Trial Outcomes & Findings for A 2-week Trial Of PF-04991532 In Patients With Type 2 Diabetes (NCT NCT01469065)
NCT ID: NCT01469065
Last Updated: 2013-10-30
Results Overview
Mean daily glucose (MDG) was calculated based on the mean of 8 glucose measurements at pre-specified time points throughout the day on Day -1 and Day 14.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
82 participants
Primary outcome timeframe
Baseline: hours -46, -44, -42, -40, -38, -36, -33, -and -30 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 4, 6, 8, 10, 12, 15, and 18 hours after Day 14 morning dose
Results posted on
2013-10-30
Participant Flow
Participant milestones
| Measure |
Placebo
PF-04991532 matching placebo orally twice daily for 2 weeks.
|
PF-04991532 25 mg
PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
|
PF-04991532 75 mg
PF-04991532 75 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 150 mg
PF-04991532 150 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 300 mg
PF-04991532 300 mg tablet orally twice daily for 2 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
16
|
16
|
17
|
|
Overall Study
COMPLETED
|
16
|
16
|
16
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
PF-04991532 matching placebo orally twice daily for 2 weeks.
|
PF-04991532 25 mg
PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
|
PF-04991532 75 mg
PF-04991532 75 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 150 mg
PF-04991532 150 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 300 mg
PF-04991532 300 mg tablet orally twice daily for 2 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Other
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A 2-week Trial Of PF-04991532 In Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Placebo
n=16 Participants
PF-04991532 matching placebo orally twice daily for 2 weeks.
|
PF-04991532 25 mg
n=17 Participants
PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
|
PF-04991532 75 mg
n=16 Participants
PF-04991532 75 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 150 mg
n=16 Participants
PF-04991532 150 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 300 mg
n=17 Participants
PF-04991532 300 mg tablet orally twice daily for 2 weeks.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age Continuous
|
59.2 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
57.4 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
57.0 years
STANDARD_DEVIATION 9.4 • n=4 Participants
|
56.1 years
STANDARD_DEVIATION 8.0 • n=21 Participants
|
57.2 years
STANDARD_DEVIATION 8.9 • n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
62 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline: hours -46, -44, -42, -40, -38, -36, -33, -and -30 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 4, 6, 8, 10, 12, 15, and 18 hours after Day 14 morning dosePopulation: The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest.
Mean daily glucose (MDG) was calculated based on the mean of 8 glucose measurements at pre-specified time points throughout the day on Day -1 and Day 14.
Outcome measures
| Measure |
Placebo
n=16 Participants
PF-04991532 matching placebo orally twice daily for 2 weeks.
|
PF-04991532 25 mg
n=16 Participants
PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
|
PF-04991532 75 mg
n=16 Participants
PF-04991532 75 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 150 mg
n=16 Participants
PF-04991532 150 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 300 mg
n=16 Participants
PF-04991532 300 mg tablet orally twice daily for 2 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline (Day -1) in Mean Daily Glucose at Day 14
Baseline (Day -1)
|
228.67 milligram/deciliter (mg/dL)
Standard Deviation 36.26
|
233.20 milligram/deciliter (mg/dL)
Standard Deviation 41.01
|
219.13 milligram/deciliter (mg/dL)
Standard Deviation 38.16
|
229.92 milligram/deciliter (mg/dL)
Standard Deviation 52.93
|
218.20 milligram/deciliter (mg/dL)
Standard Deviation 53.01
|
|
Change From Baseline (Day -1) in Mean Daily Glucose at Day 14
Change from Baseline (Day 14)
|
24.98 milligram/deciliter (mg/dL)
Standard Deviation 40.48
|
-17.55 milligram/deciliter (mg/dL)
Standard Deviation 25.40
|
-3.67 milligram/deciliter (mg/dL)
Standard Deviation 33.79
|
-9.73 milligram/deciliter (mg/dL)
Standard Deviation 21.52
|
-29.23 milligram/deciliter (mg/dL)
Standard Deviation 32.80
|
SECONDARY outcome
Timeframe: 0 (before morning dose), 0.5, 1, 2, 3, 4, 6, 10, 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14Population: The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; "n" is the number of participants analyzed for each day.
