Trial Outcomes & Findings for A Research Study To Assess The Effectiveness And Safety Of Different Doses Of Oral PF-00489791 In The Treatment Of Adult Patients With Pulmonary Arterial Hypertension (NCT NCT00853112)
NCT ID: NCT00853112
Last Updated: 2017-10-24
Results Overview
PVRI was calculated as: PVRI (in Wood units\*meter\^2 \[m\^2\]) = pulmonary vascular resistance (PVR) multiplied by body surface area (BSA). PVR (in Wood units) = (mean pulmonary artery pressure \[mean PAP\] minus pulmonary capillary wedge pressure \[PCWP\]) divided by cardiac output (CO, taken as the average of the triplicate measurements). BSA (m\^2) = (0.007184) multiplied by (height in centimeters \[cm\])\^0.725 multiplied by (weight in kilograms \[kg\])\^0.425. PVRI values were converted to dyne\*second (s)\*m\^2/centimeter (cm)\^5 from Woods units by multiplying by a factor of 79.9. The change from baseline in PVRI over 4-hour interval was calculated as the average of the change from baseline values at 1, 2, 3, and 4 hours post dose on Day 1.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Baseline, up to 4 hours post-dose on Day 1
Results posted on
2017-10-24
Participant Flow
Participant milestones
| Measure |
Placebo
Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 1 mg
Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 2 mg
Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 4 mg
Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 10 mg
Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 20 mg
Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
Sildenafil
Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
7
|
8
|
6
|
7
|
7
|
|
Overall Study
Treated
|
6
|
6
|
7
|
6
|
6
|
7
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
7
|
6
|
6
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
2
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 1 mg
Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 2 mg
Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 4 mg
Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 10 mg
Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 20 mg
Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
Sildenafil
Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Randomized but not treated
|
0
|
1
|
0
|
2
|
0
|
0
|
1
|
Baseline Characteristics
A Research Study To Assess The Effectiveness And Safety Of Different Doses Of Oral PF-00489791 In The Treatment Of Adult Patients With Pulmonary Arterial Hypertension
Baseline characteristics by cohort
| Measure |
Placebo
n=6 Participants
Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 1 mg
n=6 Participants
Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 2 mg
n=7 Participants
Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 4 mg
n=6 Participants
Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 10 mg
n=6 Participants
Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 20 mg
n=7 Participants
Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
Sildenafil
n=6 Participants
Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Between 18 and 44 Years
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
5 participants
n=4 Participants
|
2 participants
n=21 Participants
|
2 participants
n=10 Participants
|
3 participants
n=115 Participants
|
21 participants
n=6 Participants
|
|
Age, Customized
Between 45 and 64 Years
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
3 participants
n=10 Participants
|
2 participants
n=115 Participants
|
13 participants
n=6 Participants
|
|
Age, Customized
Greater than or equal to (>=) 65 Years
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
2 participants
n=10 Participants
|
1 participants
n=115 Participants
|
10 participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
30 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
14 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline, up to 4 hours post-dose on Day 1Population: Full analysis set (FAS) included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group.
PVRI was calculated as: PVRI (in Wood units\*meter\^2 \[m\^2\]) = pulmonary vascular resistance (PVR) multiplied by body surface area (BSA). PVR (in Wood units) = (mean pulmonary artery pressure \[mean PAP\] minus pulmonary capillary wedge pressure \[PCWP\]) divided by cardiac output (CO, taken as the average of the triplicate measurements). BSA (m\^2) = (0.007184) multiplied by (height in centimeters \[cm\])\^0.725 multiplied by (weight in kilograms \[kg\])\^0.425. PVRI values were converted to dyne\*second (s)\*m\^2/centimeter (cm)\^5 from Woods units by multiplying by a factor of 79.9. The change from baseline in PVRI over 4-hour interval was calculated as the average of the change from baseline values at 1, 2, 3, and 4 hours post dose on Day 1.
Outcome measures
| Measure |
Placebo
n=6 Participants
Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 1 mg
n=6 Participants
Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 2 mg
n=7 Participants
Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 4 mg
n=6 Participants
Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 10 mg
n=6 Participants
Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 20 mg
n=6 Participants
Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
Sildenafil
n=6 Participants
Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Pulmonary Vascular Resistance Index (PVRI) Over 4 Hours Post Dose
Baseline
|
2026.5 (dyne*s*m^2)/cm^5
Standard Deviation 1141.94
|
1043.1 (dyne*s*m^2)/cm^5
Standard Deviation 327.07
|
1602.4 (dyne*s*m^2)/cm^5
Standard Deviation 990.36
|
1934.3 (dyne*s*m^2)/cm^5
Standard Deviation 675.31
|
1328.2 (dyne*s*m^2)/cm^5
Standard Deviation 784.24
|
1380.8 (dyne*s*m^2)/cm^5
Standard Deviation 1058.35
|
1674.0 (dyne*s*m^2)/cm^5
Standard Deviation 925.53
|
|
Mean Change From Baseline in Pulmonary Vascular Resistance Index (PVRI) Over 4 Hours Post Dose
Change over 4 hours post-dose
|
-47.3 (dyne*s*m^2)/cm^5
Standard Deviation 507.90
|
-106.8 (dyne*s*m^2)/cm^5
Standard Deviation 136.41
|
11.6 (dyne*s*m^2)/cm^5
Standard Deviation 213.55
|
-335.3 (dyne*s*m^2)/cm^5
Standard Deviation 499.52
|
-267.0 (dyne*s*m^2)/cm^5
Standard Deviation 397.56
|
-254.0 (dyne*s*m^2)/cm^5
Standard Deviation 361.07
|
304.9 (dyne*s*m^2)/cm^5
Standard Deviation 799.78
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours post-dose on Day 1Population: Full analysis set (FAS) included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group.
PVRI was calculated as: PVRI (in Wood units\*m\^2) = PVR multiplied by BSA. PVR (in Wood units) = (mean PAP minus PCWP) divided by CO (taken as the average of the triplicate measurements). SVRI was calculated as: SVRI (Wood units\*m\^2) = systemic vascular resistance (SVR) multiplied by BSA. SVR (Wood units) = (mean systemic arterial pressure \[mean SAP\] minus right atrial pressure \[RAP\]) divided by CO (taken as the average of the triplicate measurements). BSA (m\^2) = (0.007184) multiplied by (height in cm)\^0.725 multiplied by (weight in kg)\^0.425. PVRI and SVRI values were converted to dyne\*s\*m\^2/cm\^5 from Woods units by multiplying by a factor of 79.9. For each participant the greatest reduction (GR) from baseline in PVRI and SVRI over 4-hour interval was defined as the maximum reduction (greatest decrease or smallest increase) observed at 1, 2, 3, and 4 hours post dose on Day 1.
Outcome measures
| Measure |
Placebo
n=6 Participants
Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 1 mg
n=6 Participants
Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 2 mg
n=7 Participants
Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 4 mg
n=6 Participants
Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 10 mg
n=6 Participants
Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 20 mg
n=6 Participants
Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
Sildenafil
n=6 Participants
Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Greatest Reduction From Baseline in Pulmonary Vascular Resistance Index (PVRI) and Systemic Vascular Resistance Index (SVRI) Over 4 Hours Post Dose
Baseline: SVRI
|
3560.6 (dyne*s*m^2)/cm^5
Standard Deviation 1481.67
|
2512.2 (dyne*s*m^2)/cm^5
Standard Deviation 858.62
|
2599.6 (dyne*s*m^2)/cm^5
Standard Deviation 874.85
|
3679.1 (dyne*s*m^2)/cm^5
Standard Deviation 1248.03
|
3175.8 (dyne*s*m^2)/cm^5
Standard Deviation 644.80
|
2577.1 (dyne*s*m^2)/cm^5
Standard Deviation 791.93
|
3121.8 (dyne*s*m^2)/cm^5
Standard Deviation 544.52
|
|
Greatest Reduction From Baseline in Pulmonary Vascular Resistance Index (PVRI) and Systemic Vascular Resistance Index (SVRI) Over 4 Hours Post Dose
GR over 4 hours: PVRI
|
-180.8 (dyne*s*m^2)/cm^5
Standard Deviation 487.37
|
-210.2 (dyne*s*m^2)/cm^5
Standard Deviation 132.60
|
-143.4 (dyne*s*m^2)/cm^5
Standard Deviation 188.58
|
-600.9 (dyne*s*m^2)/cm^5
Standard Deviation 453.38
|
-397.8 (dyne*s*m^2)/cm^5
Standard Deviation 386.51
|
-385.9 (dyne*s*m^2)/cm^5
Standard Deviation 455.07
|
55.8 (dyne*s*m^2)/cm^5
Standard Deviation 526.85
|
|
Greatest Reduction From Baseline in Pulmonary Vascular Resistance Index (PVRI) and Systemic Vascular Resistance Index (SVRI) Over 4 Hours Post Dose
GR over 4 hours: SVRI
|
-806.1 (dyne*s*m^2)/cm^5
Standard Deviation 480.86
|
-387.6 (dyne*s*m^2)/cm^5
Standard Deviation 428.39
|
-394.1 (dyne*s*m^2)/cm^5
Standard Deviation 594.61
|
-1110.5 (dyne*s*m^2)/cm^5
Standard Deviation 1079.75
|
-1000.6 (dyne*s*m^2)/cm^5
Standard Deviation 529.43
|
-524.1 (dyne*s*m^2)/cm^5
Standard Deviation 370.71
|
-113.6 (dyne*s*m^2)/cm^5
Standard Deviation 726.61
|
SECONDARY outcome
Timeframe: Baseline, up to 4 hours post-dose on Day 1Population: FAS included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure.
