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    Clinical Trial Results:
    A Phase III, randomized, multicenter, open-label, non-inferiority study evaluating the efficacy, safety and tolerability of switching to dolutegravir/lamivudine fixed dose combination in HIV-1 infected adults who are virologically suppressed

    Summary
    EudraCT number
    		 2018-000177-72
    Trial protocol
    		 GB   SE   DE   FR   DK   ES   IT  
    Global end of trial date
    09 Sep 2022

    Results information
    Results version number
    		 v3(current)
    This version publication date
    09 Jun 2023
    First version publication date
    04 May 2022
    Other versions
    		 v1 , v2
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    208090
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04021290
    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, ViiV Healthcare, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, ViiV Healthcare, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Oct 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Sep 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study is to demonstrate the non-inferior antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 48 weeks in virologically suppressed adults living with HIV-1.
    Protection of trial subjects
    Not Applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Nov 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 26
    Country: Number of subjects enrolled
    Belgium: 12
    Country: Number of subjects enrolled
    Brazil: 39
    Country: Number of subjects enrolled
    Canada: 20
    Country: Number of subjects enrolled
    China: 38
    Country: Number of subjects enrolled
    Denmark: 15
    Country: Number of subjects enrolled
    France: 39
    Country: Number of subjects enrolled
    Germany: 40
    Country: Number of subjects enrolled
    Italy: 37
    Country: Number of subjects enrolled
    Mexico: 27
    Country: Number of subjects enrolled
    Russian Federation: 20
    Country: Number of subjects enrolled
    South Africa: 18
    Country: Number of subjects enrolled
    Spain: 44
    Country: Number of subjects enrolled
    Sweden: 11
    Country: Number of subjects enrolled
    Taiwan: 23
    Country: Number of subjects enrolled
    United Kingdom: 20
    Country: Number of subjects enrolled
    United States: 64
    Worldwide total number of subjects
    493
    EEA total number of subjects
    198
    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)
    467
    From 65 to 84 years
    26
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study consist of two phases - Randomized phase and Continuation phase.

    Pre-assignment
    Screening details
    		 A total of 493 adult participants were enrolled in this study. Continuation phase was not applicable for participants in Sweden and Denmark.

    Period 1
    Period 1 title
    Randomized Phase (Day1 to Week 52)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Randomized Phase-Participants who received DTG/3TC FDC
    Arm description
    		 Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dolutegravir (DTG)+Lamivudine (3TC) fixed dose combination (FDC)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received DTG 50 milligrams (mg) + 3TC 300 mg FDC as a white, oval and film-coated tablet. The tablets were packed in high density polyethylene (HDPE) bottles with induction seals, 2 grams (gm) desiccant, and child resistant closures. Each 60 milliliter (mL) bottle contains 30 tablets.

    Arm title
    		 Randomized Phase-Participants who received CAR
    Arm description
    		 Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted
    Arm type
    		 Active comparator

    Investigational medicinal product name
    CAR
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    CAR will include 2 NTRIs plus either an INI, NNRTI, or boosted PI or atazanavir unboosted.

    Number of subjects in period 1
    		Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR
    Started
    246
    247
    Completed
    136
    229
    Not completed
    110
    18
         Physician decision
    1
    2
         Consent withdrawn by subject
    1
    5
         Adverse event, non-fatal
    4
    3
         Protocol Deviation
    5
    4
         Death
    1
    -
         Ongoing
    96
    -
         Lost to follow-up
    2
    1
         Lack of efficacy
    -
    3
    Period 2
    Period 2 title
    Continuation Phase (Week 52 to Week 132)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Continuation Phase-Participants who received DTG/3TC FDC
    Arm description
    		 Participants who completed 52 weeks of treatment of DTG/3TC FDC had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase up to week 132.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dolutegravir (DTG)+Lamivudine (3TC) fixed dose combination (FDC)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received DTG 50 milligrams (mg) + 3TC 300 mg FDC as a white, oval and film-coated tablet. The tablets were packed in high density polyethylene (HDPE) bottles with induction seals, 2 grams (gm) desiccant, and child resistant closures. Each 60 milliliter (mL) bottle contains 30 tablets.

    Number of subjects in period 2 [1]
    		Continuation Phase-Participants who received DTG/3TC FDC
    Started
    96
    Completed
    91
    Not completed
    5
         Physician decision
    1
         Adverse event, non-fatal
    2
         Lost to follow-up
    1
         Lack of efficacy
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Participants who completed 52 weeks of treatment of DTG/3TC FDC had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase up to week 132.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Randomized Phase-Participants who received DTG/3TC FDC
    Reporting group description
    		 Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.

    Reporting group title
    Randomized Phase-Participants who received CAR
    Reporting group description
    		 Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted

    Reporting group values
    		 Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR Total
    Number of subjects
    		 246 247 493
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 237 230 467
        From 65-84 years
    		 9 17 26
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.5 ( 11.04 ) 45.8 ( 11.99 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 108 84 192
        Male
    		 138 163 301
    Race/Ethnicity, Customized
    Units: Subjects
        African American/African Heritage
    		 45 48 93
        American Indian OR Alaska Native
    		 18 14 32
        Asian - East Asian Heritage
    		 27 36 63
        Asian - South East Asian Heritage
    		 4 3 7
        White - Arabic/North African Heritage
    		 7 4 11
        White - White/Caucasian/European Heritage
    		 142 140 282
        Multiple
    		 3 2 5

    End points

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    End points reporting groups
    Reporting group title
    Randomized Phase-Participants who received DTG/3TC FDC
    Reporting group description
    		 Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.

    Reporting group title
    Randomized Phase-Participants who received CAR
    Reporting group description
    		 Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted
    Reporting group title
    Continuation Phase-Participants who received DTG/3TC FDC
    Reporting group description
    		 Participants who completed 52 weeks of treatment of DTG/3TC FDC had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase up to week 132.

    Primary: Number of participants with plasma HIV-1 Ribonucleic acid (RNA) >=50 copies/milliliter (c/mL) as per Food and Drug Administration (FDA) snapshot category at Week 48

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    End point title
    		 Number of participants with plasma HIV-1 Ribonucleic acid (RNA) >=50 copies/milliliter (c/mL) as per Food and Drug Administration (FDA) snapshot category at Week 48
    End point description
    Number of participants with plasma HIV 1 RNA >=50 c/mL were evaluated using FDA snapshot algorithm at Week 48 to demonstrate the non-inferior antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 48 weeks. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL ), along with study drug discontinuation status. Participants with plasma HIV 1 RNA >=50 c/mL were termed as subjects with virologic failure. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately. Intent To Treat-Exposed (ITT-E) population included all randomized participants who received at least one dose of study medication either DTG/3TC or CAR.
    End point type
    Primary
    End point timeframe
    Week 48
    End point values
    		 Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR
    Number of subjects analysed
    246
    247
    Units: Participants
    1
    3
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Randomized Phase-Participants who received DTG/3TC FDC v Randomized Phase-Participants who received CAR
    Number of subjects included in analysis
    493
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    Method
    Parameter type
    		 Adjusted Difference in Percent (ADP)
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 0.8
    Notes
    [1] - Non-inferiority was be concluded if the upper bound of the two-sided 95% confidence interval (CI) for the CMH adjusted difference in the proportion of patients with plasma HIV-1 RNA ≥ 50 c/mL between each treatment group (DTG/3TC – CAR) is less than 5%.

