Trial Outcomes & Findings for Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis (NCT NCT02958865)
NCT ID: NCT02958865
Last Updated: 2022-07-21
Results Overview
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicates more severe disease activity and lower score denotes improvement of disease activity as measured by the total Mayo score.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
319 participants
Primary outcome timeframe
Week 8
Results posted on
2022-07-21
Participant Flow
The study consisted of a screening period of up to 6 weeks, an 8-week double-blind induction period, and an additional 24-week open-label active chronic dosing period followed by a 4-week follow up period after the last dose of investigational product.
A total of 319 participants were randomized and 317 participants were treated.
Participant milestones
| Measure |
Placebo (Induction)
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg -> PF-06651600 50 mg
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
|
PF-06651600 70 mg -> PF-06651600 50 mg
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
|
PF-06651600 20 mg -> PF-06651600 50 mg
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
|
Placebo -> PF-06651600 50 mg
The placebo was administered orally QD from Day 1 to Week 8 and PF-06651600 was administered at 50 mg QD from Week 9 to Week 32.
|
PF-06700841 60 mg -> PF-06700841 30 mg
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
|
PF-06700841 30 mg -> PF-06700841 30 mg
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
|
PF-06700841 10 mg -> PF-06700841 30 mg
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
|
Placebo -> PF-06700841 30 mg
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally QD from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Induction Period (Day 1 to Week 8)
STARTED
|
25
|
51
|
49
|
50
|
48
|
47
|
47
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period (Day 1 to Week 8)
COMPLETED
|
21
|
44
|
43
|
41
|
45
|
43
|
44
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period (Day 1 to Week 8)
NOT COMPLETED
|
4
|
7
|
6
|
9
|
3
|
4
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Chronic Period (Week 8 to Week 32)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
35
|
36
|
39
|
10
|
38
|
37
|
39
|
9
|
37
|
|
Chronic Period (Week 8 to Week 32)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
33
|
33
|
33
|
10
|
31
|
26
|
31
|
5
|
20
|
|
Chronic Period (Week 8 to Week 32)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
3
|
6
|
0
|
7
|
11
|
8
|
4
|
17
|
Reasons for withdrawal
| Measure |
Placebo (Induction)
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg -> PF-06651600 50 mg
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
|
PF-06651600 70 mg -> PF-06651600 50 mg
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
|
PF-06651600 20 mg -> PF-06651600 50 mg
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
|
Placebo -> PF-06651600 50 mg
The placebo was administered orally QD from Day 1 to Week 8 and PF-06651600 was administered at 50 mg QD from Week 9 to Week 32.
|
PF-06700841 60 mg -> PF-06700841 30 mg
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
|
PF-06700841 30 mg -> PF-06700841 30 mg
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
|
PF-06700841 10 mg -> PF-06700841 30 mg
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
|
Placebo -> PF-06700841 30 mg
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally QD from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Induction Period (Day 1 to Week 8)
Adverse Event
|
0
|
4
|
0
|
5
|
1
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period (Day 1 to Week 8)
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period (Day 1 to Week 8)
Physician Decision
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period (Day 1 to Week 8)
Withdrawal by Subject
|
2
|
0
|
3
|
1
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period (Day 1 to Week 8)
No longer meeting eligibility criteria
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period (Day 1 to Week 8)
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period (Day 1 to Week 8)
Lack of Efficacy
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period (Day 1 to Week 8)
Other
|
0
|
0
|
1
|
2
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period (Day 1 to Week 8)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Chronic Period (Week 8 to Week 32)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
2
|
0
|
1
|
4
|
1
|
1
|
5
|
|
Chronic Period (Week 8 to Week 32)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
5
|
0
|
2
|
0
|
8
|
|
Chronic Period (Week 8 to Week 32)
Pregnancy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Chronic Period (Week 8 to Week 32)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
6
|
3
|
3
|
2
|
|
Chronic Period (Week 8 to Week 32)
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Chronic Period (Week 8 to Week 32)
Non-compliance with study drug
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Chronic Period (Week 8 to Week 32)
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Chronic Period (Week 8 to Week 32)
No longer meeting eligibility criteria
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Placebo (Induction)
n=25 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=51 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=49 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=50 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=48 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Total
n=317 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
11 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
24 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
135 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
23 Participants
n=10 Participants
|
25 Participants
n=115 Participants
|
182 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White
|
22 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
44 Participants
n=10 Participants
|
45 Participants
n=115 Participants
|
295 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
|
Age, Continuous
|
42.8 years
STANDARD_DEVIATION 15.45 • n=5 Participants
|
41.3 years
STANDARD_DEVIATION 14.03 • n=7 Participants
|
40.2 years
STANDARD_DEVIATION 13.31 • n=5 Participants
|
37.3 years
STANDARD_DEVIATION 15.67 • n=4 Participants
|
40.8 years
STANDARD_DEVIATION 13.04 • n=21 Participants
|
40.9 years
STANDARD_DEVIATION 13.03 • n=10 Participants
|
40.3 years
STANDARD_DEVIATION 12.80 • n=115 Participants
|
40.3 years
STANDARD_DEVIATION 13.79 • n=24 Participants
|
|
Age, Customized
18-44 years
|
13 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
25 Participants
n=10 Participants
|
30 Participants
n=115 Participants
|
196 Participants
n=24 Participants
|
|
Age, Customized
45-64 years
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
108 Participants
n=24 Participants
|
|
Age, Customized
>=65 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
13 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Other (not specified)
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: The intent-to-treat (ITT) analysis set which included all randomized participants who received at least 1 dose of investigational product or placebo.
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicates more severe disease activity and lower score denotes improvement of disease activity as measured by the total Mayo score.
Outcome measures
| Measure |
Placebo (Induction)
n=25 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=51 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=49 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=50 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=48 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Total Mayo Score at Week 8 (Induction Period)
|
7.88 Units on a scale
Interval 6.95 to 8.81
|
5.85 Units on a scale
Interval 5.18 to 6.51
|
4.00 Units on a scale
Interval 3.33 to 4.67
|
3.27 Units on a scale
Interval 2.58 to 3.96
|
6.08 Units on a scale
Interval 5.43 to 6.74
|
5.60 Units on a scale
Interval 4.93 to 6.27
|
4.67 Units on a scale
Interval 4.01 to 5.33
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 8 up to Week 32Population: The safety analysis set was defined as those participants who received at least one dose of PF-06651600, PF-06700841, or placebo.
An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes: death, life-threatening experience, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. All AEs mentioned below are treatment-emergent AEs.
Outcome measures
| Measure |
Placebo (Induction)
n=35 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=36 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=39 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=10 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=38 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=37 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=39 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
n=9 Participants
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
n=37 Participants
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period)
Participants with AEs
|
18 Participants
|
27 Participants
|
18 Participants
|
8 Participants
|
21 Participants
|
23 Participants
|
26 Participants
|
4 Participants
|
18 Participants
|
|
Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period)
Participants with SAEs
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period)
Participants discontinued from study due to AEs
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From Week 8 to Week 32Population: The participants with at least one observation of the given laboratory test while on study treatment or during lag time.
The number of participants with a laboratory abnormality meeting the pre-specified criteria defined in the study protocol while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. Laboratory data included hematology test, serum chemistry test, C-creative protein and viral surveillance.
Outcome measures
| Measure |
Placebo (Induction)
n=35 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=35 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=39 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=10 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=38 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=37 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=39 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
n=9 Participants
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
n=37 Participants
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities (Chronic Period)
|
27 Participants
|
31 Participants
|
33 Participants
|
8 Participants
|
29 Participants
|
27 Participants
|
28 Participants
|
8 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: From Week 8 to Week 32Population: Number of Participants Analyzed: the participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Number Analyzed: the participants with at least one observation of the given laboratory test while on study treatment or during lag time.
The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of hematology test parameters were as follows: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils (absolute, Abs), eosinophils (Abs), monocytes (Abs), basophils (Abs), lymphocytes (Abs), prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT), and reticulocytes (% and Abs). Percentages are displayed for the laboratory tests having a category with greater or equal to 1 evaluable participant.
