Proteinuria
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Renal Failure
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Renal Impairment
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Urethral Haemorrhage
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Hepatic Steatosis
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Hepatitis
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Acanthosis
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Acne
         subjects affected / exposed
    3 / 137 (2.19%)
    0 / 136 (0.00%)
         occurrences all number
    4
    0
    Actinic Keratosis
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Blister
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Alopecia
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Dermal Cyst
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Dermatitis
         subjects affected / exposed
    1 / 137 (0.73%)
    2 / 136 (1.47%)
         occurrences all number
    1
    2
    Dry Skin
         subjects affected / exposed
    2 / 137 (1.46%)
    0 / 136 (0.00%)
         occurrences all number
    2
    0
    Eczema
         subjects affected / exposed
    3 / 137 (2.19%)
    4 / 136 (2.94%)
         occurrences all number
    3
    4
    Erythema
         subjects affected / exposed
    2 / 137 (1.46%)
    1 / 136 (0.74%)
         occurrences all number
    2
    1
    Hyperhidrosis
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Night Sweats
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    3
    Pruritus
         subjects affected / exposed
    1 / 137 (0.73%)
    3 / 136 (2.21%)
         occurrences all number
    1
    3
    Psoriasis
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Rash
         subjects affected / exposed
    7 / 137 (5.11%)
    3 / 136 (2.21%)
         occurrences all number
    7
    4
    Seborrhoea
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Skin Lesion
         subjects affected / exposed
    4 / 137 (2.92%)
    3 / 136 (2.21%)
         occurrences all number
    4
    3
    Skin Burning Sensation
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    3 / 137 (2.19%)
    0 / 136 (0.00%)
         occurrences all number
    3
    0
    Arthralgia
         subjects affected / exposed
    7 / 137 (5.11%)
    7 / 136 (5.15%)
         occurrences all number
    8
    7
    Back Pain
         subjects affected / exposed
    10 / 137 (7.30%)
    4 / 136 (2.94%)
         occurrences all number
    10
    7
    Intervertebral Disc Protrusion
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Muscle Contracture
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Muscle Spasms
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Musculoskeletal Stiffness
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Musculoskeletal Pain
         subjects affected / exposed
    2 / 137 (1.46%)
    2 / 136 (1.47%)
         occurrences all number
    2
    3
    Myalgia
         subjects affected / exposed
    4 / 137 (2.92%)
    1 / 136 (0.74%)
         occurrences all number
    4
    1
    Neck Pain
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Osteoarthritis
         subjects affected / exposed
    3 / 137 (2.19%)
    0 / 136 (0.00%)
         occurrences all number
    3
    0
    Osteoporosis
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Pain In Extremity
         subjects affected / exposed
    4 / 137 (2.92%)
    0 / 136 (0.00%)
         occurrences all number
    4
    0
    Pain In Jaw
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    2
    0
    Shoulder Deformity
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Spinal Osteoarthritis
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Tendon Disorder
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Tendonitis
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Endocrine disorders
    Adrenal Cyst
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Hyperparathyroidism Secondary
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Hyperprolactinaemia
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Dyslipidaemia
         subjects affected / exposed
    2 / 137 (1.46%)
    0 / 136 (0.00%)
         occurrences all number
    2
    0
    Gout
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Hypercholesterolaemia
         subjects affected / exposed
    7 / 137 (5.11%)
    0 / 136 (0.00%)
         occurrences all number
    7
    0
    Hypercreatininaemia
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Hyperlipasaemia
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Hyperlipidaemia
         subjects affected / exposed
    1 / 137 (0.73%)
    2 / 136 (1.47%)
         occurrences all number
    1
    3
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 137 (0.73%)
    2 / 136 (1.47%)
         occurrences all number
    1
    2
    Hypocalcaemia
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Hypophosphataemia
         subjects affected / exposed
    1 / 137 (0.73%)
    2 / 136 (1.47%)
         occurrences all number
    1
    2
    Obesity
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Hypovitaminosis
         subjects affected / exposed
    2 / 137 (1.46%)
    3 / 136 (2.21%)
         occurrences all number
    2
    3
    Vitamin D Deficiency
         subjects affected / exposed
    2 / 137 (1.46%)
    1 / 136 (0.74%)
         occurrences all number
    2
    1
    Weight Fluctuation
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Abscess Sweat Gland
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Acarodermatitis
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Acute Sinusitis
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Anal Abscess
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Anal Chlamydia Infection
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Bacterial Infection
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    4 / 137 (2.92%)
    3 / 136 (2.21%)
         occurrences all number
    4
    3
    Candidiasis
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Cellulitis
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Chlamydial Infection
         subjects affected / exposed
    3 / 137 (2.19%)
    1 / 136 (0.74%)
         occurrences all number
    5
    1
    Conjunctivitis Bacterial
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Ear Infection
         subjects affected / exposed
    2 / 137 (1.46%)
    1 / 136 (0.74%)
         occurrences all number
    2
    1
    Cystitis
         subjects affected / exposed
    2 / 137 (1.46%)
    0 / 136 (0.00%)
         occurrences all number
    5
    0
    Eye Infection
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Febrile Infection
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Folliculitis
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Fungal Infection
         subjects affected / exposed
    2 / 137 (1.46%)
    2 / 136 (1.47%)
         occurrences all number
    2
    2
    Fungal Skin Infection
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
         subjects affected / exposed
    2 / 137 (1.46%)
    0 / 136 (0.00%)
         occurrences all number
    2
    0
    Gastric Infection