    Secondary: Number of participants with plasma HIV-1 RNA <50 c/mL using the FDA Snapshot algorithm at Week 48

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    End point title
    		 Number of participants with plasma HIV-1 RNA <50 c/mL using the FDA Snapshot algorithm at Week 48
    End point description
    Number of participants with plasma HIV 1 RNA <50 c/mL were evaluated using FDA snapshot algorithm at Week 48 to demonstrate the antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 48 weeks. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL ), along with study drug discontinuation status. Participants with plasma HIV 1 RNA <50 c/mL were termed as subjects with virologic success. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately. Intent To Treat-Exposed.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR
    Number of subjects analysed
    246
    247
    Units: Participants
    232
    229
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Randomized Phase-Participants who received DTG/3TC FDC v Randomized Phase-Participants who received CAR
    Number of subjects included in analysis
    493
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    Method
    Parameter type
    		 Adjusted Difference in Percent
    Point estimate
    1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 5.9
    Notes
    [2] - Non-inferiority will be concluded if the lower bound of a 2-sided 95% confidence interval for the difference in success rates between the two treatment arms (DTG/3TC-CAR) is greater than -12%.

    Secondary: Number of participants with plasma HIV-1 RNA <50 c/mL using the FDA Snapshot algorithm at Week 24

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    End point title
    		 Number of participants with plasma HIV-1 RNA <50 c/mL using the FDA Snapshot algorithm at Week 24
    End point description
    Number of participants with plasma HIV 1 RNA <50 c/mL were evaluated using FDA snapshot algorithm at Week 24 to demonstrate the antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 24 weeks. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL ), along with study drug discontinuation status. Participants with plasma HIV 1 RNA <50 c/mL were termed as subjects with virologic success. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately. Intent To Treat-Exposed.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR
    Number of subjects analysed
    246
    247
    Units: Participants
    234
    237
    No statistical analyses for this end point

    Secondary: Number of participants with plasma HIV-1 RNA >=50 c/mL as per FDA snapshot category at Week 24

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    End point title
    		 Number of participants with plasma HIV-1 RNA >=50 c/mL as per FDA snapshot category at Week 24
    End point description
    Number of participants with plasma HIV 1 RNA >=50 c/mL were evaluated using FDA snapshot algorithm at Week 24 to demonstrate the antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 24 weeks. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL ), along with study drug discontinuation status. Participants with plasma HIV 1 RNA >=50 c/mL were termed as subjects with virologic failure. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately. Intent To Treat-Exposed.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR
    Number of subjects analysed
    246
    247
    Units: Participants
    0
    1
    No statistical analyses for this end point

    Secondary: Change from Baseline in CD4+ cell count for Week 48

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    End point title
    		 Change from Baseline in CD4+ cell count for Week 48
    End point description
    CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Lymphocyte subsets were collected for assessment of this outcome measure by flow cytometry. Change from Baseline in CD4+ lymphocyte count was assessed at Week 48 to evaluate the immune effects of DTG/3TC FDC once daily compared to continuation of CAR. Plasma samples for lymphocyte subsets were collected. Intent To Treat-Exposed. Only those participants with data available at specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 48
    End point values
    		 Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR
    Number of subjects analysed
    232
    227
    Units: cells/mm^3
        median (inter-quartile range (Q1-Q3))
    30 (-83 to 115.5)
    2 (-105 to 94)
    No statistical analyses for this end point

    Secondary: Change from Baseline in cluster of differentiation 4 (CD4+) cell count for Week 24

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    End point title
    		 Change from Baseline in cluster of differentiation 4 (CD4+) cell count for Week 24
    End point description
    CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Lymphocyte subsets were collected for assessment of this outcome measure by flow cytometry. Change from Baseline in CD4+ lymphocyte count was assessed at Week 24 to evaluate the immune effects of DTG/3TC FDC once daily compared to continuation of CAR. Plasma samples for lymphocyte subsets were collected. Intent To Treat-Exposed. Only those participants with data available at specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 24
    End point values
    		 Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR
    Number of subjects analysed
    232
    235
    Units: cells/cubic millimeter (cells/mm^3)
        median (inter-quartile range (Q1-Q3))
    30.5 (-71.5 to 111)
    10 (-79 to 95)
    No statistical analyses for this end point

    Secondary: Number of participants with Disease Progression through Week 48

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    End point title
    		 Number of participants with Disease Progression through Week 48
    End point description
    Partcipants with disease progression included incidences of HIV-associated conditions, AIDS and death. HIV-associated conditions were assessed according to the 2014 HIV infection by CDC classification system for HIV Infection in adults to evaluate the immune effects of DTG /3TC FDC once daily compared to continuation of CAR. Intent To Treat-Exposed.
    End point type
    Secondary
    End point timeframe
    Up to Week 48
    End point values
    		 Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR
    Number of subjects analysed
    246
    247
    Units: Participants
    1
    0
    No statistical analyses for this end point

    Secondary: Number of participants with adverse events (AEs) and AEs leading to discontinuation

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    End point title
    		 Number of participants with adverse events (AEs) and AEs leading to discontinuation
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Safety population included all randomized participants who received at least 1 dose of study intervention either DTG/3TC or CAR.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    		 Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR
    Number of subjects analysed
    246
    247
    Units: Participants
        AEs
    180
    172
        AEs leading to discontinuation
    5
    3
    No statistical analyses for this end point

    Secondary: Number of participants with Disease Progression through Week 24

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    End point title
    		 Number of participants with Disease Progression through Week 24
    End point description
    Partcipants with disease progression included incidences of HIV-associated conditions, Aquired Immuno Deficiency Syndrome (AIDS) and death. HIV-associated conditions were assessed according to the 2014 HIV infection by Centers for Disease Control and Prevention (CDC) classification system for HIV Infection in adults to evaluate the immune effects of DTG /3TC FDC once daily compared to continuation of CAR. Intent To Treat-Exposed.
    End point type
    Secondary
    End point timeframe
    Up to Week 24
    End point values
    		 Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR
    Number of subjects analysed
    246
    247
    Units: Participants
    0
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline in CD4+/CD8+ cell counts ratio for Week 48

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    End point title
    		 Change from Baseline in CD4+/CD8+ cell counts ratio for Week 48
    End point description
    CD4+/CD8+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Lymphocyte subsets were collected for assessment of this outcome measure by flow cytometry. Change from Baseline in CD4+/CD8+ lymphocyte cell count ratio was assessed at Week 48 to evaluate the immune effects of DTG/3TC FDC once daily compared to continuation of CAR. Plasma samples for lymphocyte subsets were collected. Intent To Treat-Exposed. Only those participants with data available at specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 48
    End point values
    		 Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR
    Number of subjects analysed
    232
    227
    Units: Ratio
        median (inter-quartile range (Q1-Q3))
    0.04 (-0.06 to 0.13)
    0.05 (-0.06 to 0.13)
    No statistical analyses for this end point

    Secondary: Change from Baseline in CD4+/ cluster of differentiation 8 (CD8+) cell counts ratio for Week 24

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    End point title
    		 Change from Baseline in CD4+/ cluster of differentiation 8 (CD8+) cell counts ratio for Week 24
    End point description
    CD4+/CD8+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Lymphocyte subsets were collected for assessment of this outcome measure by flow cytometry. Change from Baseline in CD4+/CD8+ lymphocyte cell count ratio was assessed at Week 24 to evaluate the immune effects of DTG/3TC FDC once daily compared to continuation of CAR. Plasma samples for lymphocyte subsets were collected. Intent To Treat-Exposed. Only those participants with data available at specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 24
    End point values
    		 Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR
    Number of subjects analysed
    232
    235
    Units: Ratio
        median (inter-quartile range (Q1-Q3))
    -0.02 (-0.105 to 0.07)
    0.01 (-0.06 to 0.09)
    No statistical analyses for this end point

    Secondary: Number of Participants With AEs by Severity Grades

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    End point title
    		 Number of Participants With AEs by Severity Grades
    End point description
    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Safety population included all randomized participants who received at least 1 dose of study intervention either DTG/3TC or CAR.
    End point type
    Secondary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR
    Number of subjects analysed
    246
    247
    Units: Participants
        Grade 1
    92
    67
        Grade 2
    77
    86
        Grade 3
    10
    17
        Grade 4
    0
    2
        Grade 5
    1
    0
    No statistical analyses for this end point

