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    Clinical Trial Results:
    A Phase 3, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in HIV-1 Positive Subjects who are Virologically Suppressed on Regimens containing FTC/TDF

    Summary
    EudraCT number
    		 2013-005138-39
    Trial protocol
    		 BE   IT  
    Global end of trial date
    01 Mar 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Mar 2020
    First version publication date
    15 Mar 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-311-1089
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02121795
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, 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
    01 Mar 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Aug 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Mar 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study evaluated the efficacy of switching from emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) fixed dose combination (FDC) to emtricitabine/tenofovir alafenamide (F/TAF) FDC in HIV-1 positive participants who were virologically suppressed on regimens containing FTC/TDF. This study consisted of a 96 week double-blind treatment period. After Week 96, all participants continued on blinded study drug treatment and attended visits every 12 weeks until treatment assignments were unblinded. All participants returned for an unblinding visit and were given the option to receive open-label F/TAF and attended visits every 12 weeks until F/TAF was commercially available, or the sponsor terminated the F/TAF clinical development program.
    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
    06 May 2014
    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
    United Kingdom: 41
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    France: 40
    Country: Number of subjects enrolled
    Italy: 8
    Country: Number of subjects enrolled
    United States: 527
    Country: Number of subjects enrolled
    Puerto Rico: 31
    Country: Number of subjects enrolled
    Canada: 15
    Worldwide total number of subjects
    668
    EEA total number of subjects
    95
    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)
    647
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in North America and Europe. The first participant was screened on 06 May 2014. The last study visit occurred on 1 March 2019.

    Pre-assignment
    Screening details
    		 780 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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 F/TAF + 3rd Agent
    Arm description
    		 Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Emtricitabine/tenofovir alafenamide
    Investigational medicinal product code
    Other name
    Descovy®, F/TAF
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200/25 mg or 200/10 mg tablet orally once daily

    Investigational medicinal product name
    Emtricitabine/tenofovir disoproxil fumarate placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet orally once daily

    Investigational medicinal product name
    Third agent
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Third agent orally once daily. An allowed third antiretroviral agent of the participant's pre-existing regimen included one of the following: ritonavir-boosted atazanavir (ATV/r), ritonavir-boosted lopinavir (LPV/r), ritonavir-boosted darunavir (DRV/r), efavirenz (EFV; Sustiva®), rilpivirine (RPV; Edurant®), nevirapine (NVP;Viramune®), raltegravir (RAL; Isentress®), dolutegravir (DTG;Tivicay®), and maraviroc (MVC; Selzentry®).

    Arm title
    		 FTC/TDF + 3rd Agent
    Arm description
    		 Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Emtricitabine/tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    Truvada®, FTC/TDF
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200/300 mg tablet orally once daily

    Investigational medicinal product name
    Emtricitabine/tenofovir alafenamide placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet orally once daily

    Investigational medicinal product name
    Third agent
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Third agent orally once daily. An allowed third antiretroviral agent of the participant's pre-existing regimen included one of the following: ritonavir-boosted atazanavir (ATV/r), ritonavir-boosted lopinavir (LPV/r), ritonavir-boosted darunavir (DRV/r), efavirenz (EFV; Sustiva®), rilpivirine (RPV; Edurant®), nevirapine (NVP;Viramune®), raltegravir (RAL; Isentress®), dolutegravir (DTG;Tivicay®), and maraviroc (MVC; Selzentry®).

    Number of subjects in period 1 [1]
    		F/TAF + 3rd Agent FTC/TDF + 3rd Agent
    Started
    333
    330
    Completed
    296
    300
    Not completed
    37
    30
         Physician decision
    2
    5
         Non-Compliance with Study Drug
    3
    1
         Adverse event, non-fatal
    5
    -
         Death
    1
    1
         Withdrawal by Subject
    19
    16
         Protocol Violation
    -
    3
         Lost to follow-up
    7
    4
    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: 5 participants (F/TAF + 3rd Agent: N=1; FTC/TDF + 3rd Agent: N=4) who were randomized but not treated are not included in the subject disposition table.
    Period 2
    Period 2 title
    Open-Label Phase
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Open-Label F/TAF from F/TAF
    Arm description
    		 Open-Label Phase: F/TAF (200/25 mg or 200/10 mg) tablet orally once daily until F/TAF was commercially available or until Gilead Sciences terminated the F/TAF clinical development program in participants from the F/TAF + 3rd Agent group.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Emtricitabine/tenofovir alafenamide
    Investigational medicinal product code
    Other name
    Descovy®, F/TAF
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200/25 mg or 200/10 mg tablet orally once daily

