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    Clinical Trial Results:
    A Phase 2a, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy, Safety and Tolerability of JNJ-67484703 in Participants with Atopic Dermatitis

    Summary
    EudraCT number
    		 2022-001528-14
    Trial protocol
    		 PL   DE  
    Global end of trial date
    14 May 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Jun 2025
    First version publication date
    19 Jun 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    67484703ADM2001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV
    Sponsor organisation address
    Turnhoutseweg 30, Beerse, Belgium, B-2340
    Public contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.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
    14 May 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 May 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this trial was to evaluate the efficacy of JNJ-67484703 in subjects with moderate to severe atopic dermatitis (AD).
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Feb 2023
    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
    Germany: 25
    Country: Number of subjects enrolled
    Poland: 16
    Country: Number of subjects enrolled
    Canada: 10
    Worldwide total number of subjects
    51
    EEA total number of subjects
    41
    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)
    50
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 51 subjects were enrolled, randomised (2:1 ratio) and treated either with JNJ-67484703 or placebo. Out of 51 subjects, 30 subjects completed the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A: Placebo
    Arm description
    		 Subjects received a single dose of placebo subcutaneous (SC) injection at Week 0 (Day 1), a loading dose at Week 1, followed by once every 2 weeks (Q2W) from Week 2 until Week 10. Subjects were then follow-up for safety up to 26 weeks after the administration of the last dose of study drug at Week 10.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo SC injection at Week 0 (Day 1), a loading dose at Week 1, followed by once Q2W from Week 2 until Week 10.

    Arm title
    		 Arm B: JNJ-67484703
    Arm description
    		 Subjects received a single dose of JNJ-67484703 3 milligrams per kilogram (mg/kg) SC injection at Week 0 (Day 1), a loading dose at Week 1, followed by once Q2W from Week 2 until Week 10. Subjects were then follow-up for safety up to 26 weeks after the administration of the last dose of study drug at Week 10.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-67484703
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received JNJ-67484703 3 mg/kg SC injection at Week 0 (Day 1), a loading dose at Week 1, followed by once Q2W from Week 2 until Week 10.

    Number of subjects in period 1
    		Arm A: Placebo Arm B: JNJ-67484703
    Started
    17
    34
    Completed
    9
    21
    Not completed
    8
    13
         Consent withdrawn by subject
    8
    10
         COVID-19 related
    -
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A: Placebo
    Reporting group description
    		 Subjects received a single dose of placebo subcutaneous (SC) injection at Week 0 (Day 1), a loading dose at Week 1, followed by once every 2 weeks (Q2W) from Week 2 until Week 10. Subjects were then follow-up for safety up to 26 weeks after the administration of the last dose of study drug at Week 10.

    Reporting group title
    Arm B: JNJ-67484703
    Reporting group description
    		 Subjects received a single dose of JNJ-67484703 3 milligrams per kilogram (mg/kg) SC injection at Week 0 (Day 1), a loading dose at Week 1, followed by once Q2W from Week 2 until Week 10. Subjects were then follow-up for safety up to 26 weeks after the administration of the last dose of study drug at Week 10.

    Reporting group values
    		 Arm A: Placebo Arm B: JNJ-67484703 Total
    Number of subjects
    		 17 34
    Age Categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35.5 ( 12.78 ) 35.2 ( 11.65 ) -
    Gender categorical
    Units: Subjects
        Male
    		 9 15 24
        Female
    		 8 19 27
    Race
    Units: Subjects
        Asian
    		 1 7 8
        White
    		 15 27 42
        Multiple
    		 1 0 1
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 17 34 51

    End points

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    End points reporting groups
    Reporting group title
    Arm A: Placebo
    Reporting group description
    		 Subjects received a single dose of placebo subcutaneous (SC) injection at Week 0 (Day 1), a loading dose at Week 1, followed by once every 2 weeks (Q2W) from Week 2 until Week 10. Subjects were then follow-up for safety up to 26 weeks after the administration of the last dose of study drug at Week 10.

