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    Clinical Trial Results:
    A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching from a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects who are Virologically Suppressed

    Summary
    EudraCT number
    		 2015-004025-14
    Trial protocol
    		 GB   BE   DE   ES  
    Global end of trial date
    23 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Nov 2020
    First version publication date
    07 Nov 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-380-1844
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02603120
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.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
    23 Oct 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 May 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Oct 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC as the FDC ABC/DTG/3TC in virologically suppressed Human Immunodeficiency Virus-1 (HIV-1) infected adults.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Nov 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 62
    Country: Number of subjects enrolled
    United Kingdom: 8
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    France: 12
    Country: Number of subjects enrolled
    Germany: 28
    Country: Number of subjects enrolled
    Australia: 15
    Country: Number of subjects enrolled
    Canada: 35
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    United States: 403
    Worldwide total number of subjects
    567
    EEA total number of subjects
    114
    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)
    543
    From 65 to 84 years
    24
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in North America, Europe, and Australia. The first participant was screened on 11 November 2015. The last study visit occurred on 23 October 2019.

    Pre-assignment
    Screening details
    		 646 participants were screened.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 B/F/TAF
    Arm description
    		 B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food.
    Arm type
    		 Experimental

    Investigational medicinal product name
    B/F/TAF
    Investigational medicinal product code
    Other name
    Biktarvy® (BVY)
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    B/F/TAF 50/200/25 mg FDC tablet administered orally once daily.

    Investigational medicinal product name
    ABC/DTG/3TC placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ABC/DTG/3TC placebo tablet administered orally once daily .

    Arm title
    		 ABC/DTG/3TC
    Arm description
    		 ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABC/DTG/3TC
    Investigational medicinal product code
    Other name
    Triumeq®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ABC/DTG/3TC (600/50/300 mg) FDC tablet administered orally once daily.

    Investigational medicinal product name
    B/F/TAF placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    B/F/TAF placebo tablet administered orally once daily .

    Number of subjects in period 1 [1]
    		B/F/TAF ABC/DTG/3TC
    Started
    282
    281
    Completed
    265
    267
    Not completed
    17
    14
         Adverse event, non-fatal
    3
    3
         Death
    2
    -
         Pregnancy
    1
    1
         Non-compliance with study drug
    1
    -
         Withdrew consent
    4
    8
         Lost to follow-up
    4
    2
         Investigator's discretion
    2
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 567 participants were randomized but 4 participants did not received study drug.
    Period 2
    Period 2 title
    Open-Label Phase
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 B/F/TAF from B/F/TAF
    Arm description
    		 Participants who received B/F/TAF in double-blind phase and from country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    B/F/TAF
    Investigational medicinal product code
    Other name
    Biktarvy® (BVY)
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    B/F/TAF (50/200/25 mg) FDC tablet administered orally once daily.

    Arm title
    		 B/F/TAF from ABC/DTG/3TC
    Arm description
    		 Participants who received ABC/DTG/3TC in double-blind phase and from country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    B/F/TAF
    Investigational medicinal product code
    Other name
    Biktarvy® (BVY)
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    B/F/TAF (50/200/25 mg) FDC tablet administered orally once daily.

    Number of subjects in period 2 [2]
    		B/F/TAF from B/F/TAF B/F/TAF from ABC/DTG/3TC
    Started
    259
    265
    Completed
    254
    254
    Not completed
    5
    11
         Adverse event, non-fatal
    -
    1
         Death
    -
    1
         Lost to follow-up
    3
    4
         Investigator's discretion
    1
    2
         Withdrew consent
    1
    2
         Lack of efficacy
    -
    1
    Notes
    [2] - 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: 532 participants completed the Double-Blind Phase, but 8 participants did not enter in the Open-Label Phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    B/F/TAF
    Reporting group description
    		 B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food.

    Reporting group title
    ABC/DTG/3TC
    Reporting group description
    		 ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.