Outcome measures
| Measure |
Placebo (Induction)
n=35 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=36 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=39 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=10 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=38 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=37 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=39 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
n=9 Participants
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
n=37 Participants
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period)
Hematocrit (%) <0.8× LLN
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period)
Erythrocytes (10^6/mm^3) <0.8× LLN
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period)
Reticulocytes (Abs) (10^3/mm^3) >1.5× ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period)
Erythrocytes Mean Corpuscular Volume (10^-15L) <0.9× LLN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period)
Platelets (10^3/mm^3) >1.75× ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period)
Lymphocytes (Abs) (10^3/mm^3) >1.2× ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period)
Neutrophils (Abs) (10^3/mm^3) <0.8× LLN
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period)
Basophils (Abs) (10^3/mm^3) >1.2× ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period)
Monocytes (Abs) (10^3/mm^3) >1.2× ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period)
Activated PTT (second) >1.1× ULN
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period)
PT (second) >1.1× ULN
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period)
Hemoglobin (g/dL) <0.8× LLN
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period)
Reticulocytes/Erythrocytes (%) >1.5× ULN
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period)
Leukocytes (10^3/mm^3) >1.5× ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period)
Lymphocytes (Abs) (10^3/mm^3) <0.8× LLN
|
7 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period)
Neutrophils (Abs) (10^3/mm^3) >1.2× ULN
|
3 Participants
|
8 Participants
|
11 Participants
|
1 Participants
|
8 Participants
|
6 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period)
Eosinophils (Abs) (10^3/mm^3) >1.2x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period)
Prothrombin INR >1.1× ULN
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Week 8 to Week 32Population: The participants evaluated against the criteria during the chronic period.
The vital signs data included the single sitting blood pressure, pulse rate and temperature. The criteria of vital sign abnormality are indicated below.
Outcome measures
| Measure |
Placebo (Induction)
n=35 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=35 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=39 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=10 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=38 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=37 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=39 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
n=9 Participants
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
n=37 Participants
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Vital Signs Data (Chronic Period)
Sitting Diastolic Blood Pressure Value <50 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs Data (Chronic Period)
Sitting Diastolic Blood Pressure Change ≥20 mmHg Increase
|
0 Participants
|
1 Participants
|
6 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Vital Signs Data (Chronic Period)
Sitting Pulse Rate Value <40 beat per minute (bpm)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs Data (Chronic Period)
Sitting Pulse Rate Value >120 bpm
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs Data (Chronic Period)
Sitting Systolic Blood Pressure Value <90 mmHg
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Vital Signs Data (Chronic Period)
Sitting Systolic Blood Pressure Change ≥30 mmHg Increase
|
0 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Vital Signs Data (Chronic Period)
Sitting Systolic Blood Pressure Change ≥30 mmHg Decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Vital Signs Data (Chronic Period)
Sitting Diastolic Blood Pressure Change ≥20 mmHg Decrease
|
2 Participants
|
4 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 8 to Week 32Population: The participants evaluated against the criteria during the chronic period.
The number of participants with abnormal ECG findings during the chronic period (from Week 9 to Week 32) are reported below.
Outcome measures
| Measure |
Placebo (Induction)
n=35 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=36 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=39 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=10 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=38 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=37 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=36 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
n=9 Participants
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
n=37 Participants
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal ECG Findings (Chronic Period)
Abnormal, not clinically significant
|
3 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Abnormal ECG Findings (Chronic Period)
Abnormal, clinically significant
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 8 to Week 32Population: The participants who received at least one dose of PF-06651600, PF-06700841, or placebo.
Serious infections was defined as any infection (for example, viral, bacterial, and fungal) requiring hospitalization or parenteral antimicrobials.
Outcome measures
| Measure |
Placebo (Induction)
n=35 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=36 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=39 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=10 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=38 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=37 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=39 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
n=9 Participants
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
n=37 Participants
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Infections (Chronic Period)
COVID-19 pneumonia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Serious Infections (Chronic Period)
Viral infection
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 8 to Week 32Population: Number of Participants Analyzed: the participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Number Analyzed: the participants with at least one observation of the given laboratory test while on study treatment or during lag time.
The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of serum chemistry test parameters were as follows: blood urea nitrogen, creatinine, cystatin C, glucose, calcium, sodium, potassium, gamma glutamyl transferase, chloride, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, alkaline phosphatase, uric acid, albumin, total protein, creatine kinase (CK), total cholesterol, triglycerides, high-density lipoproteins (HDL), and low-density lipoprotein (LDL).
Outcome measures
| Measure |
Placebo (Induction)
n=35 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=36 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=39 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=10 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=38 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=37 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=39 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
n=9 Participants
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
n=37 Participants
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
Bilirubin (mg/dL) >1.5 x ULN
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
Direct Bilirubin (mg/dL) >1.5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
AST (U/L) >3.0 x ULN
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
ALT (U/L) >3.0 x ULN
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
Gamma Glutamyl Transferase (U/L) >3.0 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
Cholesterol (mg/dl) >1.3 x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
Protein (g/dL) <0.8 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
Protein (g/dL) >1.2 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
Albumin (g/dL) <0.8 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
Indirect Bilirubin (mg/dL) >1.5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
Alkaline Phosphatase (U/L) >3.0 x ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
Albumin (g/dL) >1.2 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
Urea Nitrogen (mg/dL) >1.3 x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
Creatinine (mg/dL) >1.3 x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
Urate (mg/dL) >1.2 x ULN
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
HDL Cholesterol (mg/dL) <0.8 x LLN
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
LDL Cholesterol (mg/dL) >1.2 x ULN
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
Triglycerides (mg/dL) >1.3 x ULN
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
Sodium (Meq/L) <0.95 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
Sodium (Meq/L) >1.05 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
Potassium (Meq/L) <0.9 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
Potassium (Meq/L) >1.1 x ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
Chloride (Meq/L) <0.9 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
Chloride (Meq/L) >1.1 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
Calcium (mg/dL) <0.9 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
Calcium (mg/dL) >1.1 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
Glucose (mg/dL) <0.6 x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
Glucose (mg/dL) >1.5 x ULN
|
1 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
Hemoglobin A1C (%) >1.3 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
Creatine Kinase (U/L) >2.0 x ULN
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
10 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 8 to Week 32Population: Number of Participants Analyzed: the participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Number Analyzed: the participants with at least one observation of the given laboratory test while on study treatment or during lag time.
The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of urinalysis test parameters were as follows:pH, glucose (qual), protein (qual), blood (qual), ketones, nitrites, leukocyte esterase, microscopy, and spot urine albumin/creatinine ratio. The criteria of laboratory abnormality is defined as one of the following conditions was met: 1)associated with accompanying symptoms;2)Test result requires additional diagnostic testing or medical/surgical intervention;3)Test result leads to a change in study dosing (outside of any protocol specified dose adjustments) or discontinuation from the study, significant additional concomitant drug treatment, or other therapy;4)Test result is considered to be an AE by the investigator or sponsor.
Outcome measures
| Measure |
Placebo (Induction)
n=35 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=36 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=39 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=10 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=38 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=37 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=39 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
n=9 Participants
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
n=37 Participants
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period)
Hyaline Casts (/LPF) >1
|
5 Participants
|
0 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period)
WBC Casts (/LPF) >1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period)
Bacteria (No Unit) >20
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period)
pH (scalar) <4.5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period)
pH (scalar) >8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period)
Urine Glucose (No Unit) >=1
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period)
Ketones (No Unit) >=1
|
4 Participants
|
3 Participants
|
8 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period)
Urine Protein (No Unit) >=1
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period)
Urine Hemoglobin (No Unit) >=1
|
7 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
7 Participants
|
9 Participants
|
9 Participants
|
0 Participants
|
9 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period)
Nitrite (No Unit) >=1
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period)
Leukocyte Esterase (No Unit) >=1
|
8 Participants
|
13 Participants
|
11 Participants
|
1 Participants
|
14 Participants
|
7 Participants
|
8 Participants
|
1 Participants
|
9 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period)
Urine Erythrocytes (/HPF) >=20
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period)
Urine Leukocytes (/HPF) >=20
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to Week 8Population: The participants who received at least one dose of PF-06651600, PF-06700841, or placebo.
An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes: death, life-threatening experience, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. All AEs mentioned below are treatment-emergent AEs.
Outcome measures
| Measure |
Placebo (Induction)
n=25 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=51 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=49 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=50 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=48 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period)
Participants discontinued from study due to AEs
|
0 Participants
|
5 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period)
Participants with AEs
|
13 Participants
|
23 Participants
|
21 Participants
|
21 Participants
|
19 Participants
|
26 Participants
|
23 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period)
Participants with SAEs
|
0 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 up to Week 8Population: The participants with at least one observation of the given laboratory test while on study treatment or during lag time.