SVRI was calculated as: SVRI (Wood units\*m\^2) = SVR multiplied by BSA. SVR (Wood units) = (mean SAP minus RAP) divided by CO (taken as the average of the triplicate measurements). BSA (m\^2) = (0.007184) multiplied by (height in cm)\^0.725 multiplied by (weight in kg)\^0.425. SVRI values were converted to dyne\*s\*m\^2/cm\^5 from Woods units by multiplying by a factor of 79.9. The change from baseline in SVRI over 4-hour interval was calculated as the average of the change from baseline values at 1, 2, 3, and 4 hours post dose on Day 1.
Outcome measures
| Measure |
Placebo
n=6 Participants
Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 1 mg
n=6 Participants
Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 2 mg
n=7 Participants
Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 4 mg
n=6 Participants
Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 10 mg
n=6 Participants
Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 20 mg
n=6 Participants
Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
Sildenafil
n=6 Participants
Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Systemic Vascular Resistance Index (SVRI) Over 4 Hours Post Dose
|
-486.8 (dyne*s*m^2)/cm^5
Standard Deviation 543.83
|
-193.9 (dyne*s*m^2)/cm^5
Standard Deviation 336.10
|
-145.7 (dyne*s*m^2)/cm^5
Standard Deviation 557.67
|
-609.6 (dyne*s*m^2)/cm^5
Standard Deviation 1061.78
|
-704.7 (dyne*s*m^2)/cm^5
Standard Deviation 501.01
|
-272.8 (dyne*s*m^2)/cm^5
Standard Deviation 228.53
|
97.6 (dyne*s*m^2)/cm^5
Standard Deviation 810.82
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 3, 4 hours post-dose on Day 1Population: FAS included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group.
PVRI was calculated as: PVR multiplied by BSA. PVR = (mean PAP minus PCWP) divided by CO (taken as the average of the triplicate measurements). BSA (m\^2) = 0.007184 times height (cm)\^0.725 times weight (kilogram)\^0.425. Wood unit equals to 79.9 dyne\*second/cm\^5. Hourly changes from baseline in PVRI was reported.
Outcome measures
| Measure |
Placebo
n=6 Participants
Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 1 mg
n=6 Participants
Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 2 mg
n=7 Participants
Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 4 mg
n=6 Participants
Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 10 mg
n=6 Participants
Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 20 mg
n=6 Participants
Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
Sildenafil
n=6 Participants
Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Pulmonary Vascular Resistance Index (PVRI) at Hour 1, 2, 3 and 4 Post Dose
Change at hour 1
|
32.03 (dyne*s*m^2)/cm^5
Standard Deviation 637.84
|
-121.86 (dyne*s*m^2)/cm^5
Standard Deviation 228.17
|
-15.84 (dyne*s*m^2)/cm^5
Standard Deviation 245.75
|
-333.75 (dyne*s*m^2)/cm^5
Standard Deviation 482.43
|
-228.30 (dyne*s*m^2)/cm^5
Standard Deviation 526.40
|
-183.51 (dyne*s*m^2)/cm^5
Standard Deviation 123.88
|
121.33 (dyne*s*m^2)/cm^5
Standard Deviation 449.03
|
|
Change From Baseline in Pulmonary Vascular Resistance Index (PVRI) at Hour 1, 2, 3 and 4 Post Dose
Change at hour 2
|
-84.78 (dyne*s*m^2)/cm^5
Standard Deviation 554.32
|
-167.42 (dyne*s*m^2)/cm^5
Standard Deviation 169.75
|
2.91 (dyne*s*m^2)/cm^5
Standard Deviation 216.15
|
-210.86 (dyne*s*m^2)/cm^5
Standard Deviation 779.62
|
-302.42 (dyne*s*m^2)/cm^5
Standard Deviation 378.43
|
-315.71 (dyne*s*m^2)/cm^5
Standard Deviation 441.19
|
252.41 (dyne*s*m^2)/cm^5
Standard Deviation 891.95
|
|
Change From Baseline in Pulmonary Vascular Resistance Index (PVRI) at Hour 1, 2, 3 and 4 Post Dose
Change at hour 3
|
-51.15 (dyne*s*m^2)/cm^5
Standard Deviation 501.81
|
-22.45 (dyne*s*m^2)/cm^5
Standard Deviation 182.54
|
16.64 (dyne*s*m^2)/cm^5
Standard Deviation 272.36
|
-326.88 (dyne*s*m^2)/cm^5
Standard Deviation 815.60
|
-244.54 (dyne*s*m^2)/cm^5
Standard Deviation 367.99
|
-276.37 (dyne*s*m^2)/cm^5
Standard Deviation 519.49
|
392.24 (dyne*s*m^2)/cm^5
Standard Deviation 859.17
|
|
Change From Baseline in Pulmonary Vascular Resistance Index (PVRI) at Hour 1, 2, 3 and 4 Post Dose
Change at hour 4
|
-85.20 (dyne*s*m^2)/cm^5
Standard Deviation 406.10
|
-115.49 (dyne*s*m^2)/cm^5
Standard Deviation 172.46
|
42.55 (dyne*s*m^2)/cm^5
Standard Deviation 321.24
|
-416.28 (dyne*s*m^2)/cm^5
Standard Deviation 420.63
|
-292.65 (dyne*s*m^2)/cm^5
Standard Deviation 399.71
|
-240.48 (dyne*s*m^2)/cm^5
Standard Deviation 422.15
|
453.54 (dyne*s*m^2)/cm^5
Standard Deviation 1012.97
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 3, 4 hours post-dose on Day 1Population: FAS included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group.
SVRI is the product of SVR and BSA. SVR equals to (mean SAP subtracted by RAP) divided by CO (taken as the average of the triplicate measurements). BSA (m\^2) equals to 0.007184 times height (cm)\^0.725 times weight (kilogram) \^0.425. Wood unit equals to 79.9 dyne\*second/cm\^5. Hourly changes from baseline in SVRI was reported.
Outcome measures
| Measure |
Placebo
n=6 Participants
Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 1 mg
n=6 Participants
Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 2 mg
n=7 Participants
Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 4 mg
n=6 Participants
Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 10 mg
n=6 Participants
Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 20 mg
n=6 Participants
Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
Sildenafil
n=6 Participants
Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Systemic Vascular Resistance Index (SVRI) at Hour 1, 2, 3 and 4 Post Dose
Change at hour 4
|
-660.98 (dyne*s*m^2)/cm^5
Standard Deviation 524.55
|
-69.89 (dyne*s*m^2)/cm^5
Standard Deviation 290.88
|
-122.36 (dyne*s*m^2)/cm^5
Standard Deviation 560.20
|
-874.51 (dyne*s*m^2)/cm^5
Standard Deviation 1171.91
|
-569.43 (dyne*s*m^2)/cm^5
Standard Deviation 581.07
|
-325.95 (dyne*s*m^2)/cm^5
Standard Deviation 372.51
|
151.18 (dyne*s*m^2)/cm^5
Standard Deviation 902.51
|
|
Change From Baseline in Systemic Vascular Resistance Index (SVRI) at Hour 1, 2, 3 and 4 Post Dose
Change at hour 1
|
-278.74 (dyne*s*m^2)/cm^5
Standard Deviation 812.16
|
-281.26 (dyne*s*m^2)/cm^5
Standard Deviation 386.52
|
-145.25 (dyne*s*m^2)/cm^5
Standard Deviation 712.56
|
-602.63 (dyne*s*m^2)/cm^5
Standard Deviation 993.10
|
-616.40 (dyne*s*m^2)/cm^5
Standard Deviation 674.29
|
-48.54 (dyne*s*m^2)/cm^5
Standard Deviation 218.85
|
125.71 (dyne*s*m^2)/cm^5
Standard Deviation 607.77
|
|
Change From Baseline in Systemic Vascular Resistance Index (SVRI) at Hour 1, 2, 3 and 4 Post Dose
Change at hour 2
|
-518.41 (dyne*s*m^2)/cm^5
Standard Deviation 533.85
|
-308.47 (dyne*s*m^2)/cm^5
Standard Deviation 487.47
|
-222.83 (dyne*s*m^2)/cm^5
Standard Deviation 550.92
|
-381.01 (dyne*s*m^2)/cm^5
Standard Deviation 1069.58
|
-893.81 (dyne*s*m^2)/cm^5
Standard Deviation 479.01
|
-347.45 (dyne*s*m^2)/cm^5
Standard Deviation 392.26
|
34.44 (dyne*s*m^2)/cm^5
Standard Deviation 959.10
|
|
Change From Baseline in Systemic Vascular Resistance Index (SVRI) at Hour 1, 2, 3 and 4 Post Dose
Change at hour 3
|
-489.10 (dyne*s*m^2)/cm^5
Standard Deviation 531.15
|
-115.91 (dyne*s*m^2)/cm^5
Standard Deviation 321.47
|
-92.23 (dyne*s*m^2)/cm^5
Standard Deviation 551.76
|
-502.93 (dyne*s*m^2)/cm^5
Standard Deviation 1390.25
|
-739.16 (dyne*s*m^2)/cm^5
Standard Deviation 485.07
|
-369.29 (dyne*s*m^2)/cm^5
Standard Deviation 423.35
|
79.04 (dyne*s*m^2)/cm^5
Standard Deviation 844.22
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 3, 4 hours post-dose on Day 1Population: FAS included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group.