    Reporting group values
    		 B/F/TAF ABC/DTG/3TC Total
    Number of subjects
    		 282 281 563
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46 ( 11.1 ) 45 ( 11.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 35 29 64
        Male
    		 247 252 499
    Race
    Not Permitted = local regulators did not allow collection of race or ethnicity information.
    Units: Subjects
        American Indian or Alaska Native
    		 2 2 4
        Asian
    		 9 9 18
        Black
    		 59 62 121
        Native Hawaiian or Pacific Islander
    		 3 0 3
        White
    		 206 202 408
        Other
    		 3 3 6
        Not Permitted
    		 0 3 3
    Ethnicity
    Not Permitted = local regulators did not allow collection of race or ethnicity information.
    Units: Subjects
        Hispanic or Latino
    		 46 52 98
        Not Hispanic or Latino
    		 236 227 463
        Not Permitted
    		 0 2 2
    Region of Enrollment
    Units: Subjects
        Canada
    		 13 22 35
        Belgium
    		 1 1 2
        United States
    		 203 198 401
        Italy
    		 1 1 2
        United Kingdom
    		 3 3 6
        France
    		 4 8 12
        Germany
    		 17 11 28
        Spain
    		 31 31 62
        Australia
    		 9 6 15
    HIV-1 RNA Categories
    Units: Subjects
        < 50 copies/mL
    		 278 272 550
        ≥ 50 copies/mL
    		 4 9 13
    CD4 Cell Count Category
    Units: Subjects
        ≥ 50 to < 200 cells/μL
    		 6 4 10
        ≥ 200 to < 350 cells/μL
    		 16 30 46
        ≥ 350 to < 500 cells/μL
    		 33 42 75
        ≥ 500 cells/μL
    		 227 205 432
    CD4 Cell Count
    Units: cell/µL
        arithmetic mean (standard deviation)
    		 752 ( 302.2 ) 694 ( 291.6 ) -

    End points

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    End points reporting groups
    Reporting group title
    B/F/TAF
    Reporting group description
    		 B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food.

    Reporting group title
    ABC/DTG/3TC
    Reporting group description
    		 ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.
    Reporting group title
    B/F/TAF from B/F/TAF
    Reporting group description
    		 Participants who received B/F/TAF in double-blind phase and from country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

    Reporting group title
    B/F/TAF from ABC/DTG/3TC
    Reporting group description
    		 Participants who received ABC/DTG/3TC in double-blind phase and from country where B/F/TAF was not available were given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

    Primary: Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm

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    End point title
    		 Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm
    End point description
    The percentage of participants achieving HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. The Full Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Week 48
    End point values
    		 B/F/TAF ABC/DTG/3TC
    Number of subjects analysed
    282
    281
    Units: percentage of participants
        number (not applicable)
    1.1
    0.4
    Statistical analysis title
    		 Statistical Analysis- B/F/TAF vs ABC/DTG/3TC
    Statistical analysis description
    The differences in percentages of participants between treatment groups and their 95.002% CIs were calculated based on an unconditional exact method using 2 inverted 1-sided tests.
    Comparison groups
    ABC/DTG/3TC v B/F/TAF
    Number of subjects included in analysis
    563
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in Percentages
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 2.8
    Notes
    [1] - A sample size of 260 participants per treatment group would provide at least 90% power to detect a noninferiority margin of 4% in difference in percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Wk 48, between B/F/TAF group and ABC/DTG/3TC group. Sample size was based on assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL at Wk 48 and that the non-inferiority margin is 4%, and that the significance level of the test is at a one-sided 0.025 level.
    Statistical analysis title
    		 Statistical analysis- B/F/TAF vs ABC/DTG/3TC
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    563
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.62
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Defined by the US FDA-defined Snapshot Algorithm

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Defined by the US FDA-defined Snapshot Algorithm
    End point description
    The percentage of participants achieving HIV-1 RNA < 50 copies/mL at week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Participants in the Full Analysis were analysed.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 B/F/TAF ABC/DTG/3TC
    Number of subjects analysed
    282
    281
    Units: percentage of participants
        number (not applicable)
    93.6
    95.0
    Statistical analysis title
    		 Statistical analysis- B/F/TAF vs ABC/DTG/3TC
    Statistical analysis description
    The differences in percentages of participants between treatment groups and their 95.002% CIs were calculated based on an unconditional exact method using 2 inverted 1-sided tests.
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    563
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Difference in Percentages
    Point estimate
    -1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.5
         upper limit
    		 2.6
    Notes
    [2] - It would be concluded that B/F/TAF is noninferior to ABC/DTG/3TC if the lower bound of the 2-sided 95.002% CI of the difference between treatment groups (B/F/TAF group -ABC/DTG/3TC group) in the percentage of participants with HIV-1 RNA < 50 copies/mL is greater than -10%.
    Statistical analysis title
    		 Statistical analysis- B/F/TAF vs ABC/DTG/3TC
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    563
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.59
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Change From Baseline in CD4+ Cell Count at Week 48

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    End point title
    		 Change From Baseline in CD4+ Cell Count at Week 48
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 48
    End point values
    		 B/F/TAF ABC/DTG/3TC
    Number of subjects analysed
    265
    267
    Units: cells/µL
        arithmetic mean (standard deviation)
    -31 ( 181.3 )
    4 ( 191.0 )
    Statistical analysis title
    		 Statistical analysis- B/F/TAF vs ABC/DTG/3TC
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    532
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.031
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares means
    Point estimate
    -35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -67
         upper limit
    		 -3

    Secondary: Spine Bone Mineral Density (BMD) at Baseline

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    End point title
    		 Spine Bone Mineral Density (BMD) at Baseline
    End point description
    The Spine dual X-ray absorptiometry (DXA) Analysis Set included participants who were randomized into the study, received at least 1 dose of study drug, and had nonmissing baseline spine BMD values.
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 B/F/TAF ABC/DTG/3TC
    Number of subjects analysed
    256
    262
    Units: g/cm^2
        arithmetic mean (standard deviation)
    1.124 ( 0.1833 )
    1.103 ( 0.1548 )
    No statistical analyses for this end point

    Secondary: Percentage Change From Baseline in Spine BMD at Week 48

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    End point title
    		 Percentage Change From Baseline in Spine BMD at Week 48
    End point description
    Participants in the Spine DXA Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 48
    End point values
    		 B/F/TAF ABC/DTG/3TC
    Number of subjects analysed
    233
    244
    Units: percentage change
        arithmetic mean (standard deviation)
    0.692 ( 3.1296 )
    0.416 ( 2.9973 )
    Statistical analysis title
    		 Statistical analysis- B/F/TAF vs ABC/DTG/3TC
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    477
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.33
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares means
    Point estimate
    0.276
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.275
         upper limit
    		 0.827

    Secondary: Hip Bone Mineral Density at Baseline

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    End point title
    		 Hip Bone Mineral Density at Baseline
    End point description
    The Hip DXA Analysis Set included participants who were randomized into the study, received at least 1 dose of study drug, and had nonmissing baseline hip BMD values.
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 B/F/TAF ABC/DTG/3TC
    Number of subjects analysed
    256
    265
    Units: g/cm^2
        arithmetic mean (standard deviation)
    1.006 ( 0.1471 )
    0.996 ( 0.1363 )
    No statistical analyses for this end point

    Secondary: Percentage Change From Baseline in Hip BMD at Week 48

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    End point title
    		 Percentage Change From Baseline in Hip BMD at Week 48
    End point description
    Participants in the Hip DXA Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 48
    End point values
    		 B/F/TAF ABC/DTG/3TC
    Number of subjects analysed
    229
    242
    Units: percentage change
        arithmetic mean (standard deviation)
    0.156 ( 2.2138 )
    0.299 ( 2.1077 )
    Statistical analysis title
    		 Statistical analysis- B/F/TAF vs ABC/DTG/3TC
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    471
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.47
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares means
    Point estimate
    -0.143
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.534
         upper limit
    		 0.248

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First dose date up to Week 169 plus 30 days
    Adverse event reporting additional description
    The Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Double-Blind: B/F/TAF
    Reporting group description
    		 B/F/TAF 50/200/25 mg FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 48 weeks, without regard to food.

    Reporting group title
    Double-Blind: ABC/DTG/3TC
    Reporting group description
    		 ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 48 weeks, without regard to food.

    Reporting group title
    Open-label Extension: B/F/TAF from B/F/TAF
    Reporting group description
    		 Participants who received B/F/TAF in double-blind phase and from country where B/F/TAF was not available was given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

    Reporting group title
    Open-label Extension: B/F/TAF from ABC/DTG/3TC
    Reporting group description
    		 Participants who received ABC/DTG/3TC in double-blind phase and from country where B/F/TAF was not available was given the option to receive B/F/TAF orally once daily for up to 96 weeks in the open-label extension phase.

    Serious adverse events
    		 Double-Blind: B/F/TAF Double-Blind: ABC/DTG/3TC Open-label Extension: B/F/TAF from B/F/TAF Open-label Extension: B/F/TAF from ABC/DTG/3TC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 282 (6.03%)
    26 / 281 (9.25%)
    24 / 259 (9.27%)
    11 / 265 (4.15%)
         number of deaths (all causes)
    2
    0
    1
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Brain cancer metastatic
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Malignant neoplasm of thymus
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Testicular seminoma (pure) stage I
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    0 / 259 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Drug withdrawal syndrome
         subjects affected / exposed
    0 / 282 (0.00%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    1 / 282 (0.35%)
    0 / 281 (0.00%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    0 / 259 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    2 / 282 (0.71%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    2 / 282 (0.71%)
    0 / 281 (0.00%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abnormal behaviour
         subjects affected / exposed
    0 / 282 (0.00%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcohol abuse
         subjects affected / exposed
    1 / 282 (0.35%)
    0 / 281 (0.00%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression suicidal
         subjects affected / exposed
    1 / 282 (0.35%)
    0 / 281 (0.00%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paranoia
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    0 / 282 (0.00%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Self-injurious ideation
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Substance abuse
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bipolar disorder
         subjects affected / exposed
    0 / 282 (0.00%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    0 / 282 (0.00%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intentional overdose
         subjects affected / exposed
    2 / 282 (0.71%)
    0 / 281 (0.00%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    2 / 282 (0.71%)
    0 / 281 (0.00%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 282 (0.35%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    1 / 282 (0.35%)
    0 / 281 (0.00%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    0 / 259 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    1 / 282 (0.35%)
    0 / 281 (0.00%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 282 (0.35%)
    0 / 281 (0.00%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    1 / 282 (0.35%)
    0 / 281 (0.00%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Myocardial bridging
         subjects affected / exposed
    0 / 282 (0.00%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 282 (0.35%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 282 (0.35%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 282 (0.00%)
    2 / 281 (0.71%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive heart disease
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    0 / 259 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 282 (0.35%)
    0 / 281 (0.00%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    0 / 259 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hemiplegic migraine
         subjects affected / exposed
    0 / 282 (0.00%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    1 / 282 (0.35%)
    0 / 281 (0.00%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Macular detachment
         subjects affected / exposed
    0 / 282 (0.00%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    0 / 282 (0.00%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    0 / 282 (0.00%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    0 / 282 (0.00%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 282 (0.00%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    0 / 282 (0.00%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 282 (0.00%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 282 (0.00%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    0 / 282 (0.00%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 282 (0.00%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 282 (0.00%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    1 / 282 (0.35%)
    0 / 281 (0.00%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    0 / 259 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal stenosis
         subjects affected / exposed
    1 / 282 (0.35%)
    0 / 281 (0.00%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    0 / 282 (0.00%)
    2 / 281 (0.71%)
    0 / 259 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 282 (0.00%)
    1 / 281 (0.36%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine infection
         subjects affected / exposed
    1 / 282 (0.35%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shigella infection
         subjects affected / exposed
    0 / 282 (0.00%)
    1 / 281 (0.36%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute hepatitis C
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    0 / 282 (0.00%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 282 (0.00%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis of male external genital organ
         subjects affected / exposed
    0 / 282 (0.00%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    1 / 282 (0.35%)
    0 / 281 (0.00%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia infection
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye infection syphilitic
         subjects affected / exposed
    1 / 282 (0.35%)
    0 / 281 (0.00%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    0 / 259 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 282 (0.00%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenitis bacterial
         subjects affected / exposed
    1 / 282 (0.35%)
    0 / 281 (0.00%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    0 / 259 (0.00%)
    1 / 265 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural sepsis
         subjects affected / exposed
    0 / 282 (0.00%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 282 (0.00%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    0 / 282 (0.00%)
    1 / 281 (0.36%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 282 (0.00%)
    0 / 281 (0.00%)
    1 / 259 (0.39%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 282 (0.35%)
    0 / 281 (0.00%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    1 / 282 (0.35%)
    0 / 281 (0.00%)
    0 / 259 (0.00%)
    0 / 265 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Double-Blind: B/F/TAF Double-Blind: ABC/DTG/3TC Open-label Extension: B/F/TAF from B/F/TAF Open-label Extension: B/F/TAF from ABC/DTG/3TC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    122 / 282 (43.26%)
    132 / 281 (46.98%)
    84 / 259 (32.43%)
    82 / 265 (30.94%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    19 / 282 (6.74%)
    23 / 281 (8.19%)
    5 / 259 (1.93%)
    9 / 265 (3.40%)
         occurrences all number
    21
    25
    5
    9
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    26 / 282 (9.22%)
    18 / 281 (6.41%)
    20 / 259 (7.72%)
    11 / 265 (4.15%)
         occurrences all number
    27
    22
    27
    12
    Nausea
         subjects affected / exposed
    6 / 282 (2.13%)
    16 / 281 (5.69%)
    3 / 259 (1.16%)
    1 / 265 (0.38%)
         occurrences all number
    6
    16
    3
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    9 / 282 (3.19%)
    22 / 281 (7.83%)
    1 / 259 (0.39%)
    7 / 265 (2.64%)
         occurrences all number
    9
    22
    1
    7
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    21 / 282 (7.45%)
    18 / 281 (6.41%)
    8 / 259 (3.09%)
    6 / 265 (2.26%)
         occurrences all number
    22
    18
    8
    6
    Back pain
         subjects affected / exposed
    13 / 282 (4.61%)
    13 / 281 (4.63%)
    13 / 259 (5.02%)
    6 / 265 (2.26%)
         occurrences all number
    15
    14
    13
    6
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    34 / 282 (12.06%)
    32 / 281 (11.39%)
    22 / 259 (8.49%)
    26 / 265 (9.81%)
         occurrences all number
    37
    42
    27
    34
    Nasopharyngitis
         subjects affected / exposed
    21 / 282 (7.45%)
    22 / 281 (7.83%)
    20 / 259 (7.72%)
    22 / 265 (8.30%)
         occurrences all number
    26
    30
    30
    27
    Sinusitis
         subjects affected / exposed
    11 / 282 (3.90%)
    15 / 281 (5.34%)
    9 / 259 (3.47%)
    13 / 265 (4.91%)
         occurrences all number
    11
    15
    11
    16
    Bronchitis
         subjects affected / exposed
    11 / 282 (3.90%)
    15 / 281 (5.34%)
    11 / 259 (4.25%)
    8 / 265 (3.02%)
         occurrences all number
    12
    16
    13
    11

