Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   37219   clinical trials with a EudraCT protocol, of which   6124   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Multicenter, Randomized, Open-label, Efficacy Assessor-blinded, Active Comparator-controlled Phase 3b Study to Compare the Efficacy of Guselkumab to Fumaric Acid Esters (FAE [Fumaderm] Initial/ Fumaderm) for Adult Subjects with Moderate to Severe Plaque Psoriasis who are Candidates for and Naive to Systemic Treatment

    Summary
    EudraCT number
    2016-002135-15
    Trial protocol
    DE  
    Global end of trial date
    06 Feb 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    22 Feb 2020
    First version publication date
    22 Feb 2020
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    CNTO1959PSO3008
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02951533
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag GmbH
    Sponsor organisation address
    Johnson and Johnson Platz 1, Neuss, Germany, 41470
    Public contact
    Clinical Registry Group, Janssen-Cilag GmbH, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag GmbH, 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
    06 Feb 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Feb 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the study was to compare the efficacy of Guselkumab with commercially available active comparator FAE initial/FAE tablets for the treatment of adult subjects with moderate to severe plaque-type psoriasis who had not yet received any systemic therapy; and to assess the safety and tolerability of guselkumab in systemic treatment-naïve subjects with moderate to severe plaque-type psoriasis.
    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. Safety evaluations included monitoring of adverse events (AEs), infections, clinical laboratory parameters (chemistry, hematology, urinalysis), vital signs, and physical examination.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    13 Dec 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Efficacy
    Long term follow-up duration
    8 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 119
    Worldwide total number of subjects
    119
    EEA total number of subjects
    119
    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)
    110
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Total of 119 subjects were enrolled and randomized, 118 (GUS [60], FAE [58 subjects]) were treated in this study. Out of them, 42 subjects completed the study in Part III.

    Period 1
    Period 1 title
    Part I (Week 0 through Week 24)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind
    Roles blinded
    Assessor [1]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Guselkumab (GUS)
    Arm description
    Subjects received GUS 100 milligram (mg) administered as 100 mg per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, then every 8 weeks (at Week 12 and 20 - Part I). Subjects who completed Part I continued to receive GUS 100 mg at Week 28 and 32 - Part IIa. At Week 32, PASI 75 response was evaluated. PASI 75 responders and non-responders of GUS arm continued to receive GUS 100 mg SC every 8 weeks (weeks 36, 44 and 52). PASI 75 non-responders of FAE switched to 100 mg GUS SC at Week 32, continued at Week 36, 44 and 52. Safety follow-up was done at Week 32 (Part I), Week 64 (Part II) and up to 12 weeks after discontinuing drug. Subjects who received GUS in Part II (who started GUS at Week 0/ switched from FAE to GUS at Week 32), had no psoriatic arthritis at baseline and achieved PASI 90 response at end of Part II (Week 56), entered follow-up extension at Week 64 in Part III and were followed-up until loss of response/ until Week 100.
    Arm type
    Experimental

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    In Part I, subjects received 100 mg of Guselkumab as 100 milligram (mg) administered as 100 mg per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0,4,12 and 20.

    Arm title
    Fumaric Acid Esters (FAE)
    Arm description
    Subjects received FAE tablets by self-administration at Week 0. Doses were up-titrated and were taken every day with different daily doses depending on optimal individual benefit risk ratio (maximum 6*120 mg/day) as per local prescribing information up to Week 24 (Part I). Subjects who completed Part I and consented for Part IIa continued to receive same treatment up to Week 32 (Part IIa). At Week 32, PASI 75 response was evaluated and PASI 75 responders of FAE arm continued to receive commercially available FAE tablets specifically labeled for study (Part IIb) up to Week 56. PASI 75 non-responders of FAE arm were switched to 100 mg GUS SC at Weeks 32 and received 100 mg GUS SC at Week 36, 44 and Week 52 (Part IIb). For subjects who discontinued study, a safety follow-up was done at Week 32 (Part I) or Week 64 (Part II) or 12 weeks after last treatment (whatever came first). For all subjects who continued study, safety was followed-up at every visit.
    Arm type
    Active comparator

    Investigational medicinal product name
    FAE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In Part I, subjects received FAE tablets by self-administration at Week 0 until Week 24.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Single-blind, Efficacy assessor was blinded.
    Number of subjects in period 1
    Guselkumab (GUS) Fumaric Acid Esters (FAE)
    Started
    60
    59
    Treated
    60
    58
    Completed
    56
    36
    Not completed
    4
    23
         Non-compliance with study drug
    -
    1
         Adverse event, non-fatal
    -
    16
         Consent withdrawn by subject
    2
    4
         Lost to follow-up
    2
    2
    Period 2
    Period 2 title
    Part IIa (Week 24 through Week 32)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Guselkumab
    Arm description
    Subjects received GUS 100 milligram (mg) administered as 100 mg per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, then every 8 weeks (at Week 12 and 20 - Part I). Subjects who completed Part I continued to receive GUS 100 mg at Week 28 and 32 - Part IIa. At Week 32, PASI 75 response was evaluated. PASI 75 responders and non-responders of GUS arm continued to receive GUS 100 mg SC every 8 weeks (weeks 36, 44 and 52). PASI 75 non-responders of FAE switched to 100 mg GUS SC at Week 32, continued at Week 36, 44 and 52. Safety follow-up was done at Week 32 (Part I), Week 64 (Part II) and up to 12 weeks after discontinuing drug. Subjects who received GUS in Part II (who started GUS at Week 0/ switched from FAE to GUS at Week 32), had no psoriatic arthritis at baseline and achieved PASI 90 response at end of Part II (Week 56), entered follow-up extension at Week 64 in Part III and were followed-up until loss of response/ until Week 100.
    Arm type
    Experimental

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    In Part IIa, Subjects continued guselkumab 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Week 28.

    Arm title
    Fumaric Acid Esters (FAE)
    Arm description
    Subjects received FAE tablets by self-administration at Week 0. Doses were up-titrated and taken every day with different daily doses depending on optimal individual benefit risk ratio (maximum 6*120 mg/day) as per local prescribing information up to Week 24 (Part I). Subjects who completed Part I and consented for Part IIa continued to receive same treatment up to Week 32 (Part IIa). At Week 32, PASI 75 response was evaluated and PASI 75 responders of FAE arm continued to receive commercially available FAE tablets labeled for study (Part IIb) up to Week 56. PASI 75 non-responders of FAE arm were switched to 100 mg GUS at Weeks 32 and received 100 mg GUS SC at Week 36, 44 and Week 52 (Part IIb). For subjects who discontinued study, safety follow-up was done at Week 32 (Part I)/ Week 64 (Part II) or 12 weeks after last treatment (whatever came first). For all subjects who continued study, safety was followed-up at every visit. Part III was not applicable for this arm.
    Arm type
    Active comparator

    Investigational medicinal product name
    Fumaderm
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In Part IIa, subjects received commercially available FAE tablets specifically labeled for the study from Week 24 through Week 32.

    Number of subjects in period 2 [2]
    Guselkumab Fumaric Acid Esters (FAE)
    Started
    56
    35
    PASI 75 Responder at Week 32
    54 [3]
    14 [4]
    PASI 75 non-responder at Week 32
    1 [5]
    20 [6]
    Completed
    55
    34
    Not completed
    1
    1
         Adverse event
    -
    1
         Withdrawal by subject
    1
    -
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: One subject did not sign ICF for Part II.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: At Week 32, PASI 75 response evaluated, and 54 subjects were responders and 1 subject was non-responder in GUS group; and 1 subject discontinued prematurely the study treatment between W24 and Week 32.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: At Week 32, PASI 75 response evaluated, and 54 subjects were responders and 1 subject was non-responder in GUS group; and 1 subject discontinued prematurely the study treatment between W24 and Week 32.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: At Week 32, PASI 75 response evaluated, and 54 subjects were responders and 1 subject was non-responder in GUS group; and 1 subject discontinued prematurely the study treatment between W24 and Week 32.
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: At Week 32, PASI 75 response evaluated, and 54 subjects were responders and 1 subject was non-responder in GUS group; and 1 subject discontinued prematurely the study treatment between W24 and Week 32.
    Period 3
    Period 3 title
    Part IIb (Week 32 through Week 56)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Guselkumab (GUS)
    Arm description
    Subjects received GUS 100 milligram (mg) administered as 100 mg per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, then every 8 weeks (at Week 12 and 20 - Part I). Subjects who completed Part I continued to receive GUS 100 mg at Week 28 and 32 - Part IIa. At Week 32, PASI 75 response was evaluated. PASI 75 responders and non-responders of GUS arm continued to receive GUS 100 mg SC every 8 weeks (weeks 36, 44 and 52). PASI 75 non-responders of FAE switched to 100 mg GUS SC at Week 32, continued at Week 36, 44 and 52. Safety follow-up was done at Week 32 (Part I), Week 64 (Part II) and up to 12 weeks after discontinuing drug. Subjects who received GUS in Part II (who started GUS at Week 0/ switched from FAE to GUS at Week 32), had no psoriatic arthritis at baseline and achieved PASI 90 response at end of Part II (Week 56), entered follow-up extension at Week 64 in Part III and were followed-up until loss of response/ until Week 100.
    Arm type
    Experimental

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    At Week 32 (study Part IIb), PASI 75 response was evaluated. PASI 75 responders and non-responders of guselkumab arm continued to receive guselkumab 100 mg SC every 8 weeks (weeks 36, 44 and 52).

    Arm title
    Fumaric Acid Esters (FAE)
    Arm description
    Subjects received FAE tablets by self-administration at Week 0. Doses were up-titrated and were taken every day with different daily doses depending on optimal individual benefit risk ratio (maximum 6*120 mg/day) as per local prescribing information up to Week 24 (Part I). Subjects who completed Part I and consented for Part IIa continued to receive same treatment up to Week 32 (Part IIa). At Week 32, PASI 75 response was evaluated and PASI 75 responders of FAE arm continued to receive commercially available FAE tablets up to Week 56 (Part IIb). PASI 75 non-responders of FAE arm were switched to 100 mg GUS at Weeks 32 and received 100 mg GUS SC at Week 36, 44 and Week 52 (Part IIb). For subjects who discontinued study, safety follow-up was done at Week 32 (Part I)/ Week 64 (Part II) or 12 weeks after last treatment (whatever came first). For all subjects who continued study, safety was followed-up at every visit. Part III was not applicable for this arm.
    Arm type
    Active comparator

    Investigational medicinal product name
    FAE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    At Week 32, PASI 75 response was evaluated and PASI 75 responders of FAE arm continued to receive commercially available FAE tablets specifically labeled for the study during Part IIb up to Week 56.

    Arm title
    FAE to Guselkumab (GUS)
    Arm description
    At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Subjects who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Subjects who received GUS in Study Part II (subjects who switched from FAE to GUS treatment at Week 32), had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
    Arm type
    Experimental

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    At Week 32, PASI 75 response was evlauated and PASI 75 non-responders of FAE arm were switched to guselkumab group and received guselkumab SC at Weeks 32, 36, 44 and Week 52.

