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Trial record 5 of 7 for:    tofacitinib topical

Tofacitinib Ointment For Chronic Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT01831466
Recruitment Status : Completed
First Posted : April 15, 2013
Results First Posted : November 25, 2015
Last Update Posted : November 25, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Psoriasis Vulgaris
Psoriasis
Interventions Drug: tofacitinib ointment 20 mg/g
Drug: tofacitinib ointment 10 mg/g
Drug: placebo ointment (vehicle)
Enrollment 476

Recruitment Details Participants with mild (PGA-C score of 2), moderate (PGA-C score of 3), or severe (PGA-C score of 4) chronic plaque psoriasis were recruited for this study. The primary analysis population for this study included only the participants with mild and moderate disease.
Pre-assignment Details  
Arm/Group Title Mild/Moderate: Tofacitinib 20 mg/Gram (mg/g) Twice Daily (BID) Mild/Moderate: Tofacitinib 10 mg/g BID Mild/Moderate: Placebo (Vehicle) BID Mild/Moderate: Tofacitinib 20 mg/g Once Daily (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
Hide Arm/Group Description Participants with a baseline Calculated Physician’s Global Assessment (PGA-C) score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks. Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks. Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks. Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks. Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks. Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks. Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks. Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks. Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks. Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks. Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks. Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.
Period Title: Overall Study
Started 71 [1] 70 [1] 71 [1] 70 [1] 74 [1] 74 [1] 7 [1] 7 [1] 7 [1] 7 [1] 6 [1] 7 [1]
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
Reason Not Completed
Protocol Violation             1             1             2             0             0             1             0             0             0             0             0             0
Not specified             2             3             2             2             2             1             0             0             0             0             0             0
Non-compliance with study treatment             2             1             1             0             0             1             0             0             0             0             0             0
Death             0             1             0             0             0             0             0             0             0             0             0             0
Withdrawal by Subject             6             3             3             3             3             5             0             0             0             1             0             1
Lost to Follow-up             0             1             4             2             0             3             0             0             0             1             0             1
Lack of Efficacy             5             8             7             6             9             8             1             1             2             2             2             0
Adverse Event             0             0             4             6             3             7             0             1             1             1             0             2
[1]
Treated
Arm/Group Title Mild/Moderate: Tofacitinib 20 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
Hide Arm/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. Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks. Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks. Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks. Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks. Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks. Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks. Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks. Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks. Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks. Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks. Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 71 70 71 70 74 74 7 7 7 7 6 7 471
Hide Baseline Analysis Population Description
Full Analysis Set (FAS) - included all participants who were randomized to the study, received at least one dose of the randomized investigational drug (tofacitinib or vehicle), and were in a baseline PGA-C category of mild (2), moderate (3) or severe (4).
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 71 participants 70 participants 71 participants 70 participants 74 participants 74 participants 7 participants 7 participants 7 participants 7 participants 6 participants 7 participants 471 participants
< 18 years 0 0 0 0 0 0 0 0 0 0 0 0 0
18-44 years 30 23 25 21 30 25 2 0 1 3 3 2 165
45-64 years 28 34 34 38 35 39 4 6 4 2 2 2 228
>= 65 years 13 13 12 11 9 10 1 1 2 2 1 3 78
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 70 participants 71 participants 70 participants 74 participants 74 participants 7 participants 7 participants 7 participants 7 participants 6 participants 7 participants 471 participants
Female
28
  39.4%
23
  32.9%
30
  42.3%
33
  47.1%
24
  32.4%
32
  43.2%
1
  14.3%
3
  42.9%
1
  14.3%
1
  14.3%
0
   0.0%
0
   0.0%
176
  37.4%
Male
43
  60.6%
47
  67.1%
41
  57.7%
37
  52.9%
50
  67.6%
42
  56.8%
6
  85.7%
4
  57.1%
6
  85.7%
6
  85.7%
6
 100.0%
7
 100.0%
295
  62.6%
1.Primary Outcome
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
Hide 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.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population 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.
