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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
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

CNTO1959PSO3008

ISRCTN number

US NCT number

NCT02951533

WHO universal trial number (UTN)

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

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

06 Feb 2019

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

06 Feb 2019

Was the trial ended prematurely?

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?

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

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

110

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

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 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]

Are arms mutually exclusive

Yes

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.

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
Consent withdrawn by subject	2	4
Adverse event, non-fatal	-	16
Non-compliance with study drug	-	1
Lost to follow-up	2	2

Period 2 title

Part IIa (Week 24 through Week 32)

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Guselkumab

Arm description

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.

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 title

Part IIb (Week 32 through Week 56)

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Guselkumab (GUS)

Arm description

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).

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.

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 title

Part III (Week 64 through Week 100)

Is this the baseline period?

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Guselkumab

Arm description

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

FAE to Guselkumab

Arm description

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
Consent withdrawn by subject	2	2
Prohibited Medication Therapy	1	-
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

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Reporting group title

Guselkumab (GUS)

Reporting group description

Reporting group title

Fumaric Acid Esters (FAE)

Reporting group description

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 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

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Reporting group title

Guselkumab (GUS)

Reporting group description

Reporting group title

Fumaric Acid Esters (FAE)

Reporting group description

Reporting group title

Guselkumab

Reporting group description

Reporting group title

Fumaric Acid Esters (FAE)

Reporting group description

Reporting group title

Guselkumab (GUS)

Reporting group description

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

Reporting group title

Guselkumab

Reporting group description

Reporting group title

FAE to Guselkumab

Reporting group description

Subject analysis set title

Part I: Guselkumab (GUS)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Part I: Fumaric Acid Esters (FAE)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Part I/IIa: Guselkumab (GUS)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Part I/IIa: FAE

Subject analysis set type

Full analysis

Subject analysis set description

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

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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

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

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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

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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

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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

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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

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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

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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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)

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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)

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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

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

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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

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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

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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

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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

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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 name

MedDRA

Dictionary version

19.1

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
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
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
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
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
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
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%)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

More information

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Were there any global substantial amendments to the protocol? Yes

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.

Were there any global interruptions to the trial? No

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).

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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