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    Clinical Trial Results:
    A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

    Summary
    EudraCT number
    		 2009-016758-42
    Trial protocol
    		 DE   GB   FR   PT   BE   NL   AT   ES   DK   IT   SE  
    Global end of trial date
    18 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 May 2016
    First version publication date
    15 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-236-0103
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01106586
    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
    Clinical Trial Mailbox, Gilead Sciences International Ltd, clinical.trials@gilead.com
    Scientific contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd, clinical.trials@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
    18 Sep 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir-boosted atazanavir (ATV/r) plus the standard of care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF. ATV/r + FTC/TDF was selected as the active comparator for this study as it is a preferred protease inhibitor-based regimen in guidelines for the treatment of HIV-1 infected, antiretroviral treatment-naive 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
    06 Apr 2010
    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
    Germany: 65
    Country: Number of subjects enrolled
    Austria: 20
    Country: Number of subjects enrolled
    Belgium: 21
    Country: Number of subjects enrolled
    Denmark: 3
    Country: Number of subjects enrolled
    France: 47
    Country: Number of subjects enrolled
    Italy: 14
    Country: Number of subjects enrolled
    Netherlands: 6
    Country: Number of subjects enrolled
    Portugal: 3
    Country: Number of subjects enrolled
    Sweden: 1
    Country: Number of subjects enrolled
    United Kingdom: 27
    Country: Number of subjects enrolled
    Australia: 62
    Country: Number of subjects enrolled
    Canada: 41
    Country: Number of subjects enrolled
    Thailand: 11
    Country: Number of subjects enrolled
    Switzerland: 2
    Country: Number of subjects enrolled
    United States: 387
    Country: Number of subjects enrolled
    Mexico: 5
    Worldwide total number of subjects
    715
    EEA total number of subjects
    207
    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)
    709
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at 146 sites in 16 countries. The first participant was screened on 06 April 2010. The last study visit occurred on 18 September 2014.

    Pre-assignment
    Screening details
    		 1017 subjects were screened.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Stribild
    Arm description
    		 Stribild plus placebo to match ATV/r + FTC/TDF once daily for the duration of the study
    Arm type
    		 Experimental

    Investigational medicinal product name
    Stribild
    Investigational medicinal product code
    Other name
    EVG/COBI/FTC/TDF
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Stribild (elvitegravir [EVG] 150 mg/cobicistat [COBI] 150 mg/emtricitabine [FTC] 200 mg/tenofovir disoproxil fumarate [TDF] 300 mg) administered orally once daily

    Investigational medicinal product name
    ATV/r placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to match ritonavir-boosted atazanavir (ATV/r) administered orally once daily

    Investigational medicinal product name
    FTC + TDF placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to match FTC plus TDF or FTC/TDF administered orally once daily

    Arm title
    		 ATV/r + FTC/TDF
    Arm description
    		 ATV/r + FTC/TDF plus placebo to match Stribild once daily for the duration of the study
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ATV/r
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ritonavir-boosted atazanavir (ATV/r 300/100 mg) administered orally once daily

    Investigational medicinal product name
    FTC + TDF
    Investigational medicinal product code
    Other name
    Emtriva®, Viread®, Truvada®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    FTC 200 mg plus TDF 300 mg administered either as FTC tablet plus TDF tablet or as FTC/TDF fixed dose combination tablet orally once daily.

    Investigational medicinal product name
    Stribild placebo
    Investigational medicinal product code
    Other name
    EVG/COBI/FTC/TDF
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to match Stribild administered orally once daily

    Number of subjects in period 1 [1]
    		Stribild ATV/r + FTC/TDF
    Started
    353
    355
    Completed
    68
    70
    Not completed
    285
    285
         Participant joined other study
    212
    197
         Adverse event, non-fatal
    9
    15
         Protocol violation
    1
    -
         Death
    1
    3
         Pregnancy
    2
    2
         Investigator's discretion
    5
    8
         Withdrew consent
    18
    30
         Lost to follow-up
    24
    20
         Participant noncompliance
    12
    10
         Lack of efficacy
    1
    -
    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: 7 participants who were randomized but not treated are not included in the subject disposition table.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Stribild
    Reporting group description
    		 Stribild plus placebo to match ATV/r + FTC/TDF once daily for the duration of the study

