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    Clinical Trial Results:
    A Phase IIIb, randomized, open-label study of the safety and efficacy of GSK1349572 (dolutegravir, DTG) 50 mg once daily compared to darunavir/ritonavir (DRV/r) 800 mg/100 mg once daily each administered with fixed-dose dual nucleoside reverse transcriptase inhibitor therapy over 96 weeks in HIV-1 infected antiretroviral naïve adult subjects.

    Summary
    EudraCT number
    		 2011-003629-86
    Trial protocol
    		 ES   IT  
    Global end of trial date
    26 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

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    Trial identification
    Sponsor protocol code
    114915
    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
    05 Jul 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Apr 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferior antiviral activity of DTG 50 milligram (mg) administered once daily compared to DRV/r 800 mg/100 mg once daily over 48 weeks in Human Immunodeficiency Virus Type-1 (HIV-1) infected therapy-naïve participants.
    Protection of trial subjects
    99999
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Oct 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 54 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: 213
    Country: Number of subjects enrolled
    Spain: 86
    Country: Number of subjects enrolled
    France: 52
    Country: Number of subjects enrolled
    Italy: 49
    Country: Number of subjects enrolled
    Romania: 21
    Country: Number of subjects enrolled
    Germany: 20
    Country: Number of subjects enrolled
    Russian Federation: 18
    Country: Number of subjects enrolled
    Switzerland: 13
    Country: Number of subjects enrolled
    Puerto Rico: 12
    Worldwide total number of subjects
    484
    EEA total number of subjects
    228
    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)
    480
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This was a 2 sequential treatment period study. In first period (Randomization phase) participants received either dolutegravir (DTG) 50 milligram (mg) or darunavir (DRV) 800 mg with ritonavir (RTV) 100 mg once daily (QD) for 96 weeks. DTG participants who completed 96 Weeks of DTG then continued to receive DTG 50 mg in Extension phase.

    Pre-assignment
    Screening details
    		 A total of 595 participants were screened; 107 were screen failures; 488 were randomized; 485 received at least 1 dose of study medication and comprised the Intent-To-Treat exposed (ITT-E) population of which 1 participant was removed, creating the modified ITT-E population with 484 participants. 123 participants enrolled in Extension Phase.

    Period 1
    Period 1 title
    Randomization Phase 96 week
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DTG 50 mg QD
    Arm description
    		 Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dolutegravir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received once daily dolutegravir 50 mg oral tablets

    Investigational medicinal product name
    Tenofovir/Emtricitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received fixed dose combination of tenofovir/emtricitabine oral tablets

    Investigational medicinal product name
    Abacavir/Lamivudine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received fixed dose combination of abacavir/lamivudine oral tablets

    Arm title
    		 DRV 800 mg + RTV 100 mg QD
    Arm description
    		 Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received once daily ritonavir 100 mg oral tablets

    Investigational medicinal product name
    Darunavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 2 oral tablets of 400 mg darunavir once daily

    Investigational medicinal product name
    Abacavir/Lamivudine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received fixed dose combination of abacavir/lamivudine oral tablets

    Investigational medicinal product name
    Tenofovir/Emtricitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received fixed dose combination of tenofovir/emtricitabine oral tablets

    Number of subjects in period 1
    		DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
    Started
    242
    242
    Completed
    209
    189
    Not completed
    33
    53
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    2
    8
         Physician decision
    2
    3
         Adverse event, non-fatal
    4
    13
         Other: study closed/terminated
    -
    1
         Protocol-defined Stopping Criteria
    1
    -
         Lost to follow-up
    15
    18
         Lack of efficacy
    3
    4
         Protocol deviation
    5
    6
    Period 2
    Period 2 title
    Extension Phase approximately 3 years
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Extension DTG 50 mg
    Arm description
    		 DTG participants who successfully completed 96 Weeks of randomized phase continued to receive DTG 50 mg QD during Extension phase
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dolutegravir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received once daily dolutegravir 50 mg oral tablets

    Investigational medicinal product name
    Abacavir/Lamivudine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received fixed dose combination of abacavir/lamivudine oral tablets

    Investigational medicinal product name
    Tenofovir/Emtricitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received fixed dose combination of tenofovir/emtricitabine oral tablets

    Number of subjects in period 2
    		Extension DTG 50 mg
    Started
    123
    Completed
    115
    Not completed
    8
         Adverse event, non-fatal
    2
         Lost to follow-up
    4
         Lack of efficacy
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DTG 50 mg QD
    Reporting group description
    		 Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.

    Reporting group title
    DRV 800 mg + RTV 100 mg QD
    Reporting group description
    		 Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.

    Reporting group values
    		 DTG 50 mg QD DRV 800 mg + RTV 100 mg QD Total
    Number of subjects
    		 242 242
    Age categorical
    Units: Subjects
    Age continuous
    Results from the mITT-E Population are presented in this report.
    Units: years
        arithmetic mean (standard deviation)
    		 35.7 ± 10.66 36.2 ± 10.64 -
    Gender categorical
    Results from the mITT-E are presented in this report.
    Units: Subjects
        Female
    		 31 41 72
        Male
    		 211 201 412
    Race/Ethnicity, Customized
    Results from the mITT-E are presented in this report.
    Units: Subjects
        African American/African Heritage
    		 60 53 113
        American Indian or Alaska Native
    		 3 9 12
        Asian - Central/South Asian Heritage
    		 0 1 1
        Asian - Japanese Heritage
    		 1 0 1
        Asian - South East Asian Heritage
    		 1 0 1
        Native Hawaiian or other Pacific Islander
    		 2 0 2
        White - Arabic/North African Heritage
    		 4 3 7
        White - White/Caucasian/European Heritage
    		 169 173 342
        Mixed Race
    		 1 3 4
        Missing
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    DTG 50 mg QD
    Reporting group description
    		 Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.

    Reporting group title
    DRV 800 mg + RTV 100 mg QD
    Reporting group description
    		 Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
    Reporting group title
    Extension DTG 50 mg
    Reporting group description
    		 DTG participants who successfully completed 96 Weeks of randomized phase continued to receive DTG 50 mg QD during Extension phase

    Primary: Percentage of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 copies/milliliter (c/mL) at Week 48

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    End point title
    		 Percentage of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 copies/milliliter (c/mL) at Week 48
    End point description
    Assessment was done using Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) "snapshot" algorithm.This algorithm treated all participants without HIV-1 RNA data at Week 48 as nonresponders, as well as participants who switched their concomitant ART prior to Week 48 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the snapshot window (Week 48 +/- 6 weeks). Modified Intent-To-Treat Exposed (mITT-E) Population:all randomized participants who received at least one dose of investigational product
    End point type
    Primary
    End point timeframe
    Week 48
    End point values
    		 DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
    Number of subjects analysed
    242
    242
    Units: Percentage of participants
        Percentage of participants
    90
    83
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    DRV 800 mg + RTV 100 mg QD v DTG 50 mg QD
    Number of subjects included in analysis
    484
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 = 0.025 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    7.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 13.2
    Notes
    [1] - Non-inferiority of DTG 50 mg and DRV+RTV at Week 48 can be concluded if the lower bound of a two-sided 95% confidence interval (CI) for the difference in percentages (DTG - DRV+RTV) is greater than -12%. If non-inferiority is established, superiority can be tested at the nominal 5% level based on a pre-specified testing procedure.
    [2] - P-value is for test of superiority.

