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    Clinical Trial Results:
    An open-label, multi-centre, randomised, switch study to evaluate the virological efficacy over 96 weeks of 2-drug therapy with DTG+RPV FDC in antiretroviral treatment-experienced HIV-1 infected subjects virologically suppressed with NNRTIs resistance mutation K103N.

    Summary
    EudraCT number
    		 2017-004040-38
    Trial protocol
    		 GB   FR   DE   BE   ES   IT  
    Global end of trial date
    09 Nov 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jul 2024
    First version publication date
    20 Jul 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SSCR105/NEAT33
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05349838
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    NEAT ID Foundation
    Sponsor organisation address
    56 Rue des Colonies, Brussels, Belgium, 1000 Brussels
    Public contact
    WISARD Clinical Project Manager, Research Organisation KC, 0044 7376618244, WISARD@rokcservices.com
    Scientific contact
    Graeme Moyle, Chelsea and Westminster Hospital, 0044 020 7938 2355, geyyom@gmail.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
    29 Nov 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Nov 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Nov 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare efficacy of DTG/RPV combined tablet versus continued antiretroviral treatment regimen at 48 weeks in individuals with the K103N resistance mutation.
    Protection of trial subjects
    Insurance was put in place to protect trial subjects.
    Background therapy
    		 N/A
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    15 Oct 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 22
    Country: Number of subjects enrolled
    United Kingdom: 52
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    France: 36
    Country: Number of subjects enrolled
    Germany: 10
    Country: Number of subjects enrolled
    Ireland: 1
    Country: Number of subjects enrolled
    Italy: 10
    Worldwide total number of subjects
    140
    EEA total number of subjects
    88
    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)
    125
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment began with first subject consented on 15-Oct-2018 and ended with last final subject enrolled on 10-Dec-2020. Subjects were recruited from sites in the following territories: UK, Spain, France, Belgium, Italy, Germany, Ireland.

    Pre-assignment
    Screening details
    		 All subjects selected as potential suitable for the study were screened within a 30 days of the baseline visit. The purpose of the screening visits was to assess subjects for eligibility based on the eligibility criteria in the protocol. Screening data was entered into the eCRF by the study site staff and assessed by staff at the CRO.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A - Immediate switch
    Arm description
    		 Participants randomised to this arm switch to Dolutegravir/Rilpivirine Fixed Dose Combination (Juluca) at baseline.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Juluca (Dolutegravir and Rilpivirine Fixed Dose Combination)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One combined Dolutegravir 50mg/Rilpivirine 25mg Fixed Dose Combination tablet taken orally once daily for 96 weeks.

    Arm title
    		 Arm B - Deferred switch
    Arm description
    		 Subjects randomised to this arm continued on their current antiretroviral treatment until week 48 and then switched to the study IMP. They remained on the study IMP until week 96.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Juluca (Dolutegravir and Rilpivirine Fixed Dose Combination)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One combined Dolutegravir 50mg/Rilpivirine 25mg Fixed Dose Combination tablet taken orally once daily from week 48 to week 96.

    Number of subjects in period 1
    		Arm A - Immediate switch Arm B - Deferred switch
    Started
    95
    45
    Completed
    83
    37
    Not completed
    12
    8
         Consent withdrawn by subject
    2
    3
         Physician decision
    1
    1
         Adverse event, non-fatal
    3
    1
         Virological Failure
    1
    2
         Patient relocation to another country
    2
    -
         Lost to follow-up
    1
    1
         Concomitant Medication
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A - Immediate switch
    Reporting group description
    		 Participants randomised to this arm switch to Dolutegravir/Rilpivirine Fixed Dose Combination (Juluca) at baseline.

    Reporting group title
    Arm B - Deferred switch
    Reporting group description
    		 Subjects randomised to this arm continued on their current antiretroviral treatment until week 48 and then switched to the study IMP. They remained on the study IMP until week 96.

    Reporting group values
    		 Arm A - Immediate switch Arm B - Deferred switch Total
    Number of subjects
    		 95 45 140
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 84 42 126
        From 65-84 years
    		 11 3 14
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 16 10 26
        Male
    		 79 35 114
    Ethnicity
    subject ethnicity at baseline
    Units: Subjects
        White caucasian
    		 69 29 98
        White mixed
    		 2 1 3
        Asian
    		 4 0 4
        Black
    		 7 7 14
        African
    		 3 3 6
        Caribbean
    		 1 1 2
        Other
    		 9 4 13
    Time since HIV diagnosis (years)
    Time since HIV diagnosis (years)
    Units: Years
        median (inter-quartile range (Q1-Q3))
    		 17.1 (7.3 to 26.3) 22.4 (13.1 to 26.5) -
    Duration of Antiretroviral Treatment (ART) (years)
    Duration of Antiretroviral Treatment (ART) (years)
    Units: Years
        median (inter-quartile range (Q1-Q3))
    		 16 (6.3 to 23) 17.7 (10.5 to 23) -
    Subject analysis sets

    Subject analysis set title
    All subjects
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Analysis on Arm A Immediate switch and Arm B Deferred switch

    Subject analysis sets values
    		 All subjects
    Number of subjects
    140
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    126
        From 65-84 years
    14
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    26
        Male
    114
    Ethnicity
    subject ethnicity at baseline
    Units: Subjects
        White caucasian
    98
        White mixed
    3
        Asian
    4
        Black
    14
        African
    6
        Caribbean
    2
        Other
    13
    Time since HIV diagnosis (years)
    Time since HIV diagnosis (years)
    Units: Years
        median (inter-quartile range (Q1-Q3))
    19.7 (8.8 to 26.4)
    Duration of Antiretroviral Treatment (ART) (years)
    Duration of Antiretroviral Treatment (ART) (years)
    Units: Years
        median (inter-quartile range (Q1-Q3))
    16.5 (7.3 to 23)

    End points

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    End points reporting groups
    Reporting group title
    Arm A - Immediate switch
    Reporting group description
    		 Participants randomised to this arm switch to Dolutegravir/Rilpivirine Fixed Dose Combination (Juluca) at baseline.

