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Trial record 1 of 1 for:    B7451029
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Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy (JADE Compare)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03720470
Recruitment Status : Completed
First Posted : October 25, 2018
Results First Posted : January 19, 2021
Last Update Posted : January 19, 2021
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 Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Interventions Drug: PF-04965842 100 mg
Drug: PF-04965842 200 mg
Drug: Dupilumab
Drug: Oral Placebo
Drug: Injectable Placebo
Enrollment 838
Recruitment Details  
Pre-assignment Details The study had treatment period of 20 weeks. The first part of this treatment period consists of a 16-week randomized, double-blind, placebo-controlled, double-dummy treatment period where participants received PF-04965842, dupilumab and placebo. The randomization and double-blind was maintained during the final 4 weeks of the treatment period, but participants only received PF-04965842 and placebo.
Arm/Group Title Placebo up to Week 16 Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20
Hide Arm/Group Description Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16. Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 100 milligram (mg) tablet orally once daily post Week 16 up to Week 20. Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20. Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, followed by administration of PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20. Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, followed by administration of PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20. Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, followed by administration of oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20.
Period Title: Treatment Period: First Part 16 Weeks
Started 131 0 0 238 226 243
Treated/ Safety Analysis Set 131 0 0 238 226 242
Full Analysis Set 131 0 0 238 226 242
Completed 117 0 0 217 208 223
Not Completed 14 0 0 21 18 20
Reason Not Completed
Adverse Event             5             0             0             5             8             6
Lack of Efficacy             0             0             0             1             0             1
Lost to Follow-up             1             0             0             2             1             2
Pregnancy             0             0             0             0             1             1
Protocol deviation             2             0             0             2             2             1
Withdrawal by Subject             5             0             0             9             3             6
Medication Error Without Associated Adverse Event             0             0             0             1             1             0
Other             1             0             0             1             2             2
Randomized But Not Treated             0             0             0             0             0             1
Period Title: Treatment Period: Final 4 Weeks
Started 0 [1] 60 [1] 57 [1] 217 208 223
Treated/ Safety Analysis Set 0 60 57 217 208 223
Full Analysis Set 0 60 57 217 208 223
Completed 0 58 55 210 204 218
Not Completed 0 2 2 7 4 5
Reason Not Completed
Adverse Event             0             0             0             2             1             1
Lack of Efficacy             0             0             1             0             0             0
Lost to Follow-up             0             0             0             1             0             1
Pregnancy             0             0             0             0             0             1
Protocol Deviation             0             0             1             0             0             0
Withdrawal by Subject             0             1             0             2             2             2
Other             0             1             0             2             1             0
[1]
Participants received placebo till Week 16 then allocated to receive PF-04965842 post Week 16.
Arm/Group Title Placebo up to Week 16 PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 Total
Hide Arm/Group Description Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16. Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, followed by administration of PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20. Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, followed by administration of PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20. Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, followed by administration of oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20. Total of all reporting groups
Overall Number of Baseline Participants 131 238 226 242 837
Hide Baseline Analysis Population Description
Safety analysis set included all randomized participants who received at least 1 dose of study medication.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 238 participants 226 participants 242 participants 837 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
121
  92.4%
224
  94.1%
211
  93.4%
227
  93.8%
783
  93.5%
>=65 years
10
   7.6%
14
   5.9%
15
   6.6%
15
   6.2%
54
   6.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 238 participants 226 participants 242 participants 837 participants
Female
54
  41.2%
118
  49.6%
122
  54.0%
134
  55.4%
428
  51.1%
Male
77
  58.8%
120
  50.4%
104
  46.0%
108
  44.6%
409
  48.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 238 participants 226 participants 242 participants 837 participants
Hispanic or Latino
16
  12.2%
35
  14.7%
36
  15.9%
37
  15.3%
124
  14.8%
Not Hispanic or Latino
113
  86.3%
200
  84.0%
187
  82.7%
201
  83.1%
701
  83.8%
Unknown or Not Reported
2
   1.5%
3
   1.3%
3
   1.3%
4
   1.7%
12
   1.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 238 participants 226 participants 242 participants 837 participants
American Indian or Alaska Native
2
   1.5%
1
   0.4%
0
   0.0%
2
   0.8%
5
   0.6%
Asian
31
  23.7%
48
  20.2%
53
  23.5%
46
  19.0%
178
  21.3%
Native Hawaiian or Other Pacific Islander
1
   0.8%
0
   0.0%
1
   0.4%
0
   0.0%
2
   0.2%
Black or African American
6
   4.6%
6
   2.5%
9
   4.0%
14
   5.8%
35
   4.2%
White
87
  66.4%
182
  76.5%
161
  71.2%
176
  72.7%
606
  72.4%
More than one race
1
   0.8%
1
   0.4%
1
   0.4%
2
   0.8%
5
   0.6%
Unknown or Not Reported
3
   2.3%
0
   0.0%
1
   0.4%
2
   0.8%
6
   0.7%
1.Primary Outcome
Title Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Week 12
Hide Description IGA assessed severity of atopic dermatitis (AD) on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded scalp, palms and sole.
Time Frame Baseline (the last measurement prior to first dosing on Day 1), Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Placebo up to Week 16 PF-04965842 100 mg + Placebo Injection up to Week 16 PF-04965842 200 mg + Placebo Injection up to Week 16 Dupilumab 300 mg + Oral Placebo up to Week 16
Hide Arm/Group Description:
Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16.
Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16.
Overall Number of Participants Analyzed 129 235 219 241
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
14.0
(8.0 to 19.9)
36.6
(30.4 to 42.8)
48.4
(41.8 to 55.0)
36.5
(30.4 to 42.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo up to Week 16, PF-04965842 100 mg + Placebo Injection up to Week 16
Comments Difference in percentage (PF-04965842 versus placebo) and confidence interval (CI) for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 23.1
Confidence Interval (2-Sided) 95%
14.7 to 31.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo up to Week 16, PF-04965842 200 mg + Placebo Injection up to Week 16
Comments Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 34.8
Confidence Interval (2-Sided) 95%
26.1 to 43.5
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75 Percent (%) Improvement From Baseline at Week 12
Hide Description EASI evaluates severity of participants with AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Placebo up to Week 16 PF-04965842 100 mg + Placebo Injection up to Week 16 PF-04965842 200 mg + Placebo Injection up to Week 16 Dupilumab 300 mg + Oral Placebo up to Week 16
Hide Arm/Group Description:
Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16.
Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16.
Overall Number of Participants Analyzed 129 235 219 241
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
27.1
(19.5 to 34.8)
58.7
(52.4 to 65.0)
70.3
(64.3 to 76.4)
58.1
(51.9 to 64.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo up to Week 16, PF-04965842 100 mg + Placebo Injection up to Week 16
Comments Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 31.9
Confidence Interval (2-Sided) 95%
22.2 to 41.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo up to Week 16, PF-04965842 200 mg + Placebo Injection up to Week 16
Comments Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 43.2
Confidence Interval (2-Sided) 95%
33.7 to 52.7
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16
Hide Description Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity.
Time Frame Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and Week 2, 4, 8, 12, 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
Arm/Group Title Placebo up to Week 16 PF-04965842 100 mg + Placebo Injection up to Week 16 PF-04965842 200 mg + Placebo Injection up to Week 16 Dupilumab 300 mg + Oral Placebo up to Week 16
Hide Arm/Group Description:
Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16.
Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16.
