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Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata

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ClinicalTrials.gov Identifier: NCT02974868
Recruitment Status : Completed
First Posted : November 29, 2016
Results First Posted : May 26, 2020
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alopecia Areata
Interventions Drug: PF-06651600
Drug: PF-06700841
Drug: Placebo
Enrollment 142
Recruitment Details The study had a 24 week Treatment Period, a 4 week Drug Holiday, an up to 48 weeks(24 weeks + additional 24 Weeks for those received active retreatment) Single Blind Extension Period, a 4 week Drug Holiday, a 24 weeks Cross Over Open Label Extension Period.
Pre-assignment Details

Criteria for entering SBE: complete the former period without showing Key Exclusion defined in CSR Section 9.3.2.

Criteria for entering COE: non-responders (SALT change from baseline <30%) at Week 24 and continued to be non-responders at Week 52 in SBE period without showing Key Exclusion defined in CSR Section 9.3.2.

Arm/Group Title Placebo for PF-06651600 Placebo for PF-06700841 PF-06651600 PF-06700841
Hide Arm/Group Description Participants received placebo tablets QD matching for PF-06651600. Participants received placebo tablets QD matching for PF-06700841. Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period. Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.
Period Title: Initial 24-Week Treatment Period (TP)
Started 24 23 48 47
Completed 20 14 45 35
Not Completed 4 9 3 12
Reason Not Completed
Adverse Event             1             1             2             4
others             3             8             1             8
Period Title: Single-Blind Extension (SBE) Period
Started [1] 17 12 38 29
Completed [2] 15 11 27 23
Not Completed 2 1 11 6
Reason Not Completed
AE & Withdraw by participants             2             1             11             6
[1]
Among 114 participants completed initial treatment period, 96 participants entered SBE period
[2]
Week 28-52 and additional 24 weeks(AT Day 1 -AT Week 24) for those retreated with active treatment
Period Title: Cross-Over Extension (COE) Period
Started [1] 7 2 11 3
Completed [2] 5 1 8 3
Not Completed 2 1 3 0
Reason Not Completed
Withdrawal by Subject             2             1             3             0
[1]
Among 76 participants completed SBE period, 23 participants entered COE period.
[2]
Participants who were PF-06651600 non-responders at Week 52 received PF-06700841, vice versa.
Arm/Group Title TP:Placebo TP:PF-06651600 TP:PF-06700841 Total
Hide Arm/Group Description Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841. Participants received PF-06651600 200 mg tablets QD for a 4-week induction period followed by PF-06651600 50 mg tablets QD for a 20-week maintenance period. Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period. Total of all reporting groups
Overall Number of Baseline Participants 47 48 47 142
Hide Baseline Analysis Population Description
All participants received at least 1 dose of PF-06651600,PF-06700841 or matching placebo.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 48 participants 47 participants 142 participants
38.17  (14.22) 36.88  (12.62) 33.94  (11.43) 36.33  (12.84)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 48 participants 47 participants 142 participants
18-44 Years
31
  66.0%
33
  68.8%
40
  85.1%
104
  73.2%
45-64 Years
15
  31.9%
14
  29.2%
6
  12.8%
35
  24.6%
>=65 Years
1
   2.1%
1
   2.1%
1
   2.1%
3
   2.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 48 participants 47 participants 142 participants
Female
29
  61.7%
37
  77.1%
32
  68.1%
98
  69.0%
Male
18
  38.3%
11
  22.9%
15
  31.9%
44
  31.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 48 participants 47 participants 142 participants
Hispanic or Latino
2
   4.3%
3
   6.3%
5
  10.6%
10
   7.0%
Not Hispanic or Latino
45
  95.7%
45
  93.8%
42
  89.4%
132
  93.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 48 participants 47 participants 142 participants
White
45
  95.7%
38
  79.2%
36
  76.6%
119
  83.8%
Black or African American
0
   0.0%
4
   8.3%
3
   6.4%
7
   4.9%
Asian
2
   4.3%
3
   6.3%
3
   6.4%
8
   5.6%
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   2.1%
1
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
other
0
   0.0%
3
   6.3%
4
   8.5%
7
   4.9%
1.Primary Outcome
Title Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24
Hide Description SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. Score range: 0-100%. Higher score indicates more severe disease. Change from baseline is defined as the baseline value minus the value at a specific visit. Positive change from baseline signifies an improvement. Baseline is defined as the last measurement prior to first dosing (Day 1).
Time Frame Baseline, Week24
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed: All randomized participants assigned to the study treatment. Number Analyzed: Number of Participants with observed data at Week 24
Arm/Group Title PF-06651600 PF-06700841 Placebo
Hide Arm/Group Description:
Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.
Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.
Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Overall Number of Participants Analyzed 48 47 47
Least Squares Mean (90% Confidence Interval)
Unit of Measure: units on a scale
32.54
(25.35 to 39.74)
50.59
(43.15 to 58.02)
1.41
(-6.03 to 8.85)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-06651600, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments Hochberg P-value (one-sided)
Method Mixed Model Repeated Measure (MMRM)
Comments MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.
Method of Estimation Estimation Parameter Mean of Difference from Placebo
Estimated Value 31.14
Confidence Interval (2-Sided) 95%
18.78 to 43.50
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-06700841, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments Hochberg P-value (one-sided)
Method Mixed Model Repeated Measure (MMRM)
Comments MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.
Method of Estimation Estimation Parameter Mean of Difference from Placebo
Estimated Value 49.18
Confidence Interval (2-Sided) 95%
36.62 to 61.74
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.35
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Single-Blind Extension (SBE) Period
Hide Description An AE (non-serious and serious) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent Adverse Event (TEAE). Treatment-related TEAE were determined by investigators. Arms end with "withdrawal Segment" and "retreatment segment" described the same population while in different treatment segment .The reason why count on PF-06700841 differ by 1 participant is that 1 responder directly entered the retreatment segment and skipped the withdrawal segment.
Time Frame Week 28 up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set (SAS) was used , which was defined as all participants who received at least one dose of study medication.
Arm/Group Title Active Non-responders on PF-06651600 Placebo Non-responders on PF-06651600 Active Non-responders on PF-06700841 Placebo Non-responders on PF-06700841 Non-Retreated PF-06651600 Responders in the Withdrawal Segment Retreated PF-06651600 Responders in the Withdrawal Segment Non-Retreated PF-06700841 Responders in the Withdrawal Segment Retreated PF-06700841 Responders in the Withdrawal Segment Retreated PF-06651600 Responders in the Retreatment Segment Retreated Responders on PF-06700841 in the Retreatment Segment
Hide Arm/Group Description:
Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT [SALT 30]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period
Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period
Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period
Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period
Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal) without entering the Retreatment Segment of the SBE Period
Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600. This arm stands for retreated responders with TEAE within withdrawal Segment
Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal) without entering the Retreatment Segment of the SBE Period
Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841. This arm stands for retreated responders with TEAE within withdrawal Segment
Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600
Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841
Overall Number of Participants Analyzed 16 17 5 12 8 14 9 14 14 15
Measure Type: Count of Participants
Unit of Measure: Participants
TEAE (All Causalities)
8
  50.0%
12
  70.6%
4
  80.0%
10
  83.3%
4
  50.0%
3
  21.4%
6
  66.7%
9
  64.3%
11
  78.6%
9
  60.0%
TEAE (Treatment Related)
5
  31.3%
1
   5.9%
0
   0.0%
1
   8.3%
0
   0.0%
1
   7.1%
0
   0.0%
3
  21.4%
2
  14.3%
2
  13.3%
3.Primary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Cross-Over Extension (COE) Period
Hide Description An AE (non-serious and serious) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent Adverse Event (TEAE). Treatment-related TEAE were determined by investigators.
Time Frame COE day 1 up to end of study
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set (SAS) was used , which was defined as all participants who received at least one dose of study medication.
Arm/Group Title COE-PF-06651600 COE-PF-06700841
Hide Arm/Group Description:
Participants not responsive to placebo or PF-06700841 at Week 24 in the Initial 24-Week Treatment Period and not responsive to PF-06700841 at Week 52 (ie, not achieving SALT 30) in the SBE Period who were assigned to PF-06651600 in the COE Period
Participants not responsive to placebo or PF-06651600 at Week 24 in the Initial 24-Week Treatment Period and not responsive to PF-06651600 at Week 52 (ie, not achieving SALT 30; except 1 PF-06651600 responder) in the SBE Period who were assigned to PF-06700841 in the COE Period
Overall Number of Participants Analyzed 5 18
Measure Type: Count of Participants
Unit of Measure: Participants
TEAE (All Causalities)
4
  80.0%
9
  50.0%
TEAE (Treatment Related)
2
  40.0%
3
  16.7%
4.Primary Outcome
Title Number of Participants With Laboratory Abnormalities During SBE Period
Hide Description Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology(Hemoglobin, Hematocrit, RBC count, Reticulocyte count, Platelet count, WBC count with differential, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes); serum chemistry (BUN and Creatinine, Cystatin C, Creatine Phosphokinase, Glucose , Na+, K+, Cl ,Ca++, Total CO2, AST, ALT, Total Indirect & Direct Bilirubin, Alkaline phosphatase, Uric acid, Albumin,Total protein, Fasting lipid Profile Panel; urinalysis(pH, Glucose, Protein, Nitrites, Leukocyte esterase, Microscopy culture);Other(HIV, HBsAg, HBcAb, HepB reflex (HbsAB), if applicable, HCVAb, Serum pregnancy test, Urine pregnancy test, FSH, QFT G or other IGRA, or PPD, EBV, CMV, HSV1, HSV2, VZV, Skin swab for herpetiform rash, Skin swab for potential drug related rash).Retest/discontinuation criteria are defined in Protocol Appendix 6.1 and 6.2 respectively.
