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    Clinical Trial Results:
    A Phase IIb study to select a once daily oral dose of GSK1349572 administered with either abacavir/lamivudine or tenofovir/emtricitabine in HIV-1 infected antiretroviral therapy naïve adult subjects.

    Summary
    EudraCT number
    		 2009-010269-21
    Trial protocol
    		 DE   ES   FR   IT  
    Global end of trial date
    22 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Dec 2017
    First version publication date
    30 Dec 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    112276
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ViiV Healthcare
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    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
    19 Jul 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To select a GSK1349572 once daily dose for further evaluation in Phase III based on a comparison of the Week 16 antiviral activity and tolerability of a range of oral doses of GSK1349572 in Human Immunodeficiency Virus Type 1 (HIV-1) infected therapy-naïve adult participants.
    Protection of trial subjects
    99999
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jul 2009
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 86 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 81
    Country: Number of subjects enrolled
    France: 18
    Country: Number of subjects enrolled
    Germany: 28
    Country: Number of subjects enrolled
    Italy: 28
    Country: Number of subjects enrolled
    Russian Federation: 19
    Country: Number of subjects enrolled
    Spain: 31
    Worldwide total number of subjects
    205
    EEA total number of subjects
    105
    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)
    203
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Randomization Phase participants received Dolutegravir (DTG 10, 25 or 50 milligrams[mg]) with Placebo/Efavirenz (EFV) for 96 Weeks . DTG participants who completed 96 Weeks continued or were switched to receive DTG 50 mg in Open label phase until DTG was locally available.

    Pre-assignment
    Screening details
    		 A total of 278 par were screened of which 70 were screen failures and 208 were randomized; 205 received at least one dose of study medication and comprised the Intent-To-Treat exposed (ITT-E) population. 17 participants out of 155 from DTG arm withdrew during Randomization phase and total 138 participants were enrolled in an Open-label phase.

    Period 1
    Period 1 title
    Randomization Phase 96 Week
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DTG 10 mg QD
    Arm description
    		 Participants received DTG 10 mg, DTG matching placebo, and Abacavir/lamivudine (ABC/3TC) 600 mg/300 mg or tenofovir/emtricitabine (TDF/FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dolutegravir (DTG)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received once daily 10 milligram (mg) oral tablet in Treatment Arm A, in Treatment Arm B once daily 25 mg oral tablet and Treatment Arm C two oral tablets of 25 mg GSK1349572 once daily

    Investigational medicinal product name
    Tenofovir disoproxil fumarate /Emtricitabine (TDF/FTC) fixed dose combination
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received a fixed dose combination tablet containing tenofovir disoproxil fumarate 300 mg and 200 mg of emtricitabine for once daily

    Investigational medicinal product name
    Abacavir/Lamivudine (ABC/3TC) fixed dose combination
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received a fixed dose combination tablet containing abacavir 600 mg and 300 mg of lamivudine for once daily

    Arm title
    		 DTG 25 mg QD
    Arm description
    		 Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dolutegravir (DTG)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received once daily 10 milligram (mg) oral tablet in Treatment Arm A, in Treatment Arm B once daily 25 mg oral tablet and Treatment Arm C two oral tablets of 25 mg GSK1349572 once daily

    Investigational medicinal product name
    Abacavir/Lamivudine (ABC/3TC) fixed dose combination
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received a fixed dose combination tablet containing abacavir 600 mg and 300 mg of lamivudine for once daily

    Investigational medicinal product name
    Tenofovir disoproxil fumarate /Emtricitabine (TDF/FTC) fixed dose combination
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received a fixed dose combination tablet containing tenofovir disoproxil fumarate 300 mg and 200 mg of emtricitabine for once daily

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received matching placebo tablets once daily along with DTG

    Arm title
    		 DTG 50 mg QD
    Arm description
    		 Participants received DTG 50 mg matching placebo and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dolutegravir (DTG)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received once daily 10 milligram (mg) oral tablet in Treatment Arm A, in Treatment Arm B once daily 25 mg oral tablet and Treatment Arm C two oral tablets of 25 mg GSK1349572 once daily

    Investigational medicinal product name
    Tenofovir disoproxil fumarate /Emtricitabine (TDF/FTC) fixed dose combination
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received a fixed dose combination tablet containing tenofovir disoproxil fumarate 300 mg and 200 mg of emtricitabine for once daily

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received matching placebo tablets once daily along with DTG

    Investigational medicinal product name
    Abacavir/Lamivudine (ABC/3TC) fixed dose combination
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received a fixed dose combination tablet containing abacavir 600 mg and 300 mg of lamivudine for once daily

    Arm title
    		 EFV 600 mg QD
    Arm description
    		 Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Efavirenz (EFV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 600 mg oral tablet of efavirenz once daily

    Investigational medicinal product name
    Tenofovir disoproxil fumarate /Emtricitabine (TDF/FTC) fixed dose combination
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received a fixed dose combination tablet containing tenofovir disoproxil fumarate 300 mg and 200 mg of emtricitabine for once daily

    Investigational medicinal product name
    Abacavir/Lamivudine (ABC/3TC) fixed dose combination
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received a fixed dose combination tablet containing abacavir 600 mg and 300 mg of lamivudine for once daily

    Number of subjects in period 1
    		DTG 10 mg QD DTG 25 mg QD DTG 50 mg QD EFV 600 mg QD
    Started
    53
    51
    51
    50
    Completed
    48
    44
    46
    40
    Not completed
    5
    7
    5
    10
         Consent withdrawn by subject
    2
    1
    1
    2
         Adverse event, non-fatal
    1
    1
    2
    5
         Lost to follow-up
    -
    3
    1
    2
         Lack of efficacy
    1
    1
    -
    -
         Protocol deviation
    1
    1
    1
    -
         Protocol-Defined Stopping Criteria
    -
    -
    -
    1
    Period 2
    Period 2 title
    Open-label phase
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Open-label DTG 50 mg QD
    Arm description
    		 All DTG participants were switched to or continued DTG 50 mg with either ABC/3TC orally at 600 mg/300 mg (1 tablet) or TDF/FTC orally QD during the Open label phase
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dolutegravir (DTG)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received once daily 10 milligram (mg) oral tablet in Treatment Arm A, in Treatment Arm B once daily 25 mg oral tablet and Treatment Arm C two oral tablets of 25 mg GSK1349572 once daily

    Investigational medicinal product name
    Tenofovir disoproxil fumarate /Emtricitabine (TDF/FTC) fixed dose combination
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received a fixed dose combination tablet containing tenofovir disoproxil fumarate 300 mg and 200 mg of emtricitabine for once daily

    Investigational medicinal product name
    Abacavir/Lamivudine (ABC/3TC) fixed dose combination
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received a fixed dose combination tablet containing abacavir 600 mg and 300 mg of lamivudine for once daily

    Number of subjects in period 2
    		Open-label DTG 50 mg QD
    Started
    138
    Completed
    88
    Not completed
    50
         Consent withdrawn by subject
    14
         Physician decision
    8
         Adverse event, non-fatal
    3
         Lost to follow-up
    12
         Lack of efficacy
    1
         Protocol deviation
    12

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    DTG 10 mg QD
    Reporting group description
    		 Participants received DTG 10 mg, DTG matching placebo, and Abacavir/lamivudine (ABC/3TC) 600 mg/300 mg or tenofovir/emtricitabine (TDF/FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.

    Reporting group title
    DTG 25 mg QD
    Reporting group description
    		 Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.

    Reporting group title
    DTG 50 mg QD
    Reporting group description
    		 Participants received DTG 50 mg matching placebo and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.

    Reporting group title
    EFV 600 mg QD
    Reporting group description
    		 Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.

    Reporting group values
    		 DTG 10 mg QD DTG 25 mg QD DTG 50 mg QD EFV 600 mg QD Total
    Number of subjects
    		 53 51 51 50
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 34.2 ( 9.25 ) 37.0 ( 9.79 ) 37.0 ( 8.89 ) 40.7 ( 11.19 ) -
    Gender categorical
    Units: Subjects
        Female
    		 11 5 6 6 28
        Male
    		 42 46 45 44 177
    Race/Ethnicity, Customized
    Units: Subjects
        African American/African Heritage (HER)
    		 7 6 8 4 25
        American Indian or Alaska Native
    		 1 3 4 2 10
        Japanese/East Asian HER/South East Asian HER
    		 0 0 0 1 1
        Native Hawaiian or other Pacific Islander
    		 3 0 0 0 3
        White
    		 41 42 38 43 164
        African American/African HER & White
    		 0 0 1 0 1
        Asian & White
    		 1 0 0 0 1
    Subject analysis sets

    Subject analysis set title
    Overall DTG
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)

    Subject analysis sets values
    		 Overall DTG
    Number of subjects
    142
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    0 ( 0 )
    Gender categorical
    Units: Subjects
        Female
    0
        Male
    0
    Race/Ethnicity, Customized
    Units: Subjects
        African American/African Heritage (HER)
    0
        American Indian or Alaska Native
    0
        Japanese/East Asian HER/South East Asian HER
    0
        Native Hawaiian or other Pacific Islander
    0
        White
    0
        African American/African HER & White
    0
        Asian & White
    0

    End points

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    End points reporting groups
    Reporting group title
    DTG 10 mg QD
    Reporting group description
    		 Participants received DTG 10 mg, DTG matching placebo, and Abacavir/lamivudine (ABC/3TC) 600 mg/300 mg or tenofovir/emtricitabine (TDF/FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.

    Reporting group title
    DTG 25 mg QD
    Reporting group description
    		 Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.