The number of participants with a laboratory abnormality meeting the pre-specified criteria defined in the study protocol while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. Laboratory data included hematology test, serum chemistry test, C-creative protein and viral surveillance. The criteria of laboratory abnormality is defined as one of the following conditions was met: 1)associated with accompanying symptoms;2)Test result requires additional diagnostic testing or medical/surgical intervention;3)Test result leads to a change in study dosing (outside of any protocol specified dose adjustments) or discontinuation from the study, significant additional concomitant drug treatment, or other therapy;4)Test result is considered to be an AE by the investigator or sponsor.
Outcome measures
| Measure |
Placebo (Induction)
n=25 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=49 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=48 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=50 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=48 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities (Induction Period)
|
17 Participants
|
29 Participants
|
28 Participants
|
34 Participants
|
32 Participants
|
31 Participants
|
36 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 up to Week 8Population: Number of Participants Analyzed: the participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Number Analyzed: the participants with at least one observation of the given laboratory test while on study treatment or during lag time.
The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of hematology test parameters were as follows: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils (absolute, Abs), eosinophils (Abs), monocytes (Abs), basophils (Abs), lymphocytes (Abs), prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT), and reticulocytes (% and Abs). Percentages are displayed for the laboratory tests having a category with greater or equal to 1 evaluable participant.
Outcome measures
| Measure |
Placebo (Induction)
n=25 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=51 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=49 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=50 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=48 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)
Leukocytes (10^3/mm^3) <0.6× LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)
Leukocytes (10^3/mm^3) >1.5× ULN
|
0 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)
Lymphocytes (Abs) (10^3/mm^3) <0.8× LLN
|
3 Participants
|
2 Participants
|
4 Participants
|
11 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)
Lymphocytes (Abs) (10^3/mm^3) >1.2× ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)
Neutrophils (Abs) (10^3/mm^3) <0.8× LLN
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)
Neutrophils (Abs) (10^3/mm^3) >1.2× ULN
|
7 Participants
|
13 Participants
|
7 Participants
|
9 Participants
|
7 Participants
|
7 Participants
|
11 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)
Basophils (Abs) (10^3/mm^3) >1.2× ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)
Eosinophils (Abs) (10^3/mm^3) >1.2x ULN
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)
Monocytes (Abs) (10^3/mm^3) >1.2× ULN
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)
Activated PTT (second) >1.1× ULN
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)
PT (second) >1.1× ULN
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)
Prothrombin INR >1.1× ULN
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)
Hemoglobin (g/dL) <0.8× lower limit of normal (LLN)
|
3 Participants
|
2 Participants
|
5 Participants
|
9 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)
Hematocrit (%) <0.8× LLN
|
2 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)
Erythrocytes (10^6/mm^3) <0.8× LLN
|
0 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)
Reticulocytes (Abs) (10^3/mm^3) <0.5× LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)
Reticulocytes (Abs) (10^3/mm^3) >1.5× upper limit of normal (ULN)
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)
Erythrocytes Mean Corpuscular Volume (10^-15L) <0.9× LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)
Erythrocytes Mean Corpuscular Volume (10^-15L) >1.1× ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)
Platelets (10^3/mm^3) <0.5× LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)
Platelets (10^3/mm^3) >1.75× ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)
Reticulocytes/Erythrocytes (%) <0.5× LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)
Reticulocytes/Erythrocytes (%) >1.5× ULN
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 up to Week 8Population: Number of Participants Analyzed: the participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Number Analyzed: the participants with at least one observation of the given laboratory test while on study treatment or during lag time.
The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of serum chemistry test parameters were as follows: blood urea nitrogen, creatinine, cystatin C, glucose, calcium, sodium, potassium, gamma glutamyl transferase, chloride, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, alkaline phosphatase, uric acid, albumin, total protein, creatine kinase (CK), total cholesterol, triglycerides, high-density lipoproteins (HDL), and low-density lipoprotein (LDL)
Outcome measures
| Measure |
Placebo (Induction)
n=25 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=51 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=49 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=50 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=48 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
Bilirubin (mg/dL) >1.5x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
Alkaline Phosphatase (U/L) >3.0x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
Protein (g/dL) <0.8x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
Direct Bilirubin (mg/dL) >1.5x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
Indirect Bilirubin (mg/dL) >1.5x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
AST (U/L) >3.0x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
ALT (U/L) >3.0x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
Gamma Glutamyl Transferase (U/L) >3.0x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
Protein (g/dL) >1.2x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
Albumin (g/dL) <0.8x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
Albumin (g/dL) >1.2x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
Urea Nitrogen (mg/dL) >1.3x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
Creatinine (mg/dL) >1.3x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
Urate (mg/dL) >1.2x ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
HDL Cholesterol (mg/dL) <0.8x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
LDL Cholesterol (mg/dL) >1.2x ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
Triglycerides (mg/dL) >1.3x ULN
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
Sodium(Meq/L) <0.95x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
Sodium(Meq/L) >1.05x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
Potassium (Meq/L) <0.9x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
Potassium (Meq/L) >1.1x ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
Chloride (Meq/L) <0.9x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
Chloride (Meq/L) >1.1x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
Calcium (mg/dL) <0.9x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
Calcium (mg/dL) >1.1x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
Glucose (mg/dL) <0.6x LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
Glucose (mg/dL) >1.5x ULN
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
Hemoglobin A1C (%) >1.3x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
CK (U/L) >2.0x ULN
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
Cholesterol (mg/dl) >1.3x ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 up to Week 8Population: Number of Participants Analyzed: the participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Number Analyzed: the participants with at least one observation of the given laboratory test while on study treatment or during lag time.
The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of urinalysis test parameters were as follows:pH, glucose (qual), protein (qual), blood (qual), ketones, nitrites, leukocyte esterase, microscopy, and spot urine albumin/creatinine ratio. The criteria of laboratory abnormality is defined as one of the following conditions was met: 1)associated with accompanying symptoms;2)Test result requires additional diagnostic testing or medical/surgical intervention;3)Test result leads to a change in study dosing (outside of any protocol specified dose adjustments) or discontinuation from the study, significant additional concomitant drug treatment, or other therapy;4)Test result is considered to be an AE by the investigator or sponsor.
Outcome measures
| Measure |
Placebo (Induction)
n=25 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=51 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=49 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=50 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=48 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period)
pH (scalar) <4.5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period)
pH (scalar) >8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period)
Urine glucose (no unit) ≥1
|
0 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period)
Ketones (no unit) ≥1
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
4 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period)
Urine protein(no unit) ≥1
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period)
Urine hemoglobin(no unit) ≥1
|
2 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
8 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period)
Nitrite (no unit) ≥1
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period)
Leukocyte esterase (no unit) ≥1
|
3 Participants
|
11 Participants
|
4 Participants
|
10 Participants
|
7 Participants
|
8 Participants
|
14 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period)
Urine erythrocytes (/HPF) ≥20
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period)
Urine leukocytes (/HPF) ≥20
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period)
Granular casts (/LPF) >1
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period)
Hyaline casts (/LPF) >1
|
3 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period)
WBC casts (/LPF) >1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period)
Bacteria (no unit) >20
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From screening to Week 8Population: Number of participants evaluated against the criteria during the induction period.
The vital signs data included the single sitting blood pressure, pulse rate and temperature. The criteria of vital sign abnormality are indicated below.
Outcome measures
| Measure |
Placebo (Induction)
n=25 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=48 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=48 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=49 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=46 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=45 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Vital Signs Data (Induction Period)
Sitting Systolic Blood Pressure Value <90 mmHg
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs Data (Induction Period)
Sitting Systolic Blood Pressure Change ≥30 mmHg Increase
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs Data (Induction Period)
Sitting Systolic Blood Pressure Change ≥30 mmHg Decrease
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs Data (Induction Period)
Sitting Diastolic Blood Pressure Value <50 mmHg
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs Data (Induction Period)
Sitting Diastolic Blood Pressure Change ≥20 mmHg Increase
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs Data (Induction Period)
Sitting Diastolic Blood Pressure Change ≥20 mmHg Decrease
|
0 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs Data (Induction Period)
Sitting Pulse Rate Value <40 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Vital Signs Data (Induction Period)
Sitting Pulse Rate Value >120 bpm
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From screening to Week 8Population: Number of Participants Analyzed: the participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Number Analyzed: the participants evaluated at the specified time point.
The number of participants with abnormal ECG findings during the induction period (from Day 1 to Week 8) are reported below. The criteria of test abnormality is defined as one of the following conditions was met: 1)associated with accompanying symptoms;2)Test result requires additional diagnostic testing or medical/surgical intervention;3)Test result leads to a change in study dosing (outside of any protocol specified dose adjustments) or discontinuation from the study, significant additional concomitant drug treatment, or other therapy;4)Test result is considered to be an AE by the investigator or sponsor.