Time Frame Week 28 up to Week 52 for non-responders and responders in the withdrawal segment, AT day 1 up to AT Week 24 for retreatment segment (AT=active treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set (SAS) was used. Arms end with "withdrawal Segment" and "retreatment segment" described the same population while in different treatment segment .The reason why count on PF-06700841 differ by 1 participant is that 1 responder skipped the withdrawal segment and entered the retreatment segment.
Arm/Group Title Active Non-responders on PF-06651600 Placebo Non-responders on PF-06651600 Active Non-responders on PF-06700841 Placebo Non-responders on PF-06700841 Non-Retreated PF-06651600 Responders in the Withdrawal Segment Retreated PF-06651600 Responders in the Withdrawal Segment Non-Retreated PF-06700841 Responders in the Withdrawal Segment Retreated PF-06700841 Responders in the Withdrawal Segment Retreated PF-06651600 Responders in the Retreatment Segment Retreated Responders on PF-06700841 in the Retreatment Segment
Hide Arm/Group Description:
Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT [SALT 30]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period
Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period
Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period
Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period
Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal) without entering the Retreatment Segment of the SBE Period
Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600. This arm stands for retreated responders with TEAE within withdrawal Segment
Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal) without entering the Retreatment Segment of the SBE Period
Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841. This arm stands for retreated responders with TEAE within withdrawal Segment
Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600
Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841
Overall Number of Participants Analyzed 16 17 5 12 8 14 9 14 14 15
Measure Type: Count of Participants
Unit of Measure: Participants
With abnormalities without regard to baseline
13
  81.3%
11
  64.7%
4
  80.0%
11
  91.7%
6
  75.0%
9
  64.3%
7
  77.8%
10
  71.4%
11
  78.6%
14
  93.3%
Meeting Retest Criteria
3
  18.8%
5
  29.4%
2
  40.0%
7
  58.3%
2
  25.0%
0
   0.0%
3
  33.3%
2
  14.3%
4
  28.6%
4
  26.7%
Meeting Discontinuation Criteria
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   7.1%
0
   0.0%
5.Primary Outcome
Title Numbers of Participants With Specific Clinical Laboratory Abnormalities During COE Period
Hide Description Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology(Hemoglobin, Hematocrit, RBC count, Reticulocyte count, Platelet count, WBC count with differential, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes); serum chemistry (BUN and Creatinine, Cystatin C, Creatine Phosphokinase, Glucose , Na+, K+, Cl ,Ca++, Total CO2, AST, ALT, Total Indirect & Direct Bilirubin, Alkaline phosphatase, Uric acid, Albumin,Total protein, Fasting lipid Profile Panel; urinalysis(pH, Glucose, Protein, Nitrites, Leukocyte esterase, Microscopy culture);Other(HIV, HBsAg, HBcAb, HepB reflex (HbsAB), if applicable, HCVAb, Serum pregnancy test, Urine pregnancy test, FSH, QFT G or other IGRA, or PPD, EBV, CMV, HSV1, HSV2, VZV, Skin swab for herpetiform rash, Skin swab for potential drug related rash).Retest/discontinuation criteria are defined in Protocol Appendix 6.1 and 6.2 respectively.
Time Frame COE day 1 up to end of study
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in safety analysis set (SAS) who received at least 1 dose of investigational product (PF-06651600, PF-06700841 or placebo) and had abnormal laboratory data in COE period.
Arm/Group Title COE-PF-06651600 COE-PF-06700841
Hide Arm/Group Description:
Participants not responsive to placebo or PF-06700841 at Week 24 in the Initial 24-Week Treatment Period and not responsive to PF-06700841 at Week 52 (ie, not achieving SALT 30) in the SBE Period who were assigned to PF-06651600 in the COE Period
Participants not responsive to placebo or PF-06651600 at Week 24 in the Initial 24-Week Treatment Period and not responsive to PF-06651600 at Week 52 (ie, not achieving SALT 30; except 1 PF-06651600 responder) in the SBE Period who were assigned to PF-06700841 in the COE Period
Overall Number of Participants Analyzed 5 18
Measure Type: Count of Participants
Unit of Measure: Participants
With abnormalities without regard to baseline
5
 100.0%
11
  61.1%
Meeting Retest Criteria
1
  20.0%
6
  33.3%
Meeting Discontinuation Criteria
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24 -AT/AU Participants
Hide Description SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. Change from baseline is defined as the baseline value minus the value at a specific visit. Positive change from baseline implies an improvement. Alopecia totalis (AT): derived as SALT score = 100% at baseline only. Alopecia universalis (AU): derived as SALT score = 100% and both eyelash and eyebrow assessments were "none" at baseline.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed: AT/AU participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received. Number Analyzed: Number of participants with observed data at Week 24.
Arm/Group Title PF-06651600-AT/AU PF-06700841-AT/AU Placebo-AT/AU
Hide Arm/Group Description:
AT/AU Participants received PF-06651600 200 mg once daily (QD) for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.
AT/AU Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.
AT/AU Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841.
Overall Number of Participants Analyzed 20 22 20
Least Squares Mean (90% Confidence Interval)
Unit of Measure: units on a scale
27.59
(15.24 to 39.94)
48.42
(36.38 to 60.47)
1.81
(-11.00 to 14.63)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-06651600-AT/AU, Placebo-AT/AU
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0094
Comments [Not Specified]
Method Mixed Model Repeated Measure (MMRM)
Comments MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.
Method of Estimation Estimation Parameter Mean of Difference from Placebo
Estimated Value 25.78
Confidence Interval (2-Sided) 90%
7.98 to 43.58
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.64
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-06700841-AT/AU, Placebo-AT/AU
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Mixed Model Repeated Measure
Comments MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.
Method of Estimation Estimation Parameter Mean of Difference from Placebo
Estimated Value 46.61
Confidence Interval (2-Sided) 90%
29.02 to 64.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 10.51
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants Achieving SALT 30 at Week 24
Hide Description SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 30 response is a 30% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The 90% CI was calculated using Chan and Zhang method.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Full analysis set (FAS) was used and have observed data at Week 24. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.
Arm/Group Title PF-06651600 PF-06700841 Placebo
Hide Arm/Group Description:
Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.
Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.
Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Overall Number of Participants Analyzed 48 47 47
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
50.0
(37.6 to 62.4)
63.8
(51.3 to 74.9)
2.1
(0.2 to 8.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-06651600, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Chan and Zhang method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage from Placebo
Estimated Value 47.9
Confidence Interval (2-Sided) 90%
34.2 to 60.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-06700841, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Chan and Zhang method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage from Placebo
Estimated Value 61.7
Confidence Interval (2-Sided) 90%
48.2 to 73.6
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Severity of Alopecia Tool (SALT) Across Time (Treatment Period)
Hide Description SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. The SALT score can vary from 0 to 100% with higher score indicates more severe disease. Baseline is defined as the last measurement prior to first dosing (Day 1). Change from baseline is defined as the baseline value minus the value at a specific visit. Positive change from baseline implies an improvement. Least Square Mean and 90% Confidence Interval of Arms (PF-06651600 and PF-06700841) are the Least Square Mean and 90% Confidence Interval for difference from placebo respectively.
Time Frame Baseline, Weeks 2,4,6,8,12,16,20,24
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of participants analyzed": All randomized participants assigned to the study treatment. "Number analyzed" : Number of participants with observed data for each specified time point.
Arm/Group Title PF-06651600 PF-06700841 Placebo
Hide Arm/Group Description:
Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.
Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.
Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Overall Number of Participants Analyzed 48 47 47
Least Squares Mean (90% Confidence Interval)
Unit of Measure: units on a scale
Week 2 Number Analyzed 48 participants 47 participants 46 participants
-0.74
(-2.06 to 0.59)
-0.93
(-2.27 to 0.40)
1.18
(0.23 to 2.13)
Week 4 Number Analyzed 48 participants 47 participants 44 participants
2.93
(-1.32 to 7.17)
7.70
(3.43 to 11.97)
0.85
(-2.20 to 3.90)
Week 6 Number Analyzed 47 participants 45 participants 43 participants
12.44
(5.42 to 19.45)
19.37
(12.29 to 26.45)
1.32
(-3.72 to 6.35)
Week 8 Number Analyzed 47 participants 44 participants 44 participants
18.49
(9.57 to 27.41)
29.30
(20.28 to 38.32)
1.77
(-4.63 to 8.17)
Week 12 Number Analyzed 47 participants 44 participants 45 participants
24.49
(14.90 to 34.09)
36.57
(26.86 to 46.29)
1.62
(-5.26 to 8.50)
Week 16 Number Analyzed 45 participants 41 participants 42 participants
27.59
(17.67 to 37.50)
41.16
(31.11 to 51.22)
1.61
(-5.49 to 8.72)
Week 20 Number Analyzed 45 participants 40 participants 40 participants
29.32
(19.06 to 39.57)
45.55
(35.14 to 55.97)
1.62
(-5.73 to 8.98)
Week 24 Number Analyzed 44 participants 40 participants 35 participants
31.14
(20.79 to 41.49)
49.18
(38.66 to 59.70)
1.41
(-6.03 to 8.85)
9.Secondary Outcome
Title Percent Change From Baseline in Severity of Alopecia Tool (SALT) Across Time (Treatment Period)
Hide Description SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. The SALT score can vary from 0 to 100% with higher score indicates more severe disease. Baseline is defined as the last measurement prior to first dosing (Day 1). Percent change from baseline is defined as SALT baseline value minus SALT value at a specific visit divided by baseline and multiplying by 100. Positive change from baseline implies an improvement. Least Square Mean and 90% Confidence Interval of Arms (PF-06651600 and PF-06700841) are the Least Square Mean and 90% Confidence Interval for difference from placebo respectively.