Area under the plasma concentration versus time curve (AUC) from time zero to 24 hours post morning dose
Outcome measures
| Measure |
Placebo
n=16 Participants
PF-04991532 matching placebo orally twice daily for 2 weeks.
|
PF-04991532 25 mg
n=16 Participants
PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
|
PF-04991532 75 mg
n=16 Participants
PF-04991532 75 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 150 mg
n=17 Participants
PF-04991532 150 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 300 mg
PF-04991532 300 mg tablet orally twice daily for 2 weeks.
|
|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24) of PF-04991532
Day 1 (n=16, 16, 16, 17)
|
441.6 nanogram*hour/milliliter (ng*hr/mL)
Standard Deviation 172.3
|
1745 nanogram*hour/milliliter (ng*hr/mL)
Standard Deviation 757.1
|
3899 nanogram*hour/milliliter (ng*hr/mL)
Standard Deviation 1549
|
6943 nanogram*hour/milliliter (ng*hr/mL)
Standard Deviation 3053
|
—
|
|
Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24) of PF-04991532
Day 14 (n=16, 16, 16, 16)
|
487.4 nanogram*hour/milliliter (ng*hr/mL)
Standard Deviation 227.1
|
1892 nanogram*hour/milliliter (ng*hr/mL)
Standard Deviation 930.1
|
3870 nanogram*hour/milliliter (ng*hr/mL)
Standard Deviation 1369
|
7531 nanogram*hour/milliliter (ng*hr/mL)
Standard Deviation 3084
|
—
|
SECONDARY outcome
Timeframe: 0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14Population: The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; "n" is the number of participants analyzed for each day.
Area under the plasma concentration versus time curve (AUC) from time zero to 10 hours post morning dose.
Outcome measures
| Measure |
Placebo
n=16 Participants
PF-04991532 matching placebo orally twice daily for 2 weeks.
|
PF-04991532 25 mg
n=16 Participants
PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
|
PF-04991532 75 mg
n=16 Participants
PF-04991532 75 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 150 mg
n=17 Participants
PF-04991532 150 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 300 mg
PF-04991532 300 mg tablet orally twice daily for 2 weeks.
|
|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to 10 Hours Postdose (AUC10) of PF-04991532
Day 1 (n=16, 16, 16, 17)
|
372.1 ng*hr/mL
Standard Deviation 146.7
|
1447 ng*hr/mL
Standard Deviation 749.3
|
3329 ng*hr/mL
Standard Deviation 1153
|
5661 ng*hr/mL
Standard Deviation 2595
|
—
|
|
Area Under the Curve From Time Zero to 10 Hours Postdose (AUC10) of PF-04991532
Day 14 (n=16, 16, 16, 16)
|
384.7 ng*hr/mL
Standard Deviation 181.9
|
1508 ng*hr/mL
Standard Deviation 920.7
|
2882 ng*hr/mL
Standard Deviation 1128
|
5551 ng*hr/mL
Standard Deviation 2633
|
—
|
SECONDARY outcome
Timeframe: 0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morningOutcome measures
| Measure |
Placebo
n=17 Participants
PF-04991532 matching placebo orally twice daily for 2 weeks.
|
PF-04991532 25 mg
n=16 Participants
PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
|
PF-04991532 75 mg
n=16 Participants
PF-04991532 75 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 150 mg
n=17 Participants
PF-04991532 150 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 300 mg
PF-04991532 300 mg tablet orally twice daily for 2 weeks.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration of PF-04991532 After Morning Dose Administration (Cmax(AM))
Day 1 (n=17, 16, 16, 17)
|
137.7 ng/mL
Standard Deviation 57.36
|
486.6 ng/mL
Standard Deviation 363.7
|
1285 ng/mL
Standard Deviation 585.8
|
1951 ng/mL
Standard Deviation 1106
|
—
|
|
Maximum Observed Plasma Concentration of PF-04991532 After Morning Dose Administration (Cmax(AM))
Day 14 (n=16, 16, 16, 16)
|
148.2 ng/mL
Standard Deviation 74.23
|
469.8 ng/mL
Standard Deviation 495.3
|
902.4 ng/mL
Standard Deviation 489.1
|
1639 ng/mL
Standard Deviation 917.8
|
—
|
SECONDARY outcome
Timeframe: 10 (before evening dose), 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14Population: The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; "n" is the number of participants analyzed for each day.