Outcome measures
| Measure |
Placebo (Induction)
n=25 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=51 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=49 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=50 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=48 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period)
abnormal, not clinical significant (at screening)
|
2 Participants
|
8 Participants
|
6 Participants
|
4 Participants
|
9 Participants
|
10 Participants
|
8 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period)
abnormal, clinical significant (at screening)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period)
abnormal, not clinical significant (at Week 8)
|
2 Participants
|
7 Participants
|
8 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period)
abnormal, clinical significant (at Week 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 up to Week 8Population: The participants who received at least one dose of PF-06651600, PF-06700841, or placebo.
Serious infections was defined as any infection (for example, viral, bacterial, and fungal) requiring hospitalization or parenteral antimicrobials including Listeria encephalitis, Pneumonia, Viral infection.
Outcome measures
| Measure |
Placebo (Induction)
n=25 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=51 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=49 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=50 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=48 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Infections (Induction Period)
Listeria encephalitis
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Serious Infections (Induction Period)
Pneumonia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Serious Infections (Induction Period)
Viral infection
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: The ITT analysis set which included all randomized participants who received at least 1 dose of investigational product or placebo.
The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Clinical remission was defined as total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0.
Outcome measures
| Measure |
Placebo (Induction)
n=25 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=51 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=49 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=50 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=48 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 8 (Induction Period)
|
0 Percentage of participants
Interval 0.0 to 11.0
|
9.8 Percentage of participants
Interval 4.8 to 19.1
|
28.6 Percentage of participants
Interval 19.0 to 40.4
|
34.0 Percentage of participants
Interval 24.0 to 45.4
|
8.3 Percentage of participants
Interval 3.7 to 16.8
|
23.4 Percentage of participants
Interval 14.8 to 34.5
|
23.4 Percentage of participants
Interval 14.8 to 34.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: The ITT analysis set which included all randomized participants who received at least 1 dose of investigational product or placebo.
The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Improvement in endoscopic subscore appearance was defined at Mayo endoscopic subscore of ≤1.
Outcome measures
| Measure |
Placebo (Induction)
n=25 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=51 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=49 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=50 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=48 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Total Mayo Score at Week 8 (Induction Period)
|
0 Percentage of participants
Interval 0.0 to 11.0
|
21.6 Percentage of participants
Interval 13.5 to 33.1
|
34.7 Percentage of participants
Interval 24.4 to 46.4
|
42.0 Percentage of participants
Interval 30.3 to 54.6
|
20.8 Percentage of participants
Interval 11.8 to 31.5
|
31.9 Percentage of participants
Interval 20.8 to 44.4
|
29.8 Percentage of participants
Interval 19.9 to 42.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: The ITT analysis set which included all randomized participants who received at least 1 dose of investigational product or placebo.
The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Clinical response was defined as decrease from baseline in total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1.
Outcome measures
| Measure |
Placebo (Induction)
n=25 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=51 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=49 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=50 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=48 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Clinical Response Based on Total Mayo Score at Week 8 (Induction Period)
|
24.0 Percentage of participants
Interval 11.0 to 41.7
|
41.2 Percentage of participants
Interval 29.9 to 53.6
|
69.4 Percentage of participants
Interval 57.6 to 80.1
|
68.0 Percentage of participants
Interval 56.6 to 78.8
|
41.7 Percentage of participants
Interval 29.6 to 54.5
|
53.2 Percentage of participants
Interval 40.3 to 65.5
|
61.7 Percentage of participants
Interval 48.7 to 72.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: The ITT analysis set which included all randomized participants who received at least 1 dose of investigational product or placebo.
The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Endoscopic remission was defined as endoscopic subscore of 0.
Outcome measures
| Measure |
Placebo (Induction)
n=25 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=51 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=49 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=50 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=48 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Endoscopic Remission Based on Total Mayo Score at Week 8 (Induction Period)
|
0 Percentage of participants
Interval 0.0 to 11.0
|
3.9 Percentage of participants
Interval 1.0 to 11.0
|
8.2 Percentage of participants
Interval 3.6 to 16.5
|
12.0 Percentage of participants
Interval 5.4 to 21.2
|
2.1 Percentage of participants
Interval 0.2 to 8.6
|
17.0 Percentage of participants
Interval 8.8 to 28.3
|
8.5 Percentage of participants
Interval 3.8 to 17.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: The ITT analysis set which included all randomized participants who received at least 1 dose of investigational product or placebo.
The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Symptomatic remission was defined as total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and both rectal bleeding and stool frequency subscores of 0.
Outcome measures
| Measure |
Placebo (Induction)
n=25 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=51 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=49 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=50 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=48 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Symptomatic Remission Based on Total Mayo Score at Week 8 (Induction Period)
|
0 Percentage of participants
Interval 0.0 to 11.0
|
7.8 Percentage of participants
Interval 3.5 to 15.9
|
16.3 Percentage of participants
Interval 8.4 to 27.1
|
26.0 Percentage of participants
Interval 16.2 to 37.6
|
6.3 Percentage of participants
Interval 2.3 to 15.1
|
14.9 Percentage of participants
Interval 8.0 to 25.1
|
14.9 Percentage of participants
Interval 8.0 to 25.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: The ITT analysis set which included all randomized participants who received at least 1 dose of investigational product or placebo.
The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Deep remission was defined as total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a zero on both endoscopic and rectal bleeding subscore.
Outcome measures
| Measure |
Placebo (Induction)
n=25 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=51 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=49 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=50 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=48 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Deep Remission Based on Total Mayo Score at Week 8 (Induction Period)
|
0 Percentage of participants
Interval 0.0 to 11.0
|
3.9 Percentage of participants
Interval 1.0 to 11.0
|
8.2 Percentage of participants
Interval 3.6 to 16.5
|
12.0 Percentage of participants
Interval 5.4 to 21.2
|
0 Percentage of participants
Interval 0.0 to 5.6
|
14.9 Percentage of participants
Interval 8.0 to 25.1
|
6.4 Percentage of participants
Interval 2.4 to 15.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4 and 8Population: Number of Participants Analyzed: ITT analysis set which included all participants who were randomized to the study and received at least one dose of the randomized investigational drug. Number Analyzed: the participants in the ITT analysis set who had partial Mayo score at each specified time point.
The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. The partial Mayo score does not incorporate the endoscopy score and the partial Mayo score ranges from 0 to 9.
Outcome measures
| Measure |
Placebo (Induction)
n=25 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=51 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=49 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=50 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=48 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period)
Week 2
|
-0.66 Units on a scale
Standard Error 0.37
|
-1.65 Units on a scale
Standard Error 0.26
|
-2.56 Units on a scale
Standard Error 0.26
|
-3.19 Units on a scale
Standard Error 0.27
|
-1.6 Units on a scale
Standard Error 0.27
|
-1.64 Units on a scale
Standard Error 0.27
|
-2.45 Units on a scale
Standard Error 0.27
|
—
|
—
|
|
Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period)
Week 4
|
-1.64 Units on a scale
Standard Error 0.42
|
-2.24 Units on a scale
Standard Error 0.29
|
-3.29 Units on a scale
Standard Error 0.30
|
-4.24 Units on a scale
Standard Error 0.31
|
-2.31 Units on a scale
Standard Error 0.30
|
-2.06 Units on a scale
Standard Error 0.30
|
-2.95 Units on a scale
Standard Error 0.30
|
—
|
—
|
|
Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period)
Week 8
|
-1.15 Units on a scale
Standard Error 0.43
|
-2.54 Units on a scale
Standard Error 0.30
|
-4.06 Units on a scale
Standard Error 0.30
|
-4.69 Units on a scale
Standard Error 0.32
|
-2.51 Units on a scale
Standard Error 0.30
|
-2.71 Units on a scale
Standard Error 0.31
|
-3.47 Units on a scale
Standard Error 0.31
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: The intent-to-treat (ITT) analysis set which included all randomized participants who received at least 1 dose of investigational product or placebo.
The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity.
Outcome measures
| Measure |
Placebo (Induction)
n=25 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=51 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=49 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=50 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=48 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Total Mayo Score at Week 8 (Induction Period)
|
-1.14 Units on a scale
Interval -2.06 to -0.22
|
-3.17 Units on a scale
Interval -3.83 to -2.51
|
-5.02 Units on a scale
Interval -5.68 to -4.36
|
-5.74 Units on a scale
Interval -6.43 to -5.06
|
-2.93 Units on a scale
Interval -3.58 to -2.29
|
-3.42 Units on a scale
Interval -4.08 to -2.76
|
-4.35 Units on a scale
Interval -5.0 to -3.69
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4 and Week 8Population: Number of Participants Analyzed: ITT analysis set includes all participants who were randomized to the study and received at least one dose of the randomized investigational drug. Number Analyzed: the participants evaluated for IBDQ at each specified time point.