Arm/Group Title Mild/Moderate: Tofacitinib 20 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
Hide Arm/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.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Overall Number of Participants Analyzed 71 70 71 70 74 74
Measure Type: Number
Unit of Measure: Percentage of Participants
21.1 12.9 16.9 20.0 21.6 17.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mild/Moderate: Tofacitinib 20 mg/g BID, Mild/Moderate: Placebo (Vehicle) BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5425
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value 3.9
Confidence Interval (2-Sided) 80%
-4.3 to 12.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.36
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mild/Moderate: Tofacitinib 10 mg/g BID, Mild/Moderate: Placebo (Vehicle) BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4976
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value -4.0
Confidence Interval (2-Sided) 80%
-11.5 to 3.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.87
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mild/Moderate: Tofacitinib 20 mg/g QD, Mild/Moderate: Placebo (Vehicle) QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6039
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value 3.3
Confidence Interval (2-Sided) 80%
-4.9 to 11.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.36
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Mild/Moderate: Tofacitinib 10 mg/g QD, Mild/Moderate: Placebo (Vehicle) QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5279
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value 4.0
Confidence Interval (2-Sided) 80%
-4.1 to 12.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.34
Estimation Comments [Not Specified]
2.Primary Outcome
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
Hide 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.
Time Frame Baseline, Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FASm. A participant with a missing value was considered a non-responder.
Arm/Group Title Mild/Moderate: Tofacitinib 20 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
Hide Arm/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.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Overall Number of Participants Analyzed 71 70 71 70 74 74
Measure Type: Number
Unit of Measure: Percentage of Participants
22.5 10.0 11.3 18.6 14.9 8.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mild/Moderate: Tofacitinib 20 mg/g BID, Mild/Moderate: Placebo (Vehicle) BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0710
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value 10.8
Confidence Interval (2-Sided) 80%
3.1 to 18.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.99
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mild/Moderate: Tofacitinib 10 mg/g BID, Mild/Moderate: Placebo (Vehicle) BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8175
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value -1.2
Confidence Interval (2-Sided) 80%
-7.9 to 5.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.20
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mild/Moderate: Tofacitinib 20 mg/g QD, Mild/Moderate: Placebo (Vehicle) QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0513
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value 11.0
Confidence Interval (2-Sided) 80%
3.8 to 18.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.63
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Mild/Moderate: Tofacitinib 10 mg/g QD, Mild/Moderate: Placebo (Vehicle) QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2021
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rates
Estimated Value 6.7
Confidence Interval (2-Sided) 80%
-0.0 to 13.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.23
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 12
Hide 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.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FASm. A participant with a missing value was considered a non-responder.
Arm/Group Title Mild/Moderate: Tofacitinib 20 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
Hide Arm/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.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Overall Number of Participants Analyzed 71 70 71 70 74 74
Measure Type: Number
Unit of Measure: Percentage of Participants
33.8 25.7 23.9 27.1 29.7 23.0
4.Secondary Outcome
Title Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 8
Hide 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.
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FASm. A participant with a missing value was considered a non-responder.
Arm/Group Title Mild/Moderate: Tofacitinib 20 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
Hide Arm/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.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Overall Number of Participants Analyzed 71 70 71 70 74 74
Measure Type: Number
Unit of Measure: Percentage of Participants
36.6 20.0 22.5 32.9 21.6 12.2
5.Secondary Outcome
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
Hide 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.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FASm. A participant with a missing value was considered a non-responder.
Arm/Group Title Mild/Moderate: Tofacitinib 20 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
Hide Arm/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.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Overall Number of Participants Analyzed 71 70 71 70 74 74
Measure Type: Number
Unit of Measure: Percentage of Participants
18.3 11.4 14.1 15.7 18.9 12.2
6.Secondary Outcome
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
Hide 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.
Time Frame Baseline, Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FASm. A participant with a missing value was considered a non-responder.