Time Frame Baseline, Weeks 2,4,6,8,12,16,20,24
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of participants analyzed": All randomized participants assigned to the study treatment. "Number analyzed" : Number of participants with observed data for each specified time point.
Arm/Group Title PF-06651600 PF-06700841 Placebo
Hide Arm/Group Description:
Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.
Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.
Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Overall Number of Participants Analyzed 48 47 47
Least Squares Mean (90% Confidence Interval)
Unit of Measure: percent change
Week 2 Number Analyzed 48 participants 47 participants 46 participants
-0.76
(-2.26 to 0.75)
-1.13
(-2.64 to 0.39)
1.26
(0.18 to 2.33)
Week 4 Number Analyzed 48 participants 47 participants 44 participants
3.99
(-0.86 to 8.83)
9.70
(4.83 to 14.57)
0.53
(-2.96 to 4.01)
Week 6 Number Analyzed 47 participants 45 participants 43 participants
15.88
(7.84 to 23.91)
22.88
(14.77 to 30.99)
1.02
(-4.75 to 6.80)
Week 8 Number Analyzed 47 participants 44 participants 44 participants
23.22
(13.15 to 33.29)
34.78
(24.59 to 44.96)
1.31
(-5.91 to 8.54)
Week 12 Number Analyzed 47 participants 44 participants 45 participants
30.99
(19.93 to 42.05)
44.17
(32.97 to 55.37)
0.99
(-6.94 to 8.92)
Week 16 Number Analyzed 45 participants 41 participants 42 participants
35.14
(23.65 to 46.62)
49.99
(38.35 to 61.64)
0.86
(-7.38 to 9.09)
Week 20 Number Analyzed 45 participants 40 participants 40 participants
37.31
(25.37 to 49.25)
55.46
(43.34 to 67.58)
0.91
(-7.65 to 9.47)
Week 24 Number Analyzed 44 participants 40 participants 35 participants
39.67
(27.66 to 51.68)
59.71
(47.51 to 71.92)
0.43
(-8.20 to 9.06)
10.Secondary Outcome
Title Percentage of Participants Achieving SALT 30 Across Time (Treatment Period)
Hide Description SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 30 response is a 30% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.
Time Frame Baseline, Weeks 2,4,6,8,12,16,20,24
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.
Arm/Group Title PF-06651600 PF-06700841 Placebo
Hide Arm/Group Description:
Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.
Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.
Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Overall Number of Participants Analyzed 48 47 47
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
Week 2
-2.1
(-9.7 to 3.7)
-2.1
(-9.7 to 3.5)
2.1
(0.2 to 8.8)
Week 4
6.2
(-2.3 to 15.8)
12.8
(3.0 to 24.0)
2.1
(0.2 to 8.8)
Week 6
18.7
(7.0 to 31.0)
27.7
(15.4 to 40.4)
2.1
(0.2 to 8.8)
Week 8
25.0
(13.2 to 37.4)
38.3
(25.8 to 51.4)
2.1
(0.2 to 8.8)
Week 12
39.5
(26.4 to 52.6)
48.9
(35.8 to 61.8)
2.1
(0.2 to 8.8)
Week 16
45.8
(32.2 to 58.7)
55.3
(42.0 to 67.8)
2.1
(0.2 to 8.8)
Week 20
47.9
(34.2 to 60.7)
59.6
(46.3 to 71.7)
2.1
(0.2 to 8.8)
Week 24
47.9
(34.2 to 60.7)
61.7
(48.2 to 73.6)
2.1
(0.2 to 8.8)
11.Secondary Outcome
Title Percentage of Participants Achieving SALT 50 Across Time (Treatment Period)
Hide Description SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 50 response is a 50% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.
Time Frame Baseline, Weeks 2,4,6,8,12,16,20,24
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.
Arm/Group Title PF-06651600 PF-06700841 Placebo
Hide Arm/Group Description:
Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.
Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.
Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Overall Number of Participants Analyzed 48 47 47
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
Week 2
0.0
(-6.2 to 6.1)
0.0
(-6.2 to 6.2)
0
(0.0 to 5.7)
Week 4
0.0
(-6.2 to 6.1)
10.6
(3.6 to 21.1)
0
(0.0 to 5.7)
Week 6
10.4
(1.1 to 21.1)
17.0
(6.5 to 28.8)
2.1
(0.2 to 8.8)
Week 8
18.7
(7.0 to 31.0)
29.8
(17.2 to 42.7)
2.1
(0.2 to 8.8)
Week 12
27.0
(15.0 to 39.6)
36.2
(23.8 to 49.2)
2.1
(0.2 to 8.8)
Week 16
33.3
(20.3 to 46.2)
40.4
(27.8 to 53.5)
2.1
(0.2 to 8.8)
Week 20
33.3
(20.3 to 46.2)
46.8
(33.8 to 59.8)
2.1
(0.2 to 8.8)
Week 24
37.5
(24.5 to 50.6)
51.1
(37.9 to 63.8)
2.1
(0.2 to 8.8)
12.Secondary Outcome
Title Percentage of Participants Achieving SALT 75 Across Time (Treatment Period)
Hide Description SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 75 response is a 75% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.
Time Frame Baseline, Weeks 2,4,6,8,12,16,20,24
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.
Arm/Group Title PF-06651600 PF-06700841 Placebo
Hide Arm/Group Description:
Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.
Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.
Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Overall Number of Participants Analyzed 48 47 47
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
Week 2
0.0
(-6.2 to 6.1)
0.0
(-6.2 to 6.2)
0
(0.0 to 5.7)
Week 4
0.0
(-6.2 to 6.1)
0.0
(-6.2 to 6.2)
0
(0.0 to 5.7)
Week 6
8.3
(1.8 to 18.1)
10.6
(3.6 to 21.1)
0
(0.0 to 5.7)
Week 8
12.5
(2.8 to 23.6)
23.4
(11.8 to 36.2)
2.1
(0.2 to 8.8)
Week 12
16.6
(6.3 to 28.6)
27.7
(15.4 to 40.4)
2.1
(0.2 to 8.8)
Week 16
20.8
(8.6 to 33.0)
31.9
(19.0 to 44.9)
2.1
(0.2 to 8.8)
Week 20
25.0
(13.2 to 37.4)
38.3
(25.8 to 51.4)
2.1
(0.2 to 8.8)
Week 24
27.0
(15.0 to 39.6)
40.4
(27.8 to 53.5)
2.1
(0.2 to 8.8)
13.Secondary Outcome
Title Percentage of Participants Achieving SALT 90 Across Time (Treatment Period)
Hide Description SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 90 response is a 90% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.
Time Frame Baseline, Weeks 2,4,6,8,12,16,20,24
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.
Arm/Group Title PF-06651600 PF-06700841 Placebo
Hide Arm/Group Description:
Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.
Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.
Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Overall Number of Participants Analyzed 48 47 47
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
Week 2
0.0
(-6.2 to 6.1)
0.0
(-6.2 to 6.2)
0
(0.0 to 5.7)
Week 4
0.0
(-6.2 to 6.1)
0.0
(-6.2 to 6.2)
0
(0.0 to 5.7)
Week 6
0.0
(-6.2 to 6.1)
6.4
(0.2 to 15.7)
0
(0.0 to 5.7)
Week 8
4.2
(-2.0 to 12.5)
12.8
(5.2 to 23.6)
0
(0.0 to 5.7)
Week 12
10.4
(3.4 to 20.7)
25.5
(15.4 to 38.1)
0
(0.0 to 5.7)
Week 16
16.7
(8.6 to 27.7)
27.7
(17.2 to 40.3)
0
(0.0 to 5.7)
Week 20
18.7
(7.0 to 31.0)
29.8
(17.2 to 42.7)
2.1
(0.2 to 8.8)
Week 24
25.0
(15.1 to 37.3)
34.0
(22.7 to 47.0)
0
(0.0 to 5.7)
14.Secondary Outcome
Title Percentage of Participants Achieving SALT 100 Across Time (Treatment Period)
Hide Description SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 100 response is a 100% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) of Arms(PF-06651600 and PF-06700841) in this outcome measurement is the percentage and 90% CI for difference from placebo. The 90% CI was calculated using Chan and Zhang method.
Time Frame Baseline, Weeks 2,4,6,8,12,16,20,24
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.
Arm/Group Title PF-06651600 PF-06700841 Placebo
Hide Arm/Group Description:
Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.
Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.
Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Overall Number of Participants Analyzed 48 47 47
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
Week 2
0.0
(-6.2 to 6.1)
0.0
(-6.2 to 6.2)
0
(0.0 to 5.7)
Week 4
0.0
(-6.2 to 6.1)
0.0
(-6.2 to 6.2)
0
(0.0 to 5.7)
Week 6
0.0
(-6.2 to 6.1)
0.0
(-6.2 to 6.2)
0
(0.0 to 5.7)
Week 8
0.0
(-6.2 to 6.1)
2.1
(-3.5 to 9.7)
0
(0.0 to 5.7)
Week 12
2.1
(-3.8 to 9.5)
6.4
(0.2 to 15.7)
0
(0.0 to 5.7)
Week 16
2.1
(-3.8 to 9.5)
8.5
(1.9 to 18.4)
0
(0.0 to 5.7)
Week 20
4.2
(-2.0 to 12.5)
12.8
(5.2 to 23.6)
0
(0.0 to 5.7)
Week 24
12.5
(5.1 to 23.2)
12.8
(5.2 to 23.6)
0
(0.0 to 5.7)
15.Secondary Outcome
Title Number of Participants With the IGA Score Change (Treatment Period)
Hide Description The clinical evaluator of alopecia areata (AA) will perform an assessment of the overall improvement of AA and assign an Investigator Global Assessment (IGA) score(ranging from 0 to 5) with higher score representing higher regrowth rate. Baseline is defined as the last measurement prior to first dosing (Day 1).
