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    Clinical Trial Results:
    A Clinical Study of Immune Globulin Subcutaneous (Human) (IGSC), 20% for the Evaluation of Efficacy, Safety, and Pharmacokinetics in Subjects with Primary Immunodeficiency Diseases

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    2010-019459-23
    Trial protocol
    DE   AT   GB   HU   SE   NL   BE  
    Global end of trial date
    13 May 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    13 Feb 2016
    First version publication date
    13 Feb 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    170903
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Baxalta Innovations GmbH
    Sponsor organisation address
    Industriestrasse 67, Vienna, Austria, 1221
    Public contact
    Clinical Trials Registries and Results Disclosure, Baxalta Innovations GmbH, ClinicalTrialsDisclosure@baxalta.com
    Scientific contact
    Clinical Trials Registries and Results Disclosure, Baxalta Innovations GmbH, ClinicalTrialsDisclosure@baxalta.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
    13 May 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 May 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    13 May 2014
    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 efficacy of Immune Globulin Subcutaneous (Human) (IGSC), 20% in subjects with PID.
    Protection of trial subjects
    This study was conducted in accordance with the standards of Good Clinical Practice (GCP) in effect at the time of the study. The study was conducted in accordance with the principles and guidelines described in the study protocol.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    20 Jun 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 14
    Country: Number of subjects enrolled
    Austria: 1
    Country: Number of subjects enrolled
    Sweden: 3
    Country: Number of subjects enrolled
    Netherlands: 2
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Hungary: 22
    Worldwide total number of subjects
    49
    EEA total number of subjects
    49
    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)
    13
    Adolescents (12-17 years)
    12
    Adults (18-64 years)
    21
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Recruitment was conducted in Europe at 16 sites.

    Pre-assignment
    Screening details
    A total of 55 subjects provided informed consent and were screened for study participation, of which there were 6 screen failures. 49 subjects started in Epoch 1.

    Pre-assignment period milestones
    Number of subjects started
    55 [1]
    Number of subjects completed
    49

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Screen Failure: 6
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 55 subjects provided informed consent and were screened for study participation, of which there were 6 screen failures. 49 subjects started in Epoch 1.
    Period 1
    Period 1 title
    Epoch 1
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    IGIV
    Arm description
    Subjects treated with IGIV 10%.
    Arm type
    Experimental

    Investigational medicinal product name
    KIOVIG (IGIV, 10%)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    once every 3 or 4 weeks, dose as during pre-study period (300 mg/kg – 1.0 g/kg body weight [BW]/4 weeks)

    Arm title
    IGSC
    Arm description
    Subjects treated with SUBCUVIA.
    Arm type
    Experimental

    Investigational medicinal product name
    SUBCUVIA (IGSC, 16%)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    once every week or once every two weeks, dose as during pre-study period (300 mg/kg – 1.0 g/kg BW/4 weeks)

    Number of subjects in period 1
    IGIV IGSC
    Started
    33
    16
    Completed
    32
    16
    Not completed
    1
    0
         Pregnancy
    1
    -
    Period 2
    Period 2 title
    Epoch 2
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    IGSC 20%
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Immune Globulin Subcutaneous (Human) (IGSC), 20%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    every week, at the same dose as used during Study Epoch 1, to be calculated on the basis of weekly equivalents (300 mg/kg – 1.0 g/kg BW/4 weeks)

    Number of subjects in period 2
    IGSC 20%
    Started
    48
    Completed
    45
    Not completed
    3
         Consent withdrawn by subject
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Epoch 1
    Reporting group description
    Epoch 1

    Reporting group values
    Epoch 1 Total
    Number of subjects
    49 49
    Age categorical
    Units: Subjects
        From 65-84 years
    3 3
        Adults (18-64 years)
    21 21
        Adolescents (12-17 years)
    12 12
        Children (2-11 years)
    13 13
    Gender categorical
    Units:
        Female
    19 19
        Male
    30 30

    End points

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    End points reporting groups
    Reporting group title
    IGIV
    Reporting group description
    Subjects treated with IGIV 10%.

    Reporting group title
    IGSC
    Reporting group description
    Subjects treated with SUBCUVIA.
    Reporting group title
    IGSC 20%
    Reporting group description
    -

    Subject analysis set title
    Safety Analysis Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects treated with any Study Drug

    Subject analysis set title
    SC 1 Week
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects treated with Subcuvia at one-week intervals

    Subject analysis set title
    SC 2 Weeks
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects treated with Subcuvia at two-week intervals

    Subject analysis set title
    IV 3 Weeks
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects treated with Kiovig at three-week intervals

    Subject analysis set title
    IV 4 Weeks
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects treated with Kiovig at four-week intervals

    Subject analysis set title
    SC 20% 1 Week
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects treated with Immune Globulin Subcutaneous (Human) (IGSC), 20% at one-week intervals

    Primary: Validated Acute Serious Bacterial Infections (VASBIs)

