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    Clinical Trial Results:
    Open Label trial to evaluate the tolerability of a combination therapy consisting of GAD-alum (Diamyd®), etanercept and vitamin D in children and adolescents newly diagnosed with type 1 diabetes

    Summary
    EudraCT number
    		 2014-001323-76
    Trial protocol
    		 SE  
    Global end of trial date
    25 Feb 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jun 2019
    First version publication date
    20 Jun 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EDCR_IIa
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02464033
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Linköping University
    Sponsor organisation address
    Crown Princess Victoria Children´s Hospital, Linköping, Sweden, 581 85
    Public contact
    Johnny Ludvigsson, Linköping University, johnny.ludvigsson@liu.se
    Scientific contact
    Johnny Ludvigsson, Linköping University, johnny.ludvigsson@liu.se
    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
    10 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Feb 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Feb 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate the tolerability of a combination therapy with Diamyd, vitamin D and etanercept
    Protection of trial subjects
    To ensure subject safety a Safety Plan is in place describing the study specific safety measures that are to be taken during the study. This Safety Plan must be used in conjunction with this protocol. The purpose of the Safety Plan is to ensure:  the safety of patients receiving etanercept, Diamyd and vitamin D treatment in the study.  that appropriately qualified medical personnel are readily available to advise on trial related medical questions or problems regarding the study drug treatment in the above mentioned study.  that study personnel are educated about know side effects of the study drug treatment and how to handle them.  that patients and their parents/legal guardian(s) are given information about possible side effects.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    9
    Adolescents (12-17 years)
    11
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 47 patients were screened and 20 entered the study.

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 GAD-Alum+Vitamin D+Etanercept
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Diamyd
    Investigational medicinal product code
    Other name
    Recombinant Human Glutamic Acid Decarboxylase (rhGAD65)
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    GAD-alum 20 μg, administered subcutaneously in the stomach area at two occasions, each on Days 30 and 60 (Visits 3 and 4 respectively).

    Investigational medicinal product name
    Etanercept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Etanercept (Enbrel®) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week from Day 1 through Day 90 (3 months duration).

    Investigational medicinal product name
    Vitamin D
    Investigational medicinal product code
    Other name
    Cholecalciferol
    Pharmaceutical forms
    Oral drops
    Routes of administration
    Oral use
    Dosage and administration details
    Vitamin D, administered as oral drops; 2000 IU per day (i.e. 25 drops per day) from Day 1 through Day 450 (15 months duration).

    Number of subjects in period 1
    		GAD-Alum+Vitamin D+Etanercept
    Started
    20
    Completed
    20
    Period 2
    Period 2 title
    Overall trial
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 GAD-Alum+Vitamin D+Etanercept
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Diamyd
    Investigational medicinal product code
    Other name
    Recombinant Human Glutamic Acid Decarboxylase (rhGAD65)
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60

    Investigational medicinal product name
    Etanercept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    From Days 1-90 all patients receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week

    Investigational medicinal product name
    Vitamin D
    Investigational medicinal product code
    Other name
    Cholecalciferol
    Pharmaceutical forms
    Oral drops
    Routes of administration
    Oral use
    Dosage and administration details
    All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months

    Number of subjects in period 2
    		GAD-Alum+Vitamin D+Etanercept
    Started
    20
    Completed
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 20 20
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 9 9
        Adolescents (12-17 years)
    		 11 11
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 12.36 ± 2.321 -
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 13 13
    Type 1 diabetes duration
    Units: days
        arithmetic mean (standard deviation)
    		 81.35 ± 22.091 -
    Body Mass Index (BMI)
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 18.38 ± 2.141 -
    Subject analysis sets

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population included all enrolled patients who received at least one dose of study drug and had at least one safety/tolerability evaluation. It was used for prior and concomitant diseases/medications and analysis safety/tolerability variables.

    Subject analysis set title
    Total
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Total Population included all patients who had consented for the study. It was used for patient listings, patient disposition and demographics.

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Intention-to-Treat Population included all enrolled patients who received at least one dose of study drug and had at least one efficacy evaluation. It was used for primary analysis of efficacy variables (diabetes-related parameters).

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per Protocol Population was a subset of ITT Population and included patients’ all study visits that followed the study protocol without any major violations.

    Subject analysis sets values
    		 Safety Total ITT PP
    Number of subjects
    20
    20
    20
    20
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
        Children (2-11 years)
    9
    9
    9
    9
        Adolescents (12-17 years)
    11
    11
    11
    11
        Adults (18-64 years)
    0
    0
    0
    0
        From 65-84 years
    0
    0
    0
    0
        85 years and over
    0
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    12.36 ± 2.321
    12.36 ± 2.321
    12.36 ± 2.321
    12.36 ± 2.321
    Gender categorical
    Units: Subjects
        Female
    7
    7
    7
    7
        Male
    13
    13
    13
    13
    Type 1 diabetes duration
    Units: days
        arithmetic mean (standard deviation)
    81.35 ± 22.091
    81.35 ± 22.091
    81.35 ± 22.091
    81.35 ± 22.091
    Body Mass Index (BMI)
    Units: kg/m2
        arithmetic mean (standard deviation)
    18.38 ± 2.141
    18.38 ± 2.141
    18.38 ± 2.141
    18.38 ± 2.141

    End points

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    End points reporting groups
    Reporting group title
    GAD-Alum+Vitamin D+Etanercept
    Reporting group description
    		 -
    Reporting group title
    GAD-Alum+Vitamin D+Etanercept
    Reporting group description
    		 -

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population included all enrolled patients who received at least one dose of study drug and had at least one safety/tolerability evaluation. It was used for prior and concomitant diseases/medications and analysis safety/tolerability variables.

    Subject analysis set title
    Total
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Total Population included all patients who had consented for the study. It was used for patient listings, patient disposition and demographics.

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Intention-to-Treat Population included all enrolled patients who received at least one dose of study drug and had at least one efficacy evaluation. It was used for primary analysis of efficacy variables (diabetes-related parameters).

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per Protocol Population was a subset of ITT Population and included patients’ all study visits that followed the study protocol without any major violations.

    Primary: Reactions of the injection site

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    End point title
    		 Reactions of the injection site [1]
    End point description
    Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching, Other). Inspection of injection site 60 minutes after GAD-Alum injection by investigator or nurse
    End point type
    Primary
    End point timeframe
    1 months
    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: This was an uncontrolled open study and no formal statistical analyses were pre-specified.
    End point values
    		 Safety
    Number of subjects analysed
    20
    Units: Number of subjects
    3
    No statistical analyses for this end point

    Primary: Reactions of the injection site

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    End point title
    		 Reactions of the injection site [2]
    End point description
    Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching, Other). Inspection of injection site 60 minutes after GAD-Alum injection by investigator or nurse
    End point type
    Primary
    End point timeframe
    2 months
    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: This was an uncontrolled open study and no formal statistical analyses were pre-specified.
    End point values
    		 Safety
    Number of subjects analysed
    20
    Units: Number of subjects
    5
    No statistical analyses for this end point

    Primary: Physical examinations, including neurological assessments.

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    End point title
    		 Physical examinations, including neurological assessments. [3]
    End point description
    Physical examinations, including neurological assessments. Number of patients with any abnormal findings after baseline.
    End point type
    Primary
    End point timeframe
    Overall treatment
    Notes
    [3] - 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: This was an uncontrolled open study and no formal statistical analyses were pre-specified.
    End point values
    		 Safety
    Number of subjects analysed
    20
    Units: Number of patients
    6
    No statistical analyses for this end point

    Primary: Laboratory Measurements

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    End point title
    		 Laboratory Measurements [4]
    End point description
    Laboratory Measurements. Number of patients with clinically significant laboratory findings during the study.
    End point type
    Primary
    End point timeframe
    Overall treatment
    Notes
    [4] - 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: This was an uncontrolled open study and no formal statistical analyses were pre-specified.
    End point values
    		 Safety
    Number of subjects analysed
    20
    Units: Number of subjects
    0
    No statistical analyses for this end point

    Primary: GAD65AB titer (GADA) change from baseline

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    End point title
    		 GAD65AB titer (GADA) change from baseline [5]
    End point description
    GAD65AB = Antibodies to GAD with molecular mass 65000
    End point type
    Primary
    End point timeframe
    6 months
    Notes
    [5] - 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: This was an uncontrolled open study and no formal statistical analyses were pre-specified.
    End point values
    		 ITT
    Number of subjects analysed
    20
    Units: U/mL
        arithmetic mean (standard deviation)
    2509.41 ± 4866.515
    No statistical analyses for this end point

    Primary: GAD65AB titer (GADA) change from baseline.

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    End point title
    		 GAD65AB titer (GADA) change from baseline. [6]
    End point description
    GAD65AB = Antibodies to GAD with molecular mass 65000
    End point type
    Primary
    End point timeframe
    15 months
    Notes
    [6] - 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: This was an uncontrolled open study and no formal statistical analyses were pre-specified.
    End point values
    		 ITT
    Number of subjects analysed
    20
    Units: U/mL
        arithmetic mean (standard deviation)
    1036.19 ± 2527.249
    No statistical analyses for this end point

    Primary: GAD65AB titer (GADA) change from baseline

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    End point title
    		 GAD65AB titer (GADA) change from baseline [7]
    End point description
    GAD65AB = Antibodies to GAD with molecular mass 65000
    End point type
    Primary
    End point timeframe
    30 months
    Notes
    [7] - 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: This was an uncontrolled open study and no formal statistical analyses were pre-specified.
    End point values
    		 ITT
    Number of subjects analysed
    20
    Units: U/mL
        arithmetic mean (standard deviation)
    347.01 ± 1564.466
    No statistical analyses for this end point

    Primary: Infections

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    End point title
    		 Infections [8]
    End point description
    Number of patients with an infection reported as Adverse Event related to study treatment (GAD-alum and/or Etanercept)
    End point type
    Primary
    End point timeframe
    Overall treatment
    Notes
    [8] - 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: This was an uncontrolled open study and no formal statistical analyses were pre-specified.
    End point values
    		 Safety
    Number of subjects analysed
    20
    Units: Number of subjects
    3
    No statistical analyses for this end point

    Secondary: Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline

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    End point title
    		 Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline
    End point description
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 ITT
    Number of subjects analysed
    18
    Units: nmol/L*min
        arithmetic mean (standard deviation)
    -0.09 ± 0.153
    No statistical analyses for this end point

    Secondary: Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline

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    End point title
    		 Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline
    End point description
    End point type
    Secondary
    End point timeframe
    15 months
    End point values
    		 ITT
    Number of subjects analysed
    20
    Units: nmol/L*min
        arithmetic mean (standard deviation)
    -0.30 ± 0.158
    No statistical analyses for this end point

    Secondary: Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline

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    End point title
    		 Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline
    End point description
    End point type
    Secondary
    End point timeframe
    30 months
    End point values
    		 ITT
    Number of subjects analysed
    19
    Units: nmol/L*min
        arithmetic mean (standard deviation)
    -0.40 ± 0.168
    No statistical analyses for this end point

    Secondary: Stimulated maximum C-peptide level above 0.2 nmol/L

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    End point title
    		 Stimulated maximum C-peptide level above 0.2 nmol/L
    End point description
    Proportion of patients with a stimulated maximum C-peptide level above 0.2 nmol/L
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 ITT
    Number of subjects analysed
    20
    Units: Number of subjects
    17
    No statistical analyses for this end point

    Secondary: Stimulated maximum C-peptide level above 0.2 nmol/L

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    End point title
    		 Stimulated maximum C-peptide level above 0.2 nmol/L
    End point description
    Proportion of patients with a stimulated maximum C-peptide level above 0.2 nmol/L
    End point type
    Secondary
    End point timeframe
    15 months
    End point values
    		 ITT
    Number of subjects analysed
    20
    Units: Number of subjects
    14
    No statistical analyses for this end point

    Secondary: Stimulated maximum C-peptide level above 0.2 nmol/L

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    End point title
    		 Stimulated maximum C-peptide level above 0.2 nmol/L
    End point description
    Proportion of patients with a stimulated maximum C-peptide level above 0.2 nmol/L
    End point type
    Secondary
    End point timeframe
    30 months
    End point values
    		 ITT
    Number of subjects analysed
    20
    Units: Number of subjects
    8
    No statistical analyses for this end point

    Secondary: Hemoglobin A1c (HbA1c), change from baseline

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    End point title
    		 Hemoglobin A1c (HbA1c), change from baseline
    End point description
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 ITT
    Number of subjects analysed
    20
    Units: mmol/mol
        arithmetic mean (standard deviation)
    0.80 ± 8.433
    No statistical analyses for this end point

    Secondary: Hemoglobin A1c (HbA1c), change from baseline

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    End point title
    		 Hemoglobin A1c (HbA1c), change from baseline
    End point description
    End point type
    Secondary
    End point timeframe
    15 months
    End point values
    		 ITT
    Number of subjects analysed
    20
    Units: mmol/mol
        arithmetic mean (standard deviation)
    6.15 ± 12.495
    No statistical analyses for this end point

    Secondary: Hemoglobin A1c (HbA1c), change from baseline

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    End point title
    		 Hemoglobin A1c (HbA1c), change from baseline
    End point description
    End point type
    Secondary
    End point timeframe
    30 months
    End point values
    		 ITT
    Number of subjects analysed
    20
    Units: mmol/mol
        arithmetic mean (standard deviation)
    7.55 ± 11.213
    No statistical analyses for this end point

    Secondary: Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline

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    End point title
    		 Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline
    End point description
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 ITT
    Number of subjects analysed
    20
    Units: IU
        arithmetic mean (standard deviation)
    0.01 ± 0.249
    No statistical analyses for this end point

    Secondary: Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline

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    End point title
    		 Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline
    End point description
    End point type
    Secondary
    End point timeframe
    15 months
    End point values
    		 ITT
    Number of subjects analysed
    20
    Units: IU
        arithmetic mean (standard deviation)
    0.25 ± 0.342
    No statistical analyses for this end point

    Secondary: Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline

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    End point title
    		 Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline
    End point description
    End point type
    Secondary
    End point timeframe
    30 months
    End point values
    		 ITT
    Number of subjects analysed
    20
    Units: IU
        arithmetic mean (standard deviation)
    0.42 ± 0.333
    No statistical analyses for this end point

    Secondary: C-peptide: Stimulated, 90 minute value, change from baseline

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    End point title
    		 C-peptide: Stimulated, 90 minute value, change from baseline
    End point description
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 ITT
    Number of subjects analysed
    18
    Units: nmol/L
        arithmetic mean (standard deviation)
    -0.09 ± 0.233
    No statistical analyses for this end point

    Secondary: C-peptide: Stimulated, 90 minute value, change from baseline

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    End point title
    		 C-peptide: Stimulated, 90 minute value, change from baseline
    End point description
    End point type
    Secondary
    End point timeframe
    15 months
    End point values
    		 ITT
    Number of subjects analysed
    20
    Units: nmol/L
        arithmetic mean (standard deviation)
    -0.35 ± 0.231
    No statistical analyses for this end point

    Secondary: C-peptide: Stimulated, 90 minute value, change from baseline

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    End point title
    		 C-peptide: Stimulated, 90 minute value, change from baseline
    End point description
    End point type
    Secondary
    End point timeframe
    30 months
    End point values
    		 ITT
    Number of subjects analysed
    19
    Units: nmol/L
        arithmetic mean (standard deviation)
    -0.49 ± 0.221
    No statistical analyses for this end point

    Secondary: Changes in fasting C-peptide concentrations

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    End point title
    		 Changes in fasting C-peptide concentrations
    End point description
    Change from baseline in fasting C-peptide concentrations
    End point type
    Secondary
    End point timeframe
    Month 6
    End point values
    		 ITT
    Number of subjects analysed
    20
    Units: nmol/L
        arithmetic mean (standard deviation)
    -0.02 ± 0.083
    No statistical analyses for this end point

    Secondary: Changes in fasting C-peptide concentrations

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    End point title
    		 Changes in fasting C-peptide concentrations
    End point description
    Change from baseline in fasting C-peptide concentrations
    End point type
    Secondary
    End point timeframe
    Month 15
    End point values
    		 ITT
    Number of subjects analysed
    20
    Units: nmol/L
        arithmetic mean (standard deviation)
    -0.10 ± 0.091
    No statistical analyses for this end point

    Secondary: Changes in fasting C-peptide concentration

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    End point title
    		 Changes in fasting C-peptide concentration
    End point description
    Changes from baseline in fasting C-peptide concentrations
    End point type
    Secondary
    End point timeframe
    Month 30
    End point values
    		 ITT
    Number of subjects analysed
    20
    Units: nmol/L
        arithmetic mean (standard deviation)
    -0.15 ± 0.093
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    GAD-Alum+Vitamin D+Etanercept
    Reporting group description
    		 -

    Serious adverse events
    		 GAD-Alum+Vitamin D+Etanercept
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 GAD-Alum+Vitamin D+Etanercept
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 20 (100.00%)
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    General disorders and administration site conditions
    Injection site reaction
         subjects affected / exposed
    13 / 20 (65.00%)
         occurrences all number
    20
    Pyrexia
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Psychiatric disorders
    Depression
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    9 / 20 (45.00%)
         occurrences all number
    11
    Influenza
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Nasopharyngitis
         subjects affected / exposed
    13 / 20 (65.00%)
         occurrences all number
    30
    Viral infection
         subjects affected / exposed
    8 / 20 (40.00%)
         occurrences all number
    15

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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