Time Frame baseline, Week 2,4,6,8,12,16,20,24
Hide Outcome Measure Data
Hide Analysis Population Description
"Number of participants analyzed": All randomized participants assigned to the study treatment. "Number analyzed" : Number of participants with observed data for each specified time point.
Arm/Group Title PF-06651600 PF-06700841 Placebo
Hide Arm/Group Description:
Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.
Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.
Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Overall Number of Participants Analyzed 48 47 47
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 48 participants 47 participants 47 participants
0 (NO CHANGE OR FURTHER LOSS)
48
 100.0%
47
 100.0%
47
 100.0%
1 (1-24% REGROWTH)
0
   0.0%
0
   0.0%
0
   0.0%
2 (25-49% REGROWTH)
0
   0.0%
0
   0.0%
0
   0.0%
3 (50-74% REGROWTH)
0
   0.0%
0
   0.0%
0
   0.0%
4 (75-99% REGROWTH)
0
   0.0%
0
   0.0%
0
   0.0%
5 (100% REGROWTH)
0
   0.0%
0
   0.0%
0
   0.0%
Week 2 Number Analyzed 48 participants 47 participants 46 participants
0 (NO CHANGE OR FURTHER LOSS)
40
  83.3%
43
  91.5%
40
  87.0%
1 (1-24% REGROWTH)
8
  16.7%
4
   8.5%
5
  10.9%
2 (25-49% REGROWTH)
0
   0.0%
0
   0.0%
1
   2.2%
3 (50-74% REGROWTH)
0
   0.0%
0
   0.0%
0
   0.0%
4 (75-99% REGROWTH)
0
   0.0%
0
   0.0%
0
   0.0%
5 (100% REGROWTH)
0
   0.0%
0
   0.0%
0
   0.0%
Week 4 Number Analyzed 48 participants 47 participants 43 participants
0 (NO CHANGE OR FURTHER LOSS)
29
  60.4%
21
  44.7%
36
  83.7%
1 (1-24% REGROWTH)
15
  31.3%
19
  40.4%
6
  14.0%
2 (25-49% REGROWTH)
4
   8.3%
2
   4.3%
1
   2.3%
3 (50-74% REGROWTH)
0
   0.0%
5
  10.6%
0
   0.0%
4 (75-99% REGROWTH)
0
   0.0%
0
   0.0%
0
   0.0%
5 (100% REGROWTH)
0
   0.0%
0
   0.0%
0
   0.0%
Week 6 Number Analyzed 47 participants 45 participants 43 participants
0 (NO CHANGE OR FURTHER LOSS)
16
  34.0%
10
  22.2%
35
  81.4%
1 (1-24% REGROWTH)
18
  38.3%
17
  37.8%
6
  14.0%
2 (25-49% REGROWTH)
7
  14.9%
9
  20.0%
1
   2.3%
3 (50-74% REGROWTH)
2
   4.3%
4
   8.9%
1
   2.3%
4 (75-99% REGROWTH)
4
   8.5%
5
  11.1%
0
   0.0%
5 (100% REGROWTH)
0
   0.0%
0
   0.0%
0
   0.0%
Week 8 Number Analyzed 47 participants 44 participants 44 participants
0 (NO CHANGE OR FURTHER LOSS)
13
  27.7%
7
  15.9%
33
  75.0%
1 (1-24% REGROWTH)
17
  36.2%
17
  38.6%
9
  20.5%
2 (25-49% REGROWTH)
7
  14.9%
5
  11.4%
1
   2.3%
3 (50-74% REGROWTH)
3
   6.4%
3
   6.8%
0
   0.0%
4 (75-99% REGROWTH)
7
  14.9%
11
  25.0%
1
   2.3%
5 (100% REGROWTH)
0
   0.0%
1
   2.3%
0
   0.0%
Week 12 Number Analyzed 47 participants 44 participants 45 participants
0 (NO CHANGE OR FURTHER LOSS)
13
  27.7%
6
  13.6%
33
  73.3%
1 (1-24% REGROWTH)
11
  23.4%
11
  25.0%
10
  22.2%
2 (25-49% REGROWTH)
9
  19.1%
9
  20.5%
1
   2.2%
3 (50-74% REGROWTH)
5
  10.6%
4
   9.1%
0
   0.0%
4 (75-99% REGROWTH)
8
  17.0%
10
  22.7%
1
   2.2%
5 (100% REGROWTH)
1
   2.1%
4
   9.1%
0
   0.0%
Week 16 Number Analyzed 45 participants 41 participants 42 participants
0 (NO CHANGE OR FURTHER LOSS)
14
  31.1%
5
  12.2%
31
  73.8%
1 (1-24% REGROWTH)
7
  15.6%
7
  17.1%
9
  21.4%
2 (25-49% REGROWTH)
7
  15.6%
9
  22.0%
1
   2.4%
3 (50-74% REGROWTH)
6
  13.3%
4
   9.8%
0
   0.0%
4 (75-99% REGROWTH)
10
  22.2%
11
  26.8%
1
   2.4%
5 (100% REGROWTH)
1
   2.2%
5
  12.2%
0
   0.0%
Week 20 Number Analyzed 45 participants 40 participants 40 participants
0 (NO CHANGE OR FURTHER LOSS)
14
  31.1%
4
  10.0%
29
  72.5%
1 (1-24% REGROWTH)
6
  13.3%
6
  15.0%
9
  22.5%
2 (25-49% REGROWTH)
8
  17.8%
7
  17.5%
1
   2.5%
3 (50-74% REGROWTH)
4
   8.9%
4
  10.0%
0
   0.0%
4 (75-99% REGROWTH)
10
  22.2%
11
  27.5%
1
   2.5%
5 (100% REGROWTH)
3
   6.7%
8
  20.0%
0
   0.0%
Week 24 Number Analyzed 44 participants 40 participants 35 participants
0 (NO CHANGE OR FURTHER LOSS)
13
  29.5%
4
  10.0%
27
  77.1%
1 (1-24% REGROWTH)
5
  11.4%
6
  15.0%
6
  17.1%
2 (25-49% REGROWTH)
7
  15.9%
5
  12.5%
1
   2.9%
3 (50-74% REGROWTH)
5
  11.4%
5
  12.5%
0
   0.0%
4 (75-99% REGROWTH)
8
  18.2%
13
  32.5%
1
   2.9%
5 (100% REGROWTH)
6
  13.6%
7
  17.5%
0
   0.0%
16.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (All-causality and Treatment-related) - Treatment Period
Hide Description An AE (non-serious and serious) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent Adverse Event (TEAE). Treatment-related TEAE were determined by investigators.
Time Frame baseline up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of investigational product (PF-06651600, PF-06700841 or placebo) in Treatment Period.
Arm/Group Title PF-06651600 PF-06700841 Placebo
Hide Arm/Group Description:
Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.
Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.
Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Overall Number of Participants Analyzed 48 47 47
Measure Type: Count of Participants
Unit of Measure: Participants
TEAE (All Causalities)
32
  66.7%
36
  76.6%
35
  74.5%
TEAE (Treatment Related)
13
  27.1%
20
  42.6%
14
  29.8%
17.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities During Treatment Period
Hide Description Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology(Hemoglobin, Hematocrit, RBC count, Reticulocyte count, Platelet count, WBC count with differential, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes); serum chemistry (BUN and Creatinine, Cystatin C, Creatine Phosphokinase, Glucose , Na+, K+, Cl ,Ca++, Total CO2, AST, ALT, Total Indirect & Direct Bilirubin, Alkaline phosphatase, Uric acid, Albumin,Total protein, Fasting lipid Profile Panel; urinalysis(pH, Glucose, Protein, Nitrites, Leukocyte esterase, Microscopy culture);Other(HIV, HBsAg, HBcAb, HepB reflex (HbsAB), if applicable, HCVAb, Serum pregnancy test, Urine pregnancy test, FSH, QFT G or other IGRA, or PPD, EBV, CMV, HSV1, HSV2, VZV, Skin swab for herpetiform rash, Skin swab for potential drug related rash).Retest/discontinuation criteria are defined in Protocol Appendix 6.1 and 6.2 respectively.
Time Frame Baseline up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in safety analysis set (SAS) who received at least 1 dose of investigational product (PF-06651600, PF-06700841 or placebo) and had abnormal laboratory data in treatment period.
Arm/Group Title PF-06651600 PF-06700841 Placebo
Hide Arm/Group Description:
Participants received PF-06651600 200 mg QD for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period.
Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period.
Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841
Overall Number of Participants Analyzed 48 47 46
Measure Type: Count of Participants
Unit of Measure: Participants
With abnormalities without regard to baseline
35
  72.9%
36
  76.6%
32
  69.6%
Meeting Safety Criteria
12
  25.0%
29
  61.7%
5
  10.9%
Meeting Retest Criteria
5
  10.4%
18
  38.3%
9
  19.6%
Meeting Discontinuation Criteria
0
   0.0%
3
   6.4%
0
   0.0%
18.Secondary Outcome
Title Time to Achieve the Retreatment Criteria During the Withdrawal/Retreatment Part of the Extension Period Among Subjects Who Achieved Primary Endpoint at Week 24 (SBE Period)
Hide Description Time to re-treatment (weeks) = (date of re-treatment criteria met - date at Week 24 +1)/7. The calendar time to retreatment was calculated. Baseline is defined as Week 24 measurement. The duration in Drug Holiday #1 (ranging from 2-6 weeks) is counted in the Kaplan-Meier analysis. One subject directly entered the re-treatment period and hence is censored at baseline in the Kaplan-Meier analysis.