    Secondary: Number of participants with Hepatobiliary Abnormalities through 52 weeks

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    End point title
    		 Number of participants with Hepatobiliary Abnormalities through 52 weeks
    End point description
    Blood samples were collected to evaluate hepatobiliary abnormalities. Number of participants with Bilirubin (BIL), Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT)/combination of these with levels more than the defined hepatobiliary abnormality criteria were presented. Hepatocellular injury is defined as ([ALT/ALT ULN]/[ALP/ALP ULN]) >= 5 and ALT >=3*ULN. Safety population.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    		 Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR
    Number of subjects analysed
    246
    247
    Units: Participants
        ALT >=3xUpper Limit of Normal (ULN) & BIL >=2xULN
    0
    0
        ALT >=3xULN & ALP <2xULN & BIL >=2xULN
    0
    0
        ALT >=3xULN & BIL >=1.5xULN
    0
    0
        AST >=3xULN & BIL >=2xULN
    0
    0
        AST >=3xULN & ALP <2xULN & BIL >=2xULN
    0
    0
        AST >=3xULN & BIL >=1.5xULN
    0
    0
        ALT+AST >=20xULN
    0
    0
        ALT+AST >=10xULN
    0
    0
        ALT+AST >=5xULN
    0
    0
        ALT+AST >=3xULN
    3
    2
        ALT >=20xULN
    0
    0
        ALT >=10xULN
    0
    0
        ALT >=5xULN
    1
    1
        ALT >=3xULN
    6
    5
        AST >=20xULN
    0
    0
        AST >=10xULN
    0
    0
        AST >=5xULN
    1
    0
        AST >=3xULN
    5
    2
        BIL >=2xULN
    0
    5
        BIL >=1.5xULN
    0
    7
        ALP >=1.5xULN
    4
    8
        ALT >=3xULN - <5xULN
    5
    4
        ALT >=5xULN - <10xULN
    1
    1
        ALT >=10xULN - <20xULN
    0
    0
        Hepatocellular injury
    5
    1
        Hepatocellular injury and BIL >=2xULN
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with any AEs and AEs by severity grades for those participants with baseline creatinine clearance of 30-49 mL/min/1.73m^2

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    End point title
    		 Number of participants with any AEs and AEs by severity grades for those participants with baseline creatinine clearance of 30-49 mL/min/1.73m^2
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with any AE were presented and AEs were graded according to the DAIDS toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Safety population. Only those participants with data available at specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR
    Number of subjects analysed
    1
    4
    Units: Participants
        Any Event
    1
    3
        Grade 1
    1
    1
        Grade 2
    0
    2
        Grade 3
    0
    0
        Grade 4
    0
    0
        Grade 5
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with any AEs and AEs by severity grades for those participants with baseline creatinine clearance of >=50 mL/min/1.73m^2

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    End point title
    		 Number of participants with any AEs and AEs by severity grades for those participants with baseline creatinine clearance of >=50 mL/min/1.73m^2
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with any AE were presented and AEs were graded according to the DAIDS toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Safety Population. Only those participants with data available at specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR
    Number of subjects analysed
    245
    243
    Units: Participants
        Any Event
    179
    169
        Grade 1
    91
    66
        Grade 2
    77
    84
        Grade 3
    10
    17
        Grade 4
    0
    2
        Grade 5
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Participants with any AEs Leading to Discontinuation Based on Baseline Creatinine Clearance of 30-49 mL/min/1.73m^2

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    End point title
    		 Number of Participants with any AEs Leading to Discontinuation Based on Baseline Creatinine Clearance of 30-49 mL/min/1.73m^2
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Safety population. Only those participants with data available at specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR
    Number of subjects analysed
    1
    4
    Units: Participants
    0
    1
    No statistical analyses for this end point

    Secondary: Number of Participants with Hepatobiliary Abnormalities through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/min/1.73m^2

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    End point title
    		 Number of Participants with Hepatobiliary Abnormalities through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/min/1.73m^2
    End point description
    Blood samples were collected to evaluate hepatobiliary abnormalities. Number of participants with Bilirubin (BIL), Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT)/combination of these with levels more than the defined hepatobiliary abnormality criteria were presented. Hepatocellular injury is defined as ([ALT/ALT ULN]/[ALP/ALP ULN]) >= 5 and ALT >=3xULN. Safety population. Only those participants with data available at specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR
    Number of subjects analysed
    1
    4
    Units: Participants
        ALT >=3xUpper Limit of Normal (ULN) & BIL >=2xULN
    0
    0
        ALT >=3xULN & ALP <2xULN & BIL >=2xULN
    0
    0
        ALT >=3xULN & BIL >=1.5xULN
    0
    0
        AST >=3xULN & BIL >=2xULN
    0
    0
        AST >=3xULN & ALP <2xULN & BIL >=2xULN
    0
    0
        AST >=3xULN & BIL >=1.5xULN
    0
    0
        ALT+AST >=20xULN
    0
    0
        ALT+AST >=10xULN
    0
    0
        ALT+AST >=5xULN
    0
    0
        ALT+AST >=3xULN
    0
    0
        ALT >=20xULN
    0
    0
        ALT >=10xULN
    0
    0
        ALT >=5xULN
    0
    0
        ALT >=3xULN
    0
    0
        AST >=20xULN
    0
    0
        AST >=10xULN
    0
    0
        AST >=5xULN
    0
    0
        AST >=3xULN
    0
    0
        BIL >=2xULN
    0
    1
        BIL >=1.5xULN
    0
    1
        ALP >=1.5xULN
    0
    0
        ALT >=3xULN - <5xULN
    0
    0
        ALT >=5xULN - <10xULN
    0
    0
        ALT >=10xULN - <20xULN
    0
    0
        Hepatocellular injury
    0
    0
        Hepatocellular injury and BIL >=2xULN
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants with any AEs Leading to Discontinuation Based on Baseline Creatinine Clearance of >=50 mL/min/1.73m^2

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    End point title
    		 Number of Participants with any AEs Leading to Discontinuation Based on Baseline Creatinine Clearance of >=50 mL/min/1.73m^2
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Safety population. Only those participants with data available at specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 52 weeks
    End point values
    		 Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR
    Number of subjects analysed
    245
    243
    Units: Participants
    5
    2
    No statistical analyses for this end point

    Secondary: Number of Participants with Hepatobiliary Abnormalities through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/min/1.73m^2

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    End point title
    		 Number of Participants with Hepatobiliary Abnormalities through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/min/1.73m^2
    End point description
    Blood samples were collected to evaluate hepatobiliary abnormalities. Number of participants with Bilirubin (BIL), Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT)/combination of these with levels more than the defined hepatobiliary abnormality criteria were presented. Hepatocellular injury is defined as ([ALT/ALT ULN]/[ALP/ALP ULN]) >= 5 and ALT >=3xULN. Safety population. Only those participants with data available at specified time points were analyzed
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    		 Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR
    Number of subjects analysed
    245
    243
    Units: Participants
        ALT >=3xUpper Limit of Normal (ULN) & BIL >=2xULN
    0
    0
        ALT >=3xULN & ALP <2xULN & BIL >=2xULN
    0
    0
        ALT >=3xULN & BIL >=1.5xULN
    0
    0
        AST >=3xULN & BIL >=2xULN
    0
    0
        AST >=3xULN & ALP <2xULN & BIL >=2xULN
    0
    0
        AST >=3xULN & BIL >=1.5xULN
    0
    0
        ALT+AST >=20xULN
    0
    0
        ALT+AST >=10xULN
    0
    0
        ALT+AST >=5xULN
    0
    0
        ALT+AST >=3xULN
    3
    2
        ALT >=20xULN
    0
    0
        ALT >=10xULN
    0
    0
        ALT >=5xULN
    1
    1
        ALT >=3xULN
    6
    5
        AST >=20xULN
    0
    0
        AST >=10xULN
    0
    0
        AST >=5xULN
    1
    0
        AST >=3xULN
    5
    2
        BIL >=2xULN
    0
    4
        BIL >=1.5xULN
    0
    6
        ALP >=1.5xULN
    4
    8
        ALT >=3xULN - <5xULN
    5
    4
        ALT >=5xULN - <10xULN
    1
    1
        ALT >=10xULN - <20xULN
    0
    0
        Hepatocellular injury
    5
    1
        Hepatocellular injury and BIL >=2xULN
    0
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline in fasting lipids at Week 24

