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    Clinical Trial Results:
    Efficacy and Safety of Fumaric Acid Esters (Fumaderm®) in the Treatment of Patients with Cutaneous Lupus Erythematosus: A Mono-Centre, Open-Label, Prospective Pilot Study

    Summary
    EudraCT number
    		 2010-023645-29
    Trial protocol
    		 DE  
    Global end of trial date
    12 Feb 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jan 2022
    First version publication date
    11 Jan 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    UKM 10_0020
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Universitätsklinikum Münster
    Sponsor organisation address
    Albert-Schweitzer-Campus 1, Münster, Germany, 48149
    Public contact
    Prof. Dr. Annegret Kuhn, Universitätsklinikum Münster, kuhnan@uni-muenster.de
    Scientific contact
    Prof. Dr. Annegret Kuhn, Universitätsklinikum Münster, kuhnan@uni-muenster.de
    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
    24 Oct 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to evaluate the therapeutic effect of fumaric acid esters (Fumaderm®) in the treatment of Cutaneous Lupus Erythematosus (CLE) with respect to proportion of responders based on the Revised Cutaneous Lupus Disease Area and Severity Index (RCLASI) activity score for skin lesions at baseline and after 24 weeks of treatment or at the latest assessment for patients who withdrew prematurely (Last Observation Carried Forward, LOCF).
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki and the ICH Guidelines in Good Clinical Practice. The study was not started before the competent ethics committee had given a favorable opinion. Written informed consent was obtained from all patients and the study was only conducted as approved by the Ethics committee and the competent authority. Amendments were only implemented after approval.
    Background therapy
    		 Throughout the trial, daily use of sunscreen (sun protection factor, SPF≥50) was recommended to all patients. The management of CLE could also involve the use of topical medications, such as topical steroids, or systemic rescue medications, such as antimalarials.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Jul 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 1 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 11
    Worldwide total number of subjects
    11
    EEA total number of subjects
    11
    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)
    11
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited in the Department of Dermatology at the University of Muenster in Germany. The recruitment period was from July 2011 to October 2013.

    Pre-assignment
    Screening details
    		 11 patients with a clinically and histologically confirmed diagnosis of CLE refractory to topical corticosteroids were included in the study.

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

    Arms
    Arm title
    		 Fumaric acid ester
    Arm description
    		 Patients who received study treatment with fumaric acid ester (Fumaderm®).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fumaderm®
    Investigational medicinal product code
    Other name
    Fumaric acid ester
    Pharmaceutical forms
    Gastro-resistant tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients were treated for 24 weeks with fumaric acid ester (Fumaderm®). Study treatment was started with one tablet of Fumaderm® initial (30mg dimethylfumarate and 75mg monoethylfumarate salts) per day and was stepwise increased weekly (during nine weeks) up to six tablets Fumaderm® (120 mg dimethylfumarate and 95 mg monoethylfumarate salts) per day. In case of side effects, the dose was adapted to the highest tolerable level.

    Number of subjects in period 1
    		Fumaric acid ester
    Started
    11
    Completed
    11

    Baseline characteristics

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

    Reporting group values
    		 Treatment period Total
    Number of subjects
    		 11 11
    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)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 11 11
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 4 4

    End points

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    End points reporting groups
    Reporting group title
    Fumaric acid ester
    Reporting group description
    		 Patients who received study treatment with fumaric acid ester (Fumaderm®).

    Subject analysis set title
    Week 0
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients treated with fumaric acid ester who were examined before starting therapy (week 0).

    Subject analysis set title
    Week 12
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients treated with fumaric acid ester who were examined during therapy (week 12).

    Subject analysis set title
    Week 24
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients treated with fumaric acid ester who were examined during therapy (week 24).

    Subject analysis set title
    Week 28
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients treated with fumaric acid ester who were examined 4 weeks after end of study treatment (week 28, Follow up).

