Trial Outcomes & Findings for Study To Evaluate The Effect Of Two Steady State Doses of PF 06882961 On Rosuvastatin And Midazolam Pharmacokinetics In Otherwise Healthy Adult Participants With Obesity (NCT NCT04621227)
NCT ID: NCT04621227
Last Updated: 2023-12-01
Results Overview
AUClast is area under the plasma concentration-time profile from time 0 to last quantifiable concentration.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
At 0 (prior to rosuvastatin dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, and 72 hours post rosuvastatin dose on Day 1 in Periods 1, 4, and 7
Results posted on
2023-12-01
Participant Flow
Participant milestones
| Measure |
All Participants
Participants underwent Period 1 to 8 and received study interventions as follows: Period 1: rosuvastatin 10mg once daily (QD) on Day 1; Period 2: midazolam 2mg QD on Day 1; Period 3: PF-06882961 (danuglipron) 10mg twice a day (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-28; Period 4: PF-06882961 120mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 5: PF-06882961 120mg BID + midazolam 2mg QD on Day 1; Period 6: PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16; Period 7: PF-06882961 200mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 8: PF-06882961 200mg BID + midazolam 2mg QD on Day 1.
|
|---|---|
|
Period 1 (5 Days)
STARTED
|
16
|
|
Period 1 (5 Days)
COMPLETED
|
16
|
|
Period 1 (5 Days)
NOT COMPLETED
|
0
|
|
Period 2 (2 Days)
STARTED
|
16
|
|
Period 2 (2 Days)
COMPLETED
|
16
|
|
Period 2 (2 Days)
NOT COMPLETED
|
0
|
|
Period 3 (29 Days)
STARTED
|
16
|
|
Period 3 (29 Days)
COMPLETED
|
14
|
|
Period 3 (29 Days)
NOT COMPLETED
|
2
|
|
Period 4 (4 Days)
STARTED
|
14
|
|
Period 4 (4 Days)
COMPLETED
|
14
|
|
Period 4 (4 Days)
NOT COMPLETED
|
0
|
|
Period 5 (1 Day)
STARTED
|
14
|
|
Period 5 (1 Day)
COMPLETED
|
14
|
|
Period 5 (1 Day)
NOT COMPLETED
|
0
|
|
Period 6 (16 Days)
STARTED
|
14
|
|
Period 6 (16 Days)
COMPLETED
|
14
|
|
Period 6 (16 Days)
NOT COMPLETED
|
0
|
|
Period 7 (4 Days)
STARTED
|
14
|
|
Period 7 (4 Days)
COMPLETED
|
14
|
|
Period 7 (4 Days)
NOT COMPLETED
|
0
|
|
Period 8 (2 Days)
STARTED
|
14
|
|
Period 8 (2 Days)
COMPLETED
|
13
|
|
Period 8 (2 Days)
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
All Participants
Participants underwent Period 1 to 8 and received study interventions as follows: Period 1: rosuvastatin 10mg once daily (QD) on Day 1; Period 2: midazolam 2mg QD on Day 1; Period 3: PF-06882961 (danuglipron) 10mg twice a day (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-28; Period 4: PF-06882961 120mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 5: PF-06882961 120mg BID + midazolam 2mg QD on Day 1; Period 6: PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16; Period 7: PF-06882961 200mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 8: PF-06882961 200mg BID + midazolam 2mg QD on Day 1.
|
|---|---|
|
Period 3 (29 Days)
Physician decision due to inappropriate behavior and noncompliance
|
1
|
|
Period 3 (29 Days)
Adverse Event
|
1
|
|
Period 8 (2 Days)
Adverse Event
|
1
|
Baseline Characteristics
Study To Evaluate The Effect Of Two Steady State Doses of PF 06882961 On Rosuvastatin And Midazolam Pharmacokinetics In Otherwise Healthy Adult Participants With Obesity
Baseline characteristics by cohort
| Measure |
All Participants
n=16 Participants
Participants underwent Period 1 to 8 and received study interventions as follows: Period 1: rosuvastatin 10mg once daily (QD) on Day 1; Period 2: midazolam 2mg QD on Day 1; Period 3: PF-06882961 (danuglipron) 10mg twice a day (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-28; Period 4: PF-06882961 120mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 5: PF-06882961 120mg BID + midazolam 2mg QD on Day 1; Period 6: PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16; Period 7: PF-06882961 200mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 8: PF-06882961 200mg BID + midazolam 2mg QD on Day 1.
|
|---|---|
|
Age, Continuous
|
49.0 Years
STANDARD_DEVIATION 11.34 • n=5 Participants
|
|
Age, Customized
<18 Years
|
0 Participants
n=5 Participants
|
|
Age, Customized
18-44 Years
|
5 Participants
n=5 Participants
|
|
Age, Customized
45-65 Years
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 0 (prior to rosuvastatin dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, and 72 hours post rosuvastatin dose on Day 1 in Periods 1, 4, and 7Population: The PK parameter analysis population was defined as all participants who received at least 1 dose of rosuvastatin and had at least 1 of the PK parameters of interest calculated.