IBDQ is a psychometrically validated patient reported outcome (PRO) instrument for measuring the disease specific quality of life in participants with inflammatory bowel disease (IBD). The IBDQ is comprised of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35.; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better quality of life.
Outcome measures
| Measure |
Placebo (Induction)
n=25 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=51 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=49 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=50 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=48 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period)
Week 4(Systemic Systems Domain score)
|
20.87 Units on a scale
Interval 18.56 to 23.18
|
21.70 Units on a scale
Interval 20.34 to 23.05
|
23.74 Units on a scale
Interval 22.44 to 25.05
|
23.66 Units on a scale
Interval 22.08 to 25.23
|
20.70 Units on a scale
Interval 19.03 to 22.36
|
20.77 Units on a scale
Interval 19.24 to 22.3
|
23.61 Units on a scale
Interval 21.89 to 25.34
|
—
|
—
|
|
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period)
Week 8(Systemic Systems Domain score)
|
20.82 Units on a scale
Interval 19.11 to 22.53
|
21.85 Units on a scale
Interval 20.2 to 23.5
|
24.40 Units on a scale
Interval 22.91 to 25.89
|
25.51 Units on a scale
Interval 24.17 to 26.86
|
21.40 Units on a scale
Interval 19.56 to 23.24
|
23.07 Units on a scale
Interval 21.5 to 24.64
|
24.48 Units on a scale
Interval 22.72 to 26.24
|
—
|
—
|
|
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period)
Baseline (Social Function Domain score)
|
16.88 Units on a scale
Interval 14.41 to 19.35
|
17.25 Units on a scale
Interval 15.43 to 19.08
|
16.59 Units on a scale
Interval 14.7 to 18.48
|
17.31 Units on a scale
Interval 15.73 to 18.88
|
17.30 Units on a scale
Interval 15.69 to 18.91
|
14.91 Units on a scale
Interval 13.28 to 16.55
|
16.64 Units on a scale
Interval 15.06 to 18.22
|
—
|
—
|
|
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period)
Week 4 (Social Function Domain score)
|
22.57 Units on a scale
Interval 19.8 to 25.33
|
22.41 Units on a scale
Interval 20.57 to 24.25
|
26.21 Units on a scale
Interval 24.73 to 27.7
|
28.20 Units on a scale
Interval 26.42 to 29.99
|
22.83 Units on a scale
Interval 20.78 to 24.87
|
23.02 Units on a scale
Interval 20.82 to 25.23
|
24.86 Units on a scale
Interval 22.55 to 27.17
|
—
|
—
|
|
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period)
Week 8 (Social Function Domain score)
|
21.91 Units on a scale
Interval 19.27 to 24.55
|
23.45 Units on a scale
Interval 21.45 to 25.44
|
27.02 Units on a scale
Interval 25.06 to 28.99
|
29.80 Units on a scale
Interval 28.14 to 31.47
|
24.36 Units on a scale
Interval 22.11 to 26.6
|
25.12 Units on a scale
Interval 22.88 to 27.35
|
26.57 Units on a scale
Interval 24.5 to 28.63
|
—
|
—
|
|
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period)
Baseline (Bowel Systems Domain score)
|
35.80 Units on a scale
Interval 32.48 to 39.12
|
34.29 Units on a scale
Interval 31.74 to 36.85
|
33.71 Units on a scale
Interval 31.41 to 36.01
|
34.84 Units on a scale
Interval 32.66 to 37.01
|
34.17 Units on a scale
Interval 32.13 to 36.21
|
32.38 Units on a scale
Interval 29.99 to 34.77
|
33.38 Units on a scale
Interval 31.36 to 35.4
|
—
|
—
|
|
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period)
Week 4 (Bowel Systems Domain score)
|
44.87 Units on a scale
Interval 40.65 to 49.09
|
46.98 Units on a scale
Interval 44.05 to 49.91
|
51.00 Units on a scale
Interval 48.45 to 53.55
|
53.80 Units on a scale
Interval 50.83 to 56.76
|
44.93 Units on a scale
Interval 42.0 to 47.86
|
46.84 Units on a scale
Interval 43.56 to 50.12
|
50.64 Units on a scale
Interval 47.66 to 53.61
|
—
|
—
|
|
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period)
Week 8 (Bowel Systems Domain score)
|
44.68 Units on a scale
Interval 41.37 to 47.99
|
47.96 Units on a scale
Interval 44.68 to 51.23
|
54.27 Units on a scale
Interval 51.38 to 57.16
|
55.95 Units on a scale
Interval 53.4 to 58.5
|
46.87 Units on a scale
Interval 43.46 to 50.27
|
50.12 Units on a scale
Interval 47.12 to 53.11
|
53.45 Units on a scale
Interval 50.53 to 56.38
|
—
|
—
|
|
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period)
Baseline (Emotion Health Domain score)
|
43.76 Units on a scale
Interval 38.81 to 48.71
|
42.76 Units on a scale
Interval 39.37 to 46.16
|
42.90 Units on a scale
Interval 39.56 to 46.24
|
41.39 Units on a scale
Interval 37.88 to 44.9
|
42.40 Units on a scale
Interval 39.15 to 45.65
|
38.74 Units on a scale
Interval 35.59 to 41.9
|
41.43 Units on a scale
Interval 38.56 to 44.29
|
—
|
—
|
|
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period)
Week 4(Emotion Health Domain score)
|
54.74 Units on a scale
Interval 49.67 to 59.81
|
53.65 Units on a scale
Interval 49.92 to 57.39
|
59.89 Units on a scale
Interval 56.83 to 62.96
|
61.11 Units on a scale
Interval 57.54 to 64.68
|
52.43 Units on a scale
Interval 48.26 to 56.61
|
52.77 Units on a scale
Interval 48.99 to 56.55
|
57.86 Units on a scale
Interval 54.06 to 61.67
|
—
|
—
|
|
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period)
Week 8(Emotion Health Domain score)
|
52.50 Units on a scale
Interval 47.61 to 57.39
|
54.23 Units on a scale
Interval 50.29 to 58.17
|
62.73 Units on a scale
Interval 59.3 to 66.17
|
63.12 Units on a scale
Interval 59.28 to 66.96
|
54.44 Units on a scale
Interval 50.02 to 58.87
|
56.86 Units on a scale
Interval 53.34 to 60.38
|
60.89 Units on a scale
Interval 57.09 to 64.69
|
—
|
—
|
|
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period)
Baseline (Systemic Systems Domain score)
|
16.56 Units on a scale
Interval 14.83 to 18.29
|
16.12 Units on a scale
Interval 14.74 to 17.5
|
15.98 Units on a scale
Interval 14.67 to 17.29
|
15.41 Units on a scale
Interval 14.14 to 16.68
|
16.30 Units on a scale
Interval 14.93 to 17.67
|
15.21 Units on a scale
Interval 14.06 to 16.36
|
16.72 Units on a scale
Interval 15.4 to 18.05
|
—
|
—
|
|
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period)
Week 4 (Total IBDQ score)
|
143.04 Units on a scale
Interval 129.9 to 156.19
|
144.74 Units on a scale
Interval 135.6 to 153.88
|
160.85 Units on a scale
Interval 153.5 to 168.2
|
166.77 Units on a scale
Interval 157.55 to 176.0
|
140.89 Units on a scale
Interval 130.88 to 150.9
|
143.41 Units on a scale
Interval 133.62 to 153.2
|
156.98 Units on a scale
Interval 146.69 to 167.27
|
—
|
—
|
|
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period)
Baseline (Total IBDQ score)
|
113.00 Units on a scale
Interval 101.49 to 124.51
|
110.43 Units on a scale
Interval 101.85 to 119.01
|
109.18 Units on a scale
Interval 101.3 to 117.07
|
108.94 Units on a scale
Interval 101.2 to 116.68
|
110.17 Units on a scale
Interval 102.94 to 117.4
|
101.26 Units on a scale
Interval 93.85 to 108.66
|
108.17 Units on a scale
Interval 101.13 to 115.21
|
—
|
—
|
|
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period)
Week 8 (Total IBDQ score)
|
139.91 Units on a scale
Interval 128.72 to 151.1
|
147.49 Units on a scale
Interval 137.17 to 157.8
|
168.42 Units on a scale
Interval 159.53 to 177.31
|
174.39 Units on a scale
Interval 165.67 to 183.11
|
147.07 Units on a scale
Interval 135.79 to 158.35
|
155.16 Units on a scale
Interval 145.67 to 164.65
|
165.39 Units on a scale
Interval 155.29 to 175.49
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4 and 8Population: Number of Participants Analyzed: ITT analysis set includes all participants who were randomized to the study and received at least one dose of the randomized investigational drug. Number Analyzed: The participants with non-missing data in the intent-to-treat analysis set at each specified visit.