Outcome measures
| Measure |
Placebo
n=16 Participants
PF-04991532 matching placebo orally twice daily for 2 weeks.
|
PF-04991532 25 mg
n=16 Participants
PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
|
PF-04991532 75 mg
n=16 Participants
PF-04991532 75 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 150 mg
n=17 Participants
PF-04991532 150 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 300 mg
PF-04991532 300 mg tablet orally twice daily for 2 weeks.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration of PF-04991532 After Evening Dose Administration (Cmax(PM))
Day 1 (n=16, 16, 16, 17)
|
97.10 ng/mL
Standard Deviation 67.45
|
336.0 ng/mL
Standard Deviation 219.7
|
932.0 ng/mL
Standard Deviation 387.7
|
1645 ng/mL
Standard Deviation 1132
|
—
|
|
Maximum Observed Plasma Concentration of PF-04991532 After Evening Dose Administration (Cmax(PM))
Day 14 (n=16, 16,16, 16)
|
89.99 ng/mL
Standard Deviation 46.05
|
360.7 ng/mL
Standard Deviation 288.8
|
772.4 ng/mL
Standard Deviation 310.8
|
1687 ng/mL
Standard Deviation 914.9
|
—
|
SECONDARY outcome
Timeframe: Day 14Population: The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest.
Outcome measures
| Measure |
Placebo
n=16 Participants
PF-04991532 matching placebo orally twice daily for 2 weeks.
|
PF-04991532 25 mg
n=16 Participants
PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
|
PF-04991532 75 mg
n=16 Participants
PF-04991532 75 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 150 mg
n=16 Participants
PF-04991532 150 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 300 mg
PF-04991532 300 mg tablet orally twice daily for 2 weeks.
|
|---|---|---|---|---|---|
|
Minimum Observed Plasma Trough Concentration (Cmin) of PF-04991532
|
0.1691 ng/mL
Standard Deviation 1.373
|
5.249 ng/mL
Standard Deviation 3.112
|
11.32 ng/mL
Standard Deviation 8.126
|
21.15 ng/mL
Standard Deviation 12.73
|
—
|
SECONDARY outcome
Timeframe: 0 (predose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14Population: The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; "n" is the number of participants analyzed for each day.
Outcome measures
| Measure |
Placebo
n=17 Participants
PF-04991532 matching placebo orally twice daily for 2 weeks.
|
PF-04991532 25 mg
n=16 Participants
PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
|
PF-04991532 75 mg
n=16 Participants
PF-04991532 75 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 150 mg
n=17 Participants
PF-04991532 150 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 300 mg
PF-04991532 300 mg tablet orally twice daily for 2 weeks.
|
|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04991532 After Morning Dose Administration (Tmax(AM))
Day 1 (n=17, 16, 16, 17)
|
1.00 hour
Interval 0.5 to 1.95
|
1.00 hour
Interval 0.5 to 6.0
|
1.83 hour
Interval 1.0 to 1.95
|
1.00 hour
Interval 0.5 to 3.0
|
—
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04991532 After Morning Dose Administration (Tmax(AM))
Day 14 (n=16, 16, 16, 16)
|
1.00 hour
Interval 0.5 to 1.95
|
1.00 hour
Interval 0.5 to 6.0
|
1.83 hour
Interval 0.5 to 6.0
|
1.45 hour
Interval 1.0 to 6.0
|
—
|
SECONDARY outcome
Timeframe: 10 (before evening dose), 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14Population: The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; "n" is the number of participants analyzed for each day.
Time was computed as post morning dose.
Outcome measures
| Measure |
Placebo
n=16 Participants
PF-04991532 matching placebo orally twice daily for 2 weeks.
|
PF-04991532 25 mg
n=16 Participants
PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
|
PF-04991532 75 mg
n=16 Participants
PF-04991532 75 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 150 mg
n=17 Participants
PF-04991532 150 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 300 mg
PF-04991532 300 mg tablet orally twice daily for 2 weeks.
|
|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04991532 After Evening Dose Administration (Tmax(PM))
Day 14 (n=16, 16, 16, 16)
|
11.0 hour
Interval 11.0 to 15.0
|
11.0 hour
Interval 11.0 to 15.0
|
11.0 hour
Interval 11.0 to 18.0
|
11.0 hour
Interval 11.0 to 18.0
|
—
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04991532 After Evening Dose Administration (Tmax(PM))
Day 1 (n=16, 16, 16, 17)
|
11.0 hour
Interval 11.0 to 15.0
|
11.0 hour
Interval 11.0 to 15.0
|
11.0 hour
Interval 11.0 to 12.0
|
11.0 hour
Interval 11.0 to 13.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 14: 0 (before morning dose), 0.5, 1, 2, 3, 4, 6, 10 (before evening dose), 10.5, 11, 12, 13, 15, 18 and 24 hours after morning dosePopulation: The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; "n" is the number of participants analyzed for each day.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Outcome measures
| Measure |
Placebo
n=16 Participants
PF-04991532 matching placebo orally twice daily for 2 weeks.