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    End point title
    Validated Acute Serious Bacterial Infections (VASBIs) [1]
    End point description
    The primary endpoint is the acute serious bacterial infection rate defined as the mean number of acute serious bacterial infections per subject per year in the intent-to-treat population. Acute serious bacterial infections will include bacteremia / sepsis, bacterial meningitis, osteomyelitis / septic arthritis, bacterial pneumonia, and visceral abscess diagnosed according to the Diagnostic Criteria for Serious Acute Bacterial Infections. The analysis was conducted on subjects in the Safety Analysis Dataset.
    End point type
    Primary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    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: Statistical analysis could not be specified since there is only one arm comparison group.
    End point values
    IGIV IGSC 20% IGSC
    Number of subjects analysed
    33
    48
    16
    Units: Point estimate for rate of VASBIs/year
        number (not applicable)
    0
    0.022
    0.27
    No statistical analyses for this end point

    Secondary: Trough levels of IgG at the end of the treatment interval

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    End point title
    Trough levels of IgG at the end of the treatment interval
    End point description
    The analysis of IgG Total was conducted on subjects in the Safety Analysis Dataset.
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    SC 1 Week SC 2 Weeks IV 4 Weeks SC 20% 1 Week
    Number of subjects analysed
    14
    2
    11
    40
    Units: g/L
        median (full range (min-max))
    9.53 (5.41 to 12.28)
    8.98 (8.77 to 9.19)
    7.52 (5.25 to 12.75)
    8.26 (4.27 to 15.87)
    No statistical analyses for this end point

    Secondary: Trough level of Anti-Tetanus Antibody

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    End point title
    Trough level of Anti-Tetanus Antibody
    End point description
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    Safety Analysis Set
    Number of subjects analysed
    Units: IU/mL
    median (full range (min-max))
        IV 3 Weeks - Epoch 1 Infusion 4 (n=4)
    1.88 (1.1 to 2.71)
        IV 3 Weeks - Epoch 1 Infusion 5 (n=5)
    1.52 (1.11 to 2.75)
        IV 4 Weeks - Epoch 1 Infusion 3 (n=27)
    1.6 (0.73 to 5.85)
        IV 4 Weeks - Epoch 1 Infusion 4 (n=27)
    1.62 (0.91 to 6.57)
        SC 1 Week - Epoch 1 Infusion 12 (n=13)
    2.38 (1.31 to 3.81)
        SC 1 Week - Epoch 2 Infusion 1 (n=11)
    2.66 (1.44 to 8.3)
        SC 2 Weeks - Epoch 1 Infusion 6 (n=2)
    2.72 (2.49 to 2.94)
        SC 2 Weeks - Epoch 2 Infusion 1 (n=1)
    4.31 (4.31 to 4.31)
        SC 20% 1 Week - Epoch 2 Infusion 21 (n=43)
    2.91 (1.16 to 8.3)
        SC 20% 1 Week - Epoch 2 Infusion 27 (n=42)
    2.78 (0.22 to 7.35)
    No statistical analyses for this end point

    Secondary: Trough level of Hepatitis B Antibody

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    End point title
    Trough level of Hepatitis B Antibody
    End point description
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    Safety Analysis Set
    Number of subjects analysed
    Units: mIU/mL
    median (full range (min-max))
        IV 3 Weeks - Epoch 1 Infusion 4 (n=5)
    339 (222 to 906)
        IV 3 Weeks - Epoch 1 Infusion 5 (n=4)
    511.5 (299 to 1000)
        IV 4 Weeks - Epoch 1 Infusion 3 (n=27)
    335 (170 to 740)
        IV 4 Weeks - Epoch 1 Infusion 4 (n=27)
    327 (161 to 657)
        SC 1 Week - Epoch 1 Infusion 12 (n=13)
    264 (112 to 478)
        SC 1 Week - Epoch 2 Infusion 1 (n=12)
    230 (115 to 483)
        SC 2 Weeks - Epoch 1 Infusion 6 (n=2)
    337.5 (331 to 344)
        SC 2 Weeks - Epoch 2 Infusion 1 (n=1)
    315 (315 to 315)
        SC 20% 1 Week - Epoch 2 Infusion 21 (n=43)
    244 (120 to 446)
        SC 20% 1 Week - Epoch 2 Infusion 27 (n=42)
    230 (120 to 438)
    No statistical analyses for this end point

    Secondary: Trough level of Haemophilus Influenzae Antibody

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    End point title
    Trough level of Haemophilus Influenzae Antibody
    End point description
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    Safety Analysis Set
    Number of subjects analysed
    Units: mg/L
    median (full range (min-max))
        IV 3 Weeks - Epoch 1 Infusion 4 (n=5)
    2.56 (1.19 to 2.89)
        IV 3 Weeks - Epoch 1 Infusion 5 (n=5)
    2.73 (1.11 to 2.8)
        IV 4 Weeks - Epoch 1 Infusion 3 (n=27)
    1.93 (1.09 to 4.2)
        IV 4 Weeks - Epoch 1 Infusion 4 (n=27)
    1.76 (1.23 to 3.94)
        SC 1 Week - Epoch 1 Infusion 12 (n=13)
    2.94 (1.62 to 10.84)
        SC 1 Week - Epoch 2 Infusion 1 (n=11)
    3.02 (1.64 to 10.35)
        SC 2 Weeks - Epoch 1 Infusion 6 (n=2)
    3.41 (2.74 to 4.07)
        SC 2 Weeks - Epoch 2 Infusion 1 (n=1)
    4.01 (4.01 to 4.01)
        SC 20 % 1 Week - Epoch 2 Infusion 21 (n=43)
    2.08 (1.27 to 6.85)
        SC 20 % 1 Week - Epoch 2 Infusion 27 (n=41)
    2.04 (0.97 to 7.16)
    No statistical analyses for this end point