CI was calculated as: CI (liters per minute per square meter \[L/min/m\^2\]) = CO (taken as the average of the triplicate measurements) divided by BSA. BSA (m\^2) = (0.007184) multiplied by (height in cm)\^0.725 multiplied by (weight in kg)\^0.425.
Outcome measures
| Measure |
Placebo
n=6 Participants
Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 1 mg
n=6 Participants
Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 2 mg
n=7 Participants
Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 4 mg
n=6 Participants
Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 10 mg
n=6 Participants
Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 20 mg
n=6 Participants
Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
Sildenafil
n=6 Participants
Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Cardiac Index (CI) at Hour 1, 2, 3 and 4 Post Dose
Baseline
|
1.90 L/min/m^2
Standard Deviation 0.50
|
2.90 L/min/m^2
Standard Deviation 0.69
|
2.99 L/min/m^2
Standard Deviation 1.61
|
2.05 L/min/m^2
Standard Deviation 0.55
|
2.30 L/min/m^2
Standard Deviation 0.40
|
3.07 L/min/m^2
Standard Deviation 1.47
|
2.43 L/min/m^2
Standard Deviation 0.70
|
|
Change From Baseline in Cardiac Index (CI) at Hour 1, 2, 3 and 4 Post Dose
Change at hour 1
|
0.12 L/min/m^2
Standard Deviation 0.25
|
0.20 L/min/m^2
Standard Deviation 0.57
|
-0.06 L/min/m^2
Standard Deviation 0.67
|
0.27 L/min/m^2
Standard Deviation 0.36
|
0.49 L/min/m^2
Standard Deviation 0.67
|
-0.13 L/min/m^2
Standard Deviation 0.21
|
-0.15 L/min/m^2
Standard Deviation 0.31
|
|
Change From Baseline in Cardiac Index (CI) at Hour 1, 2, 3 and 4 Post Dose
Change at hour 2
|
0.22 L/min/m^2
Standard Deviation 0.24
|
0.36 L/min/m^2
Standard Deviation 0.78
|
0.09 L/min/m^2
Standard Deviation 0.65
|
0.17 L/min/m^2
Standard Deviation 0.46
|
0.59 L/min/m^2
Standard Deviation 0.41
|
0.14 L/min/m^2
Standard Deviation 0.88
|
-0.11 L/min/m^2
Standard Deviation 0.45
|
|
Change From Baseline in Cardiac Index (CI) at Hour 1, 2, 3 and 4 Post Dose
Change at hour 3
|
0.19 L/min/m^2
Standard Deviation 0.29
|
0.12 L/min/m^2
Standard Deviation 0.31
|
-0.15 L/min/m^2
Standard Deviation 0.77
|
0.19 L/min/m^2
Standard Deviation 0.41
|
0.54 L/min/m^2
Standard Deviation 0.62
|
0.19 L/min/m^2
Standard Deviation 0.63
|
-0.24 L/min/m^2
Standard Deviation 0.26
|
|
Change From Baseline in Cardiac Index (CI) at Hour 1, 2, 3 and 4 Post Dose
Change at hour 4
|
0.20 L/min/m^2
Standard Deviation 0.36
|
0.10 L/min/m^2
Standard Deviation 0.56
|
-0.12 L/min/m^2
Standard Deviation 0.59
|
0.36 L/min/m^2
Standard Deviation 0.30
|
0.38 L/min/m^2
Standard Deviation 0.54
|
0.26 L/min/m^2
Standard Deviation 0.38
|
-0.27 L/min/m^2
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 3, 4 hours post-dose on Day 1Population: FAS included all randomized participants who received study medication. Here, 'Number Analyzed' = participants who were evaluable at given time points for each group.
Hourly changes from baseline in hemodynamic parameters were reported. Hemodynamic parameters including mPAP, sPAP, dPAP and RAP were measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position. All hemodynamic pressure measurements were performed as triplicate measurements and average was used.
Outcome measures
| Measure |
Placebo
n=6 Participants
Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 1 mg
n=6 Participants
Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 2 mg
n=7 Participants
Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 4 mg
n=6 Participants
Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 10 mg
n=6 Participants
Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 20 mg
n=7 Participants
Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
Sildenafil
n=6 Participants
Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Pulmonary Artery Pressure (mPAP), Systolic Pulmonary Artery Pressure (sPAP), Diastolic Pulmonary Artery Pressure (dPAP), Right Atrial Pressure (RAP) at Hour 1, 2, 3 and 4 Post Dose
Baseline: mPAP
|
53.67 millimeters of mercury (mmHg)
Standard Deviation 15.36
|
45.67 millimeters of mercury (mmHg)
Standard Deviation 13.47
|
60.29 millimeters of mercury (mmHg)
Standard Deviation 22.32
|
53.83 millimeters of mercury (mmHg)
Standard Deviation 11.34
|
44.95 millimeters of mercury (mmHg)
Standard Deviation 18.98
|
50.17 millimeters of mercury (mmHg)
Standard Deviation 23.25
|
55.33 millimeters of mercury (mmHg)
Standard Deviation 18.49
|
|
Change From Baseline in Mean Pulmonary Artery Pressure (mPAP), Systolic Pulmonary Artery Pressure (sPAP), Diastolic Pulmonary Artery Pressure (dPAP), Right Atrial Pressure (RAP) at Hour 1, 2, 3 and 4 Post Dose
Baseline: sPAP
|
88.3 millimeters of mercury (mmHg)
Standard Deviation 20.69
|
71.2 millimeters of mercury (mmHg)
Standard Deviation 17.84
|
84.1 millimeters of mercury (mmHg)
Standard Deviation 32.62
|
83.8 millimeters of mercury (mmHg)
Standard Deviation 24.26
|
68.2 millimeters of mercury (mmHg)
Standard Deviation 28.93
|
68.6 millimeters of mercury (mmHg)
Standard Deviation 29.53
|
82.5 millimeters of mercury (mmHg)
Standard Deviation 28.13
|
|
Change From Baseline in Mean Pulmonary Artery Pressure (mPAP), Systolic Pulmonary Artery Pressure (sPAP), Diastolic Pulmonary Artery Pressure (dPAP), Right Atrial Pressure (RAP) at Hour 1, 2, 3 and 4 Post Dose
Baseline: dPAP
|
34.5 millimeters of mercury (mmHg)
Standard Deviation 13.28
|
29.3 millimeters of mercury (mmHg)
Standard Deviation 12.86
|
45.0 millimeters of mercury (mmHg)
Standard Deviation 17.51
|
35.7 millimeters of mercury (mmHg)
Standard Deviation 8.71
|
29.7 millimeters of mercury (mmHg)
Standard Deviation 14.68
|
39.1 millimeters of mercury (mmHg)
Standard Deviation 18.41
|
41.0 millimeters of mercury (mmHg)
Standard Deviation 16.63
|
|
Change From Baseline in Mean Pulmonary Artery Pressure (mPAP), Systolic Pulmonary Artery Pressure (sPAP), Diastolic Pulmonary Artery Pressure (dPAP), Right Atrial Pressure (RAP) at Hour 1, 2, 3 and 4 Post Dose
Baseline: RAP
|
11.5 millimeters of mercury (mmHg)
Standard Deviation 5.01
|
5.3 millimeters of mercury (mmHg)
Standard Deviation 3.72
|
9.3 millimeters of mercury (mmHg)
Standard Deviation 2.21
|
8.5 millimeters of mercury (mmHg)
Standard Deviation 4.32
|
5.7 millimeters of mercury (mmHg)
Standard Deviation 1.37
|
8.3 millimeters of mercury (mmHg)
Standard Deviation 3.64
|
6.5 millimeters of mercury (mmHg)
Standard Deviation 3.27
|
|
Change From Baseline in Mean Pulmonary Artery Pressure (mPAP), Systolic Pulmonary Artery Pressure (sPAP), Diastolic Pulmonary Artery Pressure (dPAP), Right Atrial Pressure (RAP) at Hour 1, 2, 3 and 4 Post Dose
mPAP: Change at hour 1
|
2.17 millimeters of mercury (mmHg)
Standard Deviation 8.89
|
-3.00 millimeters of mercury (mmHg)
Standard Deviation 4.47
|
-2.00 millimeters of mercury (mmHg)
Standard Deviation 5.23
|
-1.50 millimeters of mercury (mmHg)
Standard Deviation 7.69
|
0.38 millimeters of mercury (mmHg)
Standard Deviation 6.23
|
-6.00 millimeters of mercury (mmHg)
Standard Deviation 4.43
|
-2.67 millimeters of mercury (mmHg)
Standard Deviation 6.92
|
|