|
PF-04991532 25 mg
n=16 Participants
PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
|
PF-04991532 75 mg
n=16 Participants
PF-04991532 75 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 150 mg
n=17 Participants
PF-04991532 150 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 300 mg
PF-04991532 300 mg tablet orally twice daily for 2 weeks.
|
|---|---|---|---|---|---|
|
Apparent Oral Clearance (CL/F) of PF-04991532
Day 1 (n=16, 16, 16, 17)
|
1886 milliliter/minute (mL/min)
Standard Deviation 1112
|
1434 milliliter/minute (mL/min)
Standard Deviation 844.7
|
1282 milliliter/minute (mL/min)
Standard Deviation 431.5
|
1440 milliliter/minute (mL/min)
Standard Deviation 607.7
|
—
|
|
Apparent Oral Clearance (CL/F) of PF-04991532
D14 (n=16, 16, 16, 16)
|
1710 milliliter/minute (mL/min)
Standard Deviation 1200
|
1322 milliliter/minute (mL/min)
Standard Deviation 937.9
|
1292 milliliter/minute (mL/min)
Standard Deviation 624.5
|
1327 milliliter/minute (mL/min)
Standard Deviation 537.1
|
—
|
SECONDARY outcome
Timeframe: 0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14Population: The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest.
Area under the curve from time zero to 10 hours postdose of PF-04991532 (AUC10) of Day 14 divided by AUC10 of Day 1
Outcome measures
| Measure |
Placebo
n=16 Participants
PF-04991532 matching placebo orally twice daily for 2 weeks.
|
PF-04991532 25 mg
n=16 Participants
PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
|
PF-04991532 75 mg
n=16 Participants
PF-04991532 75 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 150 mg
n=16 Participants
PF-04991532 150 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 300 mg
PF-04991532 300 mg tablet orally twice daily for 2 weeks.
|
|---|---|---|---|---|---|
|
Observed Accumulation Ratio of Area Under the Curve From Time Zero to 10 Hours Postdose of PF-04991532 (Rac)
|
1.095 ratio
Standard Deviation 0.3520
|
1.049 ratio
Standard Deviation 0.2995
|
0.9004 ratio
Standard Deviation 0.3353
|
1.017 ratio
Standard Deviation 0.2946
|
—
|
SECONDARY outcome
Timeframe: 0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14Population: The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest.
Maximum observed plasma concentration of PF-04991532 after morning dose administration (Cmax(AM)) of Day 14 divided by Cmax(AM) of Day 1
Outcome measures
| Measure |
Placebo
n=16 Participants
PF-04991532 matching placebo orally twice daily for 2 weeks.
|
PF-04991532 25 mg
n=16 Participants
PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
|
PF-04991532 75 mg
n=16 Participants
PF-04991532 75 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 150 mg
n=16 Participants
PF-04991532 150 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 300 mg
PF-04991532 300 mg tablet orally twice daily for 2 weeks.
|
|---|---|---|---|---|---|
|
Observed Accumulation Ratio of Maximum Observed Plasma Concentration of PF-04991532 After Morning Dose Administration (Rac, Cmax(AM))
|
1.057 ratio
Standard Deviation 0.6267
|
0.9655 ratio
Standard Deviation 0.5913
|
0.7022 ratio
Standard Deviation 0.4744
|
0.8663 ratio
Standard Deviation 0.3648
|
—
|
SECONDARY outcome
Timeframe: 0 (before morning dose), 0.5, 1, 2, 3, 4, 6, 10, 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14Population: The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; "n" is the number of participants analyzed for each day.
Area under the curve from time zero to 24 Hours Postdose (AUC24) divided by total daily dose
Outcome measures
| Measure |
Placebo
n=16 Participants
PF-04991532 matching placebo orally twice daily for 2 weeks.
|
PF-04991532 25 mg
n=16 Participants
PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
|
PF-04991532 75 mg
n=16 Participants
PF-04991532 75 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 150 mg
n=17 Participants
PF-04991532 150 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 300 mg
PF-04991532 300 mg tablet orally twice daily for 2 weeks.
|
|---|---|---|---|---|---|
|
Dose Normalized Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24(dn)) of PF-04991532
Day 1 (n=16, 16, 16, 17)
|
4.416 ng*hr/mL/mg
Standard Deviation 1.723
|
5.810 ng*hr/mL/mg
Standard Deviation 2.520
|
6.497 ng*hr/mL/mg
Standard Deviation 2.578
|
5.787 ng*hr/mL/mg
Standard Deviation 2.540
|
—
|
|
Dose Normalized Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24(dn)) of PF-04991532
Day 14 (n=16, 16, 16, 16)
|
4.874 ng*hr/mL/mg
Standard Deviation 2.271
|
6.307 ng*hr/mL/mg
Standard Deviation 3.107
|
6.449 ng*hr/mL/mg
Standard Deviation 2.279
|
6.275 ng*hr/mL/mg
Standard Deviation 2.558
|
—
|
SECONDARY outcome
Timeframe: 0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14Population: The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; "n" is the number of participants analyzed for each day.