    Secondary: Time to virologic suppression (<50 copies/mL) through Week 48

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    End point title
    		 Time to virologic suppression (<50 copies/mL) through Week 48
    End point description
    The time to viral suppression (i.e. first viral load value <50 copies/mL) through Week 48 was derived and summarized using Kaplan-Meier plots. Participants who withdrew for any reason without having suppressed prior to the analysis were censored. Confidence intervals were estimated using the Brookmeyer-Crowley method. 99999 indicates the value was not available for the indicated time point
    End point type
    Secondary
    End point timeframe
    From Baseline through Week 48
    End point values
    		 DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
    Number of subjects analysed
    242
    242
    Units: Days
    median (confidence interval 95%)
        Days
    28.0 (-99999 to 99999)
    85.0 (84.0 to 108.0)
    No statistical analyses for this end point

    Secondary: Percentage of participants with plasma HIV-1 RNA <400 c/mL at Week 48

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    End point title
    		 Percentage of participants with plasma HIV-1 RNA <400 c/mL at Week 48
    End point description
    The percentage of participants with Plasma HIV-1 RNA <400 c/mL at Week 48 was assessed MSDF, as codified by the FDA "snapshot" algorithm. This algorithm treated all participants without HIV-1 RNA data at Week 48 as nonresponders, as well as participants who switched their concomitant ART prior to Week 48 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the snapshot window (Week 48 +/- 6 weeks).
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
    Number of subjects analysed
    242
    242
    Units: Percentage of participants
        Percentage of participants
    92
    87
    No statistical analyses for this end point

    Secondary: Change from Baseline in plasma HIV-1 RNA (log10 c/mL) at Weeks 4, 8, 12, 16, 24, 36 and 48

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    End point title
    		 Change from Baseline in plasma HIV-1 RNA (log10 c/mL) at Weeks 4, 8, 12, 16, 24, 36 and 48
    End point description
    Change from Baseline in plasma HIV-1 RNA (log10 c/mL) was assessed at Weeks 4, 8, 12, 16, 24, 36 and 48 . Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the mITT-E Population.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, 16, 24, 36 and 48
    End point values
    		 DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
    Number of subjects analysed
    242 [3]
    242 [4]
    Units: Log10 copies per mL
    arithmetic mean (standard deviation)
        Week 4, n=238, 235
    -2.80 ± 0.625
    -2.01 ± 0.454
        Week 8, n=237, 236
    -2.86 ± 0.649
    -2.40 ± 0.524
        Week 12, n=234, 227
    -2.88 ± 0.653
    -2.61 ± 0.537
        Week 16, n=229, 228
    -2.86 ± 0.691
    -2.71 ± 0.618
        Week 24, n=234, 227
    -2.86 ± 0.765
    -2.83 ± 0.663
        Week 36, n=232, 218
    -2.87 ± 0.715
    -2.85 ± 0.683
        Week 48, n=227, 212
    -2.89 ± 0.739
    -2.86 ± 0.663
    Notes
    [3] - mITT-E Population.
    [4] - mITT-E Population.
    No statistical analyses for this end point

    Secondary: Change from Baseline in CD4+ and CD8+ cell counts

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    End point title
    		 Change from Baseline in CD4+ and CD8+ cell counts
    End point description
    Change from Baseline in CD4+ cell counts was assessed at Weeks 4, 8, 12, 16, 36 and 48. Change from Baseline in CD8+ cell counts was assessed at Weeks 4, 12, 24 and 48. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits and parameters, so the overall number of participants analyzed reflects everyone in the mITT-E Population.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12, 16, 36 and 48 for CD4+ and Baseline and Weeks 4, 12, 24 and 48 for CD8+
    End point values
    		 DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
    Number of subjects analysed
    242
    242
    Units: Cells per millimeters cubed (cells/mm^3)
    arithmetic mean (standard deviation)
        CD4+ cell count, Week 4, n=237, 236
    80.1 ± 101.36
    75.6 ± 124.36
        CD4+ cell count, Week 8, n=236, 236
    126.9 ± 124.13
    118.8 ± 142.54
        CD4+ cell count, Week 12, n=234, 228
    135.2 ± 120.03
    131.8 ± 143.88
        CD4+ cell count, Week 16, n=227, 227
    156.8 ± 146.60
    146.1 ± 166.08
        CD4+ cell count, Week 24, n=233, 227
    165.1 ± 145.85
    164.3 ± 180.00
        CD4+ cell count, Week 36, n=232, 218
    206.1 ± 159.06
    186.5 ± 183.61
        CD4+ cell count, Week 48, n=227, 212
    243.8 ± 180.68
    215.4 ± 177.26
        CD8+ cell count, Week 4, n=235, 235
    -47.4 ± 276.01
    -3.7 ± 375.94
        CD8+ cell count, Week 12, n=231, 227
    -42.0 ± 343.81
    -68.9 ± 373.38
        CD8+ cell count, Week 24, n=231, 224
    -108.0 ± 350.03
    -132.9 ± 389.70
        CD8+ cell count, Week 48, n=224, 210
    -109.5 ± 360.94
    -162.1 ± 421.07
    No statistical analyses for this end point

    Secondary: Number of Participants with HIV-1 associated disease progression with the indicated shift to CDC Class C, or New CDC Class C or Death at Week 48

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    End point title
    		 Number of Participants with HIV-1 associated disease progression with the indicated shift to CDC Class C, or New CDC Class C or Death at Week 48
    End point description
    The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
    Number of subjects analysed
    242
    242
    Units: Participants
        Participants
    0
    0
    No statistical analyses for this end point

    Secondary: Change From Baseline in fasting low-density lipoprotein (LDL) cholesterol through Week 48

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    End point title
    		 Change From Baseline in fasting low-density lipoprotein (LDL) cholesterol through Week 48
    End point description
    Fasting LDL cholesterol change from Baseline was analyzed. Values represented are for adjusted means. Estimates are calculated from a repeated measures model including the following covariates: treatment, visit, Baseline plasma HIV-1 RNA, background dual NRTI therapy, Baseline LDL cholesterol, treatment*visit interaction and Baseline LDL cholesterol*visit interaction. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    From Baseline through Week 48
    End point values
    		 DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
    Number of subjects analysed
    182
    178
    Units: Millimoles per liter (mmol/L)
    arithmetic mean (standard error)
        Millimoles per liter (mmol/L)
    0.07 ± 0.041
    0.37 ± 0.041
    No statistical analyses for this end point

    Secondary: Percentage of participants with Grade 2 or higher abnormalities in fasting LDL cholesterol through Week 48

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    End point title
    		 Percentage of participants with Grade 2 or higher abnormalities in fasting LDL cholesterol through Week 48
    End point description
    Hematology and clinical chemistry data were summarized according to the division of AIDS (DAIDS) table for grading the Severity of adverse events, version 1.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for which an increase in fasting LDL cholesterol to Grade 2 or higher occurred. Only those participants with data available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    From Baseline through Week 48
    End point values
    		 DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
    Number of subjects analysed
    242
    242
    Units: Percentage of Participants
        Percentage of Participants
    2
    7
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated Grade 3 and Grade 4 maximum post-Baseline chemistry and hematology laboratory toxicities

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    End point title
    		 Number of participants with the indicated Grade 3 and Grade 4 maximum post-Baseline chemistry and hematology laboratory toxicities
    End point description
    Hematology and clinical chemistry data were summarized according to the division of AIDS (DAIDS) table for grading the Severity of adverse events, version 1.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred.
    End point type
    Secondary
    End point timeframe
    From Baseline through Week 48
    End point values
    		 DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
    Number of subjects analysed
    242
    242
    Units: Participants
        Alanine Amino Transferase, G3
    2
    1
        Alanine Amino Transferase, G4
    1
    3
        Aspartate Amino Transferase, G3
    6
    3
        Aspartate Amino Transferase, G4
    2
    0
        Cholesterol, G3
    0
    3
        Creatine Kinase, G3
    8
    5
        Creatine Kinase, G4
    8
    4
        Hyperglycaemia, G3
    1
    2
        Hypoglycaemia, G3
    0
    1
        LDL Cholesterol, G3
    2
    6
        Lipase, G3
    5
    5
        Lipase, G4
    2
    0
        Phosphorus, inorganic, G3
    7
    7
        Total Bilirubin, G3
    1
    0
        Triglycerides, G3
    1
    2
        Triglycerides, G4
    0
    1
        Hemoglobin, G3
    1
    0
        Hemoglobin, G4
    1
    0
        Platelet count, G4
    0
    1
        Total Neutrophils, G3
    5
    0
        Total Neutrophils, G4
    3
    1
    No statistical analyses for this end point

    Secondary: Number of participants (par.) with detectable virus that has genotypic or phenotypic evidence of treatment-emergent resistance to DTG, DRV+RTV and other on-study ART at time of protocol defined virology failure (PDVF)

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    End point title
    		 Number of participants (par.) with detectable virus that has genotypic or phenotypic evidence of treatment-emergent resistance to DTG, DRV+RTV and other on-study ART at time of protocol defined virology failure (PDVF)
    End point description
    An assessment was made of every change across all amino acids within the integrase (IN), reverse transcriptase (RT), and Protease (PRO) encoding region at Baseline and at time of suspected PDVF. PDVF is defined as the confirmed plasma HIV-1 RNA >200 c/mL >=Week 24. PDVF Genotypic Population included all participants in the mITT-E population with available on-treatment genotypic resistance data, at time of PDVF. Only those participants with data available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline until PDVF up to Week 48
    End point values
    		 DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
    Number of subjects analysed
    2 [5]
    2 [6]
    Units: Participants
        Participants
    0
    0
    Notes
    [5] - PDVF Genotypic Population
    [6] - PDVF Genotypic Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) bother score at Week 4, Week 24, and Week 48

