Trial Outcomes & Findings for A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus (NCT NCT03985293)
NCT ID: NCT03985293
Last Updated: 2022-06-30
Results Overview
HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
412 participants
Primary outcome timeframe
Baseline, Week 16
Results posted on
2022-06-30
Participant Flow
A total of 859 participants were screened in the study, among whom, 412 participants were randomized, and 411 participants were treated with PF-06882961 (Danuglipron)/placebo; 1 participant randomized to the PF-06882961 120 mg BID group was not treated.
Participant milestones
| Measure |
Placebo
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5mg BID
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10mg BID
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40mg BID
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80mg BID
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120mg BID
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
|---|---|---|---|---|---|---|
|
DOUBLE-BLIND TREATMENT
STARTED
|
66
|
68
|
68
|
71
|
67
|
71
|
|
DOUBLE-BLIND TREATMENT
COMPLETED
|
57
|
54
|
63
|
57
|
47
|
38
|
|
DOUBLE-BLIND TREATMENT
NOT COMPLETED
|
9
|
14
|
5
|
14
|
20
|
33
|
|
FOLLOW-UP
STARTED
|
57
|
54
|
63
|
57
|
47
|
38
|
|
FOLLOW-UP
COMPLETED
|
57
|
54
|
62
|
57
|
47
|
38
|
|
FOLLOW-UP
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5mg BID
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10mg BID
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40mg BID
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80mg BID
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120mg BID
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
|---|---|---|---|---|---|---|
|
DOUBLE-BLIND TREATMENT
Adverse Event
|
5
|
2
|
3
|
8
|
15
|
24
|
|
DOUBLE-BLIND TREATMENT
Lost to Follow-up
|
1
|
3
|
0
|
3
|
3
|
1
|
|
DOUBLE-BLIND TREATMENT
No Longer Meets Eligibility Criteria
|
1
|
1
|
0
|
1
|
0
|
0
|
|
DOUBLE-BLIND TREATMENT
Other
|
1
|
2
|
0
|
2
|
1
|
0
|
|
DOUBLE-BLIND TREATMENT
Protocol Violation
|
1
|
2
|
0
|
0
|
0
|
1
|
|
DOUBLE-BLIND TREATMENT
Withdrawal by Subject
|
0
|
4
|
2
|
0
|
1
|
7
|
|
FOLLOW-UP
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Placebo
n=66 Participants
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5mg BID
n=68 Participants
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10mg BID
n=68 Participants
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40mg BID
n=71 Participants
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80mg BID
n=67 Participants
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120mg BID
n=71 Participants
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
Total
n=411 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
Mean (SD)
|
57.9 Years
STANDARD_DEVIATION 10.27 • n=5 Participants
|
58.9 Years
STANDARD_DEVIATION 9.30 • n=7 Participants
|
58.1 Years
STANDARD_DEVIATION 9.43 • n=5 Participants
|
59.6 Years
STANDARD_DEVIATION 8.58 • n=4 Participants
|
58.4 Years
STANDARD_DEVIATION 9.18 • n=21 Participants
|
58.8 Years
STANDARD_DEVIATION 9.43 • n=10 Participants
|
58.6 Years
STANDARD_DEVIATION 9.33 • n=115 Participants
|
|
Age, Customized
18-44 Years
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
32 Participants
n=115 Participants
|
|
Age, Customized
45-64 Years
|
44 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
44 Participants
n=10 Participants
|
259 Participants
n=115 Participants
|
|
Age, Customized
>=65 Years
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
120 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
37 Participants
n=10 Participants
|
202 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
34 Participants
n=10 Participants
|
209 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
128 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
52 Participants
n=10 Participants
|
281 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White
|
57 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
59 Participants
n=10 Participants
|
343 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
27 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
35 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Age Range
|
59.0 Years
n=5 Participants
|
59.0 Years
n=7 Participants
|
60.0 Years
n=5 Participants
|
61.0 Years
n=4 Participants
|
58.0 Years
n=21 Participants
|
60.0 Years
n=10 Participants
|
59.0 Years
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.