AUClast is area under the plasma concentration-time profile from time 0 to last quantifiable concentration.
Outcome measures
| Measure |
All Participants
n=16 Participants
Participants underwent Period 1 to 8 and received study interventions as follows: Period 1: rosuvastatin 10mg once daily (QD) on Day 1; Period 2: midazolam 2mg QD on Day 1; Period 3: PF-06882961 (danuglipron) 10mg twice a day (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-28; Period 4: PF-06882961 120mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 5: PF-06882961 120mg BID + midazolam 2mg QD on Day 1; Period 6: PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16; Period 7: PF-06882961 200mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 8: PF-06882961 200mg BID + midazolam 2mg QD on Day 1.
|
PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)
n=14 Participants
Participants received PF-06882961 120mg BID on Days 1-4, and rosuvastatin 10mg QD on Day 1 in Period 4.
|
PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)
n=14 Participants
Participants received PF-06882961 200mg BID on Days 1-4 and rosuvastatin 10mg QD on Day 1 in Period 7.
|
PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)
Participants received PF-06882961 120mg BID on Days 1-4, and rosuvastatin 10mg QD on Day 1 in Period 4.
|
PF-06882961 120mg BID + Midazolam 2mg (Period 5)
Participants received PF-06882961 120mg BID and midazolam 2mg QD on Day 1 in Period 5.
|
PF-06882961 Titration up to 200mg BID (Period 6)
Participants received PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16 in Period 6.
|
PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)
Participants received PF-06882961 200mg BID on Days 1-4 and rosuvastatin 10mg QD on Day 1 in Period 7.
|
PF-06882961 200mg BID + Midazolam 2mg (Period 8)
Participants received PF-06882961 200mg BID and midazolam 2mg QD on Day 1 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Profile From Time 0 to Last Quantifiable Concentration (AUClast) of Rosuvastatin in Periods 1, 4 and 7
|
35.17 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 43
|
72.15 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 50
|
100.90 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 40
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post midazolam dose on Day 1 in Periods 2, 5, and 8Population: The PK parameter analysis population was defined as all participants who received at least 1 dose of rosuvastatin and had at least 1 of the PK parameters of interest calculated.
AUClast is area under the plasma concentration-time profile from time 0 to last quantifiable concentration.
Outcome measures
| Measure |
All Participants
n=16 Participants
Participants underwent Period 1 to 8 and received study interventions as follows: Period 1: rosuvastatin 10mg once daily (QD) on Day 1; Period 2: midazolam 2mg QD on Day 1; Period 3: PF-06882961 (danuglipron) 10mg twice a day (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-28; Period 4: PF-06882961 120mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 5: PF-06882961 120mg BID + midazolam 2mg QD on Day 1; Period 6: PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16; Period 7: PF-06882961 200mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 8: PF-06882961 200mg BID + midazolam 2mg QD on Day 1.
|
PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)
n=14 Participants
Participants received PF-06882961 120mg BID on Days 1-4, and rosuvastatin 10mg QD on Day 1 in Period 4.
|
PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)
n=13 Participants
Participants received PF-06882961 200mg BID on Days 1-4 and rosuvastatin 10mg QD on Day 1 in Period 7.
|
PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)
Participants received PF-06882961 120mg BID on Days 1-4, and rosuvastatin 10mg QD on Day 1 in Period 4.
|
PF-06882961 120mg BID + Midazolam 2mg (Period 5)
Participants received PF-06882961 120mg BID and midazolam 2mg QD on Day 1 in Period 5.
|
PF-06882961 Titration up to 200mg BID (Period 6)
Participants received PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16 in Period 6.
|
PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)
Participants received PF-06882961 200mg BID on Days 1-4 and rosuvastatin 10mg QD on Day 1 in Period 7.
|
PF-06882961 200mg BID + Midazolam 2mg (Period 8)
Participants received PF-06882961 200mg BID and midazolam 2mg QD on Day 1 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
AUClast of Midazolam in Periods 2, 5 and 8
|
39.24 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 27
|
19.98 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 49
|
20.21 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 48
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)Population: The safety analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention.