Maximum Observed Plasma Concentration of PF-04991532 after Morning Dose Administration (Cmax(AM)) divided by dose
Outcome measures
| Measure |
Placebo
n=17 Participants
PF-04991532 matching placebo orally twice daily for 2 weeks.
|
PF-04991532 25 mg
n=16 Participants
PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
|
PF-04991532 75 mg
n=16 Participants
PF-04991532 75 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 150 mg
n=17 Participants
PF-04991532 150 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 300 mg
PF-04991532 300 mg tablet orally twice daily for 2 weeks.
|
|---|---|---|---|---|---|
|
Dose Normalized Maximum Plasma Concentration After Morning Dose Administration (Cmax(AM)(dn)) of PF-04991532
Day 1 (n=17, 16, 16, 17)
|
2.754 ng/mL/mg
Standard Deviation 1.147
|
3.245 ng/mL/mg
Standard Deviation 2.431
|
4.283 ng/mL/mg
Standard Deviation 1.947
|
3.252 ng/mL/mg
Standard Deviation 1.842
|
—
|
|
Dose Normalized Maximum Plasma Concentration After Morning Dose Administration (Cmax(AM)(dn)) of PF-04991532
Day 14 (n=16, 16, 16, 16)
|
2.964 ng/mL/mg
Standard Deviation 1.484
|
3.132 ng/mL/mg
Standard Deviation 3.296
|
3.009 ng/mL/mg
Standard Deviation 1.631
|
2.732 ng/mL/mg
Standard Deviation 1.530
|
—
|
SECONDARY outcome
Timeframe: Baseline: hours -72, -70, -68, -66, -62, -60, -57, and -54 on Day -2 (Day 1 morning dose was hour 0); Day 13: 0 (before morning dose), 2, 4, 6, 10, 12, 15 and 18 hours after Day 13 morning dosePopulation: The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest.
Mean daily glucose (MDG) was calculated based on the mean of 8 glucose measurements at pre-specified time points throughout the day.
Outcome measures
| Measure |
Placebo
n=16 Participants
PF-04991532 matching placebo orally twice daily for 2 weeks.
|
PF-04991532 25 mg
n=16 Participants
PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
|
PF-04991532 75 mg
n=16 Participants
PF-04991532 75 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 150 mg
n=16 Participants
PF-04991532 150 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 300 mg
n=16 Participants
PF-04991532 300 mg tablet orally twice daily for 2 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline (Day -2) in Mean Daily Glucose at Day 13
Baseline (Day -2)
|
214.31 mg/dL
Standard Deviation 42.39
|
230.70 mg/dL
Standard Deviation 37.88
|
207.98 mg/dL
Standard Deviation 35.10
|
219.59 mg/dL
Standard Deviation 43.78
|
204.68 mg/dL
Standard Deviation 45.07
|
|
Change From Baseline (Day -2) in Mean Daily Glucose at Day 13
Change from Baseline (Day 13)
|
18.78 mg/dL
Standard Deviation 39.66
|
-27.22 mg/dL
Standard Deviation 25.34
|
-15.78 mg/dL
Standard Deviation 31.99
|
-17.29 mg/dL
Standard Deviation 17.75
|
-33.58 mg/dL
Standard Deviation 37.06
|
SECONDARY outcome
Timeframe: Baseline: hours -46, -45.75, -45.5, -45, -44.5, -44, -43, -and -42 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 2.25, 2.5, 3, 3.5, 4, 5, and 6 hours after Day 14 morning dosePopulation: The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest.
Area under the curve of glucose from time 2 to 6 hours post morning dose (Glucose AUC(2-6)) was calculated based on 8 glucose measurements at prespecified time points using the linear trapezoidal method. Nominal times were used in the calculation. Liquid meal was administered 2 hours post morning dose of PF-04991532 for mixed meal tolerance test (MMTT).
Outcome measures
| Measure |
Placebo
n=16 Participants
PF-04991532 matching placebo orally twice daily for 2 weeks.
|
PF-04991532 25 mg
n=16 Participants
PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
|
PF-04991532 75 mg
n=16 Participants
PF-04991532 75 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 150 mg
n=16 Participants
PF-04991532 150 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 300 mg
n=16 Participants
PF-04991532 300 mg tablet orally twice daily for 2 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Area Under the Curve of Glucose From Time 2 to 6 Hours Post Morning Dose (Glucose AUC(2-6)) Following Mixed Meal Tolerance Test (MMTT) at Day 14
Baseline (Day -1)
|
1091.23 mg*hr/dL
Standard Deviation 163.30
|
1126.34 mg*hr/dL
Standard Deviation 119.26
|
1029.76 mg*hr/dL
Standard Deviation 154.84
|
1085.84 mg*hr/dL
Standard Deviation 245.64
|
1050.69 mg*hr/dL
Standard Deviation 241.70
|
|
Change From Baseline in Area Under the Curve of Glucose From Time 2 to 6 Hours Post Morning Dose (Glucose AUC(2-6)) Following Mixed Meal Tolerance Test (MMTT) at Day 14
Change from Baseline (Day 14)
|
86.05 mg*hr/dL
Standard Deviation 148.94
|
-84.44 mg*hr/dL
Standard Deviation 99.91
|
-12.65 mg*hr/dL
Standard Deviation 114.19
|
-60.55 mg*hr/dL
Standard Deviation 89.36
|
-158.93 mg*hr/dL
Standard Deviation 152.09
|
SECONDARY outcome
Timeframe: Baseline: hour -48 on Day -1, hour -24 on Day 0, and hour 0 (before morning dose) on Day 1; hour 0 (before morning dose of each day) on Days 1, 2, 3, 6, and 10; and 24 hours after Day 14 morning dose on Day 15Population: The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest; "n" is the number of participants analyzed for each day.
The average of the Day -1 (hour -48), Day 0 (hour -24) and Day 1 pre-dose (hour 0) measurements was the baseline for fasting plasma glucose (FPG) analyses.
Outcome measures
| Measure |
Placebo
n=16 Participants
PF-04991532 matching placebo orally twice daily for 2 weeks.
|
PF-04991532 25 mg
n=17 Participants
PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
|
PF-04991532 75 mg
n=16 Participants
PF-04991532 75 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 150 mg
n=16 Participants
PF-04991532 150 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 300 mg
n=17 Participants
PF-04991532 300 mg tablet orally twice daily for 2 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Day 6 (n=16, 16, 16, 16, 16)
|
3.44 mg/dL
Standard Deviation 26.69
|
-9.40 mg/dL
Standard Deviation 16.68
|
-9.90 mg/dL
Standard Deviation 18.13
|
-6.33 mg/dL
Standard Deviation 12.24
|
-16.90 mg/dL
Standard Deviation 23.67
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Day 10 (n=16, 16, 16, 16, 16)
|
-10.88 mg/dL
Standard Deviation 43.97
|
-17.21 mg/dL
Standard Deviation 24.08
|
-16.96 mg/dL
Standard Deviation 26.78
|
-10.33 mg/dL
Standard Deviation 15.75
|
-17.40 mg/dL
Standard Deviation 30.99
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Day 14 (n=16, 16, 16, 16, 16)
|
9.00 mg/dL
Standard Deviation 26.90
|
-17.83 mg/dL
Standard Deviation 25.71
|
-14.52 mg/dL
Standard Deviation 23.08
|
-7.27 mg/dL
Standard Deviation 8.78
|
-11.40 mg/dL
Standard Deviation 19.12
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Day 2 (n=16, 17, 16, 16, 17)
|
-4.19 mg/dL
Standard Deviation 17.77
|
-5.04 mg/dL
Standard Deviation 10.43
|
-4.33 mg/dL
Standard Deviation 18.15
|
0.29 mg/dL
Standard Deviation 14.93
|
-5.55 mg/dL
Standard Deviation 36.08
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Day 3 (n=16, 17, 16, 16, 17)
|
-0.63 mg/dL
Standard Deviation 15.76
|
-8.92 mg/dL
Standard Deviation 11.86
|
-2.15 mg/dL
Standard Deviation 15.25
|
0.23 mg/dL
Standard Deviation 14.06
|
-7.78 mg/dL
Standard Deviation 16.40
|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
Day 15 (n=16, 16, 16, 16, 15)
|
12.63 mg/dL
Standard Deviation 44.47
|
-9.71 mg/dL
Standard Deviation 25.96
|
-8.15 mg/dL
Standard Deviation 22.81
|
-0.58 mg/dL
Standard Deviation 16.71
|
-4.22 mg/dL
Standard Deviation 37.34
|
SECONDARY outcome
Timeframe: Baseline: hours -46, -45.75, -45.5, -45, -44.5, -44, -43, -and -42 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 2.25, 2.5, 3, 3.5, 4, 5, and 6 hours after Day 14 morning dosePopulation: The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest.