Outcome measures
| Measure |
Placebo
n=52 Participants
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5 BID
n=52 Participants
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10 mg BID
n=61 Participants
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40 mg BID
n=55 Participants
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80 mg BID
n=46 Participants
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120 mg BID
n=38 Participants
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16
|
-0.02 Percent
Interval -0.22 to 0.19
|
-0.49 Percent
Interval -0.7 to -0.28
|
-0.91 Percent
Interval -1.11 to -0.72
|
-1.03 Percent
Interval -1.23 to -0.83
|
-0.96 Percent
Interval -1.18 to -0.74
|
-1.18 Percent
Interval -1.41 to -0.95
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.
Outcome measures
| Measure |
Placebo
n=52 Participants
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5 BID
n=52 Participants
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10 mg BID
n=61 Participants
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40 mg BID
n=55 Participants
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80 mg BID
n=46 Participants
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120 mg BID
n=38 Participants
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Less Than (<) 7% Glycated Hemoglobin (HbA1c) Levels
|
7.7 Percentage of Participants
|
30.8 Percentage of Participants
|
54.1 Percentage of Participants
|
58.2 Percentage of Participants
|
65.2 Percentage of Participants
|
60.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.
Outcome measures
| Measure |
Placebo
n=65 Participants
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5 BID
n=64 Participants
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10 mg BID
n=67 Participants
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40 mg BID
n=67 Participants
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80 mg BID
n=63 Participants
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120 mg BID
n=69 Participants
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 2
|
-0.09 Percent
Interval -0.17 to -0.01
|
-0.18 Percent
Interval -0.26 to -0.09
|
-0.31 Percent
Interval -0.39 to -0.23
|
-0.29 Percent
Interval -0.37 to -0.21
|
-0.33 Percent
Interval -0.41 to -0.24
|
-0.35 Percent
Interval -0.43 to -0.28
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.
Outcome measures
| Measure |
Placebo
n=60 Participants
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5 BID
n=58 Participants
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10 mg BID
n=68 Participants
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40 mg BID
n=63 Participants
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80 mg BID
n=54 Participants
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120 mg BID
n=60 Participants
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 4
|
-0.08 Percent
Interval -0.19 to 0.04
|
-0.38 Percent
Interval -0.5 to -0.26
|
-0.51 Percent
Interval -0.62 to -0.39
|
-0.63 Percent
Interval -0.74 to -0.52
|
-0.58 Percent
Interval -0.7 to -0.46
|
-0.64 Percent
Interval -0.75 to -0.53
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.
Outcome measures
| Measure |
Placebo
n=60 Participants
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5 BID
n=55 Participants
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10 mg BID
n=66 Participants
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40 mg BID
n=59 Participants
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80 mg BID
n=51 Participants
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120 mg BID
n=52 Participants
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 6
|
-0.07 Percent
Interval -0.21 to 0.07
|
-0.47 Percent
Interval -0.61 to -0.34
|
-0.71 Percent
Interval -0.84 to -0.57
|
-0.84 Percent
Interval -0.97 to -0.71
|
-0.79 Percent
Interval -0.93 to -0.65
|
-0.84 Percent
Interval -0.98 to -0.71
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.
Outcome measures
| Measure |
Placebo
n=56 Participants
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5 BID
n=51 Participants
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10 mg BID
n=66 Participants
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40 mg BID
n=58 Participants
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80 mg BID
n=45 Participants
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120 mg BID
n=42 Participants
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 8
|
-0.13 Percent
Interval -0.29 to 0.03
|
-0.50 Percent
Interval -0.66 to -0.34
|
-0.78 Percent
Interval -0.93 to -0.62
|
-0.97 Percent
Interval -1.13 to -0.82
|
-0.92 Percent
Interval -1.09 to -0.76
|
-1.02 Percent
Interval -1.18 to -0.86
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.