Overall Number of Participants Analyzed 131 238 226 242
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Day 2 Number Analyzed 117 participants 220 participants 203 participants 206 participants
5.1
(1.1 to 9.1)
5.9
(2.8 to 9.0)
7.4
(3.8 to 11.0)
2.4
(0.3 to 4.5)
Day 3 Number Analyzed 114 participants 214 participants 203 participants 213 participants
7.9
(2.9 to 12.8)
8.4
(4.7 to 12.1)
14.8
(9.9 to 19.7)
3.3
(0.9 to 5.7)
Day 4 Number Analyzed 116 participants 216 participants 199 participants 216 participants
6.0
(1.7 to 10.4)
11.6
(7.3 to 15.8)
18.6
(13.2 to 24.0)
5.6
(2.5 to 8.6)
Day 5 Number Analyzed 119 participants 211 participants 196 participants 210 participants
7.6
(2.8 to 12.3)
14.2
(9.5 to 18.9)
26.5
(20.3 to 32.7)
9.5
(5.6 to 13.5)
Day 6 Number Analyzed 119 participants 213 participants 207 participants 214 participants
10.9
(5.3 to 16.5)
15.0
(10.2 to 19.8)
25.1
(19.2 to 31.0)
14.0
(9.4 to 18.7)
Day 7 Number Analyzed 108 participants 214 participants 208 participants 216 participants
11.1
(5.2 to 17.0)
20.1
(14.7 to 25.5)
28.8
(22.7 to 35.0)
13.4
(8.9 to 18.0)
Day 8 Number Analyzed 118 participants 210 participants 207 participants 212 participants
14.4
(8.1 to 20.7)
21.4
(15.9 to 27.0)
33.3
(26.9 to 39.8)
16.5
(11.5 to 21.5)
Day 9 Number Analyzed 115 participants 204 participants 208 participants 209 participants
13.0
(6.9 to 19.2)
24.0
(18.2 to 29.9)
34.1
(27.7 to 40.6)
14.8
(10.0 to 19.7)
Day 10 Number Analyzed 114 participants 203 participants 207 participants 210 participants
13.2
(7.0 to 19.4)
25.6
(19.6 to 31.6)
34.3
(27.8 to 40.8)
17.1
(12.0 to 22.2)
Day 11 Number Analyzed 118 participants 201 participants 210 participants 210 participants
12.7
(6.7 to 18.7)
25.4
(19.4 to 31.4)
39.5
(32.9 to 46.1)
20.5
(15.0 to 25.9)
Day 12 Number Analyzed 117 participants 204 participants 202 participants 215 participants
12.0
(6.1 to 17.8)
25.5
(19.5 to 31.5)
44.1
(37.2 to 50.9)
21.9
(16.3 to 27.4)
Day 13 Number Analyzed 114 participants 196 participants 203 participants 212 participants
13.2
(7.0 to 19.4)
30.6
(24.2 to 37.1)
43.8
(37.0 to 50.7)
23.6
(17.9 to 29.3)
Day 14 Number Analyzed 121 participants 210 participants 199 participants 212 participants
15.7
(9.2 to 22.2)
31.4
(25.1 to 37.7)
45.7
(38.8 to 52.7)
24.5
(18.7 to 30.3)
Day 15 Number Analyzed 117 participants 207 participants 208 participants 211 participants
11.1
(5.4 to 16.8)
30.4
(24.2 to 36.7)
49.0
(42.2 to 55.8)
26.5
(20.6 to 32.5)
Week 2 Number Analyzed 130 participants 236 participants 226 participants 239 participants
13.8
(7.9 to 19.8)
31.8
(25.8 to 37.7)
49.1
(42.6 to 55.6)
26.4
(20.8 to 31.9)
Week 4 Number Analyzed 124 participants 224 participants 214 participants 232 participants
20.2
(13.1 to 27.2)
44.6
(38.1 to 51.2)
59.3
(52.8 to 65.9)
45.3
(38.9 to 51.7)
Week 8 Number Analyzed 122 participants 221 participants 214 participants 229 participants
27.0
(19.2 to 34.9)
47.5
(40.9 to 54.1)
64.0
(57.6 to 70.4)
50.7
(44.2 to 57.1)
Week 12 Number Analyzed 121 participants 221 participants 217 participants 224 participants
28.9
(20.8 to 37.0)
47.5
(40.9 to 54.1)
63.1
(56.7 to 69.6)
54.5
(47.9 to 61.0)
Week 16 Number Analyzed 94 participants 168 participants 172 participants 189 participants
28.7
(19.6 to 37.9)
47.0
(39.5 to 54.6)
62.8
(55.6 to 70.0)
57.1
(50.1 to 64.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo up to Week 16, PF-04965842 100 mg + Placebo Injection up to Week 16
Comments Week 2: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 17.9
Confidence Interval (2-Sided) 95%
9.5 to 26.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo up to Week 16, PF-04965842 200 mg + Placebo Injection up to Week 16
Comments Week 2: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 34.9
Confidence Interval (2-Sided) 95%
26.0 to 43.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg + Placebo Injection up to Week 16, Dupilumab 300 mg + Oral Placebo up to Week 16
Comments Week 2: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2084
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 5.2
Confidence Interval (2-Sided) 95%
-2.9 to 13.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg + Placebo Injection up to Week 16, Dupilumab 300 mg + Oral Placebo up to Week 16
Comments Week 2: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 22.1
Confidence Interval (2-Sided) 95%
13.5 to 30.7
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16
Hide Description IGA assessed severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.
Time Frame Baseline, Week 2, 4, 8 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
Arm/Group Title Placebo up to Week 16 PF-04965842 100 mg + Placebo Injection up to Week 16 PF-04965842 200 mg + Placebo Injection up to Week 16 Dupilumab 300 mg + Oral Placebo up to Week 16
Hide Arm/Group Description:
Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16.
Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16.
Overall Number of Participants Analyzed 131 238 226 242
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 128 participants 230 participants 223 participants 236 participants
6.3
(2.1 to 10.4)
15.2
(10.6 to 19.9)
18.4
(13.3 to 23.5)
4.7
(2.0 to 7.4)
Week 4 Number Analyzed 129 participants 234 participants 223 participants 238 participants
6.2
(2.0 to 10.4)
25.2
(19.6 to 30.8)
31.4
(25.3 to 37.5)
18.9
(13.9 to 23.9)
Week 8 Number Analyzed 129 participants 232 participants 225 participants 239 participants
10.1
(4.9 to 15.3)
35.8
(29.6 to 41.9)
50.7
(44.1 to 57.2)
28.5
(22.7 to 34.2)
Week 16 Number Analyzed 124 participants 230 participants 221 participants 232 participants
12.9
(7.0 to 18.8)
34.8
(28.6 to 40.9)
47.5
(40.9 to 54.1)
38.8
(32.5 to 45.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo up to Week 16, PF-04965842 100 mg + Placebo Injection up to Week 16
Comments Week 16: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 22.1
Confidence Interval (2-Sided) 95%
13.7 to 30.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo up to Week 16, PF-04965842 200 mg + Placebo Injection up to Week 16
Comments Week 16: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 35.0
Confidence Interval (2-Sided) 95%
26.3 to 43.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg + Placebo Injection up to Week 16, Dupilumab 300 mg + Oral Placebo up to Week 16
Comments Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -3.5
Confidence Interval (2-Sided) 95%
-12.2 to 5.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04965842 200 mg + Placebo Injection up to Week 16, Dupilumab 300 mg + Oral Placebo up to Week 16
Comments Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 9.4
Confidence Interval (2-Sided) 95%
0.4 to 18.5
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16
Hide Description EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time Frame Baseline, Week 2, 4, 8 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
Arm/Group Title Placebo up to Week 16 PF-04965842 100 mg + Placebo Injection up to Week 16 PF-04965842 200 mg + Placebo Injection up to Week 16 Dupilumab 300 mg + Oral Placebo up to Week 16
Hide Arm/Group Description:
Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16.
Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16.
Overall Number of Participants Analyzed 131 238 226 242
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 128 participants 228 participants 223 participants 235 participants
10.9
(5.5 to 16.3)
25.4
(19.8 to 31.1)
30.0
(24.0 to 36.1)
14.0
(9.6 to 18.5)
Week 4 Number Analyzed 128 participants 233 participants 223 participants 238 participants
15.6
(9.3 to 21.9)
44.6
(38.3 to 51.0)
57.4
(50.9 to 63.9)
38.2
(32.1 to 44.4)
Week 8 Number Analyzed 129 participants 232 participants 224 participants 239 participants
18.6
(11.9 to 25.3)
55.6
(49.2 to 62.0)
67.9
(61.7 to 74.0)
52.7
(46.4 to 59.0)
Week 16 Number Analyzed 124 participants 229 participants 221 participants 232 participants
30.6
(22.5 to 38.8)
60.3
(53.9 to 66.6)
71.0
(65.1 to 77.0)
65.5
(59.4 to 71.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo up to Week 16, PF-04965842 100 mg + Placebo Injection up to Week 16
Comments Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 24.1
Confidence Interval (2-Sided) 95%
14.0 to 34.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo up to Week 16, PF-04965842 200 mg + Placebo Injection up to Week 16
Comments Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 30.1
Confidence Interval (2-Sided) 95%
20.3 to 39.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo up to Week 16, Dupilumab 300 mg + Oral Placebo up to Week 16
Comments Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -2.7
Confidence Interval (2-Sided) 95%
-9.6 to 4.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04965842 100 mg + Placebo Injection up to Week 16, Dupilumab 300 mg + Oral Placebo up to Week 16
Comments Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 3.1
Confidence Interval (2-Sided) 95%
-3.3 to 9.6
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16
Hide Description EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time Frame Baseline, Week 2, 4, 8, 12 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
Arm/Group Title Placebo up to Week 16 PF-04965842 100 mg + Placebo Injection up to Week 16 PF-04965842 200 mg + Placebo Injection up to Week 16 Dupilumab 300 mg + Oral Placebo up to Week 16
Hide Arm/Group Description:
Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16.
Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16.
Overall Number of Participants Analyzed 131 238 226 242
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 128 participants 228 participants 223 participants 235 participants
21.9
(14.7 to 29.0)
53.1
(46.6 to 59.5)
60.5
(54.1 to 67.0)
35.7
(29.6 to 41.9)
Week 4 Number Analyzed 128 participants 233 participants 223 participants 238 participants
39.8
(31.4 to 48.3)
73.4
(67.7 to 79.1)
78.5
(73.1 to 83.9)
66.8
(60.8 to 72.8)
Week 8 Number Analyzed 129 participants 232 participants 224 participants 239 participants
48.8
(40.2 to 57.5)
78.9
(73.6 to 84.1)
88.4
(84.2 to 92.6)
77.4
(72.1 to 82.7)
Week 12 Number Analyzed 129 participants 235 participants 219 participants 241 participants
52.7
(44.1 to 61.3)
75.3
(69.8 to 80.8)
86.3
(81.7 to 90.9)
80.9
(76.0 to 85.9)
Week 16 Number Analyzed 124 participants 229 participants 221 participants 232 participants
57.3
(48.6 to 66.0)
81.2
(76.2 to 86.3)
87.3
(82.9 to 91.7)
84.1
(79.3 to 88.8)
7.Secondary Outcome
Title Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16
Hide Description EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time Frame Baseline, Week 2, 4, 8,12 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
Arm/Group Title Placebo up to Week 16 PF-04965842 100 mg + Placebo Injection up to Week 16 PF-04965842 200 mg + Placebo Injection up to Week 16 Dupilumab 300 mg + Oral Placebo up to Week 16
Hide Arm/Group Description:
Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16.
Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16.
Overall Number of Participants Analyzed 131 238 226 242
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 128 participants 228 participants 223 participants 235 participants
2.3
(0.0 to 5.0)
8.3
(4.7 to 11.9)
11.2
(7.1 to 15.4)
2.6
(0.5 to 4.6)
Week 4 Number Analyzed 128 participants 233 participants 223 participants 238 participants
6.3
(2.1 to 10.4)
20.2
(15.0 to 25.3)
32.3
(26.2 to 38.4)
12.2
(8.0 to 16.3)
Week 8 Number Analyzed 129 participants 232 participants 224 participants 239 participants
7.8
(3.1 to 12.4)
30.6
(24.7 to 36.5)
47.3
(40.8 to 53.9)
24.3
(18.8 to 29.7)
Week 12 Number Analyzed 129 participants 235 participants 219 participants 241 participants
10.1
(4.9 to 15.3)
36.6
(30.4 to 42.8)
46.1
(39.5 to 52.7)
34.9
(28.8 to 40.9)
Week 16 Number Analyzed 124 participants 229 participants 221 participants 232 participants
11.3
(5.7 to 16.9)
38.0
(31.7 to 44.3)
48.9
(42.3 to 55.5)
38.8
(32.5 to 45.1)
8.Secondary Outcome
Title Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16
Hide Description EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time Frame Baseline, Week 2, 4, 8, 12 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
Arm/Group Title Placebo up to Week 16 PF-04965842 100 mg + Placebo Injection up to Week 16 PF-04965842 200 mg + Placebo Injection up to Week 16 Dupilumab 300 mg + Oral Placebo up to Week 16
Hide Arm/Group Description:
Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16.
Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16.
Overall Number of Participants Analyzed 131 238 226 242
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 128 participants 228 participants 223 participants 235 participants
0
(0.0 to 2.8)
1.3
(0.0 to 2.8)
4.5
(1.8 to 7.2)
0.4
(0.0 to 1.3)
Week 4 Number Analyzed 128 participants 233 participants 223 participants 238 participants
0
(0.0 to 2.8)
2.6
(0.5 to 4.6)
7.2
(3.8 to 10.6)
2.5
(0.5 to 4.5)
Week 8 Number Analyzed 129 participants 232 participants 224 participants 239 participants
0
(0.0 to 2.8)
6.0
(3.0 to 9.1)
11.6
(7.4 to 15.8)
2.1
(0.3 to 3.9)
Week 12 Number Analyzed 129 participants 235 participants 219 participants 241 participants
1.6
(0.0 to 3.7)
8.1
(4.6 to 11.6)
12.3
(8.0 to 16.7)
6.6
(3.5 to 9.8)
Week 16 Number Analyzed 124 participants 229 participants 221 participants 232 participants
4.0
(0.6 to 7.5)
12.7
(8.4 to 17.0)
13.6
(9.1 to 18.1)
5.2
(2.3 to 8.0)
9.Secondary Outcome
Title Time From Baseline to First Achieve at Least 4 Points Improvement in the Severity of Pruritus NRS
Hide Description Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity.
Time Frame Baseline up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Participants with a baseline numeric rating scale score for severity of pruritus >=4 were included in the analysis.
Arm/Group Title Placebo up to Week 16 PF-04965842 100 mg + Placebo Injection up to Week 16 PF-04965842 200 mg + Placebo Injection up to Week 16 Dupilumab 300 mg + Oral Placebo up to Week 16
Hide Arm/Group Description:
Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16.
Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16.
Overall Number of Participants Analyzed 130 236 226 240
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(84.0 to NA)
29.0
(16.0 to 56.0)
13.0
(10.0 to 16.0)
31.0
(29.0 to 57.0)
[1]
Median and upper limit for 95% CI could not be estimated because there were insufficient number of participants with event.
10.Secondary Outcome
Title Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16
Hide Description 4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.
Time Frame Baseline, Week 2, 4, 8, 12 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16.
Arm/Group Title Placebo up to Week 16 PF-04965842 100 mg + Placebo Injection up to Week 16 PF-04965842 200 mg + Placebo Injection up to Week 16 Dupilumab 300 mg + Oral Placebo up to Week 16
Hide Arm/Group Description:
Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16.
Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16.
Overall Number of Participants Analyzed 131 238 226 242
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percentage BSA
Change at Week 2
-7.6
(-10.4 to -4.8)
-19.5
(-21.6 to -17.4)
-21.4
(-23.5 to -19.3)
-14.0
(-16.1 to -11.9)
Change at Week 4
-14.3
(-17.2 to -11.4)
-26.8
(-29.0 to -24.7)
-30.7
(-32.9 to -28.4)
-24.0
(-26.2 to -21.9)
Change at Week 8
-16.2
(-19.0 to -13.4)
-30.3
(-32.4 to -28.2)
-36.4
(-38.6 to -34.3)
-29.8
(-31.8 to -27.7)
Change at Week 12
-17.1
(-20.1 to -14.1)
-31.6
(-33.8 to -29.4)
-37.4
(-39.6 to -35.1)
-32.5
(-34.7 to -30.3)
Change at Week 16
-19.6
(-22.6 to -16.6)
-32.9
(-35.1 to -30.7)
-39.0
(-41.3 to -36.8)
-34.4
(-36.6 to -32.2)
11.Secondary Outcome
Title Percentage BSA at Week 18 and 20
Hide Description 4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.
Time Frame Week 18 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set for post Week 16 included all randomized participants who received at least 1 dose of study medication post Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
Arm/Group Title Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20
Hide Arm/Group Description:
Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, received oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20.
Overall Number of Participants Analyzed 60 57 217 208 223
Mean (Standard Deviation)
Unit of Measure: Percentage BSA
Week 18 Number Analyzed 55 participants 51 participants 200 participants 198 participants 204 participants
22.0  (23.67) 20.8  (22.7) 14.8  (19.3) 9.8  (13.6) 13.2  (16.4)
Week 20 Number Analyzed 57 participants 56 participants 212 participants 197 participants 214 participants
18.0  (21.2) 16.0  (19.7) 14.2  (19.0) 10.3  (14.2) 13.2  (16.3)
12.Secondary Outcome
Title Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16
Hide Description Participant responded to the following question: "Overall, how would you describe your Atopic Dermatitis right now?" on a scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity.
Time Frame Baseline, Week 2, 4, 8, 12 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Placebo up to Week 16 PF-04965842 100 mg + Placebo Injection up to Week 16 PF-04965842 200 mg + Placebo Injection up to Week 16 Dupilumab 300 mg + Oral Placebo up to Week 16
Hide Arm/Group Description:
Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16.
Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16.
Overall Number of Participants Analyzed 131 238 226 241
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change at Week 2
-0.5
(-0.6 to -0.3)
-0.8
(-0.9 to -0.7)
-1.0
(-1.1 to -0.9)
-0.7
(-0.8 to -0.6)
Change at Week 4
-0.5
(-0.7 to -0.4)
-1.0
(-1.1 to -0.9)
-1.4
(-1.5 to -1.3)
-1.1
(-1.2 to -0.9)
Change at Week 8
-0.6
(-0.7 to -0.4)
-1.1
(-1.3 to -1.0)
-1.5
(-1.6 to -1.4)
-1.3
(-1.4 to -1.1)
Change at Week 12
-0.7
(-0.8 to -0.5)
-1.2
(-1.3 to -1.1)
-1.6
(-1.7 to -1.5)
-1.3
(-1.4 to -1.2)
Change at Week 16
-0.7
(-0.9 to -0.6)
-1.2
(-1.3 to -1.0)
-1.6
(-1.7 to -1.5)
-1.4
(-1.5 to -1.2)
13.Secondary Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 12 and 16
Hide Description DLQI is a 10-item questionnaire that measures the impact of skin disease. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
Time Frame Baseline, Week 2, 12 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Placebo up to Week 16 PF-04965842 100 mg + Placebo Injection up to Week 16 PF-04965842 200 mg + Placebo Injection up to Week 16 Dupilumab 300 mg + Oral Placebo up to Week 16
Hide Arm/Group Description:
Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16.
Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16.
Overall Number of Participants Analyzed 131 238 226 241
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change at Week 2
-4.5
(-5.5 to -3.5)
-6.7
(-7.5 to -6.0)
-8.5
(-9.2 to -7.8)
-6.7
(-7.4 to -5.9)
Change at Week 12
-6.2
(-7.1 to -5.3)
-8.7
(-9.4 to -8.0)
-11.0
(-11.7 to -10.3)
-9.9
(-10.6 to -9.2)
Change at Week 16
-6.2
(-7.1 to -5.3)
-9.0
(-9.7 to -8.4)
-11.7
(-12.4 to -11.1)
-10.8
(-11.4 to -10.1)
14.Secondary Outcome
Title DLQI at Week 20
Hide Description DLQI is a 10-item questionnaire that measures the impact of skin disease. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
Time Frame Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set for post Week 16 included all randomized participants who received at least 1 dose of study medication post Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20
Hide Arm/Group Description:
Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, received oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20.
Overall Number of Participants Analyzed 55 55 210 198 216
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.3  (5.3) 5.8  (5.7) 6.3  (5.8) 4.3  (4.7) 5.6  (4.8)
15.Secondary Outcome
Title Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Index Value at Week 12 and 16
Hide Description EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study, range from 1 to -0.109. Higher (positive) scores = better health state.
Time Frame Baseline, Week 12 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Placebo up to Week 16 PF-04965842 100 mg + Placebo Injection up to Week 16 PF-04965842 200 mg + Placebo Injection up to Week 16 Dupilumab 300 mg + Oral Placebo up to Week 16
Hide Arm/Group Description:
Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16.
Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16.
Overall Number of Participants Analyzed 131 238 226 241
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change at Week 12
0.051
(0.032 to 0.070)
0.101
(0.087 to 0.115)
0.127
(0.113 to 0.141)
0.104
(0.091 to 0.118)
Change at Week 16
0.067
(0.047 to 0.087)
0.093
(0.079 to 0.107)
0.133
(0.119 to 0.148)
0.113
(0.099 to 0.127)
16.Secondary Outcome
Title Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) Score at Week 12 and 16
Hide Description EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.
Time Frame Baseline, Week 12 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Placebo up to Week 16 PF-04965842 100 mg + Placebo Injection up to Week 16 PF-04965842 200 mg + Placebo Injection up to Week 16 Dupilumab 300 mg + Oral Placebo up to Week 16
Hide Arm/Group Description:
Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16.
Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16.
Overall Number of Participants Analyzed 131 238 226 241
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change at Week 12
7.975
(5.161 to 10.789)
11.337
(9.272 to 13.401)
17.373
(15.270 to 19.476)
14.939
(12.900 to 16.978)
Change at Week 16
7.840
(4.952 to 10.727)
11.223
(9.129 to 13.318)
16.711
(14.581 to 18.841)
14.405
(12.315 to 16.496)
17.Secondary Outcome
Title EQ-5D-5L- Index Value at Week 20
Hide Description EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study, range from 1 to -0.109. Higher (positive) scores = better health state.
Time Frame Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set for post Week 16 included all randomized participants who received at least 1 dose of study medication post Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20
Hide Arm/Group Description:
Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, received oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20.
Overall Number of Participants Analyzed 55 55 210 197 216
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.905  (0.097) 0.894  (0.122) 0.883  (0.124) 0.917  (0.109) 0.890  (0.109)
18.Secondary Outcome
Title EQ-5D-5L- VAS Score at Week 20
Hide Description EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.
Time Frame Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set for post Week 16 included all randomized participants who received at least 1 dose of study medication post Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20
Hide Arm/Group Description:
Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, received oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20.
Overall Number of Participants Analyzed 55 55 210 197 216
Mean (Standard Deviation)
Unit of Measure: units on a scale
78.2  (16.3) 78.5  (20.2) 76.7  (19.5) 82.1  (17.1) 79.6  (18.0)
19.Secondary Outcome
Title Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Week 12 and 16
Hide Description HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-Anxiety (HADS-A) scale and HADS-Depression (HADS-D) scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.
Time Frame Baseline, Weeks 12 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Placebo up to Week 16 PF-04965842 100 mg + Placebo Injection up to Week 16 PF-04965842 200 mg + Placebo Injection up to Week 16 Dupilumab 300 mg + Oral Placebo up to Week 16
Hide Arm/Group Description:
Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16.
Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16.
Overall Number of Participants Analyzed 131 238 226 241
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change at Week 12
-0.4
(-0.9 to 0.1)
-1.2
(-1.5 to -0.8)
-1.6
(-2.0 to -1.2)
-1.4
(-1.7 to -1.0)
Change at Week 16
-0.4
(-0.9 to 0.1)
-1.2
(-1.6 to -0.8)
-2.0
(-2.4 to -1.6)
-1.5
(-1.9 to -1.1)
20.Secondary Outcome
Title Change From Baseline in HADS - Depression Scale at Week 12 and 16
Hide Description HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.
Time Frame Baseline, Week 12 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Placebo up to Week 16 PF-04965842 100 mg + Placebo Injection up to Week 16 PF-04965842 200 mg + Placebo Injection up to Week 16 Dupilumab 300 mg + Oral Placebo up to Week 16
Hide Arm/Group Description:
Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16.
Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16.
Overall Number of Participants Analyzed 131 238 226 241
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change at Week 12
-0.3
(-0.7 to 0.2)
-1.3
(-1.6 to -0.9)
-1.6
(-1.9 to -1.2)
-1.3
(-1.6 to -0.9)
Change at Week 16
-0.3
(-0.8 to 0.2)
-1.0
(-1.4 to -0.7)
-1.6
(-1.9 to -1.2)
-1.2
(-1.5 to -0.8)
21.Secondary Outcome
Title HADS - Anxiety Scale at Week 20
Hide Description HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.
Time Frame Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set for post Week 16 included all randomized participants who received at least 1 dose of study medication post Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20
Hide Arm/Group Description:
Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, received oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20.
Overall Number of Participants Analyzed 55 55 209 197 215
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.4  (3.2) 4.5  (4.5) 4.0  (3.8) 3.1  (3.1) 3.7  (3.5)
22.Secondary Outcome
Title HADS - Depression Scale at Week 20
Hide Description HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.
Time Frame Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set for post Week 16 included all randomized participants who received at least 1 dose of study medication post Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20
Hide Arm/Group Description:
Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, received oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20.
Overall Number of Participants Analyzed 55 55 209 197 215
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.6  (3.4) 3.6  (3.7) 2.8  (3.2) 2.2  (3.1) 2.7  (3.3)
23.Secondary Outcome
Title Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 12 and 16
Hide Description POEM is a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item is scored as following: "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28, where higher score indicated greater severity.
Time Frame Baseline, Week 12 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Placebo up to Week 16 PF-04965842 100 mg + Placebo Injection up to Week 16 PF-04965842 200 mg + Placebo Injection up to Week 16 Dupilumab 300 mg + Oral Placebo up to Week 16
Hide Arm/Group Description:
Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16.
Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16.
Overall Number of Participants Analyzed 131 238 226 241
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change at Week 12
-5.1
(-6.3 to -3.9)
-9.6
(-10.5 to -8.6)
-12.6
(-13.6 to -11.7)
-10.8
(-11.7 to -9.9)
Change at Week 16
-5.0
(-6.3 to -3.8)
-9.2
(-10.1 to -8.2)
-12.5
(-13.4 to -11.6)
-10.8
(-11.8 to -9.9)
24.Secondary Outcome
Title POEM at Week 20
Hide Description POEM is a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item is scored as following: "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28, where higher score indicated greater severity.
Time Frame Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set for post Week 16 included all randomized participants who received at least 1 dose of study medication post Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20
Hide Arm/Group Description:
Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, received oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20.
Overall Number of Participants Analyzed 55 55 209 196 215
Mean (Standard Deviation)
Unit of Measure: units on a scale
10.7  (6.8) 9.6  (7.8) 11.6  (7.7) 8.6  (7.0) 11.0  (6.9)
25.Secondary Outcome
Title Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16
Hide Description PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin [lighter or darker], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.
Time Frame Baseline, Week 1 to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Placebo up to Week 16 PF-04965842 100 mg + Placebo Injection up to Week 16 PF-04965842 200 mg + Placebo Injection up to Week 16 Dupilumab 300 mg + Oral Placebo up to Week 16
Hide Arm/Group Description:
Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16.
Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16.
Overall Number of Participants Analyzed 130 237 225 241
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Change at Week 1
-0.5
(-0.8 to -0.3)
-1.1
(-1.3 to -0.9)
-1.3
(-1.5 to -1.2)
-0.9
(-1.1 to -0.8)
Change at Week 2
-0.9
(-1.2 to -0.7)
-1.8
(-2.0 to -1.6)
-2.3
(-2.5 to -2.1)
-1.6
(-1.8 to -1.4)
Change at Week 3
-1.1
(-1.4 to -0.8)
-2.2
(-2.4 to -2.0)
-2.8
(-3.0 to -2.6)
-2.1
(-2.3 to -1.9)
Change at Week 4
-1.4
(-1.7 to -1.1)
-2.4
(-2.6 to -2.2)
-3.0
(-3.3 to -2.8)
-2.4
(-2.7 to -2.2)
Change at Week 5
-1.5
(-1.8 to -1.2)
-2.6
(-2.8 to -2.4)
-3.2
(-3.5 to -3.0)
-2.7
(-2.9 to -2.5)
Change at Week 6
-1.5
(-1.8 to -1.2)
-2.6
(-2.8 to -2.4)
-3.3
(-3.6 to -3.1)
-2.8
(-3.1 to -2.6)
Change at Week 7
-1.6
(-1.9 to -1.2)
-2.7
(-2.9 to -2.4)
-3.4
(-3.6 to -3.1)
-2.9
(-3.2 to -2.7)
Change at Week 8
-1.5
(-1.9 to -1.2)
-2.7
(-2.9 to -2.4)
-3.4
(-3.7 to -3.2)
-3.0
(-3.2 to -2.7)
Change at Week 9
-1.7
(-2.0 to -1.4)
-2.7
(-2.9 to -2.4)
-3.5
(-3.8 to -3.3)
-3.1
(-3.3 to -2.8)
Change at Week 10
-1.7
(-2.0 to -1.4)
-2.7
(-2.9 to -2.4)
-3.5
(-3.8 to -3.3)
-3.1
(-3.4 to -2.9)
Change at Week 11
-1.6
(-1.9 to -1.3)
-2.7
(-2.9 to -2.4)
-3.5
(-3.8 to -3.3)
-3.2
(-3.4 to -2.9)
Change at Week 12
-1.6
(-2.0 to -1.3)
-2.7
(-3.0 to -2.5)
-3.6
(-3.8 to -3.3)
-3.2
(-3.5 to -3.0)
Change at Week 13
-1.7
(-2.0 to -1.4)
-2.8
(-3.1 to -2.6)
-3.7
(-3.9 to -3.4)
-3.3
(-3.6 to -3.1)
Change at Week 14
-1.6
(-1.9 to -1.3)
-2.8
(-3.1 to -2.6)
-3.6
(-3.9 to -3.4)
-3.4
(-3.6 to -3.2)
Change at Week 15
-1.7
(-2.0 to -1.4)
-2.9
(-3.1 to -2.6)
-3.6
(-3.8 to -3.4)
-3.4
(-3.6 to -3.1)
Change at Week 16
-1.7
(-2.0 to -1.3)
-2.8
(-3.1 to -2.6)
-3.6
(-3.8 to -3.4)
-3.4
(-3.6 to -3.2)
26.Secondary Outcome
Title PSAAD Total Score at Week 18 and 20
Hide Description PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin [lighter or darker], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.
Time Frame Week 18 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set for post Week 16 included all randomized participants who received at least 1 dose of study medication post Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
Arm/Group Title Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20
Hide Arm/Group Description:
Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, received oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20.
Overall Number of Participants Analyzed 54 54 202 202 218
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 18 Number Analyzed 54 participants 54 participants 202 participants 202 participants 218 participants
2.6  (1.9) 3.0  (2.4) 2.2  (1.9) 1.7  (1.7) 1.8  (1.5)
Week 20 Number Analyzed 54 participants 53 participants 201 participants 199 participants 213 participants
2.5  (2.0) 2.6  (2.3) 2.2  (1.9) 1.8  (1.8) 2.0  (1.6)
27.Secondary Outcome
Title Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16
Hide Description SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.
Time Frame Baseline, Week 2, 4, 8 12 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
Arm/Group Title Placebo up to Week 16 PF-04965842 100 mg + Placebo Injection up to Week 16 PF-04965842 200 mg + Placebo Injection up to Week 16 Dupilumab 300 mg + Oral Placebo up to Week 16
Hide Arm/Group Description:
Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16.
Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16.
Overall Number of Participants Analyzed 131 238 226 242
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 128 participants 233 participants 224 participants 237 participants
10.2
(4.9 to 15.4)
23.6
(18.2 to 29.1)
38.4
(32.0 to 44.8)
15.6
(11.0 to 20.2)
Week 4 Number Analyzed 129 participants 234 participants 224 participants 238 participants
18.6
(11.9 to 25.3)
45.7
(39.3 to 52.1)
61.6
(55.2 to 68.0)
45.8
(39.5 to 52.1)
Week 8 Number Analyzed 129 participants 234 participants 225 participants 239 participants
20.2
(13.2 to 27.1)
53.4
(47.0 to 59.8)
71.6
(65.7 to 77.5)
56.9
(50.6 to 63.2)
Week 12 Number Analyzed 128 participants 234 participants 224 participants 238 participants
27.3
(19.6 to 35.1)
56.8
(50.5 to 63.2)
72.3
(66.5 to 78.2)
64.3
(58.2 to 70.4)
Week 16 Number Analyzed 123 participants 228 participants 221 participants 231 participants
33.3
(25.0 to 41.7)
56.1
(49.7 to 62.6)
68.8
(62.7 to 74.9)
67.5
(61.5 to 73.6)
28.Secondary Outcome
Title Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16
Hide Description SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.
Time Frame Baseline, Week 2, 4, 8 12 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
Arm/Group Title Placebo up to Week 16 PF-04965842 100 mg + Placebo Injection up to Week 16 PF-04965842 200 mg + Placebo Injection up to Week 16 Dupilumab 300 mg + Oral Placebo up to Week 16
Hide Arm/Group Description:
Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16.
Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16.
Overall Number of Participants Analyzed 131 238 226 242
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 2 Number Analyzed 128 participants 233 participants 224 participants 237 participants
1.6
(0.0 to 3.7)
6.4
(3.3 to 9.6)
8.5
(4.8 to 12.1)
0.8
(0.0 to 2.0)
Week 4 Number Analyzed 129 participants 234 participants 224 participants 238 participants
3.1
(0.1 to 6.1)
12.4
(8.2 to 16.6)
25.4
(19.7 to 31.2)
7.1
(3.9 to 10.4)
Week 8 Number Analyzed 129 participants 234 participants 225 participants 239 participants
3.1
(0.1 to 6.1)
19.2
(14.2 to 24.3)
41.3
(34.9 to 47.8)
16.3
(11.6 to 21.0)
Week 12 Number Analyzed 128 participants 234 participants 224 participants 238 participants
6.3
(2.1 to 10.4)
25.6
(20.0 to 31.2)
39.3
(32.9 to 45.7)
26.1
(20.5 to 31.6)
Week 16 Number Analyzed 123 participants 228 participants 221 participants 231 participants
10.6
(5.1 to 16.0)
26.8
(21.0 to 32.5)
40.3
(33.8 to 46.7)
29.4
(23.6 to 35.3)
29.Secondary Outcome
Title Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16
Hide Description SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.
Time Frame Baseline, Week 2, 4, 8 12 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Placebo up to Week 16 PF-04965842 100 mg + Placebo Injection up to Week 16 PF-04965842 200 mg + Placebo Injection up to Week 16 Dupilumab 300 mg + Oral Placebo up to Week 16
Hide Arm/Group Description:
Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16.
Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16.
Overall Number of Participants Analyzed 129 237 225 241
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Itch: Change at Week 2
-1.5
(-1.9 to -1.2)
-2.9
(-3.2 to -2.7)
-3.7
(-4.0 to -3.4)
-2.4
(-2.7 to -2.1)
Itch: Change at Week 4
-2.2
(-2.6 to -1.8)
-3.7
(-4.0 to -3.4)
-4.6
(-4.9 to -4.3)
-3.7
(-4.0 to -3.4)
Itch: Change at Week 8
-2.3
(-2.7 to -1.9)
-3.9
(-4.2 to -3.6)
-4.9
(-5.2 to -4.6)
-4.2
(-4.5 to -3.9)
Itch: Change at Week 12
-2.4
(-2.9 to -2.0)
-3.9
(-4.3 to -3.6)
-5.0
(-5.3 to -4.7)
-4.4
(-4.7 to -4.1)
Itch: Change at Week 16
-2.7
(-3.1 to -2.3)
-3.8
(-4.1 to -3.5)
-4.8
(-5.1 to -4.5)
-4.5
(-4.8 to -4.2)
Sleep loss: Change at Week 2
-1.6
(-2.0 to -1.2)
-2.6
(-2.9 to -2.3)
-3.3
(-3.6 to -3.0)
-2.3
(-2.6 to -1.9)
Sleep loss: Change at Week 4
-2.3
(-2.7 to -1.9)
-3.4
(-3.7 to -3.1)
-4.2
(-4.5 to -3.9)
-3.4
(-3.7 to -3.1)
Sleep loss: Change at Week 8
-2.3
(-2.7 to -1.9)
-3.6
(-3.9 to -3.3)
-4.4
(-4.7 to -4.1)
-3.9
(-4.2 to -3.6)
Sleep loss: Change at Week 12
-2.4
(-2.8 to -2.0)
-3.7
(-4.0 to -3.4)
-4.6
(-4.9 to -4.3)
-4.2
(-4.5 to -3.9)
Sleep loss: Change at Week 16
-2.6
(-3.0 to -2.2)
-3.7
(-4.0 to -3.4)
-4.8
(-5.1 to -4.5)
-4.3
(-4.6 to -4.0)
30.Secondary Outcome
Title SCORAD VAS of Itch and Sleep Loss at Week 18 and 20
Hide Description SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome.
Time Frame Week 18 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set for post Week 16 included all randomized participants who received at least 1 dose of study medication post Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points.
Arm/Group Title Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20
Hide Arm/Group Description:
Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20.
Participants who were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, received oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20.
Overall Number of Participants Analyzed 60 57 217 208 223
Mean (Standard Deviation)
Unit of Measure: units on a scale
Itch: Week 18 Number Analyzed 56 participants 52 participants 204 participants 201 participants 206 participants
3.2  (2.6) 2.7  (2.2) 3.0  (2.5) 2.3  (2.2) 2.7  (2.2)
Itch: Week 20 Number Analyzed 58 participants 57 participants 212 participants 199 participants 218 participants
2.9  (2.4) 2.6  (2.4) 3.2  (2.6) 2.3  (2.3) 2.8  (2.2)
Sleep loss: Week 18 Number Analyzed 56 participants 52 participants 204 participants 201 participants 206 participants
2.2  (2.3) 2.3  (2.3) 2.1  (2.3) 1.6  (2.1) 1.8  (2.0)
Sleep loss: Week 20 Number Analyzed 58 participants 57 participants 212 participants 199 participants 218 participants
2.1  (2.2) 2.0  (2.3) 2.4  (2.6) 1.5  (2.1) 1.7  (2.1)
31.Secondary Outcome
Title Least Square Mean of Number of Steroid-free Days From Baseline up to Week 16
Hide Description Number of days when a corticosteroid as a concomitant medication was not used up to Week 16 is reported as Least square mean in this outcome measure.
Time Frame Baseline up to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16.
Arm/Group Title Placebo up to Week 16 PF-04965842 100 mg + Placebo Injection up to Week 16 PF-04965842 200 mg + Placebo Injection up to Week 16 Dupilumab 300 mg + Oral Placebo up to Week 16
Hide Arm/Group Description:
Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16.
Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16.
Overall Number of Participants Analyzed 131 238 226 242
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Days
21.8
(14.9 to 28.8)
30.2
(25.1 to 35.4)
33.6
(28.3 to 38.9)
28.1
(23.0 to 33.2)
Time Frame For reporting arms till Week 16 analysis: Baseline up to Week 16; For reporting arms post Week 16 analysis: Week 16 to Week 24 (28 days after last dose of study drug)
Adverse Event Reporting Description Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all randomized participants who received at least 1 dose of study medication.
 
Arm/Group Title Placebo up to Week 16 PF-04965842 100 mg + Placebo Injection up to Week 16 PF-04965842 200 mg + Placebo Injection up to Week 16 Dupilumab 300 mg + Oral Placebo up to Week 16 Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20
Hide Arm/Group Description Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16. Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16. Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20. Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20. Participants who were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20. Participants who were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20. Participants who were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, received oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20.
All-Cause Mortality
Placebo up to Week 16 PF-04965842 100 mg + Placebo Injection up to Week 16 PF-04965842 200 mg + Placebo Injection up to Week 16 Dupilumab 300 mg + Oral Placebo up to Week 16 Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20
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   0/131 (0.00%)   0/238 (0.00%)   0/226 (0.00%)   0/242 (0.00%)   0/60 (0.00%)   0/57 (0.00%)   0/217 (0.00%)   0/208 (0.00%)   0/223 (0.00%) 
Hide Serious Adverse Events
Placebo up to Week 16 PF-04965842 100 mg + Placebo Injection up to Week 16 PF-04965842 200 mg + Placebo Injection up to Week 16 Dupilumab 300 mg + Oral Placebo up to Week 16 Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20
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   5/131 (3.82%)   6/238 (2.52%)   2/226 (0.88%)   2/242 (0.83%)   0/60 (0.00%)   0/57 (0.00%)   1/217 (0.46%)   0/208 (0.00%)   1/223 (0.45%) 
Blood and lymphatic system disorders                   
Pancytopenia * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Gastrointestinal disorders                   
Abdominal pain * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
General disorders                   
Chills * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Pyrexia * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Hepatobiliary disorders                   
Drug-induced liver injury * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Immune system disorders                   
Anaphylactic reaction * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Infections and infestations                   
Diarrhoea infectious * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Oral herpes * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Pneumonia * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Enteritis infectious * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Injury, poisoning and procedural complications                   
Ankle fracture * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Meniscus injury * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Muscle injury * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Tendon injury * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Investigations                   
Aspartate aminotransferase increased * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Musculoskeletal and connective tissue disorders                   
Intervertebral disc protrusion * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                   
Invasive ductal breast carcinoma * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Renal and urinary disorders                   
Hydronephrosis * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  1/223 (0.45%) 
Nephrolithiasis * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  1/223 (0.45%) 
Ureterolithiasis * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  1/223 (0.45%) 
Urinary tract obstruction * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  1/223 (0.45%) 
Reproductive system and breast disorders                   
Breast mass * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Uterine haemorrhage * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Respiratory, thoracic and mediastinal disorders                   
Dyspnoea * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Interstitial lung disease * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Skin and subcutaneous tissue disorders                   
Dermatitis atopic * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Night sweats * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
*
Indicates events were collected by non-systematic assessment
[1]
MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo up to Week 16 PF-04965842 100 mg + Placebo Injection up to Week 16 PF-04965842 200 mg + Placebo Injection up to Week 16 Dupilumab 300 mg + Oral Placebo up to Week 16 Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20
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   68/131 (51.91%)   121/238 (50.84%)   140/226 (61.95%)   120/242 (49.59%)   13/60 (21.67%)   16/57 (28.07%)   50/217 (23.04%)   45/208 (21.63%)   31/223 (13.90%) 
Blood and lymphatic system disorders                   
Anaemia * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  1/208 (0.48%)  0/223 (0.00%) 
Leukopenia * [1]  0/131 (0.00%)  1/238 (0.42%)  3/226 (1.33%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Lymphadenitis * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Lymphadenopathy * [1]  0/131 (0.00%)  1/238 (0.42%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Lymphopenia * [1]  0/131 (0.00%)  1/238 (0.42%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Microcytic anaemia * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Thrombocytopenia * [1]  0/131 (0.00%)  0/238 (0.00%)  2/226 (0.88%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Thrombocytosis * [1]  0/131 (0.00%)  2/238 (0.84%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Cardiac disorders                   
Arrhythmia * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Atrioventricular block first degree * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Bradycardia * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Defect conduction intraventricular * [1]  2/131 (1.53%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  1/223 (0.45%) 
Palpitations * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Sinus bradycardia * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  3/242 (1.24%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Ventricular extrasystoles * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Congenital, familial and genetic disorders                   
Dermoid cyst * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Congenital lacrimal passage anomaly * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  1/223 (0.45%) 
Ear and labyrinth disorders                   
External ear inflammation * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Vertigo positional * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Eye disorders                   
Asthenopia * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Blepharitis * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Conjunctival haemorrhage * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Conjunctival irritation * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Conjunctivitis allergic * [1]  0/131 (0.00%)  1/238 (0.42%)  1/226 (0.44%)  2/242 (0.83%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  1/223 (0.45%) 
Dry eye * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  1/223 (0.45%) 
Eye irritation * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  2/242 (0.83%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Eye pain * [1]  0/131 (0.00%)  1/238 (0.42%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Eye pruritus * [1]  1/131 (0.76%)  1/238 (0.42%)  1/226 (0.44%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Eyelid oedema * [1]  1/131 (0.76%)  3/238 (1.26%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Eyelid pain * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Eyelids pruritus * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Lacrimation increased * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Noninfective conjunctivitis * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Ocular discomfort * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Ocular hyperaemia * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Presbyopia * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Swelling of eyelid * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Vision blurred * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Eczema eyelids * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  1/208 (0.48%)  0/223 (0.00%) 
Eyelid cyst * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  1/223 (0.45%) 
Gastrointestinal disorders                   
Abdominal discomfort * [1]  0/131 (0.00%)  0/238 (0.00%)  3/226 (1.33%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Abdominal distension * [1]  1/131 (0.76%)  0/238 (0.00%)  1/226 (0.44%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  1/223 (0.45%) 
Abdominal pain * [1]  1/131 (0.76%)  0/238 (0.00%)  3/226 (1.33%)  3/242 (1.24%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Abdominal pain upper * [1]  0/131 (0.00%)  1/238 (0.42%)  2/226 (0.88%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Anal pruritus * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Constipation * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Dental caries * [1]  1/131 (0.76%)  0/238 (0.00%)  2/226 (0.88%)  0/242 (0.00%)  1/60 (1.67%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Diarrhoea * [1]  4/131 (3.05%)  4/238 (1.68%)  4/226 (1.77%)  3/242 (1.24%)  0/60 (0.00%)  2/57 (3.51%)  3/217 (1.38%)  1/208 (0.48%)  0/223 (0.00%) 
Dyspepsia * [1]  0/131 (0.00%)  2/238 (0.84%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  1/208 (0.48%)  0/223 (0.00%) 
Faeces soft *  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Flatulence * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Food poisoning * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Frequent bowel movements * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Gastritis * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Gastrooesophageal reflux disease * [1]  1/131 (0.76%)  2/238 (0.84%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Gingival pain * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Inguinal hernia * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Nausea * [1]  2/131 (1.53%)  10/238 (4.20%)  25/226 (11.06%)  7/242 (2.89%)  0/60 (0.00%)  5/57 (8.77%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Noninfective gingivitis * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Tooth impacted * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Toothache * [1]  1/131 (0.76%)  1/238 (0.42%)  1/226 (0.44%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Vomiting * [1]  1/131 (0.76%)  1/238 (0.42%)  3/226 (1.33%)  4/242 (1.65%)  0/60 (0.00%)  0/57 (0.00%)  2/217 (0.92%)  0/208 (0.00%)  0/223 (0.00%) 
Gastritis erosive * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  1/223 (0.45%) 
General disorders                   
Asthenia * [1]  0/131 (0.00%)  2/238 (0.84%)  2/226 (0.88%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Chest pain * [1]  1/131 (0.76%)  2/238 (0.84%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Chills * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Cyst * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Fatigue * [1]  1/131 (0.76%)  2/238 (0.84%)  3/226 (1.33%)  2/242 (0.83%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Feeling abnormal * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Feeling cold * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Feeling hot * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Inflammation * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Influenza like illness * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Injection site erythema * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Injection site oedema * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Injection site pain * [1]  0/131 (0.00%)  1/238 (0.42%)  2/226 (0.88%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Injection site swelling * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Mass * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Malaise * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Medical device site rash * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Oedema peripheral * [1]  0/131 (0.00%)  1/238 (0.42%)  2/226 (0.88%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Pain * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Peripheral swelling * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Pyrexia * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  2/242 (0.83%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  1/208 (0.48%)  0/223 (0.00%) 
Swelling * [1]  0/131 (0.00%)  2/238 (0.84%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Swelling face * [1]  0/131 (0.00%)  2/238 (0.84%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Therapeutic response unexpected * [1]  0/131 (0.00%)  0/238 (0.00%)  2/226 (0.88%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Xerosis * [1]  0/131 (0.00%)  2/238 (0.84%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Hepatobiliary disorders                   
Gallbladder polyp * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Biliary colic * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Hepatic function abnormal * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Hepatic lesion * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Hyperbilirubinaemia * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Liver disorder * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Immune system disorders                   
Allergy to chemicals * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  1/223 (0.45%) 
Food allergy * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  1/208 (0.48%)  0/223 (0.00%) 
Hypersensitivity * [1]  0/131 (0.00%)  0/238 (0.00%)  2/226 (0.88%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Seasonal allergy * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Infections and infestations                   
Abscess limb * [1]  0/131 (0.00%)  0/238 (0.00%)  2/226 (0.88%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Bacterial vaginosis * [1]  0/131 (0.00%)  1/238 (0.42%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Body tinea * [1]  1/131 (0.76%)  1/238 (0.42%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Bronchitis * [1]  1/131 (0.76%)  1/238 (0.42%)  1/226 (0.44%)  0/242 (0.00%)  1/60 (1.67%)  0/57 (0.00%)  0/217 (0.00%)  2/208 (0.96%)  0/223 (0.00%) 
Cellulitis * [1]  1/131 (0.76%)  0/238 (0.00%)  2/226 (0.88%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  2/217 (0.92%)  0/208 (0.00%)  0/223 (0.00%) 
Conjunctivitis * [1]  3/131 (2.29%)  2/238 (0.84%)  3/226 (1.33%)  15/242 (6.20%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  2/223 (0.90%) 
Conjunctivitis bacterial * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Cystitis * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Dermatophytosis of nail * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Ear infection * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Eczema herpeticum * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Eczema infected * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Epstein-Barr virus infection * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Erysipelas * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Folliculitis * [1]  4/131 (3.05%)  4/238 (1.68%)  4/226 (1.77%)  2/242 (0.83%)  0/60 (0.00%)  1/57 (1.75%)  0/217 (0.00%)  1/208 (0.48%)  0/223 (0.00%) 
Fungal infection * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Fungal skin infection * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Furuncle * [1]  2/131 (1.53%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  1/60 (1.67%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Gastroenteritis * [1]  1/131 (0.76%)  0/238 (0.00%)  2/226 (0.88%)  3/242 (1.24%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Gastroenteritis viral * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Gastrointestinal infection * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Gingivitis *  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Hand-foot-and-mouth disease * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Herpes dermatitis * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Herpes simplex * [1]  1/131 (0.76%)  5/238 (2.10%)  8/226 (3.54%)  2/242 (0.83%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  4/208 (1.92%)  1/223 (0.45%) 
Herpes virus infection * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Herpes zoster * [1]  0/131 (0.00%)  1/238 (0.42%)  4/226 (1.77%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  1/208 (0.48%)  0/223 (0.00%) 
Hordeolum * [1]  1/131 (0.76%)  2/238 (0.84%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Impetigo * [1]  0/131 (0.00%)  5/238 (2.10%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Influenza * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  1/242 (0.41%)  1/60 (1.67%)  0/57 (0.00%)  2/217 (0.92%)  0/208 (0.00%)  0/223 (0.00%) 
Kaposi's varicelliform eruption * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Laryngitis * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Lower respiratory tract infection * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Malassezia infection * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Molluscum contagiosum * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Nasopharyngitis * [1]  9/131 (6.87%)  22/238 (9.24%)  15/226 (6.64%)  23/242 (9.50%)  3/60 (5.00%)  2/57 (3.51%)  3/217 (1.38%)  9/208 (4.33%)  5/223 (2.24%) 
Ophthalmic herpes simplex * [1]  1/131 (0.76%)  0/238 (0.00%)  2/226 (0.88%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Ophthalmic herpes zoster * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  1/223 (0.45%) 
Oral herpes * [1]  1/131 (0.76%)  3/238 (1.26%)  2/226 (0.88%)  5/242 (2.07%)  0/60 (0.00%)  1/57 (1.75%)  0/217 (0.00%)  0/208 (0.00%)  1/223 (0.45%) 
Otitis media * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Paronychia * [1]  1/131 (0.76%)  0/238 (0.00%)  1/226 (0.44%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Perichondritis * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Pharyngitis * [1]  1/131 (0.76%)  2/238 (0.84%)  1/226 (0.44%)  2/242 (0.83%)  1/60 (1.67%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Pharyngitis bacterial * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Pharyngotonsillitis * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Pulpitis dental * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Pustule * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Rash pustular * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Respiratory tract infection * [1]  1/131 (0.76%)  2/238 (0.84%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  1/208 (0.48%)  0/223 (0.00%) 
Respiratory tract infection viral * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Rhinitis * [1]  0/131 (0.00%)  0/238 (0.00%)  2/226 (0.88%)  3/242 (1.24%)  0/60 (0.00%)  0/57 (0.00%)  2/217 (0.92%)  0/208 (0.00%)  0/223 (0.00%) 
Sinusitis * [1]  1/131 (0.76%)  1/238 (0.42%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  1/57 (1.75%)  0/217 (0.00%)  1/208 (0.48%)  0/223 (0.00%) 
Sinusitis bacterial * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Skin bacterial infection * [1]  1/131 (0.76%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Skin candida * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Skin infection * [1]  1/131 (0.76%)  1/238 (0.42%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Staphylococcal skin infection * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Subcutaneous abscess * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Tinea pedis * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Tinea versicolour * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  1/57 (1.75%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Tonsillitis * [1]  0/131 (0.00%)  1/238 (0.42%)  1/226 (0.44%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Tooth abscess * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  2/242 (0.83%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Tooth infection * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  1/208 (0.48%)  0/223 (0.00%) 
Upper respiratory tract infection * [1]  6/131 (4.58%)  12/238 (5.04%)  9/226 (3.98%)  9/242 (3.72%)  1/60 (1.67%)  0/57 (0.00%)  6/217 (2.76%)  5/208 (2.40%)  7/223 (3.14%) 
Ureaplasma infection * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Urinary tract infection * [1]  2/131 (1.53%)  4/238 (1.68%)  7/226 (3.10%)  4/242 (1.65%)  2/60 (3.33%)  0/57 (0.00%)  2/217 (0.92%)  0/208 (0.00%)  1/223 (0.45%) 
Urinary tract infection bacterial * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  2/242 (0.83%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Viral infection * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Viral upper respiratory tract infection * [1]  0/131 (0.00%)  2/238 (0.84%)  2/226 (0.88%)  0/242 (0.00%)  0/60 (0.00%)  1/57 (1.75%)  2/217 (0.92%)  0/208 (0.00%)  0/223 (0.00%) 
Vulvovaginal mycotic infection * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Wound infection * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Asymptomatic bacteriuria * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Bronchitis bacterial * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  1/57 (1.75%)  0/217 (0.00%)  1/208 (0.48%)  1/223 (0.45%) 
Bronchitis viral * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  1/208 (0.48%)  0/223 (0.00%) 
Gastrointestinal viral infection * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  1/60 (1.67%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Genital herpes simplex * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Nasal herpes * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  1/60 (1.67%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Pneumonia bacterial * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Vulvovaginal candidiasis * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Injury, poisoning and procedural complications                   
Animal bite * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  1/208 (0.48%)  0/223 (0.00%) 
Clavicle fracture * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Contusion * [1]  0/131 (0.00%)  1/238 (0.42%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Eye injury * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Fall * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Foot fracture * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Head injury * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Joint injury * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Ligament sprain * [1]  2/131 (1.53%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Limb injury * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  1/208 (0.48%)  0/223 (0.00%) 
Medication error * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Muscle strain * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Procedural pain * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Road traffic accident * [1]  2/131 (1.53%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  1/57 (1.75%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Scapula fracture * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Skin abrasion * [1]  0/131 (0.00%)  1/238 (0.42%)  3/226 (1.33%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Skin laceration * [1]  1/131 (0.76%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  1/57 (1.75%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Soft tissue injury * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Tooth fracture * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Traumatic haematoma * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Wound haemorrhage * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Arthropod bite * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Epicondylitis * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  1/208 (0.48%)  0/223 (0.00%) 
Humerus fracture * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  1/223 (0.45%) 
Thermal burn * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Wound * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  1/57 (1.75%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Investigations                   
Activated partial thromboplastin time prolonged * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Alanine aminotransferase increased * [1]  1/131 (0.76%)  2/238 (0.84%)  1/226 (0.44%)  1/242 (0.41%)  1/60 (1.67%)  0/57 (0.00%)  0/217 (0.00%)  2/208 (0.96%)  0/223 (0.00%) 
Aspartate aminotransferase increased * [1]  1/131 (0.76%)  2/238 (0.84%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Biopsy endometrium * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Blood bilirubin increased * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Blood cholesterol increased * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  1/208 (0.48%)  1/223 (0.45%) 
Blood creatine phosphokinase increased * [1]  3/131 (2.29%)  7/238 (2.94%)  6/226 (2.65%)  2/242 (0.83%)  1/60 (1.67%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Blood creatinine increased * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Blood lactate dehydrogenase increased * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Body temperature increased * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  1/208 (0.48%)  0/223 (0.00%) 
C-reactive protein increased * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Cardiac murmur * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Ejection fraction decreased * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Electrocardiogram QT prolonged * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Electrocardiogram T wave amplitude increased * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Haematocrit decreased * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Haemoglobin decreased * [1]  0/131 (0.00%)  0/238 (0.00%)  3/226 (1.33%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  2/208 (0.96%)  0/223 (0.00%) 
Lipids increased * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Liver function test increased * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Natural killer cell count decreased * [1]  0/131 (0.00%)  2/238 (0.84%)  4/226 (1.77%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  1/208 (0.48%)  0/223 (0.00%) 
Red blood cell count decreased * [1]  0/131 (0.00%)  0/238 (0.00%)  2/226 (0.88%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
T-lymphocyte count decreased * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Transaminases increased * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Weight increased * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Blood pressure increased * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  1/208 (0.48%)  0/223 (0.00%) 
Blood urea increased * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  1/208 (0.48%)  0/223 (0.00%) 
Gamma-glutamyltransferase increased * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  1/60 (1.67%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Liver function test abnormal * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  1/57 (1.75%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Urine analysis abnormal * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Eosinophil percentage increased * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Metabolism and nutrition disorders                   
Decreased appetite * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Dyslipidaemia * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Hypercholesterolaemia * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Hyperglycaemia * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Hypertriglyceridaemia * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Hypophosphataemia * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Increased appetite * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Obesity * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Type 2 diabetes mellitus * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Hyperuricaemia * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  2/208 (0.96%)  0/223 (0.00%) 
Musculoskeletal and connective tissue disorders                   
Arthralgia * [1]  1/131 (0.76%)  0/238 (0.00%)  2/226 (0.88%)  2/242 (0.83%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Arthritis * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Arthropathy * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Back pain * [1]  5/131 (3.82%)  0/238 (0.00%)  1/226 (0.44%)  7/242 (2.89%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  1/223 (0.45%) 
Bursitis * [1]  1/131 (0.76%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  1/223 (0.45%) 
Foot deformity * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Mandibular mass * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Muscle spasms * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Muscle tightness * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Musculoskeletal pain * [1]  2/131 (1.53%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Musculoskeletal stiffness * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Osteoarthritis * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Pain in extremity * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Plantar fasciitis * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Rotator cuff syndrome * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Spinal pain * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Synovitis * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Temporomandibular joint syndrome * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Tendonitis * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Joint swelling * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Intervertebral disc protrusion * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  1/223 (0.45%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                   
Anogenital warts * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Skin papilloma * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  1/223 (0.45%) 
Nervous system disorders                   
Dizziness * [1]  2/131 (1.53%)  4/238 (1.68%)  7/226 (3.10%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  2/217 (0.92%)  0/208 (0.00%)  0/223 (0.00%) 
Dysaesthesia * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
External compression headache * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Headache * [1]  6/131 (4.58%)  10/238 (4.20%)  15/226 (6.64%)  13/242 (5.37%)  1/60 (1.67%)  1/57 (1.75%)  2/217 (0.92%)  0/208 (0.00%)  2/223 (0.90%) 
Hypertonia * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Hypoaesthesia * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Migraine * [1]  1/131 (0.76%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Nerve compression * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Neuralgia * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Neuropathy peripheral * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Paraesthesia * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Parosmia * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Presyncope * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Somnolence * [1]  0/131 (0.00%)  3/238 (1.26%)  2/226 (0.88%)  2/242 (0.83%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Tension headache * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Pregnancy, puerperium and perinatal conditions                   
Pregnancy * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  1/223 (0.45%) 
Psychiatric disorders                   
Anxiety * [1]  0/131 (0.00%)  2/238 (0.84%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Apathy * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Depression * [1]  0/131 (0.00%)  1/238 (0.42%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Depression suicidal * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Insomnia * [1]  2/131 (1.53%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Irritability * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Libido decreased * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Mood swings * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Schizophrenia * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Renal and urinary disorders                   
Acute kidney injury * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Dysuria * [1]  1/131 (0.76%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Pollakiuria * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Polyuria * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Calculus urinary * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Haematuria * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Leukocyturia * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Urinary tract inflammation * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  1/208 (0.48%)  0/223 (0.00%) 
Reproductive system and breast disorders                   
Benign prostatic hyperplasia * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Dysmenorrhoea * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Erectile dysfunction * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Hypomenorrhoea * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Menorrhagia * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Metrorrhagia * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Ovarian cyst * [1]  0/131 (0.00%)  0/238 (0.00%)  2/226 (0.88%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Ovarian disorder * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Balanoposthitis * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Prostatitis * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Respiratory, thoracic and mediastinal disorders                   
Asthma * [1]  1/131 (0.76%)  2/238 (0.84%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Cough * [1]  2/131 (1.53%)  3/238 (1.26%)  4/226 (1.77%)  3/242 (1.24%)  0/60 (0.00%)  0/57 (0.00%)  3/217 (1.38%)  0/208 (0.00%)  1/223 (0.45%) 
Dyspnoea * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Epistaxis * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Nasal crusting * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  1/208 (0.48%)  0/223 (0.00%) 
Nasal dryness * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Oropharyngeal pain * [1]  2/131 (1.53%)  1/238 (0.42%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  1/223 (0.45%) 
Pulmonary mass * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Rhinorrhoea * [1]  1/131 (0.76%)  0/238 (0.00%)  2/226 (0.88%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Sinus congestion * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Snoring * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Throat irritation * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Wheezing * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  1/208 (0.48%)  0/223 (0.00%) 
Sleep apnoea syndrome * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  1/208 (0.48%)  0/223 (0.00%) 
Skin and subcutaneous tissue disorders                   
Acne * [1]  0/131 (0.00%)  7/238 (2.94%)  15/226 (6.64%)  3/242 (1.24%)  1/60 (1.67%)  0/57 (0.00%)  2/217 (0.92%)  0/208 (0.00%)  0/223 (0.00%) 
Actinic keratosis * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Alopecia * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Alopecia areata * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Angioedema * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Blister * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  1/208 (0.48%)  0/223 (0.00%) 
Dermatitis * [1]  0/131 (0.00%)  2/238 (0.84%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Dermatitis allergic * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Dermatitis atopic * [1]  4/131 (3.05%)  7/238 (2.94%)  3/226 (1.33%)  2/242 (0.83%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  4/208 (1.92%)  2/223 (0.90%) 
Drug eruption * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Dyshidrotic eczema * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Eczema * [1]  1/131 (0.76%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Erythema * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Hyperhidrosis * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Hyperkeratosis * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Ingrowing nail * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Intertrigo * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Keratosis pilaris * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Nail bed disorder * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Nail fold inflammation * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Neurodermatitis * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Neutrophilic dermatosis * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Photosensitivity reaction * [1]  1/131 (0.76%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Pruritus * [1]  1/131 (0.76%)  3/238 (1.26%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  2/217 (0.92%)  0/208 (0.00%)  0/223 (0.00%) 
Pruritus allergic * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Rash * [1]  1/131 (0.76%)  2/238 (0.84%)  2/226 (0.88%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Rash erythematous * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Rash papular * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  2/208 (0.96%)  0/223 (0.00%) 
Seborrhoea * [1]  0/131 (0.00%)  1/238 (0.42%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Seborrhoeic dermatitis * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  2/208 (0.96%)  0/223 (0.00%) 
Skin discolouration * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  1/242 (0.41%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Skin disorder * [1]  2/131 (1.53%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Skin fissures * [1]  0/131 (0.00%)  1/238 (0.42%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Skin lesion * [1]  0/131 (0.00%)  1/238 (0.42%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Urticaria * [1]  0/131 (0.00%)  3/238 (1.26%)  1/226 (0.44%)  1/242 (0.41%)  1/60 (1.67%)  0/57 (0.00%)  0/217 (0.00%)  1/208 (0.48%)  0/223 (0.00%) 
Dermatitis contact * [1]  0/131 (0.00%)  0/238 (0.00%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  1/217 (0.46%)  0/208 (0.00%)  0/223 (0.00%) 
Social circumstances                   
Victim of crime * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Surgical and medical procedures                   
Rotator cuff repair * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Tooth extraction * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Vascular disorders                   
Aortic stenosis * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Essential hypertension * [1]  0/131 (0.00%)  1/238 (0.42%)  0/226 (0.00%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Hot flush * [1]  0/131 (0.00%)  0/238 (0.00%)  1/226 (0.44%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  0/208 (0.00%)  0/223 (0.00%) 
Hypertension * [1]  0/131 (0.00%)  2/238 (0.84%)  3/226 (1.33%)  0/242 (0.00%)  0/60 (0.00%)  0/57 (0.00%)  0/217 (0.00%)  2/208 (0.96%)  1/223 (0.45%) 
*
Indicates events were collected by non-systematic assessment
[1]
MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16.
[Not Specified]
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03720470    
Other Study ID Numbers: B7451029
COMPARE ( Other Identifier: Alias Study Number )
2018-002573-21 ( EudraCT Number )
First Submitted: October 24, 2018
First Posted: October 25, 2018
Results First Submitted: December 21, 2020
Results First Posted: January 19, 2021
Last Update Posted: January 19, 2021