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    End point title
    		 Change from Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) bother score at Week 4, Week 24, and Week 48
    End point description
    SDM is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Each item is rated from 0 to 4 where 0 (complete absence of symptom) and 4 (very bothersome symptom). Overall score calculated as the sum of the scores for each of the 20 items of the questionnaire and ranged from 0 (best health) and 80 (worst health). Values represented are for adjusted mean. Estimates are calculated from an ANCOVA model adjusting for age, sex, race, baseline viral load, background dual NRTI therapy and baseline symptom bother score. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. A positive change from Baseline indicates a decline in a participant’s quality of life over that period.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 24, and Week 48
    End point values
    		 DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
    Number of subjects analysed
    242
    242
    Units: Scores on a scale
    arithmetic mean (standard error)
        Week 4, n=218, 210
    -3.20 ± 0.56
    -2.19 ± 0.56
        Week 24, n=222, 214
    -2.71 ± 0.64
    -1.65 ± 0.65
        Week 48, n= 222, 215
    -2.46 ± 0.68
    -0.77 ± 0.69
    No statistical analyses for this end point

    Secondary: Change from Baseline in European Quality of Life -5 Dimensions (EQ-5D) utility scores at Week 24 and Week 48

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    End point title
    		 Change from Baseline in European Quality of Life -5 Dimensions (EQ-5D) utility scores at Week 24 and Week 48
    End point description
    The EQ-5D is a 5-question quality of life instrument that provides a utility score and visual analogue scale score that describes the participants’ health status. The primary reason for including the EQ-5D is to elicit utility values for potential cost-effectiveness analysis for submission to health technology assessment agencies. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome. Values represented are for adjusted mean. Estimates are calculated from an ANCOVA model adjusting for age, sex, race, baseline viral load, background dual NRTI therapy and Baseline EQ-5D utility score. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24, and Week 48
    End point values
    		 DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
    Number of subjects analysed
    242
    242
    Units: Scores on a scale
    arithmetic mean (standard error)
        Week 24, n=217, 213
    0.00 ± 0.012
    0.02 ± 0.012
        Week 48, n=224, 217
    0.01 ± 0.012
    0.01 ± 0.012
    No statistical analyses for this end point

    Secondary: Change from Baseline in EQ-5D thermometer scores at Week 24 and Week 48

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    End point title
    		 Change from Baseline in EQ-5D thermometer scores at Week 24 and Week 48
    End point description
    The European Quality of Life -5 Dimensions (EQ-5D) is a 5-question quality of life instrument that provides a utility score and visual analogue scale score that describes the participants’ health status. The primary reason for including the EQ-5D is to elicit utility values for potential cost-effectiveness analysis for submission to health technology assessment agencies. Thermometer score is based on a visual analogue scale (VAS) ranging from 100 (best imaginable health state) to 0 (worst imaginable health state).Values represented are for adjusted mean. Estimates are calculated from an ANCOVA model adjusting for age, sex, race, Baseline viral load, background dual NRTI therapy and Baseline EQ-5D thermometer score. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24, and Week 48
    End point values
    		 DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
    Number of subjects analysed
    242
    242
    Units: Scores on a scale
    arithmetic mean (standard error)
        Week 24, n=221, 216
    4.95 ± 0.885
    5.96 ± 0.895
        Week 48, n=224, 220
    5.78 ± 0.762
    6.95 ± 0.769
    No statistical analyses for this end point

    Secondary: Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) total score at Week 4, Week 24, and Week 48

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    End point title
    		 Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) total score at Week 4, Week 24, and Week 48
    End point description
    Participant treatment satisfaction was measured using the self-reported scale (HIVTSQ), which consists of 10 items (1-satisfaction, 2-HIV control, 3-adverse effects, 4-level of demand, 5-convenience, 6-flexibility, 7-knowledge, 8-life habits, 9-recommendability, and 10-willingness to continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The treatment satisfaction score (range: 0-60) was the sum of the individual items. HIVTSQ mITT-E Population=Only participants from USA, France, Germany, Italy, Spain for whom valid translations were available from the mITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the HIVTSQ mITT-E population.
    End point type
    Secondary
    End point timeframe
    Week 4, Week 24, and Week 48
    End point values
    		 DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
    Number of subjects analysed
    214
    206
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Week 4, n=206, 192
    54.1 ± 6.43
    52.4 ± 7.94
        Week 24, n= 211, 200
    56.1 ± 5.16
    54.3 ± 6.94
        Week 48, n=212, 201
    56.1 ± 4.60
    54.5 ± 6.78
    No statistical analyses for this end point

    Secondary: Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) lifestyle/ease sub score at Week 4, Week 24, and Week 48

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    End point title
    		 Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) lifestyle/ease sub score at Week 4, Week 24, and Week 48
    End point description
    Participant treatment satisfaction was measured using the self-reported scale (HIVTSQ), which consists of 10 items (1-satisfaction, 2-HIV control, 3-adverse effects, 4-level of demand, 5-convenience, 6-flexibility, 7-knowledge, 8-life habits, 9-recommendability, and 10-willingness to continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The lifestyle/ease score is the sum of items 4, 5, 6, 7 and 8 (range: 0-30). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the HIVTSQ mITT-E population.
    End point type
    Secondary
    End point timeframe
    Week 4, Week 24, and Week 48
    End point values
    		 DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
    Number of subjects analysed
    214
    206
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Week 4, n=202, 190
    26.7 ± 3.61
    25.8 ± 4.48
        Week 24, n=210, 199
    27.5 ± 3.16
    26.6 ± 4.11
        Week 48, n=211, 201
    27.6 ± 3.00
    26.6 ± 4.11
    No statistical analyses for this end point

    Secondary: Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) convenience score at Week 4, Week 24, and Week 48

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    End point title
    		 Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) convenience score at Week 4, Week 24, and Week 48
    End point description
    Participant treatment satisfaction was measured using the self-reported scale (HIVTSQ), which consists of 10 items (1-satisfaction, 2-HIV control, 3-adverse effects, 4-level of demand, 5-convenience, 6-flexibility, 7-knowledge, 8-life habits, 9-recommendability, and 10-willingness to continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The convenience score is the score for item 5 (range: 0-6). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the HIVTSQ mITT-E population.
    End point type
    Secondary
    End point timeframe
    Week 4, Week 24, and Week 48
    End point values
    		 DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
    Number of subjects analysed
    214
    206
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Week 4, n=204, 190
    5.6 ± 0.71
    5.2 ± 1.11
        Week 24, n=211, 200,
    5.6 ± 0.64
    5.4 ± 1.01
        Week 48, n=212, 201
    5.7 ± 0.62
    5.4 ± 1.02
    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 adverse events (AEs) are presented from the available safety data from the start of the study medication up to end of study.
    Adverse event reporting additional description
    SAEs and non-serious AEs were reported for members of the Modified Safety Population, comprised of all participants who received at least one dose of investigational product excluding one participant at one site, which was closed due to GCP non-compliance issues in another ViiV Healthcare sponsored trial.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    DRV 800 mg + RTV 100 mg QD
    Reporting group description
    		 Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.

    Reporting group title
    DTG 50 mg QD
    Reporting group description
    		 Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.