Change From Baseline in Mean Pulmonary Artery Pressure (mPAP), Systolic Pulmonary Artery Pressure (sPAP), Diastolic Pulmonary Artery Pressure (dPAP), Right Atrial Pressure (RAP) at Hour 1, 2, 3 and 4 Post Dose
sPAP: Change at hour 1
|
1.0 millimeters of mercury (mmHg)
Standard Deviation 13.96
|
-5.3 millimeters of mercury (mmHg)
Standard Deviation 5.79
|
-3.3 millimeters of mercury (mmHg)
Standard Deviation 6.52
|
-3.0 millimeters of mercury (mmHg)
Standard Deviation 13.19
|
-2.8 millimeters of mercury (mmHg)
Standard Deviation 10.34
|
-7.0 millimeters of mercury (mmHg)
Standard Deviation 8.21
|
-6.5 millimeters of mercury (mmHg)
Standard Deviation 11.15
|
|
Change From Baseline in Mean Pulmonary Artery Pressure (mPAP), Systolic Pulmonary Artery Pressure (sPAP), Diastolic Pulmonary Artery Pressure (dPAP), Right Atrial Pressure (RAP) at Hour 1, 2, 3 and 4 Post Dose
dPAP: Change at hour 1
|
2.2 millimeters of mercury (mmHg)
Standard Deviation 6.68
|
-0.3 millimeters of mercury (mmHg)
Standard Deviation 5.09
|
-2.3 millimeters of mercury (mmHg)
Standard Deviation 4.61
|
-0.5 millimeters of mercury (mmHg)
Standard Deviation 6.72
|
4.7 millimeters of mercury (mmHg)
Standard Deviation 6.59
|
-6.4 millimeters of mercury (mmHg)
Standard Deviation 5.86
|
-2.0 millimeters of mercury (mmHg)
Standard Deviation 3.03
|
|
Change From Baseline in Mean Pulmonary Artery Pressure (mPAP), Systolic Pulmonary Artery Pressure (sPAP), Diastolic Pulmonary Artery Pressure (dPAP), Right Atrial Pressure (RAP) at Hour 1, 2, 3 and 4 Post Dose
RAP: Change at hour 1
|
0.3 millimeters of mercury (mmHg)
Standard Deviation 1.03
|
1.2 millimeters of mercury (mmHg)
Standard Deviation 1.47
|
-1.0 millimeters of mercury (mmHg)
Standard Deviation 1.83
|
-1.3 millimeters of mercury (mmHg)
Standard Deviation 2.73
|
0.2 millimeters of mercury (mmHg)
Standard Deviation 1.47
|
-1.4 millimeters of mercury (mmHg)
Standard Deviation 2.99
|
-0.3 millimeters of mercury (mmHg)
Standard Deviation 1.37
|
|
Change From Baseline in Mean Pulmonary Artery Pressure (mPAP), Systolic Pulmonary Artery Pressure (sPAP), Diastolic Pulmonary Artery Pressure (dPAP), Right Atrial Pressure (RAP) at Hour 1, 2, 3 and 4 Post Dose
mPAP: Change at hour 2
|
2.83 millimeters of mercury (mmHg)
Standard Deviation 7.17
|
-3.67 millimeters of mercury (mmHg)
Standard Deviation 4.72
|
1.29 millimeters of mercury (mmHg)
Standard Deviation 5.74
|
-0.83 millimeters of mercury (mmHg)
Standard Deviation 6.77
|
1.05 millimeters of mercury (mmHg)
Standard Deviation 5.12
|
-5.50 millimeters of mercury (mmHg)
Standard Deviation 4.14
|
-1.00 millimeters of mercury (mmHg)
Standard Deviation 6.07
|
|
Change From Baseline in Mean Pulmonary Artery Pressure (mPAP), Systolic Pulmonary Artery Pressure (sPAP), Diastolic Pulmonary Artery Pressure (dPAP), Right Atrial Pressure (RAP) at Hour 1, 2, 3 and 4 Post Dose
sPAP: Change at hour 2
|
8.3 millimeters of mercury (mmHg)
Standard Deviation 13.47
|
-8.5 millimeters of mercury (mmHg)
Standard Deviation 8.92
|
-0.6 millimeters of mercury (mmHg)
Standard Deviation 8.92
|
-4.2 millimeters of mercury (mmHg)
Standard Deviation 11.46
|
-1.7 millimeters of mercury (mmHg)
Standard Deviation 7.92
|
-6.4 millimeters of mercury (mmHg)
Standard Deviation 7.37
|
-6.5 millimeters of mercury (mmHg)
Standard Deviation 8.19
|
|
Change From Baseline in Mean Pulmonary Artery Pressure (mPAP), Systolic Pulmonary Artery Pressure (sPAP), Diastolic Pulmonary Artery Pressure (dPAP), Right Atrial Pressure (RAP) at Hour 1, 2, 3 and 4 Post Dose
dPAP: Change at hour 2
|
0.7 millimeters of mercury (mmHg)
Standard Deviation 3.50
|
-0.5 millimeters of mercury (mmHg)
Standard Deviation 7.34
|
1.6 millimeters of mercury (mmHg)
Standard Deviation 4.65
|
-0.5 millimeters of mercury (mmHg)
Standard Deviation 7.26
|
3.8 millimeters of mercury (mmHg)
Standard Deviation 6.05
|
-7.3 millimeters of mercury (mmHg)
Standard Deviation 3.55
|
-0.3 millimeters of mercury (mmHg)
Standard Deviation 3.61
|
|
Change From Baseline in Mean Pulmonary Artery Pressure (mPAP), Systolic Pulmonary Artery Pressure (sPAP), Diastolic Pulmonary Artery Pressure (dPAP), Right Atrial Pressure (RAP) at Hour 1, 2, 3 and 4 Post Dose
RAP: Change at hour 2
|
1.0 millimeters of mercury (mmHg)
Standard Deviation 1.55
|
0.0 millimeters of mercury (mmHg)
Standard Deviation 1.10
|
-1.0 millimeters of mercury (mmHg)
Standard Deviation 1.83
|
-1.5 millimeters of mercury (mmHg)
Standard Deviation 1.87
|
0.5 millimeters of mercury (mmHg)
Standard Deviation 1.76
|
-1.0 millimeters of mercury (mmHg)
Standard Deviation 2.52
|
0.0 millimeters of mercury (mmHg)
Standard Deviation 1.90
|
|
Change From Baseline in Mean Pulmonary Artery Pressure (mPAP), Systolic Pulmonary Artery Pressure (sPAP), Diastolic Pulmonary Artery Pressure (dPAP), Right Atrial Pressure (RAP) at Hour 1, 2, 3 and 4 Post Dose
mPAP: Change at hour 3
|
2.83 millimeters of mercury (mmHg)
Standard Deviation 5.27
|
1.17 millimeters of mercury (mmHg)
Standard Deviation 7.94
|
-1.71 millimeters of mercury (mmHg)
Standard Deviation 7.80
|
-3.17 millimeters of mercury (mmHg)
Standard Deviation 3.87
|
2.10 millimeters of mercury (mmHg)
Standard Deviation 6.64
|
-6.33 millimeters of mercury (mmHg)
Standard Deviation 5.96
|
-0.67 millimeters of mercury (mmHg)
Standard Deviation 7.50
|
|
Change From Baseline in Mean Pulmonary Artery Pressure (mPAP), Systolic Pulmonary Artery Pressure (sPAP), Diastolic Pulmonary Artery Pressure (dPAP), Right Atrial Pressure (RAP) at Hour 1, 2, 3 and 4 Post Dose
sPAP: Change at hour 3
|
5.0 millimeters of mercury (mmHg)
Standard Deviation 5.83
|
-2.8 millimeters of mercury (mmHg)
Standard Deviation 7.63
|
-5.0 millimeters of mercury (mmHg)
Standard Deviation 10.88
|
-4.0 millimeters of mercury (mmHg)
Standard Deviation 10.83
|
-1.3 millimeters of mercury (mmHg)
Standard Deviation 10.35
|
-8.6 millimeters of mercury (mmHg)
Standard Deviation 10.49
|
-4.5 millimeters of mercury (mmHg)
Standard Deviation 8.92
|
|
Change From Baseline in Mean Pulmonary Artery Pressure (mPAP), Systolic Pulmonary Artery Pressure (sPAP), Diastolic Pulmonary Artery Pressure (dPAP), Right Atrial Pressure (RAP) at Hour 1, 2, 3 and 4 Post Dose
dPAP: Change at hour 3
|
1.7 millimeters of mercury (mmHg)
Standard Deviation 6.53
|
3.3 millimeters of mercury (mmHg)
Standard Deviation 10.60
|
-0.4 millimeters of mercury (mmHg)
Standard Deviation 5.50
|
-1.8 millimeters of mercury (mmHg)
Standard Deviation 4.49
|
4.8 millimeters of mercury (mmHg)
Standard Deviation 9.11
|
-6.7 millimeters of mercury (mmHg)
Standard Deviation 5.44
|
-1.3 millimeters of mercury (mmHg)
Standard Deviation 2.94
|
|
Change From Baseline in Mean Pulmonary Artery Pressure (mPAP), Systolic Pulmonary Artery Pressure (sPAP), Diastolic Pulmonary Artery Pressure (dPAP), Right Atrial Pressure (RAP) at Hour 1, 2, 3 and 4 Post Dose
RAP: Change at hour 3
|
1.3 millimeters of mercury (mmHg)
Standard Deviation 3.01
|
0.5 millimeters of mercury (mmHg)
Standard Deviation 1.38
|
-1.1 millimeters of mercury (mmHg)
Standard Deviation 2.27
|
0.8 millimeters of mercury (mmHg)
Standard Deviation 5.04