    Secondary: Area under the curve (AUC) for IgG total by treatment

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    End point title
    Area under the curve (AUC) for IgG total by treatment
    End point description
    Assessments were performed in subjects 12 years and older. The analysis was conducted on subjects in the Safety Analysis Dataset.
    End point type
    Secondary
    End point timeframe
    Epoch 1: between infusion 3 and infusion 4 for subjects under IGIV, 10% and between infusion 12 of epoch 1 and infusion 1 of IGSC, 20% for subjects under IGSC, 16%. Epoch 2: between infusion 21 and infusion 22 of IGSC, 20%.
    End point values
    SC 1 Week SC 2 Weeks IV 3 Weeks IV 4 Weeks SC 20% 1 Week
    Number of subjects analysed
    2
    2
    3
    22
    2
    Units: g*days/L
        median (full range (min-max))
    68.4 (27.66 to 86.99)
    132.68 (113.52 to 151.85)
    252.1 (177.47 to 335.46)
    278.94 (168.63 to 393.35)
    62.52 (37.51 to 137.32)
    No statistical analyses for this end point

    Secondary: Clearance (for intravenous) and apparant clearance (for subcutaneous) for IgG total by treatment

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    End point title
    Clearance (for intravenous) and apparant clearance (for subcutaneous) for IgG total by treatment
    End point description
    Assessments were performed in subjects 12 years and older. The analysis was conducted on subjects in the Safety Analysis Dataset.
    End point type
    Secondary
    End point timeframe
    Epoch 1: between infusion 3 and infusion 4 for subjects under IGIV, 10% and between infusion 12 of epoch 1 and infusion 1 of IGSC, 20% for subjects under IGSC, 16%. Epoch 2: between infusion 21 and infusion 22 of IGSC, 20%.
    End point values
    SC 1 Week SC 2 Weeks IV 3 Weeks IV 4 Weeks SC 20% 1 Week
    Number of subjects analysed
    12
    2
    3
    16
    31
    Units: mL/kg/days
        median (full range (min-max))
    1.62 (1.37 to 3.47)
    1.62 (1.54 to 1.7)
    1.05 (0.97 to 1.97)
    1.42 (1.04 to 2.39)
    1.7 (1.12 to 3.24)
    No statistical analyses for this end point

    Secondary: Maximum concentration (Cmax) and minimum concentration (Cmin) for IgG total by treatment

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    End point title
    Maximum concentration (Cmax) and minimum concentration (Cmin) for IgG total by treatment
    End point description
    Assessments were performed in subjects 12 years and older. The analysis was conducted on subjects in the Safety Analysis Dataset.
    End point type
    Secondary
    End point timeframe
    Epoch 1: between infusion 3 and infusion 4 for subjects under IGIV, 10% and between infusion 12 of epoch 1 and infusion 1 of IGSC, 20% for subjects under IGSC, 16%. Epoch 2: between infusion 21 and infusion 22 of IGSC, 20%.
    End point values
    SC 1 Week SC 2 Weeks IV 3 Weeks IV 4 Weeks SC 20% 1 Week
    Number of subjects analysed
    12
    2
    3
    16
    31
    Units: g/L
    median (full range (min-max))
        Cmax
    10.9 (4.42 to 13.18)
    10.17 (8.42 to 11.92)
    15.17 (14.78 to 20.47)
    15.37 (11.7 to 21.24)
    9.8 (5.9 to 20.69)
        Cmin
    8.77 (3.37 to 11.89)
    8.76 (7.42 to 10.09)
    10.5 (6.26 to 12.98)
    6.59 (4.27 to 11.66)
    8.04 (4.42 to 16.33)
    No statistical analyses for this end point

    Secondary: Time to maximum concentration (Tmax) for IgG total by treatment

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    End point title
    Time to maximum concentration (Tmax) for IgG total by treatment
    End point description
    Assessments were performed in subjects 12 years and older. The analysis was conducted on subjects in the Safety Analysis Dataset.
    End point type
    Secondary
    End point timeframe
    Epoch 1: between infusion 3 and infusion 4 for subjects under IGIV, 10% and between infusion 12 of epoch 1 and infusion 1 of IGSC, 20% for subjects under IGSC, 16%. Epoch 2: between infusion 21 and infusion 22 of IGSC, 20%.
    End point values
    SC 1 Week SC 2 Weeks IV 3 Weeks IV 4 Weeks SC 20% 1 Week
    Number of subjects analysed
    12
    2
    3
    16
    31
    Units: hours
        median (full range (min-max))
    25.05 (22.98 to 170.85)
    167.38 (121.75 to 213)
    24.33 (23.83 to 27.8)
    4.58 (1.97 to 101.83)
    73.92 (19.78 to 192.33)
    No statistical analyses for this end point