    Number of subjects in period 3
    Guselkumab (GUS) Fumaric Acid Esters (FAE) FAE to Guselkumab (GUS)
    Started
    55
    14
    20
    Completed
    54
    10
    20
    Not completed
    1
    4
    0
         Adverse event
    -
    2
    -
         Lost to follow-up
    1
    2
    -
    Period 4
    Period 4 title
    Part III (Week 64 through Week 100)
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Guselkumab
    Arm description
    Subjects received GUS 100 milligram (mg) administered as 100 mg per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, then every 8 weeks (at Week 12 and 20 - Part I). Subjects who completed Part I continued to receive GUS 100 mg at Week 28 and 32 - Part IIa. At Week 32, PASI 75 response was evaluated. PASI 75 responders and non-responders of GUS arm continued to receive GUS 100 mg SC every 8 weeks (weeks 36, 44 and 52). PASI 75 non-responders of FAE switched to 100 mg GUS SC at Week 32, continued at Week 36, 44 and 52. Safety follow-up was done at Week 32 (Part I), Week 64 (Part II) and up to 12 weeks after discontinuing drug. Subjects who received GUS in Part II (who started GUS at Week 0/ switched from FAE to GUS at Week 32), had no psoriatic arthritis at baseline and achieved PASI 90 response at end of Part II (Week 56), entered follow-up extension at Week 64 in Part III and were followed-up until loss of response/ until Week 100.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    FAE to Guselkumab
    Arm description
    At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Subjects who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Subjects who received GUS in Study Part II (subjects who switched from FAE to GUS treatment at Week 32), had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 4 [7]
    Guselkumab FAE to Guselkumab
    Started
    36
    12
    Completed
    32
    10
    Not completed
    4
    2
         Prohibited Medication Therapy
    1
    -
         Consent withdrawn by subject
    2
    2
         Lost to follow-up
    1
    -
    Notes
    [7] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 18 subjects in Guselkumab group were not eligible to enter Part III and 8 subjects FAE to Guselkumab group were not eligible to enter Part III.

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Guselkumab (GUS)
    Reporting group description
    Subjects received GUS 100 milligram (mg) administered as 100 mg per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, then every 8 weeks (at Week 12 and 20 - Part I). Subjects who completed Part I continued to receive GUS 100 mg at Week 28 and 32 - Part IIa. At Week 32, PASI 75 response was evaluated. PASI 75 responders and non-responders of GUS arm continued to receive GUS 100 mg SC every 8 weeks (weeks 36, 44 and 52). PASI 75 non-responders of FAE switched to 100 mg GUS SC at Week 32, continued at Week 36, 44 and 52. Safety follow-up was done at Week 32 (Part I), Week 64 (Part II) and up to 12 weeks after discontinuing drug. Subjects who received GUS in Part II (who started GUS at Week 0/ switched from FAE to GUS at Week 32), had no psoriatic arthritis at baseline and achieved PASI 90 response at end of Part II (Week 56), entered follow-up extension at Week 64 in Part III and were followed-up until loss of response/ until Week 100.

    Reporting group title
    Fumaric Acid Esters (FAE)
    Reporting group description
    Subjects received FAE tablets by self-administration at Week 0. Doses were up-titrated and were taken every day with different daily doses depending on optimal individual benefit risk ratio (maximum 6*120 mg/day) as per local prescribing information up to Week 24 (Part I). Subjects who completed Part I and consented for Part IIa continued to receive same treatment up to Week 32 (Part IIa). At Week 32, PASI 75 response was evaluated and PASI 75 responders of FAE arm continued to receive commercially available FAE tablets specifically labeled for study (Part IIb) up to Week 56. PASI 75 non-responders of FAE arm were switched to 100 mg GUS SC at Weeks 32 and received 100 mg GUS SC at Week 36, 44 and Week 52 (Part IIb). For subjects who discontinued study, a safety follow-up was done at Week 32 (Part I) or Week 64 (Part II) or 12 weeks after last treatment (whatever came first). For all subjects who continued study, safety was followed-up at every visit.

    Reporting group values
    Guselkumab (GUS) Fumaric Acid Esters (FAE) Total
    Number of subjects
    60 59 119
    Title for AgeCategorical
    Units: subjects
        Adults (18-64 years)
    56 54 110
        From 65 to 84 years
    4 5 9
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    39 ± 13.98 45.8 ± 13.72 -
    Title for Gender
    Units: subjects
        Female
    20 17 37
        Male
    40 42 82
    Subject analysis sets

    Subject analysis set title
    Part I: Guselkumab (GUS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Subjects who completed the treatment phase until Week 24 entered the Part II of the study.

    Subject analysis set title
    Part I: Fumaric Acid Esters (FAE)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects received FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6*120 mg/day) according to local prescribing information up to Week 24. Subjects who completed the treatment phase until Week 24 entered the Part II of the study.

    Subject analysis set title
    Part I/IIa: Guselkumab (GUS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    In Part I, subjects received GUS 100 mg treatment administered as 100 mg/mL solution SC at Weeks 0, 4, 12 and 20. Subjects who completed treatment phase until Week 24 entered Part II of study. Subjects who completed Part I continued to receive GUS 100 mg SC at Week 28 and 32 during study Part IIa. For subjects who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all subjects who continued study, safety was followed-up at every visit.

    Subject analysis set title
    Part I/IIa: FAE
    Subject analysis set type
    Full analysis
    Subject analysis set description
    In Part I, subjects received FAE tablets by self-administration at Week 0. The doses were up-titrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6*120 mg/day) according to local prescribing information up to Week 24. Subjects who completed the treatment phase until Week 24 entered the Part II of the study. Subjects who completed Part I and consented for Part IIa continued to receive commercially available FAE tablets specifically labeled for the study from Week 24 through Week 32 during study Part IIa. For subjects who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all subjects who continued study, safety was followed-up at every visit.

    Subject analysis sets values
    Part I: Guselkumab (GUS) Part I: Fumaric Acid Esters (FAE) Part I/IIa: Guselkumab (GUS) Part I/IIa: FAE
    Number of subjects
    60
    59
    60
    59
    Title for AgeCategorical
    Units: subjects
        Adults (18-64 years)
    56
    54
        From 65 to 84 years
    4
    5
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    39 ± 13.98
    45.8 ± 13.72
    ±
    ±
    Title for Gender
    Units: subjects
        Female
    20
    17
        Male
    40
    42

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Guselkumab (GUS)
    Reporting group description
    Subjects received GUS 100 milligram (mg) administered as 100 mg per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, then every 8 weeks (at Week 12 and 20 - Part I). Subjects who completed Part I continued to receive GUS 100 mg at Week 28 and 32 - Part IIa. At Week 32, PASI 75 response was evaluated. PASI 75 responders and non-responders of GUS arm continued to receive GUS 100 mg SC every 8 weeks (weeks 36, 44 and 52). PASI 75 non-responders of FAE switched to 100 mg GUS SC at Week 32, continued at Week 36, 44 and 52. Safety follow-up was done at Week 32 (Part I), Week 64 (Part II) and up to 12 weeks after discontinuing drug. Subjects who received GUS in Part II (who started GUS at Week 0/ switched from FAE to GUS at Week 32), had no psoriatic arthritis at baseline and achieved PASI 90 response at end of Part II (Week 56), entered follow-up extension at Week 64 in Part III and were followed-up until loss of response/ until Week 100.

    Reporting group title
    Fumaric Acid Esters (FAE)
    Reporting group description
    Subjects received FAE tablets by self-administration at Week 0. Doses were up-titrated and were taken every day with different daily doses depending on optimal individual benefit risk ratio (maximum 6*120 mg/day) as per local prescribing information up to Week 24 (Part I). Subjects who completed Part I and consented for Part IIa continued to receive same treatment up to Week 32 (Part IIa). At Week 32, PASI 75 response was evaluated and PASI 75 responders of FAE arm continued to receive commercially available FAE tablets specifically labeled for study (Part IIb) up to Week 56. PASI 75 non-responders of FAE arm were switched to 100 mg GUS SC at Weeks 32 and received 100 mg GUS SC at Week 36, 44 and Week 52 (Part IIb). For subjects who discontinued study, a safety follow-up was done at Week 32 (Part I) or Week 64 (Part II) or 12 weeks after last treatment (whatever came first). For all subjects who continued study, safety was followed-up at every visit.
    Reporting group title
    Guselkumab
    Reporting group description
    Subjects received GUS 100 milligram (mg) administered as 100 mg per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, then every 8 weeks (at Week 12 and 20 - Part I). Subjects who completed Part I continued to receive GUS 100 mg at Week 28 and 32 - Part IIa. At Week 32, PASI 75 response was evaluated. PASI 75 responders and non-responders of GUS arm continued to receive GUS 100 mg SC every 8 weeks (weeks 36, 44 and 52). PASI 75 non-responders of FAE switched to 100 mg GUS SC at Week 32, continued at Week 36, 44 and 52. Safety follow-up was done at Week 32 (Part I), Week 64 (Part II) and up to 12 weeks after discontinuing drug. Subjects who received GUS in Part II (who started GUS at Week 0/ switched from FAE to GUS at Week 32), had no psoriatic arthritis at baseline and achieved PASI 90 response at end of Part II (Week 56), entered follow-up extension at Week 64 in Part III and were followed-up until loss of response/ until Week 100.

    Reporting group title
    Fumaric Acid Esters (FAE)
    Reporting group description
    Subjects received FAE tablets by self-administration at Week 0. Doses were up-titrated and taken every day with different daily doses depending on optimal individual benefit risk ratio (maximum 6*120 mg/day) as per local prescribing information up to Week 24 (Part I). Subjects who completed Part I and consented for Part IIa continued to receive same treatment up to Week 32 (Part IIa). At Week 32, PASI 75 response was evaluated and PASI 75 responders of FAE arm continued to receive commercially available FAE tablets labeled for study (Part IIb) up to Week 56. PASI 75 non-responders of FAE arm were switched to 100 mg GUS at Weeks 32 and received 100 mg GUS SC at Week 36, 44 and Week 52 (Part IIb). For subjects who discontinued study, safety follow-up was done at Week 32 (Part I)/ Week 64 (Part II) or 12 weeks after last treatment (whatever came first). For all subjects who continued study, safety was followed-up at every visit. Part III was not applicable for this arm.
    Reporting group title
    Guselkumab (GUS)
    Reporting group description
    Subjects received GUS 100 milligram (mg) administered as 100 mg per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, then every 8 weeks (at Week 12 and 20 - Part I). Subjects who completed Part I continued to receive GUS 100 mg at Week 28 and 32 - Part IIa. At Week 32, PASI 75 response was evaluated. PASI 75 responders and non-responders of GUS arm continued to receive GUS 100 mg SC every 8 weeks (weeks 36, 44 and 52). PASI 75 non-responders of FAE switched to 100 mg GUS SC at Week 32, continued at Week 36, 44 and 52. Safety follow-up was done at Week 32 (Part I), Week 64 (Part II) and up to 12 weeks after discontinuing drug. Subjects who received GUS in Part II (who started GUS at Week 0/ switched from FAE to GUS at Week 32), had no psoriatic arthritis at baseline and achieved PASI 90 response at end of Part II (Week 56), entered follow-up extension at Week 64 in Part III and were followed-up until loss of response/ until Week 100.

    Reporting group title
    Fumaric Acid Esters (FAE)
    Reporting group description
    Subjects received FAE tablets by self-administration at Week 0. Doses were up-titrated and were taken every day with different daily doses depending on optimal individual benefit risk ratio (maximum 6*120 mg/day) as per local prescribing information up to Week 24 (Part I). Subjects who completed Part I and consented for Part IIa continued to receive same treatment up to Week 32 (Part IIa). At Week 32, PASI 75 response was evaluated and PASI 75 responders of FAE arm continued to receive commercially available FAE tablets up to Week 56 (Part IIb). PASI 75 non-responders of FAE arm were switched to 100 mg GUS at Weeks 32 and received 100 mg GUS SC at Week 36, 44 and Week 52 (Part IIb). For subjects who discontinued study, safety follow-up was done at Week 32 (Part I)/ Week 64 (Part II) or 12 weeks after last treatment (whatever came first). For all subjects who continued study, safety was followed-up at every visit. Part III was not applicable for this arm.