|
0.7 millimeters of mercury (mmHg)
Standard Deviation 2.25
|
-2.4 millimeters of mercury (mmHg)
Standard Deviation 3.51
|
-0.2 millimeters of mercury (mmHg)
Standard Deviation 1.72
|
|
Change From Baseline in Mean Pulmonary Artery Pressure (mPAP), Systolic Pulmonary Artery Pressure (sPAP), Diastolic Pulmonary Artery Pressure (dPAP), Right Atrial Pressure (RAP) at Hour 1, 2, 3 and 4 Post Dose
mPAP: Change at hour 4
|
2.67 millimeters of mercury (mmHg)
Standard Deviation 6.47
|
-3.50 millimeters of mercury (mmHg)
Standard Deviation 5.54
|
-0.86 millimeters of mercury (mmHg)
Standard Deviation 9.32
|
-2.50 millimeters of mercury (mmHg)
Standard Deviation 2.74
|
-0.28 millimeters of mercury (mmHg)
Standard Deviation 6.48
|
-6.33 millimeters of mercury (mmHg)
Standard Deviation 6.53
|
-0.67 millimeters of mercury (mmHg)
Standard Deviation 9.03
|
|
Change From Baseline in Mean Pulmonary Artery Pressure (mPAP), Systolic Pulmonary Artery Pressure (sPAP), Diastolic Pulmonary Artery Pressure (dPAP), Right Atrial Pressure (RAP) at Hour 1, 2, 3 and 4 Post Dose
sPAP: Change at hour 4
|
0.3 millimeters of mercury (mmHg)
Standard Deviation 11.91
|
-7.7 millimeters of mercury (mmHg)
Standard Deviation 10.56
|
-4.9 millimeters of mercury (mmHg)
Standard Deviation 14.42
|
-3.3 millimeters of mercury (mmHg)
Standard Deviation 10.23
|
-8.7 millimeters of mercury (mmHg)
Standard Deviation 8.76
|
-4.9 millimeters of mercury (mmHg)
Standard Deviation 11.58
|
-3.7 millimeters of mercury (mmHg)
Standard Deviation 11.60
|
|
Change From Baseline in Mean Pulmonary Artery Pressure (mPAP), Systolic Pulmonary Artery Pressure (sPAP), Diastolic Pulmonary Artery Pressure (dPAP), Right Atrial Pressure (RAP) at Hour 1, 2, 3 and 4 Post Dose
dPAP: Change at hour 4
|
3.7 millimeters of mercury (mmHg)
Standard Deviation 6.77
|
-0.7 millimeters of mercury (mmHg)
Standard Deviation 5.54
|
1.1 millimeters of mercury (mmHg)
Standard Deviation 7.03
|
-2.2 millimeters of mercury (mmHg)
Standard Deviation 4.36
|
5.3 millimeters of mercury (mmHg)
Standard Deviation 8.26
|
-8.9 millimeters of mercury (mmHg)
Standard Deviation 8.59
|
-1.0 millimeters of mercury (mmHg)
Standard Deviation 4.20
|
|
Change From Baseline in Mean Pulmonary Artery Pressure (mPAP), Systolic Pulmonary Artery Pressure (sPAP), Diastolic Pulmonary Artery Pressure (dPAP), Right Atrial Pressure (RAP) at Hour 1, 2, 3 and 4 Post Dose
RAP: Change at hour 4
|
1.2 millimeters of mercury (mmHg)
Standard Deviation 2.71
|
1.0 millimeters of mercury (mmHg)
Standard Deviation 2.00
|
-0.7 millimeters of mercury (mmHg)
Standard Deviation 2.56
|
0.0 millimeters of mercury (mmHg)
Standard Deviation 4.60
|
0.3 millimeters of mercury (mmHg)
Standard Deviation 2.42
|
-1.7 millimeters of mercury (mmHg)
Standard Deviation 3.09
|
0.5 millimeters of mercury (mmHg)
Standard Deviation 3.33
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 3, 4 hours post-dose on Day 1Population: FAS included all randomized participants who received study medication. Here, 'Number Analyzed' = participants who were evaluable at given time points for each group.
Hourly changes from baseline in hemodynamic parameters were reported. Hemodynamic parameters including PCWP, SAP, sSAP and dSAP were measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position. All hemodynamic pressure measurements (except PCWP for which 1 measurement is sufficient) were performed as triplicate measurements and average was used.
Outcome measures
| Measure |
Placebo
n=6 Participants
Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 1 mg
n=6 Participants
Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 2 mg
n=7 Participants
Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 4 mg
n=6 Participants
Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 10 mg
n=6 Participants
Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 20 mg
n=7 Participants
Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
Sildenafil
n=6 Participants
Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP), Mean Systemic Arterial Pressure (SAP), Systolic Systemic Arterial Pressure (sSAP) and Diastolic Systemic Arterial Pressure (dSAP) at Hour 1, 2, 3 and 4 Post Dose
dSAP: Change at hour 3
|
-1.3 mmHg
Standard Deviation 5.82
|
-1.2 mmHg
Standard Deviation 5.04
|
-5.4 mmHg
Standard Deviation 8.70
|
-6.7 mmHg
Standard Deviation 7.97
|
-1.0 mmHg
Standard Deviation 15.03
|
-9.5 mmHg
Standard Deviation 5.17
|
-9.2 mmHg
Standard Deviation 10.30
|
|
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP), Mean Systemic Arterial Pressure (SAP), Systolic Systemic Arterial Pressure (sSAP) and Diastolic Systemic Arterial Pressure (dSAP) at Hour 1, 2, 3 and 4 Post Dose
Baseline: PCWP
|
11.0 mmHg
Standard Deviation 1.79
|
8.2 mmHg
Standard Deviation 3.76
|
11.7 mmHg
Standard Deviation 1.70
|
7.3 mmHg
Standard Deviation 3.56
|
9.5 mmHg
Standard Deviation 2.07
|
10.4 mmHg
Standard Deviation 2.88
|
10.2 mmHg
Standard Deviation 1.72
|
|
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP), Mean Systemic Arterial Pressure (SAP), Systolic Systemic Arterial Pressure (sSAP) and Diastolic Systemic Arterial Pressure (dSAP) at Hour 1, 2, 3 and 4 Post Dose
Baseline: SAP
|
89.2 mmHg
Standard Deviation 14.06
|
91.0 mmHg
Standard Deviation 13.78
|
91.6 mmHg
Standard Deviation 11.62
|
96.0 mmHg
Standard Deviation 12.70
|
94.7 mmHg
Standard Deviation 10.69
|
95.5 mmHg
Standard Deviation 9.50
|
97.5 mmHg
Standard Deviation 10.58
|
|
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP), Mean Systemic Arterial Pressure (SAP), Systolic Systemic Arterial Pressure (sSAP) and Diastolic Systemic Arterial Pressure (dSAP) at Hour 1, 2, 3 and 4 Post Dose
Baseline: sSAP
|
122.5 mmHg
Standard Deviation 12.76
|
132.0 mmHg
Standard Deviation 19.45
|
116.9 mmHg
Standard Deviation 6.07
|
131.2 mmHg
Standard Deviation 8.80
|
131.5 mmHg
Standard Deviation 15.67
|
126.5 mmHg
Standard Deviation 23.37
|
128.3 mmHg
Standard Deviation 15.81
|
|
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP), Mean Systemic Arterial Pressure (SAP), Systolic Systemic Arterial Pressure (sSAP) and Diastolic Systemic Arterial Pressure (dSAP) at Hour 1, 2, 3 and 4 Post Dose
Baseline: dSAP
|
71.3 mmHg
Standard Deviation 12.55
|
67.0 mmHg
Standard Deviation 9.55
|
74.9 mmHg
Standard Deviation 12.81
|
77.2 mmHg
Standard Deviation 12.19
|
71.0 mmHg
Standard Deviation 8.46
|
78.2 mmHg
Standard Deviation 7.03
|
79.3 mmHg
Standard Deviation 7.00
|
|
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP), Mean Systemic Arterial Pressure (SAP), Systolic Systemic Arterial Pressure (sSAP) and Diastolic Systemic Arterial Pressure (dSAP) at Hour 1, 2, 3 and 4 Post Dose
PCWP: Change at hour 1
|
-0.5 mmHg
Standard Deviation 2.43
|
0.3 mmHg
Standard Deviation 3.08
|
-0.3 mmHg
Standard Deviation 0.49
|
0.8 mmHg
Standard Deviation 1.72
|
0.3 mmHg
Standard Deviation 1.37
|
-1.7 mmHg
Standard Deviation 2.80
|
-0.6 mmHg
Standard Deviation 1.52
|
|
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP), Mean Systemic Arterial Pressure (SAP), Systolic Systemic Arterial Pressure (sSAP) and Diastolic Systemic Arterial Pressure (dSAP) at Hour 1, 2, 3 and 4 Post Dose