    Secondary: Annual rate of infections per subject (all infections; sinus infections)

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    End point title
    Annual rate of infections per subject (all infections; sinus infections)
    End point description
    Rate = Number of infections divided by the total number of subject-years under treatment
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    Safety Analysis Set
    Number of subjects analysed
    49
    Units: Rate
    number (not applicable)
        IV - All infections
    6.29
        IV - Sinus bacterial
    0.59
        IV - Sinusitis
    0.12
        SC - All infections
    8.92
        SC - Acute sinusitis
    0.54
        SC 20% - All infections
    4.38
        SC 20% - Sinusitis
    0.15
        SC 20% - Acute sinusitis
    0.09
        SC 20% - Chronic sinusitis
    0.02
        SC 20% - Sinusitis bacterial
    0.02
    No statistical analyses for this end point

    Secondary: Annual rate of fever episodes per subject

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    End point title
    Annual rate of fever episodes per subject
    End point description
    The analysis was conducted on subjects in the Safety Analysis Dataset.
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    IGIV IGSC 20% IGSC
    Number of subjects analysed
    33
    48
    16
    Units: Rate
        number (not applicable)
    0.95
    0.88
    2.16
    No statistical analyses for this end point

    Secondary: Days off school or work

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    End point title
    Days off school or work
    End point description
    The analysis was conducted on subjects in the Safety Analysis Dataset.
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    IGIV IGSC 20% IGSC
    Number of subjects analysed
    33
    48
    16
    Units: Days
    90
    710
    187
    No statistical analyses for this end point

    Secondary: Days on antibiotics

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    End point title
    Days on antibiotics
    End point description
    The analysis was conducted on subjects in the Safety Analysis Dataset.
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    IGIV IGSC 20% IGSC
    Number of subjects analysed
    33
    48
    16
    Units: Days
    165
    827
    201
    No statistical analyses for this end point

    Secondary: Number of hospitalizations

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    End point title
    Number of hospitalizations
    End point description
    The analysis was conducted on subjects in the Safety Analysis Dataset.
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    IGIV IGSC 20% IGSC
    Number of subjects analysed
    33
    48
    16
    Units: Days
    1
    7
    2
    No statistical analyses for this end point

    Secondary: Length of stay in hospital (in days)

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    End point title
    Length of stay in hospital (in days)
    End point description
    The analysis was conducted on subjects in the Safety Analysis Dataset.
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    IGIV IGSC 20% IGSC
    Number of subjects analysed
    33
    48
    16
    Units: Days
    1
    76
    9
    No statistical analyses for this end point

    Secondary: Number of acute physician visits

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    End point title
    Number of acute physician visits
    End point description
    The analysis was conducted on subjects in the Safety Analysis Dataset.
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    IGIV IGSC 20% IGSC
    Number of subjects analysed
    33
    48
    16
    Units: Number of visits
    43
    172
    28
    No statistical analyses for this end point

    Secondary: Number of related AEs (including and excluding infections) divided by the number of subjects

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    End point title
    Number of related AEs (including and excluding infections) divided by the number of subjects
    End point description
    The analysis was conducted on subjects in the Safety Analysis Dataset.
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    IGIV IGSC 20% IGSC
    Number of subjects analysed
    33
    48
    16
    Units: Percent
    number (not applicable)
        Including infections
    21.2
    41.7
    31.3
        Excluding infections
    21.2
    41.7
    31.3
    No statistical analyses for this end point

    Secondary: Number of related AEs (including and excluding infections) divided by the number of infusions

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    End point title
    Number of related AEs (including and excluding infections) divided by the number of infusions
    End point description
    The analysis was conducted on subjects in the Safety Analysis Dataset.
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    IGIV IGSC 20% IGSC
    Number of subjects analysed
    33
    48
    16
    Units: Percent
    number (not applicable)
        Including infections
    12.2
    7.8
    5
        Excluding infections
    12.2
    7.8
    5
    No statistical analyses for this end point

    Secondary: Annual rate of SAEs, related and not related

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    End point title
    Annual rate of SAEs, related and not related
    End point description
    Rate per year = number of AEs divided by the total number of subject-years under treatment. The analysis was conducted on subjects in the Safety Analysis Dataset.
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    IGIV IGSC 20% IGSC
    Number of subjects analysed
    33
    48
    16
    Units: Rate per year
    number (not applicable)
        Unrelated
    0.24
    0.18
    0.54
        Related
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Rates of AEs (including and excluding infections) defined as number of AEs under IGIV treatment divided by the number of subjects