    Reporting group title
    Extension DTG 50 mg
    Reporting group description
    		 DTG participants who successfully completed 96 Weeks of randomized phase continued to receive DTG 50 mg QD during Extension phase

    Serious adverse events
    		 DRV 800 mg + RTV 100 mg QD DTG 50 mg QD Extension DTG 50 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 242 (8.68%)
    36 / 242 (14.88%)
    4 / 123 (3.25%)
         number of deaths (all causes)
    0
    1
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hodgkin's disease
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Complication of pregnancy
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Allergy to arthropod sting
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    0 / 242 (0.00%)
    3 / 242 (1.24%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Drug use disorder
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back injury
         subjects affected / exposed
    0 / 242 (0.00%)
    0 / 242 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative ileus
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stab wound
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiomyopathy alcoholic
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congestive cardiomyopathy
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lacunar stroke
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Methaemoglobinaemia
         subjects affected / exposed
    0 / 242 (0.00%)
    0 / 242 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea haemorrhagic
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Odynophagia
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 242 (0.00%)
    0 / 242 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myofascial pain syndrome
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Polyarthritis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Acute hepatitis C
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute sinusitis
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster disseminated
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster infection neurological
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neurosyphilis
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Perineal abscess
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Proctitis infectious
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 DRV 800 mg + RTV 100 mg QD DTG 50 mg QD Extension DTG 50 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    214 / 242 (88.43%)
    221 / 242 (91.32%)
    52 / 123 (42.28%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts
         subjects affected / exposed
    13 / 242 (5.37%)
    8 / 242 (3.31%)
    1 / 123 (0.81%)
         occurrences all number
    17
    10
    1
    Lipoma
         subjects affected / exposed
    2 / 242 (0.83%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    2
    2
    0
    Melanocytic naevus
         subjects affected / exposed
    3 / 242 (1.24%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    3
    1
    0
    Basal cell carcinoma
         subjects affected / exposed
    2 / 242 (0.83%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    2
    0
    0
    Seborrhoeic keratosis
         subjects affected / exposed
    2 / 242 (0.83%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    3
    0
    0
    Skin papilloma
         subjects affected / exposed
    2 / 242 (0.83%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    2
    0
    0
    Acrochordon
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Fibroma
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Oral neoplasm
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Papilloma
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    10 / 242 (4.13%)
    7 / 242 (2.89%)
    0 / 123 (0.00%)
         occurrences all number
    10
    7
    0
    Hot flush
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Varicose vein
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Haematoma
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Hypertensive crisis
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Vomiting in pregnancy
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    16 / 242 (6.61%)
    16 / 242 (6.61%)
    0 / 123 (0.00%)
         occurrences all number
    17
    17
    0
    Fatigue
         subjects affected / exposed
    14 / 242 (5.79%)
    15 / 242 (6.20%)
    0 / 123 (0.00%)
         occurrences all number
    15
    17
    0
    Asthenia
         subjects affected / exposed
    11 / 242 (4.55%)
    5 / 242 (2.07%)
    2 / 123 (1.63%)
         occurrences all number
    11
    7
    2
    Influenza like illness
         subjects affected / exposed
    6 / 242 (2.48%)
    9 / 242 (3.72%)
    0 / 123 (0.00%)
         occurrences all number
    7
    11
    0
    Chest pain
         subjects affected / exposed
    7 / 242 (2.89%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    8
    3
    0
    Pain
         subjects affected / exposed
    5 / 242 (2.07%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    6
    3
    0
    Chills
         subjects affected / exposed
    4 / 242 (1.65%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    4
    2
    0
    Feeling hot
         subjects affected / exposed
    4 / 242 (1.65%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    5
    2
    0
    Malaise
         subjects affected / exposed
    2 / 242 (0.83%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    2
    3
    0
    Peripheral swelling
         subjects affected / exposed
    2 / 242 (0.83%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    2
    3
    0
    Local swelling
         subjects affected / exposed
    2 / 242 (0.83%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    2
    1
    0
    Chest discomfort
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Discomfort
         subjects affected / exposed
    2 / 242 (0.83%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    2
    0
    0
    Thirst
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Abscess sterile
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Axillary pain
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Cyst
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Dysplasia
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Feeling abnormal
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Hunger
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Nodule
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Submandibular mass
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Thirst decreased
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Vaccination site erythema
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    3 / 242 (1.24%)
    3 / 242 (1.24%)
    1 / 123 (0.81%)
         occurrences all number
    3
    3
    1
    Hypersensitivity
         subjects affected / exposed
    1 / 242 (0.41%)
    4 / 242 (1.65%)
    1 / 123 (0.81%)
         occurrences all number
    1
    5
    1
    Multiple allergies
         subjects affected / exposed
    3 / 242 (1.24%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    3
    1
    0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Food allergy
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Jarisch-Herxheimer reaction
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Social circumstances
    Bereavement
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Family stress
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Substance use
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Treatment noncompliance
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    4 / 242 (1.65%)
    4 / 242 (1.65%)
    0 / 123 (0.00%)
         occurrences all number
    4
    5
    0
    Prostatitis
         subjects affected / exposed
    1 / 242 (0.41%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    4
    2
    0
    Balanoposthitis
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Breast cyst
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    1 / 123 (0.81%)
         occurrences all number
    1
    0
    1
    Genital lesion
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Penile discharge
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Varicocele
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Asthenospermia
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Breast discharge
         subjects affected / exposed
    0 / 242 (0.00%)
    0 / 242 (0.00%)
    1 / 123 (0.81%)
         occurrences all number
    0
    0
    1
    Breast mass
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Cervical dysplasia
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Ejaculation failure
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Genital discomfort
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Genital rash
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Gynaecomastia
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Haematospermia
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Menorrhagia
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Ovarian cyst
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Testicular pain
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Vulvovaginal pruritus
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    19 / 242 (7.85%)
    18 / 242 (7.44%)
    1 / 123 (0.81%)
         occurrences all number
    21
    20
    1
    Oropharyngeal pain
         subjects affected / exposed
    10 / 242 (4.13%)
    10 / 242 (4.13%)
    0 / 123 (0.00%)
         occurrences all number
    10
    10
    0
    Sinus congestion
         subjects affected / exposed
    8 / 242 (3.31%)
    6 / 242 (2.48%)
    0 / 123 (0.00%)
         occurrences all number
    9
    8
    0
    Nasal congestion
         subjects affected / exposed
    6 / 242 (2.48%)
    4 / 242 (1.65%)
    1 / 123 (0.81%)
         occurrences all number
    6
    7
    1
    Rhinitis allergic
         subjects affected / exposed
    3 / 242 (1.24%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    3
    3
    0
    Asthma
         subjects affected / exposed
    4 / 242 (1.65%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    4
    3
    0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 242 (0.00%)
    4 / 242 (1.65%)
    1 / 123 (0.81%)
         occurrences all number
    0
    4
    1
    Productive cough
         subjects affected / exposed
    3 / 242 (1.24%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    3
    3
    0
    Rhinorrhoea
         subjects affected / exposed
    2 / 242 (0.83%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    3
    3
    0
    Dyspnoea
         subjects affected / exposed
    2 / 242 (0.83%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    2
    2
    0
    Epistaxis
         subjects affected / exposed
    0 / 242 (0.00%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    0
    5
    0
    Pharyngeal erythema
         subjects affected / exposed
    2 / 242 (0.83%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    2
    2
    0
    Pulmonary congestion
         subjects affected / exposed
    0 / 242 (0.00%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    0
    4
    0
    Tonsillar hypertrophy
         subjects affected / exposed
    1 / 242 (0.41%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    1
    2
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    1 / 242 (0.41%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    1
    3
    0
    Allergic sinusitis
         subjects affected / exposed
    2 / 242 (0.83%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    2
    0
    0
    Dysphonia
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    1 / 123 (0.81%)
         occurrences all number
    1
    0
    1
    Dyspnoea exertional
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Paranasal sinus hypersecretion
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    0
    3
    0
    Respiratory tract congestion
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Adenoidal hypertrophy
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Asthmatic crisis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Emphysema
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Hypoventilation
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Laryngeal oedema
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Lower respiratory tract congestion
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Nasal discharge discolouration
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Nasal oedema
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Pharyngeal disorder
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Pharyngeal ulceration
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Rales