Area Under the Curve of Insulin from Time 2 to 6 Hours Post Morning Dose (Insulin AUC(2-6)) was calculated based on 8 insulin measurements at prespecified time points using the linear trapezoidal method. Nominal times were used in the calculation. Liquid meal was administered 2 hours post morning dose of PF-04991532 for mixed meal tolerance test (MMTT).
Outcome measures
| Measure |
Placebo
n=16 Participants
PF-04991532 matching placebo orally twice daily for 2 weeks.
|
PF-04991532 25 mg
n=13 Participants
PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
|
PF-04991532 75 mg
n=15 Participants
PF-04991532 75 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 150 mg
n=14 Participants
PF-04991532 150 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 300 mg
n=14 Participants
PF-04991532 300 mg tablet orally twice daily for 2 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Area Under the Curve of Insulin From Time 2 to 6 Hours Post Morning Dose (Insulin AUC(2-6)) Following Mixed Meal Tolerance Test (MMTT) at Day 14
Baseline (Day -1)
|
149.12 milliUnit*hour/liter (mU*hr/L)
Standard Deviation 117.08
|
139.40 milliUnit*hour/liter (mU*hr/L)
Standard Deviation 77.81
|
166.87 milliUnit*hour/liter (mU*hr/L)
Standard Deviation 132.39
|
111.13 milliUnit*hour/liter (mU*hr/L)
Standard Deviation 69.16
|
276.61 milliUnit*hour/liter (mU*hr/L)
Standard Deviation 313.03
|
|
Change From Baseline in Area Under the Curve of Insulin From Time 2 to 6 Hours Post Morning Dose (Insulin AUC(2-6)) Following Mixed Meal Tolerance Test (MMTT) at Day 14
Change from Baseline (Day 14)
|
-3.96 milliUnit*hour/liter (mU*hr/L)
Standard Deviation 18.09
|
15.87 milliUnit*hour/liter (mU*hr/L)
Standard Deviation 27.16
|
-3.06 milliUnit*hour/liter (mU*hr/L)
Standard Deviation 32.79
|
11.82 milliUnit*hour/liter (mU*hr/L)
Standard Deviation 24.87
|
-38.06 milliUnit*hour/liter (mU*hr/L)
Standard Deviation 73.89
|
SECONDARY outcome
Timeframe: Baseline: hours -46, -45.75, -45.5, -45, -44.5, -44, -43, -and -42 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 2.25, 2.5, 3, 3.5, 4, 5, and 6 hours after Day 14 morning dosePopulation: The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest.
Area Under the Curve of C-peptide from Time 2 to 6 Hours Post Morning Dose (C-peptide AUC(2-6)) was calculated based on 8 C-peptide measurements at prespecified timepoints using the linear trapezoidal method. Nominal times were used in the calculation. Liquid meal was administered 2 hours post morning dose of PF-04991532 for mixed meal tolerance test (MMTT).
Outcome measures
| Measure |
Placebo
n=16 Participants
PF-04991532 matching placebo orally twice daily for 2 weeks.
|
PF-04991532 25 mg
n=16 Participants
PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
|
PF-04991532 75 mg
n=16 Participants
PF-04991532 75 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 150 mg
n=16 Participants
PF-04991532 150 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 300 mg
n=16 Participants
PF-04991532 300 mg tablet orally twice daily for 2 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Area Under the Curve of C-peptide From Time 2 to 6 Hours Post Morning Dose (C-peptide AUC(2-6)) Following Mixed Meal Tolerance Test (MMTT) at Day 14
Baseline (Day -1)
|
15.79 ng*hr/mL
Standard Deviation 6.08
|
17.04 ng*hr/mL
Standard Deviation 6.73
|
17.20 ng*hr/mL
Standard Deviation 5.89
|
15.23 ng*hr/mL
Standard Deviation 4.51
|
19.21 ng*hr/mL
Standard Deviation 7.61
|
|
Change From Baseline in Area Under the Curve of C-peptide From Time 2 to 6 Hours Post Morning Dose (C-peptide AUC(2-6)) Following Mixed Meal Tolerance Test (MMTT) at Day 14
Change from Baseline (Day 14)
|
0.09 ng*hr/mL
Standard Deviation 2.15
|
1.34 ng*hr/mL
Standard Deviation 2.64
|
-1.53 ng*hr/mL
Standard Deviation 2.88
|
-0.55 ng*hr/mL
Standard Deviation 1.63
|
-2.12 ng*hr/mL
Standard Deviation 2.97
|
SECONDARY outcome
Timeframe: Baseline: hour -48 on Day -1, hour -24 on Day 0, and hour 0 on Day 1 for TG and Hour 0 (before morning dose) on Day 1 for TC, HDL, and LDL; 48 hours after morning dose on Day 16 for TG and Hour 0 (before morning dose) on Day14 for TC, HDL, and LDLPopulation: The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest; "n" is the number of participants analyzed for each day.
Baseline for fasting triglycerides (TG) was defined as the average of the Day -1 (hour -48), Day 0 (hour -24), and Day 1 pre-dose (hour 0) measurements. Baseline for fasting total cholesterol (TC), cholesterol (high-density lipoprotein (HDL)), and cholesterol (low-density lipoprotein (LDL)) was defined as the Day 1 pre-dose (hour 0) measurement.
Outcome measures
| Measure |
Placebo
n=16 Participants
PF-04991532 matching placebo orally twice daily for 2 weeks.
|
PF-04991532 25 mg
n=16 Participants
PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
|
PF-04991532 75 mg
n=16 Participants
PF-04991532 75 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 150 mg
n=16 Participants
PF-04991532 150 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 300 mg
n=16 Participants
PF-04991532 300 mg tablet orally twice daily for 2 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Lipid Parameters at Day 14 and 16
Triglycerides (Day 16) (n=16, 16, 16, 16, 16)
|
-9.81 mg/dL
Standard Deviation 35.87
|
12.79 mg/dL
Standard Deviation 45.64
|
37.52 mg/dL
Standard Deviation 98.13
|
18.24 mg/dL
Standard Deviation 36.08
|
58.00 mg/dL
Standard Deviation 67.31
|
|
Change From Baseline in Fasting Lipid Parameters at Day 14 and 16
Total Cholesterol (Day 14) (n=16, 16, 16, 15, 16)
|
0.06 mg/dL
Standard Deviation 16.98
|
-11.75 mg/dL
Standard Deviation 31.62
|
4.19 mg/dL
Standard Deviation 20.04
|
1.80 mg/dL
Standard Deviation 19.29
|
11.38 mg/dL
Standard Deviation 30.17
|
|
Change From Baseline in Fasting Lipid Parameters at Day 14 and 16
Cholesterol HDL (Day 14) (n=16, 16, 16, 16, 16)
|
1.75 mg/dL
Standard Deviation 4.48
|
-1.88 mg/dL
Standard Deviation 7.75
|
1.88 mg/dL
Standard Deviation 6.04
|
0.69 mg/dL
Standard Deviation 8.44
|
3.94 mg/dL
Standard Deviation 7.17
|
|
Change From Baseline in Fasting Lipid Parameters at Day 14 and 16
Cholesterol LDL (Day 14) (n=16, 16, 15, 14, 15)
|
2.38 mg/dL
Standard Deviation 17.64
|
-8.06 mg/dL
Standard Deviation 26.98
|
4.67 mg/dL
Standard Deviation 22.48
|
-0.79 mg/dL
Standard Deviation 16.40
|
1.53 mg/dL
Standard Deviation 25.53
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
PF-04991532 25 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PF-04991532 75 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
PF-04991532 150 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-04991532 300 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=16 participants at risk
PF-04991532 matching placebo orally twice daily for 2 weeks.
|
PF-04991532 25 mg
n=17 participants at risk
PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
|
PF-04991532 75 mg
n=16 participants at risk
PF-04991532 75 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 150 mg
n=16 participants at risk
PF-04991532 150 mg tablet orally twice daily for 2 weeks.
|
PF-04991532 300 mg
n=17 participants at risk
PF-04991532 300 mg tablet orally twice daily for 2 weeks.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
2/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Vision blurred
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.9%
1/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.9%
1/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gingivitis
|
6.2%
1/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.9%
1/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Infusion site swelling
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.9%
1/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pain
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Carbuncle
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.9%
1/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cystitis
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.9%
1/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Rhinitis
|
6.2%
1/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.9%
1/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.9%
1/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Electrocardiogram ST-T change
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.9%
1/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.5%
2/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.9%
1/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
18.8%
3/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.2%
1/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Nocturia
|
6.2%
1/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/16
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/17
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 subject and as nonserious in another subject, or one subject 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