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    End point title
    		 Change from Baseline in fasting lipids at Week 24
    End point description
    Lipid parameters included total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides. Safety Population. Only those participants with data available at specified time points has been analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 24
    End point values
    		 Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR
    Number of subjects analysed
    191
    168
    Units: milligram/deciliter (mg/dL)
    arithmetic mean (standard deviation)
        Serum or Plasma Triglycerides (mg/dL)
    -4.944 ( 56.4947 )
    -3.571 ( 61.9494 )
        Serum or Plasma HDL Cholesterol, Direct (mg/dL)
    -0.326 ( 9.1737 )
    0.585 ( 8.3277 )
        Serum or Plasma Cholesterol (mg/dL)
    -3.096 ( 31.6634 )
    0.058 ( 25.8019 )
        Serum/Plasma LDL Cholesterol (Calculated, Direct)
    -1.64 ( 25.5153 )
    -0.06 ( 19.802 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in fasting lipids at Week 48

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    End point title
    		 Change from Baseline in fasting lipids at Week 48
    End point description
    Lipid parameters included total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides. Safety Population. Only those participants with data available at specified time points has been analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 48
    End point values
    		 Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR
    Number of subjects analysed
    186
    159
    Units: mg/dL
    arithmetic mean (standard deviation)
        Serum or Plasma Triglycerides (mg/dL)
    -3.112 ( 66.9065 )
    -4.002 ( 71.0132 )
        Serum or Plasma HDL Cholesterol, Direct (mg/dL)
    -0.809 ( 10.5651 )
    0.688 ( 8.5584 )
        Serum or Plasma Cholesterol (mg/dL)
    0.131 ( 30.271 )
    2.668 ( 27.0351 )
        Serum/Plasma LDL Cholesterol (Calculated, Direct)
    1.753 ( 22.8585 )
    2.734 ( 20.0256 )
    No statistical analyses for this end point

    Secondary: Number of participants with observed genotypic and phenotypic resistance to antiretrovirals (ARVs) for participants meeting confirmed virologic withdrawal (CVW) criteria

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    End point title
    		 Number of participants with observed genotypic and phenotypic resistance to antiretrovirals (ARVs) for participants meeting confirmed virologic withdrawal (CVW) criteria
    End point description
    Genotypic and phenotypic testing was conducted for participants who met the confirmed virologic withdrawal criteria, i.e., one assessment with HIV-1 RNA ≥200 c/mL after Day 1 with an immediately prior HIV-1 RNA ≥50 c/mL at any point in the study. Confirmed Virologic Withdrawal (CVW) population. No participants met the CVW criteria over 48 weeks; therefore, the genotypic and phenotypic resistance virologic analyses were not assessed.
    End point type
    Secondary
    End point timeframe
    Up to week 48
    End point values
    		 Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR
    Number of subjects analysed
    0 [3]
    0 [4]
    Units: Participants
    Notes
    [3] - No participants met the CVW criteria over 48 weeks, hence the virologic analyses were not assessed.
    [4] - No participants met the CVW criteria over 48 weeks, hence the virologic analyses were not assessed.
    No statistical analyses for this end point

    Secondary: Change from Baseline in health status by Symptom Distress Module (SDM) at Week 24

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    End point title
    		 Change from Baseline in health status by Symptom Distress Module (SDM) at Week 24
    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). ITT-E. Only those participants with data available at specified time points has been analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 24
    End point values
    		 Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR
    Number of subjects analysed
    235
    239
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    -2.6 ( 8.69 )
    -0.7 ( 8.01 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Randomized Phase-Participants who received DTG/3TC FDC v Randomized Phase-Participants who received CAR
    Number of subjects included in analysis
    474
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.021
    Method
    		 Mixed Model Repeated Measures
    Parameter type
    		 Adjusted Mean
    Point estimate
    -1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.9
         upper limit
    		 -0.2

    Secondary: Change from Baseline in health status by HIV TSQ at Week 48

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    End point title
    		 Change from Baseline in health status by HIV TSQ at Week 48
    End point description
    The HIVTSQ is a 10-item self-reported scale that consists of a total score ranging from 0 to 60. Higher scores indicate a greater level of patient-reported satisfaction with their current therapy. ITT-E. Only those participants with data available at specified time points has been analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 48
    End point values
    		 Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR
    Number of subjects analysed
    229
    229
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    2.9 ( 6 )
    1 ( 5.14 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Randomized Phase-Participants who received DTG/3TC FDC v Randomized Phase-Participants who received CAR
    Number of subjects included in analysis
    458
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 Mixed Model Repeated Measures
    Parameter type
    		 Adjusted Mean
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 2.2

    Secondary: Change from Baseline in health status by HIV Treatment Satisfaction Questionnaire (TSQ) at Week 24

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    End point title
    		 Change from Baseline in health status by HIV Treatment Satisfaction Questionnaire (TSQ) at Week 24
    End point description
    The HIV Treatment Satisfaction Questionnaire (HIVTSQ) is a 10-item self-reported scale that consists of a total score ranging from 0 to 60. Higher scores indicate a greater level of patient-reported satisfaction with their current therapy. ITT-E. Only those participants with data available at specified time points has been analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 24
    End point values
    		 Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR
    Number of subjects analysed
    236
    240
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    2.9 ( 5.85 )
    1 ( 5.16 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Randomized Phase-Participants who received DTG/3TC FDC v Randomized Phase-Participants who received CAR
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 Mixed Model Repeated Measures
    Parameter type
    		 Adjusted Mean
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 2.2

    Secondary: Change from Baseline in health status by SDM at Week 48

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    End point title
    		 Change from Baseline in health status by SDM at 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). ITT-E. Only those participants with data available at specified time points has been analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 48
    End point values
    		 Randomized Phase-Participants who received DTG/3TC FDC Randomized Phase-Participants who received CAR
    Number of subjects analysed
    228
    226
    Units: Scores on a scale
        arithmetic mean (standard deviation)
    -2.4 ( 7.64 )
    -1.5 ( 7.92 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Randomized Phase-Participants who received DTG/3TC FDC v Randomized Phase-Participants who received CAR
    Number of subjects included in analysis
    454
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.398
    Method
    		 Mixed Model Repeated Measures
    Parameter type
    		 Adjusted Mean
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 0.7

    Secondary: Change from baseline in Health Status by SDM in continuation phase

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    End point title
    		 Change from baseline in Health Status by SDM in continuation phase
    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). Intent To Treat-Exposed (ITT-E) Continuation Phase population included participants who received at least one dose of DTG/3TC during continuation phase. Only those participants with data available at specified time points has been analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 76, Week 100, and Week 132
    End point values
    		 Continuation Phase-Participants who received DTG/3TC FDC
    Number of subjects analysed
    96
    Units: Scores on a scale
    arithmetic mean (standard deviation)
        Week 76 (N=56)
    -4.1 ( 8.69 )
        Week 100 (N=26)
    -3.4 ( 11.33 )
        Week 132 (N=32)
    -6.1 ( 9.94 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from day 1 to week 52 for Randomized Phase and from week 52 to week 132 for continuation phase.
    Adverse event reporting additional description
    Safety Population included all randomized participants who received at least 1 dose of study intervention.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Participants who received DTG/3TC FDC
    Reporting group description
    		 Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.

    Reporting group title
    Participants who received CAR
    Reporting group description
    		 Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.

    Reporting group title
    Participants who received DTG/3TC FDC-Continuation Phase
    Reporting group description
    		 Participants who completed 52 weeks of treatment of DTG/3TC FDC had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase up to week 132.

    Serious adverse events
    		 Participants who received DTG/3TC FDC Participants who received CAR Participants who received DTG/3TC FDC-Continuation Phase
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 246 (2.85%)
    16 / 247 (6.48%)
    1 / 96 (1.04%)
         number of deaths (all causes)
    1
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous cell carcinoma of the cervix
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (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
    Pituitary tumour benign
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (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
    Gastrointestinal stromal tumour
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (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
    Breast cancer
         subjects affected / exposed
    0 / 246 (0.00%)
    0 / 247 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (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 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (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
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (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
    Post procedural complication
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (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
    Hip fracture
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (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
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (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
    Depressed level of consciousness
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (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
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal impairment
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (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
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (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
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (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
    COVID-19
         subjects affected / exposed
    1 / 246 (0.41%)
    3 / 247 (1.21%)
    0 / 96 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tracheitis
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (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
    Cellulitis
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (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
    Gastroenteritis
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (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 bacterial
         subjects affected / exposed
    0 / 246 (0.00%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Participants who received DTG/3TC FDC Participants who received CAR Participants who received DTG/3TC FDC-Continuation Phase
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    179 / 246 (72.76%)
    169 / 247 (68.42%)
    43 / 96 (44.79%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign breast neoplasm
         subjects affected / exposed
    2 / 246 (0.81%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    2
    0
    0
    Basal cell carcinoma
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Colon adenoma
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Dysplastic naevus
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Fibroadenoma of breast
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatic neoplasm
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Malignant melanoma
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    2
    0
    Lipoma
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Melanocytic naevus
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Seborrhoeic keratosis
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    2
    0
    0
    Colorectal adenoma
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    6 / 246 (2.44%)
    7 / 247 (2.83%)
    2 / 96 (2.08%)
         occurrences all number
    7
    7
    2
    Hot flush
         subjects affected / exposed
    2 / 246 (0.81%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    2
    0
    0
    Essential hypertension
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Peripheral coldness
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Peripheral venous disease
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Vasodilatation
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    5 / 246 (2.03%)
    6 / 247 (2.43%)
    0 / 96 (0.00%)
         occurrences all number
    5
    6
    0
    Pyrexia
         subjects affected / exposed
    6 / 246 (2.44%)
    7 / 247 (2.83%)
    0 / 96 (0.00%)
         occurrences all number
    8
    7
    0
    Chest discomfort
         subjects affected / exposed
    2 / 246 (0.81%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    2
    1
    0
    Chest pain
         subjects affected / exposed
    1 / 246 (0.41%)
    3 / 247 (1.21%)
    0 / 96 (0.00%)
         occurrences all number
    1
    3
    0
    Asthenia
         subjects affected / exposed
    2 / 246 (0.81%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    2
    1
    0
    Influenza like illness
         subjects affected / exposed
    2 / 246 (0.81%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    2
    1
    0
    Feeling abnormal
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    1
    1
    0
    Pain
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    1
    1
    0
    Chills
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Cyst
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Ill-defined disorder
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Malaise
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    1 / 96 (1.04%)
         occurrences all number
    0
    1
    1
    Oedema peripheral
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    2
    0
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    3
    0
    Immune system disorders
    Food allergy
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Hypersensitivity
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Seasonal allergy
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Immunisation reaction
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Social circumstances
    Stress at work
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    3 / 246 (1.22%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    3
    1
    0
    Vaginal haemorrhage
         subjects affected / exposed
    2 / 246 (0.81%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    2
    0
    0
    Atrophic vulvovaginitis
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Amenorrhoea
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Dysmenorrhoea
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Menstruation delayed
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Pelvic pain
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Prostatitis
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Pruritus genital
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Uterine polyp
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Vaginal discharge
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Intermenstrual bleeding
         subjects affected / exposed
    0 / 246 (0.00%)
    0 / 247 (0.00%)
    1 / 96 (1.04%)
         occurrences all number
    0
    0
    1
    Menstruation irregular
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    1 / 96 (1.04%)
         occurrences all number
    1
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    4 / 246 (1.63%)
    2 / 247 (0.81%)
    1 / 96 (1.04%)
         occurrences all number
    4
    2
    1
    Cough
         subjects affected / exposed
    3 / 246 (1.22%)
    4 / 247 (1.62%)
    0 / 96 (0.00%)
         occurrences all number
    3
    4
    0
    Rhinitis allergic
         subjects affected / exposed
    3 / 246 (1.22%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    4
    1
    0
    Respiratory disorder
         subjects affected / exposed
    2 / 246 (0.81%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    2
    1
    0
    Dyspnoea
         subjects affected / exposed
    0 / 246 (0.00%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    0
    2
    0
    Productive cough
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    1
    1
    0
    Asthma
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Dry throat
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Emphysema
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Epistaxis
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Hiccups
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Nasal congestion
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Nasal discomfort
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Nasal dryness
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Nasal obstruction
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    1 / 96 (1.04%)
         occurrences all number
    1
    1
    1
    Nasal septum deviation
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Pharyngeal disorder
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    14 / 246 (5.69%)
    4 / 247 (1.62%)
    1 / 96 (1.04%)
         occurrences all number
    15
    4
    1
    Anxiety
         subjects affected / exposed
    5 / 246 (2.03%)
    6 / 247 (2.43%)
    5 / 96 (5.21%)
         occurrences all number
    5
    6
    5
    Sleep disorder
         subjects affected / exposed
    3 / 246 (1.22%)
    3 / 247 (1.21%)
    0 / 96 (0.00%)
         occurrences all number
    3
    3
    0
    Depression
         subjects affected / exposed
    2 / 246 (0.81%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    2
    2
    0
    Abnormal dreams
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    1
    1
    0
    Loss of libido
         subjects affected / exposed
    2 / 246 (0.81%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    2
    0
    0
    Suicidal ideation
         subjects affected / exposed
    0 / 246 (0.00%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    0
    2
    0
    Bipolar disorder
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Adjustment disorder
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Adjustment disorder with depressed mood
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Affective disorder
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Alcohol abuse
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Anxiety disorder
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Depressed mood
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    1 / 96 (1.04%)
         occurrences all number
    1
    0
    1
    Initial insomnia
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Nightmare
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    2
    0
    0
    Mixed anxiety and depressive disorder
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Stress
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Product issues
    Device physical property issue
         subjects affected / exposed
    0 / 246 (0.00%)
    0 / 247 (0.00%)
    1 / 96 (1.04%)
         occurrences all number
    0
    0
    1
    Hepatobiliary disorders
    Hepatic steatosis
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    1
    1
    0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Weight increased
         subjects affected / exposed
    20 / 246 (8.13%)
    5 / 247 (2.02%)
    3 / 96 (3.13%)
         occurrences all number
    20
    5
    3
    Low density lipoprotein increased
         subjects affected / exposed
    2 / 246 (0.81%)
    4 / 247 (1.62%)
    4 / 96 (4.17%)
         occurrences all number
    2
    4
    4
    Blood creatinine increased
         subjects affected / exposed
    3 / 246 (1.22%)
    3 / 247 (1.21%)
    2 / 96 (2.08%)
         occurrences all number
    3
    3
    2
    Blood cholesterol increased
         subjects affected / exposed
    2 / 246 (0.81%)
    3 / 247 (1.21%)
    2 / 96 (2.08%)
         occurrences all number
    2
    3
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 246 (0.00%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    0
    2
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 246 (0.00%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    0
    2
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    2 / 246 (0.81%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    2
    0
    0
    Blood glucose increased
         subjects affected / exposed
    2 / 246 (0.81%)
    0 / 247 (0.00%)
    1 / 96 (1.04%)
         occurrences all number
    2
    0
    1
    Blood pressure increased
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    2 / 96 (2.08%)
         occurrences all number
    1
    2
    2
    Blood triglycerides increased
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    1
    1
    0
    Creatinine renal clearance increased
         subjects affected / exposed
    0 / 246 (0.00%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    0
    2
    0
    Glomerular filtration rate decreased
         subjects affected / exposed
    2 / 246 (0.81%)
    0 / 247 (0.00%)
    3 / 96 (3.13%)
         occurrences all number
    2
    0
    3
    Platelet count decreased
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    1
    1
    0
    Transaminases increased
         subjects affected / exposed
    0 / 246 (0.00%)
    2 / 247 (0.81%)
    1 / 96 (1.04%)
         occurrences all number
    0
    2
    1
    Urine protein/creatinine ratio increased
         subjects affected / exposed
    0 / 246 (0.00%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    0
    2
    0
    Weight decreased
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    1
    1
    0
    Blood cholesterol decreased
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Blood creatine increased
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Blood glucose abnormal
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Blood prolactin increased
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Blood urine present
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Blood insulin increased
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Creatinine renal clearance decreased
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Crystal urine present
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Glucose urine present
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Protein urine present
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Pulse absent
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    SARS-CoV-2 test positive
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Urine albumin/creatinine ratio increased
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Blood urea increased
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Meniscus injury
         subjects affected / exposed
    2 / 246 (0.81%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    2
    1
    0
    Ankle fracture
         subjects affected / exposed
    0 / 246 (0.00%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    0
    2
    0
    Muscle strain
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    1
    1
    0
    Vaccination complication
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    1
    1
    0
    Back injury
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Contusion
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Dental restoration failure
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Face injury
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Fall
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Foot fracture
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Hand fracture
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Head injury
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Joint dislocation
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Joint injury
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Ligament sprain
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    1 / 96 (1.04%)
         occurrences all number
    1
    0
    1
    Limb injury
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Neck injury
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Pelvic organ injury
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Penis injury
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Post procedural complication
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Post-traumatic pain
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Skin abrasion
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Skin injury
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Spinal compression fracture
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Road traffic accident
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Upper limb fracture
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Skin laceration
         subjects affected / exposed
    0 / 246 (0.00%)
    0 / 247 (0.00%)
    1 / 96 (1.04%)
         occurrences all number
    0
    0
    1
    Thermal burn
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Congenital, familial and genetic disorders
    Dysplastic naevus syndrome
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Left ventricular hypertrophy
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    13 / 246 (5.28%)
    6 / 247 (2.43%)
    1 / 96 (1.04%)
         occurrences all number
    15
    7
    1
    Headache
         subjects affected / exposed
    16 / 246 (6.50%)
    17 / 247 (6.88%)
    3 / 96 (3.13%)
         occurrences all number
    18
    20
    3
    Hypoaesthesia
         subjects affected / exposed
    1 / 246 (0.41%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    2
    2
    0
    Paraesthesia
         subjects affected / exposed
    1 / 246 (0.41%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    1
    2
    0
    Sciatica
         subjects affected / exposed
    0 / 246 (0.00%)
    3 / 247 (1.21%)
    0 / 96 (0.00%)
         occurrences all number
    0
    3
    0
    Memory impairment
         subjects affected / exposed
    2 / 246 (0.81%)
    0 / 247 (0.00%)
    1 / 96 (1.04%)
         occurrences all number
    2
    0
    1
    Presyncope
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    1
    1
    0
    Sensory loss
         subjects affected / exposed
    0 / 246 (0.00%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    0
    2
    0
    Syncope
         subjects affected / exposed
    0 / 246 (0.00%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    0
    2
    0
    Anosmia
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    1 / 96 (1.04%)
         occurrences all number
    1
    1
    1
    Ageusia
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Burning sensation
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    1 / 96 (1.04%)
         occurrences all number
    1
    0
    1
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Cervical radiculopathy
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Cervicobrachial syndrome
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Dysgeusia
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Hemianopia heteronymous
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Hemiparesis
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Migraine
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Nerve compression
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Neuralgia
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Tremor
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Bell's palsy
         subjects affected / exposed
    0 / 246 (0.00%)
    0 / 247 (0.00%)
    1 / 96 (1.04%)
         occurrences all number
    0
    0
    1
    Trigeminal neuralgia
         subjects affected / exposed
    0 / 246 (0.00%)
    0 / 247 (0.00%)
    1 / 96 (1.04%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 246 (0.81%)
    5 / 247 (2.02%)
    0 / 96 (0.00%)
         occurrences all number
    2
    6
    0
    Lymphadenopathy
         subjects affected / exposed
    2 / 246 (0.81%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    2
    0
    0
    Neutropenia
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    3 / 246 (1.22%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    3
    0
    0
    Ear pain
         subjects affected / exposed
    2 / 246 (0.81%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    2
    0
    0
    Cerumen impaction
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Ear discomfort
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Ear pruritus
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Hypoacusis
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Meniere's disease
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Tinnitus
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    2 / 246 (0.81%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    2
    0
    0
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    1
    1
    0
    Conjunctivitis allergic
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Dry eye
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Glaucoma
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Ocular hypertension
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Vision blurred
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    2
    0
    Visual acuity reduced
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    4 / 246 (1.63%)
    5 / 247 (2.02%)
    1 / 96 (1.04%)
         occurrences all number
    4
    7
    1
    Constipation
         subjects affected / exposed
    1 / 246 (0.41%)
    6 / 247 (2.43%)
    0 / 96 (0.00%)
         occurrences all number
    1
    6
    0
    Diarrhoea
         subjects affected / exposed
    7 / 246 (2.85%)
    8 / 247 (3.24%)
    0 / 96 (0.00%)
         occurrences all number
    7
    9
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    4 / 246 (1.63%)
    7 / 247 (2.83%)
    0 / 96 (0.00%)
         occurrences all number
    4
    7
    0
    Nausea
         subjects affected / exposed
    6 / 246 (2.44%)
    4 / 247 (1.62%)
    1 / 96 (1.04%)
         occurrences all number
    7
    6
    1
    Abdominal pain
         subjects affected / exposed
    4 / 246 (1.63%)
    1 / 247 (0.40%)
    1 / 96 (1.04%)
         occurrences all number
    5
    1
    1
    Dyspepsia
         subjects affected / exposed
    4 / 246 (1.63%)
    1 / 247 (0.40%)
    1 / 96 (1.04%)
         occurrences all number
    4
    1
    1
    Abdominal pain upper
         subjects affected / exposed
    3 / 246 (1.22%)
    2 / 247 (0.81%)
    1 / 96 (1.04%)
         occurrences all number
    3
    3
    1
    Flatulence
         subjects affected / exposed
    3 / 246 (1.22%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    3
    2
    0
    Toothache
         subjects affected / exposed
    3 / 246 (1.22%)
    2 / 247 (0.81%)
    1 / 96 (1.04%)
         occurrences all number
    3
    2
    1
    Vomiting
         subjects affected / exposed
    3 / 246 (1.22%)
    2 / 247 (0.81%)
    1 / 96 (1.04%)
         occurrences all number
    3
    2
    1
    Abdominal pain lower
         subjects affected / exposed
    2 / 246 (0.81%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    2
    2
    0
    Gastritis
         subjects affected / exposed
    1 / 246 (0.41%)
    3 / 247 (1.21%)
    0 / 96 (0.00%)
         occurrences all number
    1
    3
    0
    Umbilical hernia
         subjects affected / exposed
    1 / 246 (0.41%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    1
    2
    0
    Dental caries
         subjects affected / exposed
    3 / 246 (1.22%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    3
    0
    0
    Haemorrhoids
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    1
    1
    0
    Abdominal discomfort
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Anal fissure
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Anogenital dysplasia
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Colitis ulcerative
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Colitis
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Diverticulum intestinal
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Duodenitis
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Dysphagia
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    2
    0
    0
    Food poisoning
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Frequent bowel movements
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Gastric cyst
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Gastric dilatation
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Gingival pain
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Gingival swelling
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Hiatus hernia
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Inguinal hernia
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Lip swelling
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    6 / 246 (2.44%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    7
    1
    0
    Dermatitis
         subjects affected / exposed
    4 / 246 (1.63%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    5
    1
    0
    Acne
         subjects affected / exposed
    3 / 246 (1.22%)
    2 / 247 (0.81%)
    1 / 96 (1.04%)
         occurrences all number
    3
    2
    1
    Alopecia
         subjects affected / exposed
    2 / 246 (0.81%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    2
    0
    0
    Eczema
         subjects affected / exposed
    2 / 246 (0.81%)
    2 / 247 (0.81%)
    1 / 96 (1.04%)
         occurrences all number
    2
    3
    1
    Dermal cyst
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    1
    1
    0
    Dermatitis allergic
         subjects affected / exposed
    2 / 246 (0.81%)
    0 / 247 (0.00%)
    1 / 96 (1.04%)
         occurrences all number
    2
    0
    1
    Dry skin
         subjects affected / exposed
    0 / 246 (0.00%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    0
    2
    0
    Actinic keratosis
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Pruritus
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    1 / 96 (1.04%)
         occurrences all number
    1
    1
    1
    Rash papular
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    1
    1
    0
    Skin lesion
         subjects affected / exposed
    0 / 246 (0.00%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    0
    2
    0
    Dermatitis atopic
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Dermatitis bullous
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Dermatitis contact
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Dyshidrotic eczema
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Erythema
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    1 / 96 (1.04%)
         occurrences all number
    1
    0
    1
    Lichen planus
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    1 / 96 (1.04%)
         occurrences all number
    1
    0
    1
    Miliaria
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Night sweats
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Photosensitivity reaction
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    2
    0
    0
    Pseudofolliculitis
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Psoriasis
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Skin odour abnormal
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Skin plaque
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Skin ulcer
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Solar dermatitis
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Solar lentigo
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Rash erythematous
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Rash maculo-papular
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Rosacea
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Rash pruritic
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Renal and urinary disorders
    Renal impairment
         subjects affected / exposed
    4 / 246 (1.63%)
    3 / 247 (1.21%)
    0 / 96 (0.00%)
         occurrences all number
    4
    3
    0
    Haematuria
         subjects affected / exposed
    1 / 246 (0.41%)
    2 / 247 (0.81%)
    1 / 96 (1.04%)
         occurrences all number
    1
    2
    1
    Proteinuria
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    1
    1
    0
    Acute kidney injury
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Dysuria
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    1 / 96 (1.04%)
         occurrences all number
    0
    1
    1
    Glycosuria
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Nephrolithiasis
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Renal colic
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary incontinence
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Urine odour abnormal
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Bladder pain
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    1 / 96 (1.04%)
         occurrences all number
    1
    0
    1
    Endocrine disorders
    Acromegaly
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Diabetes insipidus
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Hypopituitarism
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Secondary hypothyroidism
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Secondary adrenocortical insufficiency
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Thyroid disorder
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 246 (2.03%)
    10 / 247 (4.05%)
    2 / 96 (2.08%)
         occurrences all number
    5
    11
    2
    Back pain
         subjects affected / exposed
    14 / 246 (5.69%)
    7 / 247 (2.83%)
    3 / 96 (3.13%)
         occurrences all number
    15
    7
    3
    Myalgia
         subjects affected / exposed
    5 / 246 (2.03%)
    1 / 247 (0.40%)
    2 / 96 (2.08%)
         occurrences all number
    5
    1
    2
    Pain in extremity
         subjects affected / exposed
    5 / 246 (2.03%)
    3 / 247 (1.21%)
    1 / 96 (1.04%)
         occurrences all number
    5
    3
    1
    Neck pain
         subjects affected / exposed
    4 / 246 (1.63%)
    4 / 247 (1.62%)
    0 / 96 (0.00%)
         occurrences all number
    4
    6
    0
    Muscle spasms
         subjects affected / exposed
    2 / 246 (0.81%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    3
    2
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    1
    1
    0
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    1
    1
    0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    1
    2
    0
    Bone formation increased
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Cervical spinal stenosis
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Chondropathy
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Finger deformity
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Jaw cyst
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Joint effusion
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Muscle fatigue
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Muscle tightness
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    2
    0
    0
    Muscular weakness
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal discomfort
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Osteoarthritis
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Patellofemoral pain syndrome
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Tendon pain
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Osteochondritis
         subjects affected / exposed
    0 / 246 (0.00%)
    0 / 247 (0.00%)
    1 / 96 (1.04%)
         occurrences all number
    0
    0
    1
    Osteoporosis
         subjects affected / exposed
    0 / 246 (0.00%)
    0 / 247 (0.00%)
    1 / 96 (1.04%)
         occurrences all number
    0
    0
    1
    Bone hypertrophy
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    14 / 246 (5.69%)
    8 / 247 (3.24%)
    3 / 96 (3.13%)
         occurrences all number
    14
    8
    3
    Nasopharyngitis
         subjects affected / exposed
    11 / 246 (4.47%)
    9 / 247 (3.64%)
    3 / 96 (3.13%)
         occurrences all number
    12
    10
    3
    Syphilis
         subjects affected / exposed
    9 / 246 (3.66%)
    5 / 247 (2.02%)
    1 / 96 (1.04%)
         occurrences all number
    10
    5
    1
    Upper respiratory tract infection
         subjects affected / exposed
    11 / 246 (4.47%)
    15 / 247 (6.07%)
    3 / 96 (3.13%)
         occurrences all number
    11
    16
    3
    Urinary tract infection
         subjects affected / exposed
    3 / 246 (1.22%)
    5 / 247 (2.02%)
    3 / 96 (3.13%)
         occurrences all number
    4
    5
    3
    Gastroenteritis
         subjects affected / exposed
    3 / 246 (1.22%)
    5 / 247 (2.02%)
    2 / 96 (2.08%)
         occurrences all number
    3
    5
    2
    Sinusitis
         subjects affected / exposed
    1 / 246 (0.41%)
    4 / 247 (1.62%)
    1 / 96 (1.04%)
         occurrences all number
    1
    4
    1
    Conjunctivitis
         subjects affected / exposed
    2 / 246 (0.81%)
    3 / 247 (1.21%)
    0 / 96 (0.00%)
         occurrences all number
    2
    3
    0
    Bronchitis
         subjects affected / exposed
    2 / 246 (0.81%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    2
    2
    0
    Chlamydial infection
         subjects affected / exposed
    2 / 246 (0.81%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    2
    3
    0
    Influenza
         subjects affected / exposed
    1 / 246 (0.41%)
    3 / 247 (1.21%)
    1 / 96 (1.04%)
         occurrences all number
    1
    3
    1
    Onychomycosis