    Reporting group title
    ATV/r + FTC/TDF
    Reporting group description
    		 ATV/r + FTC/TDF plus placebo to match Stribild once daily for the duration of the study

    Reporting group values
    		 Stribild ATV/r + FTC/TDF Total
    Number of subjects
    		 353 355 708
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 38 ( 10.5 ) 39 ( 9.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 29 39 68
        Male
    		 324 316 640
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 2 3 5
        Asian
    		 17 17 34
        Black or African Heritage
    		 72 47 119
        Native Hawaiian or Pacific Islander
    		 1 2 3
        White
    		 250 277 527
        Other
    		 11 9 20
    HIV Disease Status
    Units: Subjects
        Asymptomatic
    		 285 293 578
        Symptomatic HIV Infections
    		 36 38 74
        AIDS
    		 32 24 56
    Hepatitis B Virus (HBV) Infection Status
    Units: Subjects
        Negative
    		 347 346 693
        Positive
    		 5 7 12
        Indeterminate
    		 0 1 1
        Not done
    		 1 1 2
    Hepatitis C Virus (HCV) Infection Status
    Units: Subjects
        Negative
    		 335 344 679
        Positive
    		 18 10 28
        Indeterminate
    		 0 0 0
        Not done
    		 0 1 1
    HIV-1 RNA Category
    Units: Subjects
        ≤ 100,000 copies/mL
    		 203 214 417
        > 100,000 copies/mL
    		 150 141 291
    CD4 Cell Count (/µL)
    Units: Subjects
        ≤ 50 μL
    		 12 5 17
        51 to ≤ 200 μL
    		 42 34 76
        201 to ≤ 350 μL
    		 122 124 246
        351 to ≤ 500 μL
    		 122 122 244
        > 500 μL
    		 55 70 125

    End points

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    End points reporting groups
    Reporting group title
    Stribild
    Reporting group description
    		 Stribild plus placebo to match ATV/r + FTC/TDF once daily for the duration of the study

    Reporting group title
    ATV/r + FTC/TDF
    Reporting group description
    		 ATV/r + FTC/TDF plus placebo to match Stribild once daily for the duration of the study

    Primary: The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL at Week 48

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    End point title
    		 The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL at Week 48
    End point description
    ITT analysis set: participants who were randomized into the study and received at least 1 dose of study drug. To preserve the overall alpha level: 0.05, accounting for 2 interim analyses for Independent Data Monitoring Committee meetings, the 95.2% CI in the statistical analysis was computed using normal approximation stratified by baseline HIV-1 RNA (≤ 100,000 or > 100,000 copies/mL).
    End point type
    Primary
    End point timeframe
    Week 48
    End point values
    		 Stribild ATV/r + FTC/TDF
    Number of subjects analysed
    353
    355
    Units: percentage of participants
        number (not applicable)
    89.5
    86.8
    Statistical analysis title
    		 Difference in response rates
    Statistical analysis description
    The null hypothesis was that the Stribild group is at least 12% worse than the ATV/r + FTC/TDF group with respect to percentage of participants achieving HIV-1 RNA < 50 copies/mL (response rate as defined by the snapshot analysis algorithm) at Week 48; the alternative hypothesis was that the response rate in the Stribild group is less than 12% worse than that in the ATV/r + FTC/TDF Group.
    Comparison groups
    Stribild v ATV/r + FTC/TDF
    Number of subjects included in analysis
    708
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in response rates
    Point estimate
    3
    Confidence interval
         level
    		 95.2%
         sides
    2-sided
         lower limit
    		 -1.9
         upper limit
    		 7.8
    Notes
    [1] - A total of 700 HIV-1 infected participants, randomized in a 1:1 ratio to 2 groups would achieve at least 95% power to establish noninferiority in Week 48 response (HIV-1 RNA < 50 copies/mL per the FDA-defined snapshot analysis) rate difference between the 2 groups. For sample size and power computation, it was assumed that both treatment groups have a response rate of 0.795, a noninferiority margin of 0.12, and that the significance level of the test is at a one-sided, 0.025 level.