    Reporting group title
    Arm B: JNJ-67484703
    Reporting group description
    		 Subjects received a single dose of JNJ-67484703 3 milligrams per kilogram (mg/kg) SC injection at Week 0 (Day 1), a loading dose at Week 1, followed by once Q2W from Week 2 until Week 10. Subjects were then follow-up for safety up to 26 weeks after the administration of the last dose of study drug at Week 10.

    Primary: Percentage of Subjects Who Achieved Eczema Area and Severity Index (EASI)-75 at Week 12

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    End point title
    		 Percentage of Subjects Who Achieved Eczema Area and Severity Index (EASI)-75 at Week 12
    End point description
    Percentage of subjects who achieved EASI-75 at Week 12 were reported. EASI-75 response was defined as at least 75 percent (%) improvement from baseline in EASI total score. The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration/papulation, excoriation and lichenification on 4 anatomic regions of the body: head or neck, trunk, upper and lower limbs. The total EASI score ranged from 0 (minimum) to 72 (maximum) points, with the higher scores indicated the worse severity of AD. Full analysis set (FAS) included all randomised subjects who had received at least 1 dose of study intervention and provided both baseline and at least 1 postbaseline data.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 Arm A: Placebo Arm B: JNJ-67484703
    Number of subjects analysed
    17
    32
    Units: Percentage of subjects
        number (not applicable)
    11.8
    25.0
    Statistical analysis title
    		 Statistical Analysis-1
    Comparison groups
    Arm B: JNJ-67484703 v Arm A: Placebo
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.459
    Method
    		 Fisher exact
    Parameter type
    		 Treatment difference
    Point estimate
    13.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -4.8
         upper limit
    		 31.2

    Secondary: Percentage of Subjects With Improvement (Reduction From Baseline) in Eczema Related Itch Numeric Rating Scale (NRS) Score of >=4 at Week 12 Among Subjects With a Baseline Itch Value >=4

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    End point title
    		 Percentage of Subjects With Improvement (Reduction From Baseline) in Eczema Related Itch Numeric Rating Scale (NRS) Score of >=4 at Week 12 Among Subjects With a Baseline Itch Value >=4
    End point description
    Percentage of subjects with improvement (reduction from baseline) in eczema-related itch NRS score of >=4 at Week 12 among subjects with a baseline itch value >=4 was reported. The eczema skin pain and Itch NRS is a 3-item patient-reported outcome that subjects used to rate the severity of their eczema-related skin pain and eczema related itch daily. Subjects were asked the following questions: please rate the severity of eczema-related itch at its worst in the past 24 hours. Each item was on a 0 to 10 NRS ranging from 0 "none" to 10 "worst possible”. Higher score indicated more severity. FAS included all randomised subjects who had received at least 1 dose of study intervention and provided both baseline and at least 1 postbaseline data.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Arm A: Placebo Arm B: JNJ-67484703
    Number of subjects analysed
    15
    26
    Units: Percentage of subjects
        number (not applicable)
    13.3
    11.5
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in Eczema Related Itch Score (item 2 on Eczema Skin Pain and Itch Numeric Rating Scale [ESPI NRS]) at Weeks 1, 4, and 6

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    End point title
    		 Percent Change from Baseline in Eczema Related Itch Score (item 2 on Eczema Skin Pain and Itch Numeric Rating Scale [ESPI NRS]) at Weeks 1, 4, and 6
    End point description
    The eczema skin pain and Itch NRS is a 3-item patient-reported outcome that subjects used to rate the severity of their eczema-related skin pain and eczema related itch daily. Subjects were asked the following questions: please rate the severity of eczema-related itch at its worst in the past 24 hours. Each item was on a 0 to 10 NRS ranging from 0 "none" to 10 "worst possible”. Higher score indicated more severity. FAS included all randomised subjects who had received at least 1 dose of study intervention and provided both baseline and at least 1 postbaseline data. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint and ‘n’: number of subjects evaluable at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 1, 4, and 6
    End point values
    		 Arm A: Placebo Arm B: JNJ-67484703
    Number of subjects analysed
    14
    27
    Units: Percent change
    arithmetic mean (standard deviation)
        Week 1 (n=13, 27)
    -4.21 ( 18.668 )
    3.84 ( 40.641 )
        Week 4 (n=14, 27)
    -4.84 ( 13.706 )
    -6.86 ( 49.608 )
        Week 6 (n=14, 27)
    -13.36 ( 28.879 )
    -11.43 ( 46.763 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 and a Reduction From Baseline of >=2 Points at Week 12