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Feb 2016
    The following changes were made: 1. Additional investigational centers were included to expand the number of sites participating. 2. Updated inclusion criterion to remove the limit of number of prior regimens at screening. 3. Clarified criteria for discontinuation of study treatment and for management of laboratory toxicity. 4. Included guidance for management of potential hepatobiliary toxicity.
    19 Oct 2016
    The following changes were made: 1. Revised the number of centers participating in the study. 2. Revised prior and concomitant medications. 3. Added OL rollover extension and treatment assessments for participants who receive OL B/F/TAF for up to 96 weeks. 4. Clarified that participants were only receive OL B/F/TAF if safety and efficacy of B/F/TAF is demonstrated following review of unblinded data. 5. Updated the Early Study Drugs Discontinuation (ESDD) assessments for participants who discontinue during the OL rollover extension. 6. Added hepatitis B virus (HBV) and hepatitis C virus (HCV) serology testing at Week 48 and every 48 weeks in the OL extension (Weeks 48 and 96 OL). 7. Revised Gilead reporting requirements to clarify that, in addition to using the reference safety information in the investigator’s brochure and relevant local label as applicable, Gilead may also use the European Union (EU) summary of product characteristics (SmPC) for assessment of expectedness of serious adverse events (SAEs) for ABC/DTG/3TC. 8. Revised the definition of special situations.

    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/31430369
    http://www.ncbi.nlm.nih.gov/pubmed/29925489
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