    Secondary: The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 96

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    End point title
    		 The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 96
    End point description
    ITT Analysis Set
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 Stribild ATV/r + FTC/TDF
    Number of subjects analysed
    353
    355
    Units: percentage of participants
        number (not applicable)
    83.3
    82.3
    No statistical analyses for this end point

    Secondary: The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 144

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    End point title
    		 The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 144
    End point description
    ITT Analysis Set
    End point type
    Secondary
    End point timeframe
    Week 144
    End point values
    		 Stribild ATV/r + FTC/TDF
    Number of subjects analysed
    353
    355
    Units: percentage of participants
        number (not applicable)
    77.6
    74.6
    No statistical analyses for this end point

    Secondary: The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 192

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    End point title
    		 The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 192
    End point description
    Week 192 modified intent-to-treat (MITT) Analysis Set: Participants in the ITT analysis set, excluding those who either 1) transferred to other Gilead-sponsored studies after completing their Week 144 Visit and before the lower limit of the Week 192 analysis window, or 2) prematurely discontinued study drug prior to the Week 144 Visit.
    End point type
    Secondary
    End point timeframe
    Week 192
    End point values
    		 Stribild ATV/r + FTC/TDF
    Number of subjects analysed
    74
    78
    Units: percentage of participants
        number (not applicable)
    78.4
    73.1
    No statistical analyses for this end point

    Secondary: The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm

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    End point title
    		 The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm
    End point description
    ITT analysis set
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Stribild ATV/r + FTC/TDF
    Number of subjects analysed
    353
    355
    Units: percentage of participants
        number (not applicable)
    86.1
    84.8
    No statistical analyses for this end point

    Secondary: The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, 144, and 192

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    End point title
    		 The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, 144, and 192
    End point description
    ITT analysis set. The missing = excluded (M = E) method was used in which participants with missing data were excluded from analysis. Change = value of the relevant time point minus the baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 48, 96, 144, and 192
    End point values
    		 Stribild ATV/r + FTC/TDF
    Number of subjects analysed
    353
    355
    Units: cells/μL
    arithmetic mean (standard deviation)
        Change at Wk 48 (Stribild, n=334; ATV/r, n=321)
    207 ( 164.2 )
    211 ( 160.3 )
        Change at Wk 96 (Stribild, n=317; ATV/r, n=315)
    256 ( 166.8 )
    261 ( 188 )
        Change at Wk 144 (Stribild, n=297; ATV/r, n=286)
    280 ( 159.8 )
    293 ( 211.5 )
        Change at Wk 192 (Stribild, n=69; ATV/r, n=72)
    338 ( 186.8 )
    340 ( 224.2 )
    No statistical analyses for this end point

    Secondary: The Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48

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    End point title
    		 The Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
    End point description
    ITT analysis set. The missing = failure (M = F) method was used in which all missing data were considered as failure (HIV-1 RNA ≥ 50 copies/mL).
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Stribild ATV/r + FTC/TDF
    Number of subjects analysed
    353
    355
    Units: percentage of participants
        number (not applicable)
    91.5
    88.5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are reported from baseline to the end of treatment (up to maximum of 216 weeks) plus 30 days
    Adverse event reporting additional description
    Safety Analysis Set: 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
    17.0
    Reporting groups
    Reporting group title
    Stribild
    Reporting group description
    		 Stribild plus placebo to match ATV/r + FTC/TDF once daily for the duration of the study

    Reporting group title
    ATV/r + FTC/TDF
    Reporting group description
    		 ATV/r + FTC/TDF plus placebo to match Stribild once daily for the duration of the study