Arm/Group Title Mild/Moderate: Tofacitinib 20 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
Hide Arm/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.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Overall Number of Participants Analyzed 71 70 71 70 74 74
Measure Type: Number
Unit of Measure: Percentage of Participants
21.1 7.1 11.3 15.7 9.5 4.1
7.Secondary Outcome
Title Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)
Hide 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.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FASm. Only observed data were analyzed.
Arm/Group Title Mild/Moderate: Tofacitinib 20 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
Hide Arm/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.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Overall Number of Participants Analyzed 58 57 55 53 62 52
Mean (Standard Deviation)
Unit of Measure: Percent Change from Baseline
-36.6  (40.88) -35.7  (43.78) -32.0  (49.47) -38.6  (36.37) -31.4  (42.36) -30.0  (38.68)
8.Secondary Outcome
Title Percent Change From Baseline to Week 8 in PASI
Hide 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.
Time Frame Baseline, Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FASm. Only observed data were analyzed.
Arm/Group Title Mild/Moderate: Tofacitinib 20 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
Hide Arm/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.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Overall Number of Participants Analyzed 61 64 55 60 67 58
Mean (Standard Deviation)
Unit of Measure: Percent Change from Baseline
-36.7  (36.01) -29.1  (40.86) -28.8  (37.06) -36.5  (33.87) -29.0  (29.47) -27.1  (32.93)
9.Secondary Outcome
Title Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at Week 12
Hide 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.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FASm. A participant with a missing value was considered a non-responder.
Arm/Group Title Mild/Moderate: Tofacitinib 20 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
Hide Arm/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.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Overall Number of Participants Analyzed 71 70 71 70 74 74
Measure Type: Number
Unit of Measure: Percentage of Participants
16.9 12.9 12.7 15.7 10.8 6.8
10.Secondary Outcome
Title Percentage of Participants Achieving PASI75, Relative to Baseline at Week 8
Hide 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.
Time Frame Baseline, Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FASm. A participant with a missing value was considered a non-responder.
Arm/Group Title Mild/Moderate: Tofacitinib 20 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
Hide Arm/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.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Overall Number of Participants Analyzed 71 70 71 70 74 74
Measure Type: Number
Unit of Measure: Percentage of Participants
14.1 8.6 7.0 15.7 6.8 6.8
11.Secondary Outcome
Title Percent Change From Baseline to Week 12 in Body Surface Area (BSA) Affected With Psoriasis
Hide 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.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FASm. Only observed data were analyzed.
Arm/Group Title Mild/Moderate: Tofacitinib 20 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
Hide Arm/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.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Overall Number of Participants Analyzed 58 57 55 53 62 52
Mean (Standard Deviation)
Unit of Measure: Percent Change from Baseline
-32.8  (40.92) -27.5  (36.40) -27.7  (43.43) -24.6  (36.29) -15.6  (36.63) -11.2  (56.38)
12.Secondary Outcome
Title Percent Change From Baseline to Week 8 in BSA Affected With Psoriasis
Hide 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.
Time Frame Baseline, Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FASm. Only observed data were analyzed.
Arm/Group Title Mild/Moderate: Tofacitinib 20 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
Hide Arm/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.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Overall Number of Participants Analyzed 61 64 55 60 67 58
Mean (Standard Deviation)
Unit of Measure: Percent Change from Baseline
-25.4  (44.75) -22.5  (35.87) -20.5  (34.90) -17.8  (28.59) -9.0  (30.08) -11.7  (38.29)
13.Secondary Outcome
Title Change From Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores
Hide 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).
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FASm. Only observed data were analyzed.
Arm/Group Title Mild/Moderate: Tofacitinib 20 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
Hide Arm/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.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Overall Number of Participants Analyzed 57 57 55 52 62 52
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
-2.88  (3.140) -2.89  (3.320) -1.73  (2.460) -2.38  (3.182) -1.94  (3.151) -1.50  (2.961)
14.Secondary Outcome
Title Change From Baseline to Week 8 in Clinic-Based ISI Scores
Hide 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).
Time Frame Baseline, Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FASm. Only observed data were analyzed.
Arm/Group Title Mild/Moderate: Tofacitinib 20 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
Hide Arm/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.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Overall Number of Participants Analyzed 61 64 55 59 66 58
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
-3.07  (2.971) -2.38  (2.984) -1.45  (2.847) -2.49  (2.769) -1.91  (3.166) -1.34  (3.285)
15.Secondary Outcome
Title Change From Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score
Hide 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.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FASm. Only observed data were analyzed.
Arm/Group Title Mild/Moderate: Tofacitinib 20 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
Hide Arm/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.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Overall Number of Participants Analyzed 58 57 55 53 62 52
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
-4.6  (5.55) -3.2  (5.32) -2.6  (5.45) -5.6  (7.04) -3.3  (5.97) -2.3  (6.34)
16.Secondary Outcome
Title Change From Baseline to Week 8 in the DLQI Total Score
Hide 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.
Time Frame Baseline, Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FASm. Only observed data were analyzed.
Arm/Group Title Mild/Moderate: Tofacitinib 20 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
Hide Arm/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.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Overall Number of Participants Analyzed 61 64 55 60 67 58
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
-4.6  (5.16) -2.6  (4.98) -2.8  (4.01) -5.0  (5.85) -2.7  (4.79) -2.2  (5.63)
17.Secondary Outcome
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
Hide 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).
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FASm. Only observed data were analyzed.
Arm/Group Title Mild/Moderate: Tofacitinib 20 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
Hide Arm/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.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Overall Number of Participants Analyzed 57 57 55 53 62 52
Measure Type: Number
Unit of Measure: Percentage of Participants
8.8 17.5 7.3 13.2 14.5 7.7
18.Secondary Outcome
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
Hide 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).
Time Frame Baseline, Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FASm. Only observed data were analyzed.
Arm/Group Title Mild/Moderate: Tofacitinib 20 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
Hide Arm/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.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
Overall Number of Participants Analyzed 60 64 55 60 67 58
Measure Type: Number
Unit of Measure: Percentage of Participants
5.0 6.3 10.9 10.0 6.0 1.7
Time Frame 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 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.
 
Arm/Group Title Mild/Moderate: Tofacitinib 20 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
Hide Arm/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. Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks. Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks. Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks. Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks. Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks. Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks. Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks. Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks. Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks. Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks. Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.
All-Cause Mortality
Mild/Moderate: Tofacitinib 20 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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Mild/Moderate: Tofacitinib 20 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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/71 (0.00%)   5/70 (7.14%)   2/71 (2.82%)   0/70 (0.00%)   2/74 (2.70%)   1/74 (1.35%)   0/7 (0.00%)   0/7 (0.00%)   0/7 (0.00%)   0/7 (0.00%)   0/6 (0.00%)   1/7 (14.29%) 
Cardiac disorders                         
Arrhythmia * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/74 (1.35%)  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%) 
Atrial fibrillation * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Cardiac failure congestive * 1  0/71 (0.00%)  1/70 (1.43%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Myocardial infarction * 1  0/71 (0.00%)  1/70 (1.43%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
General disorders                         
Non-cardiac chest pain * 1  0/71 (0.00%)  1/70 (1.43%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Systemic inflammatory response syndrome * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/74 (1.35%)  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%) 
Infections and infestations                         
Urinary tract infection * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/74 (1.35%)  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%) 
Injury, poisoning and procedural complications                         
Abdominal wound dehiscence * 1  0/71 (0.00%)  1/70 (1.43%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Metabolism and nutrition disorders                         
Diabetes mellitus * 1  0/71 (0.00%)  1/70 (1.43%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Musculoskeletal and connective tissue disorders                         
Osteoarthritis * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/74 (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%) 
Psoriatic arthropathy * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/74 (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%) 
Nervous system disorders                         
Transient ischaemic attack * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mild/Moderate: Tofacitinib 20 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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   30/71 (42.25%)   29/70 (41.43%)   27/71 (38.03%)   34/70 (48.57%)   28/74 (37.84%)   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%) 
Blood and lymphatic system disorders                         
Anaemia * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/74 (1.35%)  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%) 
Leukocytosis * 1  1/71 (1.41%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Leukopenia * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/74 (1.35%)  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%) 
Pancytopenia * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/74 (1.35%)  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%) 
Ear and labyrinth disorders                         
Cerumen impaction * 1  0/71 (0.00%)  2/70 (2.86%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Ear discomfort * 1  1/71 (1.41%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Vertigo * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/74 (1.35%)  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%) 
Endocrine disorders                         
Hypothyroidism * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Eye disorders                         
Erythema of eyelid * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  0/74 (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%) 
Eyelid oedema * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  0/74 (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%) 
Lacrimation increased * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  0/74 (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%) 
Gastrointestinal disorders                         
Abdominal pain upper * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  1/74 (1.35%)  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%) 
Chronic gastritis * 1  1/71 (1.41%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Dental caries * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/74 (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%) 
Diarrhoea * 1  2/71 (2.82%)  0/70 (0.00%)  1/71 (1.41%)  3/70 (4.29%)  1/74 (1.35%)  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%) 
Dyspepsia * 1  0/71 (0.00%)  1/70 (1.43%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Food poisoning * 1  1/71 (1.41%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Gastritis * 1  1/71 (1.41%)  1/70 (1.43%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Gastrooesophageal reflux disease * 1  1/71 (1.41%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/74 (1.35%)  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%) 
Hiatus hernia * 1  1/71 (1.41%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Inguinal hernia * 1  1/71 (1.41%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Nausea * 1  2/71 (2.82%)  1/70 (1.43%)  1/71 (1.41%)  1/70 (1.43%)  3/74 (4.05%)  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%) 
Tongue ulceration * 1  0/71 (0.00%)  1/70 (1.43%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Vomiting * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  1/70 (1.43%)  1/74 (1.35%)  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%) 
Abdominal tenderness * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Constipation * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
General disorders                         
Application site pain * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/74 (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%) 
Application site papules * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Asthenia * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/74 (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%) 
Chest pain * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/74 (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%) 
Fatigue * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/74 (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%) 
Influenza like illness * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Oedema peripheral * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  0/74 (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%) 
Pyrexia * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  1/70 (1.43%)  1/74 (1.35%)  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%) 
Application site pruritus * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Immune system disorders                         
Seasonal allergy * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/74 (1.35%)  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%) 
Infections and infestations                         
Bacteriuria * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  0/74 (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%) 
Bronchitis * 1  2/71 (2.82%)  1/70 (1.43%)  0/71 (0.00%)  1/70 (1.43%)  1/74 (1.35%)  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%) 
Chronic tonsillitis * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/74 (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%) 
Conjunctivitis * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  0/74 (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%) 
Ear infection * 1  1/71 (1.41%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Fungal infection * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/74 (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%) 
Gastroenteritis viral * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  2/70 (2.86%)  0/74 (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%) 
Gastrointestinal viral infection * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Gingivitis * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  0/74 (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%) 
Infected bites * 1  1/71 (1.41%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Influenza * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  2/70 (2.86%)  1/74 (1.35%)  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%) 
Nasopharyngitis * 1  3/71 (4.23%)  2/70 (2.86%)  1/71 (1.41%)  5/70 (7.14%)  7/74 (9.46%)  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%) 
Oral candidiasis * 1  0/71 (0.00%)  1/70 (1.43%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Oral herpes * 1  1/71 (1.41%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Otitis externa * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/74 (1.35%)  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%) 
Paronychia * 1  1/71 (1.41%)  1/70 (1.43%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Pharyngitis * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  1/74 (1.35%)  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%) 
Pulpitis dental * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/74 (1.35%)  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%) 
Pyelonephritis * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/74 (1.35%)  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%) 
Rash pustular * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/74 (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%) 
Rhinitis * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  0/74 (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%) 
Sepsis * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/74 (1.35%)  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%) 
Sinusitis * 1  1/71 (1.41%)  1/70 (1.43%)  2/71 (2.82%)  0/70 (0.00%)  1/74 (1.35%)  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%) 
Tooth abscess * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/74 (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%) 
Tooth infection * 1  2/71 (2.82%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Upper respiratory tract infection * 1  2/71 (2.82%)  10/70 (14.29%)  6/71 (8.45%)  2/70 (2.86%)  0/74 (0.00%)  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%) 
Urinary tract infection * 1  0/71 (0.00%)  2/70 (2.86%)  6/71 (8.45%)  1/70 (1.43%)  2/74 (2.70%)  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%) 
Viral upper respiratory tract infection * 1  1/71 (1.41%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Cystitis * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Cystitis escherichia * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Erysipelas * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Impetigo * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Injury, poisoning and procedural complications                         
Accident at work * 1  1/71 (1.41%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Arthropod bite * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  0/74 (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%) 
Burns first degree * 1  0/71 (0.00%)  1/70 (1.43%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Drug dispensing error * 1  1/71 (1.41%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Fall * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  1/70 (1.43%)  0/74 (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%) 
Foot fracture * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  0/74 (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%) 
Laceration * 1  0/71 (0.00%)  1/70 (1.43%)  1/71 (1.41%)  0/70 (0.00%)  0/74 (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%) 
Muscle strain * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  1/70 (1.43%)  1/74 (1.35%)  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%) 
Post-traumatic neck syndrome * 1  0/71 (0.00%)  1/70 (1.43%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Procedural pain * 1  0/71 (0.00%)  1/70 (1.43%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Scar * 1  0/71 (0.00%)  1/70 (1.43%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Skin abrasion * 1  1/71 (1.41%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Investigations                         
Alanine aminotransferase increased * 1  0/71 (0.00%)  2/70 (2.86%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Aspartate aminotransferase increased * 1  0/71 (0.00%)  2/70 (2.86%)  0/71 (0.00%)  1/70 (1.43%)  0/74 (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%) 
Blood cholesterol increased * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  0/74 (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%) 
Blood creatinine increased * 1  1/71 (1.41%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Blood triglycerides increased * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/74 (1.35%)  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%) 
Eosinophil percentage increased * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  0/74 (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%) 
Gamma-glutamyltransferase increased * 1  0/71 (0.00%)  1/70 (1.43%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Liver function test abnormal * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  1/74 (1.35%)  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%) 
Low density lipoprotein increased * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  0/74 (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%) 
Vitamin B12 decreased * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/74 (1.35%)  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%) 
White blood cell count decreased * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/74 (1.35%)  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%) 
Metabolism and nutrition disorders                         
Dehydration * 1  1/71 (1.41%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Hypercholesterolaemia * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/74 (1.35%)  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%) 
Hyperglycaemia * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/74 (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%) 
Hyperlipidaemia * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/74 (1.35%)  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%) 
Hypertriglyceridaemia * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  2/74 (2.70%)  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%) 
Hypoglycaemia * 1  0/71 (0.00%)  1/70 (1.43%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Hypokalaemia * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/74 (1.35%)  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%) 
Hypomagnesaemia * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/74 (1.35%)  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%) 
Type 2 diabetes mellitus * 1  0/71 (0.00%)  1/70 (1.43%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Musculoskeletal and connective tissue disorders                         
Arthralgia * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  0/74 (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%) 
Back pain * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  0/74 (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%) 
Exostosis * 1  1/71 (1.41%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Joint range of motion decreased * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  0/74 (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%) 
Joint stiffness * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Neck pain * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/74 (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%) 
Pain in extremity * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  1/74 (1.35%)  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%) 
Psoriatic arthropathy * 1  1/71 (1.41%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  1/74 (1.35%)  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%) 
Spinal osteoarthritis * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/74 (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%) 
Intervertebral disc degeneration * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Osteoarthritis * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                         
Squamous cell carcinoma * 1  1/71 (1.41%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Lipoma * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Nervous system disorders                         
Dizziness * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/74 (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%) 
Dysaesthesia * 1  1/71 (1.41%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Generalised tonic-clonic seizure * 1  1/71 (1.41%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Headache * 1  0/71 (0.00%)  2/70 (2.86%)  2/71 (2.82%)  3/70 (4.29%)  3/74 (4.05%)  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%) 
Migraine * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  0/74 (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%) 
Tension headache * 1  0/71 (0.00%)  1/70 (1.43%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Psychiatric disorders                         
Anxiety * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Depression * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Insomnia * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/74 (1.35%)  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%) 
Stress * 1  1/71 (1.41%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Renal and urinary disorders                         
Haematuria * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Nephrolithiasis * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/74 (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%) 
Proteinuria * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  1/74 (1.35%)  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%) 
Glycosuria * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Reproductive system and breast disorders                         
Erectile dysfunction * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/74 (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%) 
Vaginal haemorrhage * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Respiratory, thoracic and mediastinal disorders                         
Asthma * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Catarrh * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/74 (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%) 
Dry throat * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  0/74 (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%) 
Dyspnoea * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/74 (1.35%)  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%) 
Nasal congestion * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  0/74 (0.00%)  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%) 
Oropharyngeal pain * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  2/70 (2.86%)  0/74 (0.00%)  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%) 
Paranasal sinus discomfort * 1  1/71 (1.41%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Respiratory tract congestion * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Sinus congestion * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/74 (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%) 
Sneezing * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  0/74 (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%) 
Cough * 1  0/71 (0.00%)  1/70 (1.43%)  1/71 (1.41%)  1/70 (1.43%)  0/74 (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%) 
Skin and subcutaneous tissue disorders                         
Acne * 1  0/71 (0.00%)  1/70 (1.43%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Dermal cyst * 1  1/71 (1.41%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Dermatitis contact * 1  1/71 (1.41%)  1/70 (1.43%)  2/71 (2.82%)  0/70 (0.00%)  0/74 (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%) 
Dry skin * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Erythema * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  1/74 (1.35%)  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%) 
Hyperhidrosis * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/74 (1.35%)  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%) 
Intertrigo * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  1/74 (1.35%)  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%) 
Nail psoriasis * 1  2/71 (2.82%)  1/70 (1.43%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Onychoclasis * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  0/74 (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%) 
Pruritus * 1  1/71 (1.41%)  0/70 (0.00%)  1/71 (1.41%)  2/70 (2.86%)  2/74 (2.70%)  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%) 
Psoriasis * 1  1/71 (1.41%)  1/70 (1.43%)  0/71 (0.00%)  7/70 (10.00%)  6/74 (8.11%)  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%) 
Rash macular * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/74 (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%) 
Skin burning sensation * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  1/70 (1.43%)  0/74 (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%) 
Skin fissures * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  0/74 (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%) 
Skin lesion * 1  0/71 (0.00%)  0/70 (0.00%)  0/71 (0.00%)  1/70 (1.43%)  2/74 (2.70%)  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%) 
Vascular disorders                         
Haematoma * 1  0/71 (0.00%)  1/70 (1.43%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Hypertension * 1  1/71 (1.41%)  1/70 (1.43%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
Hypotension * 1  0/71 (0.00%)  0/70 (0.00%)  1/71 (1.41%)  0/70 (0.00%)  0/74 (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%) 
Vasculitis * 1  1/71 (1.41%)  0/70 (0.00%)  0/71 (0.00%)  0/70 (0.00%)  0/74 (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%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.1
Efficacy results for participants in the severe population were not reported since this was considered an exploratory population.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The PI must remove any previously undisclosed Confidential Information (other than the Study results themselves) before public release.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01831466     History of Changes
Other Study ID Numbers: A3921082
2012-005645-20 ( EudraCT Number )
First Submitted: March 28, 2013
First Posted: April 15, 2013
Results First Submitted: September 15, 2015
Results First Posted: November 25, 2015
Last Update Posted: November 25, 2015