    Reporting group title
    FAE to Guselkumab (GUS)
    Reporting group description
    At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Subjects who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Subjects who received GUS in Study Part II (subjects who switched from FAE to GUS treatment at Week 32), had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.
    Reporting group title
    Guselkumab
    Reporting group description
    Subjects received GUS 100 milligram (mg) administered as 100 mg per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, then every 8 weeks (at Week 12 and 20 - Part I). Subjects who completed Part I continued to receive GUS 100 mg at Week 28 and 32 - Part IIa. At Week 32, PASI 75 response was evaluated. PASI 75 responders and non-responders of GUS arm continued to receive GUS 100 mg SC every 8 weeks (weeks 36, 44 and 52). PASI 75 non-responders of FAE switched to 100 mg GUS SC at Week 32, continued at Week 36, 44 and 52. Safety follow-up was done at Week 32 (Part I), Week 64 (Part II) and up to 12 weeks after discontinuing drug. Subjects who received GUS in Part II (who started GUS at Week 0/ switched from FAE to GUS at Week 32), had no psoriatic arthritis at baseline and achieved PASI 90 response at end of Part II (Week 56), entered follow-up extension at Week 64 in Part III and were followed-up until loss of response/ until Week 100.

    Reporting group title
    FAE to Guselkumab
    Reporting group description
    At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Subjects who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Subjects who received GUS in Study Part II (subjects who switched from FAE to GUS treatment at Week 32), had no psoriatic arthritis at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.

    Subject analysis set title
    Part I: Guselkumab (GUS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects received GUS 100 milligram (mg) treatment administered as 100 milligram per milliliter (mg/mL) solution subcutaneously (SC) at Weeks 0, 4, 12 and 20. Subjects who completed the treatment phase until Week 24 entered the Part II of the study.

    Subject analysis set title
    Part I: Fumaric Acid Esters (FAE)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects received FAE tablets by self-administration at Week 0. The doses were uptitrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6*120 mg/day) according to local prescribing information up to Week 24. Subjects who completed the treatment phase until Week 24 entered the Part II of the study.

    Subject analysis set title
    Part I/IIa: Guselkumab (GUS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    In Part I, subjects received GUS 100 mg treatment administered as 100 mg/mL solution SC at Weeks 0, 4, 12 and 20. Subjects who completed treatment phase until Week 24 entered Part II of study. Subjects who completed Part I continued to receive GUS 100 mg SC at Week 28 and 32 during study Part IIa. For subjects who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all subjects who continued study, safety was followed-up at every visit.

    Subject analysis set title
    Part I/IIa: FAE
    Subject analysis set type
    Full analysis
    Subject analysis set description
    In Part I, subjects received FAE tablets by self-administration at Week 0. The doses were up-titrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6*120 mg/day) according to local prescribing information up to Week 24. Subjects who completed the treatment phase until Week 24 entered the Part II of the study. Subjects who completed Part I and consented for Part IIa continued to receive commercially available FAE tablets specifically labeled for the study from Week 24 through Week 32 during study Part IIa. For subjects who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all subjects who continued study, safety was followed-up at every visit.

    Primary: Part I: Percentage of Subjects who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 24

    Close Top of page
    End point title
    Part I: Percentage of Subjects who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 24
    End point description
    PASI is system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, lower extremities. Each area is assessed separately for percentage of area involved, which translates to numeric score from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 (none) to 4 (severe). PASI produces score range from 0 (no visible skin involvement) to 72 (maximal skin involvement of whole body). Higher score indicates more severe disease. PASI 90 response denotes subjects achieving 90% improvement from baseline in PASI score. Efficacy analysis set (EAS) included all subjects randomized to 1 of 2 treatments (GUS or FAE) at Week 0 regardless of treatment they received. Missing data was imputed by non-responder imputation (NRI) (subjects with missing data at Week 4,16 and 24 were non-responders).
    End point type
    Primary
    End point timeframe
    Week 24
    End point values
    Part I: Guselkumab (GUS) Part I: Fumaric Acid Esters (FAE)
    Number of subjects analysed
    60
    59
    Units: Percentage of Subjects
        number (not applicable)
    81.7
    13.6
    Statistical analysis title
    Statistical Analysis
    Comparison groups
    Part I: Guselkumab (GUS) v Part I: Fumaric Acid Esters (FAE)
    Number of subjects included in analysis
    119
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Chi-squared
    Confidence interval

    Secondary: Part I: Percentage of Subjects who Achieved PASI 75 Response at Week 24

    Close Top of page
    End point title
    Part I: Percentage of Subjects who Achieved PASI 75 Response at Week 24
    End point description
    PASI is system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, lower extremities. Each area is assessed separately for percentage of area involved, which translates to numeric score from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 (none) to 4 (severe). PASI produces numeric score range from 0 (no visible skin involvement) to 72 (maximal skin involvement of whole body). Higher score indicates more severe disease. PASI 75 response denotes subjects achieving 75% improvement from baseline in PASI score. EAS included all subjects who were randomized to 1 of 2 treatment groups (GUS or FAE) at Week 0 regardless of treatment they actually received. Missing data was imputed using NRI (subjects with missing data at Week 4,16 and 24 were considered non-responders).
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Part I: Guselkumab (GUS) Part I: Fumaric Acid Esters (FAE)
    Number of subjects analysed
    60
    59
    Units: Percentage of Subjects
        number (not applicable)
    90.0
    27.1
    No statistical analyses for this end point

    Secondary: Part I: Percentage of Subjects who Achieved a Dermatology Life Quality Index (DLQI) Score of Less Than or Equal to (=<) 1 at Week 24

    Close Top of page
    End point title
    Part I: Percentage of Subjects who Achieved a Dermatology Life Quality Index (DLQI) Score of Less Than or Equal to (=<) 1 at Week 24
    End point description
    DLQI is 10-item questionnaire that measures impact of skin disease on subject's quality of life, used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work/school performance, 5) personal relationships, 6) treatment. Each question was evaluated on 4-point scale ranging from 0 (not at all) to 3 (very much); higher scores indicate more impact on quality of life. DLQI produces total numeric score ranging from 0 (not at all) to 30 (very much): 0-1=no effect at all on subject's life; 2-6=small effect 7-12=moderate effect; 13-18 =very large effect; 19-30 =extremely large effect. Higher score indicates low quality of life due to more severe disease. EAS included all subjects who were randomized to 1 of 2 treatment groups (GUS or FAE) at Week 0 regardless of treatment they actually received. Missing data was imputed using NRI (subjects with missing data at Week 4,16 and 24 were considered non-responders).
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Part I: Guselkumab (GUS) Part I: Fumaric Acid Esters (FAE)
    Number of subjects analysed
    60
    59
    Units: Percentage of Subjects
        number (not applicable)
    61.7
    16.9
    No statistical analyses for this end point

    Secondary: Part I: Percentage of Subjects who Achieved PASI 100 Response at Week 24

    Close Top of page
    End point title
    Part I: Percentage of Subjects who Achieved PASI 100 Response at Week 24
    End point description
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents subjects who achieved a 100% improvement from baseline in the PASI score.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Part I: Guselkumab (GUS) Part I: Fumaric Acid Esters (FAE)
    Number of subjects analysed
    60
    59
    Units: Percentage of Subjects
        number (not applicable)
    31.7
    3.4
    No statistical analyses for this end point

    Secondary: Part I: Change from Baseline in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) Score at Week 24

    Close Top of page
    End point title
    Part I: Change from Baseline in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) Score at Week 24
    End point description
    PSSD (7-day version) patient-reported outcome questionnaire designed and validated to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. It consisted 11 items covering symptoms (itch, pain, stinging, burning, skin tightness) and signs (skin dryness, cracking, scaling, shedding/ flaking, redness, bleeding) with 0 (absent) to 10 (worst imaginable) scale for severity. Items averaged on daily symptom score and sign score when at least 3 items >= 50% of 5 items on these scales are answered. Average value converted into 0-100 scoring, such that Symptom [or Sign] score=average value*10, where, 0=least severe and 100=most severe, higher score indicates more severe disease. EAS included all subjects randomized to 1 of 2 groups (GUS or FAE) at Week 0 regardless of treatment received. Missing data imputed using last observed carried forward (LOCF) imputation method. Here N (number of subjects analysed) is number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    Part I: Guselkumab (GUS) Part I: Fumaric Acid Esters (FAE)
    Number of subjects analysed
    60
    58
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Sign score
    -59.8 ± 18.3
    -39.7 ± 26.7
        Symptom score
    -52.0 ± 22.0
    -34.0 ± 25.4
    No statistical analyses for this end point

    Secondary: Part I: Change from Baseline in the Individual Scale Scores for Itch, Pain, and Scaling of PSSD Components at Week 24

    Close Top of page
    End point title
    Part I: Change from Baseline in the Individual Scale Scores for Itch, Pain, and Scaling of PSSD Components at Week 24
    End point description
    PSSD (7-day version) patient-reported outcome questionnaire designed and validated to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. It consisted 11 items covering symptoms (itch, pain, stinging, burning, skin tightness) and signs (skin dryness, cracking, scaling, shedding/ flaking, redness, bleeding) with 0 (absent) to 10 (worst imaginable) scale for severity. Items averaged on daily symptom score and sign score when at least 3 items >= 50% of 5 items on these scales are answered. Average value converted into 0-100 scoring, such that Symptom [or Sign] score=average value*10, where, 0=least severe and 100=most severe, higher score indicates more severe disease. EAS included all subjects randomized to 1 of 2 groups (GUS or FAE) at Week 0 regardless of treatment received. Missing data imputed using last observed carried forward (LOCF) imputation method. Here N (number of subjects analysed) is number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    Part I: Guselkumab (GUS) Part I: Fumaric Acid Esters (FAE)
    Number of subjects analysed
    60
    58
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Itch score
    -5.85 ± 2.83
    -3.90 ± 2.86
        Pain score
    -5.07 ± 2.86
    -2.93 ± 3.12
        Scaling score
    -6.48 ± 2.25
    -4.43 ± 3.02
    No statistical analyses for this end point

    Secondary: Part I: Percentage of Subjects who Achieved an Absolute PASI Score less Than or Equal to (=<) 1 at Week 24

    Close Top of page
    End point title
    Part I: Percentage of Subjects who Achieved an Absolute PASI Score less Than or Equal to (=<) 1 at Week 24
    End point description
    PASI is system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, lower extremities. Each areas is assessed separately for percentage of area involved, which translates to numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on scale of 0 (none) to 4 (severe). PASI produces numeric score that range from 0 (no visible skin involvement) to 72 (maximal skin involvement of whole body). Higher score indicates more severe disease. Percentage of subjects who achieved absolute PASI score <=1 were assessed. EAS included all subjects randomized to 1 of 2 treatment groups (GUS or FAE) at Week 0 regardless of treatment they actually received. Missing data was imputed using NRI (subjects with missing data at Week 4,16 and 24 were considered non-responders).
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Part I: Guselkumab (GUS) Part I: Fumaric Acid Esters (FAE)
    Number of subjects analysed
    60
    59
    Units: Percentage of Subjects
        number (not applicable)
    66.7
    10.2
    No statistical analyses for this end point

    Secondary: Part I: Percentage of Subjects who Achieved an Investigator’s Global Assessment (IGA) Score 0 at Week 24

    Close Top of page
    End point title
    Part I: Percentage of Subjects who Achieved an Investigator’s Global Assessment (IGA) Score 0 at Week 24
    End point description
    The Investigator’s Global Assessment (IGA) documents the investigator’s assessment of the subject's psoriasis at a given time. Overall lesions are graded for induration, erythema, and scaling. The subject's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). EAS included all subjects who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (subjects with missing data at Week 4,16 and 24 were considered non-responders).
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Part I: Guselkumab (GUS) Part I: Fumaric Acid Esters (FAE)
    Number of subjects analysed
    60
    59
    Units: Percentage of Subjects
        number (not applicable)
    51.7
    6.8
    No statistical analyses for this end point