    Serious adverse events
    		 Stribild ATV/r + FTC/TDF
    Total subjects affected by serious adverse events
         subjects affected / exposed
    58 / 353 (16.43%)
    62 / 355 (17.46%)
         number of deaths (all causes)
    1
    3
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anal cancer
         subjects affected / exposed
    1 / 353 (0.28%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hodgkin's disease
         subjects affected / exposed
    1 / 353 (0.28%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal squamous cell carcinoma
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anogenital warts
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    B-cell lymphoma stage II
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burkitt's lymphoma
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Orthostatic hypotension
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral embolism
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 353 (0.28%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Treatment noncompliance
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 353 (0.28%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 353 (0.28%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory depression
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillar hypertrophy
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    3 / 353 (0.85%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    2 / 353 (0.57%)
    2 / 355 (0.56%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    1 / 353 (0.28%)
    2 / 355 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    2 / 353 (0.57%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    1 / 353 (0.28%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bipolar disorder
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depressed mood
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depressive symptom
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug dependence
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mania
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-traumatic stress disorder
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Substance abuse
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Substance-induced psychotic disorder
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    2 / 353 (0.57%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Toxicity to various agents
         subjects affected / exposed
    1 / 353 (0.28%)
    2 / 355 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 353 (0.28%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle rupture
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle strain
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post concussion syndrome
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fractured base
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Congenital ureteric anomaly
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 353 (0.28%)
    2 / 355 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    2 / 353 (0.57%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 353 (0.28%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical radiculopathy
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coma
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Critical illness polyneuropathy
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tension headache
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIIth nerve paralysis
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Iridocyclitis
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 353 (0.28%)
    4 / 355 (1.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 353 (0.28%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 353 (0.57%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erosive oesophagitis
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer haemorrhage
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Drug eruption
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Rhabdomyolysis
         subjects affected / exposed
    1 / 353 (0.28%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis reactive
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot deformity
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc displacement
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in jaw
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    1 / 353 (0.28%)
    3 / 355 (0.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    3 / 353 (0.85%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 353 (0.28%)
    2 / 355 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 353 (0.28%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    2 / 353 (0.57%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 353 (0.28%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 353 (0.00%)
    2 / 355 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Abscess limb
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess neck
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis infective
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast abscess
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear infection
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis cryptosporidial
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster oticus
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impetigo
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incision site infection
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious colitis
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphogranuloma venereum
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaria
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant syphilis
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis aseptic
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis enteroviral
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis viral
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pilonidal cyst
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia bacterial
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia streptococcal
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salpingitis
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal abscess
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Secondary syphilis
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shigella infection
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 355 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 355 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Stribild ATV/r + FTC/TDF
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    326 / 353 (92.35%)
    326 / 355 (91.83%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anorectal human papilloma virus infection