Time Frame Week 24 up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who were responsive at Week 24 (ie, achieving SALT30 at Week 24).All randomized participants who were responsive at Week 24 (ie, achieving SALT30 at Week 24).
Arm/Group Title PF-06651600 Responders PF-06700841 Responders
Hide Arm/Group Description:
Participants received PF-06651600 200 mg once daily (QD) for 4 weeks induction period followed by PF-06651600 50 mg QD for a 20 weeks maintenance period responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal)
Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal)
Overall Number of Participants Analyzed 22 24
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Weeks
Q1 time to retreatment (25th percentile of time)
10.1
(4.3 to 12.6)
11.0
(4.1 to 16.1)
Median time to retreatment
16.1
(10.1 to 20.3)
24.1 [1] 
(14.6 to NA)
Q3 time to retreatment (75th percentile of time)
21.1 [2] 
(16.1 to NA)
NA [3] 
(24.3 to NA)
[1]
NA indicates not estimable. The withdrawal segment is not lengthy enough to observe upper limit of the 95% CI for the median time to retreatment (ie. 50% of participants meeting the criterion).
[2]
NA indicates not estimable. The withdrawal segment is not lengthy enough to observe upper limit of the 95% CI for the Q3 time to retreatment (ie. 75% of participants meeting the criterion).
[3]
NA indicates not estimable. The withdrawal segment is not lengthy enough to observe Q3 time to retreatment (ie. 75% of participants meeting the criterion) and corresponding upper limit of the 95% CI.
19.Secondary Outcome
Title Change From Baseline in SALT Across Time (SBE Period)
Hide Description SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. The SALT score can vary from 0 to 100% with higher score indicates more severe disease. Baseline is defined as the last measurement prior to first dosing (Day 1). Change from baseline is defined as the baseline value minus the value at a specific visit. Positive change from baseline implies an improvement. Least Square Mean and 90% confidence interval in this outcome measurement is the LSM and 90%CI for difference from initial 24-week treatment period placebo respectively.
Time Frame Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)
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Hide Analysis Population Description
Number of Participants Analyzed: All randomized participants assigned to the study treatment. Number Analyzed: Number of Participants with observed data. 6 groups of participants were each compared with initial 24-week treatment period placebo.
Arm/Group Title Active Non-responders on PF-06651600 Active Non-responders on PF-06700841 Placebo Non-responders on PF-06651600 Placebo Non-responders on PF-06700841 Retreated PF-06651600 Responders in the Retreatment Segment Retreated Responders on PF-06700841 in the Retreatment Segment
Hide Arm/Group Description:
Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT [SALT 30]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period
Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period
Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period
Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period
Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600
Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841
Overall Number of Participants Analyzed 16 5 17 12 14 15
Least Squares Mean (90% Confidence Interval)
Unit of Measure: unit on a scale
Week 30/ AT Week 2 Number Analyzed 15 participants 5 participants 16 participants 10 participants 13 participants 14 participants
1.76
(-4.47 to 7.99)
0.09
(-9.83 to 10.01)
2.99
(-4.56 to 10.54)
-0.31
(-9.53 to 8.92)
25.04
(15.01 to 35.08)
19.83
(10.00 to 29.66)
Week 32/ AT Week 4 Number Analyzed 16 participants 4 participants 17 participants 12 participants 14 participants 14 participants
1.85
(-4.37 to 8.07)
2.22
(-7.78 to 12.21)
3.37
(-4.06 to 10.79)
3.71
(-4.93 to 12.35)
27.63
(17.67 to 37.59)
15.66
(5.82 to 25.51)
Week 34/ AT Week 6 Number Analyzed 16 participants 4 participants 16 participants 12 participants 13 participants 13 participants
1.80
(-4.42 to 8.02)
3.16
(-6.90 to 13.23)
10.16
(2.55 to 17.77)
24.67
(16.00 to 33.34)
33.78
(23.72 to 43.83)
20.09
(10.17 to 30.02)
Week 36/ AT Week 8 Number Analyzed 14 participants 4 participants 16 participants 11 participants 13 participants 13 participants
2.16
(-4.09 to 8.40)
3.01
(-7.12 to 13.14)
8.93
(1.34 to 16.52)
42.32
(33.37 to 51.28)
38.80
(28.75 to 48.84)
27.35
(17.42 to 37.27)
Week 40/ AT Week 12 Number Analyzed 13 participants 4 participants 16 participants 12 participants 12 participants 13 participants
3.35
(-2.91 to 9.61)
3.19
(-7.00 to 13.38)
18.30
(10.73 to 25.86)
50.27
(41.65 to 58.90)
43.70
(33.58 to 53.82)
39.28
(29.36 to 49.19)
Week 44/ AT Week 16 Number Analyzed 15 participants 3 participants 14 participants 11 participants 10 participants 11 participants
3.41
(-2.84 to 9.67)
3.12
(-7.19 to 13.43)
25.71
(17.70 to 33.72)
54.69
(45.73 to 63.64)
48.93
(38.59 to 59.27)
50.58
(40.48 to 60.69)
Week 48/ AT Week 20 Number Analyzed 15 participants 3 participants 15 participants 10 participants 10 participants 10 participants
4.70
(-1.57 to 10.97)
2.97
(-7.39 to 13.34)
25.28
(17.42 to 33.13)
62.45
(53.13 to 71.77)
53.74
(43.39 to 64.09)
53.79
(43.57 to 64.02)
Week 52/ AT Week 24 Number Analyzed 13 participants 3 participants 12 participants 11 participants 9 participants 10 participants
7.06
(0.75 to 13.38)
3.01
(-7.47 to 13.49)
28.88
(20.20 to 37.56)
58.53
(49.42 to 67.63)
55.94
(45.42 to 66.46)
58.37
(48.11 to 68.64)
20.Secondary Outcome
Title Percentage of Participants Achieving SALT 30 Across Time (SBE Period)
Hide Description SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 30 response is a 30% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.
Time Frame Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.
Arm/Group Title Active Non-responders on PF-06651600 Active Non-responders on PF-06700841 Placebo Non-responders on PF-06651600 Placebo Non-responders on PF-06700841 Retreated PF-06651600 Responders in the Retreatment Segment Retreated Responders on PF-06700841 in the Retreatment Segment
Hide Arm/Group Description:
Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT [SALT 30]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period
Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period
Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period
Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period
Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600
Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841
Overall Number of Participants Analyzed 16 5 17 12 14 15
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percent of participants
Week 30/ AT Week 2
4.1
(-5.3 to 23.0)
-2.1
(-10.9 to 40.0)
3.8
(-5.5 to 21.6)
-2.1
(-9.7 to 18.9)
47.9
(25.3 to 70.0)
31.2
(12.8 to 54.0)
Week 32/ AT Week 4
4.1
(-5.3 to 23.0)
-2.1
(-10.9 to 40.0)
9.6
(-2.4 to 30.2)
14.5
(0.4 to 39.4)
62.2
(38.2 to 81.5)
11.2
(-1.0 to 33.5)
Week 34/ AT Week 6
4.1
(-5.3 to 23.0)
-2.1
(-10.9 to 40.0)
21.4
(4.8 to 43.2)
31.2
(10.9 to 57.0)
69.3
(45.3 to 86.5)
31.2
(12.8 to 54.0)
Week 36/ AT Week 8
4.1
(-5.3 to 23.0)
-2.1
(-10.9 to 40.0)
21.4
(4.8 to 43.2)
56.2
(30.8 to 78.2)
69.3
(45.3 to 86.5)
44.5
(23.2 to 66.5)
Week 40/ AT Week 12
10.4
(-1.5 to 31.8)
-2.1
(-10.9 to 40.0)
27.3
(8.5 to 49.6)
81.2
(55.6 to 94.4)
62.2
(38.2 to 81.5)
51.2
(28.9 to 72.2)
Week 44/ AT Week 16
10.4
(-1.5 to 31.8)
-2.1
(-10.9 to 40.0)
33.2
(15.2 to 54.5)
64.5
(38.4 to 84.5)
62.2
(38.2 to 81.5)
51.2
(28.9 to 72.2)
Week 48/ AT Week 20
10.4
(-1.5 to 31.8)
-2.1
(-10.9 to 40.0)
39.0
(20.0 to 60.1)
64.5
(38.4 to 84.5)
69.3
(45.3 to 86.5)
51.2
(28.9 to 72.2)
Week 52/ AT Week 24
10.4
(-1.5 to 31.8)
-2.1
(-10.9 to 40.0)
27.3
(8.5 to 49.6)
64.5
(38.4 to 84.5)
55.0
(31.6 to 76.0)
51.2
(28.9 to 72.2)
21.Secondary Outcome
Title Percentage of Participants Achieving SALT 50 Across Time (SBE Period)
Hide Description SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 50 response is a 50% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.
Time Frame Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.