    Arm title
    		 Open-Label F/TAF from FTC/TDF
    Arm description
    		 Open-Label Phase: F/TAF (200/25 mg or 200/10 mg) tablet orally once daily until F/TAF was commercially available or until Gilead Sciences terminated the F/TAF clinical development program in participants from the FTC/TDF + 3rd Agent group.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Emtricitabine/tenofovir alafenamide
    Investigational medicinal product code
    Other name
    Descovy®, F/TAF
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200/25 mg or 200/10mg tablet orally once daily

    Number of subjects in period 2 [2]
    		Open-Label F/TAF from F/TAF Open-Label F/TAF from FTC/TDF
    Started
    33
    31
    Completed
    21
    21
    Not completed
    12
    10
         Physician decision
    8
    8
         Withdrawal by Subject
    3
    2
         Lost to follow-up
    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: Not all participants entered the Open-Label Phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    F/TAF + 3rd Agent
    Reporting group description
    		 Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks.

    Reporting group title
    FTC/TDF + 3rd Agent
    Reporting group description
    		 Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.

    Reporting group values
    		 F/TAF + 3rd Agent FTC/TDF + 3rd Agent Total
    Number of subjects
    		 333 330 663
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47 ± 9.9 48 ± 9.7 -
    Gender categorical
    Units: Subjects
        Female
    		 48 54 102
        Male
    		 285 276 561
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 48 78 126
        Not Hispanic or Latino
    		 285 252 537
        Unknown or Not Reported
    		 0 0 0
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaska Native
    		 2 1 3
        Asian
    		 6 0 6
        Black
    		 69 67 136
        Native Hawaiian or Pacific Islander
    		 2 1 3
        White
    		 244 253 497
        Not Permitted
    		 1 1 2
        Other
    		 9 7 16
    Region of Enrollment
    Units: Subjects
        Canada
    		 5 9 14
        Belgium
    		 3 3 6
        United States
    		 282 274 556
        Italy
    		 2 6 8
        United Kingdom
    		 23 17 40
        France
    		 18 21 39
    Baseline Third Agent
    Units: Subjects
        Atazanavir boosted with ritonavir (ATV/r)
    		 53 50 103
        Darunavir boosted with ritonavir (DRV/r)
    		 84 82 166
        Lopinavir boosted with ritonavir (LPV/r)
    		 18 18 36
        Dolutegravir (DTG)
    		 26 23 49
        Efavirenz (EFV)
    		 8 6 14
        Maraviroc (MVC)
    		 1 6 7
        Nevirapine (NVP)
    		 74 66 140
        Raltegravir (RAL)
    		 66 73 139
        Rilpivirine (RPV)
    		 3 6 9
    HIV-1 RNA Categories
    Units: Subjects
        < 50 copies/mL
    		 329 326 655
        >= 50 copies/mL
    		 4 4 8
    CD4 Cell Count
    Units: cells/µL
        arithmetic mean (standard deviation)
    		 691 ± 272.6 667 ± 272.3 -

    End points

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    End points reporting groups
    Reporting group title
    F/TAF + 3rd Agent
    Reporting group description
    		 Double-Blind Phase: F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks.

    Reporting group title
    FTC/TDF + 3rd Agent
    Reporting group description
    		 Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.
    Reporting group title
    Open-Label F/TAF from F/TAF
    Reporting group description
    		 Open-Label Phase: F/TAF (200/25 mg or 200/10 mg) tablet orally once daily until F/TAF was commercially available or until Gilead Sciences terminated the F/TAF clinical development program in participants from the F/TAF + 3rd Agent group.