IBDQ is a psychometrically validated PRO instrument for measuring the disease specific quality of life in participants with IBD. The IBDQ is comprised of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35.; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better quality of life. Baseline value is defined as the last non-missing measurement collected prior to or on Day 1.
Outcome measures
| Measure |
Placebo (Induction)
n=25 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=51 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=49 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=50 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=48 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in IBDQ Total Score at Weeks 4 and 8 (Induction Period)
Week 4
|
30.30 Units on a scale
Standard Error 6.51
|
33.71 Units on a scale
Standard Error 4.60
|
51.12 Units on a scale
Standard Error 4.61
|
57.01 Units on a scale
Standard Error 4.78
|
28.45 Units on a scale
Standard Error 4.68
|
37.94 Units on a scale
Standard Error 4.72
|
49.79 Units on a scale
Standard Error 4.73
|
—
|
—
|
|
Change From Baseline in IBDQ Total Score at Weeks 4 and 8 (Induction Period)
Week 8
|
24.23 Units on a scale
Standard Error 7.40
|
37.91 Units on a scale
Standard Error 5.15
|
59.20 Units on a scale
Standard Error 5.23
|
62.17 Units on a scale
Standard Error 5.47
|
36.60 Units on a scale
Standard Error 5.29
|
48.81 Units on a scale
Standard Error 5.33
|
56.39 Units on a scale
Standard Error 5.33
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4 and Week 8Population: Number of Participants Analyzed: ITT analysis set includes all participants who were randomized to the study and received at least one dose of the randomized investigational drug. Number Analyzed: ITT analysis set which included all participants who were randomized to the study and received at least one dose of the randomized investigational drug, with non-responder imputation of missing data (treating the missing data as non-responders).
IBDQ is a psychometrically validated PRO instrument for measuring the disease specific quality of life in participants with IBD. The IBDQ is comprised of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35.; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better quality of life.
Outcome measures
| Measure |
Placebo (Induction)
n=25 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=51 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=49 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=50 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=48 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With IBDQ Total Score Greater Than or Equal to 170 at Weeks 4 and 8 (Induction Period)
Week 4
|
24.0 Percentage of participants
Interval 11.0 to 41.7
|
21.6 Percentage of participants
Interval 13.5 to 33.1
|
40.8 Percentage of participants
Interval 28.9 to 53.6
|
46.0 Percentage of participants
Interval 34.2 to 58.5
|
27.1 Percentage of participants
Interval 16.8 to 39.4
|
27.7 Percentage of participants
Interval 17.2 to 40.3
|
38.3 Percentage of participants
Interval 27.1 to 51.3
|
—
|
—
|
|
Percentage of Participants With IBDQ Total Score Greater Than or Equal to 170 at Weeks 4 and 8 (Induction Period)
Week 8
|
20.0 Percentage of participants
Interval 10.1 to 36.2
|
29.4 Percentage of participants
Interval 19.1 to 40.6
|
57.1 Percentage of participants
Interval 44.4 to 69.2
|
44.0 Percentage of participants
Interval 33.0 to 56.6
|
31.3 Percentage of participants
Interval 20.4 to 43.4
|
40.4 Percentage of participants
Interval 28.3 to 53.5
|
51.1 Percentage of participants
Interval 38.9 to 62.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and 8Population: Number of Participants Analyzed: ITT analysis set includes all participants who were randomized to the study and received at least one dose of the randomized investigational drug. Number Analyzed: ITT analysis set which included all participants who were randomized to the study and received at least one dose of the randomized investigational drug, with non-responder imputation of missing data (treating the missing data as non-responders).
IBDQ is a psychometrically validated PRO instrument for measuring the disease specific quality of life in participants with IBD. The IBDQ is comprised of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35.; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better quality of life.
Outcome measures
| Measure |
Placebo (Induction)
n=25 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=51 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=49 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=50 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=48 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Greater Than or Equal to 16 Points Increase in IBDQ Total Score From Baseline at Weeks 4 and 8 (Induction Period)
Week 4
|
48.0 Percentage of participants
Interval 30.7 to 64.0
|
60.8 Percentage of participants
Interval 48.4 to 72.3
|
83.7 Percentage of participants
Interval 72.9 to 91.6
|
80.0 Percentage of participants
Interval 69.7 to 88.7
|
64.6 Percentage of participants
Interval 52.5 to 75.3
|
78.7 Percentage of participants
Interval 67.8 to 88.0
|
72.3 Percentage of participants
Interval 59.7 to 82.8
|
—
|
—
|
|
Percentage of Participants With Greater Than or Equal to 16 Points Increase in IBDQ Total Score From Baseline at Weeks 4 and 8 (Induction Period)
Week 8
|
56.0 Percentage of participants
Interval 38.9 to 73.0
|
54.9 Percentage of participants
Interval 42.5 to 66.9
|
79.6 Percentage of participants
Interval 69.2 to 88.5
|
70.0 Percentage of participants
Interval 58.5 to 80.5
|
62.5 Percentage of participants
Interval 50.0 to 73.6
|
80.9 Percentage of participants
Interval 69.7 to 88.8
|
78.7 Percentage of participants
Interval 67.8 to 88.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4 and Week 8Population: Number of Participants Analyzed: ITT analysis set includes all participants who were randomized to the study and received at least one dose of the randomized investigational drug. Number Analyzed: ITT analysis set which included all participants who were randomized to the study and received at least one dose of the randomized investigational drug, with non-responder imputation of missing data (treating the missing data as non-responders).
IBDQ is a psychometrically validated PRO instrument for measuring the disease specific quality of life in participants with IBD. The IBDQ is comprised of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35.; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better quality of life. The improvement in IBDQ bowel symptom domain was defined as an increase of ≥1.2 points from baseline in average score among bowel symptoms domain (items 1, 5, 9, 13, 17, 20, 22, 24, 26, 29).
Outcome measures
| Measure |
Placebo (Induction)
n=25 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=51 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=49 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=50 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=48 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Improvement in IBDQ Bowel Symptom Domain at Weeks 4 and 8 (Induction Period)
Week 4
|
20.0 Percentage of participants
Interval 10.1 to 36.2
|
51.0 Percentage of participants
Interval 38.7 to 63.2
|
65.3 Percentage of participants
Interval 53.6 to 75.6
|
64.0 Percentage of participants
Interval 42.6 to 75.1
|
37.5 Percentage of participants
Interval 26.4 to 50.0
|
53.2 Percentage of participants
Interval 40.3 to 65.5
|
57.5 Percentage of participants
Interval 44.4 to 69.7
|
—
|
—
|
|
Percentage of Participants With Improvement in IBDQ Bowel Symptom Domain at Weeks 4 and 8 (Induction Period)
Week 8
|
24.0 Percentage of participants
Interval 11.0 to 41.7
|
47.1 Percentage of participants
Interval 35.0 to 59.4
|
69.4 Percentage of participants
Interval 57.6 to 80.1
|
62.0 Percentage of participants
Interval 50.0 to 73.5
|
50.0 Percentage of participants
Interval 37.6 to 62.4
|
63.8 Percentage of participants
Interval 51.3 to 74.9
|
66.0 Percentage of participants
Interval 53.5 to 77.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4 and Week 8Population: Number of Participants Analyzed: ITT analysis set includes all participants who were randomized to the study and received at least one dose of the randomized investigational drug. Number Analyzed: Number of participants with non-missing data in the ITT analysis set at each specified visit.
The SF-36 version 2 (Acute version) is a 36-item generic health status measure. It measures 8 general health concepts or domains: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH). These 8 domains can also be summarized as physical and mental component scores. The summary component scores, Physical Component Summary (PCS) and Mental Component Summary (MCS), are based on a normalized sum of the 8 scale scores PF, RP, BP, GH, VT, SF, RE, and MH . All domains and summary components are scored such that a higher score indicates a higher functioning or health level. The minimum and maximum scores of the PCS Score are 6.1 and 79.7, respectively. The minimum and maximum scores of the MCS Score are -3.8 and 78.7, respectively.