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.
Outcome measures
| Measure |
All Participants
n=16 Participants
Participants underwent Period 1 to 8 and received study interventions as follows: Period 1: rosuvastatin 10mg once daily (QD) on Day 1; Period 2: midazolam 2mg QD on Day 1; Period 3: PF-06882961 (danuglipron) 10mg twice a day (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-28; Period 4: PF-06882961 120mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 5: PF-06882961 120mg BID + midazolam 2mg QD on Day 1; Period 6: PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16; Period 7: PF-06882961 200mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 8: PF-06882961 200mg BID + midazolam 2mg QD on Day 1.
|
PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)
n=16 Participants
Participants received PF-06882961 120mg BID on Days 1-4, and rosuvastatin 10mg QD on Day 1 in Period 4.
|
PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)
n=16 Participants
Participants received PF-06882961 200mg BID on Days 1-4 and rosuvastatin 10mg QD on Day 1 in Period 7.
|
PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)
n=14 Participants
Participants received PF-06882961 120mg BID on Days 1-4, and rosuvastatin 10mg QD on Day 1 in Period 4.
|
PF-06882961 120mg BID + Midazolam 2mg (Period 5)
n=14 Participants
Participants received PF-06882961 120mg BID and midazolam 2mg QD on Day 1 in Period 5.
|
PF-06882961 Titration up to 200mg BID (Period 6)
n=14 Participants
Participants received PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16 in Period 6.
|
PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)
n=14 Participants
Participants received PF-06882961 200mg BID on Days 1-4 and rosuvastatin 10mg QD on Day 1 in Period 7.
|
PF-06882961 200mg BID + Midazolam 2mg (Period 8)
n=14 Participants
Participants received PF-06882961 200mg BID and midazolam 2mg QD on Day 1 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Treatment-related TEAEs
|
0 Participants
|
0 Participants
|
11 Participants
|
5 Participants
|
5 Participants
|
10 Participants
|
3 Participants
|
7 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
All-causality TEAEs
|
0 Participants
|
2 Participants
|
13 Participants
|
6 Participants
|
5 Participants
|
11 Participants
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: From BL (Day 1, the last pre-dose measurement in Period 1) to Follow Up visit (Days 68-71) (approximately up to 71 days)Population: The analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable laboratory values were analyzed.
Safety laboratory assessments included clinical chemistry, hematology, urinalysis, and other tests. Abnormality was determined at the investigator's discretion.
Outcome measures
| Measure |
All Participants
n=16 Participants
Participants underwent Period 1 to 8 and received study interventions as follows: Period 1: rosuvastatin 10mg once daily (QD) on Day 1; Period 2: midazolam 2mg QD on Day 1; Period 3: PF-06882961 (danuglipron) 10mg twice a day (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-28; Period 4: PF-06882961 120mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 5: PF-06882961 120mg BID + midazolam 2mg QD on Day 1; Period 6: PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16; Period 7: PF-06882961 200mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 8: PF-06882961 200mg BID + midazolam 2mg QD on Day 1.
|
PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)
n=16 Participants
Participants received PF-06882961 120mg BID on Days 1-4, and rosuvastatin 10mg QD on Day 1 in Period 4.
|
PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)
n=16 Participants
Participants received PF-06882961 200mg BID on Days 1-4 and rosuvastatin 10mg QD on Day 1 in Period 7.
|
PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)
n=14 Participants
Participants received PF-06882961 120mg BID on Days 1-4, and rosuvastatin 10mg QD on Day 1 in Period 4.
|
PF-06882961 120mg BID + Midazolam 2mg (Period 5)
n=14 Participants
Participants received PF-06882961 120mg BID and midazolam 2mg QD on Day 1 in Period 5.
|
PF-06882961 Titration up to 200mg BID (Period 6)
n=14 Participants
Participants received PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16 in Period 6.
|
PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)
n=14 Participants
Participants received PF-06882961 200mg BID on Days 1-4 and rosuvastatin 10mg QD on Day 1 in Period 7.
|
PF-06882961 200mg BID + Midazolam 2mg (Period 8)
n=14 Participants
Participants received PF-06882961 200mg BID and midazolam 2mg QD on Day 1 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline [BL] Abnormality)
|
0 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: From BL (Day 1, the last pre-dose measurement in Period 1) to Follow Up visit (Days 68-71) (approximately up to 71 days)Population: The analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable vital signs data were analyzed.