    Primary: RCLASI activity score for skin lesions

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    End point title
    		 RCLASI activity score for skin lesions
    End point description
    Efficacy of fumaric acid ester on disease severity as evaluated by RCLASI activity score for skin lesions.
    End point type
    Primary
    End point timeframe
    Week 0, 12, 24 and 28
    End point values
    		 Week 0 Week 12 Week 24 Week 28
    Number of subjects analysed
    11
    9
    11
    11
    Units: Activity score
        arithmetic mean (standard deviation)
    14.8 ± 6.7
    9.4 ± 5.2
    9.5 ± 6.1
    9.9 ± 4.2
    Statistical analysis title
    		 RCLASI activity score skin lesions - week 0 vs 12
    Statistical analysis description
    As this study was an exploratory study, all inferential statistics were exploratory (hypotheses generating), not confirmatory, and were interpreted accordingly; i.e. p values are interpreted as a metric weight of evidence against the respective null hypothesis of no effect/ no difference. No adjustment for multiple testing was performed.
    Comparison groups
    Week 0 v Week 12
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002 [1]
    Method
    		 t-test for paired data
    Confidence interval
    Notes
    [1] - The inferential analyses were carried out by means of student’s t-tests for paired data.
    Statistical analysis title
    		 RCLASI activity score skin lesions - week 0 vs 24
    Statistical analysis description
    As this study was an exploratory study, all inferential statistics were exploratory (hypotheses generating), not confirmatory, and were interpreted accordingly; i.e. p values are interpreted as a metric weight of evidence against the respective null hypothesis of no effect/ no difference. No adjustment for multiple testing was performed.
    Comparison groups
    Week 0 v Week 24
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009 [2]
    Method
    		 t-test for paired data
    Confidence interval
    Notes
    [2] - The inferential analyses were carried out by means of student’s t-tests for paired data.
    Statistical analysis title
    		 RCLASI activity score skin lesions - week 0 vs 28
    Statistical analysis description
    As this study was an exploratory study, all inferential statistics were exploratory (hypotheses generating), not confirmatory, and were interpreted accordingly; i.e. p values are interpreted as a metric weight of evidence against the respective null hypothesis of no effect/ no difference. No adjustment for multiple testing was performed.
    Comparison groups
    Week 0 v Week 28
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01 [3]
    Method
    		 t-test for paired data
    Confidence interval
    Notes
    [3] - The inferential analyses were carried out by means of student’s t-tests for paired data.

    Secondary: RCLASI activity score total

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    End point title
    		 RCLASI activity score total
    End point description
    Efficacy of fumaric acid ester on disease severity as evaluated by total RCLASI activity score.
    End point type
    Secondary
    End point timeframe
    Week 0, 12, 24 and 28
    End point values
    		 Week 0 Week 12 Week 24 Week 28
    Number of subjects analysed
    11
    9
    11
    11
    Units: Activity score
        arithmetic mean (standard deviation)
    15.5 ± 5.3
    9.9 ± 4.9
    10.1 ± 6.6
    10.5 ± 4.6
    Statistical analysis title
    		 RCLASI activity score total - week 0 vs week 12
    Statistical analysis description
    As this study was an exploratory study, all inferential statistics were exploratory (hypotheses generating), not confirmatory, and were interpreted accordingly; i.e. p values are interpreted as a metric weight of evidence against the respective null hypothesis of no effect/ no difference. No adjustment for multiple testing was performed.
    Comparison groups
    Week 0 v Week 12
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002 [4]
    Method
    		 t-test for paired data
    Confidence interval
    Notes
    [4] - The inferential analyses were carried out by means of student’s t-tests for paired data.
    Statistical analysis title
    		 RCLASI activity score total - week 0 vs week 24
    Statistical analysis description
    As this study was an exploratory study, all inferential statistics were exploratory (hypotheses generating), not confirmatory, and were interpreted accordingly; i.e. p values are interpreted as a metric weight of evidence against the respective null hypothesis of no effect/ no difference. No adjustment for multiple testing was performed.
    Comparison groups
    Week 0 v Week 24
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009 [5]
    Method
    		 t-test for paired data
    Confidence interval
    Notes
    [5] - The inferential analyses were carried out by means of student’s t-tests for paired data.
    Statistical analysis title
    		 RCLASI activity score total - week 0 vs week 28
    Statistical analysis description
    As this study was an exploratory study, all inferential statistics were exploratory (hypotheses generating), not confirmatory, and were interpreted accordingly; i.e. p values are interpreted as a metric weight of evidence against the respective null hypothesis of no effect/ no difference. No adjustment for multiple testing was performed.
    Comparison groups
    Week 0 v Week 28
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01 [6]
    Method
    		 t-test for paired data
    Confidence interval
    Notes
    [6] - The inferential analyses were carried out by means of student’s t-tests for paired data.