    Reporting group title
    Open-Label F/TAF from FTC/TDF
    Reporting group description
    		 Open-Label Phase: F/TAF (200/25 mg or 200/10 mg) tablet orally once daily until F/TAF was commercially available or until Gilead Sciences terminated the F/TAF clinical development program in participants from the FTC/TDF + 3rd Agent group.

    Primary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Analysis

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Analysis
    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 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 all participants who were randomized into the study and received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    48 Weeks
    End point values
    		 F/TAF + 3rd Agent FTC/TDF + 3rd Agent
    Number of subjects analysed
    333
    330
    Units: percentage of participants
        number (not applicable)
    94.3
    93.0
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    F/TAF + 3rd Agent v FTC/TDF + 3rd Agent
    Number of subjects included in analysis
    663
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 = 0.5 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Percentage difference
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 5.1
    Notes
    [1] - Noninferiority was assessed using a conventional 95.002% confidence interval (CI) approach, with a noninferiority margin of 10%.
    [2] - P-value was from Cochran-Mantel-Haenszel (CMH) test stratified by third agent.

    Secondary: Percentage Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48

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    End point title
    		 Percentage Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
    End point description
    Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan. Participants in the Hip DXA Analysis Set (participants who were randomized and received at least one dose of study drug and had nonmissing baseline hip BMD data) with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 48
    End point values
    		 F/TAF + 3rd Agent FTC/TDF + 3rd Agent
    Number of subjects analysed
    304
    305
    Units: percentage change
        arithmetic mean (standard deviation)
    1.236 ± 2.6602
    -0.071 ± 2.3316
    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
    Spine BMD was assessed by DXA scan. Participants in the Spine DXA Analysis Set (participants who were randomized and received at least one dose of study drug and had nonmissing baseline spine BMD data) with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 48
    End point values
    		 F/TAF + 3rd Agent FTC/TDF + 3rd Agent
    Number of subjects analysed
    304
    309
    Units: percentage change
        arithmetic mean (standard deviation)
    1.662 ± 3.1279
    -0.109 ± 3.3476
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the FDA Snapshot Analysis

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the FDA Snapshot Analysis
    End point description
    The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response 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 Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 F/TAF + 3rd Agent FTC/TDF + 3rd Agent
    Number of subjects analysed
    333
    330
    Units: percentage of participants
        number (not applicable)
    91.6
    90.9
    No statistical analyses for this end point

    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 on-treatment data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 48
    End point values
    		 F/TAF + 3rd Agent FTC/TDF + 3rd Agent
    Number of subjects analysed
    313
    311
    Units: cells/μL
        arithmetic mean (standard deviation)
    20 ± 161.8
    21 ± 152.7
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the FDA Snapshot Analysis

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the FDA Snapshot Analysis
    End point description
    The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response 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 Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 F/TAF + 3rd Agent FTC/TDF + 3rd Agent
    Number of subjects analysed
    333
    330
    Units: percentage of participants
        number (not applicable)
    83.5
    86.1
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 as Defined by the FDA Snapshot Analysis

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 as Defined by the FDA Snapshot Analysis
    End point description
    The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response 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 Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 F/TAF + 3rd Agent FTC/TDF + 3rd Agent
    Number of subjects analysed
    333
    330
    Units: percentage of participants
        number (not applicable)
    88.6
    89.1
    No statistical analyses for this end point

    Secondary: Percentage Change From Baseline in Hip BMD at Week 96

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    End point title
    		 Percentage Change From Baseline in Hip BMD at Week 96
    End point description
    Hip BMD was assessed by DXA scan. Participants in the Hip DXA Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 96
    End point values
    		 F/TAF + 3rd Agent FTC/TDF + 3rd Agent
    Number of subjects analysed
    291
    292
    Units: percentage change
        arithmetic mean (standard deviation)
    1.856 ± 3.2195
    -0.289 ± 2.9912
    No statistical analyses for this end point