Single, supine vital signs assessments included systolic blood pressure (BP), diastolic BP and pulse rate. Abnormality in vital signs included: pulse rate \<40 beats per minute (bpm) or \>120bpm; supine diastolic BP \<50 millimeter of mercury (mmHg), increase and decrease in change from BL of \>=20mmHg; supine systolic blood pressure \<90mmHg, increase and decrease in change from BL of \>=30mmHg.
Outcome measures
| Measure |
All Participants
n=16 Participants
Participants underwent Period 1 to 8 and received study interventions as follows: Period 1: rosuvastatin 10mg once daily (QD) on Day 1; Period 2: midazolam 2mg QD on Day 1; Period 3: PF-06882961 (danuglipron) 10mg twice a day (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-28; Period 4: PF-06882961 120mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 5: PF-06882961 120mg BID + midazolam 2mg QD on Day 1; Period 6: PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16; Period 7: PF-06882961 200mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 8: PF-06882961 200mg BID + midazolam 2mg QD on Day 1.
|
PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)
n=16 Participants
Participants received PF-06882961 120mg BID on Days 1-4, and rosuvastatin 10mg QD on Day 1 in Period 4.
|
PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)
n=16 Participants
Participants received PF-06882961 200mg BID on Days 1-4 and rosuvastatin 10mg QD on Day 1 in Period 7.
|
PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)
n=14 Participants
Participants received PF-06882961 120mg BID on Days 1-4, and rosuvastatin 10mg QD on Day 1 in Period 4.
|
PF-06882961 120mg BID + Midazolam 2mg (Period 5)
n=14 Participants
Participants received PF-06882961 120mg BID and midazolam 2mg QD on Day 1 in Period 5.
|
PF-06882961 Titration up to 200mg BID (Period 6)
n=14 Participants
Participants received PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16 in Period 6.
|
PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)
n=14 Participants
Participants received PF-06882961 200mg BID on Days 1-4 and rosuvastatin 10mg QD on Day 1 in Period 7.
|
PF-06882961 200mg BID + Midazolam 2mg (Period 8)
n=14 Participants
Participants received PF-06882961 200mg BID and midazolam 2mg QD on Day 1 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Supine systolic BP value <90mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Pulse rate value >120bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Supine diastolic BP value <50mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Supine systolic BP change >=30mmHg increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Pulse rate value <40bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Supine diastolic BP change >=20mmHg decrease
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Supine diastolic BP change >=20mmHg increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Supine systolic BP change >=30mmHg decrease
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At BL (Period 1 Day 1), on Period 3 Days 1, 8, 15 and 22, Period 4 Day 1, Period 6 Days 1 and 9, Period 7 Day 1, Period 8 Day 2, and at Follow Up visit (Days 68-71)Population: The analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable body weight data were analyzed.
Changes from Baseline in body weight of the participants were measured.
Outcome measures
| Measure |
All Participants
n=16 Participants
Participants underwent Period 1 to 8 and received study interventions as follows: Period 1: rosuvastatin 10mg once daily (QD) on Day 1; Period 2: midazolam 2mg QD on Day 1; Period 3: PF-06882961 (danuglipron) 10mg twice a day (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-28; Period 4: PF-06882961 120mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 5: PF-06882961 120mg BID + midazolam 2mg QD on Day 1; Period 6: PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16; Period 7: PF-06882961 200mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 8: PF-06882961 200mg BID + midazolam 2mg QD on Day 1.
|
PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)
Participants received PF-06882961 120mg BID on Days 1-4, and rosuvastatin 10mg QD on Day 1 in Period 4.
|
PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)
Participants received PF-06882961 200mg BID on Days 1-4 and rosuvastatin 10mg QD on Day 1 in Period 7.
|
PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)
Participants received PF-06882961 120mg BID on Days 1-4, and rosuvastatin 10mg QD on Day 1 in Period 4.
|
PF-06882961 120mg BID + Midazolam 2mg (Period 5)
Participants received PF-06882961 120mg BID and midazolam 2mg QD on Day 1 in Period 5.
|
PF-06882961 Titration up to 200mg BID (Period 6)
Participants received PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16 in Period 6.
|
PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)
Participants received PF-06882961 200mg BID on Days 1-4 and rosuvastatin 10mg QD on Day 1 in Period 7.