    Reporting group title
    Arm B - Deferred switch
    Reporting group description
    		 Subjects randomised to this arm continued on their current antiretroviral treatment until week 48 and then switched to the study IMP. They remained on the study IMP until week 96.

    Subject analysis set title
    All subjects
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Analysis on Arm A Immediate switch and Arm B Deferred switch

    Primary: Virological Response at Week 48

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    End point title
    		 Virological Response at Week 48
    End point description
    End point type
    Primary
    End point timeframe
    Week 48
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    95
    45
    Units: Percentage
    number (confidence interval 95%)
        HIV RNA <50 copies/mL
    88.4 (80.2 to 94.1)
    88.9 (75.9 to 96.3)
        HIV RNA >=50 copies/mL
    3.2 (0.7 to 9.0)
    2.2 (0.1 to 11.8)
        No virologic data at week 48
    8.4 (3.7 to 15.9)
    8.9 (2.5 to 21.2)
    Attachments
    		 Untitled (Filename: FDA Snapshot Week 48.png)
    Statistical analysis title
    		 ITT FDA Snapshot
    Statistical analysis description
    Proportion of participants with HIV-RNA <50 copies/mL at week 48, with the ITT FDA Snapshot method
    Comparison groups
    Arm A - Immediate switch v Arm B - Deferred switch
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.1
    Method
    		 Regression, Logistic
    Parameter type
    		 ITT FDA Snapshot
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation
    Notes
    [1] - The two-sided 95% confidence interval of the difference in therapeutic success rate will be calculated. The effect of study treatment will also be assessed in the mITT population using logistic regression model with treatment group adjusted for the presence of M184V mutation at baseline and CD4 count at baseline (above versus below 350 cells/μL) as well as all baseline variables potentially associated with the outcome, with univariable P-value <0.10.

    Secondary: Change from baseline in CD4 cell count

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    End point title
    		 Change from baseline in CD4 cell count
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 48, Change from week 48 to week 96; Change from baseline to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    94
    45
    Units: count/mm3
    arithmetic mean (standard error)
        Change from baseline to week 48
    -31.7 ( 34.8 )
    9.2 ( 51 )
        Change from week 48 to week 96
    27.3 ( 36.3 )
    -9.8 ( 55.3 )
        Change from baseline to week 96
    -4.4 ( 47.1 )
    -0.7 ( 71.0 )
    Attachments
    		 Untitled (Filename: Change from BL in CD4 cell count.png)
    No statistical analyses for this end point

    Secondary: Change from baseline in CD8 cell count

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    End point title
    		 Change from baseline in CD8 cell count
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    94
    45
    Units: count/mm3
    arithmetic mean (standard error)
        Change from baseline to week 48
    -58.8 ( 41.3 )
    9.7 ( 60.4 )
        Change from week 48 to week 96
    -5.7 ( 43.2 )
    -55.8 ( 66.6 )
        Change from baseline to week 96
    -64.5 ( 53.4 )
    -46.1 ( 81.3 )
    Attachments
    		 Untitled (Filename: Change from BL in CD8 cell count.png)
    No statistical analyses for this end point

    Secondary: Change from baseline in CD4/CD8 ratio

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    End point title
    		 Change from baseline in CD4/CD8 ratio
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    94
    45
    Units: Cd4/Cd8 ratio
    arithmetic mean (standard error)
        Change from baseline to week 48
    0.03 ( 0.06 )
    0.02 ( 0.09 )
        Change from week 48 to week 96
    0.04 ( 0.06 )
    0 ( 0.10 )
        Change from baseline to week 96
    0.07 ( 0.08 )
    0.01 ( 0.13 )
    Attachments
    		 Untitled (Filename: Change from BL in CD4 CD8 ratio.png)
    No statistical analyses for this end point

    Secondary: Change from baseline in body weight

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    End point title
    		 Change from baseline in body weight
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    95
    45
    Units: Body weight, kg
    arithmetic mean (standard error)
        Change from baseline to week 48
    0.7 ( 2.1 )
    1.3 ( 3.1 )
        Change from week 48 to week 96
    1.7 ( 2.2 )
    1.3 ( 3.4 )
        Change from baseline to week 96
    2.4 ( 3.0 )
    2.6 ( 4.5 )
    Attachments
    		 Untitled (Filename: Change from BL in body weight.png)
    No statistical analyses for this end point

    Secondary: Change from baseline in BMI

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    End point title
    		 Change from baseline in BMI
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    95
    45
    Units: kg/m2
    arithmetic mean (standard error)
        Change from baseline to week 48
    0.3 ( 0.6 )
    0.6 ( 0.9 )
        Change from week 48 to week 96
    0.5 ( 0.7 )
    0.3 ( 1.0 )
        Change from baseline to week 96
    0.8 ( 0.9 )
    0.9 ( 1.3 )
    Attachments
    		 Untitled (Filename: Change from BL in BMI.png)
    No statistical analyses for this end point