    Secondary: Percentage Change From Baseline in Spine BMD at Week 96

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    End point title
    		 Percentage Change From Baseline in Spine BMD at Week 96
    End point description
    Spine BMD was assessed by DXA scan. Participants in the Spine DXA Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 96
    End point values
    		 F/TAF + 3rd Agent FTC/TDF + 3rd Agent
    Number of subjects analysed
    290
    296
    Units: percentage change
        arithmetic mean (standard deviation)
    2.159 ± 3.8374
    -0.109 ± 3.6738
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4+ Cell Count at Week 96

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    End point title
    		 Change From Baseline in CD4+ Cell Count at Week 96
    End point description
    Participants in the Full Analysis Set with on-treatment data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 96
    End point values
    		 F/TAF + 3rd Agent FTC/TDF + 3rd Agent
    Number of subjects analysed
    299
    296
    Units: cells/μL
        arithmetic mean (standard deviation)
    50 ± 198.7
    46 ± 169.4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First dose of study drug to the last dose (maximum: 227.4 weeks) plus 30 days
    Adverse event reporting additional description
    The Safety Analysis Set included all randomized participants who received at least one dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    F/TAF + 3rd Agent (Double-Blind)
    Reporting group description
    		 Double-Blind Phase: emtricitabine/tenofovir alafenamide (F/TAF) (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks.

    Reporting group title
    FTC/TDF + 3rd Agent (Double-Blind)
    Reporting group description
    		 Double-Blind Phase: FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks.

    Reporting group title
    Open-Label F/TAF From F/TAF
    Reporting group description
    		 Open-Label Phase: F/TAF (200/25 mg or 200/10 mg) tablet orally once daily until F/TAF was commercially available or until Gilead Sciences terminated the F/TAF clinical development program in participants from the F/TAF + 3rd Agent group.

    Reporting group title
    Open-Label F/TAF From FTC/TDF
    Reporting group description
    		 Open-Label Phase: F/TAF (200/25 mg or 200/10 mg) tablet orally once daily until F/TAF was commercially available or until Gilead Sciences terminated the F/TAF clinical development program in participants from the FTC/TDF + 3rd Agent group.