SAP: Change at hour 1
|
-2.0 mmHg
Standard Deviation 7.13
|
-5.8 mmHg
Standard Deviation 9.70
|
-5.9 mmHg
Standard Deviation 7.93
|
-6.3 mmHg
Standard Deviation 6.12
|
-1.4 mmHg
Standard Deviation 6.36
|
-6.7 mmHg
Standard Deviation 7.47
|
-4.2 mmHg
Standard Deviation 6.08
|
|
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP), Mean Systemic Arterial Pressure (SAP), Systolic Systemic Arterial Pressure (sSAP) and Diastolic Systemic Arterial Pressure (dSAP) at Hour 1, 2, 3 and 4 Post Dose
sSAP: Change at hour 1
|
2.3 mmHg
Standard Deviation 17.11
|
-9.5 mmHg
Standard Deviation 16.28
|
-0.6 mmHg
Standard Deviation 11.52
|
-7.2 mmHg
Standard Deviation 5.64
|
-2.3 mmHg
Standard Deviation 11.96
|
-7.3 mmHg
Standard Deviation 8.16
|
-5.2 mmHg
Standard Deviation 6.08
|
|
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP), Mean Systemic Arterial Pressure (SAP), Systolic Systemic Arterial Pressure (sSAP) and Diastolic Systemic Arterial Pressure (dSAP) at Hour 1, 2, 3 and 4 Post Dose
dSAP: Change at hour 1
|
-0.7 mmHg
Standard Deviation 1.63
|
-4.3 mmHg
Standard Deviation 7.03
|
-6.7 mmHg
Standard Deviation 8.96
|
-5.0 mmHg
Standard Deviation 6.03
|
-0.7 mmHg
Standard Deviation 4.23
|
-7.2 mmHg
Standard Deviation 5.64
|
-3.5 mmHg
Standard Deviation 5.82
|
|
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP), Mean Systemic Arterial Pressure (SAP), Systolic Systemic Arterial Pressure (sSAP) and Diastolic Systemic Arterial Pressure (dSAP) at Hour 1, 2, 3 and 4 Post Dose
PCWP: Change at hour 2
|
0.2 mmHg
Standard Deviation 2.48
|
-0.3 mmHg
Standard Deviation 2.34
|
-1.0 mmHg
Standard Deviation 1.15
|
0.0 mmHg
Standard Deviation 0.82
|
-0.2 mmHg
Standard Deviation 1.33
|
-1.7 mmHg
Standard Deviation 2.16
|
-0.4 mmHg
Standard Deviation 1.14
|
|
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP), Mean Systemic Arterial Pressure (SAP), Systolic Systemic Arterial Pressure (sSAP) and Diastolic Systemic Arterial Pressure (dSAP) at Hour 1, 2, 3 and 4 Post Dose
SAP: Change at hour 2
|
-3.3 mmHg
Standard Deviation 7.03
|
-6.1 mmHg
Standard Deviation 8.75
|
-3.3 mmHg
Standard Deviation 10.00
|
-5.3 mmHg
Standard Deviation 6.02
|
-6.1 mmHg
Standard Deviation 11.44
|
-6.8 mmHg
Standard Deviation 6.55
|
-8.8 mmHg
Standard Deviation 10.07
|
|
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP), Mean Systemic Arterial Pressure (SAP), Systolic Systemic Arterial Pressure (sSAP) and Diastolic Systemic Arterial Pressure (dSAP) at Hour 1, 2, 3 and 4 Post Dose
sSAP: Change at hour 2
|
-0.5 mmHg
Standard Deviation 13.90
|
-8.2 mmHg
Standard Deviation 14.93
|
-0.7 mmHg
Standard Deviation 15.90
|
-6.0 mmHg
Standard Deviation 4.90
|
-5.2 mmHg
Standard Deviation 12.84
|
-5.8 mmHg
Standard Deviation 9.66
|
-10.3 mmHg
Standard Deviation 13.17
|
|
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP), Mean Systemic Arterial Pressure (SAP), Systolic Systemic Arterial Pressure (sSAP) and Diastolic Systemic Arterial Pressure (dSAP) at Hour 1, 2, 3 and 4 Post Dose
dSAP: Change at hour 2
|
-2.5 mmHg
Standard Deviation 4.46
|
-4.3 mmHg
Standard Deviation 7.26
|
-3.0 mmHg
Standard Deviation 9.87
|
-3.0 mmHg
Standard Deviation 5.10
|
-4.5 mmHg
Standard Deviation 8.19
|
-7.7 mmHg
Standard Deviation 5.85
|
-7.5 mmHg
Standard Deviation 8.09
|
|
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP), Mean Systemic Arterial Pressure (SAP), Systolic Systemic Arterial Pressure (sSAP) and Diastolic Systemic Arterial Pressure (dSAP) at Hour 1, 2, 3 and 4 Post Dose
PCWP: Change at hour 3
|
-0.3 mmHg
Standard Deviation 2.07
|
0.8 mmHg
Standard Deviation 2.56
|
-0.7 mmHg
Standard Deviation 1.11
|
0.3 mmHg
Standard Deviation 0.96
|
1.0 mmHg
Standard Deviation 4.00
|
-0.8 mmHg
Standard Deviation 1.30
|
-0.6 mmHg
Standard Deviation 1.52
|
|
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP), Mean Systemic Arterial Pressure (SAP), Systolic Systemic Arterial Pressure (sSAP) and Diastolic Systemic Arterial Pressure (dSAP) at Hour 1, 2, 3 and 4 Post Dose
SAP: Change at hour 3
|
-2.5 mmHg
Standard Deviation 9.20
|
-1.5 mmHg
Standard Deviation 5.86
|
-4.7 mmHg
Standard Deviation 9.09
|
-7.0 mmHg
Standard Deviation 8.60
|
-1.7 mmHg
Standard Deviation 22.10
|
-10.5 mmHg
Standard Deviation 8.71
|
-10.8 mmHg
Standard Deviation 12.09
|
|
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP), Mean Systemic Arterial Pressure (SAP), Systolic Systemic Arterial Pressure (sSAP) and Diastolic Systemic Arterial Pressure (dSAP) at Hour 1, 2, 3 and 4 Post Dose
sSAP: Change at hour 3
|
-0.3 mmHg
Standard Deviation 14.01
|
-5.5 mmHg
Standard Deviation 11.15
|
1.3 mmHg
Standard Deviation 14.34
|
-8.0 mmHg
Standard Deviation 10.66
|
-9.2 mmHg
Standard Deviation 16.15
|
-9.3 mmHg
Standard Deviation 13.75
|
-12.2 mmHg
Standard Deviation 16.13
|
|
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP), Mean Systemic Arterial Pressure (SAP), Systolic Systemic Arterial Pressure (sSAP) and Diastolic Systemic Arterial Pressure (dSAP) at Hour 1, 2, 3 and 4 Post Dose
PCWP: Change at hour 4
|
-0.7 mmHg
Standard Deviation 1.51
|
0.8 mmHg
Standard Deviation 2.32
|
-0.1 mmHg
Standard Deviation 1.35
|
-0.7 mmHg
Standard Deviation 1.51
|
1.7 mmHg
Standard Deviation 3.78
|
-1.0 mmHg
Standard Deviation 1.87
|
0.0 mmHg
Standard Deviation 0.00
|
|
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP), Mean Systemic Arterial Pressure (SAP), Systolic Systemic Arterial Pressure (sSAP) and Diastolic Systemic Arterial Pressure (dSAP) at Hour 1, 2, 3 and 4 Post Dose
SAP: Change at hour 4
|
-5.8 mmHg
Standard Deviation 9.02
|
-4.3 mmHg
Standard Deviation 4.63
|
-4.6 mmHg
Standard Deviation 7.63
|
-4.3 mmHg
Standard Deviation 10.35
|
-2.2 mmHg
Standard Deviation 8.08
|
-9.0 mmHg
Standard Deviation 9.55
|
-8.8 mmHg
Standard Deviation 11.86
|
|
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP), Mean Systemic Arterial Pressure (SAP), Systolic Systemic Arterial Pressure (sSAP) and Diastolic Systemic Arterial Pressure (dSAP) at Hour 1, 2, 3 and 4 Post Dose
sSAP: Change at hour 4
|
-1.3 mmHg
Standard Deviation 16.24
|
-4.3 mmHg
Standard Deviation 9.69
|
-1.7 mmHg
Standard Deviation 12.41
|
-6.8 mmHg
Standard Deviation 13.63
|
-4.7 mmHg
Standard Deviation 14.12
|
-9.3 mmHg
Standard Deviation 15.13
|
-10.8 mmHg
Standard Deviation 13.69
|
|
Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP), Mean Systemic Arterial Pressure (SAP), Systolic Systemic Arterial Pressure (sSAP) and Diastolic Systemic Arterial Pressure (dSAP) at Hour 1, 2, 3 and 4 Post Dose
dSAP: Change at hour 4
|
-2.8 mmHg
Standard Deviation 7.36
|
-2.3 mmHg
Standard Deviation 4.13
|
-4.1 mmHg
Standard Deviation 8.05
|
-3.7 mmHg
Standard Deviation 10.46
|
-0.8 mmHg
Standard Deviation 6.11
|
-7.7 mmHg
Standard Deviation 5.01
|
-7.5 mmHg
Standard Deviation 10.88
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 3, 4 hours post-dose on Day 1Population: FAS included all randomized participants who received study medication. Here, 'Number Analyzed' = participants who were evaluable at given time points for each group.