    Secondary: Part I: Change from Baseline in Percent Body Surface Area (%BSA) Psoriatic Involvement at Week 24

    Close Top of page
    End point title
    Part I: Change from Baseline in Percent Body Surface Area (%BSA) Psoriatic Involvement at Week 24
    End point description
    BSA as physical measure to define disease severity is to determine how much of the Body Surface Area (BSA) is affected by psoriasis. Involved BSA is calculated by using the palm of the subject's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis. EAS included all subjects who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using LOCF imputation method. Here N (number of subjects analysed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    Part I: Guselkumab (GUS) Part I: Fumaric Acid Esters (FAE)
    Number of subjects analysed
    59
    57
    Units: Change in BSA (% points)
        arithmetic mean (standard deviation)
    -18.5 ± 10.4
    -9.2 ± 11.2
    No statistical analyses for this end point

    Secondary: Part I: Change From Baseline in DLQI Score at Week 24

    Close Top of page
    End point title
    Part I: Change From Baseline in DLQI Score at Week 24
    End point description
    DLQI is 10-item questionnaire that measures impact of skin disease on subject's quality of life, assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work/school performance, 5) personal relationships, 6) treatment. Each question evaluated on 4-point scale ranging from 0 (not at all) to 3 (very much); higher scores indicate more impact on quality of life. DLQI produces total numeric score ranging from 0 (not at all) to 30 (very much): 0-1=no effect at all on subject's life; 2-6 =small effect; 7-12 =moderate effect; 13-18 =very large effect; 19-30 =extremely large effect. Higher score indicates low quality of life due to more severe disease. EAS included all subjects randomized to 1 of 2 treatment groups (GUS or FAE) at Week 0 regardless of treatment received. Missing data was imputed using LOCF imputation method. Here N (number of subjects analysed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    Part I: Guselkumab (GUS) Part I: Fumaric Acid Esters (FAE)
    Number of subjects analysed
    60
    58
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -15.2 ± 5.1
    -9.4 ± 7.2
    No statistical analyses for this end point

    Secondary: Part I: Percentage of Subjects who Achieved an Scalp Specific Investigator´s Global Assessment (ss-IGA) Score of Absence of Disease (0) at Week 24

    Close Top of page
    End point title
    Part I: Percentage of Subjects who Achieved an Scalp Specific Investigator´s Global Assessment (ss-IGA) Score of Absence of Disease (0) at Week 24
    End point description
    The ss-IGA instrument is used to evaluate disease severity of scalp psoriasis (SP). The lesions are assessed in terms of clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4). EAS included subjects randomized to one of two treatments (GUS or FAE) at Week 0 regardless of treatment received and SP, ss-IGA Score>=2 at Baseline. Missing data was imputed using NRI (subjects with missing data at Week 4,16, 24 were non-responders).
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Part I: Guselkumab (GUS) Part I: Fumaric Acid Esters (FAE)
    Number of subjects analysed
    54
    53
    Units: Percentage of Subjects
        number (not applicable)
    48.1
    13.2
    No statistical analyses for this end point

    Secondary: Part I: Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36 V2) Physical Component Summary (PCS) and Mental Component Summary (MCS) at Week 24

    Close Top of page
    End point title
    Part I: Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36 V2) Physical Component Summary (PCS) and Mental Component Summary (MCS) at Week 24
    End point description
    SF-36 V2 is 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Subjects self-report on items in subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of time, some of time, etc.). Summations of item scores of same subscale give subscale scores, which are transformed into range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores indicate better health status. EAS included all subjects randomized to 1 of 2 groups (GUS or FAE) at Week 0 regardless of treatment received. Missing data was imputed using LOCF. Here N (number of subjects analysed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    Part I: Guselkumab (GUS) Part I: Fumaric Acid Esters (FAE)
    Number of subjects analysed
    59
    57
    Units: Units on a scale
    arithmetic mean (standard deviation)
        SF-36 PCS scores
    8.0 ± 6.9
    2.3 ± 8.2
        SF-36 MCS scores
    5.8 ± 10.6
    6.5 ± 9.3
    No statistical analyses for this end point

    Secondary: Part IIb: Percentage of Subjects with a PASI 75 Response at Week 32 who Maintained Response at Week 56

    Close Top of page
    End point title
    Part IIb: Percentage of Subjects with a PASI 75 Response at Week 32 who Maintained Response at Week 56
    End point description
    PASI is system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, lower extremities. Each area is assessed separately for percentage of area involved, which translates to numeric score from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 (none) to 4 (severe). PASI produces numeric score range from 0 (no visible skin involvement) to 72 (maximal skin involvement of whole body). Higher score indicates more severe disease. PASI 75 response denotes subjects achieving 75% improvement from baseline in PASI score. Part IIb analysis set included all subjects who entered Part IIb and treated with 1 of 2 treatments (GUS or FAE) during treatment period from Week 32 to 56. Missing data imputed using NRI (subjects with missing data at Week 40, 48, and 56 considered non-responders).
    End point type
    Secondary
    End point timeframe
    Week 56
    End point values
    Guselkumab (GUS) Fumaric Acid Esters (FAE)
    Number of subjects analysed
    54
    14
    Units: Percentage of Subjects
        number (not applicable)
    98.1
    64.3
    No statistical analyses for this end point

    Secondary: Part IIb: Percentage of Subjects with a PASI 90 Response at Week 32 who Maintained Response at Week 56

    Close Top of page
    End point title
    Part IIb: Percentage of Subjects with a PASI 90 Response at Week 32 who Maintained Response at Week 56
    End point description
    PASI is system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, lower extremities. Each area is assessed separately for percentage of area involved, which translates to numeric score from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 (none) to 4 (severe). PASI produces numeric score range from 0 (no visible skin involvement) to 72 (maximal skin involvement of whole body). Higher score indicates more severe disease. PASI 90 response denotes subjects achieving 90% improvement from baseline in PASI score. Part IIb analysis set included all subjects who entered Part IIb and treated with 1 of 2 treatments (GUS or FAE) during treatment period from Week 32 to 56. Missing data imputed using NRI (subjects with missing data at Week 40, 48, and 56 considered non-responders).
    End point type
    Secondary
    End point timeframe
    Week 56
    End point values
    Guselkumab (GUS) Fumaric Acid Esters (FAE)
    Number of subjects analysed
    54
    14
    Units: Percentage of Subjects
        number (not applicable)
    85.2
    35.7
    No statistical analyses for this end point

    Secondary: Part IIb: Percentage of Subjects with DLQI Score of 0 or 1 at Week 32 who Maintained Response at Week 56

    Close Top of page
    End point title
    Part IIb: Percentage of Subjects with DLQI Score of 0 or 1 at Week 32 who Maintained Response at Week 56
    End point description
    DLQI is 10-item questionnaire that measures impact of skin disease on subject's quality of life, used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work/school performance, 5) personal relationships, 6) treatment. Each question was evaluated on 4-point scale ranging from 0 (not at all) to 3 (very much); higher scores indicate more impact on quality of life. DLQI produces total numeric score ranging from 0 (not at all) to 30 (very much): 0-1=no effect at all on subject's life; 2-6=small effect 7-12=moderate effect; 13-18 =very large effect; 19-30 =extremely large effect. Higher score indicates low quality of life due to more severe disease. Part IIb analysis set included all subjects who entered Part IIb and treated with 1 of 2 treatments (GUS or FAE) from Week 32 to 56. Missing data imputed by NRI (subjects missing data at Week 40,48 and 56 were considered non-responders).
    End point type
    Secondary
    End point timeframe
    Week 56
    End point values
    Guselkumab (GUS) Fumaric Acid Esters (FAE)
    Number of subjects analysed
    54
    14
    Units: Percentage of Subjects
        number (not applicable)
    64.8
    21.4
    No statistical analyses for this end point

    Secondary: Part IIb: Percentage of Subjects with a PASI 75 Response at Week 56

    Close Top of page
    End point title
    Part IIb: Percentage of Subjects with a PASI 75 Response at Week 56
    End point description
    PASI is system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, lower extremities. Each area is assessed separately for percentage of area involved, which translates to numeric score from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 (none) to 4 (severe). PASI produces numeric score range from 0 (no visible skin involvement) to 72 (maximal skin involvement of whole body). Higher score indicates more severe disease. PASI 75 response denotes subjects achieving 75% improvement from baseline in PASI score. Part IIb analysis set included all subjects who entered Part IIb and treated with 1 of 2 treatments (GUS or FAE) during treatment period from Week 32 to 56. Missing data imputed using NRI (subjects with missing data at Week 40, 48, and 56 considered non-responders).
    End point type
    Secondary
    End point timeframe
    Week 56
    End point values
    Guselkumab (GUS) Fumaric Acid Esters (FAE)
    Number of subjects analysed
    54
    14
    Units: Percentage of Subjects
        number (not applicable)
    98.1
    64.3
    No statistical analyses for this end point

    Secondary: Part IIb: Percentage of Subjects with a PASI 90 Response at Week 56

    Close Top of page
    End point title
    Part IIb: Percentage of Subjects with a PASI 90 Response at Week 56
    End point description
    PASI is system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, lower extremities. Each area is assessed separately for percentage of area involved, which translates to numeric score from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 (none) to 4 (severe). PASI produces numeric score range from 0 (no visible skin involvement) to 72 (maximal skin involvement of whole body). Higher score indicates more severe disease. PASI 90 response denotes subjects achieving 90% improvement from baseline in PASI score. Part IIb analysis set included all subjects who entered Part IIb and treated with 1 of 2 treatments (GUS or FAE) during treatment period from Week 32 to 56. Missing data imputed using NRI (subjects with missing data at Week 40, 48, and 56 considered non-responders).
    End point type
    Secondary
    End point timeframe
    Week 56
    End point values
    Guselkumab (GUS) Fumaric Acid Esters (FAE)
    Number of subjects analysed
    54
    14
    Units: Percentage of Subjects
        number (not applicable)
    90.7
    50.0
    No statistical analyses for this end point

    Secondary: Part IIb: Percentage of Subjects with a PASI 100 Response at Week 56

    Close Top of page
    End point title
    Part IIb: Percentage of Subjects with a PASI 100 Response at Week 56
    End point description
    PASI is system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, lower extremities. Each area is assessed separately for percentage of area involved, which translates to numeric score from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 (none) to 4 (severe). PASI produces numeric score range from 0 (no visible skin involvement) to 72 (maximal skin involvement of whole body). Higher score indicates more severe disease. PASI 100 response denotes subjects achieving 100% improvement from baseline in PASI score. Part IIb analysis set included all subjects who entered Part IIb and treated with 1 of 2 treatments (GUS or FAE) during treatment period from Week 32 to 56. Missing data imputed using NRI (subjects with missing data at Week 40, 48, and 56 considered non-responders).
    End point type
    Secondary
    End point timeframe
    Week 56
    End point values
    Guselkumab (GUS) Fumaric Acid Esters (FAE)
    Number of subjects analysed
    54
    14
    Units: Percentage of Subjects
        number (not applicable)
    53.7
    21.4
    No statistical analyses for this end point

    Secondary: Part IIb: Percentage of Subjects with a DLQI Score of 0 or 1 at Week 56

