Trial Outcomes & Findings for A 12-WEEK TITRATE STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF PF-06882961 IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND IN NON-DIABETIC ADULTS WITH OBESITY (NCT NCT04617275)
NCT ID: NCT04617275
Last Updated: 2022-12-08
Results Overview
An 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. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE. Assessments of AE intensity were defined as mild (easily tolerated, causing minimal discomfort and not interfering with daily activities), moderate (causing sufficient discomfort and interferes with normal daily activities) and severe (preventing normal daily activities).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
151 participants
Primary outcome timeframe
Baseline through follow-up (Day 112)
Results posted on
2022-12-08
Participant Flow
Participants were enrolled from 06 January 2021 to 17 November 2021 in the United States.
A total of 370 participants were screened for eligibility, of which 151 participants (123 in the type 2 diabetes mellitus \[T2DM\] arms and 28 in the non-diabetic obesity arms) were randomized to receive the danuglipron or placebo in one of the 8 treatment arms.
Participant milestones
| Measure |
Placebo (T2DM)
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks in following steps: 5 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID and 80 mg BID.
|
PF-06882961 80 mg BID High, Slow (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks in following steps: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID and 80 mg BID.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks in following steps: 5 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID.
|
PF-06882961 120 mg BID High, Fast (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks in following steps: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID.
|
PF-06882961 200 mg BID (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks in following steps: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID,140 mg BID, 160 mg BID, 180 mg BID, 200 mg BID.
|
Placebo (Non-diabetic Obesity)
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks in following steps: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID,140 mg BID, 160 mg BID, 180 mg BID, 200 mg BID.
|
|---|---|---|---|---|---|---|---|---|
|
Follow-up Period
NOT COMPLETED
|
3
|
3
|
4
|
6
|
6
|
7
|
1
|
8
|
|
Treatment Period
STARTED
|
16
|
20
|
22
|
22
|
22
|
21
|
6
|
22
|
|
Treatment Period
COMPLETED
|
13
|
13
|
16
|
13
|
13
|
10
|
5
|
6
|
|
Treatment Period
NOT COMPLETED
|
3
|
7
|
6
|
9
|
9
|
11
|
1
|
16
|
|
Follow-up Period
STARTED
|
16
|
20
|
22
|
22
|
22
|
21
|
6
|
22
|
|
Follow-up Period
COMPLETED
|
13
|
17
|
18
|
16
|
16
|
14
|
5
|
14
|
Reasons for withdrawal
| Measure |
Placebo (T2DM)
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks in following steps: 5 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID and 80 mg BID.
|
PF-06882961 80 mg BID High, Slow (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks in following steps: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID and 80 mg BID.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks in following steps: 5 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID.
|
PF-06882961 120 mg BID High, Fast (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks in following steps: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID.
|
PF-06882961 200 mg BID (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks in following steps: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID,140 mg BID, 160 mg BID, 180 mg BID, 200 mg BID.
|
Placebo (Non-diabetic Obesity)
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks in following steps: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID,140 mg BID, 160 mg BID, 180 mg BID, 200 mg BID.
|
|---|---|---|---|---|---|---|---|---|
|
Treatment Period
Adverse Event
|
1
|
6
|
4
|
6
|
7
|
8
|
0
|
12
|
|
Treatment Period
Lost to Follow-up
|
0
|
0
|
2
|
0
|
0
|
3
|
0
|
2
|
|
Treatment Period
No longer meets eligibility criteria
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Period
Other
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period
Withdrawal by Subject
|
2
|
0
|
0
|
2
|
2
|
0
|
1
|
2
|
|
Follow-up Period
Adverse Event
|
1
|
1
|
2
|
3
|
4
|
3
|
0
|
3
|
|
Follow-up Period
Lost to Follow-up
|
0
|
1
|
2
|
0
|
0
|
4
|
0
|
3
|
|
Follow-up Period
No longer meets eligibility criteria
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Follow-up Period
Other
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Follow-up Period
Withdrawal by Subject
|
2
|
0
|
0
|
2
|
2
|
0
|
1
|
2
|
Baseline Characteristics
A 12-WEEK TITRATE STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF PF-06882961 IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND IN NON-DIABETIC ADULTS WITH OBESITY
Baseline characteristics by cohort
| Measure |
Placebo (T2DM)
n=16 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
Placebo (Non-diabetic Obesity)
n=6 Participants
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=20 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
n=21 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
n=22 Participants
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Mean (SD)
|
53.9 Years
STANDARD_DEVIATION 9.10 • n=5 Participants
|
49.5 Years
STANDARD_DEVIATION 5.79 • n=7 Participants
|
59.5 Years
STANDARD_DEVIATION 9.55 • n=5 Participants
|
60.9 Years
STANDARD_DEVIATION 8.69 • n=4 Participants
|
58.3 Years
STANDARD_DEVIATION 7.11 • n=21 Participants
|
57.2 Years
STANDARD_DEVIATION 11.8 • n=8 Participants
|
59 Years
STANDARD_DEVIATION 9.31 • n=8 Participants
|
48.5 Years
STANDARD_DEVIATION 13.12 • n=24 Participants
|
56.5 Years
STANDARD_DEVIATION 10.55 • n=42 Participants
|
|
Age, Continuous
|
53.0 Years
n=5 Participants
|
49.0 Years
n=7 Participants
|
60.5 Years
n=5 Participants
|
61.5 Years
n=4 Participants
|
58.5 Years
n=21 Participants
|
60.0 Years
n=8 Participants
|
59.0 Years
n=8 Participants
|
52.0 Years
n=24 Participants
|
58.0 Years
n=42 Participants
|
|
Age, Customized
<18
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Customized
18-44
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
16 Participants
n=42 Participants
|
|
Age, Customized
45-64
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
99 Participants
n=42 Participants
|
|
Age, Customized
>=65
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
36 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
78 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
73 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
18 Participants
n=24 Participants
|
125 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
23 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
83 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
68 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline through follow-up (Day 112)Population: Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of investigational products (IP).
An 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. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE. Assessments of AE intensity were defined as mild (easily tolerated, causing minimal discomfort and not interfering with daily activities), moderate (causing sufficient discomfort and interferes with normal daily activities) and severe (preventing normal daily activities).
Outcome measures
| Measure |
Placebo (T2DM)
n=16 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=20 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
n=21 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
n=6 Participants
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
n=22 Participants
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity
All Causality - Mild
|
5 Participants
|
4 Participants
|
10 Participants
|
9 Participants
|
8 Participants
|
10 Participants
|
1 Participants
|
6 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity
All Causality - Moderate
|
3 Participants
|
8 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
11 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity
All Causality - Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity
Treatment Related - Mild
|
2 Participants
|
4 Participants
|
8 Participants
|
3 Participants
|
7 Participants
|
9 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity
Treatment Related - Moderate
|
2 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
7 Participants
|
3 Participants
|
1 Participants
|
11 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity
Treatment Related - Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline through Visit 10 (Day 91)Population: Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of IP.
Safety laboratory assessments included clinical chemistry, hematology, urinalysis, and other tests. Abnormality was determined at the investigator's discretion.
Outcome measures
| Measure |
Placebo (T2DM)
n=15 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=20 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
n=21 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
n=21 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
n=19 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
n=6 Participants
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
n=22 Participants
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
|
12 Participants
|
16 Participants
|
17 Participants
|
20 Participants
|
17 Participants
|
14 Participants
|
4 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline through Visit 10 (Day 91)Population: Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of IP.
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 \>=30 mmHg; 5) change from baseline (increase or decrease) in supine DBP \>=20 mmHg.
Outcome measures
| Measure |
Placebo (T2DM)
n=16 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=20 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
n=21 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
n=6 Participants
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
n=22 Participants
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs Meeting the Pre-defined Categorical Summarization Criteria
Supine SBP <90 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Meeting the Pre-defined Categorical Summarization Criteria
Supine SBP Increase >=30 mmHg
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Meeting the Pre-defined Categorical Summarization Criteria
Supine SBP Decrease >=30 mmHg
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Vital Signs Meeting the Pre-defined Categorical Summarization Criteria
Supine DBP <50 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Meeting the Pre-defined Categorical Summarization Criteria
Supine DBP Increase >=20 mmHg
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Meeting the Pre-defined Categorical Summarization Criteria
Supine DBP Decrease >=20 mmHg
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Meeting the Pre-defined Categorical Summarization Criteria
Supine Pulse Rate <40 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Meeting the Pre-defined Categorical Summarization Criteria
Supine Pulse Rate >120 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline through Visit 10 (Day 91)Population: Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of IP.
ECG assessments included pulse rate (PR), QT, heart rate, QTcF intervals and QRS complex. ECG abnormalities criteria included: PR interval value \>= 300 msec, or baseline (BL) \>200 msec and \>=25% increase from BL, or BL \<=200 msec and \>=50% increase from BL; QRS interval value \>= 140msec, or \>=50% increase from BL; QTcF value \>450 and \<=480 msec, or \>480 and \<=500 msec, or \>500 msec, or increase from BL\>30 and \<=60 msec, or \>60msec.
Outcome measures
| Measure |
Placebo (T2DM)
n=16 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=20 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
n=21 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
n=6 Participants
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
n=22 Participants
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
PR interval >=300 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
Change in QTcF interval >60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
%Change in PR interval >=25/50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
QRS interval >=140 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
%Change in QRS interval >=50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
QTcF interval >450 and <=480 msec
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
QTcF interval >480 and <=500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
QTcF interval >500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
Change in QTcF interval >30 and <=60 msec
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 0, 2, 4, 6, 8, 10, 12, 13-14Population: Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of IP.
The C-SSRS is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. Participants who responded "yes" to the questions will be counted. Data relevant to the assessment of suicidality were mapped to the Columbia-Classification Algorithm of Suicide Assessment (C-CASA) codes.
Outcome measures
| Measure |
Placebo (T2DM)
n=16 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=6 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
n=20 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
n=21 Participants
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
n=22 Participants
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 8 - <2> Suicide Attempt
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 10 - <4> Suicidal Ideation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 0 - <1> Completed Suicide
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 0 - <2> Suicide Attempt
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 0 - <3> Preparatory Acts Towards Imminent Suicidal Behavior
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 0 - <4> Suicidal Ideation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 0 - <7> Self-injurious Behavior, No Suicidal Intent
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 2 - <1> Completed Suicide
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 2 - <2> Suicide Attempt
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 4 - <7> Self-injurious Behavior, No Suicidal Intent
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 2 - <3> Preparatory Acts Towards Imminent Suicidal Behavior
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 2 - <4> Suicidal Ideation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 2 - <7> Self-injurious Behavior, No Suicidal Intent
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 4 - <1> Completed Suicide
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 4 - <2> Suicide Attempt
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 4 - <3> Preparatory Acts Towards Imminent Suicidal Behavior
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 4 - <4> Suicidal Ideation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 6 - <1> Completed Suicide
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 6 - <2> Suicide Attempt
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 6 - <3> Preparatory Acts Towards Imminent Suicidal Behavior
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 6 - <4> Suicidal Ideation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 6 - <7> Self-injurious Behavior, No Suicidal Intent
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 8 - <1> Completed Suicide
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 8 - <3> Preparatory Acts Towards Imminent Suicidal Behavior
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 8 - <4> Suicidal Ideation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 8 - <7> Self-injurious Behavior, No Suicidal Intent
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 10 - <1> Completed Suicide
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 10 - <2> Suicide Attempt
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 10 - <3> Preparatory Acts Towards Imminent Suicidal Behavior
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 10 - <7> Self-injurious Behavior, No Suicidal Intent
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 12 - <1> Completed Suicide
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 12 - <2> Suicide Attempt
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 12 - <3> Preparatory Acts Towards Imminent Suicidal Behavior
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 12 - <4> Suicidal Ideation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Week 12 - <7> Self-injurious Behavior, No Suicidal Intent
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Follow-Up - <1> Completed Suicide
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Follow-Up - <2> Suicide Attempt
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Follow-Up - <3> Preparatory Acts Towards Imminent Suicidal Behavior
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Follow-Up - <4> Suicidal Ideation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Follow-Up - <7> Self-injurious Behavior, No Suicidal Intent
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 0, 2, 4, 6, 8, 10, 12, 13-14.Population: Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of IP.
The PHQ-9 is a 9 item self-report scale for the assessment of depressive symptoms. The PHQ-9 were completed by participants and reviewed by site staff at the pre-defined time points.
Outcome measures
| Measure |
Placebo (T2DM)
n=16 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=6 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
n=20 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
n=21 Participants
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
n=22 Participants
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Trouble Falling or Staying Asleep - Several Days
|
2 Participants
|
2 Participants
|
6 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Trouble Falling or Staying Asleep - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Poor Appetite or Overeating - Not At All
|
10 Participants
|
2 Participants
|
15 Participants
|
16 Participants
|
14 Participants
|
11 Participants
|
10 Participants
|
12 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Feeling Tired or Little Energy - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Feeling Down Depressed or Hopeless - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Feeling Tired or Little Energy - Nearly Every Day
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Feeling Bad About Yourself - Not At All
|
14 Participants
|
5 Participants
|
19 Participants
|
21 Participants
|
21 Participants
|
22 Participants
|
18 Participants
|
17 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Feeling Bad About Yourself - Several Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Trouble Concentrating on Things - Not At All
|
14 Participants
|
5 Participants
|
17 Participants
|
20 Participants
|
20 Participants
|
19 Participants
|
18 Participants
|
18 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Feeling Bad About Yourself - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Feeling Bad About Yourself - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Trouble Concentrating on Things - Not At All
|
13 Participants
|
4 Participants
|
16 Participants
|
20 Participants
|
20 Participants
|
21 Participants
|
19 Participants
|
16 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Trouble Concentrating on Things - Several Days
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Feeling Bad About Yourself - Several Days
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Feeling Down Depressed or Hopeless - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Trouble Concentrating on Things - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Trouble Concentrating on Things - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Moving Slowly or Fidgety/Restless - Not At All
|
14 Participants
|
4 Participants
|
18 Participants
|
20 Participants
|
21 Participants
|
21 Participants
|
19 Participants
|
17 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Feeling Bad About Yourself - More Than Half the Days
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Feeling Bad About Yourself - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Moving Slowly or Fidgety/Restless - Several Days
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Moving Slowly or Fidgety/Restless - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Moving Slowly or Fidgety/Restless - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Trouble Concentrating on Things - Several Days
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Thoughts You Be Better Off Dead - Not At All
|
14 Participants
|
5 Participants
|
19 Participants
|
21 Participants
|
21 Participants
|
22 Participants
|
19 Participants
|
17 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Thoughts You Be Better Off Dead - Several Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Thoughts You Be Better Off Dead - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Trouble Concentrating on Things - More Than Half the Days
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Thoughts You Be Better Off Dead - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Trouble Concentrating on Things - Nearly Every Day
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Little Interest/Pleasure in Things - Not At All
|
12 Participants
|
4 Participants
|
15 Participants
|
17 Participants
|
19 Participants
|
16 Participants
|
14 Participants
|
14 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Little Interest/Pleasure in Things - Several Days
|
2 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Little Interest/Pleasure in Things - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Little Interest/Pleasure in Things - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Moving Slowly or Fidgety/Restless - Not At All
|
14 Participants
|
5 Participants
|
19 Participants
|
20 Participants
|
21 Participants
|
21 Participants
|
18 Participants
|
20 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Feeling Down Depressed or Hopeless - Not At All
|
12 Participants
|
5 Participants
|
18 Participants
|
20 Participants
|
18 Participants
|
18 Participants
|
15 Participants
|
13 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Moving Slowly or Fidgety/Restless - Several Days
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Feeling Down Depressed or Hopeless - Several Days
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Moving Slowly or Fidgety/Restless - More Than Half the Days
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Feeling Down Depressed or Hopeless - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Feeling Down Depressed or Hopeless - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Moving Slowly or Fidgety/Restless - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Trouble Falling or Staying Asleep - Not At All
|
12 Participants
|
4 Participants
|
12 Participants
|
14 Participants
|
16 Participants
|
18 Participants
|
12 Participants
|
10 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Trouble Falling or Staying Asleep - Several Days
|
1 Participants
|
0 Participants
|
7 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Trouble Falling or Staying Asleep - More Than Half the Days
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Trouble Falling or Staying Asleep - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Poor Appetite or Overeating - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Feeling Tired or Little Energy - Not At All
|
12 Participants
|
2 Participants
|
11 Participants
|
16 Participants
|
15 Participants
|
15 Participants
|
10 Participants
|
10 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Thoughts You Be Better Off Dead - Not At All
|
14 Participants
|
6 Participants
|
20 Participants
|
21 Participants
|
21 Participants
|
21 Participants
|
19 Participants
|
20 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Feeling Tired or Little Energy - Several Days
|
2 Participants
|
2 Participants
|
7 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Feeling Tired or Little Energy - More Than Half the Days
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Poor Appetite or Overeating - Not At All
|
12 Participants
|
2 Participants
|
14 Participants
|
14 Participants
|
15 Participants
|
13 Participants
|
9 Participants
|
12 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Thoughts You Be Better Off Dead - Several Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Poor Appetite or Overeating - Several Days
|
2 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Poor Appetite or Overeating - More Than Half the Days
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Poor Appetite or Overeating - Nearly Every Day
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Thoughts You Be Better Off Dead - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Feeling Bad About Yourself - Not At All
|
14 Participants
|
5 Participants
|
18 Participants
|
20 Participants
|
19 Participants
|
19 Participants
|
16 Participants
|
15 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Feeling Bad About Yourself - Several Days
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Feeling Bad About Yourself - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Thoughts You Be Better Off Dead - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Feeling Bad About Yourself - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Trouble Concentrating on Things - Not At All
|
13 Participants
|
4 Participants
|
14 Participants
|
19 Participants
|
19 Participants
|
18 Participants
|
16 Participants
|
14 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Trouble Concentrating on Things - Several Days
|
1 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Little Interest/Pleasure in Things - Not At All
|
12 Participants
|
4 Participants
|
16 Participants
|
20 Participants
|
21 Participants
|
19 Participants
|
18 Participants
|
16 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Trouble Concentrating on Things - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Trouble Concentrating on Things - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Little Interest/Pleasure in Things - Several Days
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Moving Slowly or Fidgety/Restless - Not At All
|
14 Participants
|
5 Participants
|
18 Participants
|
20 Participants
|
19 Participants
|
18 Participants
|
16 Participants
|
15 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Moving Slowly or Fidgety/Restless - Several Days
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Little Interest/Pleasure in Things - More Than Half the Days
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Moving Slowly or Fidgety/Restless - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 -Moving Slowly or Fidgety/Restless - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Feeling Tired or Little Energy - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 - Thoughts You Be Better Off Dead - Not At All
|
14 Participants
|
5 Participants
|
18 Participants
|
20 Participants
|
19 Participants
|
19 Participants
|
16 Participants
|
15 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Little Interest/Pleasure in Things - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 - Thoughts You Be Better Off Dead - Several Days
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 -Feeling Down Depressed or Hopeless - Not At All
|
13 Participants
|
5 Participants
|
18 Participants
|
18 Participants
|
21 Participants
|
22 Participants
|
18 Participants
|
15 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 - Thoughts You Be Better Off Dead - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 6 - Thoughts You Be Better Off Dead - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Feeling Tired or Little Energy - Not At All
|
11 Participants
|
2 Participants
|
11 Participants
|
14 Participants
|
14 Participants
|
17 Participants
|
12 Participants
|
9 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Little Interest/Pleasure in Things - Not At All
|
13 Participants
|
5 Participants
|
16 Participants
|
16 Participants
|
18 Participants
|
17 Participants
|
15 Participants
|
13 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Feeling Tired or Little Energy - Several Days
|
2 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Little Interest/Pleasure in Things - Several Days
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Feeling Tired or Little Energy - More Than Half the Days
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Feeling Tired or Little Energy - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Poor Appetite or Overeating - Not At All
|
11 Participants
|
3 Participants
|
13 Participants
|
16 Participants
|
15 Participants
|
16 Participants
|
12 Participants
|
12 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Poor Appetite or Overeating - Several Days
|
2 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Little Interest/Pleasure in Things - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Little Interest/Pleasure in Things - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Poor Appetite or Overeating - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Feeling Bad About Yourself - Not At All
|
13 Participants
|
5 Participants
|
17 Participants
|
18 Participants
|
16 Participants
|
17 Participants
|
13 Participants
|
13 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Feeling Down Depressed or Hopeless - Not At All
|
14 Participants
|
5 Participants
|
18 Participants
|
17 Participants
|
16 Participants
|
18 Participants
|
15 Participants
|
14 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Feeling Bad About Yourself - Several Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Feeling Down Depressed or Hopeless - Several Days
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Feeling Bad About Yourself - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Feeling Down Depressed or Hopeless - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Feeling Bad About Yourself - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Trouble Concentrating on Things - Not At All
|
12 Participants
|
5 Participants
|
17 Participants
|
16 Participants
|
16 Participants
|
17 Participants
|
14 Participants
|
13 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Trouble Falling or Staying Asleep - Not At All
|
13 Participants
|
3 Participants
|
12 Participants
|
13 Participants
|
15 Participants
|
17 Participants
|
13 Participants
|
10 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Trouble Concentrating on Things - Several Days
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Trouble Falling or Staying Asleep - Several Days
|
1 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Trouble Concentrating on Things - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Trouble Falling or Staying Asleep - More Than Half the Days
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Trouble Falling or Staying Asleep - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Feeling Tired or Little Energy - Not At All
|
11 Participants
|
3 Participants
|
13 Participants
|
16 Participants
|
16 Participants
|
16 Participants
|
9 Participants
|
10 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Feeling Tired or Little Energy - Several Days
|
3 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Feeling Tired or Little Energy - More Than Half the Days
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Poor Appetite or Overeating - Not At All
|
11 Participants
|
2 Participants
|
15 Participants
|
13 Participants
|
15 Participants
|
13 Participants
|
9 Participants
|
12 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Poor Appetite or Overeating - Several Days
|
3 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Poor Appetite or Overeating - More Than Half the Days
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Feeling Bad About Yourself - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Poor Appetite or Overeating - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Feeling Bad About Yourself - Not At All
|
14 Participants
|
5 Participants
|
18 Participants
|
18 Participants
|
18 Participants
|
18 Participants
|
15 Participants
|
14 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Feeling Bad About Yourself - Several Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Feeling Bad About Yourself - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Trouble Concentrating on Things - Not At All
|
13 Participants
|
4 Participants
|
14 Participants
|
16 Participants
|
18 Participants
|
17 Participants
|
15 Participants
|
14 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Trouble Concentrating on Things - Several Days
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Trouble Concentrating on Things - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Trouble Concentrating on Things - Nearly Every Day
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Moving Slowly or Fidgety/Restless - Not At All
|
14 Participants
|
5 Participants
|
17 Participants
|
18 Participants
|
18 Participants
|
18 Participants
|
16 Participants
|
15 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Moving Slowly or Fidgety/Restless - Several Days
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Moving Slowly or Fidgety/Restless - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Moving Slowly or Fidgety/Restless - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Thoughts You Be Better Off Dead - Not At All
|
14 Participants
|
5 Participants
|
18 Participants
|
18 Participants
|
18 Participants
|
18 Participants
|
16 Participants
|
15 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Thoughts You Be Better Off Dead - Several Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Thoughts You Be Better Off Dead - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 8 - Thoughts You Be Better Off Dead - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Little Interest/Pleasure in Things - Not At All
|
13 Participants
|
5 Participants
|
17 Participants
|
15 Participants
|
16 Participants
|
16 Participants
|
14 Participants
|
13 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Little Interest/Pleasure in Things - Several Days
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Little Interest/Pleasure in Things - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Little Interest/Pleasure in Things - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Feeling Down Depressed or Hopeless - Not At All
|
13 Participants
|
5 Participants
|
18 Participants
|
16 Participants
|
15 Participants
|
17 Participants
|
14 Participants
|
14 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Feeling Down Depressed or Hopeless - Several Days
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Feeling Down Depressed or Hopeless - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Feeling Down Depressed or Hopeless - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Trouble Falling or Staying Asleep - Not At All
|
13 Participants
|
3 Participants
|
13 Participants
|
14 Participants
|
14 Participants
|
15 Participants
|
12 Participants
|
10 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Trouble Falling or Staying Asleep - Several Days
|
1 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Trouble Falling or Staying Asleep - More Than Half the Days
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Trouble Falling or Staying Asleep - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Feeling Tired or Little Energy - Not At All
|
11 Participants
|
2 Participants
|
11 Participants
|
14 Participants
|
14 Participants
|
13 Participants
|
12 Participants
|
9 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Feeling Tired or Little Energy - Several Days
|
3 Participants
|
2 Participants
|
7 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Feeling Tired or Little Energy - More Than Half the Days
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Poor Appetite or Overeating - Several Days
|
4 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Poor Appetite or Overeating - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Poor Appetite or Overeating - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Feeling Bad About Yourself - Not At All
|
14 Participants
|
5 Participants
|
18 Participants
|
18 Participants
|
16 Participants
|
17 Participants
|
14 Participants
|
15 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Little Interest/Pleasure in Things - Not At All
|
11 Participants
|
5 Participants
|
15 Participants
|
14 Participants
|
16 Participants
|
16 Participants
|
13 Participants
|
14 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Feeling Bad About Yourself - Several Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Feeling Down Depressed or Hopeless - Several Days
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Feeling Down Depressed or Hopeless - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Feeling Down Depressed or Hopeless - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Feeling Tired or Little Energy - Not At All
|
11 Participants
|
2 Participants
|
10 Participants
|
17 Participants
|
18 Participants
|
17 Participants
|
14 Participants
|
9 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Feeling Bad About Yourself - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Trouble Falling or Staying Asleep - Not At All
|
13 Participants
|
3 Participants
|
11 Participants
|
14 Participants
|
20 Participants
|
18 Participants
|
16 Participants
|
14 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Trouble Falling or Staying Asleep - Several Days
|
1 Participants
|
1 Participants
|
8 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Feeling Bad About Yourself - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Trouble Falling or Staying Asleep - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Trouble Falling or Staying Asleep - Nearly Every Day
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Trouble Concentrating on Things - Not At All
|
13 Participants
|
5 Participants
|
17 Participants
|
17 Participants
|
16 Participants
|
16 Participants
|
15 Participants
|
15 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Feeling Tired or Little Energy - Several Days
|
3 Participants
|
1 Participants
|
8 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
8 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Trouble Concentrating on Things - Several Days
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Trouble Concentrating on Things - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Trouble Concentrating on Things - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Moving Slowly or Fidgety/Restless - Not At All
|
14 Participants
|
5 Participants
|
17 Participants
|
17 Participants
|
16 Participants
|
16 Participants
|
15 Participants
|
15 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Moving Slowly or Fidgety/Restless - Several Days
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Moving Slowly or Fidgety/Restless - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Moving Slowly or Fidgety/Restless - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Trouble Concentrating on Things - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Moving Slowly or Fidgety/Restless - Not At All
|
12 Participants
|
5 Participants
|
17 Participants
|
18 Participants
|
16 Participants
|
17 Participants
|
14 Participants
|
14 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Moving Slowly or Fidgety/Restless - Several Days
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Moving Slowly or Fidgety/Restless - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Little Interest/Pleasure in Things - Several Days
|
1 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Moving Slowly or Fidgety/Restless - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Thoughts You Be Better Off Dead - Not At All
|
14 Participants
|
5 Participants
|
18 Participants
|
18 Participants
|
16 Participants
|
17 Participants
|
15 Participants
|
15 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Thoughts You Be Better Off Dead - Several Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Thoughts You Be Better Off Dead - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Thoughts You Be Better Off Dead - Not At All
|
13 Participants
|
5 Participants
|
17 Participants
|
18 Participants
|
16 Participants
|
17 Participants
|
14 Participants
|
14 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 10 - Thoughts You Be Better Off Dead - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Thoughts You Be Better Off Dead - Several Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Thoughts You Be Better Off Dead - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Thoughts You Be Better Off Dead - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Little Interest/Pleasure in Things - Several Days
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Little Interest/Pleasure in Things - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Little Interest/Pleasure in Things - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Feeling Down Depressed or Hopeless - Not At All
|
11 Participants
|
5 Participants
|
18 Participants
|
17 Participants
|
16 Participants
|
16 Participants
|
13 Participants
|
14 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Feeling Tired or Little Energy - More Than Half the Days
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Little Interest/Pleasure in Things - Not At All
|
15 Participants
|
6 Participants
|
16 Participants
|
20 Participants
|
20 Participants
|
20 Participants
|
19 Participants
|
21 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Feeling Tired or Little Energy - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Little Interest/Pleasure in Things - Several Days
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Little Interest/Pleasure in Things - More Than Half the Days
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Poor Appetite or Overeating - Not At All
|
11 Participants
|
3 Participants
|
14 Participants
|
18 Participants
|
20 Participants
|
16 Participants
|
16 Participants
|
13 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Poor Appetite or Overeating - Several Days
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Little Interest/Pleasure in Things - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Feeling Down Depressed or Hopeless - Not At All
|
14 Participants
|
6 Participants
|
19 Participants
|
18 Participants
|
19 Participants
|
22 Participants
|
19 Participants
|
19 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Feeling Down Depressed or Hopeless - Several Days
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Poor Appetite or Overeating - More Than Half the Days
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Feeling Down Depressed or Hopeless - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Feeling Down Depressed or Hopeless - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Trouble Falling or Staying Asleep - Not At All
|
15 Participants
|
5 Participants
|
13 Participants
|
16 Participants
|
17 Participants
|
17 Participants
|
17 Participants
|
15 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Trouble Falling or Staying Asleep - Several Days
|
1 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
7 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Trouble Falling or Staying Asleep - More Than Half the Days
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Trouble Falling or Staying Asleep - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Feeling Tired or Little Energy - Not At All
|
13 Participants
|
3 Participants
|
13 Participants
|
15 Participants
|
17 Participants
|
16 Participants
|
14 Participants
|
15 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Feeling Tired or Little Energy - Several Days
|
3 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Feeling Tired or Little Energy - More Than Half the Days
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Feeling Tired or Little Energy - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 4 - Poor Appetite or Overeating - Nearly Every Day
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Poor Appetite or Overeating - Not At All
|
15 Participants
|
3 Participants
|
13 Participants
|
19 Participants
|
18 Participants
|
19 Participants
|
21 Participants
|
20 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Poor Appetite or Overeating - Several Days
|
1 Participants
|
2 Participants
|
6 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Feeling Bad About Yourself - Several Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Poor Appetite or Overeating - More Than Half the Days
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Poor Appetite or Overeating - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Feeling Bad About Yourself - Not At All
|
16 Participants
|
6 Participants
|
20 Participants
|
22 Participants
|
20 Participants
|
22 Participants
|
21 Participants
|
21 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Feeling Bad About Yourself - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Feeling Bad About Yourself - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Trouble Concentrating on Things - Not At All
|
16 Participants
|
5 Participants
|
16 Participants
|
21 Participants
|
19 Participants
|
20 Participants
|
21 Participants
|
20 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Trouble Concentrating on Things - Several Days
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Trouble Concentrating on Things - More Than Half the Days
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Trouble Concentrating on Things - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Moving Slowly or Fidgety/Restless - Not At All
|
16 Participants
|
6 Participants
|
19 Participants
|
22 Participants
|
21 Participants
|
21 Participants
|
21 Participants
|
21 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Moving Slowly or Fidgety/Restless - Several Days
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Moving Slowly or Fidgety/Restless - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Moving Slowly or Fidgety/Restless - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Thoughts You Be Better Off Dead - Not At All
|
16 Participants
|
6 Participants
|
20 Participants
|
22 Participants
|
21 Participants
|
22 Participants
|
21 Participants
|
22 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Thoughts You Be Better Off Dead - Several Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Thoughts You Be Better Off Dead - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 0 - Thoughts You Be Better Off Dead - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Little Interest/Pleasure in Things - Not At All
|
13 Participants
|
5 Participants
|
16 Participants
|
17 Participants
|
21 Participants
|
19 Participants
|
16 Participants
|
18 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Little Interest/Pleasure in Things - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Little Interest/Pleasure in Things - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Feeling Down Depressed or Hopeless - Not At All
|
12 Participants
|
6 Participants
|
18 Participants
|
20 Participants
|
21 Participants
|
21 Participants
|
17 Participants
|
18 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Feeling Down Depressed or Hopeless - Several Days
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Feeling Down Depressed or Hopeless - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Trouble Falling or Staying Asleep - Not At All
|
14 Participants
|
4 Participants
|
14 Participants
|
16 Participants
|
19 Participants
|
17 Participants
|
13 Participants
|
15 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Trouble Falling or Staying Asleep - Several Days
|
0 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Trouble Falling or Staying Asleep - More Than Half the Days
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Trouble Falling or Staying Asleep - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Feeling Tired or Little Energy - Not At All
|
11 Participants
|
3 Participants
|
13 Participants
|
17 Participants
|
18 Participants
|
17 Participants
|
16 Participants
|
14 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Feeling Tired or Little Energy - Several Days
|
3 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Feeling Tired or Little Energy - More Than Half the Days
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Feeling Tired or Little Energy - Nearly Every Day
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Poor Appetite or Overeating - Not At All
|
12 Participants
|
2 Participants
|
15 Participants
|
15 Participants
|
19 Participants
|
18 Participants
|
17 Participants
|
17 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Poor Appetite or Overeating - Several Days
|
2 Participants
|
3 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Poor Appetite or Overeating - More Than Half the Days
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Poor Appetite or Overeating - Nearly Every Day
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 2 - Feeling Bad About Yourself - Not At All
|
14 Participants
|
6 Participants
|
18 Participants
|
21 Participants
|
21 Participants
|
20 Participants
|
19 Participants
|
19 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Feeling Down Depressed or Hopeless - Several Days
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Feeling Down Depressed or Hopeless - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Feeling Down Depressed or Hopeless - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Trouble Falling or Staying Asleep - Not At All
|
11 Participants
|
3 Participants
|
12 Participants
|
12 Participants
|
15 Participants
|
14 Participants
|
12 Participants
|
9 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Trouble Falling or Staying Asleep - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Feeling Tired or Little Energy - Not At All
|
10 Participants
|
3 Participants
|
12 Participants
|
14 Participants
|
14 Participants
|
14 Participants
|
11 Participants
|
9 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Feeling Tired or Little Energy - Several Days
|
3 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Feeling Tired or Little Energy - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Feeling Tired or Little Energy - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Poor Appetite or Overeating - Not At All
|
10 Participants
|
2 Participants
|
14 Participants
|
13 Participants
|
14 Participants
|
14 Participants
|
9 Participants
|
12 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Poor Appetite or Overeating - Several Days
|
3 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Poor Appetite or Overeating - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Poor Appetite or Overeating - Nearly Every Day
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Feeling Bad About Yourself - Not At All
|
13 Participants
|
5 Participants
|
18 Participants
|
18 Participants
|
16 Participants
|
16 Participants
|
13 Participants
|
14 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Feeling Bad About Yourself - Several Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Feeling Bad About Yourself - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Feeling Bad About Yourself - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Trouble Concentrating on Things - Not At All
|
11 Participants
|
5 Participants
|
17 Participants
|
17 Participants
|
16 Participants
|
16 Participants
|
14 Participants
|
14 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Trouble Concentrating on Things - Several Days
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Trouble Concentrating on Things - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Trouble Concentrating on Things - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Moving Slowly or Fidgety/Restless - Not At All
|
12 Participants
|
5 Participants
|
17 Participants
|
18 Participants
|
16 Participants
|
16 Participants
|
14 Participants
|
14 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Moving Slowly or Fidgety/Restless - Several Days
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Moving Slowly or Fidgety/Restless - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Moving Slowly or Fidgety/Restless - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Thoughts You Be Better Off Dead - Not At All
|
13 Participants
|
5 Participants
|
18 Participants
|
18 Participants
|
16 Participants
|
16 Participants
|
14 Participants
|
14 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Thoughts You Be Better Off Dead - Several Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Thoughts You Be Better Off Dead - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Week 12 - Thoughts You Be Better Off Dead - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Little Interest/Pleasure in Things - Not At All
|
11 Participants
|
5 Participants
|
14 Participants
|
17 Participants
|
16 Participants
|
17 Participants
|
13 Participants
|
12 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Little Interest/Pleasure in Things - Several Days
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Little Interest/Pleasure in Things - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Little Interest/Pleasure in Things - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Trouble Falling or Staying Asleep - More Than Half the Days
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Feeling Down Depressed or Hopeless - Not At All
|
13 Participants
|
5 Participants
|
17 Participants
|
17 Participants
|
16 Participants
|
16 Participants
|
13 Participants
|
12 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Feeling Down Depressed or Hopeless - Several Days
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Feeling Down Depressed or Hopeless - More Than Half the Days
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Feeling Down Depressed or Hopeless - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Trouble Falling or Staying Asleep - Not At All
|
12 Participants
|
4 Participants
|
12 Participants
|
13 Participants
|
14 Participants
|
15 Participants
|
12 Participants
|
9 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Trouble Falling or Staying Asleep - Several Days
|
0 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Response to Patient Health Questionnaire-9 (PHQ-9)
Follow-Up - Trouble Falling or Staying Asleep - Nearly Every Day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2Population: Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored.