    Secondary: Change from baseline in hsCRP

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    End point title
    		 Change from baseline in hsCRP
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    52
    24
    Units: mg/L
    arithmetic mean (standard error)
        Change from baseline to week 48
    0.8 ( 1.2 )
    -1.3 ( 1.8 )
        Change from week 48 to week 96
    0.5 ( 1.2 )
    -0.9 ( 1.9 )
        Change from baseline to week 96
    1.3 ( 1.4 )
    -2.2 ( 2.1 )
    Attachments
    		 Untitled (Filename: Change from BL in hsCRP.png)
    No statistical analyses for this end point

    Secondary: Change from baseline in Systolic Blood Pressure

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    End point title
    		 Change from baseline in Systolic Blood Pressure
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    93
    45
    Units: mmHg
    arithmetic mean (standard error)
        Change from baseline to week 48
    -1.4 ( 2.2 )
    4.9 ( 3.3 )
        Change from week 48 to week 96
    -0.1 ( 2.3 )
    5.6 ( 3.6 )
        Change from baseline to week 96
    -1.5 ( 2.7 )
    10.5 ( 4.1 )
    Attachments
    		 Untitled (Filename: Change from BL in systolic blood pressure.png)
    No statistical analyses for this end point

    Secondary: Change from baseline in Diastolic Blood Pressure

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    End point title
    		 Change from baseline in Diastolic Blood Pressure
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    95
    45
    Units: mmHg
    arithmetic mean (standard error)
        Change from baseline to week 48
    0.2 ( 1.5 )
    3.1 ( 2.2 )
        Change from week 48 to week 96
    -0.7 ( 1.6 )
    0.8 ( 2.4 )
        Change from baseline to week 96
    -0.5 ( 1.8 )
    4.0 ( 2.7 )
    Attachments
    		 Untitled (Filename: Change from BL in diastolic blood pressure.png)
    No statistical analyses for this end point

    Secondary: Change from baseline in Pulse rate

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    End point title
    		 Change from baseline in Pulse rate
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    95
    45
    Units: Pulse rate
    arithmetic mean (standard error)
        Change from baseline to week 48
    2.1 ( 1.6 )
    2.7 ( 2.4 )
        Change from week 48 to week 96
    -2.5 ( 1.8 )
    -1.5 ( 2.6 )
        Change from baseline to week 96
    -0.4 ( 2.0 )
    1.2 ( 2.9 )
    Attachments
    		 Untitled (Filename: Change from BL in pulse.png)
    No statistical analyses for this end point

    Secondary: Change from baseline in Red blood cells

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    End point title
    		 Change from baseline in Red blood cells
    End point description
    Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    93
    45
    Units: 10^12/L
    arithmetic mean (standard error)
        Change from baseline to week 48
    0.20 ( 0.06 )
    -0.07 ( 0.09 )
        Change from week 48 to week 96;
    -0.02 ( 0.07 )
    0.19 ( 0.10 )
        Change from baseline to week 96
    0.17 ( 0.09 )
    0.12 ( 0.13 )
    Attachments
    		 Untitled (Filename: Change from BL in RBC.png)
    No statistical analyses for this end point

    Secondary: Change from baseline in White blood cells

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    End point title
    		 Change from baseline in White blood cells
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    95
    45
    Units: 10^12/L
    arithmetic mean (standard error)
        Change from baseline to week 48
    -0.08 ( 0.26 )
    -0.06 ( 0.38 )
        Change from week 48 to week 96
    0.09 ( 0.27 )
    -0.03 ( 0.41 )
        Change from baseline to week 96
    0.01 ( 0.34 )
    -0.09 ( 0.51 )
    Attachments
    		 Untitled (Filename: Change from BL in WBC.png)
    No statistical analyses for this end point

    Secondary: Change from baseline in Platelet counts

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    End point title
    		 Change from baseline in Platelet counts
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    95
    45
    Units: 10^9/L
    arithmetic mean (standard error)
        Change from baseline to week 48
    3.4 ( 8.2 )
    -2.6 ( 12.1 )
        Change from week 48 to week 96
    0.6 ( 8.6 )
    9.3 ( 13.1 )
        Change from baseline to week 96
    4.0 ( 11.1 )
    6.7 ( 16.8 )
    Attachments
    		 Untitled (Filename: Change from BL in Platelet count.png)
    No statistical analyses for this end point

    Secondary: Change from baseline in Haemoglobin

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    End point title
    		 Change from baseline in Haemoglobin
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    95
    45
    Units: g/dL
    arithmetic mean (standard error)
        Change from baseline to week 48
    0.1 ( 0.2 )
    0 ( 0.3 )
        Change from week 48 to week 96
    0 ( 0.2 )
    0.2 ( 0.3 )
        Change from baseline to week 96
    0.1 ( 0.3 )
    0.2 ( 0.4 )
    Attachments
    		 Untitled (Filename: Change from BL in haemoglobin.png)
    No statistical analyses for this end point

    Secondary: Change from baseline in Sodium

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    End point title
    		 Change from baseline in Sodium
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    95
    45
    Units: mmol/L
    arithmetic mean (standard error)
        Change from baseline to week 48
    0.3 ( 0.3 )
    -0.8 ( 0.4 )
        Change from week 48 to week 96
    -0.5 ( 0.3 )
    0.3 ( 0.4 )
        Change from baseline to week 96
    -0.2 ( 0.3 )
    -0.5 ( 0.5 )
    Attachments
    		 Untitled (Filename: Change from BL in sodium.png)
    No statistical analyses for this end point

    Secondary: Change from baseline in ALT

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    End point title
    		 Change from baseline in ALT
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    93
    45
    Units: U/L
    arithmetic mean (standard error)
        Change from baseline to week 48
    2.4 ( 3.2 )
    -0.6 ( 4.7 )
        Change from week 48 to week 96
    -0.7 ( 3.4 )
    1.1 ( 5.1 )
        Change from baseline to week 96
    1.8 ( 3.7 )
    0.6 ( 5.6 )
    Attachments
    		 Untitled (Filename: Change from BL in ALT.png)
    No statistical analyses for this end point

    Secondary: Change from baseline in Total Bilirubin

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    End point title
    		 Change from baseline in Total Bilirubin
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    94
    45
    Units: umol/L
    arithmetic mean (standard error)
        Change from baseline to week 48
    -0.6 ( 1.4 )
    -1.9 ( 2.0 )
        Change from week 48 to week 96
    -1.3 ( 1.4 )
    -2.2 ( 2.2 )
        Change from baseline to week 96
    -1.9 ( 1.4 )
    -4.1 ( 2.1 )
    Attachments
    		 Untitled (Filename: Change from BL in bilirubin.png)
    No statistical analyses for this end point

    Secondary: Change from baseline in Glucose

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    End point title
    		 Change from baseline in Glucose
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    93
    43
    Units: mmol/L
    arithmetic mean (standard error)
        Change from baseline to week 48
    -0.15 ( 0.16 )
    -0.06 ( 0.23 )
        Change from week 48 to week 96
    0.09 ( 0.17 )
    -0.11 ( 0.25 )
        Change from baseline to week 96
    -0.06 ( 0.21 )
    -0.17 ( 0.31 )
    Attachments
    		 Untitled (Filename: Change from BL in glucose.png)
    No statistical analyses for this end point

    Secondary: Change from baseline in Total Cholesterol

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    End point title
    		 Change from baseline in Total Cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    93
    45
    Units: mmol/L
    arithmetic mean (standard error)
        Change from baseline to week 48
    -0.09 ( 0.14 )
    0.05 ( 0.20 )
        Change from week 48 to week 96
    0.02 ( 0.15 )
    -0.19 ( 0.22 )
        Change from baseline to week 96
    -0.07 ( 0.18 )
    -0.13 ( 0.27 )
    Attachments
    		 Untitled (Filename: Change from BL in total cholesterol.png)
    No statistical analyses for this end point

    Secondary: Change from baseline in HDL cholesterol

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    End point title
    		 Change from baseline in HDL cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    93
    44
    Units: mmol/L
    arithmetic mean (standard error)
        Change from baseline to week 48
    0.06 ( 0.05 )
    0.03 ( 0.07 )
        Change from week 48 to week 96
    -0.03 ( 0.05 )
    0.01 ( 0.08 )
        Change from baseline to week 96
    0.03 ( 0.06 )
    0.04 ( 0.10 )
    Attachments
    		 Untitled (Filename: Change from BL in HDL cholesterol.png)
    No statistical analyses for this end point

    Secondary: Change from baseline in LDL cholesterol

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    End point title
    		 Change from baseline in LDL cholesterol
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    93
    42
    Units: mmol/L
    arithmetic mean (standard error)
        Change from baseline to week 48
    -0.05 ( 0.12 )
    0 ( 0.18 )
        Change from week 48 to week 96
    0.02 ( 0.12 )
    -0.14 ( 0.19 )
        Change from baseline to week 96
    -0.02 ( 0.15 )
    -0.14 ( 0.23 )
    Attachments
    		 Untitled (Filename: Change from BL in LDL cholesterol.png)
    No statistical analyses for this end point

    Secondary: Change from baseline in Triglycerides

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    End point title
    		 Change from baseline in Triglycerides
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    93
    45
    Units: mmol/L
    arithmetic mean (standard error)
        Change from baseline to week 48
    -0.26 ( 0.15 )
    -0.02 ( 0.22 )
        Change from week 48 to week 96
    0.14 ( 0.15 )
    -0.16 ( 0.23 )
        Change from baseline to week 96
    -0.12 ( 0.18 )
    -0.18 ( 0.27 )
    Attachments
    		 Untitled (Filename: Change from BL in triglycerides.png)
    No statistical analyses for this end point

    Secondary: Change from baseline in Creatinine

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    End point title
    		 Change from baseline in Creatinine
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    95
    44
    Units: umol/L
    arithmetic mean (standard error)
        Change from baseline to week 48
    3.0 ( 2.3 )
    0.3 ( 3.4 )
        Change from week 48 to week 9
    0.3 ( 2.4 )
    5.5 ( 3.7 )
        Change from baseline to week 96
    3.3 ( 3.1 )
    5.8 ( 4.7 )
    Attachments
    		 Untitled (Filename: Change from BL in creatinine.png)
    No statistical analyses for this end point

    Secondary: Change from baseline in Creatinine clearance

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    End point title
    		 Change from baseline in Creatinine clearance
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    95
    44
    Units: mL/min
    arithmetic mean (standard error)
        Change from baseline to week 48
    -1.7 ( 2.2 )
    -1.3 ( 3.3 )
        Change from week 48 to week 96
    -1.2 ( 2.3 )
    -3.4 ( 3.6 )
        Change from baseline to week 96
    -2.9 ( 2.8 )
    -4.7 ( 4.2 )
    Attachments
    		 Untitled (Filename: Change from BL in creatinine clearance.png)
    No statistical analyses for this end point