         subjects affected / exposed
    21 / 353 (5.95%)
    12 / 355 (3.38%)
         occurrences all number
    23
    12
    Vascular disorders
    Hypertension
         subjects affected / exposed
    24 / 353 (6.80%)
    12 / 355 (3.38%)
         occurrences all number
    24
    12
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    60 / 353 (17.00%)
    60 / 355 (16.90%)
         occurrences all number
    66
    66
    Pyrexia
         subjects affected / exposed
    23 / 353 (6.52%)
    22 / 355 (6.20%)
         occurrences all number
    27
    26
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    17 / 353 (4.82%)
    19 / 355 (5.35%)
         occurrences all number
    19
    21
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    38 / 353 (10.76%)
    46 / 355 (12.96%)
         occurrences all number
    44
    52
    Oropharyngeal pain
         subjects affected / exposed
    19 / 353 (5.38%)
    32 / 355 (9.01%)
         occurrences all number
    27
    34
    Psychiatric disorders
    Depression
         subjects affected / exposed
    47 / 353 (13.31%)
    52 / 355 (14.65%)
         occurrences all number
    53
    55
    Insomnia
         subjects affected / exposed
    37 / 353 (10.48%)
    36 / 355 (10.14%)
         occurrences all number
    42
    39
    Anxiety
         subjects affected / exposed
    22 / 353 (6.23%)
    29 / 355 (8.17%)
         occurrences all number
    24
    33
    Nervous system disorders
    Headache
         subjects affected / exposed
    67 / 353 (18.98%)
    55 / 355 (15.49%)
         occurrences all number
    81
    67
    Dizziness
         subjects affected / exposed
    25 / 353 (7.08%)
    28 / 355 (7.89%)
         occurrences all number
    27
    30
    Paraesthesia
         subjects affected / exposed
    9 / 353 (2.55%)
    21 / 355 (5.92%)
         occurrences all number
    11
    22
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    23 / 353 (6.52%)
    16 / 355 (4.51%)
         occurrences all number
    26
    16
    Eye disorders
    Ocular icterus
         subjects affected / exposed
    2 / 353 (0.57%)
    52 / 355 (14.65%)
         occurrences all number
    2
    62
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    99 / 353 (28.05%)
    121 / 355 (34.08%)
         occurrences all number
    130
    160
    Nausea
         subjects affected / exposed
    80 / 353 (22.66%)
    78 / 355 (21.97%)
         occurrences all number
    103
    93
    Vomiting
         subjects affected / exposed
    26 / 353 (7.37%)
    35 / 355 (9.86%)
         occurrences all number
    36
    41
    Abdominal pain
         subjects affected / exposed
    25 / 353 (7.08%)
    26 / 355 (7.32%)
         occurrences all number
    30
    29
    Flatulence
         subjects affected / exposed
    16 / 353 (4.53%)
    32 / 355 (9.01%)
         occurrences all number
    17
    34
    Constipation
         subjects affected / exposed
    20 / 353 (5.67%)
    14 / 355 (3.94%)
         occurrences all number
    22
    15
    Dyspepsia
         subjects affected / exposed
    13 / 353 (3.68%)
    19 / 355 (5.35%)
         occurrences all number
    13
    21
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    0 / 353 (0.00%)
    34 / 355 (9.58%)
         occurrences all number
    0
    40
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    30 / 353 (8.50%)
    37 / 355 (10.42%)
         occurrences all number
    41
    40
    Night sweats
         subjects affected / exposed
    10 / 353 (2.83%)
    18 / 355 (5.07%)
         occurrences all number
    12
    18
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    46 / 353 (13.03%)
    37 / 355 (10.42%)
         occurrences all number
    55
    41
    Arthralgia
         subjects affected / exposed
    35 / 353 (9.92%)
    32 / 355 (9.01%)
         occurrences all number
    39
    37
    Pain in extremity
         subjects affected / exposed
    22 / 353 (6.23%)
    21 / 355 (5.92%)
         occurrences all number
    25
    25
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    86 / 353 (24.36%)
    97 / 355 (27.32%)
         occurrences all number
    157
    156
    Nasopharyngitis
         subjects affected / exposed
    53 / 353 (15.01%)
    57 / 355 (16.06%)
         occurrences all number
    70
    91
    Bronchitis
         subjects affected / exposed
    47 / 353 (13.31%)
    42 / 355 (11.83%)
         occurrences all number
    59
    52
    Sinusitis
         subjects affected / exposed
    35 / 353 (9.92%)
    38 / 355 (10.70%)
         occurrences all number
    41
    52
    Syphilis
         subjects affected / exposed
    27 / 353 (7.65%)
    29 / 355 (8.17%)
         occurrences all number
    28
    35
    Influenza
         subjects affected / exposed
    31 / 353 (8.78%)
    24 / 355 (6.76%)
         occurrences all number
    39
    29
    Gastroenteritis
         subjects affected / exposed
    18 / 353 (5.10%)
    28 / 355 (7.89%)
         occurrences all number
    19
    30
    Folliculitis
         subjects affected / exposed
    19 / 353 (5.38%)
    22 / 355 (6.20%)
         occurrences all number
    21
    23
    Pharyngitis
         subjects affected / exposed
    23 / 353 (6.52%)
    18 / 355 (5.07%)
         occurrences all number
    27
    19
    Urinary tract infection
         subjects affected / exposed
    18 / 353 (5.10%)
    20 / 355 (5.63%)
         occurrences all number
    21
    29
    Chlamydial infection
         subjects affected / exposed
    18 / 353 (5.10%)
    17 / 355 (4.79%)
         occurrences all number
    21
    20
    Herpes zoster
         subjects affected / exposed
    15 / 353 (4.25%)
    20 / 355 (5.63%)
         occurrences all number
    15
    21
    Onychomycosis
         subjects affected / exposed
    21 / 353 (5.95%)
    13 / 355 (3.66%)
         occurrences all number
    23
    13
    Metabolism and nutrition disorders
    Vitamin D deficiency
         subjects affected / exposed
    21 / 353 (5.95%)
    19 / 355 (5.35%)
         occurrences all number
    21
    19
    Decreased appetite
         subjects affected / exposed
    14 / 353 (3.97%)
    19 / 355 (5.35%)
         occurrences all number
    16
    19

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Mar 2010
    Updated statistical objectives, endpoints, and methods based on feedback from the US FDA.
    30 Jan 2012
    Extended the blinded phase of the study from 96 weeks of treatment to 192 weeks of treatment.

    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/22748590
    http://www.ncbi.nlm.nih.gov/pubmed/23337366
    http://www.ncbi.nlm.nih.gov/pubmed/24346640
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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