Outcome measures
| Measure |
Placebo
n=55 Participants
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5 BID
n=53 Participants
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10 mg BID
n=63 Participants
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40 mg BID
n=58 Participants
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80 mg BID
n=46 Participants
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120 mg BID
n=38 Participants
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12
|
-0.09 Percent
Interval -0.28 to 0.1
|
-0.53 Percent
Interval -0.72 to -0.34
|
-0.88 Percent
Interval -1.06 to -0.7
|
-1.06 Percent
Interval -1.25 to -0.88
|
-0.91 Percent
Interval -1.12 to -0.71
|
-1.11 Percent
Interval -1.32 to -0.91
|
SECONDARY outcome
Timeframe: Baseline, Week 2Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 milligram per deciliter (mg/dL) to 99 mg/dL.
Outcome measures
| Measure |
Placebo
n=65 Participants
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5 BID
n=64 Participants
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10 mg BID
n=67 Participants
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40 mg BID
n=68 Participants
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80 mg BID
n=63 Participants
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120 mg BID
n=68 Participants
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose at Week 2
|
-5.58 mg/dL
Interval -12.66 to 1.49
|
-22.72 mg/dL
Interval -29.78 to -15.65
|
-21.96 mg/dL
Interval -28.91 to -15.01
|
-27.79 mg/dL
Interval -34.6 to -20.98
|
-24.18 mg/dL
Interval -31.28 to -17.08
|
-30.92 mg/dL
Interval -37.66 to -24.17
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.
Outcome measures
| Measure |
Placebo
n=60 Participants
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5 BID
n=58 Participants
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10 mg BID
n=68 Participants
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40 mg BID
n=62 Participants
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80 mg BID
n=55 Participants
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120 mg BID
n=60 Participants
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose at Week 4
|
-5.98 mg/dL
Interval -13.62 to 1.66
|
-17.77 mg/dL
Interval -25.46 to -10.09
|
-24.66 mg/dL
Interval -31.98 to -17.35
|
-33.42 mg/dL
Interval -40.83 to -26.0
|
-33.34 mg/dL
Interval -41.25 to -25.44
|
-34.06 mg/dL
Interval -41.52 to -26.6
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.
Outcome measures
| Measure |
Placebo
n=60 Participants
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5 BID
n=55 Participants
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10 mg BID
n=66 Participants
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40 mg BID
n=60 Participants
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80 mg BID
n=51 Participants
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120 mg BID
n=53 Participants
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose at Week 6
|
-0.88 mg/dL
Interval -8.62 to 6.86
|
-16.78 mg/dL
Interval -24.67 to -8.89
|
-26.41 mg/dL
Interval -33.88 to -18.94
|
-30.89 mg/dL
Interval -38.47 to -23.3
|
-28.36 mg/dL
Interval -36.51 to -20.21
|
-32.65 mg/dL
Interval -40.44 to -24.87
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.
Outcome measures
| Measure |
Placebo
n=57 Participants
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5 BID
n=53 Participants
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10 mg BID
n=64 Participants
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40 mg BID
n=58 Participants
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80 mg BID
n=48 Participants
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120 mg BID
n=42 Participants
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose at Week 8
|
-9.10 mg/dL
Interval -16.8 to -1.41
|
-12.73 mg/dL
Interval -20.53 to -4.93
|
-26.23 mg/dL
Interval -33.57 to -18.89
|
-29.74 mg/dL
Interval -37.26 to -22.23
|
-33.22 mg/dL
Interval -41.36 to -25.09
|
-34.31 mg/dL
Interval -42.46 to -26.16
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.
Outcome measures
| Measure |
Placebo
n=55 Participants
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5 BID
n=53 Participants
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10 mg BID
n=63 Participants
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40 mg BID
n=58 Participants
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80 mg BID
n=46 Participants
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120 mg BID
n=37 Participants
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose at Week 12
|
1.21 mg/dL
Interval -7.93 to 10.35
|
-6.49 mg/dL
Interval -15.7 to 2.73
|
-22.56 mg/dL
Interval -31.17 to -13.95
|
-32.01 mg/dL
Interval -40.89 to -23.14
|
-30.45 mg/dL
Interval -40.26 to -20.64
|
-32.38 mg/dL
Interval -42.83 to -21.94
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL.
Outcome measures
| Measure |
Placebo
n=52 Participants
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5 BID
n=52 Participants
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10 mg BID
n=61 Participants
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40 mg BID
n=56 Participants
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80 mg BID
n=45 Participants
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120 mg BID
n=38 Participants
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose at Week 16
|
1.31 mg/dL
Interval -7.58 to 10.2
|
-12.81 mg/dL
Interval -21.71 to -3.91
|
-24.53 mg/dL
Interval -32.88 to -16.18
|
-30.47 mg/dL
Interval -39.06 to -21.87
|
-25.71 mg/dL
Interval -35.15 to -16.26
|
-31.93 mg/dL
Interval -41.73 to -22.13
|
SECONDARY outcome
Timeframe: Baseline, Week 2Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.
Outcome measures
| Measure |
Placebo
n=65 Participants
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5 BID
n=64 Participants
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10 mg BID
n=68 Participants
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40 mg BID
n=68 Participants
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80 mg BID
n=63 Participants
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120 mg BID
n=69 Participants
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Body Weight at Week 2
|
-0.15 Kilogram
Interval -0.47 to 0.17
|
-0.09 Kilogram
Interval -0.41 to 0.23
|
-0.12 Kilogram
Interval -0.44 to 0.19
|
-0.23 Kilogram
Interval -0.54 to 0.08
|
-0.57 Kilogram
Interval -0.89 to -0.24
|
-0.54 Kilogram
Interval -0.85 to -0.24
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.
Outcome measures
| Measure |
Placebo
n=61 Participants
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5 BID
n=58 Participants
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10 mg BID
n=68 Participants
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40 mg BID
n=63 Participants
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80 mg BID
n=55 Participants
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120 mg BID
n=61 Participants
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Body Weight at Week 4
|
-0.25 Kilogram
Interval -0.64 to 0.15
|
-0.33 Kilogram
Interval -0.72 to 0.07
|
-0.08 Kilogram
Interval -0.46 to 0.3
|
-0.77 Kilogram
Interval -1.15 to -0.39
|
-1.05 Kilogram
Interval -1.45 to -0.64
|
-1.33 Kilogram
Interval -1.71 to -0.95
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.
Outcome measures
| Measure |
Placebo
n=60 Participants
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5 BID
n=55 Participants
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10 mg BID
n=66 Participants
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40 mg BID
n=60 Participants
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80 mg BID
n=51 Participants
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120 mg BID
n=53 Participants
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Body Weight at Week 6
|
-0.09 Kilogram
Interval -0.57 to 0.4
|
-0.19 Kilogram
Interval -0.68 to 0.31
|
-0.32 Kilogram
Interval -0.78 to 0.15
|
-0.83 Kilogram
Interval -1.31 to -0.36
|
-1.69 Kilogram
Interval -2.2 to -1.19
|
-2.34 Kilogram
Interval -2.83 to -1.85
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.
Outcome measures
| Measure |
Placebo
n=57 Participants
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5 BID
n=54 Participants
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10 mg BID
n=66 Participants
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40 mg BID
n=58 Participants
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80 mg BID
n=48 Participants
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120 mg BID
n=42 Participants
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Body Weight at Week 8
|
-0.36 Kilogram
Interval -0.89 to 0.16
|
-0.05 Kilogram
Interval -0.59 to 0.49
|
-0.27 Kilogram
Interval -0.78 to 0.23
|
-1.09 Kilogram
Interval -1.6 to -0.57
|
-1.97 Kilogram
Interval -2.52 to -1.42
|
-3.31 Kilogram
Interval -3.85 to -2.77
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.
Outcome measures
| Measure |
Placebo
n=55 Participants
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5 BID
n=53 Participants
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10 mg BID
n=63 Participants
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40 mg BID
n=58 Participants
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80 mg BID
n=46 Participants
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120 mg BID
n=38 Participants
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Body Weight at Week 12
|
-0.24 Kilogram
Interval -0.85 to 0.38
|
-0.09 Kilogram
Interval -0.72 to 0.53
|
-0.00 Kilogram
Interval -0.59 to 0.58
|
-1.05 Kilogram
Interval -1.65 to -0.44
|
-2.52 Kilogram
Interval -3.17 to -1.87
|
-3.81 Kilogram
Interval -4.46 to -3.16
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg.
Outcome measures
| Measure |
Placebo
n=52 Participants
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5 BID
n=53 Participants
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10 mg BID
n=62 Participants
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40 mg BID
n=57 Participants
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80 mg BID
n=46 Participants
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120 mg BID
n=38 Participants
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Body Weight at Week 16
|
-0.43 Kilogram
Interval -1.12 to 0.25
|
0.02 Kilogram
Interval -0.68 to 0.72
|
-0.06 Kilogram
Interval -0.71 to 0.6
|
-1.16 Kilogram
Interval -1.84 to -0.49
|
-2.48 Kilogram
Interval -3.2 to -1.75
|
-4.60 Kilogram
Interval -5.34 to -3.86
|
SECONDARY outcome
Timeframe: Baseline up to Week 21Population: Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment.
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.
Outcome measures
| Measure |
Placebo
n=66 Participants
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5 BID
n=68 Participants
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10 mg BID
n=68 Participants
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40 mg BID
n=71 Participants
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80 mg BID
n=67 Participants
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120 mg BID
n=71 Participants
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs])
Number of Participants With Treatment Emergent AEs
|
32 Participants
|
32 Participants
|
31 Participants
|
42 Participants
|
43 Participants
|
44 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs])
Number of Participants With Treatment Emergent SAEs
|
1 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline Through Week 21Population: Overall number of participants analyzed included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment and had at least 1 measurement available.
Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time, PT/INR, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin); lipid panel (low density lipoprotein cholesterol, high density lipoprotein cholesterol).
Outcome measures
| Measure |
Placebo
n=65 Participants
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5 BID
n=68 Participants
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10 mg BID
n=68 Participants
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40 mg BID
n=71 Participants
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80 mg BID
n=67 Participants
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120 mg BID
n=71 Participants
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities Without Regard to Baseline Abnormality
|
60 Participants
|
57 Participants
|
57 Participants
|
57 Participants
|
60 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: Baseline through Week 21Population: Overall number of participants analyzed included all participants randomly assigned to study treatment, took at least 1 dose of study treatment and had at least 1 measurement available.
Vital signs abnormality criteria: 1) supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) \<50 mmHg; 3) supine pulse rate \<40 or \>120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (\>=) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP \>= 20 mmHg.
Outcome measures
| Measure |
Placebo
n=65 Participants
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5 BID
n=68 Participants
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10 mg BID
n=68 Participants
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40 mg BID
n=71 Participants
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80 mg BID
n=67 Participants
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120 mg BID
n=71 Participants
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Vital Signs Abnormalities
Supine pulse rate >120 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Vital Signs Abnormalities
Supine SBP <90 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Vital Signs Abnormalities
Supine DBP decrease >=20 mmHg
|
3 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Vital Signs Abnormalities
Supine pulse rate <40 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Vital Signs Abnormalities
Supine SBP increase >=30 mmHg
|
3 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants With Treatment Emergent Vital Signs Abnormalities
Supine SBP decrease >=30 mmHg
|
4 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Vital Signs Abnormalities
Supine DBP <50 mmHg
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Vital Signs Abnormalities
Supine DBP increase >=20 mmHg
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline Through Week 21Population: Overall number of participants analyzed included all participants randomly assigned to study treatment, took at least 1 dose of study treatment and had at least 1 measurement available.
ECG categorical abnormality criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) greater than or equal to (\>=) 300 millisecond (msec), b) \>=25% increase when baseline is \> 200 msec or \>=50% increase when baseline is less than or equal to (\<=) 200 msec. 2\. QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) \>=140 msec, b) \>=50% increase from baseline. 3\. QTcF interval (QT corrected using the Fridericia formula): a) \>450 msec and \<=480 msec, b) \>480 msec and \<=500 msec, c) \>500 msec, d) \>30 msec and \<=60 msec increase from baseline, e) \>60 msec increase from baseline.