|
PF-06882961 200mg BID + Midazolam 2mg (Period 8)
Participants received PF-06882961 200mg BID and midazolam 2mg QD on Day 1 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Body Weight
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID
|
-7.5 kilogram (kg)
Standard Deviation 2.49
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Body Weight
Period 7 Day 1 / PF-06882961 200 mg BID + rosuvastatin 10 mg
|
-9.1 kilogram (kg)
Standard Deviation 2.76
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Body Weight
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID
|
-1.5 kilogram (kg)
Standard Deviation 0.82
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Body Weight
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID
|
-1.9 kilogram (kg)
Standard Deviation 1.56
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Body Weight
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID
|
-3.3 kilogram (kg)
Standard Deviation 1.24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Body Weight
Period 3 Day 22 / PF-06882961 titration up to 120 mg BID
|
-4.3 kilogram (kg)
Standard Deviation 1.69
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Body Weight
Period 4 Day 1 / PF-06882961 120 mg BID + rosuvastatin 10 mg
|
-5.2 kilogram (kg)
Standard Deviation 1.87
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Body Weight
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID
|
-6.1 kilogram (kg)
Standard Deviation 2.18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Body Weight
Period 8 Day 2 / PF-06882961 200 mg BID + midazolam 2 mg
|
-9.9 kilogram (kg)
Standard Deviation 3.15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Body Weight
Follow up
|
-5.7 kilogram (kg)
Standard Deviation 3.05
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From BL (Day 1, the last pre-dose measurement in Period 1) to Follow Up visit (Days 68-71) (approximately up to 71 days)Population: The analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable ECG data were analyzed.
ECG assessments included pulse rate (PR), QT, QTcF intervals and QRS complex. ECG abnormalities criteria included: PR interval value \>= 300msec, or BL \>200msec and \>=25% increase from BL, or BL \<=200msec and \>=50% increase from BL; QRS interval value \>= 140msec, or percent change from BL \>=50%; QTcF value \>400 and \<=480msec, or \>480 and \<=500 msec, or \>500msec, or change from BL\>30 and \<=60msec, or change from BL \>60msec.
Outcome measures
| Measure |
All Participants
n=16 Participants
Participants underwent Period 1 to 8 and received study interventions as follows: Period 1: rosuvastatin 10mg once daily (QD) on Day 1; Period 2: midazolam 2mg QD on Day 1; Period 3: PF-06882961 (danuglipron) 10mg twice a day (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-28; Period 4: PF-06882961 120mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 5: PF-06882961 120mg BID + midazolam 2mg QD on Day 1; Period 6: PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16; Period 7: PF-06882961 200mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 8: PF-06882961 200mg BID + midazolam 2mg QD on Day 1.
|
PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)
n=16 Participants
Participants received PF-06882961 120mg BID on Days 1-4, and rosuvastatin 10mg QD on Day 1 in Period 4.
|
PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)
n=16 Participants
Participants received PF-06882961 200mg BID on Days 1-4 and rosuvastatin 10mg QD on Day 1 in Period 7.
|
PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)
n=14 Participants
Participants received PF-06882961 120mg BID on Days 1-4, and rosuvastatin 10mg QD on Day 1 in Period 4.
|
PF-06882961 120mg BID + Midazolam 2mg (Period 5)
n=14 Participants
Participants received PF-06882961 120mg BID and midazolam 2mg QD on Day 1 in Period 5.
|
PF-06882961 Titration up to 200mg BID (Period 6)
n=14 Participants
Participants received PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16 in Period 6.
|
PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)
n=14 Participants
Participants received PF-06882961 200mg BID on Days 1-4 and rosuvastatin 10mg QD on Day 1 in Period 7.
|
PF-06882961 200mg BID + Midazolam 2mg (Period 8)
n=14 Participants
Participants received PF-06882961 200mg BID and midazolam 2mg QD on Day 1 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
QTcF value >500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
QRS interval value>=140 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
QRS interval %change >=50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
QTcF value >480 and <=500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
QTcF change >30 and <=60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
QTcF change >60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
PR interval value>=300 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
PR interval %change >=25/50% (BL >200 msec and >=25% increase or BL <=200 msec and >=50% increase)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
QTcF value >450 and <=480 msec
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At BL (Period 1 Day 1), on Period 3 Days 1, 8, 15, and 22, Period 4 Day 1, Period 6 Days 1, 9, and 16, Period 8 Day 2, at Follow Up visit (Days 68-71) and Early TerminationPopulation: The analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable C-SSRS results were analyzed.
