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Clinical Trial Results:
A PHASE 2B, MULTI-SITE, RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, PARALLEL-GROUP STUDY OF THE EFFICACY, SAFETY, LOCAL TOLERABILITY AND PHARMACOKINETICS OF 2 DOSE STRENGTHS AND 2 REGIMENS OF TOFACITINIB OINTMENT IN SUBJECTS WITH CHRONIC PLAQUE PSORIASIS

Summary
EudraCT number	2012-005645-20
Trial protocol	DK
Global end of trial date	16 Sep 2014

Results information
Results version number	v1(current)
This version publication date	16 Sep 2016
First version publication date	16 Sep 2016
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

A3921082

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Pfizer Inc.

Sponsor organisation address

235 E 42nd Street, New York,, United States, NY 10017

Public contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.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

16 Sep 2014

Is this the analysis of the primary completion data?

Yes

Primary completion date

16 Sep 2014

Global end of trial reached?

Yes

Global end of trial date

16 Sep 2014

Was the trial ended prematurely?

Main objective of the trial

The Primary Objectives were: To characterize the efficacy of tofacitinib ointment (10 mg/g and 20 mg/g) applied once daily (QD) or twice daily (BID) over 12 weeks in subjects with mild or moderate chronic plaque psoriasis compared to the corresponding placebo ointment (vehicle) (QD or BID). To characterize safety of tofacitinib ointment (10 mg/g and 20 mg/g) applied QD or BID over 12 weeks in subjects with mild or moderate chronic plaque psoriasis. To characterize local tolerability of tofacitinib ointment (10 mg/g and 20 mg/g) applied QD or BID over 12 weeks in subjects with mild or moderate chronic plaque psoriasis. The Secondary Objectives were: To characterize effects on patient reported outcome (PRO) measures of tofacitinib ointment (10 mg/g and 20 mg/g) applied QD or BID over 12 weeks of treatment in subjects with mild or moderate chronic plaque psoriasis.

Protection of trial subjects

The study was conducted in accordance with legal and regulatory requirements, as well as the general principles set forth in the International Ethical Guidelines for Biomedical Research Involving Human Subjects (Council for International Organizations of Medical Sciences 2002), Guidelines for Good Clinical Practice (ICH 1996), and the Declaration of Helsinki (World Medical Association 1996 and 2008). The informed consent document was in compliance with International Conference on Harmonisation (ICH) GCP, local regulatory requirements, and legal requirements. The informed consent document used during the informed consent process was reviewed by the sponsor, approved by the IRB/IEC, and available for inspection. The investigator was to inform Pfizer immediately of any urgent safety measures taken by the investigator to protect the study subjects against any immediate hazard, and of any serious breaches of this protocol or of ICH GCP that the investigator became aware of.

Background therapy

Evidence for comparator

Actual start date of recruitment

13 May 2013

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Canada: 127

Country: Number of subjects enrolled

Denmark: 5

Country: Number of subjects enrolled

Poland: 109

Country: Number of subjects enrolled

United States: 230

Worldwide total number of subjects

471

EEA total number of subjects

114

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)

393

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Advertisements approved by ethics committees and investigator databases could be used as recruitment procedures.

Screening details

Subjects were screened within 28 days (+4 days) prior to Visit 1 (Baseline/Day 1) to confirm that they were suitable and potentially eligible for the study. Screening procedures could be performed over more than one visit in the 28 days (+4 days) prior to Visit 1 (Baseline/Day 1).

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Carer

Blinding implementation details

Carer equals the physician treating the subject Investigator equals the sponsor of the trial.

Are arms mutually exclusive

Yes

Mild/Moderate: Tofacitinib 20 mg/gram (mg/g) BID

Arm description

Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.

Arm type

Active comparator

Investigational medicinal product name

Tofacitinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Ointment

Routes of administration

Topical use

Dosage and administration details

20 mg/g BID

Mild/Moderate: Tofacitinib 10 mg/g BID

Arm description

Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.

Arm type

Active comparator

Investigational medicinal product name

Tofacitinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Ointment

Routes of administration

Topical use

Dosage and administration details

10 mg/g BID

Mild/Moderate: Placebo (vehicle) BID

Arm description

Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Ointment

Routes of administration

Topical use

Dosage and administration details

placebo BID

Mild/Moderate: Tofacitinib 20 mg/g QD

Arm description

Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.

Arm type

Active comparator

Investigational medicinal product name

Tofacitinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Ointment

Routes of administration

Topical use

Dosage and administration details

20 mg/g QD

Mild/Moderate: Tofacitinib 10 mg/g QD

Arm description

Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.

Arm type

Active comparator

Investigational medicinal product name

Tofacitinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Ointment

Routes of administration

Topical use

Dosage and administration details

10 mg/g QD

Mild/Moderate: Placebo (vehicle) QD

Arm description

Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Ointment

Routes of administration

Topical use

Dosage and administration details

placebo QD

Severe: Tofacitinib 20 mg/g BID

Arm description

Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.

Arm type

Active comparator

Investigational medicinal product name

Tofacitinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Ointment

Routes of administration

Topical use

Dosage and administration details

20 mg/g BID

Severe: Tofacitinib 10 mg/g BID

Arm description

Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.

Arm type

Active comparator

Investigational medicinal product name

Tofacitinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Ointment

Routes of administration

Topical use

Dosage and administration details

10 mg/g BID

Severe: Placebo (vehicle) BID

Arm description

Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Ointment

Routes of administration

Topical use

Dosage and administration details

placebo BID

Severe: Tofacitinib 20 mg/g QD

Arm description

Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.

Arm type

Active comparator

Investigational medicinal product name

Tofacitinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Ointment

Routes of administration

Topical use

Dosage and administration details

20 mg/g QD

Severe: Tofacitinib 10 mg/g QD

Arm description

Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.

Arm type

Active comparator

Investigational medicinal product name

Tofacitinib

Investigational medicinal product code

Other name

Pharmaceutical forms

Ointment

Routes of administration

Topical use

Dosage and administration details

10 mg/g QD

Severe: Placebo (vehicle) QD

Arm description

Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Ointment

Routes of administration

Topical use

Dosage and administration details

placebo QD

Number of subjects in period 1	Mild/Moderate: Tofacitinib 20 mg/gram (mg/g) BID	Mild/Moderate: Tofacitinib 10 mg/g BID	Mild/Moderate: Placebo (vehicle) BID	Mild/Moderate: Tofacitinib 20 mg/g QD	Mild/Moderate: Tofacitinib 10 mg/g QD	Mild/Moderate: Placebo (vehicle) QD	Severe: Tofacitinib 20 mg/g BID	Severe: Tofacitinib 10 mg/g BID	Severe: Placebo (vehicle) BID	Severe: Tofacitinib 20 mg/g QD	Severe: Tofacitinib 10 mg/g QD	Severe: Placebo (vehicle) QD
Started	71	70	71	70	74	74	7	7	7	7	6	7
Completed	55	52	48	51	57	48	6	5	4	2	4	3
Not completed	16	18	23	19	17	26	1	2	3	5	2	4
Adverse event, serious fatal	-	1	-	-	-	-	-	-	-	-	-	-
Consent withdrawn by subject	6	3	3	3	3	5	-	-	-	1	-	1
Adverse event, non-fatal	-	-	4	6	3	7	-	1	1	1	-	2
Not specified	2	3	2	2	2	1	-	-	-	-	-	-
Non-compliance with study treatment	2	1	1	-	-	1	-	-	-	-	-	-
Lost to follow-up	-	1	4	2	-	3	-	-	-	1	-	1
Lack of efficacy	5	8	7	6	9	8	1	1	2	2	2	-
Protocol deviation	1	1	2	-	-	1	-	-	-	-	-	-

Baseline characteristics

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Reporting group title

Mild/Moderate: Tofacitinib 20 mg/gram (mg/g) BID

Reporting group description

Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.

Reporting group title

Mild/Moderate: Tofacitinib 10 mg/g BID

Reporting group description

Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.

Reporting group title

Mild/Moderate: Placebo (vehicle) BID

Reporting group description

Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.

Reporting group title

Mild/Moderate: Tofacitinib 20 mg/g QD

Reporting group description

Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.

Reporting group title

Mild/Moderate: Tofacitinib 10 mg/g QD

Reporting group description

Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.

Reporting group title

Mild/Moderate: Placebo (vehicle) QD

Reporting group description

Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.

Reporting group title

Severe: Tofacitinib 20 mg/g BID

Reporting group description

Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.

Reporting group title

Severe: Tofacitinib 10 mg/g BID

Reporting group description

Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.

Reporting group title

Severe: Placebo (vehicle) BID

Reporting group description

Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks.

Reporting group title

Severe: Tofacitinib 20 mg/g QD

Reporting group description

Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.

Reporting group title

Severe: Tofacitinib 10 mg/g QD

Reporting group description

Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.

Reporting group title

Severe: Placebo (vehicle) QD

Reporting group description

Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.

Reporting group values	Mild/Moderate: Tofacitinib 20 mg/gram (mg/g) BID	Mild/Moderate: Tofacitinib 10 mg/g BID	Mild/Moderate: Placebo (vehicle) BID	Mild/Moderate: Tofacitinib 20 mg/g QD	Mild/Moderate: Tofacitinib 10 mg/g QD	Mild/Moderate: Placebo (vehicle) QD	Severe: Tofacitinib 20 mg/g BID	Severe: Tofacitinib 10 mg/g BID	Severe: Placebo (vehicle) BID	Severe: Tofacitinib 20 mg/g QD	Severe: Tofacitinib 10 mg/g QD	Severe: Placebo (vehicle) QD	Total
Number of subjects	71	70	71	70	74	74	7	7	7	7	6	7	471
Age categorical
Units: Subjects
Adults (18-64 years)	58	57	59	59	65	64	6	6	5	5	5	4	393
From 65-84 years	13	13	12	11	8	10	1	1	2	2	1	3	77
85 years and over	0	0	0	0	1	0	0	0	0	0	0	0	1
Gender, Male/Female
Units: Participants
Female	28	23	30	33	24	32	1	3	1	1	0	0	176
Male	43	47	41	37	50	42	6	4	6	6	6	7	295

End points

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Reporting group title

Mild/Moderate: Tofacitinib 20 mg/gram (mg/g) BID

Reporting group description

Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.

Reporting group title

Mild/Moderate: Tofacitinib 10 mg/g BID

Reporting group description

Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.

Reporting group title

Mild/Moderate: Placebo (vehicle) BID

Reporting group description

Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.

Reporting group title

Mild/Moderate: Tofacitinib 20 mg/g QD

Reporting group description

Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.

Reporting group title

Mild/Moderate: Tofacitinib 10 mg/g QD

Reporting group description

Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.

Reporting group title

Mild/Moderate: Placebo (vehicle) QD

Reporting group description

Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.

Reporting group title

Severe: Tofacitinib 20 mg/g BID

Reporting group description

Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.

Reporting group title

Severe: Tofacitinib 10 mg/g BID

Reporting group description

Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.

Reporting group title

Severe: Placebo (vehicle) BID

Reporting group description

Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks.

Reporting group title

Severe: Tofacitinib 20 mg/g QD

Reporting group description

Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.

Reporting group title

Severe: Tofacitinib 10 mg/g QD

Reporting group description

Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.

Reporting group title

Severe: Placebo (vehicle) QD

Reporting group description

Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.

Primary: Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (≥) 2 Grade/point Improvement from Baseline at Week 12

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End point title

Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (≥) 2 Grade/point Improvement from Baseline at Week 12 ^[1]

End point description

Clinical signs of plaque psoriasis (erythema [E], induration [I], and scaling [S]) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.

End point type

Primary

End point timeframe

Baseline, Week 12

Notes
[1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: A statistical analysis for this outcome measure was not included, because this study was an estimation trial, not a confirmatory trial.

End point values	Mild/Moderate: Tofacitinib 20 mg/gram (mg/g) BID	Mild/Moderate: Tofacitinib 10 mg/g BID	Mild/Moderate: Placebo (vehicle) BID	Mild/Moderate: Tofacitinib 20 mg/g QD	Mild/Moderate: Tofacitinib 10 mg/g QD	Mild/Moderate: Placebo (vehicle) QD
Number of subjects analysed	71	70	71	70	74	74
Units: Percentage of Participants
number (not applicable)	21.1	12.9	16.9	20	21.6	17.6

Mild/Moderate BID: Tofacitinib 20 mg/g vs Placebo

Statistical analysis description

The mild/moderate full analysis set (FASm) included all participants in the FAS with a baseline PGA-C disease severity of mild (2) or moderate (3). A participant with a missing value was considered a non-responder.

Comparison groups

Mild/Moderate: Placebo (vehicle) BID v Mild/Moderate: Tofacitinib 20 mg/gram (mg/g) BID

Number of subjects included in analysis

142

Analysis specification

Pre-specified

Analysis type

other ^[2]

P-value

= 0.5425

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in response rates

Point estimate

3.9

Confidence interval

level

80%

sides

2-sided

lower limit

-4.3

upper limit

Variability estimate

Standard error of the mean

Dispersion value

6.36

Notes
[2] - Large sample approximation to the difference in binomial proportions adjusted for the baseline PGA-C disease severity using the Cochran‑Mantel-Haenszel approach.

Mild/Moderate BID: Tofacitinib 10 mg/g vs Placebo

Statistical analysis description

FASm included all participants in the FAS with a baseline PGA-C disease severity of mild (2) or moderate (3). A participant with a missing value was considered a non-responder.

Comparison groups

Mild/Moderate: Tofacitinib 10 mg/g BID v Mild/Moderate: Placebo (vehicle) BID

Number of subjects included in analysis

141

Analysis specification

Pre-specified

Analysis type

other ^[3]

P-value

= 0.4976

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in response rates

Point estimate

-4

Confidence interval

level

80%

sides

2-sided

lower limit

-11.5

upper limit

3.5

Variability estimate

Standard error of the mean

Dispersion value

5.87

Notes
[3] - Large sample approximation to the difference in binomial proportions adjusted for the baseline PGA-C disease severity using the Cochran‑Mantel-Haenszel approach

Mild/Moderate QD: Tofacitinib 20 mg/g vs Placebo

Statistical analysis description

FASm included all participants in the FAS with a baseline PGA-C disease severity of mild (2) or moderate (3). A participant with a missing value was considered a non-responder.

Comparison groups

Mild/Moderate: Tofacitinib 20 mg/g QD v Mild/Moderate: Placebo (vehicle) QD

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[4]

P-value

= 0.6039

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in response rates

Point estimate

3.3

Confidence interval

level

80%

sides

2-sided

lower limit

-4.9

upper limit

11.5

Variability estimate

Standard error of the mean

Dispersion value

6.36

Notes
[4] - Large sample approximation to the difference in binomial proportions adjusted for the baseline PGA-C disease severity using the Cochran‑Mantel-Haenszel approach

Mild/Moderate QD: Tofacitinib 10 mg/g vs Placebo

Statistical analysis description

FASm included all participants in the FAS with a baseline PGA-C disease severity of mild (2) or moderate (3). A participant with a missing value was considered a non-responder.

Comparison groups

Mild/Moderate: Tofacitinib 10 mg/g QD v Mild/Moderate: Placebo (vehicle) QD

Number of subjects included in analysis

148

Analysis specification

Pre-specified

Analysis type

other ^[5]

P-value

= 0.5279

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in response rate

Point estimate

Confidence interval

level

80%

sides

2-sided

lower limit

-4.1

upper limit

12.1

Variability estimate

Standard error of the mean

Dispersion value

6.34

Notes
[5] - Large sample approximation to the difference in binomial proportions adjusted for the baseline PGA-C disease severity using the Cochran‑Mantel-Haenszel approach

Primary: Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and ≥2 Grade/point Improvement from Baseline at Week 8

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End point title

Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and ≥2 Grade/point Improvement from Baseline at Week 8 ^[6]

End point description

Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.

End point type

Primary

End point timeframe

Baseline, Week 8

Notes
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: A statistical analysis for this outcome measure was not included, because this study was an estimation trial, not a confirmatory trial.

End point values	Mild/Moderate: Tofacitinib 20 mg/gram (mg/g) BID	Mild/Moderate: Tofacitinib 10 mg/g BID	Mild/Moderate: Placebo (vehicle) BID	Mild/Moderate: Tofacitinib 20 mg/g QD	Mild/Moderate: Tofacitinib 10 mg/g QD	Mild/Moderate: Placebo (vehicle) QD
Number of subjects analysed	71	70	71	70	74	74
Units: Percentage of Participants
number (not applicable)	22.5	10	11.3	18.6	14.9	8.1

Mild/Moderate BID: Tofacitinib 20 mg/g vs Placebo

Statistical analysis description

FASm. A participant with a missing value was considered a non-responder.

Comparison groups

Mild/Moderate: Placebo (vehicle) BID v Mild/Moderate: Tofacitinib 20 mg/gram (mg/g) BID

Number of subjects included in analysis

142

Analysis specification

Pre-specified

Analysis type

other ^[7]

P-value

= 0.071

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in response rates

Point estimate

10.8

Confidence interval

level

80%

sides

2-sided

lower limit

3.1

upper limit

18.5

Variability estimate

Standard error of the mean

Dispersion value

5.99

Notes
[7] - Large sample approximation to the difference in binomial proportions adjusted for the baseline PGA-C disease severity using the Cochran‑Mantel-Haenszel approach

Mild/Moderate BID: Tofacitinib 10 mg/g vs Placebo

Statistical analysis description

FASm. A participant with a missing value was considered a non-responder.

Comparison groups

Mild/Moderate: Tofacitinib 10 mg/g BID v Mild/Moderate: Placebo (vehicle) BID

Number of subjects included in analysis

141

Analysis specification

Pre-specified

Analysis type

other ^[8]

P-value

= 0.8175

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in response rates

Point estimate

-1.2

Confidence interval

level

80%

sides

2-sided

lower limit

-7.9

upper limit

5.5

Variability estimate

Standard error of the mean

Dispersion value

5.2

Notes
[8] - Large sample approximation to the difference in binomial proportions adjusted for the baseline PGA-C disease severity using the Cochran‑Mantel-Haenszel approach

Mild/Moderate QD: Tofacitinib 20 mg/g vs Placebo

Statistical analysis description

FASm. A participant with a missing value was considered a non-responder.

Comparison groups

Mild/Moderate: Tofacitinib 20 mg/g QD v Mild/Moderate: Placebo (vehicle) QD

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[9]

P-value

= 0.0513

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in response rates

Point estimate

Confidence interval

level

80%

sides

2-sided

lower limit

3.8

upper limit

18.2

Variability estimate

Standard error of the mean

Dispersion value

5.63

Notes
[9] - Large sample approximation to the difference in binomial proportions adjusted for the baseline PGA-C disease severity using the Cochran‑Mantel-Haenszel approach

Mild/Moderate QD: Tofacitinib 10 mg/g vs Placebo

Statistical analysis description

FASm. A participant with a missing value was considered a non-responder.

Comparison groups

Mild/Moderate: Tofacitinib 10 mg/g QD v Mild/Moderate: Placebo (vehicle) QD

Number of subjects included in analysis

148

Analysis specification

Pre-specified

Analysis type

other ^[10]

P-value

= 0.2021

Method

Cochran-Mantel-Haenszel

Parameter type

Difference in response rates

Point estimate

6.7

Confidence interval

level

80%

sides

2-sided

lower limit

upper limit

13.4

Variability estimate

Standard error of the mean

Dispersion value

5.23

Notes
[10] - Large sample approximation to the difference in binomial proportions adjusted for the baseline PGA-C disease severity using the Cochran‑Mantel-Haenszel approach

Secondary: Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 12

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End point title

Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 12 ^[11]

End point description

End point type

Secondary

End point timeframe

Week 12

Notes
[11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: A statistical analysis for this outcome measure was not included, because this study was an estimation trial, not a confirmatory trial.

End point values	Mild/Moderate: Tofacitinib 20 mg/gram (mg/g) BID	Mild/Moderate: Tofacitinib 10 mg/g BID	Mild/Moderate: Placebo (vehicle) BID	Mild/Moderate: Tofacitinib 20 mg/g QD	Mild/Moderate: Tofacitinib 10 mg/g QD	Mild/Moderate: Placebo (vehicle) QD
Number of subjects analysed	71	70	71	70	74	74
Units: Percentage of Participants
number (not applicable)	33.8	25.7	23.9	27.1	29.7	23

No statistical analyses for this end point

Secondary: Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 8

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End point title

Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 8 ^[12]

End point description

End point type

Secondary

End point timeframe

Week 8

Notes
[12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: A statistical analysis for this outcome measure was not included, because this study was an estimation trial, not a confirmatory trial.

End point values	Mild/Moderate: Tofacitinib 20 mg/gram (mg/g) BID	Mild/Moderate: Tofacitinib 10 mg/g BID	Mild/Moderate: Placebo (vehicle) BID	Mild/Moderate: Tofacitinib 20 mg/g QD	Mild/Moderate: Tofacitinib 10 mg/g QD	Mild/Moderate: Placebo (vehicle) QD
Number of subjects analysed	71	70	71	70	74	74
Units: Percentage of Participants
number (not applicable)	36.6	20	22.5	32.9	21.6	12.2

No statistical analyses for this end point

Secondary: Percentage of Participants Achieving a Gestalt Physician's Global Assessment (PGA-G) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/point Improvement from Baseline at Week 12

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End point title

Percentage of Participants Achieving a Gestalt Physician's Global Assessment (PGA-G) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/point Improvement from Baseline at Week 12 ^[13]

End point description

Clinical signs of plaque psoriasis (E, I and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. After scoring each of the PGA subscores, a clinical evaluator of psoriasis performed an assessment of the overall severity of psoriasis and assigned a PGA-G score and category. 0=Clear, except for any residual discoloration (post-inflammatory hyperpigmentation and/or hypopigmentation) and 1=almost clear, the psoriasis is not entirely cleared and remaining plaques are light pink (not including post inflammatory hyperpigmentation), and/or have barely palpable elevation and/or have occasional fine scale. The PGA-G was a static assessment; i.e., without regard to a previous assessment.

End point type

Secondary

End point timeframe

Baseline, Week 12

Notes
[13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: A statistical analysis for this outcome measure was not included, because this study was an estimation trial, not a confirmatory trial.

End point values	Mild/Moderate: Tofacitinib 20 mg/gram (mg/g) BID	Mild/Moderate: Tofacitinib 10 mg/g BID	Mild/Moderate: Placebo (vehicle) BID	Mild/Moderate: Tofacitinib 20 mg/g QD	Mild/Moderate: Tofacitinib 10 mg/g QD	Mild/Moderate: Placebo (vehicle) QD
Number of subjects analysed	71	70	71	70	74	74
Units: Percentage of Participants
number (not applicable)	18.3	11.4	14.1	15.7	18.9	12.2

No statistical analyses for this end point

Secondary: Percentage of Participants Achieving a PGA-G Response of Clear (0) or Almost Clear (1) and ≥2 Grade/point Improvement from Baseline at Week 8

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End point title

Percentage of Participants Achieving a PGA-G Response of Clear (0) or Almost Clear (1) and ≥2 Grade/point Improvement from Baseline at Week 8 ^[14]

End point description

End point type

Secondary

End point timeframe

Baseline, Week 8

Notes
[14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: A statistical analysis for this outcome measure was not included, because this study was an estimation trial, not a confirmatory trial.

End point values	Mild/Moderate: Tofacitinib 20 mg/gram (mg/g) BID	Mild/Moderate: Tofacitinib 10 mg/g BID	Mild/Moderate: Placebo (vehicle) BID	Mild/Moderate: Tofacitinib 20 mg/g QD	Mild/Moderate: Tofacitinib 10 mg/g QD	Mild/Moderate: Placebo (vehicle) QD
Number of subjects analysed	71	70	71	70	74	74
Units: Percentage of Participants
number (not applicable)	21.1	7.1	11.3	15.7	9.5	4.1

No statistical analyses for this end point

Secondary: Percent Change from Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)

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End point title

Percent Change from Baseline to Week 12 in Psoriasis Area and Severity Index (PASI) ^[15]

End point description

Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent (%) area of skin involved was estimated: 0=0% to 6=90–100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region*area score*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was <72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.

End point type

Secondary

End point timeframe

Baseline, Week 12

Notes
[15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: A statistical analysis for this outcome measure was not included, because this study was an estimation trial, not a confirmatory trial.

End point values	Mild/Moderate: Tofacitinib 20 mg/gram (mg/g) BID	Mild/Moderate: Tofacitinib 10 mg/g BID	Mild/Moderate: Placebo (vehicle) BID	Mild/Moderate: Tofacitinib 20 mg/g QD	Mild/Moderate: Tofacitinib 10 mg/g QD	Mild/Moderate: Placebo (vehicle) QD
Number of subjects analysed	58	57	55	53	62	52
Units: Percent Change from Baseline
arithmetic mean (standard deviation)	-36.6 ± 40.88	-35.7 ± 43.78	-32 ± 49.47	-38.6 ± 36.37	-31.4 ± 42.36	-30 ± 38.68

No statistical analyses for this end point

Secondary: Percent Change from Baseline to Week 8 in PASI

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End point title

Percent Change from Baseline to Week 8 in PASI ^[16]

End point description

Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region*area score*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was <72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.

End point type

Secondary

End point timeframe

Baseline, Week 8

Notes
[16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: A statistical analysis for this outcome measure was not included, because this study was an estimation trial, not a confirmatory trial.

End point values	Mild/Moderate: Tofacitinib 20 mg/gram (mg/g) BID	Mild/Moderate: Tofacitinib 10 mg/g BID	Mild/Moderate: Placebo (vehicle) BID	Mild/Moderate: Tofacitinib 20 mg/g QD	Mild/Moderate: Tofacitinib 10 mg/g QD	Mild/Moderate: Placebo (vehicle) QD
Number of subjects analysed	61	64	55	60	67	58
Units: Percent Change from Baseline
arithmetic mean (standard deviation)	-36.7 ± 36.01	-29.1 ± 40.86	-28.8 ± 37.06	-36.5 ± 33.87	-29 ± 29.47	-27.1 ± 32.93

No statistical analyses for this end point

Secondary: Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at Week 12

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End point title

Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at Week 12 ^[17]

End point description

End point type

Secondary

End point timeframe

Baseline, Week 12

Notes
[17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: A statistical analysis for this outcome measure was not included, because this study was an estimation trial, not a confirmatory trial.

End point values	Mild/Moderate: Tofacitinib 20 mg/gram (mg/g) BID	Mild/Moderate: Tofacitinib 10 mg/g BID	Mild/Moderate: Placebo (vehicle) BID	Mild/Moderate: Tofacitinib 20 mg/g QD	Mild/Moderate: Tofacitinib 10 mg/g QD	Mild/Moderate: Placebo (vehicle) QD
Number of subjects analysed	71	70	71	70	74	74
Units: Percentage of Participants
number (not applicable)	16.9	12.9	12.7	15.7	10.8	6.8

No statistical analyses for this end point

Secondary: Percentage of Participants Achieving PASI75, Relative to Baseline at Week 8

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End point title

Percentage of Participants Achieving PASI75, Relative to Baseline at Week 8 ^[18]

End point description

End point type

Secondary

End point timeframe

Baseline, Week 8

Notes
[18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: A statistical analysis for this outcome measure was not included, because this study was an estimation trial, not a confirmatory trial.

End point values	Mild/Moderate: Tofacitinib 20 mg/gram (mg/g) BID	Mild/Moderate: Tofacitinib 10 mg/g BID	Mild/Moderate: Placebo (vehicle) BID	Mild/Moderate: Tofacitinib 20 mg/g QD	Mild/Moderate: Tofacitinib 10 mg/g QD	Mild/Moderate: Placebo (vehicle) QD
Number of subjects analysed	71	70	71	70	74	74
Units: Percentage of Participants
number (not applicable)	14.1	8.6	7	15.7	6.8	6.8

No statistical analyses for this end point

Secondary: Percent Change from Baseline to Week 12 in Body Surface Area (BSA) Affected with Psoriasis

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End point title

Percent Change from Baseline to Week 12 in Body Surface Area (BSA) Affected with Psoriasis ^[19]

End point description

Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. BSA (%)=the sum of the BSAs of the 4 body regions. BSA assessment excluded head and neck, palms, finger nails, soles and toe nails.

End point type

Secondary

End point timeframe

Baseline, Week 12

Notes
[19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: A statistical analysis for this outcome measure was not included, because this study was an estimation trial, not a confirmatory trial.

End point values	Mild/Moderate: Tofacitinib 20 mg/gram (mg/g) BID	Mild/Moderate: Tofacitinib 10 mg/g BID	Mild/Moderate: Placebo (vehicle) BID	Mild/Moderate: Tofacitinib 20 mg/g QD	Mild/Moderate: Tofacitinib 10 mg/g QD	Mild/Moderate: Placebo (vehicle) QD
Number of subjects analysed	58	57	55	53	62	52
Units: Percent Change from Baseline
arithmetic mean (standard deviation)	-32.8 ± 40.92	-27.5 ± 36.4	-27.7 ± 43.43	-24.6 ± 36.29	-15.6 ± 36.63	-11.2 ± 56.38

No statistical analyses for this end point

Secondary: Percent Change from Baseline to Week 8 in BSA Affected with Psoriasis

Top of page

End point title

Percent Change from Baseline to Week 8 in BSA Affected with Psoriasis ^[20]

End point description

End point type

Secondary

End point timeframe

Baseline, Week 8

Notes
[20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: A statistical analysis for this outcome measure was not included, because this study was an estimation trial, not a confirmatory trial.

End point values	Mild/Moderate: Tofacitinib 20 mg/gram (mg/g) BID	Mild/Moderate: Tofacitinib 10 mg/g BID	Mild/Moderate: Placebo (vehicle) BID	Mild/Moderate: Tofacitinib 20 mg/g QD	Mild/Moderate: Tofacitinib 10 mg/g QD	Mild/Moderate: Placebo (vehicle) QD
Number of subjects analysed	61	64	55	60	67	58
Units: Percent Change from Baseline
arithmetic mean (standard deviation)	-25.4 ± 44.75	-22.5 ± 35.87	-20.5 ± 34.9	-17.8 ± 28.59	-9 ± 30.08	-11.7 ± 38.29

No statistical analyses for this end point

Secondary: Change from Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores

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End point title

Change from Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores ^[21]

End point description

The severity of itch (pruritus) due to psoriasis was assessed using the ISI. Participants were asked to assess their “worst itching due to psoriasis over the past 24 hours” on a numeric rating scale anchored by the terms “no itching” (0) and “worst possible itching” (10) at the ends. Participants completed the ISI assessments at the clinic (i.e., clinic-based).

End point type

Secondary

End point timeframe

Baseline, Week 12

Notes
[21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: A statistical analysis for this outcome measure was not included, because this study was an estimation trial, not a confirmatory trial.

End point values	Mild/Moderate: Tofacitinib 20 mg/gram (mg/g) BID	Mild/Moderate: Tofacitinib 10 mg/g BID	Mild/Moderate: Placebo (vehicle) BID	Mild/Moderate: Tofacitinib 20 mg/g QD	Mild/Moderate: Tofacitinib 10 mg/g QD	Mild/Moderate: Placebo (vehicle) QD
Number of subjects analysed	57	57	55	52	62	52
Units: Score on a Scale
arithmetic mean (standard deviation)	-2.88 ± 3.14	-2.89 ± 3.32	-1.73 ± 2.46	-2.38 ± 3.182	-1.94 ± 3.151	-1.5 ± 2.961

No statistical analyses for this end point

Secondary: Change from Baseline to Week 8 in Clinic-Based ISI Scores

Top of page

End point title

Change from Baseline to Week 8 in Clinic-Based ISI Scores ^[22]

End point description

End point type

Secondary

End point timeframe

Baseline, Week 8

Notes
[22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: A statistical analysis for this outcome measure was not included, because this study was an estimation trial, not a confirmatory trial.

End point values	Mild/Moderate: Tofacitinib 20 mg/gram (mg/g) BID	Mild/Moderate: Tofacitinib 10 mg/g BID	Mild/Moderate: Placebo (vehicle) BID	Mild/Moderate: Tofacitinib 20 mg/g QD	Mild/Moderate: Tofacitinib 10 mg/g QD	Mild/Moderate: Placebo (vehicle) QD
Number of subjects analysed	61	64	55	59	66	58
Units: Score on a Scale
arithmetic mean (standard deviation)	-3.07 ± 2.971	-2.38 ± 2.984	-1.45 ± 2.847	-2.49 ± 2.769	-1.91 ± 3.166	-1.34 ± 3.285

No statistical analyses for this end point

Secondary: Change from Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score

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End point title

Change from Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score ^[23]

End point description

DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire assesses participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.

End point type

Secondary

End point timeframe

Baseline, Week 12

Notes
[23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: A statistical analysis for this outcome measure was not included, because this study was an estimation trial, not a confirmatory trial.

End point values	Mild/Moderate: Tofacitinib 20 mg/gram (mg/g) BID	Mild/Moderate: Tofacitinib 10 mg/g BID	Mild/Moderate: Placebo (vehicle) BID	Mild/Moderate: Tofacitinib 20 mg/g QD	Mild/Moderate: Tofacitinib 10 mg/g QD	Mild/Moderate: Placebo (vehicle) QD
Number of subjects analysed	58	57	55	53	62	52
Units: Score on a Scale
arithmetic mean (standard deviation)	-4.6 ± 5.55	-3.2 ± 5.32	-2.6 ± 5.45	-5.6 ± 7.04	-3.3 ± 5.97	-2.3 ± 6.34

No statistical analyses for this end point

Secondary: Change from Baseline to Week 8 in the DLQI Total Score

Top of page

End point title

Change from Baseline to Week 8 in the DLQI Total Score ^[24]

End point description

End point type

Secondary

End point timeframe

Baseline, Week 8

Notes
[24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: A statistical analysis for this outcome measure was not included, because this study was an estimation trial, not a confirmatory trial.

End point values	Mild/Moderate: Tofacitinib 20 mg/gram (mg/g) BID	Mild/Moderate: Tofacitinib 10 mg/g BID	Mild/Moderate: Placebo (vehicle) BID	Mild/Moderate: Tofacitinib 20 mg/g QD	Mild/Moderate: Tofacitinib 10 mg/g QD	Mild/Moderate: Placebo (vehicle) QD
Number of subjects analysed	61	64	55	60	67	58
Units: Score on a Scale
arithmetic mean (standard deviation)	-4.6 ± 5.16	-2.6 ± 4.98	-2.8 ± 4.01	-5 ± 5.85	-2.7 ± 4.79	-2.2 ± 5.63

No statistical analyses for this end point

Secondary: Percentage of Participants Achieving a Patient's Global Assessment (PtGA) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/point Improvement from Baseline at Week 12 for Participants with a PtGA Score ≥2 at Baseline

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End point title

Percentage of Participants Achieving a Patient's Global Assessment (PtGA) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/point Improvement from Baseline at Week 12 for Participants with a PtGA Score ≥2 at Baseline ^[25]

End point description

The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe).

End point type

Secondary

End point timeframe

Baseline, Week 12

Notes
[25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: A statistical analysis for this outcome measure was not included, because this study was an estimation trial, not a confirmatory trial.

End point values	Mild/Moderate: Tofacitinib 20 mg/gram (mg/g) BID	Mild/Moderate: Tofacitinib 10 mg/g BID	Mild/Moderate: Placebo (vehicle) BID	Mild/Moderate: Tofacitinib 20 mg/g QD	Mild/Moderate: Tofacitinib 10 mg/g QD	Mild/Moderate: Placebo (vehicle) QD
Number of subjects analysed	57	57	55	53	62	52
Units: Percentage of Participants
number (not applicable)	8.8	17.5	7.3	13.2	14.5	7.7

No statistical analyses for this end point

Secondary: Percentage of Participants Achieving a PtGA Response of Clear (0) or Almost Clear (1) and ≥2 Grade/point Improvement from Baseline at Week 8 for Participants with a PtGA Score ≥2 at Baseline

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End point title

Percentage of Participants Achieving a PtGA Response of Clear (0) or Almost Clear (1) and ≥2 Grade/point Improvement from Baseline at Week 8 for Participants with a PtGA Score ≥2 at Baseline ^[26]

End point description

The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe).

End point type

Secondary

End point timeframe

Baseline, Week 8

Notes
[26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: A statistical analysis for this outcome measure was not included, because this study was an estimation trial, not a confirmatory trial.

End point values	Mild/Moderate: Tofacitinib 20 mg/gram (mg/g) BID	Mild/Moderate: Tofacitinib 10 mg/g BID	Mild/Moderate: Placebo (vehicle) BID	Mild/Moderate: Tofacitinib 20 mg/g QD	Mild/Moderate: Tofacitinib 10 mg/g QD	Mild/Moderate: Placebo (vehicle) QD
Number of subjects analysed	60	64	55	60	67	58
Units: Percentage of Participants
number (not applicable)	5	6.3	10.9	10	6	1.7

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

SAEs were assessed from informed consent through and including 28 calendar days after last administration of study treatment. Non-SAEs were recorded from time of first dose of study treatment through last participant visit.

Adverse event reporting additional description

The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study. All AEs (including treatment area AEs) are presented.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

17.1

Reporting group title

Mild/Moderate: Tofacitinib 10 mg/g BID

Reporting group description

Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.

Reporting group title

Mild/Moderate: Tofacitinib 20 mg/g BID

Reporting group description

Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.

Reporting group title

Mild/Moderate: Placebo (vehicle) BID

Reporting group description

Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.

Reporting group title

Mild/Moderate: Tofacitinib 10 mg/g QD

Reporting group description

Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.

Reporting group title

Mild/Moderate: Tofacitinib 20 mg/g QD

Reporting group description

Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.

Reporting group title

Mild/Moderate: Placebo (vehicle) QD

Reporting group description

Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.

Reporting group title

Severe: Tofacitinib 20 mg/g BID

Reporting group description

Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.

Reporting group title

Severe: Tofacitinib 10 mg/g BID

Reporting group description

Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.

Reporting group title

Severe: Placebo (vehicle) BID

Reporting group description

Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks.

Reporting group title

Severe: Tofacitinib 20 mg/g QD

Reporting group description

Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.

Reporting group title

Severe: Tofacitinib 10 mg/g QD

Reporting group description

Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.

Reporting group title

Severe: Placebo (vehicle) QD

Reporting group description

Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.

Mild/Moderate: Tofacitinib 10 mg/g BID

Mild/Moderate: Tofacitinib 20 mg/g BID

Mild/Moderate: Placebo (vehicle) BID

Mild/Moderate: Tofacitinib 10 mg/g QD

Mild/Moderate: Tofacitinib 20 mg/g QD

Mild/Moderate: Placebo (vehicle) QD

Severe: Tofacitinib 20 mg/g BID

Severe: Tofacitinib 10 mg/g BID

Severe: Placebo (vehicle) BID

Severe: Tofacitinib 20 mg/g QD

Severe: Tofacitinib 10 mg/g QD

Severe: Placebo (vehicle) QD

Total subjects affected by serious adverse events

subjects affected / exposed

5 / 70 (7.14%)

0 / 71 (0.00%)

2 / 71 (2.82%)

2 / 74 (2.70%)

0 / 70 (0.00%)

1 / 74 (1.35%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 7 (14.29%)

number of deaths (all causes)

number of deaths resulting from adverse events

Injury, poisoning and procedural complications

Abdominal wound dehiscence

subjects affected / exposed

1 / 70 (1.43%)

0 / 71 (0.00%)

0 / 74 (0.00%)

0 / 70 (0.00%)

0 / 74 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

Arrhythmia

subjects affected / exposed

0 / 70 (0.00%)

0 / 71 (0.00%)

1 / 74 (1.35%)

0 / 70 (0.00%)

0 / 74 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Atrial fibrillation

subjects affected / exposed

0 / 70 (0.00%)

0 / 71 (0.00%)

0 / 74 (0.00%)

0 / 70 (0.00%)

1 / 74 (1.35%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac failure congestive

subjects affected / exposed

1 / 70 (1.43%)

0 / 71 (0.00%)

0 / 74 (0.00%)

0 / 70 (0.00%)

0 / 74 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Myocardial infarction

subjects affected / exposed

1 / 70 (1.43%)

0 / 71 (0.00%)

0 / 74 (0.00%)

0 / 70 (0.00%)

0 / 74 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 1

0 / 0

Nervous system disorders

Transient ischaemic attack

subjects affected / exposed

0 / 70 (0.00%)

0 / 71 (0.00%)

0 / 74 (0.00%)

0 / 70 (0.00%)

0 / 74 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 7 (14.29%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

General disorders and administration site conditions

Non-cardiac chest pain

subjects affected / exposed

1 / 70 (1.43%)

0 / 71 (0.00%)

0 / 74 (0.00%)

0 / 70 (0.00%)

0 / 74 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Systemic inflammatory response syndrome

subjects affected / exposed

0 / 70 (0.00%)

0 / 71 (0.00%)

1 / 74 (1.35%)

0 / 70 (0.00%)

0 / 74 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Musculoskeletal and connective tissue disorders

Osteoarthritis

subjects affected / exposed

0 / 70 (0.00%)

0 / 71 (0.00%)

1 / 71 (1.41%)

0 / 74 (0.00%)

0 / 70 (0.00%)

0 / 74 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Psoriatic arthropathy

subjects affected / exposed

0 / 70 (0.00%)

0 / 71 (0.00%)

1 / 71 (1.41%)

0 / 74 (0.00%)

0 / 70 (0.00%)

0 / 74 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

Urinary tract infection

subjects affected / exposed

0 / 70 (0.00%)

0 / 71 (0.00%)

1 / 74 (1.35%)

0 / 70 (0.00%)

0 / 74 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metabolism and nutrition disorders

Diabetes mellitus

subjects affected / exposed

1 / 70 (1.43%)

0 / 71 (0.00%)

0 / 74 (0.00%)

0 / 70 (0.00%)

0 / 74 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 7 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Mild/Moderate: Tofacitinib 10 mg/g BID	Mild/Moderate: Tofacitinib 20 mg/g BID	Mild/Moderate: Placebo (vehicle) BID	Mild/Moderate: Tofacitinib 10 mg/g QD	Mild/Moderate: Tofacitinib 20 mg/g QD	Mild/Moderate: Placebo (vehicle) QD	Severe: Tofacitinib 20 mg/g BID	Severe: Tofacitinib 10 mg/g BID	Severe: Placebo (vehicle) BID	Severe: Tofacitinib 20 mg/g QD	Severe: Tofacitinib 10 mg/g QD	Severe: Placebo (vehicle) QD
Total subjects affected by non serious adverse events
subjects affected / exposed	29 / 70 (41.43%)	30 / 71 (42.25%)	27 / 71 (38.03%)	28 / 74 (37.84%)	34 / 70 (48.57%)	40 / 74 (54.05%)	2 / 7 (28.57%)	4 / 7 (57.14%)	4 / 7 (57.14%)	3 / 7 (42.86%)	2 / 6 (33.33%)	2 / 7 (28.57%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
subjects affected / exposed	0 / 70 (0.00%)	1 / 71 (1.41%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Lipoma
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0
Vascular disorders
Haematoma
subjects affected / exposed	1 / 70 (1.43%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Hypertension
subjects affected / exposed	1 / 70 (1.43%)	1 / 71 (1.41%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0	1	0	0	0
Hypotension
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Vasculitis
subjects affected / exposed	0 / 70 (0.00%)	1 / 71 (1.41%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
General disorders and administration site conditions
Application site pain
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	0 / 74 (0.00%)	0 / 70 (0.00%)	2 / 74 (2.70%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	2	0	0	0	0	0	0
Application site papules
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	1 / 74 (1.35%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Asthenia
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Chest pain
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	1	0	0	0
Fatigue
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	1	0	0	0
Influenza like illness
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	1 / 74 (1.35%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Oedema peripheral
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	1 / 70 (1.43%)	0 / 74 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	1	0	0	0	0
Pyrexia
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	1 / 74 (1.35%)	1 / 70 (1.43%)	1 / 74 (1.35%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	1	1	1	0	0	0	0	0	0
Application site pruritus
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0
Immune system disorders
Seasonal allergy
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	1 / 74 (1.35%)	0 / 70 (0.00%)	1 / 74 (1.35%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	0	0	0
Reproductive system and breast disorders
Erectile dysfunction
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Vaginal haemorrhage
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	1 / 74 (1.35%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Catarrh
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Dry throat
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	1 / 70 (1.43%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Dyspnoea
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	1 / 74 (1.35%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	1	0	0	0	0
Nasal congestion
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	1 / 70 (1.43%)	1 / 74 (1.35%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	1	0	0	0	0	0	0
Oropharyngeal pain
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	2 / 70 (2.86%)	3 / 74 (4.05%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	3	3	0	0	0	0	0	0
Paranasal sinus discomfort
subjects affected / exposed	0 / 70 (0.00%)	1 / 71 (1.41%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Respiratory tract congestion
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	1 / 74 (1.35%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Sinus congestion
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Sneezing
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	1 / 70 (1.43%)	1 / 74 (1.35%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	1	0	0	0	0	0	0
Cough
subjects affected / exposed	1 / 70 (1.43%)	0 / 71 (0.00%)	1 / 71 (1.41%)	0 / 74 (0.00%)	1 / 70 (1.43%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	1	0	1	0	0	0	0	0	0	0
Psychiatric disorders
Anxiety
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	1 / 74 (1.35%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Depression
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	1 / 74 (1.35%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Insomnia
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	1 / 74 (1.35%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	1	0	0	0	0
Stress
subjects affected / exposed	0 / 70 (0.00%)	1 / 71 (1.41%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Investigations
Alanine aminotransferase increased
subjects affected / exposed	2 / 70 (2.86%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	2	0	0	0	0	0	0	0	0	0	0	1
Aspartate aminotransferase increased
subjects affected / exposed	2 / 70 (2.86%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	1 / 70 (1.43%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	2	0	0	0	1	0	0	0	0	0	0	0
Blood cholesterol increased
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	1 / 70 (1.43%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Blood creatinine increased
subjects affected / exposed	0 / 70 (0.00%)	1 / 71 (1.41%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Blood triglycerides increased
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	1 / 74 (1.35%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Eosinophil percentage increased
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	1 / 70 (1.43%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Gamma-glutamyltransferase increased
subjects affected / exposed	1 / 70 (1.43%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	1
Liver function test abnormal
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	1 / 74 (1.35%)	1 / 70 (1.43%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	1	0	0	0	0	0	0	0
Low density lipoprotein increased
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	1 / 70 (1.43%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Vitamin B12 decreased
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	1 / 74 (1.35%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
White blood cell count decreased
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	1 / 74 (1.35%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Injury, poisoning and procedural complications
Accident at work
subjects affected / exposed	0 / 70 (0.00%)	1 / 71 (1.41%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Arthropod bite
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	1 / 70 (1.43%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Burns first degree
subjects affected / exposed	1 / 70 (1.43%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Drug dispensing error
subjects affected / exposed	0 / 70 (0.00%)	1 / 71 (1.41%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Fall
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	0 / 74 (0.00%)	1 / 70 (1.43%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	2	0	0	0	0	0	0	0
Foot fracture
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	1 / 70 (1.43%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Laceration
subjects affected / exposed	1 / 70 (1.43%)	0 / 71 (0.00%)	1 / 71 (1.41%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	1	0	0	0	0	0	0	0	0	0
Muscle strain
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	1 / 74 (1.35%)	1 / 70 (1.43%)	0 / 74 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	1	1	0	1	0	0	0	0	0
Post-traumatic neck syndrome
subjects affected / exposed	1 / 70 (1.43%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Procedural pain
subjects affected / exposed	1 / 70 (1.43%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0	0	0	0
Scar
subjects affected / exposed	1 / 70 (1.43%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Skin abrasion
subjects affected / exposed	0 / 70 (0.00%)	1 / 71 (1.41%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Nervous system disorders
Dizziness
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	1	1	0	0	0
Dysaesthesia
subjects affected / exposed	0 / 70 (0.00%)	1 / 71 (1.41%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Generalised tonic-clonic seizure
subjects affected / exposed	0 / 70 (0.00%)	1 / 71 (1.41%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Headache
subjects affected / exposed	2 / 70 (2.86%)	0 / 71 (0.00%)	2 / 71 (2.82%)	3 / 74 (4.05%)	3 / 70 (4.29%)	2 / 74 (2.70%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	2	0	2	3	3	2	0	0	0	0	0	0
Migraine
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	1 / 70 (1.43%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Tension headache
subjects affected / exposed	1 / 70 (1.43%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	1 / 74 (1.35%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	1	0	0	0	0	0	0	0	0
Leukocytosis
subjects affected / exposed	0 / 70 (0.00%)	1 / 71 (1.41%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Leukopenia
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	1 / 74 (1.35%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Pancytopenia
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	1 / 74 (1.35%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Ear and labyrinth disorders
Cerumen impaction
subjects affected / exposed	2 / 70 (2.86%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0	0	0	0
Ear discomfort
subjects affected / exposed	0 / 70 (0.00%)	1 / 71 (1.41%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Vertigo
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	1 / 74 (1.35%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Eye disorders
Erythema of eyelid
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	1 / 70 (1.43%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Eyelid oedema
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	1 / 70 (1.43%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Lacrimation increased
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	1 / 70 (1.43%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Gastrointestinal disorders
Abdominal pain upper
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	1 / 74 (1.35%)	1 / 70 (1.43%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	1	0	0	0	0	0	0	0
Chronic gastritis
subjects affected / exposed	0 / 70 (0.00%)	1 / 71 (1.41%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Dental caries
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	0 / 74 (0.00%)	0 / 70 (0.00%)	1 / 74 (1.35%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	1	0	0	0	0	0	0
Diarrhoea
subjects affected / exposed	0 / 70 (0.00%)	2 / 71 (2.82%)	1 / 71 (1.41%)	1 / 74 (1.35%)	3 / 70 (4.29%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	2	1	1	3	0	0	0	0	0	0	0
Dyspepsia
subjects affected / exposed	1 / 70 (1.43%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	1 / 74 (1.35%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	0	1	0	0	0	0	0	0
Food poisoning
subjects affected / exposed	0 / 70 (0.00%)	1 / 71 (1.41%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Gastritis
subjects affected / exposed	1 / 70 (1.43%)	1 / 71 (1.41%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	0	0
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 70 (0.00%)	1 / 71 (1.41%)	0 / 71 (0.00%)	1 / 74 (1.35%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	1	0	0	0	0	0	0	0	0
Hiatus hernia
subjects affected / exposed	0 / 70 (0.00%)	1 / 71 (1.41%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Inguinal hernia
subjects affected / exposed	0 / 70 (0.00%)	1 / 71 (1.41%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	0	0
Nausea
subjects affected / exposed	1 / 70 (1.43%)	2 / 71 (2.82%)	1 / 71 (1.41%)	3 / 74 (4.05%)	1 / 70 (1.43%)	0 / 74 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	2	2	2	4	1	0	1	0	0	0	0	0
Tongue ulceration
subjects affected / exposed	1 / 70 (1.43%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Vomiting
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	1 / 74 (1.35%)	1 / 70 (1.43%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	2	1	1	0	0	0	0	0	0	0
Abdominal tenderness
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0
Constipation
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	1 / 70 (1.43%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Dermal cyst
subjects affected / exposed	0 / 70 (0.00%)	1 / 71 (1.41%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Dermatitis contact
subjects affected / exposed	1 / 70 (1.43%)	1 / 71 (1.41%)	2 / 71 (2.82%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	1	2	0	0	0	0	0	0	0	0	0
Dry skin
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	2 / 74 (2.70%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	2	0	0	0	0	0	0
Erythema
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	1 / 74 (1.35%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	2	1	0	0	0	0	0	0	0	0
Hyperhidrosis
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	1 / 74 (1.35%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Intertrigo
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	1 / 74 (1.35%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Nail psoriasis
subjects affected / exposed	1 / 70 (1.43%)	2 / 71 (2.82%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	1 / 74 (1.35%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	2	0	0	0	1	0	0	0	0	0	0
Onychoclasis
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	1 / 70 (1.43%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Pruritus
subjects affected / exposed	0 / 70 (0.00%)	1 / 71 (1.41%)	1 / 71 (1.41%)	2 / 74 (2.70%)	2 / 70 (2.86%)	4 / 74 (5.41%)	0 / 7 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	2	2	3	2	4	0	0	1	0	0	0
Psoriasis
subjects affected / exposed	1 / 70 (1.43%)	1 / 71 (1.41%)	0 / 71 (0.00%)	6 / 74 (8.11%)	7 / 70 (10.00%)	6 / 74 (8.11%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 7 (0.00%)	2 / 7 (28.57%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	1	1	0	8	12	6	1	0	0	4	0	2
Rash macular
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Skin burning sensation
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	0 / 74 (0.00%)	1 / 70 (1.43%)	1 / 74 (1.35%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	1	1	0	0	0	0	0	0
Skin fissures
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	1 / 70 (1.43%)	1 / 74 (1.35%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	2	1	0	0	0	0	0	0
Skin lesion
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	2 / 74 (2.70%)	1 / 70 (1.43%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	2	1	0	0	0	0	0	0	0
Renal and urinary disorders
Haematuria
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	1 / 74 (1.35%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Nephrolithiasis
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Proteinuria
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	1 / 74 (1.35%)	1 / 70 (1.43%)	3 / 74 (4.05%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	1	2	0	0	0	0	0	0
Glycosuria
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1
Endocrine disorders
Hypothyroidism
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	1 / 70 (1.43%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Back pain
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	1 / 70 (1.43%)	1 / 74 (1.35%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	1	0	0	0	0	0	0
Exostosis
subjects affected / exposed	0 / 70 (0.00%)	1 / 71 (1.41%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Joint range of motion decreased
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	1 / 70 (1.43%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Joint stiffness
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	1 / 74 (1.35%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Neck pain
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Pain in extremity
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	1 / 74 (1.35%)	1 / 70 (1.43%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	1	0	0	0	0	0	0	0
Psoriatic arthropathy
subjects affected / exposed	0 / 70 (0.00%)	1 / 71 (1.41%)	0 / 71 (0.00%)	1 / 74 (1.35%)	1 / 70 (1.43%)	2 / 74 (2.70%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	1	1	2	0	0	0	0	0	0
Spinal osteoarthritis
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Intervertebral disc degeneration
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0
Osteoarthritis
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0
Infections and infestations
Bacteriuria
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Bronchitis
subjects affected / exposed	1 / 70 (1.43%)	2 / 71 (2.82%)	0 / 71 (0.00%)	1 / 74 (1.35%)	1 / 70 (1.43%)	1 / 74 (1.35%)	1 / 7 (14.29%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	2	0	1	1	1	1	0	1	0	0	0
Chronic tonsillitis
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Conjunctivitis
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	1 / 70 (1.43%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Ear infection
subjects affected / exposed	0 / 70 (0.00%)	1 / 71 (1.41%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	1	0
Fungal infection
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Gastroenteritis viral
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	2 / 70 (2.86%)	1 / 74 (1.35%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	2	1	0	0	0	0	0	0
Gastrointestinal viral infection
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	1 / 74 (1.35%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Gingivitis
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	1 / 70 (1.43%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Infected bites
subjects affected / exposed	0 / 70 (0.00%)	1 / 71 (1.41%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Influenza
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	1 / 74 (1.35%)	2 / 70 (2.86%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	1	2	0	0	0	0	0	0	0
Nasopharyngitis
subjects affected / exposed	2 / 70 (2.86%)	3 / 71 (4.23%)	1 / 71 (1.41%)	7 / 74 (9.46%)	5 / 70 (7.14%)	11 / 74 (14.86%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	2	3	1	7	6	13	0	1	0	0	0	0
Oral candidiasis
subjects affected / exposed	1 / 70 (1.43%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Oral herpes
subjects affected / exposed	0 / 70 (0.00%)	1 / 71 (1.41%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Otitis externa
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	1 / 74 (1.35%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Paronychia
subjects affected / exposed	1 / 70 (1.43%)	1 / 71 (1.41%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	0	0
Pharyngitis
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	1 / 74 (1.35%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0	0
Pulpitis dental
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	1 / 74 (1.35%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Pyelonephritis
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	1 / 74 (1.35%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Rash pustular
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Rhinitis
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	1 / 70 (1.43%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Sepsis
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	1 / 74 (1.35%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Sinusitis
subjects affected / exposed	1 / 70 (1.43%)	1 / 71 (1.41%)	2 / 71 (2.82%)	1 / 74 (1.35%)	0 / 70 (0.00%)	1 / 74 (1.35%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	1	2	1	0	1	0	0	0	0	0	0
Tooth abscess
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Tooth infection
subjects affected / exposed	0 / 70 (0.00%)	2 / 71 (2.82%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	3	0	0	0	0	0	0	0	0	0	0
Upper respiratory tract infection
subjects affected / exposed	10 / 70 (14.29%)	2 / 71 (2.82%)	6 / 71 (8.45%)	0 / 74 (0.00%)	2 / 70 (2.86%)	1 / 74 (1.35%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	11	2	7	0	2	1	1	0	0	0	0	0
Urinary tract infection
subjects affected / exposed	2 / 70 (2.86%)	0 / 71 (0.00%)	6 / 71 (8.45%)	2 / 74 (2.70%)	1 / 70 (1.43%)	1 / 74 (1.35%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	2	0	6	2	1	1	0	0	0	1	0	0
Viral upper respiratory tract infection
subjects affected / exposed	0 / 70 (0.00%)	1 / 71 (1.41%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	1 / 74 (1.35%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	1	0	0	0	0	0	0
Cystitis
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0
Cystitis escherichia
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0
Erysipelas
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0
Impetigo
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	0 / 70 (0.00%)	1 / 71 (1.41%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Hypercholesterolaemia
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	1 / 74 (1.35%)	0 / 70 (0.00%)	2 / 74 (2.70%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	2	0	0	0	0	0	0
Hyperglycaemia
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	1 / 71 (1.41%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	1	0	0	0	1	0	0	0	0	1
Hyperlipidaemia
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	1 / 74 (1.35%)	0 / 70 (0.00%)	0 / 74 (0.00%)	1 / 7 (14.29%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	1	0	0	0	0	0
Hypertriglyceridaemia
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	2 / 74 (2.70%)	1 / 70 (1.43%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	2	1	0	0	0	0	0	0	0
Hypoglycaemia
subjects affected / exposed	1 / 70 (1.43%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Hypokalaemia
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	1 / 74 (1.35%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Hypomagnesaemia
subjects affected / exposed	0 / 70 (0.00%)	0 / 71 (0.00%)	0 / 71 (0.00%)	1 / 74 (1.35%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Type 2 diabetes mellitus
subjects affected / exposed	1 / 70 (1.43%)	0 / 71 (0.00%)	0 / 71 (0.00%)	0 / 74 (0.00%)	0 / 70 (0.00%)	0 / 74 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0

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Were there any global substantial amendments to the protocol? Yes

09 Dec 2013

Added Text for clarity in Sections: Protocol Summary, Schedule of Activities, Section 1.1.4, Section 3, Section 4, Section 5.2, Section 6, Section 7.1, Section 7.3.1, Section 7.4, Section 7.5, Section 7.7, Section 7.8, Section 8.2, Section 8.3, Section 8.5, Section 8.9, Section 8.10, Section 8.12.3, Section 9.5, Section 9.7, Section 9.9, Section 12.2, Section 12.3, Appendix 2.1, Appendix 4, Appendix 5.

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.

Efficacy results for participants in the severe population were not reported since this was considered an exploratory population.

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Clinical trials

Clinical Trial Results: A PHASE 2B, MULTI-SITE, RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, PARALLEL-GROUP STUDY OF THE EFFICACY, SAFETY, LOCAL TOLERABILITY AND PHARMACOKINETICS OF 2 DOSE STRENGTHS AND 2 REGIMENS OF TOFACITINIB OINTMENT IN SUBJECTS WITH CHRONIC PLAQUE PSORIASIS

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (≥) 2 Grade/point Improvement from Baseline at Week 12

Primary: Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (≥) 2 Grade/point Improvement from Baseline at Week 12

Primary: Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and ≥2 Grade/point Improvement from Baseline at Week 8

Primary: Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and ≥2 Grade/point Improvement from Baseline at Week 8

Secondary: Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 12

Secondary: Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 12

Secondary: Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 8

Secondary: Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 8

Secondary: Percentage of Participants Achieving a Gestalt Physician's Global Assessment (PGA-G) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/point Improvement from Baseline at Week 12

Secondary: Percentage of Participants Achieving a Gestalt Physician's Global Assessment (PGA-G) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/point Improvement from Baseline at Week 12

Secondary: Percentage of Participants Achieving a PGA-G Response of Clear (0) or Almost Clear (1) and ≥2 Grade/point Improvement from Baseline at Week 8

Secondary: Percentage of Participants Achieving a PGA-G Response of Clear (0) or Almost Clear (1) and ≥2 Grade/point Improvement from Baseline at Week 8

Secondary: Percent Change from Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)

Secondary: Percent Change from Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)

Secondary: Percent Change from Baseline to Week 8 in PASI

Secondary: Percent Change from Baseline to Week 8 in PASI

Secondary: Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at Week 12

Secondary: Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at Week 12

Secondary: Percentage of Participants Achieving PASI75, Relative to Baseline at Week 8

Secondary: Percentage of Participants Achieving PASI75, Relative to Baseline at Week 8

Secondary: Percent Change from Baseline to Week 12 in Body Surface Area (BSA) Affected with Psoriasis

Secondary: Percent Change from Baseline to Week 12 in Body Surface Area (BSA) Affected with Psoriasis

Secondary: Percent Change from Baseline to Week 8 in BSA Affected with Psoriasis

Secondary: Percent Change from Baseline to Week 8 in BSA Affected with Psoriasis

Secondary: Change from Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores

Secondary: Change from Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores

Secondary: Change from Baseline to Week 8 in Clinic-Based ISI Scores

Secondary: Change from Baseline to Week 8 in Clinic-Based ISI Scores

Secondary: Change from Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score

Secondary: Change from Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score

Secondary: Change from Baseline to Week 8 in the DLQI Total Score

Secondary: Change from Baseline to Week 8 in the DLQI Total Score

Secondary: Percentage of Participants Achieving a Patient's Global Assessment (PtGA) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/point Improvement from Baseline at Week 12 for Participants with a PtGA Score ≥2 at Baseline

Secondary: Percentage of Participants Achieving a Patient's Global Assessment (PtGA) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/point Improvement from Baseline at Week 12 for Participants with a PtGA Score ≥2 at Baseline

Secondary: Percentage of Participants Achieving a PtGA Response of Clear (0) or Almost Clear (1) and ≥2 Grade/point Improvement from Baseline at Week 8 for Participants with a PtGA Score ≥2 at Baseline

Secondary: Percentage of Participants Achieving a PtGA Response of Clear (0) or Almost Clear (1) and ≥2 Grade/point Improvement from Baseline at Week 8 for Participants with a PtGA Score ≥2 at Baseline

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical Trial Results:
A PHASE 2B, MULTI-SITE, RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, PARALLEL-GROUP STUDY OF THE EFFICACY, SAFETY, LOCAL TOLERABILITY AND PHARMACOKINETICS OF 2 DOSE STRENGTHS AND 2 REGIMENS OF TOFACITINIB OINTMENT IN SUBJECTS WITH CHRONIC PLAQUE PSORIASIS