    Secondary: Change from baseline in ALP

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    End point title
    		 Change from baseline in ALP
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    94
    45
    Units: U/L
    arithmetic mean (standard error)
        Change from baseline to week 48
    -5.3 ( 3.0 )
    -1.5 ( 4.3 )
        Change from week 48 to week 96
    3.1 ( 3.1 )
    -2.5 ( 4.7 )
        Change from baseline to week 96
    -2.2 ( 4.0 )
    -4.0 ( 6.0 )
    Attachments
    		 Untitled (Filename: Change from BL in ALP.png)
    No statistical analyses for this end point

    Secondary: Change from baseline in QOL Health status score

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    End point title
    		 Change from baseline in QOL Health status score
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    93
    43
    Units: Health status score
    arithmetic mean (standard error)
        Change from baseline to week 48
    1.7 ( 2.9 )
    6.3 ( 4.3 )
        Change from week 48 to week 96
    -2.0 ( 3.0 )
    -7.2 ( 4.6 )
        Change from baseline to week 96
    -0.3 ( 3.3 )
    -0.9 ( 5.0 )
    Attachments
    		 Untitled (Filename: Change from BL in QoL Health score.png)
    No statistical analyses for this end point

    Secondary: Change from baseline in patients’ satisfaction

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    End point title
    		 Change from baseline in patients’ satisfaction
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    94
    45
    Units: Global satisfaction score
    arithmetic mean (standard error)
        Change from baseline to week 48
    1.6 ( 0.6 )
    0.7 ( 0.9 )
        Change from week 48 to week 96
    0.2 ( 0.6 )
    0.4 ( 1.0 )
        Change from baseline to week 96
    1.8 ( 0.7 )
    1.1 ( 1.1 )
    Attachments
    		 Untitled (Filename: Change from BL in patient satisfaction.png)
    No statistical analyses for this end point

    Secondary: Change from baseline in Global Pittsburgh Sleep Quality Index (PSQI) score

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    End point title
    		 Change from baseline in Global Pittsburgh Sleep Quality Index (PSQI) score
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to week 48; Change from week 48 to week 96; Change from baseline to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    88
    40
    Units: Global PSQI Score
    arithmetic mean (standard error)
        Change from baseline to week 48
    -0.1 ( 0.3 )
    -0.7 ( 0.5 )
        Change from week 48 to week 96
    0 ( 0.3 )
    -0.5 ( 0.5 )
        Change from baseline to week 96
    -0.1 ( 0.3 )
    -1.2 ( 0.5 )
    Attachments
    		 Untitled (Filename: Change from BL in PSQI.png)
    No statistical analyses for this end point

    Secondary: Number of participants with adverse events (AEs) from baseline to week 48

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    End point title
    		 Number of participants with adverse events (AEs) from baseline to week 48
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 48
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    95
    45
    Units: Number
    number (not applicable)
        Any AEs
    78
    33
        Grade 1
    61
    25
        Grade 2
    43
    13
        Grade 3-4
    7
    2
        Drug related AEs
    22
    0
        Drug related grade 3-4 AEs
    1
    0
        AE leading to the study drugs interruption
    4
    0
    No statistical analyses for this end point

    Secondary: Number of participants with adverse events (AEs) Week 48 to week 96

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    End point title
    		 Number of participants with adverse events (AEs) Week 48 to week 96
    End point description
    End point type
    Secondary
    End point timeframe
    Week 48 to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    87
    34
    Units: Number
    number (not applicable)
        Any AEs
    54
    28
        Grade 1
    36
    18
        Grade 2
    20
    12
        Grade 3-4
    5
    5
        Drug related AEs
    1
    5
        Drug related grade 3-4 AEs
    0
    0
        AEs leading to the study drugs interruption
    1
    2
    No statistical analyses for this end point

    Secondary: Number of drug-drug interactions

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    End point title
    		 Number of drug-drug interactions [2]
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 96
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Both arms reported separately due to different timepoints reported.
    End point values
    		 Arm A - Immediate switch
    Number of subjects analysed
    95
    Units: Number
        Baseline
    90
        Week 24
    88
        Week 48
    86
        Week 96
    81
    No statistical analyses for this end point

    Secondary: Number of participants with Adverse Events (AEs) from baseline to week 48

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    End point title
    		 Number of participants with Adverse Events (AEs) from baseline to week 48
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 48
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    95
    45
    Units: number
        Any AEs
    78
    33
        Grade 1
    61
    25
        Grade 2
    43
    13
        Grade 3-4
    7
    2
        Drug related AEs
    22
    0
        Drug related grade 3-4 AEs
    1
    0
        AEs leading to the study drug interruption
    4
    0
        Missing Grade
    6
    1
        Serious Adverse Events (SAEs)
    4
    2
    No statistical analyses for this end point

    Secondary: Number of participants with adverse events (AEs) from week 48 to week 96

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    End point title
    		 Number of participants with adverse events (AEs) from week 48 to week 96
    End point description
    End point type
    Secondary
    End point timeframe
    week 48 to week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    87
    40
    Units: Number
        Any AEs
    54
    28
        Grade 1
    36
    18
        Grade 2
    20
    12
        Grade 3-4
    5
    5
        Drug related AEs
    1
    5
        Drug related grade 3-4 AEs
    0
    0
        AEs leading to the study drugs interruption
    1
    2
        Missing Grade
    7
    0
        Serious Adverse Events (SAEs)
    5
    1
    No statistical analyses for this end point