Outcome measures
| Measure |
Placebo (Induction)
n=25 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=51 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=49 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=50 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=48 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period)
Week 4 (PCS)
|
4.69 Units on a scale
Interval 2.59 to 6.8
|
5.90 Units on a scale
Interval 4.41 to 7.39
|
6.36 Units on a scale
Interval 4.88 to 7.85
|
9.21 Units on a scale
Interval 7.67 to 10.76
|
5.67 Units on a scale
Interval 4.16 to 7.19
|
5.85 Units on a scale
Interval 4.31 to 7.38
|
6.40 Units on a scale
Interval 4.87 to 7.93
|
—
|
—
|
|
Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period)
Week 8 (PCS)
|
5.37 Units on a scale
Interval 2.96 to 7.77
|
5.85 Units on a scale
Interval 4.19 to 7.52
|
8.66 Units on a scale
Interval 6.97 to 10.35
|
10.86 Units on a scale
Interval 9.08 to 12.64
|
6.29 Units on a scale
Interval 4.57 to 8.02
|
8.21 Units on a scale
Interval 6.47 to 9.95
|
8.55 Units on a scale
Interval 6.83 to 10.27
|
—
|
—
|
|
Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period)
Week 4(MCS)
|
7.83 Units on a scale
Interval 4.59 to 11.06
|
4.95 Units on a scale
Interval 2.67 to 7.23
|
7.79 Units on a scale
Interval 5.5 to 10.07
|
8.81 Units on a scale
Interval 6.43 to 11.18
|
2.44 Units on a scale
Interval 0.13 to 4.74
|
7.46 Units on a scale
Interval 5.11 to 9.82
|
9.28 Units on a scale
Interval 6.93 to 11.62
|
—
|
—
|
|
Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period)
Week 8(MCS)
|
4.24 Units on a scale
Interval 0.69 to 7.78
|
5.18 Units on a scale
Interval 2.72 to 7.64
|
9.72 Units on a scale
Interval 7.22 to 12.22
|
9.41 Units on a scale
Interval 6.79 to 12.03
|
5.22 Units on a scale
Interval 2.7 to 7.75
|
8.04 Units on a scale
Interval 5.48 to 10.61
|
10.01 Units on a scale
Interval 7.47 to 12.55
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 4 and Week 8Population: Number of Participants Analyzed: ITT analysis set includes all participants who were randomized to the study and received at least one dose of the randomized investigational drug. Number Analyzed: Number of participants with non-missing data in the ITT analysis set at each specified visit.
For EQ-5D 3L, participant rated questionnaire to assess generic health status in two parts: single utility score and visual analog scale. For utility score, participants rated their current health state on 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score was transformed and results in a total score range of 0.05 to 1.00; higher scores indicating a better health state. The EQ-5D VAS records the respondent's self rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
Outcome measures
| Measure |
Placebo (Induction)
n=25 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=51 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=49 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=50 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=48 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=47 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period)
EQ-5D 3L Utility Score (Week 4)
|
0.11 Units on a scale
Interval 0.06 to 0.16
|
0.07 Units on a scale
Interval 0.04 to 0.11
|
0.12 Units on a scale
Interval 0.09 to 0.15
|
0.13 Units on a scale
Interval 0.1 to 0.17
|
0.07 Units on a scale
Interval 0.03 to 0.1
|
0.11 Units on a scale
Interval 0.08 to 0.14
|
0.12 Units on a scale
Interval 0.09 to 0.15
|
—
|
—
|
|
Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period)
EQ-5D 3L Utility Score (Week 8)
|
0.08 Units on a scale
Interval 0.03 to 0.13
|
0.08 Units on a scale
Interval 0.05 to 0.12
|
0.15 Units on a scale
Interval 0.11 to 0.18
|
0.15 Units on a scale
Interval 0.12 to 0.19
|
0.09 Units on a scale
Interval 0.05 to 0.13
|
0.13 Units on a scale
Interval 0.1 to 0.17
|
0.14 Units on a scale
Interval 0.11 to 0.18
|
—
|
—
|
|
Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period)
EQ-5D VAS Score (Week 4)
|
8.41 Units on a scale
Interval 2.18 to 14.63
|
13.60 Units on a scale
Interval 9.2 to 18.0
|
16.35 Units on a scale
Interval 11.96 to 20.74
|
17.45 Units on a scale
Interval 12.88 to 22.02
|
10.48 Units on a scale
Interval 6.04 to 14.92
|
12.24 Units on a scale
Interval 7.72 to 16.77
|
14.44 Units on a scale
Interval 9.9 to 18.97
|
—
|
—
|
|
Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period)
EQ-5D VAS Score (Week 8)
|
13.17 Units on a scale
Interval 6.48 to 19.85
|
13.11 Units on a scale
Interval 8.48 to 17.74
|
18.88 Units on a scale
Interval 14.17 to 23.6
|
22.54 Units on a scale
Interval 17.6 to 27.49
|
10.35 Units on a scale
Interval 5.58 to 15.12
|
17.11 Units on a scale
Interval 12.28 to 21.94
|
20.01 Units on a scale
Interval 15.21 to 24.81
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 32Population: The participants with non-missing data at Week 32 in the modified intent-to-treat (MITT) analysis set which included all participants who were randomized to the study and received at least one dose of the randomized investigational drug, but were not randomized to placebo treatment during chronic period.
The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity.
Outcome measures
| Measure |
Placebo (Induction)
n=10 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=39 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=36 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=35 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=9 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=39 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=38 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
n=37 Participants
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Total Mayo Score at Week 32 (Chronic Period)
|
4.13 Units on a scale
Interval 2.82 to 5.44
|
3.47 Units on a scale
Interval 2.75 to 4.19
|
3.46 Units on a scale
Interval 2.77 to 4.16
|
2.89 Units on a scale
Interval 2.18 to 3.6
|
4.62 Units on a scale
Interval 2.62 to 6.61
|
3.81 Units on a scale
Interval 2.94 to 4.68
|
3.63 Units on a scale
Interval 2.67 to 4.59
|
3.86 Units on a scale
Interval 2.98 to 4.75
|
—
|
SECONDARY outcome
Timeframe: Week 32Population: MITT analysis set that included all participants who were randomized to the study and received at least one dose of the randomized investigational drug, but were not randomized to placebo treatment during chronic period, with treating the missing data as non-responders.
The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Clinical remission was defined as total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0.
Outcome measures
| Measure |
Placebo (Induction)
n=12 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=46 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=42 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=44 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=11 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=42 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=41 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
n=41 Participants
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 32 (Chronic Period)
|
16.7 Percentage of participants
Interval 4.5 to 39.8
|
23.9 Percentage of participants
Interval 15.1 to 35.0
|
28.6 Percentage of participants
Interval 17.4 to 41.0
|
34.1 Percentage of participants
Interval 22.3 to 46.5
|
18.2 Percentage of participants
Interval 4.9 to 43.6
|
21.4 Percentage of participants
Interval 12.6 to 34.2
|
26.8 Percentage of participants
Interval 17.1 to 39.8
|
26.8 Percentage of participants
Interval 17.1 to 39.8
|
—
|
SECONDARY outcome
Timeframe: Week 32Population: MITT analysis set that included all participants who were randomized to the study and received at least one dose of the randomized investigational drug, but were not randomized to placebo treatment during chronic period, with treating the missing data as non-responders.
The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Improvement in endoscopic appearance was defined at Mayo endoscopic subscore of ≤1.
Outcome measures
| Measure |
Placebo (Induction)
n=12 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=46 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=42 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=44 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=11 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=42 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=41 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
n=41 Participants
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Mayo Score at Week 32 (Chronic Period)
|
33.3 Percentage of participants
Interval 15.4 to 60.2
|
26.1 Percentage of participants
Interval 15.8 to 37.7
|
40.5 Percentage of participants
Interval 27.7 to 54.3
|
34.1 Percentage of participants
Interval 22.3 to 46.5
|
18.2 Percentage of participants
Interval 4.9 to 43.6
|
31.0 Percentage of participants
Interval 19.4 to 43.3
|
34.1 Percentage of participants
Interval 23.0 to 46.9
|
36.6 Percentage of participants
Interval 24.6 to 50.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 32Population: The participants with non-missing data in the MITT analysis set at Week 32. MITT analysis set that included all participants who were randomized to the study and received at least one dose of the randomized investigational drug, but were not randomized to placebo treatment during chronic period.
The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity.