    Reporting group title
    DTG 50 mg QD
    Reporting group description
    		 Participants received DTG 50 mg matching placebo and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.

    Reporting group title
    EFV 600 mg QD
    Reporting group description
    		 Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
    Reporting group title
    Open-label DTG 50 mg QD
    Reporting group description
    		 All DTG participants were switched to or continued DTG 50 mg with either ABC/3TC orally at 600 mg/300 mg (1 tablet) or TDF/FTC orally QD during the Open label phase

    Subject analysis set title
    Overall DTG
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)

    Primary: Number of participants with Human Immunodeficiency Virus Type 1 (HIV-1) ribonucleic acid (RNA) <50 copies/milliliter (c/mL) at Week 16

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    End point title
    		 Number of participants with Human Immunodeficiency Virus Type 1 (HIV-1) ribonucleic acid (RNA) <50 copies/milliliter (c/mL) at Week 16 [1]
    End point description
    Plasma samples were collected for quantitative HIV-1 RNA analysis at Week 16. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (<50 copies/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason. Data are reported per the Week 16 report. In later cuts of the data, the Week 16 values may have changed (because of the nature of the TLOVR algorithm).ITT-E Population included all randomized participants who received at least one dose of study medication
    End point type
    Primary
    End point timeframe
    Week 16
    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: There are no statistical data to report.
    End point values
    		 DTG 10 mg QD DTG 25 mg QD DTG 50 mg QD EFV 600 mg QD
    Number of subjects analysed
    53 [2]
    51
    51
    50
    Units: participants
        participants
    51
    47
    46
    29
    Notes
    [2] - ITT-E Population
    No statistical analyses for this end point

    Secondary: Viral change over the initial 2 weeks of treatment

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    End point title
    		 Viral change over the initial 2 weeks of treatment
    End point description
    Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline and Week 2. Viral change is defined as the change in plasma HIV-1 RNA over the initial 2 weeks of treatment, calculated as the value at Week 2 minus the value at Baseline. Only those participants available at the specified time point were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 2
    End point values
    		 DTG 10 mg QD DTG 25 mg QD DTG 50 mg QD EFV 600 mg QD
    Number of subjects analysed
    53 [3]
    50
    50
    48
    Units: Log10 c/mL
    arithmetic mean (standard deviation)
        Log10 c/mL
    -2.387 ( 0.4595 )
    -2.365 ( 0.5458 )
    -2.392 ( 0.4241 )
    -1.930 ( 0.4312 )
    Notes
    [3] - ITT-E Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in HIV-1 RNA at the indicated time points

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    End point title
    		 Change from Baseline in HIV-1 RNA at the indicated time points
    End point description
    Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96
    End point values
    		 DTG 10 mg QD DTG 25 mg QD DTG 50 mg QD EFV 600 mg QD
    Number of subjects analysed
    53 [4]
    51
    51
    50
    Units: Log10 c/mL
    arithmetic mean (standard deviation)
        Week 1, n=53, 50, 48, 50
    -1.815 ( 0.3999 )
    -1.773 ( 0.4650 )
    -1.738 ( 0.3840 )
    -1.562 ( 0.4158 )
        Week 2, n=53, 50, 50, 48
    -2.387 ( 0.4595 )
    -2.365 ( 0.5458 )
    -2.392 ( 0.4241 )
    -1.930 ( 0.4312 )
        Week 4, n=53, 50, 50, 45
    -2.629 ( 0.5863 )
    -2.583 ( 0.6337 )
    -2.713 ( 0.5471 )
    -2.162 ( 0.5400 )
        Week 8, n=52, 50, 49, 45
    -2.657 ( 0.6980 )
    -2.666 ( 0.6667 )
    -2.848 ( 0.6556 )
    -2.450 ( 0.5989 )
        Week 12, n=53, 49, 49, 45
    -2.685 ( 0.6831 )
    -2.671 ( 0.6850 )
    -2.860 ( 0.6772 )
    -2.603 ( 0.5869 )
        Week 16, n=52, 49, 49, 45
    -2.718 ( 0.6593 )
    -2.668 ( 0.6826 )
    -2.859 ( 0.6876 )
    -2.698 ( 0.6715 )
        Week 20, n=52, 48, 49, 44
    -2.701 ( 0.6423 )
    -2.662 ( 0.6908 )
    -2.869 ( 0.6896 )
    -2.745 ( 0.6602 )
        Week 24, n=52, 49, 48, 45
    -2.700 ( 0.6261 )
    -2.657 ( 0.6969 )
    -2.853 ( 0.6889 )
    -2.773 ( 0.7026 )
        Week 32, n=52, 49, 47, 45
    -2.717 ( 0.6588 )
    -2.658 ( 0.6991 )
    -2.855 ( 0.6963 )
    -2.772 ( 0.7021 )
        Week 40, n=51, 48, 47, 44
    -2.647 ( 0.7039 )
    -2.665 ( 0.7051 )
    -2.855 ( 0.6934 )
    -2.795 ( 0.7169 )
        Week 48, n=51, 48, 48, 45
    -2.723 ( 0.6519 )
    -2.667 ( 0.6934 )
    -2.850 ( 0.6849 )
    -2.711 ( 0.7765 )
        Week 60, n=50, 48, 48, 44
    -2.741 ( 0.6444 )
    -2.675 ( 0.7012 )
    -2.825 ( 0.7458 )
    -2.765 ( 0.7035 )
        Week 72, n=51, 47, 48, 44
    -2.742 ( 0.6453 )
    -2.622 ( 0.8052 )
    -2.860 ( 0.6930 )
    -2.757 ( 0.7094 )
        Week 84, n=51, 47, 47, 43
    -2.725 ( 0.6506 )
    -2.670 ( 0.7064 )
    -2.855 ( 0.6923 )
    -2.743 ( 0.7321 )
        Week 96, n=48, 44, 46, 39
    -2.728 ( 0.6494 )
    -2.680 ( 0.7116 )
    -2.854 ( 0.7061 )
    -2.807 ( 0.7238 )
    Notes
    [4] - ITT-E Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in cluster of differentiation 4+ (CD4+) cell counts at the indicated time points

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    End point title
    		 Change from Baseline in cluster of differentiation 4+ (CD4+) cell counts at the indicated time points
    End point description
    Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96
    End point values
    		 DTG 10 mg QD DTG 25 mg QD DTG 50 mg QD EFV 600 mg QD
    Number of subjects analysed
    53 [5]
    51
    51
    50
    Units: Cells per cubic millimeter
    median (inter-quartile range (Q1-Q3))
        Week 1, n=53, 50, 48, 50
    85.0 (18.0 to 134.0)
    94.5 (40.0 to 160.0)
    75.5 (18.5 to 129.5)
    42.5 (-23.0 to 111.0)
        Week 2, n=53, 50, 50, 47
    75.0 (37.0 to 124.0)
    79.0 (27.0 to 138.0)
    99.5 (53.0 to 160.0)
    55.0 (-10.0 to 132.0)
        Week 4, n=53, 50, 50, 45
    75.0 (34.0 to 151.0)
    89.0 (36.0 to 165.0)
    110.0 (46.0 to 170.0)
    89.0 (30.0 to 165.0)
        Week 8, n=52, 50, 49, 44
    118.5 (65.5 to 210.5)
    156.5 (93.0 to 226.0)
    129.0 (105.0 to 201.0)
    104.5 (34.5 to 240.5)
        Week 12, n=53, 48, 48, 45
    139.0 (96.0 to 284.0)
    137.5 (61.0 to 250.0)
    171.5 (107.5 to 269.0)
    127.0 (58.0 to 186.0)
        Week 16, n=52, 49, 49, 44
    153.0 (95.0 to 276.0)
    176.0 (86.0 to 227.0)
    160.0 (94.0 to 227.0)
    115.5 (65.5 to 226.0)
        Week 20, n=52, 48, 49, 44
    163.5 (79.5 to 288.5)
    200.0 (103.0 to 316.5)
    139.0 (64.0 to 238.0)
    136.0 (54.5 to 215.5)
        Week 24, n=51, 49, 47, 44
    159.0 (97.0 to 233.0)
    206.0 (102.0 to 289.0)
    167.0 (125.0 to 268.0)
    109.5 (66.0 to 229.0)
        Week 32, n=50, 48, 47, 44
    221.5 (94.0 to 300.0)
    195.5 (109.0 to 294.0)
    203.0 (125.0 to 282.0)
    146.5 (82.5 to 223.5)
        Week 40, n=50, 48, 47, 44
    205.0 (136.0 to 364.0)
    204.5 (157.5 to 346.5)
    224.0 (123.0 to 322.0)
    171.5 (123.0 to 268.0)
        Week 48, n=51, 47, 47, 45
    204.0 (127.0 to 384.0)
    249.0 (143.0 to 416.0)
    223.0 (141.0 to 292.0)
    174.0 (91.0 to 292.0)
        Week 60, n=51, 48, 47, 43
    265.0 (173.0 to 365.0)
    278.0 (198.5 to 369.5)
    229.0 (166.0 to 306.0)
    221.0 (153.0 to 355.0)
        Week 72, n=51, 47, 48, 44
    236.0 (177.0 to 351.0)
    285.0 (186.0 to 427.0)
    220.0 (146.0 to 373.0)
    195.0 (144.0 to 334.5)
        Week 84, n=51, 47, 46, 42
    292.0 (222.0 to 408.0)
    313.0 (244.0 to 366.0)
    280.0 (197.0 to 379.0)
    296.5 (187.0 to 400.0)
        Week 96, n=48, 44, 46, 39
    335.0 (253.5 to 478.5)
    391.5 (243.0 to 527.0)
    326.0 (236.0 to 451.0)
    301.0 (204.0 to 445.0)
    Notes
    [5] - ITT-E Population
    No statistical analyses for this end point