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    End point title
    		 Percentage of Subjects Who Achieved Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 and a Reduction From Baseline of >=2 Points at Week 12
    End point description
    Percentage of subjects who achieved vIGA-AD of 0 or 1 and a reduction from baseline of >=2 points at Week 12 were reported. It was an assessment instrument used in clinical studies to rate the severity of AD, based on a 5-point scale ranged from 0 to 4, where 0=Clear: No inflammatory signs of AD; 1=almost clear: Barely perceptible erythema, induration/papulation and/or lichenification. No oozing or crusting; 2=mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting; 3=moderate: Clearly perceptible erythema, induration/ papulation and/or lichenification, oozing or crusting may present, 4=severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present. Higher score indicated more severity of AD. FAS included all randomised subjects who had received at least 1 dose of study intervention and provide both baseline and at least 1 postbaseline data.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Arm A: Placebo Arm B: JNJ-67484703
    Number of subjects analysed
    17
    32
    Units: Percentage of subjects
        number (not applicable)
    5.9
    6.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved Eczema Area and Severity Index (EASI)-90 at Week 12

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    End point title
    		 Percentage of Subjects Who Achieved Eczema Area and Severity Index (EASI)-90 at Week 12
    End point description
    Percentage of subjects who achieved EASI-90 at Week 12 were reported. EASI-90 response was defined as at least 90% improvement from baseline in EASI total score. The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration/papulation, excoriation and lichenification on 4 anatomic regions of the body: head/neck, trunk, upper and lower limbs. The total EASI score ranged from 0 (minimum) to 72 (maximum) points, with the higher scores indicated the worse severity of AD. FAS included all randomised subjects who had received at least 1 dose of study intervention and provided both baseline and at least 1 postbaseline data.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Arm A: Placebo Arm B: JNJ-67484703
    Number of subjects analysed
    17
    32
    Units: Percentage of subjects
        number (not applicable)
    5.9
    9.4
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in Eczema Area and Severity Index (EASI) Score at Week 12

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    End point title
    		 Percent Change from Baseline in Eczema Area and Severity Index (EASI) Score at Week 12
    End point description
    Percent change from baseline in EASI scores in Week 12 were reported. The EASI evaluation was performed by the Principal Investigator. The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration/papulation, excoriation and lichenification on 4 anatomic regions of the body: head or neck, trunk, upper and lower limbs. The total EASI score ranged from 0 (minimum) to 72 (maximum) points, with the higher scores indicated the worse severity of AD. FAS included all randomised subjects who had received at least 1 dose of study intervention and provided both baseline and at least 1 postbaseline data. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Arm A: Placebo Arm B: JNJ-67484703
    Number of subjects analysed
    15
    30
    Units: Percent change
        arithmetic mean (standard deviation)
    -21.66 ( 42.777 )
    -42.31 ( 39.273 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Treatment-emergent Serious Adverse Events (TESAEs)

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    End point title
    		 Percentage of Subjects With Treatment-emergent Serious Adverse Events (TESAEs)
    End point description
    An AE was any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Serious adverse events (SAE) is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalisation or prolongation of existing hospitalisation, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize subject and/or may require medical or surgical intervention to prevent one of the outcomes listed above. TESAE were SAEs with onset after or on the date of the first dose of the study intervention or that were a consequence of a pre-existing condition that had worsened since baseline. The safety analysis set included all randomised subjects who had received at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to Week 36
    End point values
    		 Arm A: Placebo Arm B: JNJ-67484703
    Number of subjects analysed
    17
    34
    Units: Percentage of subjects
        number (not applicable)
    0
    2.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)