Outcome measures
| Measure |
Placebo
n=65 Participants
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5 BID
n=68 Participants
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10 mg BID
n=68 Participants
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40 mg BID
n=71 Participants
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80 mg BID
n=67 Participants
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120 mg BID
n=71 Participants
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent ECG Abnormalities
PR interval ≥300 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent ECG Abnormalities
QTcF interval >500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent ECG Abnormalities
%Change in PR interval ≥25/50%
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent ECG Abnormalities
QRS interval ≥140 msec
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent ECG Abnormalities
%Change in QRS interval ≥50%
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent ECG Abnormalities
QTcF interval >450 and ≤480 msec
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Treatment Emergent ECG Abnormalities
QTcF interval >480 and ≤500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent ECG Abnormalities
Change in QTcF interval >30 and ≤60 msec
|
2 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Treatment Emergent ECG Abnormalities
Change in QTcF interval >60 msec
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
PF-06882961 2.5mg BID
Serious events: 1 serious events
Other events: 21 other events
Deaths: 1 deaths
PF-06882961 10mg BID
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
PF-06882961 40mg BID
Serious events: 6 serious events
Other events: 33 other events
Deaths: 2 deaths
PF-06882961 80mg BID
Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths
PF-06882961 120mg BID
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=66 participants at risk
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5mg BID
n=68 participants at risk
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10mg BID
n=68 participants at risk
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40mg BID
n=71 participants at risk
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80mg BID
n=67 participants at risk
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120mg BID
n=71 participants at risk
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
1/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
1/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.4%
1/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
1/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.4%
1/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
1/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.4%
1/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.4%
1/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.5%
1/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.4%
1/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.4%
1/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.4%
1/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.4%
1/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
1/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.4%
1/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Hypertension
|
0.00%
0/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
1/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
Other adverse events
| Measure |
Placebo
n=66 participants at risk
Placebo matched to PF-06882961 was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 2.5mg BID
n=68 participants at risk
PF-06882961 2.5 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 10mg BID
n=68 participants at risk
PF-06882961 10 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up.
|
PF-06882961 40mg BID
n=71 participants at risk
PF-06882961 40 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 80mg BID
n=67 participants at risk
PF-06882961 80 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
PF-06882961 120mg BID
n=71 participants at risk
PF-06882961 120 mg was administered orally twice daily (BID) with food for a total of 16 weeks, followed by an approximate 4-week follow-up. Titration was implemented.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
1.5%
1/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
1/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.6%
4/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.5%
3/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
2/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.0%
2/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.4%
3/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.9%
4/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
11.3%
8/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
17.9%
12/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.9%
7/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.9%
4/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.4%
3/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
2/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
13.4%
9/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
2/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
1/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
2/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
2/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.0%
4/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.0%
5/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Nausea
|
3.0%
2/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.4%
5/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.4%
5/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
15.5%
11/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
32.8%
22/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
32.4%
23/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
1/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.0%
5/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.4%
11/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.4%
18/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
1/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.0%
5/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.5%
3/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.4%
1/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
SARS-CoV-2 test positive
|
3.0%
2/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.9%
4/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.4%
3/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
2/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
1/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.4%
1/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
2/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.8%
2/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
1/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.0%
5/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.1%
6/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.9%
2/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
1/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.0%
4/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
1/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
1/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.6%
4/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.0%
6/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
3/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Dizziness
|
1.5%
1/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
1/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.9%
4/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.2%
3/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
1/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.0%
5/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Headache
|
6.1%
4/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.9%
4/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
1/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.0%
5/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.0%
2/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.9%
7/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Hypertension
|
0.00%
0/66 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.5%
1/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.4%
3/68 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.4%
1/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.0%
4/67 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.4%
1/71 • Baseline up to Week 21
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
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