    Secondary: Number of participants with new HIV-associated conditions of the indicated class

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    End point title
    		 Number of participants with new HIV-associated conditions of the indicated class
    End point description
    HIV-associated conditions were assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the acquired immunodeficiency syndrome (AIDS) surveillance case definition.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 96
    End point values
    		 DTG 10 mg QD DTG 25 mg QD DTG 50 mg QD EFV 600 mg QD
    Number of subjects analysed
    53 [6]
    51
    51
    50
    Units: Participants
        Category B
    2
    0
    1
    1
        Category C
    0
    0
    1
    0
        Death
    1
    0
    0
    0
    Notes
    [6] - ITT-E Population
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated type of HIV-1 disease progression (AIDS or death)

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    End point title
    		 Number of participants with the indicated type of HIV-1 disease progression (AIDS or death)
    End point description
    Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CAT A at Baseline (BS) to CAT B event (EV), CAT A at BS to a CAT C EV; CAT B at BS to a CAT C EV; CAT C at BS to a new CAT C EV; or CAT A, B, or C at BS to death.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 96
    End point values
    		 DTG 10 mg QD DTG 25 mg QD DTG 50 mg QD EFV 600 mg QD
    Number of subjects analysed
    53 [7]
    51
    51
    50
    Units: Participants
        CAT A at Baseline to a CAT C event
    0
    0
    0
    0
        CAT B at Baseline to a CAT C event
    0
    0
    1
    0
        CAT C at Baseline to a new CAT C event
    0
    0
    0
    0
        CAT A, B, or C at Baseline to death
    1
    0
    0
    0
    Notes
    [7] - ITT-E Population
    No statistical analyses for this end point

    Secondary: Number of participants with plasma HIV-1 RNA <50 c/mL

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    End point title
    		 Number of participants with plasma HIV-1 RNA <50 c/mL
    End point description
    Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (<50 copies/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96
    End point values
    		 DTG 10 mg QD DTG 25 mg QD DTG 50 mg QD EFV 600 mg QD
    Number of subjects analysed
    53 [8]
    51
    51
    50
    Units: Participants
        Baseline
    0
    0
    0
    0
        Week 1
    6
    4
    4
    3
        Week 2
    22
    19
    11
    6
        Week 4
    37
    35
    31
    9
        Week 8
    46
    45
    43
    18
        Week 12
    50
    46
    45
    25
        Week 16
    51
    46
    47
    29
        Week 20
    51
    47
    47
    38
        Week 24
    51
    46
    47
    41
        Week 32
    50
    45
    46
    43
        Week 40
    49
    45
    46
    42
        Week 48
    48
    45
    46
    40
        Week 60
    48
    44
    46
    41
        Week 72
    48
    44
    45
    40
        Week 84
    47
    43
    46
    38
        Week 96
    42
    40
    45
    36
    Notes
    [8] - ITT-E Population
    No statistical analyses for this end point

    Secondary: Number of participants with plasma HIV-1 RNA <400 c/mL

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    End point title
    		 Number of participants with plasma HIV-1 RNA <400 c/mL
    End point description
    Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (<400 c/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96
    End point values
    		 DTG 10 mg QD DTG 25 mg QD DTG 50 mg QD EFV 600 mg QD
    Number of subjects analysed
    53 [9]
    51
    51
    50
    Units: Participants
        Baseline
    0
    0
    0
    0
        Week 1
    25
    20
    16
    15
        Week 2
    45
    45
    41
    23
        Week 4
    52
    49
    48
    32
        Week 8
    52
    49
    49
    41
        Week 12
    52
    49
    49
    45
        Week 16
    52
    48
    49
    45
        Week 20
    52
    48
    49
    45
        Week 24
    52
    47
    48
    45
        Week 32
    52
    47
    48
    45
        Week 40
    50
    47
    48
    45
        Week 48
    50
    47
    48
    44
        Week 60
    50
    46
    48
    44
        Week 72
    50
    46
    47
    43
        Week 84
    50
    45
    47
    42
        Week 96
    46
    43
    46
    39
    Notes
    [9] - ITT-E Population
    No statistical analyses for this end point

    Secondary: Number of participants with any adverse event (AE) and any serious adverse events (SAE)

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    End point title
    		 Number of participants with any adverse event (AE) and any serious adverse events (SAE)
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity; or is a congenital anomaly/birth defect. All clinically suspected cases of hypersensitivity reaction to abacavir in participants receiving abacavir/lamivudine were reported as SAEs. Medical or scientific judgment was to have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold >=3%) and SAEs.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 96/Early Withdrawal
    End point values
    		 DTG 10 mg QD DTG 25 mg QD DTG 50 mg QD EFV 600 mg QD
    Number of subjects analysed
    53 [10]
    51
    51
    50
    Units: Participants
        Any AE
    50
    46
    46
    46
        Any SAE
    5
    5
    7
    7
    Notes
    [10] - Safety Population
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated Grade 1 to Grade 4 treatment-emergent clinical chemistry and hematology toxicities

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    End point title
    		 Number of participants with the indicated Grade 1 to Grade 4 treatment-emergent clinical chemistry and hematology toxicities
    End point description
    Blood samples were collected for the measurement of clinical chemistry and hematology parameters. Toxicities were graded for severity according to the Division of AIDS (DAIDS) toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 96/Early Withdrawal
    End point values
    		 DTG 10 mg QD DTG 25 mg QD DTG 50 mg QD EFV 600 mg QD
    Number of subjects analysed
    53 [11]
    51
    51
    50
    Units: Participants
        Alanine amino transferase
    7
    11
    3
    19
        Cholesterol
    18
    16
    13
    24
        Creatinine kinase
    17
    6
    7
    5
        Lipase
    11
    13
    11
    9
        Triglycerides
    0
    1
    2
    1
        Alkaline phosphatase
    1
    0
    1
    10
        Amylase
    2
    3
    1
    4
        Aspartate amino transferase
    12
    8
    6
    9
        Carbon dioxide content/bicarbonate
    28
    24
    23
    30
        Creatinine
    0
    4
    0
    0
        Hypercalcemia
    0
    0
    0
    1
        Hyperglycaemia
    16
    15
    17
    17
        Hyperkalemia
    0
    0
    1
    1
        Hypernatremia
    1
    1
    1
    0
        Hypocalcemia
    4
    5
    5
    8
        Hypoglycaemia
    3
    3
    5
    4
        Hypokalemia
    4
    1
    3
    3
        Hyponatremia
    6
    12
    7
    13
        Low-density lipoprotein cholesterol
    14
    15
    11
    20
        Magnesium
    7
    6
    5
    4
        Phosphate, inorganic
    9
    15
    14
    11
        Total bilirubin
    3
    4
    3
    0
        Activated partial thromboplastin time
    7
    12
    6
    5
        Hemoglobin
    0
    1
    0
    1
        International normalized ratio
    6
    9
    6
    5
        Platelet count
    1
    4
    1
    1
        Prothrombin time
    7
    8
    7
    4
        Total neutrophils
    9
    7
    6
    10
        White blood cell count
    1
    1
    1
    1
    Notes
    [11] - Safety Population
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated treatment-emergent integrase (IN) mutations detected at the time of protocol-defined virologic failure (PDVF), as a measure of genotypic resistance

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    End point title
    		 Number of participants with the indicated treatment-emergent integrase (IN) mutations detected at the time of protocol-defined virologic failure (PDVF), as a measure of genotypic resistance
    End point description
    For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 4, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 without evidence of prior suppression to <400copies/mL or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >0.5 log10 copies/mL above the nadir value, where nadir is the lowest HIV-1 value >=400 copies/mL.On-treatment Genotypic Resistance Population: all participants in the ITT-E Population with available on-treatment genotypic data, excluding participants who were not protocol-defined virologic failures.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 96/Early Withdrawal
    End point values
    		 DTG 10 mg QD DTG 25 mg QD DTG 50 mg QD EFV 600 mg QD
    Number of subjects analysed
    2
    1
    0 [12]
    1
    Units: Participants
        A23A/V
    1
    0
    0
        S255N
    1
    0
    0
    Notes
    [12] - On-treatment Genotypic Resistance Population
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated treatment-emergent major mutations of other classes detected at the time of protocol-defined virologic failure (PDVF), as a measure of genotypic resistance

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    End point title
    		 Number of participants with the indicated treatment-emergent major mutations of other classes detected at the time of protocol-defined virologic failure (PDVF), as a measure of genotypic resistance
    End point description
    For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 4, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 without evidence of prior suppression to <400copies/mL or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >0.5 log10 copies/mL above the nadir value, where nadir is the lowest HIV-1 value >=400 copies/mL.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 96/Early Withdrawal
    End point values
    		 DTG 10 mg QD DTG 25 mg QD DTG 50 mg QD EFV 600 mg QD
    Number of subjects analysed
    2
    1
    0 [13]
    1
    Units: Participants
        Participants
    1
    0
    0
    Notes
    [13] - On-treatment Genotypic Resistance Population
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated fold increase in DTG FC (fold change in IC50 relative to wild-type virus) at the time of PDVF, as a measure of post-Baseline phenotypic resistance

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    End point title
    		 Number of participants with the indicated fold increase in DTG FC (fold change in IC50 relative to wild-type virus) at the time of PDVF, as a measure of post-Baseline phenotypic resistance
    End point description
    The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF. Fold increase in DTG FC at the time of PDVF was derived as the PDVF FC/Baseline FC ratio. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 4, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 without evidence of prior suppression to <400copies/mL or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >0.5 log10 copies/mL above the nadir value, where nadir is the lowest HIV-1 value >=400 copies/mL.On-treatment Phenotypic Resistance Population: all participants in the ITT-E Population with available on-treatment phenotypic data
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 96/Early Withdrawal
    End point values
    		 DTG 10 mg QD DTG 25 mg QD DTG 50 mg QD EFV 600 mg QD
    Number of subjects analysed
    2
    1
    0 [14]
    0 [15]
    Units: Participants
        <1 fold
    0
    1
        1-<2 fold
    2
    0
        2-<4 fold
    0
    0
        4-<8 fold
    0
    0
        >=8 fold
    0
    0
    Notes
    [14] - On-treatment Phenotypic Resistance Population
    [15] - On-treatment Phenotypic Resistance Population
    No statistical analyses for this end point

    Secondary: Plasma DTG concentration

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    End point title
    		 Plasma DTG concentration
    End point description
    Blood samples for the determination of plasma DTG concentration were collected from the participants randomized to receive DTG, at the following time points: pre-dose and 2-4 hours post-dose at Weeks 2, Week 12, and Week 24. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. The Pharmacokinetic (PK) Summary Population is comprised of all participants who received DTG and underwent intensive PK sampling or limited PK sampling during the study and provided evaluable DTG PK parameters. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles).Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Summary Population.
    End point type
    Secondary
    End point timeframe
    Week 2, Week 12, and Week 24
    End point values
    		 DTG 10 mg QD DTG 25 mg QD DTG 50 mg QD EFV 600 mg QD
    Number of subjects analysed
    48
    46
    46
    0 [16]
    Units: Micrograms per milliliter (µg/mL)
    arithmetic mean (standard deviation)
        Week 2, Pre-dose, n=46, 44, 43, 0
    0.3580 ( 0.18321 )
    0.6779 ( 0.44085 )
    1.4044 ( 0.88041 )
    ( )
        Week 2, 2-4 hours post-dose, n=31, 29, 29, 0
    1.0121 ( 0.28125 )
    1.9716 ( 0.71890 )
    3.8414 ( 1.87405 )
    ( )
        Week 12, Pre-dose, n= 46, 45, 44, 0
    0.3648 ( 0.16791 )
    0.5759 ( 0.32645 )
    1.4169 ( 1.00152 )
    ( )
        Week 12, 2-4 hours post-dose, n=48, 45, 45, 0
    1.0374 ( 0.27517 )
    1.7907 ( 0.70953 )
    3.6056 ( 1.33862 )
    ( )
        Week 24, Pre-dose, n=45, 44, 44, 0
    0.3766 ( 0.23399 )
    0.6636 ( 0.50767 )
    1.4534 ( 0.94283 )
    ( )
        Week 24, 2-4 hours post-dose, n=45, 45, 45, 0
    1.0113 ( 0.34083 )
    1.9021 ( 0.79430 )
    3.5397 ( 1.36538 )
    ( )
    Notes
    [16] - PK Summary Population.
    No statistical analyses for this end point

    Secondary: AUC(0-tau) of DTG

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    End point title
    		 AUC(0-tau) of DTG
    End point description
    The area under the time concentration curve over the dosing interval (AUC[0-tau]) of DTG was determined using non-compartmental analysis based on intensive PK sampling at the following time points: pre-dose; 2, 3, 4, 8, and 24 hours post-dose at Week 2. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. Only those participants available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2
    End point values
    		 DTG 10 mg QD DTG 25 mg QD DTG 50 mg QD EFV 600 mg QD
    Number of subjects analysed
    15
    15
    15
    0 [17]
    Units: Hours*µg/mL
    geometric mean (geometric coefficient of variation)
        Hours*µg/mL
    16.0 ( 40 )
    23.1 ( 48 )
    48.1 ( 40 )
    ( )
    Notes
    [17] - PK Summary Population.
    No statistical analyses for this end point

    Secondary: Maximal concentration (Cmax), minimal concentration (Cmin), and concentration at the end of dosing interval (Ctau) of DTG

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    End point title
    		 Maximal concentration (Cmax), minimal concentration (Cmin), and concentration at the end of dosing interval (Ctau) of DTG
    End point description
    The Cmax, Cmax, and Ctau of DTG were determined using non-compartmental analysis based on intensive PK sampling at the following time points: pre-dose; 2, 3, 4, 8, and 24 hours post-dose at Week 2. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2
    End point values
    		 DTG 10 mg QD DTG 25 mg QD DTG 50 mg QD EFV 600 mg QD
    Number of subjects analysed
    15
    15
    15
    0 [18]
    Units: µg/mL
    geometric mean (geometric coefficient of variation)
        Cmax
    1.10 ( 37 )
    1.71 ( 43 )
    3.40 ( 27 )
    ( )
        Cmin
    0.33 ( 64 )
    0.44 ( 68 )
    0.94 ( 74 )
    ( )
        Ctau
    0.37 ( 55 )
    0.45 ( 71 )
    1.05 ( 72 )
    ( )
    Notes
    [18] - PK Summary Population.
    No statistical analyses for this end point

    Secondary: Pre-dose concentration (C0) and C0 avg of DTG

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    End point title
    		 Pre-dose concentration (C0) and C0 avg of DTG
    End point description
    The plasma DTG C0 of DTG was determined using limited/sparse PK sampling at Week 2, Week 12, and Week 24. C0 avg was calculated at Week 24 as the mean of the C0 of DTG at Week 2, Week 12, and Week 24. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Summary Population.
    End point type
    Secondary
    End point timeframe
    Week 2, Week 12, and Week 24
    End point values
    		 DTG 10 mg QD DTG 25 mg QD DTG 50 mg QD EFV 600 mg QD
    Number of subjects analysed
    49
    46
    46
    0 [19]
    Units: Microgram per milliliter (µg/mL)
    geometric mean (geometric coefficient of variation)
        C0, Week 2, n=46, 44, 43, 0
    0.31 ( 58 )
    0.57 ( 62 )
    1.20 ( 61 )
    ( )
        C0, Week 12, n=46, 45, 44, 0
    0.33 ( 49 )
    0.47 ( 77 )
    1.13 ( 95 )
    ( )
        C0, Week 24, n=45, 44, 44, 0
    0.33 ( 67 )
    0.57 ( 74 )
    1.20 ( 74 )
    ( )
        C0 avg, n=48, 46, 46, 0
    0.34 ( 49 )
    0.56 ( 61 )
    1.25 ( 55 )
    ( )
    Notes
    [19] - PK Summary Population.
    No statistical analyses for this end point

    Secondary: Time to maximal drug concentration (tmax) of DTG

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    End point title
    		 Time to maximal drug concentration (tmax) of DTG
    End point description
    Tmax of DTG was determined using non-compartmental analysis based on intensive PK sampling at the following time points: pre-dose; 2, 3, 4, 8, and 24 hours post-dose at Week 2. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2
    End point values
    		 DTG 10 mg QD DTG 25 mg QD DTG 50 mg QD EFV 600 mg QD
    Number of subjects analysed
    15
    15
    15
    0 [20]
    Units: Hours
    median (full range (min-max))
        Hours
    2.0 (2.0 to 4.0)
    2.0 (2.0 to 8.0)
    2.0 (1.9 to 4.0)
    ( to )
    Notes
    [20] - PK Summary Population.
    No statistical analyses for this end point

    Secondary: Relationship between the change from Baseline in plasma HIV-1 RNA at Week 2 and the indicated plasma DTG PK parameters

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    End point title
    		 Relationship between the change from Baseline in plasma HIV-1 RNA at Week 2 and the indicated plasma DTG PK parameters
    End point description
    Relationships between Week 2 plasma DTG PK parameters (AUC[0-tau] [area under the time concentration curve over the dosing interval], Cmax [maximal concentration], and Ctau [concentration at the end of the dosing interval]) and the change from Baseline in plasma HIV-1 RNA at Week 2 (calculated as the post-Baseline value minus the value at Baseline) was assessed using Pearson’s correlation analyses. The Pearson's correlation coefficient is a measure of the correlation between plasma HIV-1 RNA and plasma DTG PK parameters and ranges from -1 to 1. A value of 0 indicates no statistical association; a value close to -1 or 1 indicates a higher association. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. PK/Pharmacodynamic (PD) Analysis Population: all participants with available PD measures (e.g., safety and/or efficacy data) and with evaluable DTG plasma concentration data considered suitable for investigation of relationship with the PD measures
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    		 DTG 10 mg QD DTG 25 mg QD DTG 50 mg QD EFV 600 mg QD Overall DTG
    Number of subjects analysed
    15
    15
    15
    0 [21]
    45
    Units: Pearson's correlation coefficient
    number (not applicable)
        AUC(0-tau)
    0.426
    -0.018
    -0.258
    -0.086
        Cmax
    0.452
    -0.051
    -0.150
    -0.055
        Ctau
    0.273
    -0.100
    -0.263
    -0.129
    Notes
    [21] - PK/PD Analysis Population.
    No statistical analyses for this end point

    Secondary: Relationship between the change from Baseline in CD4+ cell counts at Week 96 and the indicated plasma DTG PK parameters

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    End point title
    		 Relationship between the change from Baseline in CD4+ cell counts at Week 96 and the indicated plasma DTG PK parameters
    End point description
    Relationships between plasma DTG PK parameters (AUC[0-tau] [area under the time concentration curve over the dosing interval], Cmax [maximal concentration], C0avg [average pre-dose concentration], and Ctau [concentration at the end of the dosing interval]) and the change from Baseline in CD4+ cell counts at Week 96 (calculated as the post-Baseline value minus the value at Baseline) was assessed using Pearson’s correlation analyses. The Pearson's correlation coefficient is a measure of the correlation between CD4+ cell counts and plasma DTG PK parameters and ranges from -1 to 1. A value of 0 indicates no statistical association; a value close to -1 or 1 indicates a higher association.Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 DTG 10 mg QD DTG 25 mg QD DTG 50 mg QD EFV 600 mg QD Overall DTG
    Number of subjects analysed
    50
    46
    46
    0 [22]
    142
    Units: Pearson's correlation coefficient
    number (not applicable)
        AUC(0-tau), n=13, 14, 15, 0
    -0.100
    0.379
    0.008
    -0.005
        Cmax, n=13, 14, 15, 0
    -0.047
    0.332
    0.234
    0.037
        C0avg, n=43, 40, 42, 0
    -0.009
    -0.013
    0.206
    -0.011
        Ctau, n=13, 14, 15, 0
    -0.289
    0.299
    -0.074
    -0.055
    Notes
    [22] - PK/PD Analysis Population.
    No statistical analyses for this end point

    Secondary: Relationship between the indicated safety parameters at Week 96 and the indicated plasma DTG PK parameters

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    End point title
    		 Relationship between the indicated safety parameters at Week 96 and the indicated plasma DTG PK parameters
    End point description
    Relationships between log-transformed plasma DTG PK parameters (AUC[0-tau], Cmax, C0, C0avg, Ctau, and Cmin) and safety parameters (AE occurrence, maximum AE intensity, alanine aminotransferase [ALT], change from Baseline [CFB] in ALT, total bilirubin, CFB in total bilirubin, creatine kinase, CFB in creatine kinase, triglycerides, CFB in triglycerides, lipase, CFB in lipase, total cholesterol [TC], CFB in TC) was assessed using Pearson’s correlation analyses. The Pearson's correlation coefficient is a measure of the correlation between safety parameters and plasma DTG PK parameters and ranges from -1 to 1. A value of 0 indicates no statistical association; a value close to -1 or 1 indicates a higher association. The presence of >=1 AE was used for AE occurrence. The most severe AE grade/intensity was used for maximum AE intensity. Maximum laboratory values per participant were used for safety parameters. CFB was calculated as the post-Baseline value minus the value at Baseline.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 Overall DTG
    Number of subjects analysed
    142
    Units: Pearson's correlation coefficient
    number (not applicable)
        AUC(0-tau) versus AE occurrence, n=45
    0.114
        AUC(0-tau) versus maximum AE intensity, n=45
    0.171
        AUC(0-tau) versus ALT, n=45
    -0.196
        AUC(0-tau) versus CFB in ALT, n=45
    -0.201
        AUC(0-tau) versus total bilirubin, n=45
    0.364
        AUC(0-tau) versus CFB in total bilirubin, n=45
    0.147
        AUC(0-tau) versus creatine kinase, n=45
    -0.168
        AUC(0-tau) versus CFB in creatine kinase, n=45
    -0.145
        AUC(0-tau) vs Triglycerides, n=45
    0.104
        AUC(0-tau) versus CFB in triglycerides, n=45
    0.216
        AUC(0-tau) versus lipase, n=45
    -0.066
        AUC(0-tau) versus CFB in lipase, n=45
    0.092
        AUC(0-tau) versus total cholesterol, n=45
    -0.097
        AUC(0-tau) versus CFB in total cholesterol, n=45
    -0.153
        Cmax versus AE occurrence, n=45
    0.061
        Cmax versus maximum AE intensity, n=45
    0.110
        Cmax versus ALT, n=45
    -0.135
        Cmax versus CFB in ALT, n=45
    -0.135
        Cmax versus total bilirubin, n=45
    0.265
        Cmax versus CFB in total bilirubin, n=45
    0.033
        Cmax versus creatine kinase, n=45
    -0.188
        Cmax versus CFB in creatine kinase, n=45
    -0.161
        Cmax versus triglycerides, n=45
    0.134
        Cmax versus CFB in triglycerides, n=45
    0.244
        Cmax versus lipase, n=45
    -0.034
        Cmax versus CFB in lipase, n=45
    0.115
        Cmax versus total cholesterol, n=45
    -0.101
        Cmax versus CFB in total cholesterol, n=45
    -0.192
        C0 versus AE occurrence, n=133
    -0.080
        C0 versus maximum AE intensity, n=133
    -0.003
        C0 versus ALT, n=133
    -0.196
        C0 versus CFB in ALT, n=133
    -0.237
        C0 versus total bilirubin, n=133
    0.298
        C0 versus CFB in total bilirubin, n=133
    0.120
        C0 versus creatine kinase, n=133
    -0.094
        C0 versus CFB in creatine kinase, n=133
    -0.093
        C0 versus triglycerides, n=133
    -0.058
        C0 versus CFB in triglycerides, n=133
    -0.012
        C0 versus lipase, n=133
    -0.187
        C0 versus CFB in lipase, n=133
    -0.137
        C0 versus total cholesterol, n=133
    -0.179
        C0 versus CFB in total cholesterol, n=133
    -0.125
        C0avg versus AE occurrence, n=140
    -0.028
        C0avg versus maximum AE intensity, n=140
    0.036
        C0avg versus ALT, n=140
    -0.166
        C0avg versus CFB in ALT, n=140
    -0.177
        C0avg versus total bilirubin, n=140
    0.319
        C0avg versus CFB in total bilirubin, n=140
    0.109
        C0avg versus creatine kinase, n=140
    -0.114
        C0avg versus CFB in creatine kinase, n=140
    -0.110
        C0avg versus triglycerides, n=140
    0.057
        C0avg versus CFB in triglycerides, n=140
    0.092
        C0avg versus lipase, n=140
    -0.164
        C0avg versus CFB in lipase, n=140
    -0.120
        C0avg versus total cholesterol, n=140
    -0.170
        C0avg versus CFB in total cholesterol, n=140
    -0.083
        Ctau versus AE occurrence, n=45
    0.190
        Ctau versus maximum AE intensity, n=45
    0.205
        Ctau versus ALT, n=45
    -0.281
        Ctau versus CFB in ALT, n=45
    -0.285
        Ctau versus total bilirubin, n=45
    0.446
        Ctau versus CFB in total bilirubin, n=45
    0.237
        Ctau versus creatine kinase, n=45
    -0.143
        Ctau versus CFB in creatine kinase, n=45
    -0.125
        Ctau versus triglycerides, n=45
    0.061
        Ctau versus CFB in triglycerides, n=45
    0.172
        Ctau versus lipase, n=45
    -0.131
        Ctau versus CFB in lipase, n=45
    0.056
        Ctau versus total cholesterol, n=45
    -0.039
        Ctau versus CFB in total cholesterol, n=45
    -0.108
        Cmin versus AE occurrence, n=45
    0.156
        Cmin versus maximum AE intensity, n=45
    0.193
        Cmin versus ALT, n=45
    -0.236
        Cmin versus CFB in ALT, n=45
    -0.253
        Cmin versus total bilirubin, n=45
    0.430
        Cmin versus CFB in total bilirubin, n=45
    0.171
        Cmin versus creatine kinase, n=45
    -0.132
        Cmin versus CFB in creatine kinase, n=45
    -0.124
        Cmin versus triglycerides, n=45
    -0.042
        Cmin versus CFB in triglycerides, n=45
    0.057
        Cmin versus lipase, n=45
    -0.135
        Cmin versus CFB in lipase, n=45
    0.032
        Cmin versus total cholesterol, n=45
    -0.194
        Cmin versus CFB in total cholesterol, n=45
    -0.208
    No statistical analyses for this end point

    Secondary: Relationship between gastrointestinal system organ class AEs of special interest at Week 96 and the indicated plasma DTG PK parameters

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    End point title
    		 Relationship between gastrointestinal system organ class AEs of special interest at Week 96 and the indicated plasma DTG PK parameters
    End point description
    Logistic regressions were performed to examine the correlation between plasma DTG PK parameters (AUC[0-tau] [area under the time concentration curve over the dosing interval], Cmax [maximal concentration], Ctau [concentration at the end of the dosing interval], and C0avg [average pre-dose concentration]) on log scales and the presence of gastrointestinal system organ class AEs (abdominal pain, diarrhea, nausea, and vomiting) at Week 96. Data are presented as estimates from logistic regression, which is a measure of the association between AEs of special interest and plasma DTG PK parameters. A value of 0 indicates no statistical association; a large absolute value of the estimate indicates higher association. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. Results are presented for participants in any DTG group (overall DTG).Only those participants available at the specified time points were analyzed represented by n=X in the category titles
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 Overall DTG
    Number of subjects analysed
    142 [23]
    Units: estimated effect
    number (not applicable)
        Abdominal pain versus AUC(0-tau), n=45
    -2.49
        Abdominal pain versus Cmax, n=45
    -2.98
        Abdominal pain versus Ctau, n=45
    -1.72
        Abdominal pain versus C0avg, n=140
    -0.41
        Diarrhoea versus AUC(0-tau), n=45
    -0.62
        Diarrhoea versus Cmax, n=45
    -0.98
        Diarrhoea versus Ctau, n=45
    -0.29
        Diarrhoea versus C0avg, n=140
    0.13
        Nausea versus AUC(0-tau), n=45
    -0.31
        Nausea versus Cmax, n=45
    -0.72
        Nausea versus Ctau, n=45
    0.03
        Nausea versus C0avg, n=140
    -0.32
        Vomiting versus AUC(0-tau), n=45
    -1.29
        Vomiting versus Cmax, n=45
    -1.61
        Vomiting versus Ctau, n=45
    -1.15
        Vomiting versus C0avg, n=140
    -0.89
    Notes
    [23] - PK/PD Analysis Population.
    No statistical analyses for this end point