The C-SSRS was an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced any of the following 1: completed suicide, 2: suicide attempt (response of "yes" on "actual attempt"), 3: preparatory acts towards imminent suicidal behavior ("yes" on "aborted attempt", "interrupted attempt", "preparatory acts/behavior"), 4: suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts"), 7: self-injurious behavior, no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior"). In this outcome, number of participants with positive response (response of "yes") to suicidal behavior, ideation, or any self-injurious behavior were reported.
Outcome measures
| Measure |
All Participants
n=16 Participants
Participants underwent Period 1 to 8 and received study interventions as follows: Period 1: rosuvastatin 10mg once daily (QD) on Day 1; Period 2: midazolam 2mg QD on Day 1; Period 3: PF-06882961 (danuglipron) 10mg twice a day (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-28; Period 4: PF-06882961 120mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 5: PF-06882961 120mg BID + midazolam 2mg QD on Day 1; Period 6: PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16; Period 7: PF-06882961 200mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 8: PF-06882961 200mg BID + midazolam 2mg QD on Day 1.
|
PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)
Participants received PF-06882961 120mg BID on Days 1-4, and rosuvastatin 10mg QD on Day 1 in Period 4.
|
PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)
Participants received PF-06882961 200mg BID on Days 1-4 and rosuvastatin 10mg QD on Day 1 in Period 7.
|
PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)
Participants received PF-06882961 120mg BID on Days 1-4, and rosuvastatin 10mg QD on Day 1 in Period 4.
|
PF-06882961 120mg BID + Midazolam 2mg (Period 5)
Participants received PF-06882961 120mg BID and midazolam 2mg QD on Day 1 in Period 5.
|
PF-06882961 Titration up to 200mg BID (Period 6)
Participants received PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16 in Period 6.
|
PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)
Participants received PF-06882961 200mg BID on Days 1-4 and rosuvastatin 10mg QD on Day 1 in Period 7.
|
PF-06882961 200mg BID + Midazolam 2mg (Period 8)
Participants received PF-06882961 200mg BID and midazolam 2mg QD on Day 1 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS)
BL
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID (Since last visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID (Since last visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID (Since last visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID (Since last visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS)
Early Termination (ET) (Since last visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS)
BL (Past 12 months)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID (Since last visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID (Since last visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg (Since last visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID (Since last visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg (Since last visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS)
Follow Up (Since last visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At BL (Period 1 Day 1), on Period 3 Days 1, 8, 15, and 22, Period 4 Day 1, Period 6 Days 1, 9, and 16, Period 8 Day 2, at Follow Up visit (Days 68-71) and Early TerminationPopulation: The analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable PHQ-9 results were analyzed.
The PHQ-9 is a 9 item self-report scale for the assessment of depressive symptoms. The questions included "little interest/pleasure in things", "feeling down depressed or hopeless", "trouble falling or staying asleep", "feeling tired or little energy", "poor appetite or overeating", "feeling bad about yourself", "trouble concentrating on things", "moving slowly or fidgety/restless" and "thoughts you be better off dead". Each item was scored on scale of "not at all", "several days", "more than half the days" to "nearly every day". Total score range: 0-27 (each item with scale from 0 \[not at all\] to 3 \[nearly every day\]. Higher score=greater severity).
Outcome measures
| Measure |
All Participants
n=16 Participants
Participants underwent Period 1 to 8 and received study interventions as follows: Period 1: rosuvastatin 10mg once daily (QD) on Day 1; Period 2: midazolam 2mg QD on Day 1; Period 3: PF-06882961 (danuglipron) 10mg twice a day (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-28; Period 4: PF-06882961 120mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 5: PF-06882961 120mg BID + midazolam 2mg QD on Day 1; Period 6: PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16; Period 7: PF-06882961 200mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 8: PF-06882961 200mg BID + midazolam 2mg QD on Day 1.
|
PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)
Participants received PF-06882961 120mg BID on Days 1-4, and rosuvastatin 10mg QD on Day 1 in Period 4.
|
PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)
Participants received PF-06882961 200mg BID on Days 1-4 and rosuvastatin 10mg QD on Day 1 in Period 7.
|
PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)
Participants received PF-06882961 120mg BID on Days 1-4, and rosuvastatin 10mg QD on Day 1 in Period 4.
|
PF-06882961 120mg BID + Midazolam 2mg (Period 5)
Participants received PF-06882961 120mg BID and midazolam 2mg QD on Day 1 in Period 5.
|
PF-06882961 Titration up to 200mg BID (Period 6)
Participants received PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16 in Period 6.
|
PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)
Participants received PF-06882961 200mg BID on Days 1-4 and rosuvastatin 10mg QD on Day 1 in Period 7.