    Secondary: RCLASI damage score total

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    End point title
    		 RCLASI damage score total
    End point description
    Efficacy of fumaric acid ester on disease severity as evaluated by total RCLASI damage score.
    End point type
    Secondary
    End point timeframe
    Week 0, 12, 24 and 28
    End point values
    		 Week 0 Week 12 Week 24 Week 28
    Number of subjects analysed
    11
    9
    11
    11
    Units: Activity score
        arithmetic mean (standard deviation)
    5.7 ± 2.9
    4.4 ± 1.7
    4.9 ± 3.6
    4.2 ± 3.7
    Statistical analysis title
    		 RCLASI damage score total - week 0 vs week 12
    Statistical analysis description
    As this study was an exploratory study, all inferential statistics were exploratory (hypotheses generating), not confirmatory, and were interpreted accordingly; i.e. p values are interpreted as a metric weight of evidence against the respective null hypothesis of no effect/ no difference. No adjustment for multiple testing was performed.
    Comparison groups
    Week 0 v Week 12
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3 [7]
    Method
    		 t-test for paired data
    Confidence interval
    Notes
    [7] - The inferential analyses were carried out by means of student’s t-tests for paired data.
    Statistical analysis title
    		 RCLASI damage score total - week 0 vs week 24
    Statistical analysis description
    As this study was an exploratory study, all inferential statistics were exploratory (hypotheses generating), not confirmatory, and were interpreted accordingly; i.e. p values are interpreted as a metric weight of evidence against the respective null hypothesis of no effect/ no difference. No adjustment for multiple testing was performed.
    Comparison groups
    Week 0 v Week 24
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3 [8]
    Method
    		 t-test for paired data
    Confidence interval
    Notes
    [8] - The inferential analyses were carried out by means of student’s t-tests for paired data.
    Statistical analysis title
    		 RCLASI damage score total - week 0 vs week 28
    Statistical analysis description
    As this study was an exploratory study, all inferential statistics were exploratory (hypotheses generating), not confirmatory, and were interpreted accordingly; i.e. p values are interpreted as a metric weight of evidence against the respective null hypothesis of no effect/ no difference. No adjustment for multiple testing was performed.
    Comparison groups
    Week 0 v Week 28
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.07 [9]
    Method
    		 t-test for paired data
    Confidence interval
    Notes
    [9] - The inferential analyses were carried out by means of student’s t-tests for paired data.

    Secondary: VAS score for itch

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    End point title
    		 VAS score for itch
    End point description
    Efficacy of fumaric acid ester on disease severity as evaluated by patient assessment score VAS (Visual Analogue Scale) for itch.
    End point type
    Secondary
    End point timeframe
    Week 0, 12 and 24
    End point values
    		 Week 0 Week 12 Week 24
    Number of subjects analysed
    10
    9
    11
    Units: VAS score
        arithmetic mean (standard deviation)
    5.0 ± 3.2
    2.1 ± 1.8
    3.3 ± 2.7
    Statistical analysis title
    		 VAS score for itch - week 0 vs week 12
    Statistical analysis description
    As this study was an exploratory study, all inferential statistics were exploratory (hypotheses generating), not confirmatory, and were interpreted accordingly; i.e. p values are interpreted as a metric weight of evidence against the respective null hypothesis of no effect/ no difference. No adjustment for multiple testing was performed.
    Comparison groups
    Week 0 v Week 12
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.03 [10]
    Method
    		 t-test for paired data
    Confidence interval
    Notes
    [10] - The inferential analyses were carried out by means of student’s t-tests for paired data.
    Statistical analysis title
    		 VAS score for itch - week 0 vs week 24
    Statistical analysis description
    As this study was an exploratory study, all inferential statistics were exploratory (hypotheses generating), not confirmatory, and were interpreted accordingly; i.e. p values are interpreted as a metric weight of evidence against the respective null hypothesis of no effect/ no difference. No adjustment for multiple testing was performed.
    Comparison groups
    Week 0 v Week 24
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.06 [11]
    Method
    		 t-test for paired data
    Confidence interval
    Notes
    [11] - The inferential analyses were carried out by means of student’s t-tests for paired data.