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis Shigella
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Gastroenteritis Norovirus
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Gingival Abscess
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Genital Herpes
         subjects affected / exposed
    1 / 137 (0.73%)
    3 / 136 (2.21%)
         occurrences all number
    1
    4
    Gastroenteritis Viral
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Gonorrhoea
         subjects affected / exposed
    3 / 137 (2.19%)
    2 / 136 (1.47%)
         occurrences all number
    3
    2
    Helicobacter Gastritis
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Hepatitis C
         subjects affected / exposed
    2 / 137 (1.46%)
    0 / 136 (0.00%)
         occurrences all number
    2
    0
    Herpes Simplex
         subjects affected / exposed
    0 / 137 (0.00%)
    2 / 136 (1.47%)
         occurrences all number
    0
    2
    Herpes Zoster
         subjects affected / exposed
    6 / 137 (4.38%)
    1 / 136 (0.74%)
         occurrences all number
    6
    1
    Hordeolum
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Infection
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Impetigo
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Infection Parasitic
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    4 / 137 (2.92%)
    6 / 136 (4.41%)
         occurrences all number
    4
    7
    Latent Syphilis
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Laryngitis
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Localised Infection
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    4
    0
    Latent Tuberculosis
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Lower Respiratory Tract Infection
         subjects affected / exposed
    1 / 137 (0.73%)
    3 / 136 (2.21%)
         occurrences all number
    1
    3
    Lower Respiratory Tract Infection Viral
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Molluscum Contagiosum
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    16 / 137 (11.68%)
    11 / 136 (8.09%)
         occurrences all number
    21
    12
    Onychomycosis
         subjects affected / exposed
    4 / 137 (2.92%)
    3 / 136 (2.21%)
         occurrences all number
    4
    3
    Oral Herpes
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Oropharyngeal Gonococcal Infection
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Otitis Externa
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Otitis Media
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Papilloma Viral Infection
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Pharyngitis
         subjects affected / exposed
    3 / 137 (2.19%)
    3 / 136 (2.21%)
         occurrences all number
    3
    3
    Pneumonia
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Proctitis Bacterial
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Proctitis Chlamydial
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Proctitis Gonococcal
         subjects affected / exposed
    2 / 137 (1.46%)
    1 / 136 (0.74%)
         occurrences all number
    2
    2
    Pyelonephritis
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Rash Pustular
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Respiratory Tract Infection
         subjects affected / exposed
    3 / 137 (2.19%)
    3 / 136 (2.21%)
         occurrences all number
    4
    3
    Rhinitis
         subjects affected / exposed
    6 / 137 (4.38%)
    5 / 136 (3.68%)
         occurrences all number
    6
    5
    Shigella Infection
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    3 / 137 (2.19%)
    5 / 136 (3.68%)
         occurrences all number
    3
    5
    Skin Infection
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Syphilis
         subjects affected / exposed
    4 / 137 (2.92%)
    5 / 136 (3.68%)
         occurrences all number
    8
    5
    Tinea Pedis
         subjects affected / exposed
    0 / 137 (0.00%)
    2 / 136 (1.47%)
         occurrences all number
    0
    2
    Tinea Versicolour
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Tonsillitis
         subjects affected / exposed
    1 / 137 (0.73%)
    3 / 136 (2.21%)
         occurrences all number
    1
    4
    Tonsillitis Bacterial
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Tooth Abscess
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Tooth Infection
         subjects affected / exposed
    2 / 137 (1.46%)
    1 / 136 (0.74%)
         occurrences all number
    2
    1
    Tracheitis
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Trichomoniasis
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 137 (0.73%)
    5 / 136 (3.68%)
         occurrences all number
    2
    5
    Upper Respiratory Tract Infection Bacterial
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    2
    0
    Urethritis
         subjects affected / exposed
    4 / 137 (2.92%)
    0 / 136 (0.00%)
         occurrences all number
    6
    0
    Urethritis Chlamydial
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Urethritis Gonococcal
         subjects affected / exposed
    1 / 137 (0.73%)
    1 / 136 (0.74%)
         occurrences all number
    1
    1
    Urinary Tract Infection
         subjects affected / exposed
    4 / 137 (2.92%)
    2 / 136 (1.47%)
         occurrences all number
    4
    2
    Viral Infection
         subjects affected / exposed
    0 / 137 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    1
    Viral Pharyngitis
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 137 (0.73%)
    0 / 136 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Dec 2011
    Amendment I: The overall reason for the amendment was to change inclusion criterion 4 so that participants willing to participate could also have switched between classes in their previous highly active antiretroviral therapy (HAART) regimen and not only within class.
    24 May 2012
    Amendment II: The overall reason for the amendment was to prohibit the concomitant use of telaprevir or boceprevir for participating participants co-infected with hepatitis C, based on new drug-drug interaction data.
    26 Oct 2012
    Amendment III: The overall reason for the amendment was to clarify inclusion criterion 8, so that participants could not have CD4+ cell counts below 100 cells/millimeter3 (mm3) from the time of first known HIV infection to the start of HAART, and had to have more than 200 cells/mm3 at screening or a maximum of 4 weeks prior to screening.
    09 Jul 2014
    Amendment IV: The primary efficacy analysis at Week 48 indicated that switching to DRV/rtv monotherapy showed lower efficacy versus triple antiretroviral therapy (86% versus 95%). However, lower efficacy was seen only in participants with CD4+ nadir levels less than (<)200 cells/microliters (mcL). Having reviewed these data, the independent Data and Safety Monitoring Board (DSMB) advised that, participants in the monotherapy arm who entered the study with a nadir CD4+ count <200 cells/mcL should also receive 2 nucleoside analogues (N[t]RTIs).

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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