|
PF-06882961 200mg BID + Midazolam 2mg (Period 8)
Participants received PF-06882961 200mg BID and midazolam 2mg QD on Day 1 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1/PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Trouble Falling or Staying Asleep · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Trouble Falling or Staying Asleep · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Poor Appetite or Overeating · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Little Interest/Pleasure in Things · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating · Not At All
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Trouble Concentrating on Things · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Moving Slowly or Fidgety/Restless · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Thoughts You Be Better Off Dead · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Little Interest/Pleasure in Things · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating · Not At All
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating · Several Days
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Trouble Concentrating on Things · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Trouble Concentrating on Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Thoughts You Be Better Off Dead · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Little Interest/Pleasure in Things · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Poor Appetite or Overeating · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Moving Slowly or Fidgety/Restless · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Little Interest/Pleasure in Things · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Little Interest/Pleasure in Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Feeling Down Depressed or Hopeless · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Trouble Falling or Staying Asleep · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Trouble Falling or Staying Asleep · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Feeling Tired or Little Energy · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Feeling Tired or Little Energy · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Poor Appetite or Overeating · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Poor Appetite or Overeating · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Poor Appetite or Overeating · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Feeling Bad About Yourself · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Trouble Concentrating on Things · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Trouble Concentrating on Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Moving Slowly or Fidgety/Restless · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Thoughts You Be Better Off Dead · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
BL Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1/PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1/PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1/PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating · Several Days
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating · Not At All
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating · Several Days
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Poor Appetite or Overeating · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 22 / PF-06882961 titration up to 120mg BID Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Little Interest/Pleasure in Things · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Little Interest/Pleasure in Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Feeling Down Depressed or Hopeless · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Feeling Down Depressed or Hopeless · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Feeling Tired or Little Energy · Not At All
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Feeling Tired or Little Energy · Several Days
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Poor Appetite or Overeating · Not At All
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Poor Appetite or Overeating · Several Days
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Poor Appetite or Overeating · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Feeling Bad About Yourself · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Trouble Concentrating on Things · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Trouble Concentrating on Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Moving Slowly or Fidgety/Restless · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Thoughts You Be Better Off Dead · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Little Interest/Pleasure in Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Feeling Down Depressed or Hopeless · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Trouble Falling or Staying Asleep · Not At All
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Trouble Falling or Staying Asleep · Several Days
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Feeling Tired or Little Energy · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Feeling Tired or Little Energy · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating · Several Days
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Trouble Concentrating on Things · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200mg BID Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Little Interest/Pleasure in Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Feeling Down Depressed or Hopeless · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Trouble Falling or Staying Asleep · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Trouble Falling or Staying Asleep · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Feeling Tired or Little Energy · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Feeling Tired or Little Energy · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Down Depressed or Hopeless · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Little Interest/Pleasure in Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Trouble Falling or Staying Asleep · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Trouble Falling or Staying Asleep · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Tired or Little Energy · Not At All
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Tired or Little Energy · Several Days
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Trouble Concentrating on Things · Not At All
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Trouble Concentrating on Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Moving Slowly or Fidgety/Restless · Not At All
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Thoughts You Be Better Off Dead · Not At All
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Trouble Concentrating on Things · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Trouble Concentrating on Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Moving Slowly or Fidgety/Restless · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Thoughts You Be Better Off Dead · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 16 / PF-06882961 titration up to 200mg BID Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Little Interest/Pleasure in Things · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Little Interest/Pleasure in Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Down Depressed or Hopeless · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Trouble Falling or Staying Asleep · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Trouble Falling or Staying Asleep · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Tired or Little Energy · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Tired or Little Energy · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Poor Appetite or Overeating · Not At All
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Poor Appetite or Overeating · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Poor Appetite or Overeating · More Than Half The Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Poor Appetite or Overeating · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Bad About Yourself · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Trouble Concentrating on Things · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Trouble Concentrating on Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Moving Slowly or Fidgety/Restless · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Thoughts You Be Better Off Dead · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Little Interest/Pleasure in Things · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Little Interest/Pleasure in Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Feeling Down Depressed or Hopeless · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Trouble Falling or Staying Asleep · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Trouble Falling or Staying Asleep · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Feeling Tired or Little Energy · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Feeling Tired or Little Energy · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Poor Appetite or Overeating · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Poor Appetite or Overeating · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Poor Appetite or Overeating · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Poor Appetite or Overeating · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Feeling Bad About Yourself · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Trouble Concentrating on Things · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Trouble Concentrating on Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Moving Slowly or Fidgety/Restless · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Thoughts You Be Better Off Dead · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Little Interest/Pleasure in Things · Not At All
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Little Interest/Pleasure in Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Feeling Down Depressed or Hopeless · Not At All
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Trouble Falling or Staying Asleep · Not At All
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Trouble Falling or Staying Asleep · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Feeling Tired or Little Energy · Not At All
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Feeling Tired or Little Energy · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Poor Appetite or Overeating · Not At All
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Poor Appetite or Overeating · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Poor Appetite or Overeating · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Poor Appetite or Overeating · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Feeling Bad About Yourself · Not At All
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
ET Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Rosuvastatin 10mg (Period 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Midazolam 2mg (Period 2)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-06882961 Titration up to 120mg BID (Period 3)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
PF-06882961 120mg BID + Midazolam 2mg (Period 5)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-06882961 Titration up to 200mg BID (Period 6)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
PF-06882961 200mg BID + Midazolam 2mg (Period 8)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rosuvastatin 10mg (Period 1)
n=16 participants at risk
Participants received rosuvastatin 10mg QD on Day 1 in Period 1.