Arm/Group Title Active Non-responders on PF-06651600 Active Non-responders on PF-06700841 Placebo Non-responders on PF-06651600 Placebo Non-responders on PF-06700841 Retreated PF-06651600 Responders in the Retreatment Segment Retreated Responders on PF-06700841 in the Retreatment Segment
Hide Arm/Group Description:
Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT [SALT 30]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period
Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period
Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period
Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period
Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600
Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841
Overall Number of Participants Analyzed 16 5 17 12 14 15
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
Week 30/ AT Week 2
0.0
(-6.3 to 17.1)
0.0
(-7.4 to 45.1)
0.0
(-6.2 to 16.2)
0.0
(-6.3 to 22.1)
14.3
(2.4 to 38.5)
20.0
(5.7 to 44.0)
Week 32/ AT Week 4
0.0
(-6.3 to 17.1)
0.0
(-7.4 to 45.1)
0.0
(-6.2 to 16.2)
0.0
(-6.3 to 22.1)
21.4
(6.1 to 46.6)
6.7
(-2.1 to 27.9)
Week 34/ AT Week 6
-2.1
(-9.7 to 13.8)
-2.1
(-10.9 to 40.0)
9.6
(-2.4 to 30.2)
31.2
(10.9 to 57.0)
26.4
(6.1 to 50.0)
11.2
(-1.0 to 33.5)
Week 36/ AT Week 8
-2.1
(-9.7 to 13.8)
-2.1
(-10.9 to 40.0)
3.8
(-5.5 to 21.6)
56.2
(30.8 to 78.2)
33.6
(14.1 to 57.2)
24.5
(5.6 to 47.1)
Week 40/ AT Week 12
-2.1
(-9.7 to 13.8)
-2.1
(-10.9 to 40.0)
15.5
(1.1 to 36.8)
56.2
(30.8 to 78.2)
47.9
(25.3 to 70.0)
44.5
(23.2 to 66.5)
Week 44/ AT Week 16
-2.1
(-9.7 to 13.8)
-2.1
(-10.9 to 40.0)
21.4
(4.8 to 43.2)
64.5
(38.4 to 84.5)
47.9
(25.3 to 70.0)
44.5
(23.2 to 66.5)
Week 48/ AT Week 20
4.1
(-5.3 to 23.0)
-2.1
(-10.9 to 40.0)
27.3
(8.5 to 49.6)
64.5
(38.4 to 84.5)
47.9
(25.3 to 70.0)
37.9
(17.9 to 60.3)
Week 52/ AT Week 24
4.1
(-5.3 to 23.0)
-2.1
(-10.9 to 40.0)
27.3
(8.5 to 49.6)
64.5
(38.4 to 84.5)
47.9
(25.3 to 70.0)
44.5
(23.2 to 66.5)
22.Secondary Outcome
Title Percentage of Participants Achieving SALT 75 Across Time (SBE Period)
Hide Description SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 75 response is a 75% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.
Time Frame Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.
Arm/Group Title Active Non-responders on PF-06651600 Active Non-responders on PF-06700841 Placebo Non-responders on PF-06651600 Placebo Non-responders on PF-06700841 Retreated PF-06651600 Responders in the Retreatment Segment Retreated Responders on PF-06700841 in the Retreatment Segment
Hide Arm/Group Description:
Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT [SALT 30]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period
Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period
Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period
Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period
Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600
Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841
Overall Number of Participants Analyzed 16 5 17 12 14 15
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
Week 30/ AT Week 2
0.0
(-6.3 to 17.1)
0.0
(-7.4 to 45.1)
0.0
(-6.2 to 16.2)
0.0
(-6.3 to 22.1)
0.0
(-6.8 to 19.3)
0.0
(-6.6 to 18.1)
Week 32/ AT Week 4
0.0
(-6.3 to 17.1)
0.0
(-7.4 to 45.1)
0.0
(-6.2 to 16.2)
0.0
(-6.3 to 22.1)
7.1
(-1.9 to 29.7)
0.0
(-6.6 to 18.1)
Week 34/ AT Week 6
0.0
(-6.3 to 17.1)
0.0
(-7.4 to 45.1)
0.0
(-6.2 to 16.2)
8.3
(-1.5 to 33.9)
14.3
(2.4 to 38.5)
6.7
(-2.1 to 27.9)
Week 36/ AT Week 8
-2.1
(-9.7 to 13.8)
-2.1
(-10.9 to 40.0)
-2.1
(-9.7 to 13.3)
22.9
(2.8 to 48.7)
26.4
(6.1 to 50.0)
17.9
(1.8 to 40.6)
Week 40/ AT Week 12
-2.1
(-9.7 to 13.8)
-2.1
(-10.9 to 40.0)
3.8
(-5.5 to 21.6)
39.5
(17.0 to 64.5)
26.4
(6.1 to 50.0)
31.2
(12.8 to 54.0)
Week 44/ AT Week 16
-2.1
(-9.7 to 13.8)
-2.1
(-10.9 to 40.0)
15.5
(1.1 to 36.8)
56.2
(30.8 to 78.2)
26.4
(6.1 to 50.0)
37.9
(17.9 to 60.3)
Week 48/ AT Week 20
-2.1
(-9.7 to 13.8)
-2.1
(-10.9 to 40.0)
15.5
(1.1 to 36.8)
64.5
(38.4 to 84.5)
28.6
(6.1 to 50.0)
37.9
(17.9 to 60.3)
Week 52/ AT Week 24
4.1
(-5.3 to 23.0)
-2.1
(-10.9 to 40.0)
27.3
(8.5 to 49.6)
64.5
(38.4 to 84.5)
33.6
(14.1 to 57.2)
37.9
(17.9 to 60.3)
23.Secondary Outcome
Title Percentage of Participants Achieving SALT 90 Across Time (SBE Period)
Hide Description SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 90 response is a 90% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.
Time Frame Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.
Arm/Group Title Active Non-responders on PF-06651600 Active Non-responders on PF-06700841 Placebo Non-responders on PF-06651600 Placebo Non-responders on PF-06700841 Retreated PF-06651600 Responders in the Retreatment Segment Retreated Responders on PF-06700841 in the Retreatment Segment
Hide Arm/Group Description:
Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT [SALT 30]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period
Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period
Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period
Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period
Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600
Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841
Overall Number of Participants Analyzed 16 5 17 12 14 15
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
Week 30/ AT Week 2
0.0
(-6.3 to 17.1)
0.0
(-7.4 to 45.1)
0.0
(-6.2 to 16.2)
0.0
(-6.3 to 22.1)
0.0
(-6.8 to 19.3)
0.0
(-6.6 to 18.1)
Week 32/ AT Week 4
0.0
(-6.3 to 17.1)
0.0
(-7.4 to 45.1)
0.0
(-6.2 to 16.2)
0.0
(-6.3 to 22.1)
0.0
(-6.8 to 19.3)
0.0
(-6.6 to 18.1)
Week 34/ AT Week 6
0.0
(-6.3 to 17.1)
0.0
(-7.4 to 45.1)
0.0
(-6.2 to 16.2)
0.0
(-6.3 to 22.1)
0.0
(-6.8 to 19.3)
0.0
(-6.6 to 18.1)
Week 36/ AT Week 8
0.0
(-6.3 to 17.1)
0.0
(-7.4 to 45.1)
0.0
(-6.2 to 16.2)
8.3
(-1.5 to 33.9)
7.1
(-1.9 to 29.7)
6.7
(-2.1 to 27.9)
Week 40/ AT Week 12
0.0
(-6.3 to 17.1)
0.0
(-7.4 to 45.1)
0.0
(-6.2 to 16.2)
25.0
(7.2 to 52.7)
14.3
(2.4 to 38.5)
13.3
(2.1 to 36.3)
Week 44/ AT Week 16
0.0
(-6.3 to 17.1)
0.0
(-7.4 to 45.1)
0.0
(-6.2 to 16.2)
33.3
(12.3 to 60.9)
21.4
(6.1 to 46.6)
20.0
(5.7 to 44.0)
Week 48/ AT Week 20
-2.1
(-9.7 to 13.8)
-2.1
(-10.9 to 40.0)
3.8
(-5.5 to 21.6)
47.9
(23.6 to 71.6)
26.4
(6.1 to 50.0)
24.5
(5.6 to 47.1)
Week 52/ AT Week 24
0.0
(-6.3 to 17.1)
0.0
(-7.4 to 45.1)
17.6
(5.0 to 39.6)
50.0
(24.5 to 75.5)
28.6
(10.4 to 54.0)
40.0
(19.1 to 64.0)
24.Secondary Outcome
Title Percentage of Participants Achieving SALT 100 Across Time (SBE Period)
Hide Description SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 100 response is a 100% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease. The analysis was done using FAS (full analysis set) based on Non-responder imputation (ie. set missing values to be non-responsive) data. The percentage(Number) and 90% confidence interval (CI) in this outcome measurement is the percentage and 90% CI for difference from initial 24-week treatment period placebo. The 90% CI was calculated using Chan and Zhang method.
Time Frame Weeks 30, 32, 34, 36, 40, 44, 48, 52 for non-responders, and AT Weeks 2, 4, 6, 8, 12, 16, 20, 24 for retreated responders.(AT=active treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the Full analysis set (FAS) was used. FAS consisted of all randomized participants, assigned to the randomized treatment regardless of what treatment, if any, was received.