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    End point title
    		 Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)
    End point description
    An adverse event (AE) was any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. TEAE were AEs with onset after or on the date of the first dose of the study intervention or that were a consequence of a pre-existing condition that had worsened since baseline. The safety analysis set included all randomised subjects who had received at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to Week 36
    End point values
    		 Arm A: Placebo Arm B: JNJ-67484703
    Number of subjects analysed
    17
    34
    Units: Percentage of subjects
        number (not applicable)
    82.4
    88.2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Death: From screening (Week-5) to Week 36 (26 weeks after last dose at Week 10); SAE and Non-serious AEs: From Day 1 up to Week 36 (26 weeks after last dose at Week 10)
    Adverse event reporting additional description
    The safety analysis set included all randomised subjects who had received at least 1 dose of study intervention.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Arm B: JNJ-67484703
    Reporting group description
    		 Subjects received a single dose of JNJ-67484703 3 milligrams per kilogram (mg/kg) SC injection at Week 0 (Day 1), a loading dose at Week 1, followed by once Q2W from Week 2 until Week 10. Subjects were then follow-up for safety up to 26 weeks after the administration of the last dose of study drug at Week 10.

    Reporting group title
    Arm A: Placebo
    Reporting group description
    		 Subjects received a single dose of placebo subcutaneous (SC) injection at Week 0 (Day 1), a loading dose at Week 1, followed by once every 2 weeks (Q2W) from Week 2 until Week 10. Subjects were then follow-up for safety up to 26 weeks after the administration of the last dose of study drug at Week 10.

    Serious adverse events
    		 Arm B: JNJ-67484703 Arm A: Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 17 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm B: JNJ-67484703 Arm A: Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 34 (73.53%)
    14 / 17 (82.35%)
    Investigations
    Vitamin B12 Decreased
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    C-Reactive Protein Increased
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 17 (0.00%)
         occurrences all number
    2
    0
    Blood Triglycerides Increased
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Blood Lactate Dehydrogenase Increased
         subjects affected / exposed
    2 / 34 (5.88%)
    0 / 17 (0.00%)
         occurrences all number
    2
    0
    Blood Iron Decreased
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Blood Glucose Increased
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 34 (23.53%)
    1 / 17 (5.88%)
         occurrences all number
    8
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Microcytic Anaemia
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Swelling Face
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Aphthous Ulcer
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    Diarrhoea
         subjects affected / exposed
    3 / 34 (8.82%)
    0 / 17 (0.00%)
         occurrences all number
    3
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Dermatitis Atopic
         subjects affected / exposed
    8 / 34 (23.53%)
    3 / 17 (17.65%)
         occurrences all number
    9
    4
    Urticaria
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Muscle Tightness
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Arthralgia
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Infections and infestations
    Oral Herpes
         subjects affected / exposed
    4 / 34 (11.76%)
    0 / 17 (0.00%)
         occurrences all number
    4
    0
    Nasopharyngitis
         subjects affected / exposed
    7 / 34 (20.59%)
    5 / 17 (29.41%)
         occurrences all number
    8
    8
    Gastroenteritis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Furuncle
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Covid-19
         subjects affected / exposed
    2 / 34 (5.88%)
    2 / 17 (11.76%)
         occurrences all number
    2
    2
    Gastrointestinal Infection
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Upper Respiratory Tract Infection
         subjects affected / exposed
    3 / 34 (8.82%)
    0 / 17 (0.00%)
         occurrences all number
    4
    0
    Staphylococcal Skin Infection
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Urinary Tract Infection
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    Metabolism and nutrition disorders
    Hypocalcaemia
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    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
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