         subjects affected / exposed
    2 / 246 (0.81%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    2
    2
    0
    Otitis externa
         subjects affected / exposed
    1 / 246 (0.41%)
    3 / 247 (1.21%)
    0 / 96 (0.00%)
         occurrences all number
    1
    3
    0
    Pharyngitis
         subjects affected / exposed
    2 / 246 (0.81%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    2
    2
    0
    Proctitis gonococcal
         subjects affected / exposed
    1 / 246 (0.41%)
    3 / 247 (1.21%)
    0 / 96 (0.00%)
         occurrences all number
    1
    3
    0
    Herpes zoster
         subjects affected / exposed
    2 / 246 (0.81%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    2
    2
    0
    Oropharyngeal gonococcal infection
         subjects affected / exposed
    2 / 246 (0.81%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    2
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    2 / 246 (0.81%)
    1 / 247 (0.40%)
    1 / 96 (1.04%)
         occurrences all number
    2
    1
    1
    Rhinitis
         subjects affected / exposed
    2 / 246 (0.81%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    2
    1
    0
    Suspected COVID-19
         subjects affected / exposed
    1 / 246 (0.41%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    1
    2
    0
    Ear infection
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    1
    1
    0
    Fungal skin infection
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    1
    2
    0
    Furuncle
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    1
    1
    0
    Cellulitis
         subjects affected / exposed
    0 / 246 (0.00%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    0
    2
    0
    Cystitis
         subjects affected / exposed
    2 / 246 (0.81%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    2
    0
    0
    Gastrointestinal infection
         subjects affected / exposed
    2 / 246 (0.81%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    2
    0
    0
    Gonococcal infection
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    2
    1
    0
    Gonorrhoea
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    1
    1
    0
    Herpes simplex
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    2
    1
    0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    1
    1
    0
    Oral herpes
         subjects affected / exposed
    2 / 246 (0.81%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    3
    0
    0
    Periodontitis
         subjects affected / exposed
    2 / 246 (0.81%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    2
    0
    0
    Pharyngotonsillitis
         subjects affected / exposed
    2 / 246 (0.81%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    2
    0
    0
    Primary syphilis
         subjects affected / exposed
    0 / 246 (0.00%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    0
    2
    0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    1
    1
    0
    Tonsillitis
         subjects affected / exposed
    0 / 246 (0.00%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    0
    2
    0
    Viral infection
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    1
    1
    0
    Acarodermatitis
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Anorectal human papilloma virus infection
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Bacterial vaginosis
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Anal chlamydia infection
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Body tinea
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchitis viral
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Candida infection
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Chronic sinusitis
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Conjunctivitis bacterial
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Eyelid infection
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Folliculitis
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    1 / 96 (1.04%)
         occurrences all number
    1
    0
    1
    Fungal infection
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    2
    0
    Genital herpes
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    2
    0
    0
    Genitourinary chlamydia infection
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Genital herpes simplex
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    2
    0
    0
    Laryngitis
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Localised infection
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Otitis media acute
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Paronychia
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Pharyngeal chlamydia infection
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Pneumonia viral
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Secondary syphilis
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Skin infection
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    1 / 96 (1.04%)
         occurrences all number
    1
    0
    1
    Sinusitis bacterial
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Tinea capitis
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Tinea infection
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    2
    0
    Tinea pedis
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Tooth infection
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    2
    0
    0
    Tracheitis
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Urethritis
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Urethritis gonococcal
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Labyrinthitis
         subjects affected / exposed
    0 / 246 (0.00%)
    0 / 247 (0.00%)
    1 / 96 (1.04%)
         occurrences all number
    0
    0
    1
    Lymph gland infection
         subjects affected / exposed
    0 / 246 (0.00%)
    0 / 247 (0.00%)
    1 / 96 (1.04%)
         occurrences all number
    0
    0
    1
    Orchitis
         subjects affected / exposed
    0 / 246 (0.00%)
    0 / 247 (0.00%)
    1 / 96 (1.04%)
         occurrences all number
    0
    0
    1
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    1 / 96 (1.04%)
         occurrences all number
    1
    0
    1
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    1 / 96 (1.04%)
         occurrences all number
    1
    0
    1
    Metabolism and nutrition disorders
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 246 (0.41%)
    5 / 247 (2.02%)
    5 / 96 (5.21%)
         occurrences all number
    1
    5
    5
    Hyperlipidaemia
         subjects affected / exposed
    4 / 246 (1.63%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    4
    1
    0
    Dyslipidaemia
         subjects affected / exposed
    1 / 246 (0.41%)
    4 / 247 (1.62%)
    0 / 96 (0.00%)
         occurrences all number
    1
    4
    0
    Hypercholesterolaemia
         subjects affected / exposed
    3 / 246 (1.22%)
    3 / 247 (1.21%)
    5 / 96 (5.21%)
         occurrences all number
    3
    3
    5
    Hyperglycaemia
         subjects affected / exposed
    2 / 246 (0.81%)
    3 / 247 (1.21%)
    0 / 96 (0.00%)
         occurrences all number
    2
    3
    0
    Decreased appetite
         subjects affected / exposed
    3 / 246 (1.22%)
    0 / 247 (0.00%)
    2 / 96 (2.08%)
         occurrences all number
    3
    0
    2
    Glucose tolerance impaired
         subjects affected / exposed
    1 / 246 (0.41%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    1
    2
    0
    Insulin resistance
         subjects affected / exposed
    0 / 246 (0.00%)
    3 / 247 (1.21%)
    0 / 96 (0.00%)
         occurrences all number
    0
    3
    0
    Vitamin D deficiency
         subjects affected / exposed
    2 / 246 (0.81%)
    2 / 247 (0.81%)
    1 / 96 (1.04%)
         occurrences all number
    2
    2
    1
    Abnormal loss of weight
         subjects affected / exposed
    0 / 246 (0.00%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    0
    2
    0
    Diabetes mellitus
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    1
    1
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 246 (0.00%)
    2 / 247 (0.81%)
    0 / 96 (0.00%)
         occurrences all number
    0
    2
    0
    Increased appetite
         subjects affected / exposed
    2 / 246 (0.81%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    2
    0
    0
    Metabolic syndrome
         subjects affected / exposed
    2 / 246 (0.81%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    2
    0
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    2 / 246 (0.81%)
    0 / 247 (0.00%)
    1 / 96 (1.04%)
         occurrences all number
    2
    0
    1
    Dehydration
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperuricaemia
         subjects affected / exposed
    1 / 246 (0.41%)
    1 / 247 (0.40%)
    1 / 96 (1.04%)
         occurrences all number
    1
    1
    1
    Hypoglycaemia
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 247 (0.40%)
    0 / 96 (0.00%)
         occurrences all number
    0
    1
    0
    Obesity
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Abnormal weight gain
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (0.00%)
         occurrences all number
    1
    0
    0
    Electrolyte imbalance
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 247 (0.00%)
    0 / 96 (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
    26 Mar 2018
    A global amendment applicable to all participating countries to clarify entry criteria, correct errors and improve consistency.
    14 Nov 2018
    A global amendment applicable to all participating countries to update the study design including length of study, updates to the eligibility criteria and removing the option to remain on the study if the participant becomes pregnant. Additional changes were made to manage and mitigate risks following identification of a potential safety issue related to neural tube defects in infants born to women with exposure to dolutegravir at the time of conception. A sub-study was added to collect data on participants who withdraw for meeting CVW or PVW criteria.
    25 Mar 2019
    A global amendment, for administrative purposes, applicable to all participating countries. Edits to increase clarity around collection of virology specimens for additional testing, the timing of the eCSSRS questionnaire in relation to medication administration, and follow-up for AEs were made. Additional changes were made to correct editing errors related to the tables for liver stopping criteria, which contained both GSK and ViiV-specific stopping criteria. This amendment removed the GSK information.
    05 May 2020
    This global amendment describes possible changes in patient management related to the impact of COVID-19, COVID-19 case definition guidance, ending recruitment due to COVID-19 before the original sample size was achieved and sample size considerations and statistical analyses updates. Additionally, the list of prohibited medications was updated to add fampridine to align with the Investigator Brochure version 13 and other administrative updates were made to provide updated information, correct errors and improve accuracy and consistency.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/35235656
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