Arm/Group Title Active Non-responders on PF-06651600 Active Non-responders on PF-06700841 Placebo Non-responders on PF-06651600 Placebo Non-responders on PF-06700841 Retreated PF-06651600 Responders in the Retreatment Segment Retreated Responders on PF-06700841 in the Retreatment Segment
Hide Arm/Group Description:
Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT [SALT 30]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period
Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period
Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period
Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period
Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600
Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841
Overall Number of Participants Analyzed 16 5 17 12 14 15
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
Week 30/ AT Week 2
0.0
(-6.3 to 17.1)
0.0
(-7.4 to 45.1)
0.0
(-6.2 to 16.2)
0.0
(-6.3 to 22.1)
0.0
(-6.8 to 19.3)
0.0
(-6.6 to 18.1)
Week 32/ AT Week 4
0.0
(-6.3 to 17.1)
0.0
(-7.4 to 45.1)
0.0
(-6.2 to 16.2)
0.0
(-6.3 to 22.1)
0.0
(-6.8 to 19.3)
0.0
(-6.6 to 18.1)
Week 34/ AT Week 6
0.0
(-6.3 to 17.1)
0.0
(-7.4 to 45.1)
0.0
(-6.2 to 16.2)
0.0
(-6.3 to 22.1)
0.0
(-6.8 to 19.3)
0.0
(-6.6 to 18.1)
Week 36/ AT Week 8
0.0
(-6.3 to 17.1)
0.0
(-7.4 to 45.1)
0.0
(-6.2 to 16.2)
0.0
(-6.3 to 22.1)
0.0
(-6.8 to 19.3)
0.0
(-6.6 to 18.1)
Week 40/ AT Week 12
0.0
(-6.3 to 17.1)
0.0
(-7.4 to 45.1)
0.0
(-6.2 to 16.2)
8.3
(-1.5 to 33.9)
7.1
(-1.9 to 29.7)
0.0
(-6.6 to 18.1)
Week 44/ AT Week 16
0.0
(-6.3 to 17.1)
0.0
(-7.4 to 45.1)
0.0
(-6.2 to 16.2)
8.3
(-1.5 to 33.9)
7.1
(-1.9 to 29.7)
13.3
(2.1 to 36.3)
Week 48/ AT Week 20
0.0
(-6.3 to 17.1)
0.0
(-7.4 to 45.1)
0.0
(-6.2 to 16.2)
8.3
(-1.5 to 33.9)
7.1
(-1.9 to 29.7)
20.0
(5.7 to 44.0)
Week 52/ AT Week 24
0.0
(-6.3 to 17.1)
0.0
(-7.4 to 45.1)
0.0
(-6.2 to 16.2)
8.3
(-1.5 to 33.9)
14.3
(2.4 to 38.5)
20.0
(5.7 to 44.0)
Time Frame From first dose of study treatment up to 113 weeks
Adverse Event Reporting Description

The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.

Participants were counted only once per treatment per event.

 
Arm/Group Title Treatment Period-Placebo Treatment Period-PF-06651600 Treatment Period-PF-06700841 Single Blind Extension-Active Non-responders on PF-06651600 Single Blind Extension-Placebo Non-responders on PF-06651600 Single Blind Extension-Active Non-responders on PF-06700841 Single Blind Extension-Placebo Non-responders on PF-06700841 SBE-Non-Retreated PF-06651600 Responders in Withdrawal Segment SBE-Retreated PF-06651600 Responders in Withdrawal Segment SBE-Non-Retreated PF-06700841 Responders (Withdrawal Segment) SBE-Retreated PF-06700841 Responders in the Withdrawal Segment SBE-Retreated PF-06651600 Responders in Retreatment Segment SBE-Retreated Responders on PF-06700841 in Retreatment Segment Cross Over Extension-PF-06651600 Cross Over Extension-PF-06700841
Hide Arm/Group Description Participants received placebo tablets QD both matching for PF-06651600 and PF-06700841 Participants received PF-06651600 200 mg tablets QD for a 4-week induction period followed by PF-06651600 50 mg tablets QD for a 20-week maintenance period. Participants received PF-06700841 60 mg tablets QD for a 4-week induction period followed by PF-06700841 30 mg tablets QD for a 20-week maintenance period. Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving ≥30% improvement from baseline in SALT [SALT 30]) who were continually assigned to PF-06651600 in the Non-Responder Segment of the SBE Period Participants initially treated with placebo in the Initial 24-Week Treatment Period (1 participant receiving placebo in the Initial 24-Week Treatment Period was responsive at Week 24 but did not enter the SBE Period) who were assigned to PF-06651600 in the Non-Responder Segment of the SBE Period Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and not responsive at Week 24 (ie, not achieving SALT 30) who were continually assigned to PF-06700841 in the Non-Responder Segment of the SBE Period Participants initially treated with placebo in the Initial 24-Week Treatment Period who were assigned to PF-06700841 in the Non-Responder Segment of the SBE Period Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal) without entering the Retreatment Segment of the SBE Period

Participants initially treated with PF-06651600 in the Initial 24- Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600.

This arm described AEs for retreated responders within withdrawal Segment.

Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal) without entering the Retreatment Segment of the SBE Period Participants initially treated with PF06700841 in the Initial 24- Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841.This arm described AEs for retreated responders within Withdrawal Segment Participants initially treated with PF-06651600 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06651600 Participants initially treated with PF-06700841 in the Initial 24-Week Treatment Period and responsive at Week 24 (ie, achieving SALT 30) who were assigned to placebo (withdrawal), and then entered the Retreatment Segment of the SBE Period to receive PF-06700841 Participants not responsive to placebo or PF-06700841 at Week 24 in the Initial 24-Week Treatment Period and not responsive to PF-06700841 at Week 52 (ie, not achieving SALT 30) in the SBE Period who were assigned to PF-06651600 in the COE Period Participants not responsive to placebo or PF-06651600 at Week 24 in the Initial 24-Week Treatment Period and not responsive to PF-06651600 at Week 52 (ie, not achieving SALT 30; except 1 PF-06651600 responder) in the SBE Period who were assigned to PF-06700841 in the COE Period
All-Cause Mortality
Treatment Period-Placebo Treatment Period-PF-06651600 Treatment Period-PF-06700841 Single Blind Extension-Active Non-responders on PF-06651600 Single Blind Extension-Placebo Non-responders on PF-06651600 Single Blind Extension-Active Non-responders on PF-06700841 Single Blind Extension-Placebo Non-responders on PF-06700841 SBE-Non-Retreated PF-06651600 Responders in Withdrawal Segment SBE-Retreated PF-06651600 Responders in Withdrawal Segment SBE-Non-Retreated PF-06700841 Responders (Withdrawal Segment) SBE-Retreated PF-06700841 Responders in the Withdrawal Segment SBE-Retreated PF-06651600 Responders in Retreatment Segment SBE-Retreated Responders on PF-06700841 in Retreatment Segment Cross Over Extension-PF-06651600 Cross Over Extension-PF-06700841
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)   0/48 (0.00%)   0/47 (0.00%)   0/16 (0.00%)   0/17 (0.00%)   0/5 (0.00%)   0/12 (0.00%)   0/8 (0.00%)   0/14 (0.00%)   0/9 (0.00%)   0/14 (0.00%)   0/14 (0.00%)   0/15 (0.00%)   0/5 (0.00%)   0/18 (0.00%) 
Hide Serious Adverse Events
Treatment Period-Placebo Treatment Period-PF-06651600 Treatment Period-PF-06700841 Single Blind Extension-Active Non-responders on PF-06651600 Single Blind Extension-Placebo Non-responders on PF-06651600 Single Blind Extension-Active Non-responders on PF-06700841 Single Blind Extension-Placebo Non-responders on PF-06700841 SBE-Non-Retreated PF-06651600 Responders in Withdrawal Segment SBE-Retreated PF-06651600 Responders in Withdrawal Segment SBE-Non-Retreated PF-06700841 Responders (Withdrawal Segment) SBE-Retreated PF-06700841 Responders in the Withdrawal Segment SBE-Retreated PF-06651600 Responders in Retreatment Segment SBE-Retreated Responders on PF-06700841 in Retreatment Segment Cross Over Extension-PF-06651600 Cross Over Extension-PF-06700841
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)   0/48 (0.00%)   2/47 (4.26%)   0/16 (0.00%)   0/17 (0.00%)   0/5 (0.00%)   0/12 (0.00%)   0/8 (0.00%)   0/14 (0.00%)   0/9 (0.00%)   0/14 (0.00%)   0/14 (0.00%)   1/15 (6.67%)   0/5 (0.00%)   1/18 (5.56%) 
Infections and infestations                               
Gastroenteritis salmonella * 1  0/47 (0.00%)  0/48 (0.00%)  1/47 (2.13%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  1/18 (5.56%) 
Injury, poisoning and procedural complications                               
Lower limb fracture * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/15 (6.67%)  0/5 (0.00%)  0/18 (0.00%) 
Musculoskeletal and connective tissue disorders                               
Rhabdomyolysis * 1  0/47 (0.00%)  0/48 (0.00%)  2/47 (4.26%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
1
Term from vocabulary, MedDRA v22.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Period-Placebo Treatment Period-PF-06651600 Treatment Period-PF-06700841 Single Blind Extension-Active Non-responders on PF-06651600 Single Blind Extension-Placebo Non-responders on PF-06651600 Single Blind Extension-Active Non-responders on PF-06700841 Single Blind Extension-Placebo Non-responders on PF-06700841 SBE-Non-Retreated PF-06651600 Responders in Withdrawal Segment SBE-Retreated PF-06651600 Responders in Withdrawal Segment SBE-Non-Retreated PF-06700841 Responders (Withdrawal Segment) SBE-Retreated PF-06700841 Responders in the Withdrawal Segment SBE-Retreated PF-06651600 Responders in Retreatment Segment SBE-Retreated Responders on PF-06700841 in Retreatment Segment Cross Over Extension-PF-06651600 Cross Over Extension-PF-06700841
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   26/47 (55.32%)   23/48 (47.92%)   28/47 (59.57%)   8/16 (50.00%)   12/17 (70.59%)   4/5 (80.00%)   10/12 (83.33%)   4/8 (50.00%)   3/14 (21.43%)   6/9 (66.67%)   9/14 (64.29%)   11/14 (78.57%)   8/15 (53.33%)   4/5 (80.00%)   8/18 (44.44%) 
Blood and lymphatic system disorders                               
Lymphadenopathy * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Cardiac disorders                               
Palpitations * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Ventricular extrasystoles * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  1/17 (5.88%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Ear and labyrinth disorders                               
Tinnitus * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Eye disorders                               
Eyelids pruritus * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Gastrointestinal disorders                               
Abdominal discomfort * 1  4/47 (8.51%)  0/48 (0.00%)  1/47 (2.13%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  1/5 (20.00%)  0/18 (0.00%) 
Abdominal pain * 1  0/47 (0.00%)  0/48 (0.00%)  3/47 (6.38%)  0/16 (0.00%)  1/17 (5.88%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Abdominal pain upper * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  1/5 (20.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Constipation * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  1/18 (5.56%) 
Diarrhoea * 1  3/47 (6.38%)  4/48 (8.33%)  1/47 (2.13%)  1/16 (6.25%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/15 (6.67%)  0/5 (0.00%)  0/18 (0.00%) 
Dyspepsia * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  1/17 (5.88%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/15 (6.67%)  0/5 (0.00%)  0/18 (0.00%) 
Lip oedema * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Nausea * 1  5/47 (10.64%)  3/48 (6.25%)  3/47 (6.38%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/15 (0.00%)  1/5 (20.00%)  0/18 (0.00%) 
Toothache * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/9 (11.11%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Vomiting * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  1/15 (6.67%)  0/5 (0.00%)  0/18 (0.00%) 
Aphthous ulcer * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  1/18 (5.56%) 
General disorders                               
Fatigue * 1  3/47 (6.38%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  1/17 (5.88%)  0/5 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/14 (0.00%)  2/9 (22.22%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Inflammation * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Pyrexia * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/15 (6.67%)  0/5 (0.00%)  0/18 (0.00%) 
Influenza like illness * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  1/5 (20.00%)  0/18 (0.00%) 
Immune system disorders                               
Seasonal allergy * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Infections and infestations                               
Acute sinusitis * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  1/16 (6.25%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Bronchitis * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  2/16 (12.50%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  1/18 (5.56%) 
Conjunctivitis * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Folliculitis * 1  1/47 (2.13%)  3/48 (6.25%)  1/47 (2.13%)  0/16 (0.00%)  1/17 (5.88%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Gastroenteritis viral * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/9 (11.11%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Herpes simplex * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  1/5 (20.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Influenza * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  1/5 (20.00%)  1/12 (8.33%)  0/8 (0.00%)  1/14 (7.14%)  0/9 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Nasopharyngitis * 1  6/47 (12.77%)  6/48 (12.50%)  4/47 (8.51%)  0/16 (0.00%)  2/17 (11.76%)  0/5 (0.00%)  2/12 (16.67%)  0/8 (0.00%)  1/14 (7.14%)  1/9 (11.11%)  0/14 (0.00%)  3/14 (21.43%)  1/15 (6.67%)  1/5 (20.00%)  0/18 (0.00%) 
Oral herpes * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  1/17 (5.88%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/9 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Otitis externa * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  1/5 (20.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Pharyngitis * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  1/16 (6.25%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Pharyngitis streptococcal * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  1/17 (5.88%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Sinusitis * 1  2/47 (4.26%)  0/48 (0.00%)  3/47 (6.38%)  0/16 (0.00%)  0/17 (0.00%)  1/5 (20.00%)  1/12 (8.33%)  0/8 (0.00%)  1/14 (7.14%)  1/9 (11.11%)  1/14 (7.14%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Sinusitis bacterial * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/9 (11.11%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Soft tissue infection * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/15 (6.67%)  0/5 (0.00%)  0/18 (0.00%) 
Tinea versicolour * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/9 (11.11%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Tonsillitis * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Upper respiratory tract infection * 1  5/47 (10.64%)  4/48 (8.33%)  11/47 (23.40%)  2/16 (12.50%)  0/17 (0.00%)  1/5 (20.00%)  1/12 (8.33%)  1/8 (12.50%)  0/14 (0.00%)  1/9 (11.11%)  2/14 (14.29%)  2/14 (14.29%)  1/15 (6.67%)  1/5 (20.00%)  3/18 (16.67%) 
Urinary tract infection * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  1/16 (6.25%)  0/17 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  1/15 (6.67%)  0/5 (0.00%)  0/18 (0.00%) 
Viral infection * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Viral upper respiratory tract infection * 1  0/47 (0.00%)  2/48 (4.17%)  3/47 (6.38%)  1/16 (6.25%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  1/15 (6.67%)  0/5 (0.00%)  1/18 (5.56%) 
Hordeolum * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  1/5 (20.00%)  0/18 (0.00%) 
Rhinitis * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  1/18 (5.56%) 
Arthritis viral * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Bartholin's abscess * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Ear infection * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Laryngitis * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Orchitis * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Injury, poisoning and procedural complications                               
Chest injury * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  1/16 (6.25%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Head injury * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/15 (6.67%)  0/5 (0.00%)  0/18 (0.00%) 
Muscle strain * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Thermal burn * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  1/17 (5.88%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Wound * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Contusion * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  1/18 (5.56%) 
Skin laceration * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  1/18 (5.56%) 
Investigations                               
Blood creatine phosphokinase increased * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  1/17 (5.88%)  0/5 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/15 (6.67%)  0/5 (0.00%)  0/18 (0.00%) 
Blood creatinine increased * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  1/5 (20.00%)  1/12 (8.33%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/15 (6.67%)  0/5 (0.00%)  0/18 (0.00%) 
Glomerular filtration rate decreased * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Liver function test abnormal * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  1/16 (6.25%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Liver function test increased * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  2/14 (14.29%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Neutrophil count decreased * 1  1/47 (2.13%)  0/48 (0.00%)  3/47 (6.38%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Alanine aminotransferase increased * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Blood potassium decreased * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Metabolism and nutrition disorders                               
Hyperkalaemia * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Hyperlipidaemia * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  1/17 (5.88%)  0/5 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Musculoskeletal and connective tissue disorders                               
Arthralgia * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/15 (6.67%)  0/5 (0.00%)  0/18 (0.00%) 
Musculoskeletal pain * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  1/8 (12.50%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Myalgia * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  1/17 (5.88%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  1/14 (7.14%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Pain in extremity * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  2/17 (11.76%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Rhabdomyolysis * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/9 (11.11%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Torticollis * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  1/5 (20.00%)  0/18 (0.00%) 
Nervous system disorders                               
Dizziness * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  2/14 (14.29%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Dysgeusia * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Headache * 1  5/47 (10.64%)  6/48 (12.50%)  4/47 (8.51%)  2/16 (12.50%)  2/17 (11.76%)  0/5 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  1/14 (7.14%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  2/15 (13.33%)  0/5 (0.00%)  1/18 (5.56%) 
Migraine * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Nerve compression * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Taste disorder * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  1/16 (6.25%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Depressed level of consciousness * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Psychiatric disorders                               
Aggression * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  1/15 (6.67%)  0/5 (0.00%)  0/18 (0.00%) 
Anxiety * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  1/18 (5.56%) 
Renal and urinary disorders                               
Haematuria * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  1/5 (20.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
IgA nephropathy * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  1/5 (20.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Nephrolithiasis * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  1/5 (20.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Proteinuria * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  1/5 (20.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders                               
Cough * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  1/16 (6.25%)  1/17 (5.88%)  0/5 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Respiratory disorder * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Wheezing * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Oropharyngeal pain * 1  0/47 (0.00%)  0/48 (0.00%)  3/47 (6.38%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  1/5 (20.00%)  0/18 (0.00%) 
Nasal congestion * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Skin and subcutaneous tissue disorders                               
Acne * 1  2/47 (4.26%)  5/48 (10.42%)  5/47 (10.64%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  1/18 (5.56%) 
Dermatitis * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  2/12 (16.67%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Dermatitis atopic * 1  0/47 (0.00%)  3/48 (6.25%)  1/47 (2.13%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  1/9 (11.11%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Dermatitis contact * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Keratosis pilaris * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  1/16 (6.25%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Madarosis * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  1/17 (5.88%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Papulopustular rosacea * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  1/16 (6.25%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Pruritus * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  1/5 (20.00%)  1/12 (8.33%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  1/14 (7.14%)  0/14 (0.00%)  0/15 (0.00%)  1/5 (20.00%)  0/18 (0.00%) 
Pseudofolliculitis * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  1/17 (5.88%)  0/5 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Seborrhoeic dermatitis * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  1/14 (7.14%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Urticaria * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  1/17 (5.88%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Urticaria papular * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  1/17 (5.88%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  0/18 (0.00%) 
Hidradenitis * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  1/18 (5.56%) 
Erythema * 1  0/47 (0.00%)  0/48 (0.00%)  0/47 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  0/14 (0.00%)  0/14 (0.00%)  0/15 (0.00%)  0/5 (0.00%)  1/18 (5.56%) 
1
Term from vocabulary, MedDRA v22.0
*
Indicates events were collected by non-systematic assessment
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
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02974868    
Other Study ID Numbers: B7931005
2016-004048-13 ( EudraCT Number )
ALLEGRO ( Other Identifier: Alias Study Number )
First Submitted: November 23, 2016
First Posted: November 29, 2016
Results First Submitted: May 6, 2020
Results First Posted: May 26, 2020
Last Update Posted: May 26, 2020