    Other pre-specified: Change from Baseline in cluster of differentiation 8+ (CD8+) cell counts at the indicated time points

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    End point title
    		 Change from Baseline in cluster of differentiation 8+ (CD8+) cell counts at the indicated time points
    End point description
    Change from Baseline in CD8+ cell count data are not available; CD8+ data are only listed on a per-participant basis and were not summarized.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96
    End point values
    		 DTG 10 mg QD DTG 25 mg QD DTG 50 mg QD EFV 600 mg QD
    Number of subjects analysed
    0 [24]
    0 [25]
    0 [26]
    0 [27]
    Units: Cells per cubic millimeter
    median (inter-quartile range (Q1-Q3))
        Cells per cubic millimeter
    ( to )
    ( to )
    ( to )
    ( to )
    Notes
    [24] - ITT-E Population.
    [25] - ITT-E Population.
    [26] - ITT-E Population.
    [27] - ITT-E Population.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
    Adverse event reporting additional description
    SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    DTG 10mg QD
    Reporting group description
    		 Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.

    Reporting group title
    DTG 25mg QD
    Reporting group description
    		 Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.

    Reporting group title
    DTG 50mg QD
    Reporting group description
    		 Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.

    Reporting group title
    EFV 600mg
    Reporting group description
    		 Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.

    Reporting group title
    Open-label DTG 50 mg QD
    Reporting group description
    		 All DTG participants were switched to or continued DTG 50 mg with either ABC/3TC orally at 600 mg/300 mg (1 tablet) or TDF/FTC orally QD during the Open label phase

    Serious adverse events
    		 DTG 10mg QD DTG 25mg QD DTG 50mg QD EFV 600mg Open-label DTG 50 mg QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 53 (11.32%)
    4 / 51 (7.84%)
    7 / 51 (13.73%)
    7 / 50 (14.00%)
    16 / 138 (11.59%)
         number of deaths (all causes)
    2
    0
    0
    0
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Burkitt's lymphoma
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device malfunction
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    Injury, poisoning and procedural complications
    Wrist fracture
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Joint dislocation
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Flatulence
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mallory-Weiss syndrome
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendonitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neurosyphilis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumococcal sepsis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Primary syphilis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Lipomatosis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obesity
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 DTG 10mg QD DTG 25mg QD DTG 50mg QD EFV 600mg Open-label DTG 50 mg QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    49 / 53 (92.45%)
    46 / 51 (90.20%)
    45 / 51 (88.24%)
    46 / 50 (92.00%)
    112 / 138 (81.16%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts
         subjects affected / exposed
    2 / 53 (3.77%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    4
    0
    1
    0
    2
    Melanocytic naevus
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    1
    0
    0
    0
    2
    Infected naevus
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Papilloma
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Prostatic adenoma
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Skin papilloma
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 51 (3.92%)
    0 / 51 (0.00%)
    2 / 50 (4.00%)
    2 / 138 (1.45%)
         occurrences all number
    0
    2
    0
    2
    2
    Aortic arteriosclerosis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Arterial fibrosis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hot flush
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Peripheral coldness
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Peripheral venous disease
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Phlebitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    5 / 53 (9.43%)
    4 / 51 (7.84%)
    1 / 51 (1.96%)
    4 / 50 (8.00%)
    6 / 138 (4.35%)
         occurrences all number
    5
    4
    1
    5
    9
    Fatigue
         subjects affected / exposed
    2 / 53 (3.77%)
    4 / 51 (7.84%)
    2 / 51 (3.92%)
    6 / 50 (12.00%)
    3 / 138 (2.17%)
         occurrences all number
    2
    7
    2
    6
    4
    Asthenia
         subjects affected / exposed
    4 / 53 (7.55%)
    2 / 51 (3.92%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    3 / 138 (2.17%)
         occurrences all number
    4
    3
    1
    0
    3
    Influenza like illness
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    2 / 51 (3.92%)
    1 / 50 (2.00%)
    3 / 138 (2.17%)
         occurrences all number
    1
    0
    2
    1
    3
    Chest pain
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    2 / 50 (4.00%)
    2 / 138 (1.45%)
         occurrences all number
    1
    1
    0
    2
    2
    Malaise
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    1 / 50 (2.00%)
    2 / 138 (1.45%)
         occurrences all number
    0
    0
    1
    1
    2
    Oedema peripheral
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    0
    0
    0
    0
    2
    Pain
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    1
    1
    Adverse drug reaction
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Chest discomfort
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Drug intolerance
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Feeling drunk
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Feeling hot
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    General physical health deterioration
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Injection site pain
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Nodule
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Oedema
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 51 (3.92%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    1
    2
    1
    0
    2
    Allergy to arthropod sting
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Food allergy
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Hypersensitivity
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Multiple allergies
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    2 / 51 (3.92%)
    1 / 50 (2.00%)
    3 / 138 (2.17%)
         occurrences all number
    1
    0
    2
    1
    3
    Genital lesion
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    1
    1
    Ovarian cyst
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    1
    1
    Prostatitis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Breast discomfort
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Breast mass
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Cervical dysplasia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Gynaecomastia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Penile discharge
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Peyronie's disease
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 53 (9.43%)
    4 / 51 (7.84%)
    6 / 51 (11.76%)
    2 / 50 (4.00%)
    10 / 138 (7.25%)
         occurrences all number
    5
    4
    8
    2
    12
    Oropharyngeal pain
         subjects affected / exposed
    3 / 53 (5.66%)
    0 / 51 (0.00%)
    3 / 51 (5.88%)
    1 / 50 (2.00%)
    5 / 138 (3.62%)
         occurrences all number
    3
    0
    3
    1
    5
    Asthma
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 51 (3.92%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    3 / 138 (2.17%)
         occurrences all number
    1
    3
    1
    0
    3
    Sinus congestion
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    2 / 51 (3.92%)
    2 / 50 (4.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    2
    2
    1
    Dyspnoea
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 51 (3.92%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    0
    2
    1
    0
    5
    Rhinitis allergic
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    1 / 50 (2.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    2
    1
    2
    1
    Lung disorder
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    0
    1
    0
    0
    3
    Respiratory disorder
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    1
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    2 / 51 (3.92%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Asthmatic crisis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Bronchitis chronic
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Bronchopneumopathy
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Dysphonia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Hyperventilation
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Lower respiratory tract congestion
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Nasal congestion
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Pharyngeal disorder
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Respiratory tract congestion
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Snoring
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Upper respiratory tract congestion
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 53 (0.00%)
    7 / 51 (13.73%)
    6 / 51 (11.76%)
    6 / 50 (12.00%)
    5 / 138 (3.62%)
         occurrences all number
    0
    7
    6
    6
    5
    Depression
         subjects affected / exposed
    3 / 53 (5.66%)
    6 / 51 (11.76%)
    2 / 51 (3.92%)
    5 / 50 (10.00%)
    6 / 138 (4.35%)
         occurrences all number
    3
    6
    3
    5
    6
    Anxiety
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 51 (3.92%)
    2 / 51 (3.92%)
    3 / 50 (6.00%)
    4 / 138 (2.90%)
         occurrences all number
    2
    2
    2
    3
    4
    Abnormal dreams
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 51 (3.92%)
    0 / 51 (0.00%)
    3 / 50 (6.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    3
    0
    Nightmare
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    4 / 50 (8.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    4
    0
    Stress
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    2 / 51 (3.92%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    2
    0
    1
    Acute stress disorder
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    0
    0
    1
    Loss of libido
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Sleep disorder
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    0
    0
    1
    Affect lability
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Anxiety disorder
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Bulimia nervosa
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Disorientation
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Hallucination
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Libido increased
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Listless
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Mental disorder
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Panic attack
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Post-traumatic stress disorder
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Substance use disorder
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 53 (0.00%)
    3 / 51 (5.88%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    3
    0
    0
    1
    Blood cholesterol increased
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    1 / 50 (2.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    1
    1
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Blood glucose increased
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Lipase increased
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    0
    0
    0
    0
    2
    Amylase increased
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Anal pap smear abnormal
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Bacterial test positive
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Cardiac murmur
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Electrocardiogram repolarisation abnormality
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Liver function test increased
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Transaminases increased
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Urinary sediment present
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Weight decreased
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Weight increased
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    3 / 138 (2.17%)
         occurrences all number
    0
    0
    0
    0
    5
    Concussion
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    0
    0
    0
    0
    2
    Contusion
         subjects affected / exposed
    2 / 53 (3.77%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Laceration
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 51 (3.92%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Limb injury
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    0
    0
    1
    Muscle strain
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Procedural pain
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    0
    0
    1
    Anal injury
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Cervical vertebral fracture
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Clavicle fracture
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Epicondylitis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Face injury
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Fall
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Foot fracture
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Joint dislocation
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Rib fracture
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Scrotal haematoma
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Stress fracture
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Tendon rupture
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Vaccination complication
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Wrist fracture
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Cardiac disorders
    Sinus tachycardia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Tachycardia
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    0
    0
    0
    1
    Aortic valve incompetence
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Arrhythmia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Bradycardia
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Cardiomegaly
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Palpitations
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 53 (13.21%)
    6 / 51 (11.76%)
    8 / 51 (15.69%)
    3 / 50 (6.00%)
    8 / 138 (5.80%)
         occurrences all number
    9
    10
    12
    5
    10
    Dizziness
         subjects affected / exposed
    2 / 53 (3.77%)
    3 / 51 (5.88%)
    3 / 51 (5.88%)
    11 / 50 (22.00%)
    2 / 138 (1.45%)
         occurrences all number
    2
    4
    3
    13
    2
    Paraesthesia
         subjects affected / exposed
    3 / 53 (5.66%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    2 / 50 (4.00%)
    3 / 138 (2.17%)
         occurrences all number
    3
    0
    0
    2
    3
    Somnolence
         subjects affected / exposed
    2 / 53 (3.77%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    2 / 50 (4.00%)
    0 / 138 (0.00%)
         occurrences all number
    2
    1
    1
    2
    0
    Dysgeusia
         subjects affected / exposed
    2 / 53 (3.77%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    Memory impairment
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    2
    1
    0
    Sciatica
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    2 / 138 (1.45%)
         occurrences all number
    0
    0
    0
    1
    3
    Hypoaesthesia
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    0
    0
    0
    1
    Poor quality sleep
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Restless legs syndrome
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    2 / 50 (4.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Syncope
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Ageusia
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Anosmia
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Cervical radiculopathy
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Cluster headache
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Cognitive disorder
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Hyperaesthesia
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hypertonia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Migraine
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Neuropathy peripheral
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Post herpetic neuralgia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Presyncope
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Sinus headache
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Tongue biting
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Tremor
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Trigeminal neuralgia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Visual field defect
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    2 / 53 (3.77%)
    3 / 51 (5.88%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    Neutropenia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    1
    0
    1
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Lymphadenitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    2 / 53 (3.77%)
    1 / 51 (1.96%)
    2 / 51 (3.92%)
    2 / 50 (4.00%)
    0 / 138 (0.00%)
         occurrences all number
    2
    1
    2
    2
    0
    Tinnitus
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    2 / 138 (1.45%)
         occurrences all number
    1
    0
    0
    1
    2
    Ear pain
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 51 (3.92%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    Hypoacusis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    2 / 50 (4.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Cerumen impaction
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Ear congestion
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Ear pruritus
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Presbyacusis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Eye disorders
    Astigmatism
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Chalazion
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Dark circles under eyes
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Myopia
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Vision blurred
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Visual acuity reduced
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Vitreous floaters
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    6 / 53 (11.32%)
    9 / 51 (17.65%)
    7 / 51 (13.73%)
    5 / 50 (10.00%)
    12 / 138 (8.70%)
         occurrences all number
    6
    10
    8
    7
    14
    Nausea
         subjects affected / exposed
    10 / 53 (18.87%)
    8 / 51 (15.69%)
    6 / 51 (11.76%)
    7 / 50 (14.00%)
    2 / 138 (1.45%)
         occurrences all number
    10
    9
    6
    7
    2
    Haemorrhoids
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    2 / 51 (3.92%)
    2 / 50 (4.00%)
    8 / 138 (5.80%)
         occurrences all number
    0
    0
    2
    2
    10
    Abdominal pain
         subjects affected / exposed
    3 / 53 (5.66%)
    1 / 51 (1.96%)
    2 / 51 (3.92%)
    1 / 50 (2.00%)
    3 / 138 (2.17%)
         occurrences all number
    3
    1
    2
    1
    3
    Dyspepsia
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 51 (3.92%)
    2 / 51 (3.92%)
    2 / 50 (4.00%)
    3 / 138 (2.17%)
         occurrences all number
    1
    3
    2
    2
    3
    Abdominal pain upper
         subjects affected / exposed
    4 / 53 (7.55%)
    3 / 51 (5.88%)
    1 / 51 (1.96%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    5
    3
    1
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    2 / 50 (4.00%)
    5 / 138 (3.62%)
         occurrences all number
    0
    1
    0
    2
    5
    Vomiting
         subjects affected / exposed
    3 / 53 (5.66%)
    3 / 51 (5.88%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    1 / 138 (0.72%)
         occurrences all number
    3
    3
    0
    1
    1
    Toothache
         subjects affected / exposed
    2 / 53 (3.77%)
    2 / 51 (3.92%)
    1 / 51 (1.96%)
    1 / 50 (2.00%)
    1 / 138 (0.72%)
         occurrences all number
    2
    2
    2
    1
    2
    Gastritis
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    3 / 138 (2.17%)
         occurrences all number
    1
    1
    0
    1
    3
    Abdominal discomfort
         subjects affected / exposed
    2 / 53 (3.77%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    2
    1
    1
    1
    0
    Constipation
         subjects affected / exposed
    2 / 53 (3.77%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    3
    1
    0
    0
    2
    Proctitis
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    3 / 138 (2.17%)
         occurrences all number
    1
    1
    0
    0
    4
    Faeces soft
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    2 / 50 (4.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    1
    2
    0
    Haematochezia
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    1
    0
    0
    1
    Anal fissure
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    0
    0
    0
    0
    2
    Anal fistula
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    0
    0
    0
    0
    2
    Anogenital dysplasia
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    0
    0
    0
    1
    Aphthous ulcer
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    4
    0
    0
    1
    0
    Epigastric discomfort
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Flatulence
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    Inguinal hernia
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    0
    0
    1
    Rectal haemorrhage
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Abdominal distension
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Abdominal pain lower
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Anal pruritus
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Anal skin tags
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Anal sphincter hypertonia
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Anal ulcer
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Anorectal disorder
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Anorectal ulcer
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Change of bowel habit
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Chronic gastritis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Dental caries
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Enteritis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    3
    Enterocolitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Food poisoning
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hiatus hernia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Hypoaesthesia oral
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Intestinal polyp
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Leukoplakia oral
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Odynophagia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Pancreatic atrophy
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Perianal erythema
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Rectal polyp
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Stomatitis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Tongue discolouration
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Tongue disorder
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Umbilical hernia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Hepatobiliary disorders
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    1 / 50 (2.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    1
    1
    1
    Hepatic steatosis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    0
    0
    0
    0
    2
    Cholestasis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    5 / 53 (9.43%)
    3 / 51 (5.88%)
    2 / 51 (3.92%)
    6 / 50 (12.00%)
    2 / 138 (1.45%)
         occurrences all number
    6
    3
    2
    6
    2
    Pruritus
         subjects affected / exposed
    2 / 53 (3.77%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    3 / 50 (6.00%)
    3 / 138 (2.17%)
         occurrences all number
    3
    0
    1
    3
    3
    Dermatitis
         subjects affected / exposed
    0 / 53 (0.00%)
    3 / 51 (5.88%)
    1 / 51 (1.96%)
    1 / 50 (2.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    3
    1
    1
    1
    Alopecia
         subjects affected / exposed
    2 / 53 (3.77%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    2
    0
    1
    0
    1
    Eczema
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    1
    1
    0
    Night sweats
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 51 (1.96%)
    2 / 51 (3.92%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    2
    0
    0
    Urticaria
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    1
    1
    0
    0
    2
    Erythema
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    2
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    1
    0
    0
    4
    Photosensitivity reaction
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    2 / 51 (3.92%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    2
    1
    0
    Dry skin
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Hyperkeratosis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    1
    0
    1
    Prurigo
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    0
    0
    0
    2
    Seborrhoeic dermatitis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    2
    0
    0
    0
    1
    Skin hyperpigmentation
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    0
    0
    1
    Actinic keratosis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Blister
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Dermal cyst
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Hand dermatitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Intertrigo
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Lipoatrophy
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Miliaria
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Palmar erythema
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Pigmentation disorder
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Pruritus generalised
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Psoriasis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Rash macular
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Rash maculo-papular
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Rash papular
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Rash pruritic
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Skin erosion
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Skin lesion
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Solar dermatitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Toxic skin eruption
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    3 / 138 (2.17%)
         occurrences all number
    1
    1
    0
    0
    4
    Proteinuria
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 51 (3.92%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    0
    2
    1
    0
    2
    Nephrolithiasis
         subjects affected / exposed
    2 / 53 (3.77%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    2
    1
    0
    1
    0
    Haematuria
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    1 / 50 (2.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    1
    1
    1
    Pollakiuria
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    1
    0
    0
    0
    2
    Leukocyturia
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Acute kidney injury
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Chronic kidney disease
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Micturition urgency
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Urethral discharge
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Urethritis noninfective
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Urinary hesitation
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Endocrine disorders
    Hypogonadism
         subjects affected / exposed
    2 / 53 (3.77%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    Hypothyroidism
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    0
    0
    0
    1
    Goitre
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 53 (5.66%)
    2 / 51 (3.92%)
    2 / 51 (3.92%)
    4 / 50 (8.00%)
    10 / 138 (7.25%)
         occurrences all number
    4
    2
    2
    5
    10
    Arthralgia
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 51 (5.88%)
    2 / 51 (3.92%)
    1 / 50 (2.00%)
    5 / 138 (3.62%)
         occurrences all number
    1
    3
    2
    1
    5
    Musculoskeletal pain
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 51 (3.92%)
    3 / 51 (5.88%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    2
    3
    0
    1
    Myalgia
         subjects affected / exposed
    2 / 53 (3.77%)
    0 / 51 (0.00%)
    2 / 51 (3.92%)
    1 / 50 (2.00%)
    2 / 138 (1.45%)
         occurrences all number
    2
    0
    2
    1
    2
    Muscle spasms
         subjects affected / exposed
    0 / 53 (0.00%)
    4 / 51 (7.84%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    5
    0
    0
    1
    Exostosis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    2 / 51 (3.92%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    0
    2
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 51 (3.92%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    2
    1
    0
    1
    Tendonitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    4 / 138 (2.90%)
         occurrences all number
    0
    0
    0
    0
    6
    Arthritis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    1
    0
    1
    Facet joint syndrome
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    0
    0
    0
    1
    Osteopenia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    1
    1
    Plantar fasciitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    1
    0
    1
    Ankle impingement
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Chondropathy
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Fistula
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    Joint stiffness
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Muscle contracture
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Muscle haemorrhage
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Muscular weakness
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Musculoskeletal discomfort
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Myosclerosis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Neck pain
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Osteoarthritis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Patellofemoral pain syndrome
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Synovitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Temporomandibular joint syndrome
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Infections and infestations
    Viral upper respiratory tract infection
         subjects affected / exposed
    7 / 53 (13.21%)
    7 / 51 (13.73%)
    6 / 51 (11.76%)
    5 / 50 (10.00%)
    20 / 138 (14.49%)
         occurrences all number
    10
    10
    10
    7
    27
    Bronchitis
         subjects affected / exposed
    5 / 53 (9.43%)
    2 / 51 (3.92%)
    2 / 51 (3.92%)
    5 / 50 (10.00%)
    10 / 138 (7.25%)
         occurrences all number
    7
    3
    3
    6
    14
    Influenza
         subjects affected / exposed
    5 / 53 (9.43%)
    5 / 51 (9.80%)
    4 / 51 (7.84%)
    3 / 50 (6.00%)
    6 / 138 (4.35%)
         occurrences all number
    5
    6
    4
    3
    9
    Syphilis
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 51 (5.88%)
    1 / 51 (1.96%)
    4 / 50 (8.00%)
    12 / 138 (8.70%)
         occurrences all number
    1
    3
    1
    4
    15
    Respiratory tract infection
         subjects affected / exposed
    4 / 53 (7.55%)
    1 / 51 (1.96%)
    2 / 51 (3.92%)
    3 / 50 (6.00%)
    9 / 138 (6.52%)
         occurrences all number
    6
    2
    3
    4
    13
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 53 (3.77%)
    3 / 51 (5.88%)
    6 / 51 (11.76%)
    1 / 50 (2.00%)
    7 / 138 (5.07%)
         occurrences all number
    2
    4
    8
    1
    10
    Sinusitis
         subjects affected / exposed
    2 / 53 (3.77%)
    2 / 51 (3.92%)
    3 / 51 (5.88%)
    4 / 50 (8.00%)
    6 / 138 (4.35%)
         occurrences all number
    3
    3
    4
    6
    6
    Pharyngitis
         subjects affected / exposed
    3 / 53 (5.66%)
    3 / 51 (5.88%)
    1 / 51 (1.96%)
    2 / 50 (4.00%)
    3 / 138 (2.17%)
         occurrences all number
    3
    3
    1
    2
    3
    Gastroenteritis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    2 / 51 (3.92%)
    1 / 50 (2.00%)
    5 / 138 (3.62%)
         occurrences all number
    0
    1
    2
    1
    5
    Rhinitis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    2 / 51 (3.92%)
    0 / 50 (0.00%)
    5 / 138 (3.62%)
         occurrences all number
    1
    0
    2
    0
    7
    Tonsillitis
         subjects affected / exposed
    3 / 53 (5.66%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    3 / 138 (2.17%)
         occurrences all number
    10
    1
    0
    2
    5
    Oral herpes
         subjects affected / exposed
    4 / 53 (7.55%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    4
    1
    0
    0
    2
    Respiratory tract infection viral
         subjects affected / exposed
    3 / 53 (5.66%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    2 / 138 (1.45%)
         occurrences all number
    4
    4
    0
    1
    2
    Folliculitis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    4 / 138 (2.90%)
         occurrences all number
    0
    1
    1
    0
    4
    Herpes simplex
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    1 / 50 (2.00%)
    3 / 138 (2.17%)
         occurrences all number
    1
    0
    1
    1
    3
    Tooth abscess
         subjects affected / exposed
    2 / 53 (3.77%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    2
    1
    1
    0
    2
    Tooth infection
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 51 (3.92%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    3 / 138 (2.17%)
         occurrences all number
    0
    3
    1
    0
    3
    Urinary tract infection
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    2 / 51 (3.92%)
    0 / 50 (0.00%)
    3 / 138 (2.17%)
         occurrences all number
    1
    0
    2
    0
    3
    Viral infection
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 51 (5.88%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    3
    0
    1
    3
    Cellulitis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    2 / 50 (4.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    2
    1
    Fungal skin infection
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    1 / 50 (2.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    1
    2
    1
    1
    Herpes zoster
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    1
    1
    1
    0
    2
    Acarodermatitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    3 / 138 (2.17%)
         occurrences all number
    0
    0
    1
    0
    5
    Chlamydial infection
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    1
    0
    1
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 51 (3.92%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    2
    1
    0
    1
    Ear infection
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    2 / 138 (1.45%)
         occurrences all number
    1
    0
    0
    1
    2
    Furuncle
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    2 / 51 (3.92%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    0
    3
    0
    1
    Gonorrhoea
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    2 / 138 (1.45%)
         occurrences all number
    0
    1
    0
    1
    2
    Onychomycosis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    2 / 138 (1.45%)
         occurrences all number
    0
    1
    0
    1
    2
    Otitis media
         subjects affected / exposed
    3 / 53 (5.66%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    4
    0
    0
    0
    1
    Urethritis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    2 / 138 (1.45%)
         occurrences all number
    1
    0
    0
    1
    2
    Gastroenteritis viral
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    1 / 50 (2.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    1
    1
    1
    Herpes virus infection
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    0
    0
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    1
    0
    0
    2
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    1
    1
    0
    1
    Tinea pedis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    0
    1
    0
    1
    Amoebic dysentery
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Angular cheilitis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Bacteriuria
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Body tinea
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    0
    0
    0
    1
    Cystitis
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Dermatophytosis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    1
    0
    0
    0
    1
    Diverticulitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    0
    0
    0
    0
    3
    Fungal infection
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    Genital herpes
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    2 / 51 (3.92%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Giardiasis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    1
    0
    1
    Hepatitis C
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    1
    1
    Laryngitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    1
    0
    1
    Molluscum contagiosum
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    2 / 51 (3.92%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Otitis externa
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    0
    0
    0
    0
    2
    Papilloma viral infection
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Shigella infection
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    0
    0
    0
    0
    2
    Staphylococcal infection
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    2
    0
    3
    0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    0
    0
    0
    0
    2
    Superinfection bacterial
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    1
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    Acute hepatitis C
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Acute sinusitis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Anal abscess
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Anal infection
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Anorectal infection
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Candida infection
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Endometritis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Enterocolitis viral
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Epididymitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    External ear cellulitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Febrile infection
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Gastritis viral
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Gastroenteritis shigella
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Genital herpes simplex
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Genital infection fungal
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Genitourinary chlamydia infection
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Gingivitis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Helicobacter infection
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Impetigo
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Infection
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Joint abscess
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Lymphogranuloma venereum
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Neurosyphilis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Paronychia
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Periodontitis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Pilonidal cyst
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Pneumonia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Primary syphilis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Proctitis gonococcal
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Pulpitis dental
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Rash pustular
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Rubella
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Secondary syphilis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Sialoadenitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Skin candida
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Staphylococcal skin infection
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Tinea cruris
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Tinea infection
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Toxocariasis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Urethritis gonococcal
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Urinary tract infection bacterial
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Vaginal infection
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Viral pharyngitis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Metabolism and nutrition disorders
    Vitamin D deficiency
         subjects affected / exposed
    2 / 53 (3.77%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    4 / 138 (2.90%)
         occurrences all number
    2
    0
    1
    0
    4
    Hyperglycaemia
         subjects affected / exposed
    2 / 53 (3.77%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    3 / 138 (2.17%)
         occurrences all number
    2
    0
    1
    0
    3
    Hyperlipidaemia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    1 / 50 (2.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    2
    1
    1
    Decreased appetite
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Gout
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    0
    0
    0
    0
    2
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 51 (3.92%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    Hyperinsulinaemia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    2 / 138 (1.45%)
         occurrences all number
    0
    0
    0
    0
    2
    Diabetes mellitus
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Fat redistribution
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Fluid retention
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    1 / 138 (0.72%)
         occurrences all number
    0
    0
    0
    0
    1
    Hyponatraemia
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 50 (2.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 50 (0.00%)
    0 / 138 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Mar 2009
    • Incorporation of text to comply with GlaxoSmithKline Policy 408 • Deletion of previous Section 6.4.6.2 and reformatting of entry criteria to comply with new standards.
    18 Jun 2009
    • Removal of exclusion of women of childbearing potential following availability of final embryo-fetal toxicology data • Inclusion of additional toxicology data and exclusion criteria and toxicity management guidelines • Correction of minor typographical errors and stylistic changes.
    14 Aug 2009
    • Change minimum entry cluster of differentiation 4 (CD4) plus cell criterion to greater than and equal to 200 cells/cubic millimeter (mm^3)
    31 Aug 2009
    • Correction of omissions in Amendment No. 03 • Allow real-time urine pregnancy testing at Day 1.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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