    Secondary: Virological Response at Week 96

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    End point title
    		 Virological Response at Week 96
    End point description
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 Arm A - Immediate switch Arm B - Deferred switch
    Number of subjects analysed
    95
    45
    Units: Percentage
    number (confidence interval 95%)
        HIV RNA <50 copies/mL
    84.2 (75.3 to 90.9)
    73.3 (58.1 to 85.4)
        HIV RNA =>50 copies/mL
    5.3 (1.7 to 11.9)
    6.7 (1.4 to 18.3)
        No virologic data at week 96
    10.5 (5.2 to 18.5)
    20 (9.6 to 34.6)
    Attachments
    		 Untitled (Filename: FDA Snapshot Week 96.png)
    Statistical analysis title
    		 ITT FDA Snapshot
    Statistical analysis description
    Proportion of participants with HIV-RNA <50 copies/mL at week 96, with the ITT FDA Snapshot method
    Comparison groups
    Arm B - Deferred switch v Arm A - Immediate switch
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 < 0.1
    Method
    		 Regression, Logistic
    Parameter type
    		 ITT FDA Snapshot
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation
    Notes
    [3] - The two-sided 95% confidence interval of the difference in therapeutic success rate will be calculated. The effect of study treatment will also be assessed in the mITT population using logistic regression model with treatment group adjusted for the presence of M184V mutation at baseline and CD4 count at baseline (above versus below 350 cells/μL) as well as all baseline variables potentially associated with the outcome, with univariable P-value <0.10.

    Secondary: Number of drug-drug interactions

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    End point title
    		 Number of drug-drug interactions [4]
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 96
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Both arms reported separately due to different timepoints reported.
    End point values
    		 Arm B - Deferred switch
    Number of subjects analysed
    45
    Units: Number
        Baseline
    45
        Week 48
    39
        Week 96
    38
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The adverse event reporting period will be from consent until the subject’s final study visit (I.e. follow-up visit or end of trial visit).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Arm A - Immediate switch
    Reporting group description
    		 Participants randomised to this arm switch to Dolutegravir/Rilpivirine Fixed Dose Combination (Juluca) at baseline.

    Reporting group title
    Arm B - Deferred switch
    Reporting group description
    		 Subjects randomised to this arm continued on their current antiretroviral treatment until week 48 and then switched to the study IMP. They remained on the study IMP until week 96.

    Serious adverse events
    		 Arm A - Immediate switch Arm B - Deferred switch
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 95 (10.53%)
    4 / 45 (8.89%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Meningioma
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Penile neoplasm
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Patella fracture
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Prostatectomy
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    pachymeningitis
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia bacterial
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    covid19 pneumonia
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Legionella infection
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pilonidal cyst
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical mycobacterial infection
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (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: 0%
    Non-serious adverse events
    		 Arm A - Immediate switch Arm B - Deferred switch
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    84 / 95 (88.42%)
    38 / 45 (84.44%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts
         subjects affected / exposed
    1 / 95 (1.05%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Haemangioma of skin
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Uterine leiomyoma
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Skin papilloma
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Vascular disorders
    Hypertension
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    6 / 95 (6.32%)
    1 / 45 (2.22%)
         occurrences all number
    6
    1
    Diastolic hypertension
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Systolic Hypertension
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    Foot operation
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Skin neoplasm excision
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Acrochordon excision
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Sympathectomy
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Nasal operation
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    2 / 95 (2.11%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Chest pain
         subjects affected / exposed
    4 / 95 (4.21%)
    0 / 45 (0.00%)
         occurrences all number
    4
    0
    Discomfort
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Face oedema
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    5 / 95 (5.26%)
    0 / 45 (0.00%)
         occurrences all number
    5
    0
    Influenza like illness
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    0 / 95 (0.00%)
    2 / 45 (4.44%)
         occurrences all number
    0
    2
    Energy increased
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Ulcer
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Chills
         subjects affected / exposed
    1 / 95 (1.05%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Mass
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Vaccination site pain
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Ill-defined disorder
         subjects affected / exposed
    1 / 95 (1.05%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Inflammation
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Asthenia
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    3 / 95 (3.16%)
    0 / 45 (0.00%)
         occurrences all number
    3
    0
    Fatigue
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    3 / 95 (3.16%)
    1 / 45 (2.22%)
         occurrences all number
    3
    1
    Immune system disorders
    Hypersensitivity
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    2 / 95 (2.11%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Seasonal allergy
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Social circumstances
    Disease risk factor
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Benign Prostatic Hyperplasia
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Menstrual disorder
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Breast pain
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Prostatitis
         subjects affected / exposed
    2 / 95 (2.11%)
    1 / 45 (2.22%)
         occurrences all number
    2
    1
    Genital lesion
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Rhinitis allergic
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Asthma
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    1 / 45 (2.22%)
         occurrences all number
    2
    2
    Bronchial disorder
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Cough
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    3 / 95 (3.16%)
    1 / 45 (2.22%)
         occurrences all number
    3
    1
    Dyspnoea
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Dyspnoea exertional
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Nasal congestion
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Epistaxis
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    2 / 95 (2.11%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 95 (1.05%)
    2 / 45 (4.44%)
         occurrences all number
    1
    2
    COVID-19
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Aggression
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Anxiety
         subjects affected / exposed
    3 / 95 (3.16%)
    2 / 45 (4.44%)
         occurrences all number
    3
    2
    Depression
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    2 / 95 (2.11%)
    1 / 45 (2.22%)
         occurrences all number
    2
    1
    Stress
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Insomnia
         subjects affected / exposed
    8 / 95 (8.42%)
    1 / 45 (2.22%)
         occurrences all number
    8
    1
    Loss of libido
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Mental disorder
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Sleep disorder
         subjects affected / exposed
    3 / 95 (3.16%)
    1 / 45 (2.22%)
         occurrences all number
    3
    1
    Abnormal dreams
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    4 / 95 (4.21%)
    1 / 45 (2.22%)
         occurrences all number
    4
    1
    Depressed mood
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Investigations
    Glomerular filtration rate abnormal
         subjects affected / exposed
    0 / 95 (0.00%)
    2 / 45 (4.44%)
         occurrences all number
    0
    2
    Blood pressure systolic increased
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Creatinine renal clearance decreased
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Blood pressure diastolic increased
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Glucose urine present
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Blood cholesterol increased
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Red blood cell analysis abnormal
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Blood immunoglobulin M decreased
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Viral load increased
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Blood bilirubin
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Pathology test
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Mean cell haemoglobin decreased
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Blood phosphorus decreased
         subjects affected / exposed
    1 / 95 (1.05%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Vitamin D decreased
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Alanine aminotransferase increased
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    8 / 95 (8.42%)
    0 / 45 (0.00%)
         occurrences all number
    8
    0
    Blood pressure increased
         subjects affected / exposed
    3 / 95 (3.16%)
    0 / 45 (0.00%)
         occurrences all number
    3
    0
    Blood bilirubin increased
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Blood creatinine decreased
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Biopsy kidney
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Body temperature
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Transaminases increased
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Urine analysis abnormal
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Weight increased
         subjects affected / exposed
    2 / 95 (2.11%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Weight decreased
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    SARS-CoV-2 test positive
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Blood creatine phosphokinase increased
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    4 / 95 (4.21%)
    2 / 45 (4.44%)
         occurrences all number
    4
    5
    Blood creatinine increased
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    5 / 95 (5.26%)
    0 / 45 (0.00%)
         occurrences all number
    5
    0
    Glomerular filtration rate decreased
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    4 / 95 (4.21%)
    2 / 45 (4.44%)
         occurrences all number
    4
    2
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Exposure to communicable disease
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Dislocation of vertebra
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Limb injury
         subjects affected / exposed
    1 / 95 (1.05%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Neck injury
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Ligament sprain
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Phlebitis
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Procedural pain
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Contusion
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Soft tissue injury
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Epicondylitis
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Joint injury
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Myocardial ischaemia
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Left ventricular hypertrophy
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Palpitations
         subjects affected / exposed
    0 / 95 (0.00%)
    2 / 45 (4.44%)
         occurrences all number
    0
    2
    Nervous system disorders
    Radiculitis brachial
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Dizziness
         subjects affected / exposed
    2 / 95 (2.11%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Epilepsy
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Memory impairment
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    headache
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    16 / 95 (16.84%)
    2 / 45 (4.44%)
         occurrences all number
    21
    2
    lethargy
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Anosmia
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Ageusia
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Migraine
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    3
    0
    Sciatica
         subjects affected / exposed
    2 / 95 (2.11%)
    2 / 45 (4.44%)
         occurrences all number
    2
    2
    Restless legs syndrome
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 95 (2.11%)
    0 / 45 (0.00%)
         occurrences all number
    3
    0
    Lymphadenopathy
         subjects affected / exposed
    1 / 95 (1.05%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Lymphopenia
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Polycythaemia
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    2 / 95 (2.11%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Vertigo
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Eye disorders
    Vision blurred
         subjects affected / exposed
    1 / 95 (1.05%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Ocular hyperaemia
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Visual impairment
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    abdominal pain
         subjects affected / exposed
    3 / 95 (3.16%)
    1 / 45 (2.22%)
         occurrences all number
    3
    1
    Anal fissure
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    anal fistula
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Abdominal distension
         subjects affected / exposed
    2 / 95 (2.11%)
    1 / 45 (2.22%)
         occurrences all number
    2
    1
    constipation
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    6 / 95 (6.32%)
    0 / 45 (0.00%)
         occurrences all number
    7
    0
    Diarrhoea
         subjects affected / exposed
    6 / 95 (6.32%)
    4 / 45 (8.89%)
         occurrences all number
    6
    4
    Jejunal ulcer
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Dry mouth
         subjects affected / exposed
    2 / 95 (2.11%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Steatorrhoea
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    flatulence
         subjects affected / exposed
    3 / 95 (3.16%)
    0 / 45 (0.00%)
         occurrences all number
    3
    0
    gastrointestinal infection
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Haemorrhoids
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    4 / 95 (4.21%)
    0 / 45 (0.00%)
         occurrences all number
    4
    0
    Dyspepsia
         subjects affected / exposed
    3 / 95 (3.16%)
    2 / 45 (4.44%)
         occurrences all number
    3
    2
    Eructation
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Lip pain
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Odynophagia
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    2 / 45 (4.44%)
         occurrences all number
    1
    2
    oesophagitis
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Proctalgia
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Proctitis
         subjects affected / exposed
    2 / 95 (2.11%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Abdominal pain upper
         subjects affected / exposed
    2 / 95 (2.11%)
    1 / 45 (2.22%)
         occurrences all number
    2
    1
    Toothache
         subjects affected / exposed
    2 / 95 (2.11%)
    1 / 45 (2.22%)
         occurrences all number
    2
    1
    Abdominal discomfort
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 95 (1.05%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Gastrointestinal disorder
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Nausea
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Proctitis gonococcal
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Alopecia areata
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Blister
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Skin reaction
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Eczema
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    4
    0
    Onychomycosis
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Pruritus
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    2 / 95 (2.11%)
    1 / 45 (2.22%)
         occurrences all number
    2
    1
    Hyperkeratosis
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Intertrigo
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Dermatitis
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Skin lesion
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Rash
         subjects affected / exposed
    5 / 95 (5.26%)
    0 / 45 (0.00%)
         occurrences all number
    12
    0
    Seborrheic Dermatitis
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Alopecia
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Cellulitis
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    ALBUMINURIA
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    dysuria
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Focal segmental glomerulosclerosis
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Nocturia
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Chromaturia
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Pollakiuria
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    2 / 95 (2.11%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    renal colic
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Urge incontinence
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Urinary incontinence
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Proteinuria
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Calculus bladder
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    2 / 95 (2.11%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Periarthritis
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Bursitis
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Neck pain
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    2 / 45 (4.44%)
         occurrences all number
    1
    2
    Limb discomfort
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Arthralgia
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    5 / 95 (5.26%)
    2 / 45 (4.44%)
         occurrences all number
    5
    2
    Pain in extremity
         subjects affected / exposed
    3 / 95 (3.16%)
    3 / 45 (6.67%)
         occurrences all number
    3
    3
    Back pain
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    4 / 95 (4.21%)
    0 / 45 (0.00%)
         occurrences all number
    4
    0
    Myalgia
         subjects affected / exposed
    5 / 95 (5.26%)
    1 / 45 (2.22%)
         occurrences all number
    5
    1
    Muscle atrophy
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    2 / 95 (2.11%)
    1 / 45 (2.22%)
         occurrences all number
    2
    2
    Osteoarthritis
         subjects affected / exposed
    1 / 95 (1.05%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Osteoporosis
         subjects affected / exposed
    1 / 95 (1.05%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Plantar fasciitis
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Muscle strain
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Tendonitis
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Osteopenia
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Joint swelling
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Tenosynovitis
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Infections and infestations
    Abscess
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Muscle abscess
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Cystitis
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Amoebiasis
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Genital herpes
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    2 / 45 (4.44%)
         occurrences all number
    1
    2
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 95 (1.05%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Chlamydial infection
         subjects affected / exposed
    4 / 95 (4.21%)
    2 / 45 (4.44%)
         occurrences all number
    6
    2
    Influenza
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    2 / 95 (2.11%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Nasopharyngitis
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    6 / 95 (6.32%)
    5 / 45 (11.11%)
         occurrences all number
    8
    7
    Rhinitis
         subjects affected / exposed
    5 / 95 (5.26%)
    1 / 45 (2.22%)
         occurrences all number
    5
    1
    folliculitis
         subjects affected / exposed
    1 / 95 (1.05%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Fungal skin infection
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Fungal infection
         subjects affected / exposed
    2 / 95 (2.11%)
    0 / 45 (0.00%)
         occurrences all number
    3
    0
    Gastroenteritis
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    2 / 95 (2.11%)
    1 / 45 (2.22%)
         occurrences all number
    2
    1
    Gingivitis
         subjects affected / exposed
    2 / 95 (2.11%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Gonorrhoea
         subjects affected / exposed
    4 / 95 (4.21%)
    1 / 45 (2.22%)
         occurrences all number
    4
    2
    Oropharyngeal gonococcal infection
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Gingival abscess
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Helicobacter infection
         subjects affected / exposed
    2 / 95 (2.11%)
    1 / 45 (2.22%)
         occurrences all number
    2
    1
    Herpes virus infection
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    3
    0
    Herpes simplex
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Infected bite
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    lymphogranuloma venereum
         subjects affected / exposed
    3 / 95 (3.16%)
    1 / 45 (2.22%)
         occurrences all number
    3
    1
    Malaria
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Oral infection
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Staphylococcal infection
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Nasal abscess
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Oral candidiasis
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Ear infection
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Pharyngeal chlamydia infection
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Tinea versicolour
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    pneumonia
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    COVID-19
         subjects affected / exposed
    9 / 95 (9.47%)
    3 / 45 (6.67%)
         occurrences all number
    9
    3
    Pyelonephritis
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Syphilis
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    6 / 95 (6.32%)
    2 / 45 (4.44%)
         occurrences all number
    8
    2
    Tooth abscess
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 95 (4.21%)
    1 / 45 (2.22%)
         occurrences all number
    4
    1
    Urinary tract infection
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    6 / 95 (6.32%)
    2 / 45 (4.44%)
         occurrences all number
    7
    3
    Vaginal infection
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Viral infection
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Herpes zoster
         subjects affected / exposed
    1 / 95 (1.05%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Suspected COVID-19
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Onychomycosis
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    3 / 95 (3.16%)
    0 / 45 (0.00%)
         occurrences all number
    3
    0
    Cellulitis
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Gout
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    2
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 95 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Hypocalcaemia
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Increased appetite
         subjects affected / exposed
    1 / 95 (1.05%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Vitamin D deficiency
         subjects affected / exposed
    6 / 95 (6.32%)
    0 / 45 (0.00%)
         occurrences all number
    6
    0
    Diabetes mellitus
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    0 / 95 (0.00%)
    2 / 45 (4.44%)
         occurrences all number
    0
    2
    Hypophosphataemia
    alternative dictionary used: MedDRA 24
         subjects affected / exposed
    1 / 95 (1.05%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Jan 2021
    Global amendment to update protocol V3.0 to V5.0

    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/38417976
    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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