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    End point title
    Rates of AEs (including and excluding infections) defined as number of AEs under IGIV treatment divided by the number of subjects
    End point description
    Note: Abbreviations: incl. inf. = including infections; excl. inf. = excluding infections
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    Safety Analysis Set
    Number of subjects analysed
    33
    Units: Rate per Subject
    number (not applicable)
        Local AEs - Non-serious - Mild
    0.121
        Systemic AEs incl. inf. - Non-serious - Mild
    3.606
        Systemic AEs incl. inf. - Non-serious - Moderate
    0.879
        Systemic AEs incl. inf. - Serious - Moderate
    0.061
        Systemic AEs excl. inf. - Non-serious - Mild
    2.455
        Systemic AEs excl. inf. - Non-serious - Moderate
    0.424
        Systemic AEs excl. inf. - Serious - Moderate
    0.061
    No statistical analyses for this end point

    Secondary: Rates of AEs (including and excluding infections) defined as number of AEs under IGSC treatment divided by the number of subjects

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    End point title
    Rates of AEs (including and excluding infections) defined as number of AEs under IGSC treatment divided by the number of subjects
    End point description
    Note: Abbreviations: incl. inf. = including infections; excl. inf. = excluding infections
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    Safety Analysis Set
    Number of subjects analysed
    16
    Units: Rate per subject
    number (not applicable)
        Local AEs - Non-serious - Mild
    0.125
        Systemic AEs incl. inf. - Non-serious - Mild
    3
        Systemic AEs incl. inf. - Non-serious - Moderate
    1.063
        Systemic AEs incl. inf. - Serious - Moderate
    0.125
        Systemic AEs excl. inf. - Non-serious - Mild
    1.438
        Systemic AEs excl. inf. - Non-serious - Moderate
    0.625
        Systemic AEs excl. inf. - Serious - Moderate
    0.063
    No statistical analyses for this end point

    Secondary: Rates of AEs (including and excluding infections) defined as number of AEs under IGSC 20% treatment divided by the number of subjects

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    End point title
    Rates of AEs (including and excluding infections) defined as number of AEs under IGSC 20% treatment divided by the number of subjects
    End point description
    Note: Abbreviations: incl. inf. = including infections; excl. inf. = excluding infections
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    Safety Analysis Set
    Number of subjects analysed
    48
    Units: Rate per subject
    number (not applicable)
        Local AEs - Non-serious - Mild
    3.667
        Local AEs - Non-serious - Moderate
    0.042
        Systemic AEs incl. inf. - Non-serious - Mild
    8.646
        Systemic AEs incl. inf. - Non-serious - Moderate
    2.604
        Systemic AEs incl. inf. - Serious - Mild
    0.021
        Systemic AEs incl. inf. - Serious - Moderate
    0.104
        Systemic AEs incl. inf. - Serious - Severe
    0.042
        Systemic AEs excl. inf. - Non-serious - Mild
    5.479
        Systemic AEs excl. inf. - Non-serious - Moderate
    1.708
        Systemic AEs excl. inf. - Non-serious - Severe
    0.042
        Systemic AEs excl. inf. - Serious - Mild
    0.021
        Systemic AEs excl. inf. - Serious - Moderate
    0.063
        Systemic AEs excl. inf. - Serious - Severe
    0.042
    No statistical analyses for this end point

    Secondary: Rates of AEs (including and excluding infections) defined as number of AEs under IGIV treatment divided by the number of infusions

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    End point title
    Rates of AEs (including and excluding infections) defined as number of AEs under IGIV treatment divided by the number of infusions
    End point description
    Note: Abbreviations: incl. inf. = including infections; excl. inf. = excluding infections
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    Safety Analysis Set
    Number of subjects analysed
    33
    Units: Rate per infusion
    number (not applicable)
        Local AEs - Non-serious - Mild
    0.029
        Systemic AEs incl. inf. - Non-serious - Mild
    0.856
        Systemic AEs incl. inf. - Non-serious - Moderate
    0.209
        Systemic AEs incl. inf. - Serious - Moderate
    0.014
        Systemic AEs excl. inf. - Non-serious - Mild
    0.583
        Systemic AEs excl. inf. - Non-serious - Moderate
    0.101
        Systemic AEs excl. inf. - Serious - Moderate
    0.014
    No statistical analyses for this end point

    Secondary: Rates of AEs (including and excluding infections) defined as number of AEs under IGSC treatment divided by the number of infusions

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    End point title
    Rates of AEs (including and excluding infections) defined as number of AEs under IGSC treatment divided by the number of infusions
    End point description
    Note: Abbreviations: incl. inf. = including infections; excl. inf. = excluding infections
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    Safety Analysis Set
    Number of subjects analysed
    16
    Units: Rate per infusion
    number (not applicable)
        Local AEs - Non-serious - Mild
    0.011
        Systemic AEs incl. inf. - Non-serious - Mild
    0.265
        Systemic AEs incl. inf. - Non-serious - Moderate
    0.094
        Systemic AEs incl. inf. - Serious - Moderate
    0.011
        Systemic AEs excl. inf. - Non-serious - Mild
    0.127
        Systemic AEs excl. inf. - Non-serious - Moderate
    0.055
        Systemic AEs excl. inf. - Serious - Moderate
    0.006
    No statistical analyses for this end point

    Secondary: Rates of AEs (including and excluding infections) defined as number of AEs under IGSC 20% treatment divided by the number of infusions

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    End point title
    Rates of AEs (including and excluding infections) defined as number of AEs under IGSC 20% treatment divided by the number of infusions
    End point description
    Note: Abbreviations: incl. inf. = including infections; excl. inf. = excluding infections. Rate per infusion for systemic AEs including infections - Serious - Mild: 0.001 entered instead of <0.001. Rate per infusion for systemic AEs excluding infections - Serious - Mild: 0.001 entered instead of <0.001.
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    Safety Analysis Set
    Number of subjects analysed
    48
    Units: Rate per infusion
    number (not applicable)
        Local AEs - Non-serious - Mild
    0.075
        Local AEs - Non-serious - Moderate
    0.001
        Systemic AEs incl. inf. - Non-serious - Mild
    0.177
        Systemic AEs incl. inf. - Non-serious - Moderate
    0.053
        Systemic AEs incl. inf. - Serious - Mild
    0.001
        Systemic AEs incl. inf. - Serious - Moderate
    0.002
        Systemic AEs incl. inf. - Serious - Severe
    0.001
        Systemic AEs excl. inf. - Non-serious - Mild
    0.112
        Systemic AEs excl. inf. - Non-serious - Moderate
    0.035
        Systemic AEs excl. inf. - Non-serious - Severe
    0.001
        Systemic AEs excl. inf. - Serious - Mild
    0.001
        Systemic AEs excl. inf. - Serious - Moderate
    0.001
        Systemic AEs excl. inf. - Serious - Severe
    0.001
    No statistical analyses for this end point

    Secondary: Proportion of infusions associated with one or more related non-serious AE (including and excluding infections)

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    End point title
    Proportion of infusions associated with one or more related non-serious AE (including and excluding infections)
    End point description
    The analysis was conducted on subjects in the Safety Analysis Dataset.
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    IGIV IGSC 20% IGSC
    Number of subjects analysed
    33
    48
    16
    Units: Proportion of infusions
    number (not applicable)
        Including infections
    12.2
    7.8
    5
        Excluding infections
    12.2
    7.8
    5
    No statistical analyses for this end point

    Secondary: Proportion of subjects reporting one or more related non-serious AE (including and excluding infections)

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    End point title
    Proportion of subjects reporting one or more related non-serious AE (including and excluding infections)
    End point description
    The analysis was conducted on subjects in the Safety Analysis Dataset.
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    IGIV IGSC 20% IGSC
    Number of subjects analysed
    33
    48
    16
    Units: Proportion of subjects
    number (not applicable)
        Including Infections
    21.2
    41.7
    31.3
        Excluding infection
    21.2
    41.7
    31.3
    No statistical analyses for this end point

    Secondary: Number of temporally associated AEs (including and excluding infections) divided by the number of subjects

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    End point title
    Number of temporally associated AEs (including and excluding infections) divided by the number of subjects
    End point description
    Temporally associated AEs are defined as AEs occurring during or within 72 hours of infusion completion. Rate per subject = total number of AEs divided by the total number of subjects under treatment. The analysis was conducted on subjects in the Safety Analysis Dataset.
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    IGIV IGSC 20% IGSC
    Number of subjects analysed
    33
    48
    16
    Units: Rate per subject
    number (not applicable)
        Including infections
    1.303
    9.458
    1.938
        Excluding infections
    1.212
    7.917
    1.25
    No statistical analyses for this end point

    Secondary: Number of temporally associated AEs (including and excluding infections) divided by the number of infusions

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    End point title
    Number of temporally associated AEs (including and excluding infections) divided by the number of infusions
    End point description
    Temporally associated AEs are defined as AEs occurring during or within 72 hours of infusion completion. Rate per infusion = total number of AEs divided by the total number of infusions under treatment. The analysis was conducted on subjects in the Safety Analysis Dataset.
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    IGIV IGSC 20% IGSC
    Number of subjects analysed
    33
    48
    16
    Units: Rate per infusion
    number (not applicable)
        Including infections
    0.309
    0.193
    0.171
        Excluding infections
    0.288
    0.162
    0.11
    No statistical analyses for this end point

    Secondary: Proportion of infusions for which the infusion rate was reduced and/or the infusion interrupted or stopped for tolerability concerns or for AEs

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    End point title
    Proportion of infusions for which the infusion rate was reduced and/or the infusion interrupted or stopped for tolerability concerns or for AEs
    End point description
    The analysis was conducted on subjects in the Safety Analysis Dataset.
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    IGIV IGSC 20% IGSC
    Number of subjects analysed
    33
    48
    16
    Units: Percentage of infusions
        number (not applicable)
    0.7
    0.2
    0
    No statistical analyses for this end point

    Secondary: Proportion of subjects for whom the infusion rate was reduced and/or the infusion interrupted or stopped for tolerability concerns or for AEs