    Serious adverse events
    		 F/TAF + 3rd Agent (Double-Blind) FTC/TDF + 3rd Agent (Double-Blind) Open-Label F/TAF From F/TAF Open-Label F/TAF From FTC/TDF
    Total subjects affected by serious adverse events
         subjects affected / exposed
    29 / 333 (8.71%)
    31 / 330 (9.39%)
    2 / 33 (6.06%)
    3 / 31 (9.68%)
         number of deaths (all causes)
    2
    1
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung adenocarcinoma
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Lymphoma
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Metastases to lung
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Metastases to lymph nodes
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Tonsil cancer
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Venous thrombosis limb
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    2 / 333 (0.60%)
    1 / 330 (0.30%)
    1 / 33 (3.03%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drowning
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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 / 1
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 333 (0.30%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 333 (0.30%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Pleural effusion
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Pneumonia aspiration
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Pneumothorax
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Pulmonary embolism
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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 failure
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Psychiatric disorders
    Alcoholism
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Delirium
         subjects affected / exposed
    0 / 333 (0.00%)
    0 / 330 (0.00%)
    1 / 33 (3.03%)
    0 / 31 (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
    Depressed mood
         subjects affected / exposed
    0 / 333 (0.00%)
    0 / 330 (0.00%)
    1 / 33 (3.03%)
    0 / 31 (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
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Suicide attempt
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Investigations
    Lipase increased
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Anastomotic stenosis
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Ankle fracture
         subjects affected / exposed
    0 / 333 (0.00%)
    2 / 330 (0.61%)
    0 / 33 (0.00%)
    0 / 31 (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
    Limb injury
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Overdose
         subjects affected / exposed
    1 / 333 (0.30%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 333 (0.00%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    1 / 31 (3.23%)
         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
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Nervous system disorders
    Carotid artery stenosis
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Dizziness exertional
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Encephalopathy
         subjects affected / exposed
    0 / 333 (0.00%)
    2 / 330 (0.61%)
    0 / 33 (0.00%)
    0 / 31 (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
    Headache
         subjects affected / exposed
    1 / 333 (0.30%)
    2 / 330 (0.61%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Syncope
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Abdominal pain upper
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Chronic gastritis
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Colitis
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Constipation
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Diarrhoea
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Haematemesis
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Haemorrhoids
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Intestinal stenosis
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Intestinal ulcer
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Obstructive pancreatitis
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Oesophageal stenosis
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Pancreatitis
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Pancreatitis acute
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 333 (0.30%)
    2 / 330 (0.61%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 333 (0.30%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Cholelithiasis obstructive
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Arthralgia
         subjects affected / exposed
    0 / 333 (0.00%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    1 / 31 (3.23%)
         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
    Arthritis
         subjects affected / exposed
    0 / 333 (0.00%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Intervertebral disc protrusion
         subjects affected / exposed
    3 / 333 (0.90%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Rhabdomyolysis
         subjects affected / exposed
    2 / 333 (0.60%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Infections and infestations
    Acute hepatitis C
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Arthritis bacterial
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Bone tuberculosis
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Diverticulitis
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Enteritis infectious
         subjects affected / exposed
    0 / 333 (0.00%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    1 / 31 (3.23%)
         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
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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 infection
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Herpes zoster
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Influenza
         subjects affected / exposed
    0 / 333 (0.00%)
    0 / 330 (0.00%)
    1 / 33 (3.03%)
    0 / 31 (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
    Laryngitis
         subjects affected / exposed
    0 / 333 (0.00%)
    0 / 330 (0.00%)
    1 / 33 (3.03%)
    0 / 31 (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
    Localised infection
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Lung infection
         subjects affected / exposed
    0 / 333 (0.00%)
    0 / 330 (0.00%)
    1 / 33 (3.03%)
    0 / 31 (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
    Mycobacterium abscessus infection
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (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
    Oesophagitis bacterial
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Pneumonia
         subjects affected / exposed
    0 / 333 (0.00%)
    3 / 330 (0.91%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostatitis Escherichia col
         subjects affected / exposed
    0 / 333 (0.00%)
    0 / 330 (0.00%)
    1 / 33 (3.03%)
    0 / 31 (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
    Pyelonephritis
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Subcutaneous abscess
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 333 (0.30%)
    0 / 330 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fluid overload
         subjects affected / exposed
    0 / 333 (0.00%)
    1 / 330 (0.30%)
    0 / 33 (0.00%)
    0 / 31 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 F/TAF + 3rd Agent (Double-Blind) FTC/TDF + 3rd Agent (Double-Blind) Open-Label F/TAF From F/TAF Open-Label F/TAF From FTC/TDF
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    242 / 333 (72.67%)
    226 / 330 (68.48%)
    12 / 33 (36.36%)
    13 / 31 (41.94%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    16 / 333 (4.80%)
    20 / 330 (6.06%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    16
    20
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    33 / 333 (9.91%)
    22 / 330 (6.67%)
    0 / 33 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    35
    25
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    26 / 333 (7.81%)
    23 / 330 (6.97%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    26
    24
    0
    0
    Influenza like illness
         subjects affected / exposed
    6 / 333 (1.80%)
    10 / 330 (3.03%)
    0 / 33 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    6
    10
    0
    2
    Pyrexia
         subjects affected / exposed
    6 / 333 (1.80%)
    17 / 330 (5.15%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    7
    21
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    44 / 333 (13.21%)
    42 / 330 (12.73%)
    1 / 33 (3.03%)
    0 / 31 (0.00%)
         occurrences all number
    50
    51
    1
    0
    Nausea
         subjects affected / exposed
    23 / 333 (6.91%)
    19 / 330 (5.76%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    24
    19
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    37 / 333 (11.11%)
    20 / 330 (6.06%)
    2 / 33 (6.06%)
    2 / 31 (6.45%)
         occurrences all number
    42
    21
    2
    2
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    19 / 333 (5.71%)
    11 / 330 (3.33%)
    1 / 33 (3.03%)
    0 / 31 (0.00%)
         occurrences all number
    19
    11
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    15 / 333 (4.50%)
    20 / 330 (6.06%)
    2 / 33 (6.06%)
    1 / 31 (3.23%)
         occurrences all number
    15
    20
    2
    1
    Insomnia
         subjects affected / exposed
    15 / 333 (4.50%)
    13 / 330 (3.94%)
    0 / 33 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    15
    13
    0
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    35 / 333 (10.51%)
    23 / 330 (6.97%)
    0 / 33 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    37
    25
    0
    2
    Back pain
         subjects affected / exposed
    37 / 333 (11.11%)
    28 / 330 (8.48%)
    3 / 33 (9.09%)
    2 / 31 (6.45%)
         occurrences all number
    42
    28
    3
    2
    Pain in extremity
         subjects affected / exposed
    26 / 333 (7.81%)
    22 / 330 (6.67%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
         occurrences all number
    27
    23
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    32 / 333 (9.61%)
    26 / 330 (7.88%)
    1 / 33 (3.03%)
    1 / 31 (3.23%)
         occurrences all number
    37
    35
    1
    1
    Fungal skin infection
         subjects affected / exposed
    1 / 333 (0.30%)
    2 / 330 (0.61%)
    0 / 33 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    1
    2
    0
    2
    Gastroenteritis
         subjects affected / exposed
    11 / 333 (3.30%)
    8 / 330 (2.42%)
    2 / 33 (6.06%)
    0 / 31 (0.00%)
         occurrences all number
    11
    8
    2
    0
    Influenza
         subjects affected / exposed
    23 / 333 (6.91%)
    15 / 330 (4.55%)
    0 / 33 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    27
    15
    0
    2
    Nasopharyngitis
         subjects affected / exposed
    43 / 333 (12.91%)
    27 / 330 (8.18%)
    4 / 33 (12.12%)
    2 / 31 (6.45%)
         occurrences all number
    59
    32
    5
    3
    Onychomycosis
         subjects affected / exposed
    6 / 333 (1.80%)
    3 / 330 (0.91%)
    0 / 33 (0.00%)
    3 / 31 (9.68%)
         occurrences all number
    6
    3
    0
    3
    Sinusitis
         subjects affected / exposed
    23 / 333 (6.91%)
    28 / 330 (8.48%)
    2 / 33 (6.06%)
    3 / 31 (9.68%)
         occurrences all number
    26
    32
    4
    3
    Syphilis
         subjects affected / exposed
    18 / 333 (5.41%)
    7 / 330 (2.12%)
    3 / 33 (9.09%)
    2 / 31 (6.45%)
         occurrences all number
    20
    8
    3
    2
    Upper respiratory tract infection
         subjects affected / exposed
    54 / 333 (16.22%)
    67 / 330 (20.30%)
    1 / 33 (3.03%)
    0 / 31 (0.00%)
         occurrences all number
    64
    92
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Feb 2014
    Amendment 1: Changed from open-label to double-blind; Changed the non-inferiority margin from 12% to 10%; Updated the statistical analysis method with stratified analysis of bone mineral density (BMD) by use of ritonavir; Added requirement for blood sample collection from both treatment groups for pharmacokinetic (PK) assessment; Added trough PK sample collection at Week 4 to determine tenofovir diphosphate (TFV-DP) concentration in peripheral blood mononuclear cells (PBMCs).
    28 Apr 2014
    Amendment 2: Changed TAF dose from 25 mg to 10 mg for subjects receiving DRV/r; Changed inclusion criteria so that plasma HIV-1 RNA levels should be < 50 copies/mL for ≥6 months preceding the screening visit as opposed to at least 6 months prior to the screening visit; Added new criteria to exclude subjects receiving ongoing treatment with bisphosphonate; Clarified that change in third agent was not permitted; Changed virologic failure management criteria so that virologic failure was defined as a subject having at least 2 consecutive plasma HIV-1 RNA levels ≥ 50 copies/mL compared to ≥ 400 copies/mL; Added criteria to describe the management of exacerbations of Hepatitis B virus (HBV) following discontinuation of study drugs.

    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/27036991
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