|
Midazolam 2mg (Period 2)
n=16 participants at risk
Participants received midazolam 2mg QD on Day 1 in Period 2.
|
PF-06882961 Titration up to 120mg BID (Period 3)
n=16 participants at risk
Participants received PF-06882961 10mg twice a day (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-28 in Period 3.
|
PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)
n=14 participants at risk
Participants received PF-06882961 120mg BID on Days 1-4, and rosuvastatin 10mg QD on Day 1 in Period 4.
|
PF-06882961 120mg BID + Midazolam 2mg (Period 5)
n=14 participants at risk
Participants received PF-06882961 120mg BID and midazolam 2mg QD on Day 1 in Period 5.
|
PF-06882961 Titration up to 200mg BID (Period 6)
n=14 participants at risk
Participants received PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16 in Period 6.
|
PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)
n=14 participants at risk
Participants received PF-06882961 200mg BID on Days 1-4 and rosuvastatin 10mg QD on Day 1 in Period 7.
|
PF-06882961 200mg BID + Midazolam 2mg (Period 8)
n=14 participants at risk
Participants received PF-06882961 200mg BID and midazolam 2mg QD on Day 1 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Investigations
Transaminases increased
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
Other adverse events
| Measure |
Rosuvastatin 10mg (Period 1)
n=16 participants at risk
Participants received rosuvastatin 10mg QD on Day 1 in Period 1.
|
Midazolam 2mg (Period 2)
n=16 participants at risk
Participants received midazolam 2mg QD on Day 1 in Period 2.
|
PF-06882961 Titration up to 120mg BID (Period 3)
n=16 participants at risk
Participants received PF-06882961 10mg twice a day (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-28 in Period 3.
|
PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)
n=14 participants at risk
Participants received PF-06882961 120mg BID on Days 1-4, and rosuvastatin 10mg QD on Day 1 in Period 4.
|
PF-06882961 120mg BID + Midazolam 2mg (Period 5)
n=14 participants at risk
Participants received PF-06882961 120mg BID and midazolam 2mg QD on Day 1 in Period 5.
|
PF-06882961 Titration up to 200mg BID (Period 6)
n=14 participants at risk
Participants received PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16 in Period 6.
|
PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)
n=14 participants at risk
Participants received PF-06882961 200mg BID on Days 1-4 and rosuvastatin 10mg QD on Day 1 in Period 7.
|
PF-06882961 200mg BID + Midazolam 2mg (Period 8)
n=14 participants at risk
Participants received PF-06882961 200mg BID and midazolam 2mg QD on Day 1 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
50.0%
8/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
35.7%
5/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
28.6%
4/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
62.5%
10/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
4/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
18.8%
3/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
21.4%
3/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.2%
1/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
18.8%
3/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.2%
1/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.2%
1/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
21.4%
3/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
21.4%
3/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
35.7%
5/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
37.5%
6/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
14.3%
2/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.2%
1/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
2/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Early satiety
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
31.2%
5/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Fatigue
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
14.3%
2/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Exercise tolerance decreased
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Malaise
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.2%
1/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Pain
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.2%
1/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
2/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
2/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle discomfort
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.2%
1/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
6.2%
1/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/16 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
7.1%
1/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/14 • From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)
SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
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