    Close Top of page
    End point title
    Part IIb: Percentage of Subjects with a DLQI Score of 0 or 1 at Week 56
    End point description
    DLQI is 10-item questionnaire that measures impact of skin disease on subject's quality of life, used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work/school performance, 5) personal relationships, 6) treatment. Each question was evaluated on 4-point scale ranging from 0 (not at all) to 3 (very much); higher scores indicate more impact on quality of life. DLQI produces total numeric score ranging from 0 (not at all) to 30 (very much): 0-1=no effect at all on subject's life; 2-6=small effect 7-12=moderate effect; 13-18 =very large effect; 19-30 =extremely large effect. Higher score indicates low quality of life due to more severe disease. Part IIb analysis set included all subjects who entered Part IIb and treated with 1 of 2 treatments (GUS or FAE) from Week 32 to 56. Missing data imputed by NRI (subjects missing data at Week 40,48 and 56 considered non-responders).
    End point type
    Secondary
    End point timeframe
    Week 56
    End point values
    Guselkumab (GUS) Fumaric Acid Esters (FAE)
    Number of subjects analysed
    54
    14
    Units: Percentage of Subjects
        number (not applicable)
    72.2
    28.6
    No statistical analyses for this end point

    Secondary: Part I/IIa: Percentage of Subjects who Achieved PASI 75 Response at Week 32

    Close Top of page
    End point title
    Part I/IIa: Percentage of Subjects who Achieved PASI 75 Response at Week 32
    End point description
    PASI is system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, lower extremities. Each area is assessed separately for percentage of area involved, which translates to numeric score from 0 (indicates no involvement) to 6 (90-100% involvement), and for erythema, induration, scaling, each rated on scale of 0 (none) to 4 (severe). PASI produces numeric score range from 0 (no visible skin involvement) to 72 (maximal skin involvement of whole body). Higher score indicates more severe disease. PASI 75 response denotes subjects with 75% improvement from baseline in PASI score. Population included EAS. Missing data was imputed using NRI (subjects with missing data at Week 4,16 and 24 were considered non-responders). Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 32
    End point values
    Part I/IIa: Guselkumab (GUS) Part I/IIa: FAE
    Number of subjects analysed
    60
    59
    Units: Percentage of Subjects
        number (not applicable)
    90.0
    23.7
    No statistical analyses for this end point

    Secondary: Part I/IIa: Percentage of Subjects who Achieved PASI 90 Response at Week 32

    Close Top of page
    End point title
    Part I/IIa: Percentage of Subjects who Achieved PASI 90 Response at Week 32
    End point description
    PASI is system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, lower extremities. Each area is assessed separately for percentage of area involved, which translates to numeric score from 0 (indicates no involvement) to 6 (90 - 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 (none) to 4 (severe). PASI produces numeric score range from 0 (no visible skin involvement) to 72 (maximal skin involvement of whole body). Higher score indicates more severe disease. PASI 90 response denotes subjects achieving 90% improvement from baseline in PASI score. Population included EAS. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 32
    End point values
    Part I/IIa: Guselkumab (GUS) Part I/IIa: FAE
    Number of subjects analysed
    60
    59
    Units: Percentage of Subjects
        number (not applicable)
    78.3
    11.9
    No statistical analyses for this end point

    Secondary: Part I/IIa: Percentage of Subjects who Achieved PASI 100 Response at Week 32

    Close Top of page
    End point title
    Part I/IIa: Percentage of Subjects who Achieved PASI 100 Response at Week 32
    End point description
    PASI: system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, lower extremities. Each area is assessed separately for percentage of area involved, and translates to numeric score of 0 (indicates no involvement) to 6 (90-100% involvement), and for erythema, induration, scaling, each rated on scale of 0 (none) to 4 (severe). PASI produces numeric score range from 0 (no visible skin involvement) to 72 (maximal skin involvement of whole body). Higher score indicates more severe disease. PASI 100 response denotes subjects with 100% improvement from baseline in PASI score. Population included EAS. Missing data was imputed using NRI (subjects with missing data at Week 4,16 and 24 were considered non-responders). Data reported collectively for Part I and Part IIa (that is from Week 0-32) per planned analysis for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 32
    End point values
    Part I/IIa: Guselkumab (GUS) Part I/IIa: FAE
    Number of subjects analysed
    60
    59
    Units: Percentage of Subjects
        number (not applicable)
    43.3
    6.8
    No statistical analyses for this end point

    Secondary: Part I/IIa: Percentage of Subjects with a DLQI Score of 0 or 1 at Week 32

    Close Top of page
    End point title
    Part I/IIa: Percentage of Subjects with a DLQI Score of 0 or 1 at Week 32
    End point description
    DLQI: 10-item questionnaire measures impact of skin disease on subject's quality of life, assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work/school performance, 5) personal relationships, 6) treatment. Each question evaluated on 4-point scale range from 0 (not at all) to 3 (very much); higher scores indicate more impact on quality of life. DLQI produces total numeric score range from 0 (not at all) to 30 (very much): 0-1=no effect at all on subject's life; 2-6=small effect 7-12=moderate effect; 13-18=very large effect; 19-30=extremely large effect. Higher score indicates low quality of life due to more severe disease. Population included EAS. Missing data was imputed using NRI (subjects with missing data at Week 4,16 and 24 were considered non-responders). Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 32
    End point values
    Part I/IIa: Guselkumab (GUS) Part I/IIa: FAE
    Number of subjects analysed
    60
    59
    Units: Percentage of Subjects
        number (not applicable)
    63.3
    16.9
    No statistical analyses for this end point

    Secondary: Part III: Percentage of Subjects with a PASI 90 Response at Week 56 who Maintained Response (that is who had PASI Score <=5) at Week 100 After Drug Withdrawal

    Close Top of page
    End point title
    Part III: Percentage of Subjects with a PASI 90 Response at Week 56 who Maintained Response (that is who had PASI Score <=5) at Week 100 After Drug Withdrawal
    End point description
    PASI is system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, lower extremities. Each area is assessed separately for percentage of area involved, which translates to numeric score from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 (none) to 4 (severe). PASI produces numeric score range from 0 (no visible skin involvement) to 72 (maximal skin involvement of whole body). Higher score indicates more severe disease. PASI 90 response denotes subjects achieving 90% improvement from baseline in PASI score. Part III analysis set included all subjects who were treated with guselkumab during Part IIb (Weeks 32 to 64) and entered Part III. Missing data was imputed using NRI (subjects with missing data at Week 64,76,88 and 100 were considered non-responders).
    End point type
    Secondary
    End point timeframe
    Week 100
    End point values
    Guselkumab FAE to Guselkumab
    Number of subjects analysed
    36
    12
    Units: Percentage of Subjects
        number (not applicable)
    47.2
    25.0
    No statistical analyses for this end point

    Secondary: Part III: Time to Loss of Response (PASI Score >5) from Week 56 After Guselkumab Withdrawal at Week 100

    Close Top of page
    End point title
    Part III: Time to Loss of Response (PASI Score >5) from Week 56 After Guselkumab Withdrawal at Week 100
    End point description
    Time to loss of response from Week 56 after GUS withdrawal at Week 100 calculated as time from Week 56 to first onset of loss of response (PASI score>5). PASI system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, lower extremities. Each areas is assessed separately for percentage of area involved, translates to numeric score ranging from 0 (no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 (none) to 4 (severe). PASI produces numeric score ranging from 0 (no visible skin involvement) to 72 (maximal skin involvement of whole body). Higher score indicates more severe disease. Part III analysis set included all subjects treated with GUS during Part IIb (Weeks 32 to 64) and entered Part III. In Part III GUS arm, 99999 indicates ‘upper level of 95% CI was not reached due to insufficient event rate'.
    End point type
    Secondary
    End point timeframe
    Week 100
    End point values
    Guselkumab FAE to Guselkumab
    Number of subjects analysed
    36
    12
    Units: Days
        median (confidence interval 95%)
    315 (301 to 99999)
    293 (219 to 315)
    No statistical analyses for this end point

    Secondary: Part III: Time to PASI Score >3 from Week 56 After Guselkumab Withdrawal at Week 100

    Close Top of page
    End point title
    Part III: Time to PASI Score >3 from Week 56 After Guselkumab Withdrawal at Week 100
    End point description
    The time to PASI>3 from Week 56 after guselkumab withdrawal at Week 100 was calculated as time from Week 56 to PASI response that is PASI >3. PASI is system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for percentage of area involved, which translates to numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on scale of 0 (none) to 4 (severe). PASI produces numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of whole body). Higher score indicates more severe disease. Part III analysis set included all subjects who were treated with guselkumab during Part IIb (Weeks 32 to 64) and entered Part III. Results were reported for observed cases.
    End point type
    Secondary
    End point timeframe
    Week 100
    End point values
    Guselkumab FAE to Guselkumab
    Number of subjects analysed
    36
    12
    Units: Days
        median (confidence interval 95%)
    306 (227 to 308)
    226 (141 to 308)
    No statistical analyses for this end point

    Secondary: Part III: Time to Loss of Response (PASI Score >5) from Week 52 After Guselkumab Withdrawal at Week 100

    Close Top of page
    End point title
    Part III: Time to Loss of Response (PASI Score >5) from Week 52 After Guselkumab Withdrawal at Week 100
    End point description
    Time to loss of response from Week 52 after GUS withdrawal at Week 100 calculated as time from Week 52 to first onset of loss of response (PASI score >5). PASI system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, lower extremities. Each areas is assessed separately for percentage of area involved, translates to numeric score ranging from 0 (no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 (none) to 4 (severe). PASI produces numeric score ranging from 0 (no visible skin involvement) to 72 (maximal skin involvement of whole body). Higher score indicates more severe disease. Part III analysis set included all subjects treated with GUS during Part IIb (Weeks 32 to 64) and entered Part III. In Part III GUS arm, 99999 indicates 'upper level of 95% CI was not reached due to insufficient event rate'.
    End point type
    Secondary
    End point timeframe
    Week 100
    End point values
    Guselkumab FAE to Guselkumab
    Number of subjects analysed
    36
    12
    Units: Days
        median (confidence interval 95%)
    336 (322 to 99999)
    321 (251 to 350)
    No statistical analyses for this end point

    Secondary: Part III: Time to PASI Score >3 from Week 52 After Guselkumab Withdrawal at Week 100

    Close Top of page
    End point title
    Part III: Time to PASI Score >3 from Week 52 After Guselkumab Withdrawal at Week 100
    End point description
    The time to PASI>3 from Week 52 after guselkumab withdrawal at Week 100 was calculated as time from Week 52 to PASI response that is PASI >3. PASI is system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for percentage of area involved, which translates to numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on scale of 0 (none) to 4 (severe). PASI produces numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of whole body). Higher score indicates more severe disease. Part III analysis set included all subjects who were treated with guselkumab during Part IIb (Weeks 32 to 64) and entered Part III. Results were reported for observed cases.
    End point type
    Secondary
    End point timeframe
    Week 100
    End point values
    Guselkumab FAE to Guselkumab
    Number of subjects analysed
    36
    12
    Units: Days
        median (confidence interval 95%)
    334 (252 to 337)
    254 (173 to 329)
    No statistical analyses for this end point

    Secondary: Part III: Percentage of Subjects with PASI 90 Response at Week 56 who Maintained PASI 90 Response at Week 100 After Drug Withdrawal

    Close Top of page
    End point title
    Part III: Percentage of Subjects with PASI 90 Response at Week 56 who Maintained PASI 90 Response at Week 100 After Drug Withdrawal
    End point description
    PASI is system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, lower extremities. Each area is assessed separately for percentage of area involved, which translates to numeric score from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 (none) to 4 (severe). PASI produces numeric score range from 0 (no visible skin involvement) to 72 (maximal skin involvement of whole body). Higher score indicates more severe disease. PASI 90 response denotes subjects achieving 90% improvement from baseline in PASI score. Part III analysis set included all subjects who were treated with guselkumab during Part IIb (Weeks 32 to 64) and entered Part III. Missing data was imputed by NRI (subjects with missing data at Week 64,76,88 and 100 were considered non-responders).
    End point type
    Secondary
    End point timeframe
    Week 100
    End point values
    Guselkumab FAE to Guselkumab
    Number of subjects analysed
    36
    12
    Units: Percentage of Subjects
        number (not applicable)
    13.9
    8.3
    No statistical analyses for this end point

    Secondary: Part III: Percentage of Subjects who Achieved PASI 100 Response at Week 100

    Close Top of page
    End point title
    Part III: Percentage of Subjects who Achieved PASI 100 Response at Week 100
    End point description
    PASI is system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, lower extremities. Each area is assessed separately for percentage of area involved, which translates to numeric score from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 (none) to 4 (severe). PASI produces numeric score range from 0 (no visible skin involvement) to 72 (maximal skin involvement of whole body). Higher score indicates more severe disease. PASI 100 response denotes subjects achieving 100% improvement from baseline in PASI score. Part III analysis set included all subjects who were treated with guselkumab during Part IIb (Weeks 32 to 64) and entered Part III. Missing data was imputed using NRI (subjects with missing data at Week 64,76,88 and 100 were considered non-responders).
    End point type
    Secondary
    End point timeframe
    Week 100
    End point values
    Guselkumab FAE to Guselkumab
    Number of subjects analysed
    36
    12
    Units: Percentage of Subjects
        number (not applicable)
    5.6
    0.0
    No statistical analyses for this end point

    Secondary: Part III: Percentage of Subjects who Achieved an Absolute PASI score <=1, <=2, <=3, <=5 at Week 100

    Close Top of page
    End point title
    Part III: Percentage of Subjects who Achieved an Absolute PASI score <=1, <=2, <=3, <=5 at Week 100
    End point description
    PASI is system used for assessing and grading severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, lower extremities. Each area is assessed separately for percentage of area involved, which translates to numeric score from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 (none) to 4 (severe). PASI produces numeric score range from 0 (no visible skin involvement) to 72 (maximal skin involvement of whole body). Higher score indicates more severe disease. Part III analysis set included all subjects who were treated with guselkumab during Part IIb (Weeks 32 to 64) and entered Part III. Missing data was imputed using NRI (subjects with missing data at Week 64,76,88 and 100 were considered non-responders).
    End point type
    Secondary
    End point timeframe
    Week 100
    End point values
    Guselkumab FAE to Guselkumab
    Number of subjects analysed
    36
    12
    Units: Percentage of Subjects
    number (not applicable)
        PASI Score <=1
    8.3
    0.0
        PASI Score <=2
    19.4
    8.3
        PASI Score <=3
    30.6
    16.7
        PASI Score <=5
    47.2
    25.0
    No statistical analyses for this end point

    Secondary: Part III: Change from Baseline (Week 56) in Signs and Symptoms Aggregate Scores of the Psoriasis Symptom and Sign Diary (PSSD) at Week 100

    Close Top of page
    End point title
    Part III: Change from Baseline (Week 56) in Signs and Symptoms Aggregate Scores of the Psoriasis Symptom and Sign Diary (PSSD) at Week 100
    End point description
    PSSD (7-day version) is patient-reported outcome (PRO) questionnaire designed and validated to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on daily symptom score and sign score when at least 3 items >= 50 percentage of 5 items on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score=average value*10, where, 0= least severe and 100=most severe and higher score indicates more severe disease. Part III analysis set included all subjects who were treated with guselkumab during Part IIb (Weeks 32 to 64) and entered Part III. Missing data was imputed using LOCF imputation method.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 56) and Week 100
    End point values
    Guselkumab FAE to Guselkumab
    Number of subjects analysed
    36
    12
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Symptom Score at Baseline (Week 56)
    3.4 ± 5.4
    11.2 ± 13.2
        Change in Symptom score at Week 100
    25.1 ± 24.7
    30.7 ± 21.7
        Sign Score at Baseline (Week 56)
    5.4 ± 9.3
    13.5 ± 12.9
        Change in Sign score at Week 100
    29.4 ± 24.8
    37.9 ± 28.7
    No statistical analyses for this end point

    Secondary: Part III: Percentage of Subjects who Achieved an Investigator’s Global Assessment (IGA) Score of 0 at Week 100

    Close Top of page
    End point title
    Part III: Percentage of Subjects who Achieved an Investigator’s Global Assessment (IGA) Score of 0 at Week 100
    End point description
    The Investigator’s Global Assessment (IGA) documents the investigator’s assessment of the subject's psoriasis at a given time. Overall lesions are graded for induration, erythema, and scaling. The subject's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Study Part III analysis set included all subjects who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study) and entered Study Part III. Missing data was imputed using NRI (subjects with missing data at Week 64, 76,88 and 100 were considered non-responders).
    End point type
    Secondary
    End point timeframe
    Week 100
    End point values
    Guselkumab FAE to Guselkumab
    Number of subjects analysed
    36
    12
    Units: Percentage of Subjects
        number (not applicable)
    8.3
    0.0
    No statistical analyses for this end point

    Secondary: Part III: Percentage of Subjects who Achieved an Investigator’s Global Assessment (IGA) Score of 0 or 1 at Week 100

    Close Top of page
    End point title
    Part III: Percentage of Subjects who Achieved an Investigator’s Global Assessment (IGA) Score of 0 or 1 at Week 100
    End point description
    The Investigator’s Global Assessment (IGA) documents the investigator’s assessment of the subject's psoriasis at a given time. Overall lesions are graded for induration, erythema, and scaling. The subject's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Study Part III analysis set included all subjects who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study) and entered Study Part III. Missing data was imputed using NRI (subjects with missing data at Week 64, 76,88 and 100 were considered non-responders).
    End point type
    Secondary
    End point timeframe
    Week 100
    End point values
    Guselkumab FAE to Guselkumab
    Number of subjects analysed
    36
    12
    Units: Percentage of Subjects
        number (not applicable)
    30.6
    16.7
    No statistical analyses for this end point

    Secondary: Part III: Change from Baseline (Week 56) in Percent Body Surface Area (%BSA) Psoriatic Involvement at Week 100

    Close Top of page
    End point title
    Part III: Change from Baseline (Week 56) in Percent Body Surface Area (%BSA) Psoriatic Involvement at Week 100
    End point description
    BSA as physical measure to define disease severity is to determine how much of the Body Surface Area (BSA) is affected by psoriasis. Involved BSA is calculated by using the palm of the subject's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis. Study Part III analysis set included all subjects who were treated with guselkumab during Part IIb (Weeks 32 to 64) and entered Part III. Missing data was imputed using LOCF imputation method.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 56) and Week 100
    End point values
    Guselkumab FAE to Guselkumab
    Number of subjects analysed
    36
    12
    Units: Change in BSA (% points)
    arithmetic mean (standard deviation)
        Baseline (Week 56)
    0.9 ± 1.2
    1.5 ± 2.1
        Change at Week 100
    6.1 ± 6.3
    9.1 ± 5.8
    No statistical analyses for this end point

    Secondary: Part III: Percentage of Subjects with a DLQI Score of 0 or 1 at Week 100

    Close Top of page
    End point title
    Part III: Percentage of Subjects with a DLQI Score of 0 or 1 at Week 100
    End point description
    DLQI is 10-item questionnaire that measures impact of skin disease on subject's quality of life, used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work/school performance, 5) personal relationships, 6) treatment. Each question was evaluated on 4-point scale ranging from 0 (not at all) to 3 (very much); higher scores indicate more impact on quality of life. DLQI produces total numeric score ranging from 0 (not at all) to 30 (very much): 0-1=no effect at all on subject's life; 2-6=small effect 7-12=moderate effect; 13-18 =very large effect; 19-30 =extremely large effect. Higher score indicates low quality of life due to more severe disease. Study Part III analysis set included all subjects who were treated with guselkumab during Part IIb (Weeks 32 to 64) and entered Study Part III. Missing data was imputed using LOCF imputation method.
    End point type
    Secondary
    End point timeframe
    Week 100
    End point values
    Guselkumab FAE to Guselkumab
    Number of subjects analysed
    36
    12
    Units: Percentage of Subjects
        number (not applicable)
    25
    8.3
    No statistical analyses for this end point

    Secondary: Part III: Change from Baseline in DLQI Score at Week 100

    Close Top of page
    End point title
    Part III: Change from Baseline in DLQI Score at Week 100
    End point description
    DLQI is 10-item questionnaire that measures impact of skin disease on subject's quality of life, used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work/school performance, 5) personal relationships, 6) treatment. Each question was evaluated on 4-point scale ranging from 0 (not at all) to 3 (very much); higher scores indicate more impact on quality of life. DLQI produces total numeric score ranging from 0 (not at all) to 30 (very much): 0-1=no effect at all on subject's life; 2-6=small effect 7-12=moderate effect; 13-18 =very large effect; 19-30 =extremely large effect. Higher score indicates low quality of life due to more severe disease. Study Part III analysis set included all subjects who were treated with guselkumab during Part IIb (Weeks 32 to 64) and entered Part III. Missing data was imputed using LOCF imputation method.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 56) and Week 100
    End point values
    Guselkumab FAE to Guselkumab
    Number of subjects analysed
    36
    12
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Baseline (Week 56)
    0.9 ± 1.3
    3.5 ± 4.0
        Change at Week 100
    5.3 ± 6.0
    8.0 ± 5.4
    No statistical analyses for this end point

    Secondary: Part III: Percentage of Subjects with a DLQI Score of 0 or 1 at Week 56 who Maintained Response at Week 100

    Close Top of page
    End point title
    Part III: Percentage of Subjects with a DLQI Score of 0 or 1 at Week 56 who Maintained Response at Week 100
    End point description
    DLQI is 10-item questionnaire that measures impact of skin disease on subject's quality of life, used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work/school performance, 5) personal relationships, 6) treatment. Each question was evaluated on 4-point scale ranging from 0 (not at all) to 3 (very much); higher scores indicate more impact on quality of life. DLQI produces total numeric score ranging from 0 (not at all) to 30 (very much): 0-1=no effect at all on subject's life; 2-6=small effect 7-12=moderate effect; 13-18 =very large effect; 19-30 =extremely large effect. Higher score indicates low quality of life due to more severe disease. Study Part III analysis set included all subjects who were treated with guselkumab during Part II b (Weeks 32 to 64) and entered Part III. Missing data imputed using NRI (subjects with missing data at Week 64,76,88 and 100 were considered non-responders).
    End point type
    Secondary
    End point timeframe
    Week 100
    End point values
    Guselkumab FAE to Guselkumab
    Number of subjects analysed
    36
    12
    Units: Percentage of Subjects
        number (not applicable)
    25
    8.3
    No statistical analyses for this end point

    Secondary: Part III: Percentage of Subjects who Achieved ss-IGA Score of Absence of Disease (0) at Week 100 in Subjects with Scalp Psoriasis and ss-IGA Score>=2 (at least mild disease) at Baseline (Week 0)

    Close Top of page
    End point title
    Part III: Percentage of Subjects who Achieved ss-IGA Score of Absence of Disease (0) at Week 100 in Subjects with Scalp Psoriasis and ss-IGA Score>=2 (at least mild disease) at Baseline (Week 0)
    End point description
    The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis (SP). The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4). Part III analysis set included all subjects treated with GUS during Part IIb (Weeks 32 to 64) and entered Part III. Missing data imputed using NRI (subjects with missing data at Week 64,76,88 and 100 were considered non-responders). Here N (number of subjects analysed) signifies number of subjects with Scalp Psoriasis and ss-IGA Score>=2 (at least mild disease) at Baseline (Week 0).
    End point type
    Secondary
    End point timeframe
    Week 100
    End point values
    Guselkumab FAE to Guselkumab
    Number of subjects analysed
    34
    12
    Units: Percentage of Subjects
        number (not applicable)
    14.7
    8.3
    No statistical analyses for this end point

    Secondary: Part III: Percentage of Subjects who Achieved ss-IGA Score of 0 or 1 at Week 100 in Subjects with Scalp Psoriasis and ss-IGA Score>=2 (at least mild disease) at Baseline (Week 0)

    Close Top of page
    End point title
    Part III: Percentage of Subjects who Achieved ss-IGA Score of 0 or 1 at Week 100 in Subjects with Scalp Psoriasis and ss-IGA Score>=2 (at least mild disease) at Baseline (Week 0)
    End point description
    The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis (SP). The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4). Part III analysis set included all subjects treated with GUS during Part IIb (Weeks 32 to 64) and entered Part III. Missing data imputed using NRI (subjects with missing data at Week 64,76,88 and 100 were considered non-responders). Here N (number of subjects analysed) signifies number of subjects with Scalp Psoriasis and ss-IGA Score>=2 (at least mild disease) at Baseline (Week 0).
    End point type
    Secondary
    End point timeframe
    Week 100
    End point values
    Guselkumab FAE to Guselkumab
    Number of subjects analysed
    34
    12
    Units: Percentage of Subjects
        number (not applicable)
    32.4
    25.0
    No statistical analyses for this end point

    Secondary: Part III: Change From Baseline (week 56) in 36-Item Short-Form Health Survey Version 2 (SF-36 V2) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Week 100

    Close Top of page
    End point title
    Part III: Change From Baseline (week 56) in 36-Item Short-Form Health Survey Version 2 (SF-36 V2) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Week 100
    End point description
    SF-36 V2 is generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: PCS and MCS. SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Subjects self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of time, some of time, etc.). Summations of item scores of same subscale give subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. Higher scores indicate better health status. Part III analysis set included all subjects who were treated with guselkumab during Part IIb (Weeks 32 to 64) and entered Part III. Missing data was imputed using LOCF method.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 56) and Week 100
    End point values
    Guselkumab FAE to Guselkumab
    Number of subjects analysed
    36
    12
    Units: Units on a scale
    arithmetic mean (standard deviation)
        SF-36 PCS scores: Baseline (Week 56)
    57.8 ± 3.0
    54.9 ± 5.5
        SF-36 PCS scores: Change at Week 100
    -4.3 ± 6.7
    -3.7 ± 7.0
        SF-36 MCS scores: Baseline (Week 56)
    53.4 ± 6.2
    44.2 ± 11.3
        SF-36 MCS scores: Change at Week 100
    -2.8 ± 5.9
    -3.1 ± 5.9
    No statistical analyses for this end point

    Secondary: Part I/IIa: Percentage of Subjects with Treatment-Emergent Adverse Events (TEAEs) (up to Week 32) as a Measure of Safety and Tolerability

    Close Top of page
    End point title
    Part I/IIa: Percentage of Subjects with Treatment-Emergent Adverse Events (TEAEs) (up to Week 32) as a Measure of Safety and Tolerability
    End point description
    An adverse event (AE) is any untoward medical event that occurs in a subject administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Treatment-emergent AEs (TEAEs) were defined as AEs that occurred during active treatment period through Week 32 after the start of initial study drug administration or AEs that were present at Baseline but worsened in severity after the start of initial study drug administration. Safety analysis set included all randomized subjects treated with at least 1 dose of study drug (guselkumab or FAE). Here N (number of subjects analysed) signifies number of subjects evaluable for this endpoint. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
    End point type
    Secondary
    End point timeframe
    Up to Week 32
    End point values
    Part I/IIa: Guselkumab (GUS) Part I/IIa: FAE
    Number of subjects analysed
    60
    58
    Units: Percentage of Subjects
        number (not applicable)
    78.3
    98.3
    No statistical analyses for this end point

    Secondary: Part IIb: Percentage of Subjects with Treatment-Emergent Adverse Events (TEAEs) (Week 32 to Week 64) as a Measure of safety and Tolerability

    Close Top of page
    End point title
    Part IIb: Percentage of Subjects with Treatment-Emergent Adverse Events (TEAEs) (Week 32 to Week 64) as a Measure of safety and Tolerability
    End point description
    An AE is any untoward medical event that occurs in a subject administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were defined as those AEs that occurred during the active treatment period from Week 32 to Week 56 or the safety follow-up period from Week 56 through Week 64 or those AEs that were present before Week 32 but worsened in severity after Week 32. Study Part IIb analysis set included all subjects who entered Study Part IIb and were treated with 1 of 2 treatments (GUS or FAE) at least once during the treatment period from Week 32 to Week 56. Here, n (number of subjects analyzed) signifies number of subjects analyzed for this endpoint for specified category.
    End point type
    Secondary
    End point timeframe
    Week 32 to Week 64
    End point values
    Guselkumab (GUS) Fumaric Acid Esters (FAE) FAE to Guselkumab (GUS)
    Number of subjects analysed
    55
    14
    20
    Units: Percentage of Subjects
    number (not applicable)
        PASI75 Responders, n= 54, 14, 0
    79.6
    92.9
    0
        PASI75 Non-responders, n= 1, 0, 20
    0
    0
    70.0
    No statistical analyses for this end point

    Secondary: Part III: Percentage of Subjects with Adverse Drug Reactions (ADRs) as a Measure of safety and Tolerability

    Close Top of page
    End point title
    Part III: Percentage of Subjects with Adverse Drug Reactions (ADRs) as a Measure of safety and Tolerability
    End point description
    ADRs were defined as those adverse events with causality 'very likely', 'probable', or 'possible' that occurred during the follow-up extension period from Week 64 to Week 100 or those present before Week 64 but ongoing at Week 64. Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study) and entered Study Part III.
    End point type
    Secondary
    End point timeframe
    Week 64 to Week 100
    End point values
    Guselkumab FAE to Guselkumab
    Number of subjects analysed
    36
    12
    Units: Percentage of Subjects
        number (not applicable)
    5.6
    0
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 100
    Adverse event reporting additional description
    Population included safety analysis set, Part IIb and Part III analysis set. AEs/SAEs till Week 64, and ADRs and deaths from Week 64 to 100 were analyzed and reported. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Part I/IIa (Week 0 to Week 32): Guselkumab (GUS)
    Reporting group description
    In Part I, subjects received GUS 100 mg treatment administered as 100 mg/mL solution SC at Weeks 0, 4, 12 and 20. Subjects who completed treatment phase until Week 24 entered Part II of study. Subjects who completed Part I continued to receive GUS 100 mg SC at Week 28 and 32 during study Part IIa. For subjects who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all subjects, who continued study, safety was followed-up at every visit.

    Reporting group title
    Part I/IIa (Week 0 to Week 32): Fumaric Acid Esters (FAE)
    Reporting group description
    In Part I, subjects received FAE initial/FAE tablets by self-administration at Week 0. The doses were up-titrated and had to be taken every day with different daily doses depending on the optimal individual benefit risk ratio (maximum 6*120 mg/day) according to local prescribing information up to Week 24. Subjects who completed the treatment phase until Week 24 entered the Part II of the study. Subjects who completed Part I and consented for Part IIa continued to receive commercially available FAE tablets specifically labeled for the study from Week 24 through Week 32 during study Part IIa. For subjects who discontinued study, a safety follow-up was done at Week 32 (Part I) or 12 weeks after last treatment (whatever came first). For all subjects who continued study, safety was followed-up at every visit.

    Reporting group title
    Part IIb (Week 32 through Week 56): Guselkumab (GUS)
    Reporting group description
    At Week 32 (study Part IIb), PASI 75 response was evaluated and PASI 75 responders and non-responders of guselkumab arm continued to receive guselkumab 100 mg SC every 8 weeks (weeks 36, 44 and 52). Safety follow-up was done at Week 64 (Part II). Subjects who discontinued at any timepoint were followed up 12 weeks after last treatment dose. For all subjects who continued study, safety was followed-up at every visit.

    Reporting group title
    Part IIb (Week 32 through Week 56): Fumaric Acid Esters (FAE)
    Reporting group description
    At Week 32, PASI 75 response was evaluated and PASI 75 responders of the FAE arm continued to receive commercially available FAE tablets specifically labeled for the study during Part IIb up to Week 56. Safety follow-up was done at Week 64 (Part II). Subjects who discontinued at any timepoint were followed up 12 weeks after last treatment dose. For all subjects who continued study, safety was followed-up at every visit.

    Reporting group title
    Part IIb (Week 32 through Week 56): FAE to Guselkumab (GUS)
    Reporting group description
    At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to 100 mg guselkumab SC at Weeks 32 and continued at Week 36, 44 and Week 52. Safety follow-up was done at Week 64 (Part II). Subjects who discontinued at any timepoint were followed up 12 weeks after last treatment dose. For all subjects who continued study, safety was followed-up at every visit.

    Reporting group title
    Part III (Week 64 through Week 100): Guselkumab (GUS)
    Reporting group description
    Subjects who received GUS in Study Part II (subjects who started GUS treatment at Week 0), had no psoriatic arthritis diagnosed at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.

    Reporting group title
    Part III (Week 64 through Week 100): FAE to Guselkumab (GUS)
    Reporting group description
    At Week 32, PASI 75 response was evaluated and PASI 75 non-responders of FAE arm were switched to GUS and received GUS 100 mg SC at week 32, 36, 44 and 52. Safety follow-up was done at Week 64 (Part II). Subjects who discontinued at any timepoint were followed-up 12 weeks after last treatment dose. Subjects who switched from FAE to GUS treatment at Week 32), had no psoriatic arthritis diagnosed at baseline and achieved a PASI 90 response at end of Study Part II (Week 56) entered follow-up extension at Week 64 in Study Part III (GUS withdrawal phase) and were followed-up until loss of response or until Week 100.

    Serious adverse events
    Part I/IIa (Week 0 to Week 32): Guselkumab (GUS) Part I/IIa (Week 0 to Week 32): Fumaric Acid Esters (FAE) Part IIb (Week 32 through Week 56): Guselkumab (GUS) Part IIb (Week 32 through Week 56): Fumaric Acid Esters (FAE) Part IIb (Week 32 through Week 56): FAE to Guselkumab (GUS) Part III (Week 64 through Week 100): Guselkumab (GUS) Part III (Week 64 through Week 100): FAE to Guselkumab (GUS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 60 (5.00%)
    2 / 58 (3.45%)
    3 / 55 (5.45%)
    1 / 14 (7.14%)
    2 / 20 (10.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Clavicle Fracture
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    1 / 20 (5.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb Injury
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post Procedural Haemorrhage
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radius Fracture
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lipoma
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial Infarction
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    1 / 20 (5.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Sarcoidosis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Thymus Enlargement
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inguinal Hernia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Psoriatic Arthropathy
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    1 / 14 (7.14%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Tonsillitis
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Part I/IIa (Week 0 to Week 32): Guselkumab (GUS) Part I/IIa (Week 0 to Week 32): Fumaric Acid Esters (FAE) Part IIb (Week 32 through Week 56): Guselkumab (GUS) Part IIb (Week 32 through Week 56): Fumaric Acid Esters (FAE) Part IIb (Week 32 through Week 56): FAE to Guselkumab (GUS) Part III (Week 64 through Week 100): Guselkumab (GUS) Part III (Week 64 through Week 100): FAE to Guselkumab (GUS)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 60 (78.33%)
    57 / 58 (98.28%)
    43 / 55 (78.18%)
    13 / 14 (92.86%)
    14 / 20 (70.00%)
    2 / 36 (5.56%)
    0 / 12 (0.00%)
    Vascular disorders
    Aortic Elongation
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Flushing
         subjects affected / exposed
    0 / 60 (0.00%)
    19 / 58 (32.76%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    23
    0
    0
    0
    0
    0
    Hypertension
         subjects affected / exposed
    4 / 60 (6.67%)
    2 / 58 (3.45%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    4
    2
    0
    0
    0
    0
    0
    Hypotension
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Lymphoedema
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Peripheral Venous Disease
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Surgical and medical procedures
    Dental Operation
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Skin Neoplasm Excision
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal Cell Carcinoma
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Dysplastic Naevus
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Giant Cell Tumour of Tendon Sheath
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Lipoma
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Papilloma
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Skin Papilloma
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    2 / 55 (3.64%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Immune system disorders
    Seasonal Allergy
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Chills
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Fatigue
         subjects affected / exposed
    1 / 60 (1.67%)
    5 / 58 (8.62%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    1 / 20 (5.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    6
    0
    0
    1
    0
    0
    Feeling Hot
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Hypothermia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Inflammation
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Injection Site Rash
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Malaise
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    Oedema Peripheral
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    4
    0
    0
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 60 (1.67%)
    2 / 58 (3.45%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    1 / 20 (5.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Mood Altered
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Restlessness
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Vaginal Haemorrhage
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Arthropod Bite
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Bone Contusion
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Contusion
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Joint Injury
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Laceration
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Ligament Sprain
         subjects affected / exposed
    1 / 60 (1.67%)
    2 / 58 (3.45%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    1 / 20 (5.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    2
    0
    0
    1
    0
    0
    Limb Injury
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Post Procedural Haematoma
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Post Procedural Haemorrhage
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Post-Traumatic Neck Syndrome
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Procedural Pain
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Sunburn
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Traumatic Haematoma
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Wound
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    4 / 60 (6.67%)
    3 / 58 (5.17%)
    3 / 55 (5.45%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    4
    4
    3
    0
    0
    0
    0
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    1 / 60 (1.67%)
    2 / 58 (3.45%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    1 / 36 (2.78%)
    0 / 12 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    1
    0
    Blood Glucose Decreased
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Blood Glucose Increased
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Breath Sounds Abnormal
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Gamma-Glutamyltransferase Increased
         subjects affected / exposed
    0 / 60 (0.00%)
    3 / 58 (5.17%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    0
    Hepatic Enzyme Increased
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    Human Chorionic Gonadotropin Increased
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Lymph Node Palpable
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Lymphocyte Count Increased
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    2 / 55 (3.64%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Lymphocyte Morphology Abnormal
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    2 / 55 (3.64%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    Protein Urine Present
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    1 / 14 (7.14%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Transaminases Increased
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Weight Decreased
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Weight Increased
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    White Blood Cells Urine Positive
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Ventricular Extrasystoles
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 60 (3.33%)
    2 / 58 (3.45%)
    2 / 55 (3.64%)
    1 / 14 (7.14%)
    1 / 20 (5.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    2
    3
    2
    1
    0
    0
    Oropharyngeal Pain
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    3 / 55 (5.45%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    3
    0
    0
    0
    0
    Pharyngeal Erythema
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Pulmonary Arterial Hypertension
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    2 / 20 (10.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    2
    0
    0
    Throat Irritation
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Eosinophilia
         subjects affected / exposed
    1 / 60 (1.67%)
    5 / 58 (8.62%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    5
    0
    0
    0
    0
    0
    Leukopenia
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 58 (3.45%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    1 / 20 (5.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    0
    0
    1
    0
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Lymphopenia
         subjects affected / exposed
    0 / 60 (0.00%)
    21 / 58 (36.21%)
    0 / 55 (0.00%)
    5 / 14 (35.71%)
    1 / 20 (5.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    25
    0
    6
    1
    0
    0
    Monocytosis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Nervous system disorders
    Carpal Tunnel Syndrome
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    Cervicogenic Vertigo
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    Dizziness
         subjects affected / exposed
    1 / 60 (1.67%)
    2 / 58 (3.45%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    Dysaesthesia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Headache
         subjects affected / exposed
    9 / 60 (15.00%)
    8 / 58 (13.79%)
    3 / 55 (5.45%)
    1 / 14 (7.14%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    13
    12
    3
    1
    0
    0
    0
    Hypoaesthesia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Migraine
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    1 / 14 (7.14%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Paraesthesia
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Transient Ischaemic Attack
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Eye disorders
    Dry Eye
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Eye Haemorrhage
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Visual Acuity Reduced
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Visual Impairment
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    1 / 14 (7.14%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Ear Pain
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Middle Ear Inflammation
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Tympanic Membrane Perforation
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Vertigo
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    1 / 14 (7.14%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    0
    Gastrointestinal disorders
    Abdominal Discomfort
         subjects affected / exposed
    0 / 60 (0.00%)
    3 / 58 (5.17%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    0
    Abdominal Distension
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Abdominal Pain
         subjects affected / exposed
    1 / 60 (1.67%)
    9 / 58 (15.52%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    9
    0
    0
    0
    0
    0
    Abdominal Pain Upper
         subjects affected / exposed
    2 / 60 (3.33%)
    18 / 58 (31.03%)
    0 / 55 (0.00%)
    1 / 14 (7.14%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    23
    0
    1
    0
    0
    0
    Constipation
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Defaecation Urgency
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    7 / 60 (11.67%)
    34 / 58 (58.62%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    7
    67
    0
    0
    0
    0
    0
    Dry Mouth
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    1 / 60 (1.67%)
    2 / 58 (3.45%)
    2 / 55 (3.64%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    2
    2
    0
    0
    0
    0
    Enteritis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Faeces Soft
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Flatulence
         subjects affected / exposed
    1 / 60 (1.67%)
    2 / 58 (3.45%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    Gastritis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Gastrointestinal Disorder
         subjects affected / exposed
    1 / 60 (1.67%)
    2 / 58 (3.45%)
    0 / 55 (0.00%)
    1 / 14 (7.14%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    2
    0
    1
    0
    0
    0
    Gastrointestinal Pain
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Haematochezia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    1 / 60 (1.67%)
    6 / 58 (10.34%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    8
    0
    0
    0
    0
    0
    Tooth Disorder
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Toothache
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    0
    Renal and urinary disorders
    Glycosuria
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    1 / 20 (5.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    1
    0
    0
    2
    0
    0
    Haematuria
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Ketonuria
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    1 / 20 (5.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    0
    0
    2
    0
    0
    Leukocyturia
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Proteinuria
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Renal Failure
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Ureterolithiasis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Hepatobiliary disorders
    Hepatic Steatosis
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    1 / 20 (5.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    1 / 14 (7.14%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Alopecia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Dermatitis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Dermatitis Allergic
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Dermatitis Contact
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Erythema
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Hyperkeratosis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Neurodermatitis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Night Sweats
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Polymorphic Light Eruption
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Prurigo
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Pruritus
         subjects affected / exposed
    2 / 60 (3.33%)
    5 / 58 (8.62%)
    2 / 55 (3.64%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    6
    2
    0
    0
    0
    0
    Psoriasis
         subjects affected / exposed
    2 / 60 (3.33%)
    6 / 58 (10.34%)
    0 / 55 (0.00%)
    1 / 14 (7.14%)
    1 / 20 (5.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    14
    0
    1
    1
    0
    0
    Rash
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Rash Erythematous
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    Rosacea
         subjects affected / exposed
    1 / 60 (1.67%)
    3 / 58 (5.17%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    0
    Seborrhoea
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Skin Burning Sensation
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 58 (3.45%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    Skin Exfoliation
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Urticaria
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Product issues
    Device Breakage
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 60 (6.67%)
    3 / 58 (5.17%)
    2 / 55 (3.64%)
    0 / 14 (0.00%)
    1 / 20 (5.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    4
    5
    2
    0
    1
    0
    0
    Arthritis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    1 / 20 (5.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    Articular Calcification
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Back Pain
         subjects affected / exposed
    3 / 60 (5.00%)
    2 / 58 (3.45%)
    3 / 55 (5.45%)
    1 / 14 (7.14%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    3
    3
    4
    1
    0
    0
    0
    Bursitis
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    1 / 20 (5.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    1
    0
    0
    1
    0
    0
    Femoroacetabular Impingement
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Intervertebral Disc Protrusion
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Muscle Tightness
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Musculoskeletal Pain
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Myalgia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Neck Pain
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Osteoarthritis
         subjects affected / exposed
    3 / 60 (5.00%)
    1 / 58 (1.72%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    3
    2
    1
    0
    0
    0
    0
    Osteochondrosis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Pain in Extremity
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Spinal Osteoarthritis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Spinal Pain
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Tendonitis
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Diabetes Mellitus
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    1 / 14 (7.14%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Food Intolerance
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    1 / 20 (5.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Hyperuricaemia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Vitamin D Deficiency
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 58 (1.72%)
    5 / 55 (9.09%)
    1 / 14 (7.14%)
    1 / 20 (5.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    1
    5
    1
    1
    0
    0
    Bronchitis Viral
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Cystitis
         subjects affected / exposed
    2 / 60 (3.33%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    1 / 20 (5.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    1
    0
    0
    1
    0
    0
    Ear Infection
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    Folliculitis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Furuncle
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    2 / 60 (3.33%)
    2 / 58 (3.45%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    2
    1
    0
    0
    0
    0
    Gastroenteritis Norovirus
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Gastroenteritis Salmonella
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Gastrointestinal Infection
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    1 / 14 (7.14%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    Herpes Zoster
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 58 (3.45%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    Impetigo
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Influenza
         subjects affected / exposed
    2 / 60 (3.33%)
    2 / 58 (3.45%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    1 / 20 (5.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    2
    1
    0
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    25 / 60 (41.67%)
    19 / 58 (32.76%)
    28 / 55 (50.91%)
    8 / 14 (57.14%)
    8 / 20 (40.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    41
    30
    41
    11
    13
    0
    0
    Onychomycosis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    1 / 20 (5.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    Oral Herpes
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Otitis Media
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 58 (1.72%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    Periodontitis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Pharyngitis
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 58 (3.45%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    1 / 20 (5.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    1
    0
    1
    0
    0
    Pulpitis Dental
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Pyelonephritis
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    2 / 14 (14.29%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    Rhinitis
         subjects affected / exposed
    5 / 60 (8.33%)
    0 / 58 (0.00%)
    2 / 55 (3.64%)
    1 / 14 (7.14%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    5
    0
    3
    2
    0
    0
    0
    Root Canal Infection
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Rotavirus Infection
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    2 / 60 (3.33%)
    1 / 58 (1.72%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    1
    1
    0
    0
    0
    0
    Skin Candida
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Tinea Pedis
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 58 (1.72%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    Tonsillitis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
    1 / 55 (1.82%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    Tooth Infection
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 58 (0.00%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    1 / 36 (2.78%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Urinary Tract Infection
         subjects affected / exposed
    3 / 60 (5.00%)
    1 / 58 (1.72%)
    2 / 55 (3.64%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    4
    1
    2
    0
    0
    0
    0
    Viral Infection
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
    0 / 55 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
    0 / 36 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Apr 2017
    As per protocol amendment-1, the study was split into two parts (Study Part I and II), allowing subjects to enter a 32-week study extension until Week 56.
    22 Jan 2018
    Protocol amendment -2 was implemented to investigate maintenance of response after guselkumab withdrawal in 36-week study extension in subjects who responded well (Psoriasis Area and Severity Index [PASI] 90 response) to guselkumab.

    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.
    In Part III, small groups with less subjects generated through Part IIb, and further decline in subjects enrolled in Part III (ie, subjects started guselkumab (GUS) at Week 0/ switched from FAE to GUS in Week 32, and had PASI 90 response at Week 56).
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA