Trial Outcomes & Findings for A Study of PF-05175157 in Healthy Volunteers and Type 2 Diabetic Patients (NCT NCT01396161)
NCT ID: NCT01396161
Last Updated: 2016-11-07
Results Overview
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to PF-05175157 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
64 participants
Primary outcome timeframe
2 weeks
Results posted on
2016-11-07
Participant Flow
Participant milestones
| Measure |
Placebo - Healthy and Overweight Participants (HOV)
HOV participants administered orally matched placebo capsules once daily (QD) for 14 days
|
Placebo - Type 2 Diabetes Mellitus Participants (T2DM)
T2DM participants administered orally matched placebo capsules QD for 14 days
|
PF-05175157 30 mg QD - HOV
HOV participants administered orally 30 milligram (mg) capsules of PF-05175157 QD for 14 days
|
PF-05175157 100 mg QD - HOV
HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 200 mg QD - HOV
HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 100 mg BID - HOV
HOV participants administered orally 100 mg capsules of PF-05175157 twice daily (BID) for 14 days
|
PF-05175157 200 mg QD - T2DM
T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
5
|
9
|
9
|
9
|
9
|
11
|
|
Overall Study
COMPLETED
|
12
|
5
|
9
|
9
|
8
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo - Healthy and Overweight Participants (HOV)
HOV participants administered orally matched placebo capsules once daily (QD) for 14 days
|
Placebo - Type 2 Diabetes Mellitus Participants (T2DM)
T2DM participants administered orally matched placebo capsules QD for 14 days
|
PF-05175157 30 mg QD - HOV
HOV participants administered orally 30 milligram (mg) capsules of PF-05175157 QD for 14 days
|
PF-05175157 100 mg QD - HOV
HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 200 mg QD - HOV
HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 100 mg BID - HOV
HOV participants administered orally 100 mg capsules of PF-05175157 twice daily (BID) for 14 days
|
PF-05175157 200 mg QD - T2DM
T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of PF-05175157 in Healthy Volunteers and Type 2 Diabetic Patients
Baseline characteristics by cohort
| Measure |
Placebo - HOV
n=12 Participants
HOV participants administered orally matched placebo capsules QD for 14 days
|
Placebo - T2DM
n=5 Participants
T2DM participants administered orally matched placebo capsules QD for 14 days
|
PF-05175157 30 mg QD - HOV
n=9 Participants
HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 100 mg QD -HOV
n=9 Participants
HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 200 mg QD - HOV
n=9 Participants
HOV participants administered orally 200 mg capsules PF-05175157 QD for 14 days
|
PF-05175157 100 mg BID - HOV
n=9 Participants
HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
|
PF-05175157 200 mg QD - T2DM
n=11 Participants
T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18 to 44 years
|
9 participants
n=5 Participants
|
2 participants
n=7 Participants
|
9 participants
n=5 Participants
|
7 participants
n=4 Participants
|
8 participants
n=21 Participants
|
7 participants
n=10 Participants
|
2 participants
n=115 Participants
|
44 participants
n=6 Participants
|
|
Age, Customized
45 to 64 years
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
1 participants
n=21 Participants
|
2 participants
n=10 Participants
|
9 participants
n=115 Participants
|
20 participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
61 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Safety Analysis Set: all participants who received at least 1 dose of study medication (PF-05175157 or placebo).
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to PF-05175157 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Outcome measures
| Measure |
Placebo - HOV
n=12 Participants
HOV participants administered orally matched placebo capsules QD for 14 days
|
Placebo - T2DM
n=5 Participants
T2DM participants administered orally matched placebo capsules QD for 14 days
|
PF-05175157 30 mg QD - HOV
n=9 Participants
HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 100 mg QD - HOV
n=9 Participants
HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 200 mg QD - HOV
n=9 Participants
HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 100 mg BID - HOV
n=9 Participants
HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
|
PF-05175157 200 mg QD - T2DM
n=11 Participants
T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
2 participants
|
2 participants
|
1 participants
|
1 participants
|
2 participants
|
5 participants
|
3 participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11Population: Pharmacokinetic Concentration (PKC) Analysis Population: all enrolled participants who received at least 1 dose of PF-05175157 and had at least 1 concentration value reported. Number of Participants Analyzed (N): number of participants with evaluable data
Outcome measures
| Measure |
Placebo - HOV
n=9 Participants
HOV participants administered orally matched placebo capsules QD for 14 days
|
Placebo - T2DM
n=8 Participants
T2DM participants administered orally matched placebo capsules QD for 14 days
|
PF-05175157 30 mg QD - HOV
n=8 Participants
HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 100 mg QD - HOV
n=9 Participants
HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 200 mg QD - HOV
n=10 Participants
HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 100 mg BID - HOV
HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
|
PF-05175157 200 mg QD - T2DM
T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
|
|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
3.07 micrograms per milliliter (µg/mL)
Standard Deviation 0.28
|
7.52 micrograms per milliliter (µg/mL)
Standard Deviation 2.87
|
21.75 micrograms per milliliter (µg/mL)
Standard Deviation 4.44
|
15.18 micrograms per milliliter (µg/mL)
Standard Deviation 2.11
|
23.26 micrograms per milliliter (µg/mL)
Standard Deviation 4.43
|
—
|
—
|
SECONDARY outcome
Timeframe: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11Population: Pharmacokinetic Parameter (PKP) Analysis Population: all enrolled participante who received at least 1 dose of PF05175157 and had at least 1 PKP of interest calculated;Number of Participants Analyzed (N): number of participants with evaluable data
Outcome measures
| Measure |
Placebo - HOV
n=9 Participants
HOV participants administered orally matched placebo capsules QD for 14 days
|
Placebo - T2DM
n=8 Participants
T2DM participants administered orally matched placebo capsules QD for 14 days
|
PF-05175157 30 mg QD - HOV
n=8 Participants
HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 100 mg QD - HOV
n=9 Participants
HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 200 mg QD - HOV
n=10 Participants
HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 100 mg BID - HOV
HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
|
PF-05175157 200 mg QD - T2DM
T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
|
|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
4.00 hours (hrs)
Interval 1.0 to 4.0
|
1.00 hours (hrs)
Interval 1.0 to 6.0
|
4.00 hours (hrs)
Interval 3.0 to 4.0
|
3.00 hours (hrs)
Interval 3.0 to 4.0
|
4.00 hours (hrs)
Interval 2.0 to 6.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11Population: PKP analysis population; Participants Analyzed (N): number of participants with evaluable data
Outcome measures
| Measure |
Placebo - HOV
n=9 Participants
HOV participants administered orally matched placebo capsules QD for 14 days
|
Placebo - T2DM
n=8 Participants
T2DM participants administered orally matched placebo capsules QD for 14 days
|
PF-05175157 30 mg QD - HOV
n=8 Participants
HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 100 mg QD - HOV
n=9 Participants
HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 200 mg QD - HOV
n=10 Participants
HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 100 mg BID - HOV
HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
|
PF-05175157 200 mg QD - T2DM
T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
|
|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
|
32.86 µg times (*)hr divided by mL (µg *hr/mL)
Standard Deviation 4.01
|
90.50 µg times (*)hr divided by mL (µg *hr/mL)
Standard Deviation 33.40
|
255.9 µg times (*)hr divided by mL (µg *hr/mL)
Standard Deviation 36.98
|
125.6 µg times (*)hr divided by mL (µg *hr/mL)
Standard Deviation 16.73
|
282.6 µg times (*)hr divided by mL (µg *hr/mL)
Standard Deviation 66.21
|
—
|
—
|
SECONDARY outcome
Timeframe: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11Population: PKP analysis population; Participants Analyzed (N): number of participants with evaluable data
Rˇac for the AUC is defined as AUC (τ, single dose \[ss\]) / AUC (τ, multiple dose \[sd\]).
Outcome measures
| Measure |
Placebo - HOV
n=9 Participants
HOV participants administered orally matched placebo capsules QD for 14 days
|
Placebo - T2DM
n=8 Participants
T2DM participants administered orally matched placebo capsules QD for 14 days
|
PF-05175157 30 mg QD - HOV
n=8 Participants
HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 100 mg QD - HOV
n=9 Participants
HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 200 mg QD - HOV
n=10 Participants
HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 100 mg BID - HOV
HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
|
PF-05175157 200 mg QD - T2DM
T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
|
|---|---|---|---|---|---|---|---|
|
Accumulation Ratio for Area Under the Concentration-Time Curve (Rˇac, AUC)
|
1.39 ratio
Standard Deviation 0.11
|
1.01 ratio
Standard Deviation 0.34
|
1.47 ratio
Standard Deviation 0.22
|
2.53 ratio
Standard Deviation 0.76
|
1.54 ratio
Standard Deviation 0.22
|
—
|
—
|
SECONDARY outcome
Timeframe: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11Population: PKP analysis population; Participants Analyzed (N): number of participants with evaluable data
CLr is the amount of unchanged drug excreted in the participants urine from time zero to end of dosing interval.
Outcome measures
| Measure |
Placebo - HOV
n=9 Participants
HOV participants administered orally matched placebo capsules QD for 14 days
|
Placebo - T2DM
n=8 Participants
T2DM participants administered orally matched placebo capsules QD for 14 days
|
PF-05175157 30 mg QD - HOV
n=8 Participants
HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 100 mg QD - HOV
n=9 Participants
HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 200 mg QD - HOV
n=10 Participants
HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 100 mg BID - HOV
HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
|
PF-05175157 200 mg QD - T2DM
T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
|
|---|---|---|---|---|---|---|---|
|
Renal Clearance (CLr)
|
5.48 mL/min
Standard Deviation 1.25
|
5.30 mL/min
Standard Deviation 1.42
|
4.57 mL/min
Standard Deviation 1.83
|
5.93 mL/min
Standard Deviation 1.86
|
5.42 mL/min
Standard Deviation 1.38
|
—
|
—
|
SECONDARY outcome
Timeframe: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11Population: It was not possible to calculate data for half-life as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase, which is needed for the calculation of the half-life.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11Population: PKP analysis population; Participants Analyzed (N): number of participants with evaluable data
Percentage of PF-05175157 excreted unchanged in urine over the dosing interval.
Outcome measures
| Measure |
Placebo - HOV
n=9 Participants
HOV participants administered orally matched placebo capsules QD for 14 days
|
Placebo - T2DM
n=8 Participants
T2DM participants administered orally matched placebo capsules QD for 14 days
|
PF-05175157 30 mg QD - HOV
n=8 Participants
HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 100 mg QD - HOV
n=9 Participants
HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 200 mg QD - HOV
n=10 Participants
HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 100 mg BID - HOV
HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
|
PF-05175157 200 mg QD - T2DM
T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
|
|---|---|---|---|---|---|---|---|
|
Urinary Recovery
|
35.59 percentage
Standard Deviation 7.78
|
27.30 percentage
Standard Deviation 8.14
|
33.75 percentage
Standard Deviation 9.53
|
43.60 percentage
Standard Deviation 10.72
|
44.31 percentage
Standard Deviation 7.79
|
—
|
—
|
Adverse Events
Placebo - HOV
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo - T2DM
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-05175157 30 mg QD - HOV
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PF-05175157 100 mg QD - HOV
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PF-05175157 200 mg QD - HOV
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-05175157 100 mg BID - HOV
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-05175157 200 mg QD - T2DM
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo - HOV
n=12 participants at risk
HOV participants administered orally matched placebo capsules QD for 14 days
|
Placebo - T2DM
n=5 participants at risk
T2DM participants administered orally matched placebo capsules QD for 14 days
|
PF-05175157 30 mg QD - HOV
n=9 participants at risk
HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 100 mg QD - HOV
n=9 participants at risk
HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 200 mg QD - HOV
n=9 participants at risk
HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
|
PF-05175157 100 mg BID - HOV
n=9 participants at risk
HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
|
PF-05175157 200 mg QD - T2DM
n=11 participants at risk
T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
|
|---|---|---|---|---|---|---|---|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
11.1%
1/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctival irritation
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
11.1%
1/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
11.1%
1/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Dry eye
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
11.1%
1/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
11.1%
1/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
18.2%
2/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
11.1%
1/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
11.1%
1/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
11.1%
1/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
11.1%
1/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
11.1%
1/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/9
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
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