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Sinus pain
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Sneezing
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Throat irritation
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Tonsillar exudate
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Vocal cord polyp
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Vocal cord thickening
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Wheezing
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    16 / 242 (6.61%)
    19 / 242 (7.85%)
    1 / 123 (0.81%)
         occurrences all number
    17
    21
    1
    Anxiety
         subjects affected / exposed
    9 / 242 (3.72%)
    13 / 242 (5.37%)
    1 / 123 (0.81%)
         occurrences all number
    9
    13
    1
    Depression
         subjects affected / exposed
    8 / 242 (3.31%)
    12 / 242 (4.96%)
    0 / 123 (0.00%)
         occurrences all number
    9
    14
    0
    Abnormal dreams
         subjects affected / exposed
    3 / 242 (1.24%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    3
    3
    0
    Drug use disorder
         subjects affected / exposed
    2 / 242 (0.83%)
    4 / 242 (1.65%)
    0 / 123 (0.00%)
         occurrences all number
    2
    4
    0
    Sleep disorder
         subjects affected / exposed
    1 / 242 (0.41%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    1
    3
    0
    Depressed mood
         subjects affected / exposed
    3 / 242 (1.24%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    3
    0
    0
    Libido decreased
         subjects affected / exposed
    2 / 242 (0.83%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    2
    1
    0
    Nightmare
         subjects affected / exposed
    0 / 242 (0.00%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    0
    3
    0
    Panic attack
         subjects affected / exposed
    1 / 242 (0.41%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    1
    2
    0
    Adjustment disorder with depressed mood
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Alcohol abuse
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Bipolar disorder
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Irritability
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Libido disorder
         subjects affected / exposed
    2 / 242 (0.83%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    2
    0
    0
    Tobacco abuse
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Adjustment disorder
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Aggression
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Anorexia nervosa
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Burnout syndrome
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Dissociation
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Eating disorder
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Flat affect
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Initial insomnia
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Intentional self-injury
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Loss of libido
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Middle insomnia
         subjects affected / exposed
    0 / 242 (0.00%)
    0 / 242 (0.00%)
    1 / 123 (0.81%)
         occurrences all number
    0
    0
    1
    Mood swings
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Nervousness
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Persistent depressive disorder
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Psychomotor retardation
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Stress
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Suicide attempt
         subjects affected / exposed
    0 / 242 (0.00%)
    0 / 242 (0.00%)
    1 / 123 (0.81%)
         occurrences all number
    0
    0
    1
    Substance use disorder
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Tic
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Hepatic steatosis
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Gallbladder cholesterolosis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatitis alcoholic
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatosplenomegaly
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    2 / 242 (0.83%)
    9 / 242 (3.72%)
    0 / 123 (0.00%)
         occurrences all number
    2
    9
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    4 / 242 (1.65%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    4
    2
    0
    Blood triglycerides increased
         subjects affected / exposed
    3 / 242 (1.24%)
    1 / 242 (0.41%)
    1 / 123 (0.81%)
         occurrences all number
    3
    1
    1
    Weight increased
         subjects affected / exposed
    2 / 242 (0.83%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    2
    3
    0
    Blood cholesterol increased
         subjects affected / exposed
    3 / 242 (1.24%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    3
    3
    0
    Blood creatinine increased
         subjects affected / exposed
    0 / 242 (0.00%)
    4 / 242 (1.65%)
    0 / 123 (0.00%)
         occurrences all number
    0
    4
    0
    Transaminases increased
         subjects affected / exposed
    2 / 242 (0.83%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    2
    2
    0
    Weight decreased
         subjects affected / exposed
    3 / 242 (1.24%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    3
    1
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 242 (1.24%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    3
    0
    0
    Lipase increased
         subjects affected / exposed
    3 / 242 (1.24%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    4
    0
    0
    Blood phosphorus decreased
         subjects affected / exposed
    2 / 242 (0.83%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    3
    0
    0
    Blood testosterone decreased
         subjects affected / exposed
    2 / 242 (0.83%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    2
    0
    0
    High density lipoprotein decreased
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Blood creatine phosphokinase abnormal
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    2
    0
    0
    Blood creatinine abnormal
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Blood glucose increased
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    3
    0
    0
    Blood urine present
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Campylobacter test positive
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Creatinine renal clearance decreased
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Electrocardiogram abnormal
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Electrocardiogram repolarisation abnormality
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Glomerular filtration rate decreased
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Lipids increased
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Liver function test increased
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Low density lipoprotein increased
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Lymph node palpable
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Neutrophil count decreased
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Neutrophil count increased
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Parasite stool test positive
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Protein urine present
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    White blood cells urine positive
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    2 / 242 (0.83%)
    4 / 242 (1.65%)
    0 / 123 (0.00%)
         occurrences all number
    2
    4
    0
    Procedural pain
         subjects affected / exposed
    1 / 242 (0.41%)
    5 / 242 (2.07%)
    0 / 123 (0.00%)
         occurrences all number
    1
    5
    0
    Contusion
         subjects affected / exposed
    4 / 242 (1.65%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    4
    1
    0
    Ligament sprain
         subjects affected / exposed
    1 / 242 (0.41%)
    4 / 242 (1.65%)
    0 / 123 (0.00%)
         occurrences all number
    1
    4
    0
    Hand fracture
         subjects affected / exposed
    2 / 242 (0.83%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    3
    2
    0
    Animal bite
         subjects affected / exposed
    2 / 242 (0.83%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    3
    1
    0
    Fall
         subjects affected / exposed
    2 / 242 (0.83%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    2
    1
    0
    Laceration
         subjects affected / exposed
    0 / 242 (0.00%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    0
    3
    0
    Muscle strain
         subjects affected / exposed
    1 / 242 (0.41%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    1
    2
    0
    Thermal burn
         subjects affected / exposed
    2 / 242 (0.83%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    2
    1
    0
    Burn oral cavity
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Foot fracture
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    1 / 123 (0.81%)
         occurrences all number
    0
    1
    1
    Joint injury
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    1 / 123 (0.81%)
         occurrences all number
    0
    1
    1
    Ligament rupture
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Meniscus injury
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Rib fracture
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Road traffic accident
         subjects affected / exposed
    2 / 242 (0.83%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    2
    0
    0
    Skin abrasion
         subjects affected / exposed
    2 / 242 (0.83%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    2
    0
    0
    Tooth fracture
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Arthropod sting
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Axillary nerve injury
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Back injury
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Burns first degree
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Burns second degree
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Burns third degree
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Concussion
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Corneal abrasion
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Epicondylitis
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Eye injury
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Head injury
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Incision site haemorrhage
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Incision site pain
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Limb injury
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Patella fracture
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Penis injury
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Post procedural swelling
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Post-traumatic pain
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Product use complaint
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Scrotal haematoma
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Skin injury
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Sports injury
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Sunburn
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Tendon rupture
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Congenital, familial and genetic disorders
    Bicuspid aortic valve
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Type V hyperlipidaemia
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 242 (0.00%)
    4 / 242 (1.65%)
    0 / 123 (0.00%)
         occurrences all number
    0
    4
    0
    Extrasystoles
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Tachycardia
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Arrhythmia
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Bradycardia
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Bundle branch block left
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac failure
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Myocardial infarction
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Pericarditis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Ventricular hypertrophy
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    26 / 242 (10.74%)
    40 / 242 (16.53%)
    2 / 123 (1.63%)
         occurrences all number
    29
    45
    2
    Dizziness
         subjects affected / exposed
    13 / 242 (5.37%)
    14 / 242 (5.79%)
    0 / 123 (0.00%)
         occurrences all number
    14
    15
    0
    Hypoaesthesia
         subjects affected / exposed
    2 / 242 (0.83%)
    4 / 242 (1.65%)
    0 / 123 (0.00%)
         occurrences all number
    2
    4
    0
    Paraesthesia
         subjects affected / exposed
    4 / 242 (1.65%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    5
    1
    0
    Sciatica
         subjects affected / exposed
    0 / 242 (0.00%)
    4 / 242 (1.65%)
    1 / 123 (0.81%)
         occurrences all number
    0
    4
    1
    Somnolence
         subjects affected / exposed
    3 / 242 (1.24%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    3
    2
    0
    Migraine
         subjects affected / exposed
    4 / 242 (1.65%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    4
    0
    0
    Balance disorder
         subjects affected / exposed
    3 / 242 (1.24%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    3
    0
    0
    Memory impairment
         subjects affected / exposed
    2 / 242 (0.83%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    2
    1
    0
    Syncope
         subjects affected / exposed
    1 / 242 (0.41%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    1
    2
    0
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Dysgeusia
         subjects affected / exposed
    2 / 242 (0.83%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    2
    0
    0
    Burning sensation
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Cervicobrachial syndrome
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Disturbance in attention
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Dysarthria
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Facial paralysis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Lethargy
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Lumbar radiculopathy
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Mental impairment
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Nerve compression
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Neuropathy peripheral
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Post herpetic neuralgia
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    2
    0
    0
    Sinus headache
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    6 / 242 (2.48%)
    7 / 242 (2.89%)
    0 / 123 (0.00%)
         occurrences all number
    6
    7
    0
    Neutropenia
         subjects affected / exposed
    3 / 242 (1.24%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    3
    3
    0
    Anaemia
         subjects affected / exposed
    1 / 242 (0.41%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    1
    3
    0
    Eosinophilia
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Haemorrhagic anaemia
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Leukocytosis
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Leukopenia
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Ear and labyrinth disorders
    Ear congestion
         subjects affected / exposed
    1 / 242 (0.41%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    1
    3
    0
    Tinnitus
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    1 / 123 (0.81%)
         occurrences all number
    1
    3
    1
    Vertigo
         subjects affected / exposed
    3 / 242 (1.24%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    4
    0
    0
    Deafness
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Cerumen impaction
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Ear canal erythema
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Tympanic membrane perforation
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    1 / 242 (0.41%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    1
    2
    0
    Chalazion
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Vitreous floaters
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Cataract
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Keratitis
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Scleral discolouration
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Xerophthalmia
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    74 / 242 (30.58%)
    43 / 242 (17.77%)
    2 / 123 (1.63%)
         occurrences all number
    98
    46
    2
    Nausea
         subjects affected / exposed
    48 / 242 (19.83%)
    40 / 242 (16.53%)
    2 / 123 (1.63%)
         occurrences all number
    56
    45
    2
    Vomiting
         subjects affected / exposed
    17 / 242 (7.02%)
    15 / 242 (6.20%)
    0 / 123 (0.00%)
         occurrences all number
    22
    16
    0
    Abdominal pain
         subjects affected / exposed
    12 / 242 (4.96%)
    13 / 242 (5.37%)
    0 / 123 (0.00%)
         occurrences all number
    12
    14
    0
    Constipation
         subjects affected / exposed
    5 / 242 (2.07%)
    13 / 242 (5.37%)
    0 / 123 (0.00%)
         occurrences all number
    5
    13
    0
    Abdominal distension
         subjects affected / exposed
    9 / 242 (3.72%)
    8 / 242 (3.31%)
    0 / 123 (0.00%)
         occurrences all number
    9
    10
    0
    Haemorrhoids
         subjects affected / exposed
    6 / 242 (2.48%)
    8 / 242 (3.31%)
    1 / 123 (0.81%)
         occurrences all number
    6
    8
    1
    Flatulence
         subjects affected / exposed
    11 / 242 (4.55%)
    5 / 242 (2.07%)
    0 / 123 (0.00%)
         occurrences all number
    11
    6
    0
    Abdominal pain upper
         subjects affected / exposed
    4 / 242 (1.65%)
    10 / 242 (4.13%)
    0 / 123 (0.00%)
         occurrences all number
    4
    10
    0
    Dyspepsia
         subjects affected / exposed
    7 / 242 (2.89%)
    5 / 242 (2.07%)
    0 / 123 (0.00%)
         occurrences all number
    9
    6
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    4 / 242 (1.65%)
    6 / 242 (2.48%)
    0 / 123 (0.00%)
         occurrences all number
    4
    8
    0
    Abdominal discomfort
         subjects affected / exposed
    6 / 242 (2.48%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    7
    3
    0
    Rectal haemorrhage
         subjects affected / exposed
    3 / 242 (1.24%)
    4 / 242 (1.65%)
    1 / 123 (0.81%)
         occurrences all number
    3
    4
    1
    Faeces soft
         subjects affected / exposed
    3 / 242 (1.24%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    3
    3
    0
    Anal fissure
         subjects affected / exposed
    3 / 242 (1.24%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    3
    2
    0
    Dry mouth
         subjects affected / exposed
    2 / 242 (0.83%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    2
    4
    0
    Toothache
         subjects affected / exposed
    3 / 242 (1.24%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    3
    2
    0
    Dental caries
         subjects affected / exposed
    2 / 242 (0.83%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    2
    2
    0
    Gastritis
         subjects affected / exposed
    3 / 242 (1.24%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    3
    1
    0
    Proctalgia
         subjects affected / exposed
    0 / 242 (0.00%)
    4 / 242 (1.65%)
    0 / 123 (0.00%)
         occurrences all number
    0
    4
    0
    Aphthous ulcer
         subjects affected / exposed
    0 / 242 (0.00%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    0
    3
    0
    Colitis
         subjects affected / exposed
    1 / 242 (0.41%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    1
    2
    0
    Haematochezia
         subjects affected / exposed
    1 / 242 (0.41%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    1
    2
    0
    Proctitis
         subjects affected / exposed
    1 / 242 (0.41%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    1
    2
    0
    Anal ulcer
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Anogenital dysplasia
         subjects affected / exposed
    2 / 242 (0.83%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    2
    0
    0
    Anorectal disorder
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Diarrhoea haemorrhagic
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Enterocolitis
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Food poisoning
         subjects affected / exposed
    2 / 242 (0.83%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    2
    0
    0
    Frequent bowel movements
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Oral pain
         subjects affected / exposed
    2 / 242 (0.83%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    2
    0
    0
    Tongue coated
         subjects affected / exposed
    2 / 242 (0.83%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    2
    0
    0
    Abdominal hernia
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal pain lower
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Abdominal tenderness
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Anal haemorrhage
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Anal pruritus
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Anorectal discomfort
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Colitis microscopic
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Crohn's disease
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Dysphagia
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Epigastric discomfort
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal erosion
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal inflammation
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Gingival disorder
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Gingival recession
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Glossodynia
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Haemorrhoids thrombosed
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperchlorhydria
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Inguinal hernia
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Intestinal polyp
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Leukoplakia oral
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Mouth ulceration
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Mucous stools
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Noninfective gingivitis
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Odynophagia
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Oedema mouth
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Oesophagitis
         subjects affected / exposed
    0 / 242 (0.00%)
    0 / 242 (0.00%)
    1 / 123 (0.81%)
         occurrences all number
    0
    0
    1
    Palatal disorder
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Pancreatitis chronic
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Rectal lesion
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Stomatitis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Tongue disorder
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Tongue dry
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Tongue ulceration
         subjects affected / exposed
    0 / 242 (0.00%)
    0 / 242 (0.00%)
    1 / 123 (0.81%)
         occurrences all number
    0
    0
    1
    Tooth impacted
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    17 / 242 (7.02%)
    13 / 242 (5.37%)
    0 / 123 (0.00%)
         occurrences all number
    19
    13
    0
    Pruritus
         subjects affected / exposed
    7 / 242 (2.89%)
    5 / 242 (2.07%)
    0 / 123 (0.00%)
         occurrences all number
    9
    6
    0
    Night sweats
         subjects affected / exposed
    6 / 242 (2.48%)
    2 / 242 (0.83%)
    1 / 123 (0.81%)
         occurrences all number
    6
    2
    1
    Alopecia
         subjects affected / exposed
    1 / 242 (0.41%)
    5 / 242 (2.07%)
    0 / 123 (0.00%)
         occurrences all number
    1
    5
    0
    Dry skin
         subjects affected / exposed
    3 / 242 (1.24%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    3
    3
    0
    Acne
         subjects affected / exposed
    1 / 242 (0.41%)
    4 / 242 (1.65%)
    0 / 123 (0.00%)
         occurrences all number
    1
    4
    0
    Eczema
         subjects affected / exposed
    2 / 242 (0.83%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    2
    3
    0
    Dermatitis
         subjects affected / exposed
    3 / 242 (1.24%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    3
    1
    0
    Erythema
         subjects affected / exposed
    0 / 242 (0.00%)
    3 / 242 (1.24%)
    1 / 123 (0.81%)
         occurrences all number
    0
    3
    1
    Psoriasis
         subjects affected / exposed
    4 / 242 (1.65%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    4
    0
    0
    Rash macular
         subjects affected / exposed
    2 / 242 (0.83%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    2
    2
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    4 / 242 (1.65%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    4
    0
    0
    Urticaria
         subjects affected / exposed
    3 / 242 (1.24%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    4
    1
    0
    Dermal cyst
         subjects affected / exposed
    0 / 242 (0.00%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    0
    3
    0
    Dermatitis allergic
         subjects affected / exposed
    2 / 242 (0.83%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    2
    1
    0
    Dermatitis contact
         subjects affected / exposed
    1 / 242 (0.41%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    1
    2
    0
    Dyshidrotic eczema
         subjects affected / exposed
    1 / 242 (0.41%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    1
    2
    0
    Skin lesion
         subjects affected / exposed
    0 / 242 (0.00%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    0
    3
    0
    Drug eruption
         subjects affected / exposed
    2 / 242 (0.83%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    2
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Pruritus generalised
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Seborrhoea
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Alopecia areata
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Blister
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Cold sweat
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Dermatosis
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Guttate psoriasis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Hair colour changes
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Hand dermatitis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperkeratosis
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Intertrigo
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Lipodystrophy acquired
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Miliaria
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Mucocutaneous ulceration
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Penile ulceration
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Pityriasis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Prurigo
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Rash erythematous
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    2
    0
    0
    Rash generalised
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Rash morbilliform
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Rash pruritic
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Rosacea
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Skin disorder
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Skin erosion
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Skin exfoliation
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Skin fissures
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Skin hyperpigmentation
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Swelling face
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    3 / 242 (1.24%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    3
    3
    0
    Nephrolithiasis
         subjects affected / exposed
    2 / 242 (0.83%)
    2 / 242 (0.83%)
    1 / 123 (0.81%)
         occurrences all number
    3
    2
    1
    Chromaturia
         subjects affected / exposed
    1 / 242 (0.41%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    1
    2
    0
    Haematuria
         subjects affected / exposed
    2 / 242 (0.83%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    2
    1
    0
    Pollakiuria
         subjects affected / exposed
    1 / 242 (0.41%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    1
    2
    0
    Renal colic
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    2 / 123 (1.63%)
         occurrences all number
    2
    0
    2
    Acute kidney injury
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    1 / 123 (0.81%)
         occurrences all number
    0
    1
    1
    Renal tubular dysfunction
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    1 / 123 (0.81%)
         occurrences all number
    0
    1
    1
    Urine flow decreased
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Bladder disorder
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Micturition disorder
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Micturition urgency
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Renal failure
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Urethral discharge
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary hesitation
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary incontinence
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary retention
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Endocrine disorders
    Hypogonadism
         subjects affected / exposed
    2 / 242 (0.83%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    2
    2
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    17 / 242 (7.02%)
    14 / 242 (5.79%)
    0 / 123 (0.00%)
         occurrences all number
    17
    14
    0
    Arthralgia
         subjects affected / exposed
    15 / 242 (6.20%)
    9 / 242 (3.72%)
    0 / 123 (0.00%)
         occurrences all number
    19
    10
    0
    Myalgia
         subjects affected / exposed
    12 / 242 (4.96%)
    7 / 242 (2.89%)
    1 / 123 (0.81%)
         occurrences all number
    13
    7
    1
    Pain in extremity
         subjects affected / exposed
    9 / 242 (3.72%)
    9 / 242 (3.72%)
    0 / 123 (0.00%)
         occurrences all number
    12
    9
    0
    Muscle spasms
         subjects affected / exposed
    3 / 242 (1.24%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    3
    3
    0
    Neck pain
         subjects affected / exposed
    4 / 242 (1.65%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    4
    2
    0
    Muscle contracture
         subjects affected / exposed
    1 / 242 (0.41%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    1
    3
    0
    Osteopenia
         subjects affected / exposed
    1 / 242 (0.41%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    1
    3
    0
    Tendonitis
         subjects affected / exposed
    1 / 242 (0.41%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    1
    3
    0
    Flank pain
         subjects affected / exposed
    1 / 242 (0.41%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    2
    2
    0
    Joint swelling
         subjects affected / exposed
    3 / 242 (1.24%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    3
    0
    0
    Osteoporosis
         subjects affected / exposed
    2 / 242 (0.83%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    2
    1
    0
    Pain in jaw
         subjects affected / exposed
    1 / 242 (0.41%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    1
    2
    0
    Arthritis
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Bursitis
         subjects affected / exposed
    2 / 242 (0.83%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    2
    0
    0
    Groin pain
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    1 / 123 (0.81%)
         occurrences all number
    0
    1
    1
    Musculoskeletal pain
         subjects affected / exposed
    2 / 242 (0.83%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    2
    0
    0
    Osteoarthritis
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Spinal disorder
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    1 / 123 (0.81%)
         occurrences all number
    1
    0
    1
    Axillary mass
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Costochondritis
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Fibromyalgia
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Foot deformity
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Intervertebral disc disorder
         subjects affected / exposed
    0 / 242 (0.00%)
    0 / 242 (0.00%)
    1 / 123 (0.81%)
         occurrences all number
    0
    0
    1
    Joint range of motion decreased
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Joint stiffness
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Metatarsalgia
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Muscular weakness
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Temporomandibular joint syndrome
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Tendon disorder
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Torticollis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Viral upper respiratory tract infection
         subjects affected / exposed
    24 / 242 (9.92%)
    26 / 242 (10.74%)
    5 / 123 (4.07%)
         occurrences all number
    26
    33
    5
    Upper respiratory tract infection
         subjects affected / exposed
    27 / 242 (11.16%)
    16 / 242 (6.61%)
    1 / 123 (0.81%)
         occurrences all number
    30
    22
    1
    Bronchitis
         subjects affected / exposed
    17 / 242 (7.02%)
    12 / 242 (4.96%)
    0 / 123 (0.00%)
         occurrences all number
    20
    12
    0
    Gastroenteritis
         subjects affected / exposed
    14 / 242 (5.79%)
    12 / 242 (4.96%)
    3 / 123 (2.44%)
         occurrences all number
    16
    13
    3
    Pharyngitis
         subjects affected / exposed
    14 / 242 (5.79%)
    11 / 242 (4.55%)
    1 / 123 (0.81%)
         occurrences all number
    15
    11
    1
    Syphilis
         subjects affected / exposed
    12 / 242 (4.96%)
    11 / 242 (4.55%)
    2 / 123 (1.63%)
         occurrences all number
    12
    12
    2
    Sinusitis
         subjects affected / exposed
    13 / 242 (5.37%)
    9 / 242 (3.72%)
    0 / 123 (0.00%)
         occurrences all number
    14
    10
    0
    Influenza
         subjects affected / exposed
    11 / 242 (4.55%)
    4 / 242 (1.65%)
    2 / 123 (1.63%)
         occurrences all number
    11
    4
    2
    Folliculitis
         subjects affected / exposed
    6 / 242 (2.48%)
    7 / 242 (2.89%)
    0 / 123 (0.00%)
         occurrences all number
    6
    7
    0
    Urethritis
         subjects affected / exposed
    4 / 242 (1.65%)
    8 / 242 (3.31%)
    1 / 123 (0.81%)
         occurrences all number
    4
    8
    1
    Conjunctivitis
         subjects affected / exposed
    7 / 242 (2.89%)
    4 / 242 (1.65%)
    1 / 123 (0.81%)
         occurrences all number
    7
    4
    1
    Gonorrhoea
         subjects affected / exposed
    4 / 242 (1.65%)
    8 / 242 (3.31%)
    0 / 123 (0.00%)
         occurrences all number
    4
    9
    0
    Rhinitis
         subjects affected / exposed
    6 / 242 (2.48%)
    4 / 242 (1.65%)
    1 / 123 (0.81%)
         occurrences all number
    8
    4
    1
    Urinary tract infection
         subjects affected / exposed
    4 / 242 (1.65%)
    7 / 242 (2.89%)
    0 / 123 (0.00%)
         occurrences all number
    5
    7
    0
    Tonsillitis
         subjects affected / exposed
    3 / 242 (1.24%)
    5 / 242 (2.07%)
    1 / 123 (0.81%)
         occurrences all number
    4
    5
    1
    Oral herpes
         subjects affected / exposed
    2 / 242 (0.83%)
    6 / 242 (2.48%)
    0 / 123 (0.00%)
         occurrences all number
    2
    6
    0
    Respiratory tract infection
         subjects affected / exposed
    5 / 242 (2.07%)
    2 / 242 (0.83%)
    1 / 123 (0.81%)
         occurrences all number
    5
    3
    1
    Furuncle
         subjects affected / exposed
    4 / 242 (1.65%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    5
    3
    0
    Herpes zoster
         subjects affected / exposed
    5 / 242 (2.07%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    5
    2
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 242 (0.83%)
    3 / 242 (1.24%)
    2 / 123 (1.63%)
         occurrences all number
    2
    3
    2
    Tooth abscess
         subjects affected / exposed
    5 / 242 (2.07%)
    1 / 242 (0.41%)
    1 / 123 (0.81%)
         occurrences all number
    7
    1
    1
    Viral infection
         subjects affected / exposed
    1 / 242 (0.41%)
    6 / 242 (2.48%)
    0 / 123 (0.00%)
         occurrences all number
    1
    6
    0
    Acarodermatitis
         subjects affected / exposed
    1 / 242 (0.41%)
    5 / 242 (2.07%)
    0 / 123 (0.00%)
         occurrences all number
    1
    5
    0
    Chlamydial infection
         subjects affected / exposed
    3 / 242 (1.24%)
    2 / 242 (0.83%)
    1 / 123 (0.81%)
         occurrences all number
    3
    2
    1
    Fungal skin infection
         subjects affected / exposed
    4 / 242 (1.65%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    5
    2
    0
    Tooth infection
         subjects affected / exposed
    5 / 242 (2.07%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    5
    1
    0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 242 (0.41%)
    3 / 242 (1.24%)
    1 / 123 (0.81%)
         occurrences all number
    1
    3
    1
    Cellulitis
         subjects affected / exposed
    0 / 242 (0.00%)
    4 / 242 (1.65%)
    0 / 123 (0.00%)
         occurrences all number
    0
    4
    0
    Fungal infection
         subjects affected / exposed
    2 / 242 (0.83%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    2
    2
    0
    Genital herpes
         subjects affected / exposed
    1 / 242 (0.41%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    1
    4
    0
    Gingivitis
         subjects affected / exposed
    2 / 242 (0.83%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    2
    2
    0
    Hordeolum
         subjects affected / exposed
    3 / 242 (1.24%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    4
    1
    0
    Herpes simplex
         subjects affected / exposed
    0 / 242 (0.00%)
    4 / 242 (1.65%)
    0 / 123 (0.00%)
         occurrences all number
    0
    4
    0
    Tinea pedis
         subjects affected / exposed
    3 / 242 (1.24%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    3
    1
    0
    Abscess
         subjects affected / exposed
    1 / 242 (0.41%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    1
    2
    0
    Abscess limb
         subjects affected / exposed
    1 / 242 (0.41%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    2
    2
    0
    Body tinea
         subjects affected / exposed
    0 / 242 (0.00%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    0
    3
    0
    Dermatophytosis
         subjects affected / exposed
    1 / 242 (0.41%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    2
    2
    0
    Ear infection
         subjects affected / exposed
    2 / 242 (0.83%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    2
    1
    0
    Herpes virus infection
         subjects affected / exposed
    1 / 242 (0.41%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    2
    2
    0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 242 (0.41%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    1
    2
    0
    Onychomycosis
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    1 / 123 (0.81%)
         occurrences all number
    0
    2
    1
    Oral fungal infection
         subjects affected / exposed
    3 / 242 (1.24%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    3
    0
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    2 / 242 (0.83%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    2
    1
    0
    Pneumonia
         subjects affected / exposed
    1 / 242 (0.41%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    1
    2
    0
    Staphylococcal infection
         subjects affected / exposed
    2 / 242 (0.83%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    2
    1
    0
    Abdominal abscess
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    2
    1
    0
    Acute sinusitis
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Anal abscess
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Anal chlamydia infection
         subjects affected / exposed
    2 / 242 (0.83%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    2
    0
    0
    Cystitis
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Ear infection fungal
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Hepatitis C
         subjects affected / exposed
    2 / 242 (0.83%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    2
    0
    0
    Infected bite
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Latent tuberculosis
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Molluscum contagiosum
         subjects affected / exposed
    2 / 242 (0.83%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    2
    0
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Papilloma viral infection
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Paronychia
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    1 / 123 (0.81%)
         occurrences all number
    0
    1
    1
    Proctitis gonococcal
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Periodontitis
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    0
    3
    0
    Rash pustular
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    2
    1
    0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    1 / 123 (0.81%)
         occurrences all number
    2
    0
    1
    Secondary syphilis
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Tinea cruris
         subjects affected / exposed
    2 / 242 (0.83%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    2
    0
    0
    Tinea versicolour
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Trichomoniasis
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Urethritis chlamydial
         subjects affected / exposed
    1 / 242 (0.41%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    1
    1
    0
    Urethritis gonococcal
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    1 / 123 (0.81%)
         occurrences all number
    0
    1
    1
    Viral rhinitis
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Viral rash
         subjects affected / exposed
    0 / 242 (0.00%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Vulvovaginal candidiasis
         subjects affected / exposed
    2 / 242 (0.83%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    2
    0
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    2 / 242 (0.83%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    3
    0
    0
    Anal infection
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Bacterial vaginosis
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Borrelia infection
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchitis viral
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Candida infection
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Carbuncle
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Chronic sinusitis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Chronic tonsillitis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Condyloma latum
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Diarrhoea infectious
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Empyema
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Enterobiasis
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Eye infection syphilitic
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Genital candidiasis
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Genitourinary chlamydia infection
         subjects affected / exposed
    0 / 242 (0.00%)
    0 / 242 (0.00%)
    1 / 123 (0.81%)
         occurrences all number
    0
    0
    1
    Groin abscess
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Helicobacter gastritis
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Infected fistula
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Infection
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Labyrinthitis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Laryngitis
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Latent syphilis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Localised infection
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Orchitis
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Oropharyngeal candidiasis
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Oropharyngitis fungal
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Osteomyelitis
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Otitis externa
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Otitis media
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Parotitis
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Peritonsillar abscess
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Pertussis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Primary syphilis
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Proctitis chlamydial
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    2
    0
    Rotavirus infection
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Salmonellosis
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Shigella infection
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Sialoadenitis
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Skin candida
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Strongyloidiasis
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Superinfection bacterial
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Tinea capitis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Tongue fungal infection
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Tonsillitis bacterial
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Tracheitis
         subjects affected / exposed
    0 / 242 (0.00%)
    0 / 242 (0.00%)
    1 / 123 (0.81%)
         occurrences all number
    0
    0
    1
    Ureaplasma infection
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Vaginal infection
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Viral pharyngitis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Wound infection staphylococcal
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    8 / 242 (3.31%)
    4 / 242 (1.65%)
    0 / 123 (0.00%)
         occurrences all number
    8
    4
    0
    Vitamin D deficiency
         subjects affected / exposed
    5 / 242 (2.07%)
    5 / 242 (2.07%)
    0 / 123 (0.00%)
         occurrences all number
    5
    5
    0
    Dyslipidaemia
         subjects affected / exposed
    4 / 242 (1.65%)
    3 / 242 (1.24%)
    0 / 123 (0.00%)
         occurrences all number
    4
    4
    0
    Hyperlipidaemia
         subjects affected / exposed
    5 / 242 (2.07%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    5
    1
    0
    Hypercholesterolaemia
         subjects affected / exposed
    5 / 242 (2.07%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    5
    0
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    3 / 242 (1.24%)
    0 / 242 (0.00%)
    1 / 123 (0.81%)
         occurrences all number
    3
    0
    1
    Hyponatraemia
         subjects affected / exposed
    1 / 242 (0.41%)
    2 / 242 (0.83%)
    0 / 123 (0.00%)
         occurrences all number
    1
    2
    0
    Hypophosphataemia
         subjects affected / exposed
    2 / 242 (0.83%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    2
    1
    0
    Abnormal loss of weight
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Abnormal weight gain
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Dehydration
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Diabetes mellitus
         subjects affected / exposed
    0 / 242 (0.00%)
    0 / 242 (0.00%)
    1 / 123 (0.81%)
         occurrences all number
    0
    0
    1
    Diabetes mellitus inadequate control
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Gout
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 242 (0.00%)
    0 / 242 (0.00%)
    1 / 123 (0.81%)
         occurrences all number
    0
    0
    1
    Hyperlipasaemia
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Hypoglycaemia
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Hypovolaemia
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Iron deficiency
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Lipid metabolism disorder
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolic acidosis
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Obesity
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Type 1 diabetes mellitus
         subjects affected / exposed
    0 / 242 (0.00%)
    1 / 242 (0.41%)
    0 / 123 (0.00%)
         occurrences all number
    0
    1
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 242 (0.41%)
    0 / 242 (0.00%)
    0 / 123 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Aug 2011
    • Addition of Child-Pugh classification to the Time and Events table. • Addition of Rash toxicity as a study withdrawal criterion. • EudraCT number correction. • Use of Health Outcomes instruments only in countries where translations are available. • Addition of an electrocardiogram (ECG) at Week 48. • Addition of the PSRAE form • Addition of information regarding rash associated with DTG. • Addition of text regarding the snapshot algorithm and switching of background regimen and update to study results availability.

    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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