    Secondary: VAS score for pain

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    End point title
    		 VAS score for pain
    End point description
    Efficacy of fumaric acid ester on disease severity as evaluated by patient assessment score VAS for pain.
    End point type
    Secondary
    End point timeframe
    Week 0, 12 and 24
    End point values
    		 Week 0 Week 12 Week 24
    Number of subjects analysed
    10
    9
    11
    Units: VAS score
        arithmetic mean (standard deviation)
    3.4 ± 3.4
    2.0 ± 2.7
    2.4 ± 2.2
    Statistical analysis title
    		 VAS score for pain - week 0 vs week 12
    Statistical analysis description
    As this study was an exploratory study, all inferential statistics were exploratory (hypotheses generating), not confirmatory, and were interpreted accordingly; i.e. p values are interpreted as a metric weight of evidence against the respective null hypothesis of no effect/ no difference. No adjustment for multiple testing was performed.
    Comparison groups
    Week 0 v Week 12
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.05
    Method
    		 t-test for paired data
    Confidence interval
    Statistical analysis title
    		 VAS score for pain - week 0 vs week 24
    Statistical analysis description
    As this study was an exploratory study, all inferential statistics were exploratory (hypotheses generating), not confirmatory, and were interpreted accordingly; i.e. p values are interpreted as a metric weight of evidence against the respective null hypothesis of no effect/ no difference. No adjustment for multiple testing was performed.
    Comparison groups
    Week 0 v Week 24
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4
    Method
    		 t-test for paired data
    Confidence interval

    Secondary: PAGI Score

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    End point title
    		 PAGI Score
    End point description
    Efficacy of fumaric acid ester on disease severity as evaluated by patient assessment score PAGI (Patient Assessment of Global Improvement).
    End point type
    Secondary
    End point timeframe
    Week 0, 12 and 24
    End point values
    		 Week 0 Week 12 Week 24
    Number of subjects analysed
    11
    9
    10
    Units: PAGI score
        arithmetic mean (standard deviation)
    -0.6 ± 0.7
    1.4 ± 0.7
    1.3 ± 0.8
    Statistical analysis title
    		 PAGI score - week 0 vs week 12
    Statistical analysis description
    As this study was an exploratory study, all inferential statistics were exploratory (hypotheses generating), not confirmatory, and were interpreted accordingly; i.e. p values are interpreted as a metric weight of evidence against the respective null hypothesis of no effect/ no difference. No adjustment for multiple testing was performed.
    Comparison groups
    Week 0 v Week 12
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0003 [12]
    Method
    		 t-test for paired data
    Confidence interval
    Notes
    [12] - The inferential analyses were carried out by means of student’s t-tests for paired data.
    Statistical analysis title
    		 PAGI score - week 0 vs week 24
    Statistical analysis description
    As this study was an exploratory study, all inferential statistics were exploratory (hypotheses generating), not confirmatory, and were interpreted accordingly; i.e. p values are interpreted as a metric weight of evidence against the respective null hypothesis of no effect/ no difference. No adjustment for multiple testing was performed.
    Comparison groups
    Week 0 v Week 24
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0007 [13]
    Method
    		 t-test for paired data
    Confidence interval
    Notes
    [13] - The inferential analyses were carried out by means of student’s t-tests for paired data.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were recorded from the time of informed consent until the final study visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Safety group
    Reporting group description
    		 Patients who received at least one dose of fumaric acid ester (Fumaderm®).

    Serious adverse events
    		 Safety group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 11 (18.18%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    General disorders and administration site conditions
    Medical device pain
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Safety group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 11 (100.00%)
    Investigations
    Transaminases increased
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Vascular disorders
    Flushing
         subjects affected / exposed
    4 / 11 (36.36%)
         occurrences all number
    5
    Hypertension
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences all number
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    3 / 11 (27.27%)
         occurrences all number
    6
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    5 / 11 (45.45%)
         occurrences all number
    7
    Abdominal pain upper
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    2
    Diarrhoea
         subjects affected / exposed
    4 / 11 (36.36%)
         occurrences all number
    8
    Flatulence
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Gastrointestinal pain
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    2
    Nausea
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Psoriasis
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Rash papular
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Skin exfoliation
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Infections and infestations
    Bronchitis bacterial
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Ear infection
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences all number
    2
    Erysipelas
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Gastrointestinal infection
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Helicobacter infection
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    4 / 11 (36.36%)
         occurrences all number
    4
    Sinusitis
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences all number
    2
    Tonsillitis
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 11 (9.09%)
         occurrences all number
    1

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27147621
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