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    End point title
    Proportion of subjects for whom the infusion rate was reduced and/or the infusion interrupted or stopped for tolerability concerns or for AEs
    End point description
    The analysis was conducted on subjects in the Safety Analysis Dataset.
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    IGIV IGSC 20% IGSC
    Number of subjects analysed
    33
    48
    16
    Units: Percentage of subjects
        number (not applicable)
    3
    4.2
    0
    No statistical analyses for this end point

    Secondary: Proportion of infusions tolerated

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    End point title
    Proportion of infusions tolerated
    End point description
    The analysis was conducted on subjects in the Safety Analysis Dataset.
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    IGIV IGSC 20% IGSC
    Number of subjects analysed
    33
    48
    16
    Units: Percentage of infusions
        number (not applicable)
    100
    100
    100
    No statistical analyses for this end point

    Secondary: Number of adults and adolescents who experienced potential hemolysis (a decline in hemoglobin of 2.0 g/dL or more)

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    End point title
    Number of adults and adolescents who experienced potential hemolysis (a decline in hemoglobin of 2.0 g/dL or more)
    End point description
    Adults and adolescent subjects in the study (36) were evaluated pre- and post infusion for hemolysis. Further testing was performed when there was a decline in hemoglobin of 2.0 g/dL or more. The analysis was conducted on subjects in the Safety Analysis Dataset. Note: Six subjects experienced a decline in hemoglobin of 2.0 g/dL or more. None of the incidences of a fall in hemoglobin was assessed to be due to a hemolytic reaction.
    End point type
    Secondary
    End point timeframe
    From first infusion until the end of the study, approximately 15 months per subject
    End point values
    Safety Analysis Set
    Number of subjects analysed
    36
    Units: Number of subjects
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the study period of 2 years and 11 months
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    IGIV
    Reporting group description
    Subjects treated with Kiovig

    Reporting group title
    IGSC 20%
    Reporting group description
    Subjects treated with Immune Globulin Subcutaneous (Human) (IGSC), 20%

    Reporting group title
    IGSC
    Reporting group description
    Subjects treated with Subcuvia