Outcome measures
| Measure |
Placebo (Induction)
n=10 Participants
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=39 Participants
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=36 Participants
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=35 Participants
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=9 Participants
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=39 Participants
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=38 Participants
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
Placebo -> PF-06700841 30 mg
n=37 Participants
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
The placebo was administered orally from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Total Mayo Score at Week 32 (Chronic Period)
|
-4.88 Units on a scale
Interval -6.19 to -3.57
|
-5.54 Units on a scale
Interval -6.26 to -4.82
|
-5.55 Units on a scale
Interval -6.24 to -4.85
|
-6.12 Units on a scale
Interval -6.83 to -5.41
|
-4.45 Units on a scale
Interval -6.45 to -2.45
|
-5.26 Units on a scale
Interval -6.12 to -4.39
|
-5.21 Units on a scale
Interval -6.09 to -4.32
|
-5.44 Units on a scale
Interval -6.39 to -4.48
|
—
|
Adverse Events
Placebo (Induction)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
PF-06651600 20 mg (Induction)
Serious events: 3 serious events
Other events: 8 other events
Deaths: 1 deaths
PF-06651600 70 mg (Induction)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
PF-06651600 200 mg (Induction)
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-06700841 10 mg (Induction)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-06700841 30 mg (Induction)
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
PF-06700841 60 mg (Induction)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
PF-06651600 200 mg -> PF-06651600 50 mg
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
PF-06651600 70 mg -> PF-06651600 50 mg
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
PF-06651600 20 mg -> PF-06651600 50 mg
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo -> PF-06651600 50 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
PF-06700841 60 mg -> PF-06700841 30 mg
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
PF-06700841 30 mg -> PF-06700841 30 mg
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
PF-06700841 10 mg -> PF-06700841 30 mg
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo -> PF-06700841 30 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Pooling Placebo During Chronic
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Induction)
n=25 participants at risk
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=51 participants at risk
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=49 participants at risk
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=50 participants at risk
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=48 participants at risk
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=47 participants at risk
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=47 participants at risk
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg -> PF-06651600 50 mg
n=35 participants at risk
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
|
PF-06651600 70 mg -> PF-06651600 50 mg
n=36 participants at risk
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
|
PF-06651600 20 mg -> PF-06651600 50 mg
n=39 participants at risk
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
|
Placebo -> PF-06651600 50 mg
n=10 participants at risk
The placebo was administered orally QD from Day 1 to Week 8 and PF-06651600 was administered at 50 mg QD from Week 9 to Week 32.
|
PF-06700841 60 mg -> PF-06700841 30 mg
n=38 participants at risk
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
|
PF-06700841 30 mg -> PF-06700841 30 mg
n=37 participants at risk
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
|
PF-06700841 10 mg -> PF-06700841 30 mg
n=39 participants at risk
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
|
Placebo -> PF-06700841 30 mg
n=9 participants at risk
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
n=37 participants at risk
The placebo was administered orally QD from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.1%
1/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.0%
1/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.7%
1/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.0%
1/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.0%
1/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.1%
1/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.8%
1/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.4%
2/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.7%
1/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
General disorders
Pyrexia
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.1%
1/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Infections and infestations
Listeria encephalitis
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.0%
1/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.0%
1/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Infections and infestations
Viral infection
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.0%
1/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.0%
1/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.9%
1/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.9%
1/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Surgical and medical procedures
Haemorrhoid operation
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.1%
1/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.9%
1/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.1%
1/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
Other adverse events
| Measure |
Placebo (Induction)
n=25 participants at risk
The placebo was administered orally once daily (QD) from Day 1 to Week 8.
|
PF-06651600 20 mg (Induction)
n=51 participants at risk
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8.
|
PF-06651600 70 mg (Induction)
n=49 participants at risk
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg (Induction)
n=50 participants at risk
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8.
|
PF-06700841 10 mg (Induction)
n=48 participants at risk
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8.
|
PF-06700841 30 mg (Induction)
n=47 participants at risk
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8.
|
PF-06700841 60 mg (Induction)
n=47 participants at risk
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8.
|
PF-06651600 200 mg -> PF-06651600 50 mg
n=35 participants at risk
PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
|
PF-06651600 70 mg -> PF-06651600 50 mg
n=36 participants at risk
PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
|
PF-06651600 20 mg -> PF-06651600 50 mg
n=39 participants at risk
PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8 and at 50 mg QD from Week 9 to Week 32.
|
Placebo -> PF-06651600 50 mg
n=10 participants at risk
The placebo was administered orally QD from Day 1 to Week 8 and PF-06651600 was administered at 50 mg QD from Week 9 to Week 32.
|
PF-06700841 60 mg -> PF-06700841 30 mg
n=38 participants at risk
PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
|
PF-06700841 30 mg -> PF-06700841 30 mg
n=37 participants at risk
PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
|
PF-06700841 10 mg -> PF-06700841 30 mg
n=39 participants at risk
PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8 and at 30 mg QD from Week 9 to Week 32.
|
Placebo -> PF-06700841 30 mg
n=9 participants at risk
The placebo was administered orally from Day 1 to Week 8 and PF-06700841 was administered orally at 30 mg QD from Week 9 to Week 32.
|
Pooling Placebo During Chronic
n=37 participants at risk
The placebo was administered orally QD from Week 9 to Week 32 regardless of what was administered from Day 1 to Week 8.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
10.0%
1/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.0%
1/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.0%
1/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
4.1%
2/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
8.0%
4/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.1%
1/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.1%
1/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
8.5%
4/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.9%
1/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
10.0%
1/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.1%
2/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
11.1%
1/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.4%
2/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.0%
2/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.0%
1/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.0%
1/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
4.3%
2/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
4.3%
2/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.8%
1/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.7%
1/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.1%
2/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.7%
1/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
3.9%
2/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.0%
1/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
10.6%
5/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
6.4%
3/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.9%
1/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.8%
1/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
10.5%
4/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
13.5%
5/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.1%
2/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
11.1%
1/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
10.8%
4/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
3.9%
2/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.0%
1/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.1%
1/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
6.4%
3/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.1%
1/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.7%
2/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.8%
1/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
10.0%
1/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.3%
2/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.7%
1/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
10.3%
4/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.7%
1/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Nervous system disorders
Headache
|
8.0%
2/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.9%
3/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
6.1%
3/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.1%
1/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
8.5%
4/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
20.0%
2/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.7%
1/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.1%
2/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.7%
1/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
20.0%
2/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Eye disorders
Visual impairment
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
10.0%
1/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.6%
2/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
11.4%
4/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
13.9%
5/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
10.3%
4/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
30.0%
3/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.3%
2/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.4%
2/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
15.4%
6/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
11.1%
1/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
21.6%
8/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.9%
1/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.6%
2/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
20.0%
2/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.4%
2/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.8%
1/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
10.0%
1/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.4%
2/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.8%
1/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.1%
2/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
General disorders
Feeling hot
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
10.0%
1/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
General disorders
Influenza like illness
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.6%
2/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
General disorders
Oedema peripheral
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
10.0%
1/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.7%
1/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
General disorders
Pyrexia
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.9%
1/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.6%
2/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
10.0%
1/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.1%
2/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
11.1%
1/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.7%
1/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
General disorders
Swelling face
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.9%
1/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
10.0%
1/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Infections and infestations
COVID-19
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.8%
1/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.1%
2/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.1%
2/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
10.0%
1/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
8.3%
3/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Infections and infestations
Influenza
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.1%
2/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.7%
1/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.7%
1/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
10.0%
1/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.3%
2/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.4%
2/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.8%
1/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
8.1%
3/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
7.7%
3/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Investigations
Blood urine present
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.1%
2/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Investigations
Protein urine present
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.1%
2/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.8%
1/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
10.0%
1/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
10.0%
1/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
20.0%
2/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.8%
1/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
10.0%
1/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
11.1%
1/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.8%
1/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
11.1%
1/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
11.1%
1/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.3%
2/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
11.1%
1/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.9%
1/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
10.0%
1/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.3%
2/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.9%
1/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.8%
1/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
10.0%
1/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.7%
1/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
10.0%
1/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.9%
1/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.6%
1/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
10.0%
1/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
|
Vascular disorders
Hypertension
|
0.00%
0/25 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/51 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/49 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/50 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/48 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/47 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/35 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
11.1%
4/36 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
20.0%
2/10 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/38 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
2.7%
1/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
5.1%
2/39 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/9 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
0.00%
0/37 • From the time the participants took at least 1 dose of study treatment up to 28 days after the last treatment administration. (approximately 36 Weeks)
The analysis of AEs included all participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Totals number of participants at a higher level were not necessarily the sum of those at the lower levels since a participant may report two or more different AEs within the higher level category.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER