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    Clinical Trial Results:
    A Phase 2/3, Open-Label Study to Evaluate the Safety and Efficacy of E/C/F/TAF in HIV-1 Infected Virologically Suppressed Adolescents

    Summary
    EudraCT number
    		 2014-002673-11
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    23 Oct 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Mar 2018
    First version publication date
    23 Mar 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-292-1515
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02276612
    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 Trials Mailbox, Gilead Sciences International Ltd, GileadClinicalTrials@gilead.com
    Scientific contact
    Clinical Trials Mailbox, Gilead Sciences International Ltd, GileadClinicalTrials@gilead.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001460-PIP01-13
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Oct 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Nov 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Oct 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) in HIV-infected virologically suppressed adolescents 12 to < 18 years of age.
    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
    03 Dec 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    South Africa: 52
    Country: Number of subjects enrolled
    United States: 8
    Worldwide total number of subjects
    60
    EEA total number of subjects
    0
    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)
    50
    Adults (18-64 years)
    10
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in South Africa and the United States. The first participant was screened on 03 December 2014. The last study visit occurred on 23 October 2017.

    Pre-assignment
    Screening details
    		 68 participants were screened.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 E/C/F/TAF (12 - 17 Years of Age)
    Arm description
    		 Participants 12 - 17 years of age received E/C/F/TAF for 48 weeks. Following completion of 48 weeks of treatment, eligible participants 12 - 17 years of age received E/C/F/TAF during the open-label extension phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide
    Investigational medicinal product code
    Other name
    E/C/F/TAF, Genvoya®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150/150/200/10 mg fixed-dose combination (FDC) tablet administered once daily with food

    Arm title
    		 E/C/F/TAF (≥ 18 Years of Age)
    Arm description
    		 Participants 18 years of age or older received E/C/F/TAF for 48 weeks. Following completion of 48 weeks of treatment, eligible participants ≥ 18 years of age received E/C/F/TAF during the open-label extension phase. NOTE: Participants from Gilead Study GS-US-162-0112 were allowed to roll over into this Study GS-US-292-1515 even if they were 18 years or older at the time of screening.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide
    Investigational medicinal product code
    Other name
    E/C/F/TAF, Genvoya®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150/150/200/10 mg FDC tablet administered once daily with food

    Number of subjects in period 1
    		E/C/F/TAF (12 - 17 Years of Age) E/C/F/TAF (≥ 18 Years of Age)
    Started
    50
    10
    Completed
    46
    10
    Not completed
    4
    0
         Adverse event, serious fatal
    1
    -
         Withdrew Consent
    1
    -
         Pregnancy
    1
    -
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    E/C/F/TAF (12 - 17 Years of Age)
    Reporting group description
    		 Participants 12 - 17 years of age received E/C/F/TAF for 48 weeks. Following completion of 48 weeks of treatment, eligible participants 12 - 17 years of age received E/C/F/TAF during the open-label extension phase.

    Reporting group title
    E/C/F/TAF (≥ 18 Years of Age)
    Reporting group description
    		 Participants 18 years of age or older received E/C/F/TAF for 48 weeks. Following completion of 48 weeks of treatment, eligible participants ≥ 18 years of age received E/C/F/TAF during the open-label extension phase. NOTE: Participants from Gilead Study GS-US-162-0112 were allowed to roll over into this Study GS-US-292-1515 even if they were 18 years or older at the time of screening.

    Reporting group values
    		 E/C/F/TAF (12 - 17 Years of Age) E/C/F/TAF (≥ 18 Years of Age) Total
    Number of subjects
    		 50 10 60
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 15 ( 1.6 ) 19 ( 1.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 32 3 35
        Male
    		 18 7 25
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 0 1
        Not Hispanic or Latino
    		 49 10 59
    Race
    Units: Subjects
        Black
    		 49 9 58
        White
    		 1 0 1
        Other
    		 0 1 1
    HIV-1 RNA Category
    Units: Subjects
        < 50 copies/mL
    		 49 9 58
        ≥ 50 copies/mL
    		 1 1 2
    CD4 Cell Count
    Units: cells/µL
        arithmetic mean (standard deviation)
    		 753 ( 222.5 ) 776 ( 179.9 ) -
    CD4 Percentage
    Units: percentage
        arithmetic mean (standard deviation)
    		 34.3 ( 6.72 ) 35.9 ( 6.53 ) -

    End points

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    End points reporting groups
    Reporting group title
    E/C/F/TAF (12 - 17 Years of Age)
    Reporting group description
    		 Participants 12 - 17 years of age received E/C/F/TAF for 48 weeks. Following completion of 48 weeks of treatment, eligible participants 12 - 17 years of age received E/C/F/TAF during the open-label extension phase.

    Reporting group title
    E/C/F/TAF (≥ 18 Years of Age)
    Reporting group description
    		 Participants 18 years of age or older received E/C/F/TAF for 48 weeks. Following completion of 48 weeks of treatment, eligible participants ≥ 18 years of age received E/C/F/TAF during the open-label extension phase. NOTE: Participants from Gilead Study GS-US-162-0112 were allowed to roll over into this Study GS-US-292-1515 even if they were 18 years or older at the time of screening.

    Primary: Incidence of Treatment-Emergent Serious Adverse Events

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    End point title
    		 Incidence of Treatment-Emergent Serious Adverse Events [1]
    End point description
    The percentage of participants experiencing any treatment-emergent serious adverse event was summarized. Safety Analysis Set included participants who were enrolled in the study and received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Up to Week 48
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical comparison was planned or performed.
    End point values
    		 E/C/F/TAF (12 - 17 Years of Age) E/C/F/TAF (≥ 18 Years of Age)
    Number of subjects analysed
    50
    10
    Units: percentage of participants
        number (not applicable)
    4.0
    0
    No statistical analyses for this end point

    Primary: Incidence of Treatment-Emergent Adverse Events

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    End point title
    		 Incidence of Treatment-Emergent Adverse Events [2]
    End point description
    The percentage of participants experiencing any treatment-emergent adverse event was summarized. Participants in the Safety Analysis Set were analyzed.
    End point type
    Primary
    End point timeframe
    Up to Week 48
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical comparison was planned or performed.
    End point values
    		 E/C/F/TAF (12 - 17 Years of Age) E/C/F/TAF (≥ 18 Years of Age)
    Number of subjects analysed
    50
    10
    Units: percentage of participants
        number (not applicable)
    92.0
    100.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 24 (FDA-defined Snapshot Analysis)

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    End point title
    		 Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 24 (FDA-defined Snapshot Analysis)
    End point description
    The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Full Analysis Set included participants who were enrolled in the study and received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 E/C/F/TAF (12 - 17 Years of Age) E/C/F/TAF (≥ 18 Years of Age)
    Number of subjects analysed
    50
    10
    Units: percentage of participants
        number (confidence interval 95%)
    96.0 (86.3 to 99.5)
    100.0 (69.2 to 100.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 48 (FDA-defined Snapshot Analysis)

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    End point title
    		 Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 48 (FDA-defined Snapshot Analysis)
    End point description
    The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 E/C/F/TAF (12 - 17 Years of Age) E/C/F/TAF (≥ 18 Years of Age)
    Number of subjects analysed
    50
    10
    Units: percentage of participants
        number (confidence interval 95%)
    90.0 (78.2 to 96.7)
    100.0 (69.2 to 100.0)
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Cell Count at Week 24

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    End point title
    		 Change From Baseline in CD4 Cell Count at Week 24
    End point description
    Participants in the Full Analysis Set with on-treatment data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 24
    End point values
    		 E/C/F/TAF (12 - 17 Years of Age) E/C/F/TAF (≥ 18 Years of Age)
    Number of subjects analysed
    50
    10
    Units: cells/µL
        arithmetic mean (standard deviation)
    -72 ( 189.8 )
    -85 ( 245.9 )
    No statistical analyses for this end point

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

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    End point title
    		 Change From Baseline in CD4 Cell Count at Week 48
    End point description
    Participants in the Full Analysis Set with on-treatment data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 48
    End point values
    		 E/C/F/TAF (12 - 17 Years of Age) E/C/F/TAF (≥ 18 Years of Age)
    Number of subjects analysed
    48
    10
    Units: cells/µL
        arithmetic mean (standard deviation)
    -43 ( 201.1 )
    -41 ( 143.0 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Percentage at Week 24

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    End point title
    		 Change From Baseline in CD4 Percentage at Week 24
    End point description
    Participants in the Full Analysis Set with on-treatment data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 24
    End point values
    		 E/C/F/TAF (12 - 17 Years of Age) E/C/F/TAF (≥ 18 Years of Age)
    Number of subjects analysed
    50
    10
    Units: percentage
        arithmetic mean (standard deviation)
    -0.6 ( 5.46 )
    -0.6 ( 5.46 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Percentage at Week 48

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    End point title
    		 Change From Baseline in CD4 Percentage at Week 48
    End point description
    Participants in the Full Analysis Set with on-treatment data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 48
    End point values
    		 E/C/F/TAF (12 - 17 Years of Age) E/C/F/TAF (≥ 18 Years of Age)
    Number of subjects analysed
    48
    10
    Units: percentage
        arithmetic mean (standard deviation)
    -0.1 ( 3.95 )
    -1.1 ( 7.29 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 128 weeks plus 30 days
    Adverse event reporting additional description
    Safety Analysis Set: participants who were enrolled in 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
    20.0
    Reporting groups
    Reporting group title
    E/C/F/TAF (12 - 17 Years of Age)
    Reporting group description
    		 Participants 12 - 17 years of age received E/C/F/TAF for 48 weeks. Following completion of 48 weeks of treatment, eligible participants 12 - 17 years of age received E/C/F/TAF during the open-label extension phase.

    Reporting group title
    E/C/F/TAF (≥ 18 Years of Age)
    Reporting group description
    		 Participants 18 years of age or older received E/C/F/TAF for 48 weeks. Following completion of 48 weeks of treatment, eligible participants ≥ 18 years of age received E/C/F/TAF during the open-label extension phase. NOTE: Participants from Gilead Study GS-US-162-0112 were allowed to roll over into this Study GS-US-292-1515 even if they were 18 years or older at the time of screening.

    Serious adverse events
    		 E/C/F/TAF (12 - 17 Years of Age) E/C/F/TAF (≥ 18 Years of Age)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 10 (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
    Electrocution
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    1 / 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
    		 E/C/F/TAF (12 - 17 Years of Age) E/C/F/TAF (≥ 18 Years of Age)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    42 / 50 (84.00%)
    10 / 10 (100.00%)
    Investigations
    Vitamin D decreased
         subjects affected / exposed
    7 / 50 (14.00%)
    0 / 10 (0.00%)
         occurrences all number
    7
    0
    Bone density decreased
         subjects affected / exposed
    2 / 50 (4.00%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    Weight decreased
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Thermal burn
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 50 (12.00%)
    2 / 10 (20.00%)
         occurrences all number
    6
    2
    Dizziness
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Neutropenia
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Lymphadenopathy
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    2 / 50 (4.00%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    Axillary pain
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Chest pain
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Pain
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    7 / 50 (14.00%)
    2 / 10 (20.00%)
         occurrences all number
    9
    2
    Vomiting
         subjects affected / exposed
    8 / 50 (16.00%)
    1 / 10 (10.00%)
         occurrences all number
    8
    2
    Abdominal pain upper
         subjects affected / exposed
    3 / 50 (6.00%)
    1 / 10 (10.00%)
         occurrences all number
    3
    2
    Abdominal pain
         subjects affected / exposed
    2 / 50 (4.00%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    Constipation
         subjects affected / exposed
    2 / 50 (4.00%)
    1 / 10 (10.00%)
         occurrences all number
    3
    1
    Anal fissure
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    12 / 50 (24.00%)
    5 / 10 (50.00%)
         occurrences all number
    16
    6
    Nasal obstruction
         subjects affected / exposed
    3 / 50 (6.00%)
    3 / 10 (30.00%)
         occurrences all number
    4
    3
    Asthma
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    6 / 50 (12.00%)
    0 / 10 (0.00%)
         occurrences all number
    6
    0
    Rash
         subjects affected / exposed
    5 / 50 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    5
    0
    Pruritus
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Back pain
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Pain in extremity
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    11 / 50 (22.00%)
    6 / 10 (60.00%)
         occurrences all number
    15
    6
    Viral upper respiratory tract infection
         subjects affected / exposed
    7 / 50 (14.00%)
    0 / 10 (0.00%)
         occurrences all number
    7
    0
    Sinusitis
         subjects affected / exposed
    3 / 50 (6.00%)
    1 / 10 (10.00%)
         occurrences all number
    6
    1
    Urinary tract infection
         subjects affected / exposed
    4 / 50 (8.00%)
    0 / 10 (0.00%)
         occurrences all number
    5
    0
    Acarodermatitis
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Bronchitis
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Gastroenteritis
         subjects affected / exposed
    2 / 50 (4.00%)
    1 / 10 (10.00%)
         occurrences all number
    5
    1
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Oral herpes
         subjects affected / exposed
    1 / 50 (2.00%)
    2 / 10 (20.00%)
         occurrences all number
    1
    2
    Otitis media
         subjects affected / exposed
    2 / 50 (4.00%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    Pharyngitis
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 10 (0.00%)
         occurrences all number
    4
    0
    Herpes simplex
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Sinusitis bacterial
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Tonsillitis
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    4 / 50 (8.00%)
    1 / 10 (10.00%)
         occurrences all number
    4
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Oct 2016
    ● Updated total treatment duration from 96 weeks to 48 weeks to align with E.U. Pediatric Investigational Plan endpoints ● Removed Week 72 and Week 96 visits as these visits are no longer applicable ● Added Unscheduled Visit section to allow investigators to conduct additional study related safety visits when necessary ● Clarified which assessments are to be completed at the extension phase of the study, and how often they are to be completed

    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
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