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Outcome measures
| Measure |
Placebo (T2DM)
n=16 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=20 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
n=21 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline (CFB) in Fasting Plasma Glucose at Week 2
|
-5.63 mg/dL
Interval -19.0 to 7.74
|
-3.32 mg/dL
Interval -14.62 to 7.97
|
-23.04 mg/dL
Interval -34.05 to -12.03
|
-36.48 mg/dL
Interval -47.44 to -25.52
|
-39.29 mg/dL
Interval -50.23 to -28.35
|
-25.15 mg/dL
Interval -36.59 to -13.72
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored.
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Outcome measures
| Measure |
Placebo (T2DM)
n=16 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=20 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
n=21 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
CFB in Fasting Plasma Glucose at Week 4
|
-13.12 mg/dL
Interval -26.88 to 0.64
|
-16.45 mg/dL
Interval -28.11 to -4.79
|
-32.77 mg/dL
Interval -43.98 to -21.55
|
-45.92 mg/dL
Interval -57.2 to -34.64
|
-48.97 mg/dL
Interval -60.52 to -37.42
|
-41.60 mg/dL
Interval -53.38 to -29.83
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored.
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Outcome measures
| Measure |
Placebo (T2DM)
n=16 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=20 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
n=21 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
CFB in Fasting Plasma Glucose at Week 6
|
-3.75 mg/dL
Interval -19.85 to 12.35
|
-29.33 mg/dL
Interval -43.35 to -15.31
|
-36.70 mg/dL
Interval -50.13 to -23.27
|
-43.82 mg/dL
Interval -57.9 to -29.75
|
-49.22 mg/dL
Interval -63.14 to -35.31
|
-37.38 mg/dL
Interval -51.77 to -22.99
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored.
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Outcome measures
| Measure |
Placebo (T2DM)
n=16 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=20 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
n=21 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
CFB in Fasting Plasma Glucose at Week 8
|
-5.90 mg/dL
Interval -20.83 to 9.04
|
-33.69 mg/dL
Interval -47.42 to -19.96
|
-31.57 mg/dL
Interval -44.56 to -18.58
|
-52.84 mg/dL
Interval -66.55 to -39.13
|
-39.69 mg/dL
Interval -53.63 to -25.75
|
-48.02 mg/dL
Interval -62.47 to -33.57
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 10Population: Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored.
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Outcome measures
| Measure |
Placebo (T2DM)
n=16 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=20 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
n=21 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
CFB in Fasting Plasma Glucose at Week 10
|
-23.39 mg/dL
Interval -39.07 to -7.71
|
-36.24 mg/dL
Interval -51.69 to -20.78
|
-38.21 mg/dL
Interval -52.17 to -24.26
|
-57.36 mg/dL
Interval -72.43 to -42.29
|
-22.08 mg/dL
Interval -36.88 to -7.29
|
-37.81 mg/dL
Interval -53.52 to -22.11
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored.
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Outcome measures
| Measure |
Placebo (T2DM)
n=16 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=20 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
n=21 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
CFB in Fasting Plasma Glucose at Week 12
|
-13.09 mg/dL
Interval -29.75 to 3.57
|
-41.74 mg/dL
Interval -58.49 to -25.0
|
-40.41 mg/dL
Interval -55.25 to -25.57
|
-53.94 mg/dL
Interval -70.26 to -37.63
|
-23.34 mg/dL
Interval -39.52 to -7.17
|
-37.48 mg/dL
Interval -55.27 to -19.69
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 2Population: Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored.
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Outcome measures
| Measure |
Placebo (T2DM)
n=16 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=20 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
n=21 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
CFB in Glycolated Hemoglobin A1c (HbA1c) at Week 2
|
-0.03 Percentage
Interval -0.2 to 0.14
|
-0.12 Percentage
Interval -0.26 to 0.02
|
-0.29 Percentage
Interval -0.43 to -0.15
|
-0.37 Percentage
Interval -0.51 to -0.24
|
-0.35 Percentage
Interval -0.49 to -0.21
|
-0.20 Percentage
Interval -0.34 to -0.05
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored.
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Outcome measures
| Measure |
Placebo (T2DM)
n=16 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=20 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
n=21 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
CFB in Glycolated HbA1c at Week 4
|
-0.22 Percentage
Interval -0.45 to 0.0
|
-0.33 Percentage
Interval -0.52 to -0.14
|
-0.59 Percentage
Interval -0.77 to -0.41
|
-0.81 Percentage
Interval -1.0 to -0.63
|
-0.75 Percentage
Interval -0.94 to -0.56
|
-0.58 Percentage
Interval -0.78 to -0.39
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored.
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Outcome measures
| Measure |
Placebo (T2DM)
n=16 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=20 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
n=21 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
CFB in Glycolated HbA1c at Week 6
|
-0.26 Percentage
Interval -0.56 to 0.04
|
-0.49 Percentage
Interval -0.75 to -0.24
|
-0.92 Percentage
Interval -1.16 to -0.67
|
-1.11 Percentage
Interval -1.36 to -0.86
|
-0.97 Percentage
Interval -1.22 to -0.72
|
-0.93 Percentage
Interval -1.19 to -0.68
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored.
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Outcome measures
| Measure |
Placebo (T2DM)
n=16 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=20 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
n=21 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
CFB in Glycolated HbA1c at Week 8
|
-0.27 Percentage
Interval -0.6 to 0.05
|
-0.71 Percentage
Interval -0.99 to -0.43
|
-1.14 Percentage
Interval -1.41 to -0.88
|
-1.38 Percentage
Interval -1.65 to -1.1
|
-1.20 Percentage
Interval -1.48 to -0.92
|
-1.18 Percentage
Interval -1.47 to -0.89
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 10Population: Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored.
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Outcome measures
| Measure |
Placebo (T2DM)
n=16 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=20 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
n=21 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
CFB in Glycolated HbA1c at Week 10
|
-0.32 Percentage
Interval -0.69 to 0.05
|
-1.00 Percentage
Interval -1.33 to -0.67
|
-1.26 Percentage
Interval -1.57 to -0.95
|
-1.48 Percentage
Interval -1.81 to -1.16
|
-1.22 Percentage
Interval -1.55 to -0.89
|
-1.36 Percentage
Interval -1.7 to -1.03
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored.
Baseline was defined as the result closest prior to dosing at Day1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.
Outcome measures
| Measure |
Placebo (T2DM)
n=16 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=20 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
n=21 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
CFB in Glycolated HbA1c at Week 12
|
-0.32 Percentage
Interval -0.73 to 0.1
|
-1.07 Percentage
Interval -1.45 to -0.7
|
-1.32 Percentage
Interval -1.67 to -0.97
|
-1.56 Percentage
Interval -1.94 to -1.19
|
-1.04 Percentage
Interval -1.42 to -0.67
|
-1.57 Percentage
Interval -1.96 to -1.18
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 2Population: Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored.
Baseline was defined as the average of a duplicate measurement closest prior to dosing at Day 1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. Average of the duplicate measurements (where applicable) was used in analyses.
Outcome measures
| Measure |
Placebo (T2DM)
n=20 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
n=21 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
CFB in Body Weight at Week 2 (Participants With T2DM)
|
-0.14 kg
Interval -0.72 to 0.44
|
-0.40 kg
Interval -0.89 to 0.08
|
-0.22 kg
Interval -0.7 to 0.26
|
-0.46 kg
Interval -0.94 to 0.02
|
-0.63 kg
Interval -1.11 to -0.16
|
-0.21 kg
Interval -0.72 to 0.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored.
Baseline was defined as the average of a duplicate measurement closest prior to dosing at Day 1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. Average of the duplicate measurements (where applicable) was used in analyses.
Outcome measures
| Measure |
Placebo (T2DM)
n=20 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
n=21 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
CFB in Body Weight at Week 4 (Participants With T2DM)
|
-0.46 kg
Interval -1.4 to 0.47
|
-1.23 kg
Interval -2.03 to -0.44
|
-0.34 kg
Interval -1.11 to 0.43
|
-1.58 kg
Interval -2.35 to -0.81
|
-1.47 kg
Interval -2.25 to -0.7
|
-0.41 kg
Interval -1.23 to 0.41
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored.
Baseline was defined as the average of a duplicate measurement closest prior to dosing at Day 1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. Average of the duplicate measurements (where applicable) was used in analyses.
Outcome measures
| Measure |
Placebo (T2DM)
n=20 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
n=21 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
CFB in Body Weight at Week 6 (Participants With T2DM)
|
-0.38 kg
Interval -1.42 to 0.66
|
-1.86 kg
Interval -2.77 to -0.95
|
-0.65 kg
Interval -1.52 to 0.23
|
-2.74 kg
Interval -3.65 to -1.83
|
-2.23 kg
Interval -3.13 to -1.33
|
-1.16 kg
Interval -2.1 to -0.21
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored.
Baseline was defined as the average of a duplicate measurement closest prior to dosing at Day 1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. Average of the duplicate measurements (where applicable) was used in analyses.
Outcome measures
| Measure |
Placebo (T2DM)
n=20 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
n=21 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
CFB in Body Weight at Week 8 (Participants With T2DM)
|
-0.36 kg
Interval -1.51 to 0.8
|
-2.52 kg
Interval -3.55 to -1.48
|
-1.08 kg
Interval -2.07 to -0.09
|
-3.82 kg
Interval -4.86 to -2.79
|
-2.41 kg
Interval -3.43 to -1.38
|
-3.32 kg
Interval -4.42 to -2.23
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 10Population: Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored.
Baseline was defined as the average of a duplicate measurement closest prior to dosing at Day 1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. Average of the duplicate measurements (where applicable) was used in analyses.
Outcome measures
| Measure |
Placebo (T2DM)
n=20 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
n=21 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
CFB in Body Weight at Week 10 (Participants With T2DM)
|
-0.67 kg
Interval -1.96 to 0.61
|
-3.14 kg
Interval -4.34 to -1.93
|
-1.71 kg
Interval -2.83 to -0.58
|
-4.95 kg
Interval -6.15 to -3.75
|
-3.35 kg
Interval -4.53 to -2.18
|
-4.38 kg
Interval -5.64 to -3.12
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Estimand Set 1A that all evaluable participants with T2DM randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP and/or received glycemic rescue medication, all subsequent values were censored.
Baseline was defined as the average of a duplicate measurement closest prior to dosing at Day 1. The MMRM model included treatment, time, strata (male versus female) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. An unstructured covariance matrix was used to estimate the variances and covariance within participant across time points. Average of the duplicate measurements (where applicable) was used in analyses.
Outcome measures
| Measure |
Placebo (T2DM)
n=20 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
n=21 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
CFB in Body Weight at Week 12 (Participants With T2DM)
|
-0.42 kg
Interval -1.87 to 1.03
|
-3.64 kg
Interval -5.03 to -2.24
|
-1.93 kg
Interval -3.22 to -0.64
|
-5.38 kg
Interval -6.77 to -3.98
|
-2.93 kg
Interval -4.29 to -1.56
|
-5.37 kg
Interval -6.86 to -3.88
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 2Population: Estimand set 1B that all evaluable non-diabetic participants with obesity randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP, all subsequent values were censored.
Body weight were measured in duplicate as indicated. The second weight measurement were obtained at least 1-2 minutes apart from the first weight measurement. Weight were 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; ie, the device distinguished a difference between 68.4 kg vs 68.3 kg. The scale was placed on a stable, flat surface. Weight measurement was taken under the following conditions: participant is in a fasted state; after void of urine; after removal of shoes, bulky layers of clothing and jackets so that only light clothing remained; while remaining was during the measurement.
Outcome measures
| Measure |
Placebo (T2DM)
n=6 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
CFB in Body Weight at Week 2 (Non-diabetic Participants With Obesity)
|
0.23 kg
Interval -0.81 to 1.26
|
-0.73 kg
Interval -1.34 to -0.13
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: Estimand set 1B that all evaluable non-diabetic participants with obesity randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP, all subsequent values were censored.
Body weight were measured in duplicate as indicated. The second weight measurement were obtained at least 1-2 minutes apart from the first weight measurement. Weight were 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; ie, the device distinguished a difference between 68.4 kg vs 68.3 kg. The scale was placed on a stable, flat surface. Weight measurement was taken under the following conditions: participant is in a fasted state; after void of urine; after removal of shoes, bulky layers of clothing and jackets so that only light clothing remained; while remaining was during the measurement.
Outcome measures
| Measure |
Placebo (T2DM)
n=6 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
CFB in Body Weight at Week 4 (Non-diabetic Participants With Obesity)
|
0.09 kg
Interval -1.21 to 1.4
|
-1.50 kg
Interval -2.25 to -0.74
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Estimand set 1B that all evaluable non-diabetic participants with obesity randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP, all subsequent values were censored.
Body weight were measured in duplicate as indicated. The second weight measurement were obtained at least 1-2 minutes apart from the first weight measurement. Weight were 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; ie, the device distinguished a difference between 68.4 kg vs 68.3 kg. The scale was placed on a stable, flat surface. Weight measurement was taken under the following conditions: participant is in a fasted state; after void of urine; after removal of shoes, bulky layers of clothing and jackets so that only light clothing remained; while remaining was during the measurement.
Outcome measures
| Measure |
Placebo (T2DM)
n=6 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
CFB in Body Weight at Week 6 (Non-diabetic Participants With Obesity)
|
-0.10 kg
Interval -2.28 to 2.08
|
-1.59 kg
Interval -2.86 to -0.33
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Estimand set 1B that all evaluable non-diabetic participants with obesity randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP, all subsequent values were censored.
Body weight were measured in duplicate as indicated. The second weight measurement were obtained at least 1-2 minutes apart from the first weight measurement. Weight were 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; ie, the device distinguished a difference between 68.4 kg vs 68.3 kg. The scale was placed on a stable, flat surface. Weight measurement was taken under the following conditions: participant is in a fasted state; after void of urine; after removal of shoes, bulky layers of clothing and jackets so that only light clothing remained; while remaining was during the measurement.
Outcome measures
| Measure |
Placebo (T2DM)
n=6 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
CFB in Body Weight at Week 8 (Non-diabetic Participants With Obesity)
|
0.26 kg
Interval -2.57 to 3.09
|
-2.36 kg
Interval -4.08 to -0.65
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 10Population: Estimand set 1B that all evaluable non-diabetic participants with obesity randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP, all subsequent values were censored.
Body weight were measured in duplicate as indicated. The second weight measurement were obtained at least 1-2 minutes apart from the first weight measurement. Weight were 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; ie, the device distinguished a difference between 68.4 kg vs 68.3 kg. The scale was placed on a stable, flat surface. Weight measurement was taken under the following conditions: participant is in a fasted state; after void of urine; after removal of shoes, bulky layers of clothing and jackets so that only light clothing remained; while remaining was during the measurement.
Outcome measures
| Measure |
Placebo (T2DM)
n=6 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
CFB in Body Weight at Week 10 (Non-diabetic Participants With Obesity)
|
-0.40 kg
Interval -3.17 to 2.37
|
-3.47 kg
Interval -5.21 to -1.73
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Estimand set 1B that all evaluable non-diabetic participants with obesity randomly assigned to IP and who took at least 1 dose of IP. For participants who discontinued IP, all subsequent values were censored.
Body weight were measured in duplicate as indicated. The second weight measurement were obtained at least 1-2 minutes apart from the first weight measurement. Weight were 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; ie, the device distinguished a difference between 68.4 kg vs 68.3 kg. The scale was placed on a stable, flat surface. Weight measurement was taken under the following conditions: participant is in a fasted state; after void of urine; after removal of shoes, bulky layers of clothing and jackets so that only light clothing remained; while remaining was during the measurement.
Outcome measures
| Measure |
Placebo (T2DM)
n=6 Participants
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=22 Participants
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
Placebo (Non-diabetic Obesity)
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
CFB in Body Weight at Week 12 (Non-diabetic Participants With Obesity)
|
-0.11 kg
Interval -3.93 to 3.72
|
-3.85 kg
Interval -6.25 to -1.44
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo (T2DM)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo (Non-diabetic Obesity)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
PF-06882961 80 mg BID Low, Slow (T2DM)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
PF-06882961 80 mg BID High, Slow (T2DM)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
PF-06882961 120 mg BID Low, Fast (T2DM)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
PF-06882961 120 mg BID High, Fast (T2DM)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
PF-06882961 200 mg BID (T2DM)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
PF-06882961 200 mg BID (Non-diabetic Obesity)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo (T2DM)
n=16 participants at risk
Participants with T2DM received matching placebo tablets orally twice daily (BID) with food.
|
Placebo (Non-diabetic Obesity)
n=6 participants at risk
Participants with non-diabetic obesity received matching placebo tablets orally BID with food.
|
PF-06882961 80 mg BID Low, Slow (T2DM)
n=20 participants at risk
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 80 mg over 12 weeks.
|
PF-06882961 80 mg BID High, Slow (T2DM)
n=22 participants at risk
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 80 mg over 12 weeks.
|
PF-06882961 120 mg BID Low, Fast (T2DM)
n=22 participants at risk
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 5 mg to 120 mg over 12 weeks.
|
PF-06882961 120 mg BID High, Fast (T2DM)
n=22 participants at risk
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 120 mg over 12 weeks.
|
PF-06882961 200 mg BID (T2DM)
n=21 participants at risk
Participants with T2DM received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
PF-06882961 200 mg BID (Non-diabetic Obesity)
n=22 participants at risk
Participants with non-diabetic obesity received PF-06882961 tablets orally BID with food. The dose were titrated from 10 mg to 200 mg over 12 weeks.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
5.0%
1/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
9.1%
2/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
1/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
16.7%
1/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
9.1%
2/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
|
Eye disorders
Pinguecula
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
Abdominal distension
|
0.00%
0/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
5.0%
1/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
9.5%
2/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
1/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
Abdominal pain
|
0.00%
0/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
10.0%
2/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
9.1%
2/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
4.8%
1/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
Abdominal pain upper
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
5.0%
1/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
13.6%
3/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
9.1%
2/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
1/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
13.6%
3/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
Constipation
|
0.00%
0/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
5.0%
1/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
1/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
1/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
1/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
9.5%
2/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
9.1%
2/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
|
12.5%
2/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
10.0%
2/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
1/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
22.7%
5/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
22.7%
5/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
4.8%
1/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
1/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
5.0%
1/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
1/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
9.1%
2/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
22.7%
5/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
4.8%
1/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
1/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
Faeces discoloured
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
1/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
Food poisoning
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
10.0%
2/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
1/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
1/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
4.8%
1/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
1/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
|
12.5%
2/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
20.0%
4/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
22.7%
5/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
27.3%
6/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
36.4%
8/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
47.6%
10/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
59.1%
13/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
|
12.5%
2/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
25.0%
5/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
18.2%
4/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
27.3%
6/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
40.9%
9/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
28.6%
6/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
45.5%
10/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
|
General disorders
Asthenia
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
1/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
|
General disorders
Chest discomfort
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
|
General disorders
Chest pain
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
|
General disorders
Fatigue
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
1/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
1/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
9.1%
2/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
|
General disorders
Pre-existing condition improved
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
Gastroenteritis
|
0.00%
0/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
16.7%
1/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
Gastroenteritis viral
|
0.00%
0/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
16.7%
1/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
Infected bite
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
Upper respiratory tract infection
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
1/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
10.0%
2/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
1/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
1/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
Muscle strain
|
0.00%
0/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
9.1%
2/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
Blood triglycerides increased
|
0.00%
0/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
9.5%
2/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
Electrocardiogram QT prolonged
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
Weight decreased
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
9.1%
2/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
5.0%
1/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
9.1%
2/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
18.2%
4/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
1/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
19.0%
4/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
Dyslipidaemia
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
5.0%
1/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
13.6%
3/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
13.6%
3/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
4.8%
1/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
9.1%
2/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
4.8%
1/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
9.1%
2/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
16.7%
1/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
16.7%
1/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
4.8%
1/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
Amnesia
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
10.0%
2/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
1/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
9.1%
2/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
9.1%
2/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
18.2%
4/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
16.7%
1/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
5.0%
1/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
13.6%
3/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
1/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
1/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
9.1%
2/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
Neuropathy peripheral
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
|
Renal and urinary disorders
Polyuria
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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
|
6.2%
1/16 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/6 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/20 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/21 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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%
0/22 • Baseline through follow-up (Day 112-119).
Same event may appear as both an AE and 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