    Serious adverse events
    IGIV IGSC 20% IGSC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 33 (6.06%)
    6 / 48 (12.50%)
    2 / 16 (12.50%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Forearm fracture
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 48 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 48 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 48 (2.08%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 48 (2.08%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Nasal septum deviation
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 48 (2.08%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rhinorrhoea
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 48 (2.08%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 48 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Brain stem infarction
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 48 (2.08%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Enteritis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 48 (2.08%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia bacterial
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 48 (2.08%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 48 (2.08%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    IGIV IGSC 20% IGSC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 33 (78.79%)
    46 / 48 (95.83%)
    16 / 16 (100.00%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 48 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    2
    Investigations
    Body temperature increased
         subjects affected / exposed
    3 / 33 (9.09%)
    0 / 48 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    4
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 33 (9.09%)
    11 / 48 (22.92%)
    0 / 16 (0.00%)
         occurrences all number
    3
    18
    0
    Rhinorrhoea
         subjects affected / exposed
    3 / 33 (9.09%)
    2 / 48 (4.17%)
    0 / 16 (0.00%)
         occurrences all number
    4
    3
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 33 (0.00%)
    5 / 48 (10.42%)
    2 / 16 (12.50%)
         occurrences all number
    0
    6
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 33 (33.33%)
    15 / 48 (31.25%)
    5 / 16 (31.25%)
         occurrences all number
    33
    106
    11
    Migraine
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 48 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    1
    Restless legs syndrome
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 48 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 33 (9.09%)
    6 / 48 (12.50%)
    1 / 16 (6.25%)
         occurrences all number
    3
    8
    1
    Chills
         subjects affected / exposed
    2 / 33 (6.06%)
    1 / 48 (2.08%)
    0 / 16 (0.00%)
         occurrences all number
    2
    1
    0
    Influenza like illness
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 48 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Catheter site related reaction
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 48 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Infusion site pruritus
         subjects affected / exposed
    0 / 33 (0.00%)
    6 / 48 (12.50%)
    1 / 16 (6.25%)
         occurrences all number
    0
    29
    1
    Malaise
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 48 (4.17%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    1
    Infusion site erythema
         subjects affected / exposed
    0 / 33 (0.00%)
    9 / 48 (18.75%)
    0 / 16 (0.00%)
         occurrences all number
    0
    53
    0
    Infusion site swelling
         subjects affected / exposed
    0 / 33 (0.00%)
    4 / 48 (8.33%)
    0 / 16 (0.00%)
         occurrences all number
    0
    46
    0
    Infusion site pain
         subjects affected / exposed
    1 / 33 (3.03%)
    6 / 48 (12.50%)
    0 / 16 (0.00%)
         occurrences all number
    4
    12
    0
    Infusion site discomfort
         subjects affected / exposed
    0 / 33 (0.00%)
    3 / 48 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    11
    0
    Injection site pain
         subjects affected / exposed
    0 / 33 (0.00%)
    3 / 48 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    11
    0
    Pyrexia
         subjects affected / exposed
    0 / 33 (0.00%)
    4 / 48 (8.33%)
    0 / 16 (0.00%)
         occurrences all number
    0
    5
    0
    Gastrointestinal disorders
    Diarrhoe
         subjects affected / exposed
    6 / 33 (18.18%)
    12 / 48 (25.00%)
    1 / 16 (6.25%)
         occurrences all number
    7
    68
    1
    Nausea
         subjects affected / exposed
    3 / 33 (9.09%)
    3 / 48 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    3
    3
    1
    Vomiting
         subjects affected / exposed
    6 / 33 (18.18%)
    3 / 48 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    6
    4
    0
    Abdominal pain upper
         subjects affected / exposed
    2 / 33 (6.06%)
    3 / 48 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    2
    15
    2
    Toothache
         subjects affected / exposed
    2 / 33 (6.06%)
    1 / 48 (2.08%)
    0 / 16 (0.00%)
         occurrences all number
    2
    1
    0
    Enteritis
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 48 (2.08%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    2
    Abdominal pain
         subjects affected / exposed
    1 / 33 (3.03%)
    3 / 48 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    1
    5
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 48 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Urticaria
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 48 (2.08%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 33 (9.09%)
    3 / 48 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    5
    10
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 48 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    2
    Metabolism and nutrition disorders
    Vitamin D deficiency
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 48 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    5 / 33 (15.15%)
    7 / 48 (14.58%)
    0 / 16 (0.00%)
         occurrences all number
    7
    16
    0
    Viral rhinitis
         subjects affected / exposed
    4 / 33 (12.12%)
    3 / 48 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    5
    4
    0
    Sinusitis bacterial
         subjects affected / exposed
    2 / 33 (6.06%)
    1 / 48 (2.08%)
    0 / 16 (0.00%)
         occurrences all number
    5
    1
    0
    Bacterial rhinitis
         subjects affected / exposed
    2 / 33 (6.06%)
    0 / 48 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    4
    0
    0
    Viral infection
         subjects affected / exposed
    3 / 33 (9.09%)
    2 / 48 (4.17%)
    0 / 16 (0.00%)
         occurrences all number
    3
    2
    0
    Viral pharyngitis
         subjects affected / exposed
    2 / 33 (6.06%)
    5 / 48 (10.42%)
    0 / 16 (0.00%)
         occurrences all number
    3
    5
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 33 (6.06%)
    1 / 48 (2.08%)
    1 / 16 (6.25%)
         occurrences all number
    3
    1
    1
    Bronchitis
         subjects affected / exposed
    2 / 33 (6.06%)
    7 / 48 (14.58%)
    2 / 16 (12.50%)
         occurrences all number
    2
    14
    2
    Respiratory tract infection viral
         subjects affected / exposed
    2 / 33 (6.06%)
    3 / 48 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    2
    3
    2
    Rhinitis
         subjects affected / exposed
    2 / 33 (6.06%)
    11 / 48 (22.92%)
    0 / 16 (0.00%)
         occurrences all number
    2
    11
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 33 (6.06%)
    18 / 48 (37.50%)
    7 / 16 (43.75%)
         occurrences all number
    2
    46
    8
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 33 (3.03%)
    2 / 48 (4.17%)
    3 / 16 (18.75%)
         occurrences all number
    1
    4
    3
    Tinea pedis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 48 (2.08%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    3
    Conjunctivitis
         subjects affected / exposed
    1 / 33 (3.03%)
    4 / 48 (8.33%)
    1 / 16 (6.25%)
         occurrences all number
    2
    6
    2
    Acute sinusitis
         subjects affected / exposed
    0 / 33 (0.00%)
    3 / 48 (6.25%)
    2 / 16 (12.50%)
         occurrences all number
    0
    4
    2
    Oral herpes
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 48 (4.17%)
    2 / 16 (12.50%)
         occurrences all number
    0
    7
    2
    Enteritis infectious
         subjects affected / exposed
    1 / 33 (3.03%)
    5 / 48 (10.42%)
    1 / 16 (6.25%)
         occurrences all number
    2
    9
    1
    Influenza
         subjects affected / exposed
    0 / 33 (0.00%)
    2 / 48 (4.17%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    1
    Pharyngitis
         subjects affected / exposed
    1 / 33 (3.03%)
    6 / 48 (12.50%)
    1 / 16 (6.25%)
         occurrences all number
    1
    8
    1
    Otitis media
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 48 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Tonsillitis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 48 (2.08%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Vaginal infection
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 48 (2.08%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    1
    Viral tonsillitis
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 48 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Bronchitis bacterial
         subjects affected / exposed
    0 / 33 (0.00%)
    3 / 48 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    4
    0
    Sinusitis
         subjects affected / exposed
    1 / 33 (3.03%)
    5 / 48 (10.42%)
    0 / 16 (0.00%)
         occurrences all number
    1
    7
    0
    Ear infection
         subjects affected / exposed
    0 / 33 (0.00%)
    3 / 48 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    3
    0
    Otitis media acute
         subjects affected / exposed
    0 / 33 (0.00%)
    3 / 48 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    4
    0

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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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