Hourly changes from baseline in PVR and SVR were reported. PVR was calculated by: PVR (Wood units) = (mean PAP minus PCWP) divided by CO (taken as the average of the triplicate measurements). SVR (Wood units) = (mean SAP minus RAP) divided by CO (taken as the average of the triplicate measurements).
Outcome measures
| Measure |
Placebo
n=6 Participants
Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 1 mg
n=6 Participants
Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 2 mg
n=7 Participants
Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 4 mg
n=6 Participants
Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 10 mg
n=6 Participants
Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 20 mg
n=7 Participants
Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
Sildenafil
n=6 Participants
Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) and Systemic Vascular Resistance (SVR) at Hour 1, 2, 3 and 4 Post Dose
PVR: Baseline
|
1217.0 Wood units
Standard Deviation 765.98
|
665.1 Wood units
Standard Deviation 267.93
|
995.3 Wood units
Standard Deviation 638.42
|
1117.2 Wood units
Standard Deviation 523.04
|
820.5 Wood units
Standard Deviation 565.07
|
815.4 Wood units
Standard Deviation 600.27
|
966.6 Wood units
Standard Deviation 441.55
|
|
Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) and Systemic Vascular Resistance (SVR) at Hour 1, 2, 3 and 4 Post Dose
SVR: Baseline
|
2122.7 Wood units
Standard Deviation 906.19
|
1537.4 Wood units
Standard Deviation 448.23
|
1648.8 Wood units
Standard Deviation 713.36
|
2089.7 Wood units
Standard Deviation 800.79
|
1873.9 Wood units
Standard Deviation 552.78
|
1654.8 Wood units
Standard Deviation 580.26
|
1948.8 Wood units
Standard Deviation 418.21
|
|
Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) and Systemic Vascular Resistance (SVR) at Hour 1, 2, 3 and 4 Post Dose
PVR: Change at hour 1
|
60.2 Wood units
Standard Deviation 377.48
|
-82.9 Wood units
Standard Deviation 158.83
|
-24.2 Wood units
Standard Deviation 165.45
|
-182.4 Wood units
Standard Deviation 306.17
|
-147.1 Wood units
Standard Deviation 360.44
|
-138.4 Wood units
Standard Deviation 85.91
|
67.9 Wood units
Standard Deviation 256.27
|
|
Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) and Systemic Vascular Resistance (SVR) at Hour 1, 2, 3 and 4 Post Dose
SVR: Change at hour 1
|
-125.0 Wood units
Standard Deviation 439.77
|
-174.7 Wood units
Standard Deviation 231.65
|
-139.0 Wood units
Standard Deviation 526.65
|
-371.3 Wood units
Standard Deviation 678.24
|
-373.1 Wood units
Standard Deviation 461.11
|
-39.1 Wood units
Standard Deviation 128.88
|
63.9 Wood units
Standard Deviation 352.95
|
|
Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) and Systemic Vascular Resistance (SVR) at Hour 1, 2, 3 and 4 Post Dose
PVR: Change at hour 2
|
-19.8 Wood units
Standard Deviation 316.70
|
-112.5 Wood units
Standard Deviation 129.43
|
-6.5 Wood units
Standard Deviation 132.03
|
-114.0 Wood units
Standard Deviation 487.12
|
-196.7 Wood units
Standard Deviation 264.20
|
-194.4 Wood units
Standard Deviation 207.82
|
142.8 Wood units
Standard Deviation 509.00
|
|
Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) and Systemic Vascular Resistance (SVR) at Hour 1, 2, 3 and 4 Post Dose
SVR: Change at hour 2
|
-281.4 Wood units
Standard Deviation 252.62
|
-194.2 Wood units
Standard Deviation 296.66
|
-173.7 Wood units
Standard Deviation 382.66
|
-238.7 Wood units
Standard Deviation 715.18
|
-538.9 Wood units
Standard Deviation 327.15
|
-206.3 Wood units
Standard Deviation 208.43
|
12.7 Wood units
Standard Deviation 551.13
|
|
Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) and Systemic Vascular Resistance (SVR) at Hour 1, 2, 3 and 4 Post Dose
PVR: Change at hour 3
|
0.9 Wood units
Standard Deviation 292.22
|
-8.4 Wood units
Standard Deviation 112.08
|
-3.2 Wood units
Standard Deviation 173.46
|
-215.6 Wood units
Standard Deviation 549.52
|
-153.9 Wood units
Standard Deviation 254.82
|
-150.7 Wood units
Standard Deviation 272.64
|
223.3 Wood units
Standard Deviation 488.72
|
|
Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) and Systemic Vascular Resistance (SVR) at Hour 1, 2, 3 and 4 Post Dose
SVR: Change at hour 3
|
-269.3 Wood units
Standard Deviation 256.20
|
-66.6 Wood units
Standard Deviation 189.66
|
-93.8 Wood units
Standard Deviation 389.95
|
-337.2 Wood units
Standard Deviation 935.47
|
-432.3 Wood units
Standard Deviation 298.78
|
-233.7 Wood units
Standard Deviation 272.19
|
30.9 Wood units
Standard Deviation 487.52
|
|
Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) and Systemic Vascular Resistance (SVR) at Hour 1, 2, 3 and 4 Post Dose
PVR: Change at hour 4
|
-28.9 Wood units
Standard Deviation 236.91
|
-81.7 Wood units
Standard Deviation 127.73
|
10.5 Wood units
Standard Deviation 187.79
|
-247.4 Wood units
Standard Deviation 281.78
|
-188.5 Wood units
Standard Deviation 280.24
|
-133.6 Wood units
Standard Deviation 219.26
|
260.9 Wood units
Standard Deviation 574.22
|
|
Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) and Systemic Vascular Resistance (SVR) at Hour 1, 2, 3 and 4 Post Dose
SVR: Change at hour 4
|
-385.7 Wood units
Standard Deviation 290.25
|
-53.2 Wood units
Standard Deviation 185.94
|
-117.8 Wood units
Standard Deviation 412.25
|
-505.2 Wood units
Standard Deviation 731.80
|
-353.9 Wood units
Standard Deviation 403.12
|
-215.6 Wood units
Standard Deviation 272.13
|
92.3 Wood units
Standard Deviation 517.94
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 3, 4 hours post-dose on Day 1Population: FAS included all randomized participants who received study medication.
Hourly changes from baseline in HR were reported.
Outcome measures
| Measure |
Placebo
n=6 Participants
Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 1 mg
n=6 Participants
Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 2 mg
n=7 Participants
Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 4 mg
n=6 Participants
Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 10 mg
n=6 Participants
Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 20 mg
n=7 Participants
Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
Sildenafil
n=6 Participants
Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Heart Rate (HR) at Hour 1, 2, 3 and 4 Post Dose
Baseline
|
78.2 beats per minute (bpm)
Standard Deviation 13.21
|
85.3 beats per minute (bpm)
Standard Deviation 16.28
|
90.1 beats per minute (bpm)
Standard Deviation 17.10
|
75.5 beats per minute (bpm)
Standard Deviation 14.05
|
77.2 beats per minute (bpm)
Standard Deviation 15.94
|
91.9 beats per minute (bpm)
Standard Deviation 17.90
|
86.7 beats per minute (bpm)
Standard Deviation 19.43
|
|
Mean Change From Baseline in Heart Rate (HR) at Hour 1, 2, 3 and 4 Post Dose
Change at hour 1
|
-0.3 beats per minute (bpm)
Standard Deviation 11.60
|
-3.5 beats per minute (bpm)
Standard Deviation 5.50
|
-1.1 beats per minute (bpm)
Standard Deviation 5.01
|
4.3 beats per minute (bpm)
Standard Deviation 11.17
|
6.8 beats per minute (bpm)
Standard Deviation 7.31
|
-0.9 beats per minute (bpm)
Standard Deviation 6.09
|
-2.7 beats per minute (bpm)
Standard Deviation 6.47
|
|
Mean Change From Baseline in Heart Rate (HR) at Hour 1, 2, 3 and 4 Post Dose
Change at hour 2
|
-0.5 beats per minute (bpm)
Standard Deviation 8.14
|
-2.8 beats per minute (bpm)
Standard Deviation 3.60
|
0.1 beats per minute (bpm)
Standard Deviation 5.52
|
4.2 beats per minute (bpm)
Standard Deviation 9.37
|
9.7 beats per minute (bpm)
Standard Deviation 8.02
|
-2.3 beats per minute (bpm)
Standard Deviation 4.75
|
-0.5 beats per minute (bpm)
Standard Deviation 6.12
|
|
Mean Change From Baseline in Heart Rate (HR) at Hour 1, 2, 3 and 4 Post Dose
Change at hour 3
|
-1.0 beats per minute (bpm)
Standard Deviation 10.39
|
-1.2 beats per minute (bpm)
Standard Deviation 3.19
|
-3.3 beats per minute (bpm)
Standard Deviation 9.66
|
-1.8 beats per minute (bpm)
Standard Deviation 7.05
|
10.2 beats per minute (bpm)
Standard Deviation 4.12
|
-3.1 beats per minute (bpm)
Standard Deviation 7.99
|
-0.8 beats per minute (bpm)
Standard Deviation 6.82
|
|
Mean Change From Baseline in Heart Rate (HR) at Hour 1, 2, 3 and 4 Post Dose
Change at hour 4
|
1.5 beats per minute (bpm)
Standard Deviation 8.17
|
-3.3 beats per minute (bpm)
Standard Deviation 2.80
|
-2.0 beats per minute (bpm)
Standard Deviation 11.17
|
6.0 beats per minute (bpm)
Standard Deviation 8.34
|
5.7 beats per minute (bpm)
Standard Deviation 4.32
|
-6.1 beats per minute (bpm)
Standard Deviation 6.72
|
-0.5 beats per minute (bpm)
Standard Deviation 8.60
|
SECONDARY outcome
Timeframe: Baseline up-to follow up (Day 3 to 5)Population: Safety analysis set included all randomized participants who received study medication.
Criteria for clinically significant laboratory values:hemoglobin, hematocrit and red blood cells(less than\[\<\]0.8\*lower limit of normal\[LLN\]); leucocytes (\<0.6\*LLN/greater than\[\>\]1.5\*upper limit of normal\[ULN\]);platelets (\<0.5\*LLN\>\</0\>1.75\* ULN);neutrophils, lymphocytes(\<0.8\*LLN\>\</0\>1.2\* ULN); eosinophils, basophils, monocytes (\>1.2\*ULN);bilirubin (\>1.5\*ULN);aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase(\>3\*ULN);creatinine, blood urea nitrogen (\>1.3\*ULN);glucose(\<0.6\*LLN\>\</0\>1.5\* ULN); uric acid(\>1.2\*ULN);sodium(\<0.95\*LLN\>\</0\>1.05\*ULN); potassium, chloride, calcium(\<0.9\*LLN\>\</0\>1.1\* ULN); albumin, total protein(\<0.8\>\</0\>1.2\* ULN); creatine kinase(\>2.0\*ULN);urine red blood cells(RBCs), urine white blood cells(WBCs)(\>=6 per high-powered field);qualitative urine glucose, urine ketones, urine protein, urine blood/hemoglobin(\>=1); urine bacteria(\>20 per high-powered field); pregnancy test, urine protein, quantitative random serum pregnancy test (\>=1).
Outcome measures
| Measure |
Placebo
n=6 Participants
Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 1 mg
n=6 Participants
Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 2 mg
n=7 Participants
Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 4 mg
n=6 Participants
Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 10 mg
n=6 Participants
Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 20 mg
n=7 Participants
Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
Sildenafil
n=6 Participants
Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Values
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline up-to follow up (Day 3 to 5)Population: Safety analysis set included all randomized participants who received study medication.
Criteria for clinically significant changes (changes of potential clinical concern) in ECG parameters: increase from baseline of \>=30 to \<60 milliseconds (msec) or \>=60 msec in corrected QT interval (QTc), QT interval corrected using Fridericia's correction (QTcF) and QT interval corrected using Bazett's correction (QTcB); Increase from baseline of \>= 25% (when baseline was \>200 msec) or increase from baseline of \>=50% (when baseline was \<=200 msec) in PR interval; and Increase from baseline of \>= 25% (when baseline was \>100 msec) or increase from baseline of \>=50% (when baseline was \<=100 msec) in QRS interval. Number of participants with any clinically significant change in ECG values were reported.
Outcome measures
| Measure |
Placebo
n=6 Participants
Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 1 mg
n=6 Participants
Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 2 mg
n=7 Participants
Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 4 mg
n=6 Participants
Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 10 mg
n=6 Participants
Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 20 mg
n=7 Participants
Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
Sildenafil
n=6 Participants
Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline; 1, 4 hours post-dose on Day 1Population: Safety analysis set included all randomized participants who received study medication. Here, N (overall number of participants analyzed) = participants evaluable for this measure and 'Number Analyzed' = participants who were evaluable at given time points for each group.
Arterial blood samples for PaO2 and PaCO2 collected via an arterial line were assessed. PaO2 is the measure of oxygen level in the arterial blood and PaCO2 is the measure of carbon dioxide level in the arterial blood.
Outcome measures
| Measure |
Placebo
n=6 Participants
Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 1 mg
n=5 Participants
Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 2 mg
n=7 Participants
Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 4 mg
n=5 Participants
Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 10 mg
n=6 Participants
Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 20 mg
n=6 Participants
Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
Sildenafil
n=6 Participants
Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Mean Partial Pressure of Oxygen (PaO2) and Carbon Dioxide (PaCO2) at Hour 1 and 4 Post Dose
PaO2: Baseline
|
64.1 mmHg
Standard Deviation 9.47
|
63.0 mmHg
Standard Deviation 14.92
|
65.4 mmHg
Standard Deviation 16.98
|
82.0 mmHg
Standard Deviation 16.32
|
72.4 mmHg
Standard Deviation 25.85
|
73.2 mmHg
Standard Deviation 15.75
|
64.9 mmHg
Standard Deviation 9.78
|
|
Change From Baseline in Mean Partial Pressure of Oxygen (PaO2) and Carbon Dioxide (PaCO2) at Hour 1 and 4 Post Dose
PaCO2: Baseline
|
32.8 mmHg
Standard Deviation 4.79
|
32.0 mmHg
Standard Deviation 6.71
|
38.7 mmHg
Standard Deviation 7.53
|
31.4 mmHg
Standard Deviation 4.83
|
36.3 mmHg
Standard Deviation 6.09
|
39.3 mmHg
Standard Deviation 10.75
|
41.6 mmHg
Standard Deviation 15.07
|
|
Change From Baseline in Mean Partial Pressure of Oxygen (PaO2) and Carbon Dioxide (PaCO2) at Hour 1 and 4 Post Dose
PaO2: Change at Hour 1
|
-1.4 mmHg
Standard Deviation 11.06
|
-4.4 mmHg
Standard Deviation 6.22
|
-0.6 mmHg
Standard Deviation 7.98
|
-6.5 mmHg
Standard Deviation 12.16
|
-10.8 mmHg
Standard Deviation 12.99
|
-13.7 mmHg
Standard Deviation 11.17
|
2.4 mmHg
Standard Deviation 12.48
|
|
Change From Baseline in Mean Partial Pressure of Oxygen (PaO2) and Carbon Dioxide (PaCO2) at Hour 1 and 4 Post Dose
PaCO2: Change at Hour 1
|
0.5 mmHg
Standard Deviation 2.69
|
1.4 mmHg
Standard Deviation 1.96
|
-0.7 mmHg
Standard Deviation 3.70
|
-0.2 mmHg
Standard Deviation 3.62
|
-2.1 mmHg
Standard Deviation 2.98
|
1.4 mmHg
Standard Deviation 4.26
|
-1.4 mmHg
Standard Deviation 3.77
|
|
Change From Baseline in Mean Partial Pressure of Oxygen (PaO2) and Carbon Dioxide (PaCO2) at Hour 1 and 4 Post Dose
PaO2: Change at Hour 4
|
0.8 mmHg
Standard Deviation 8.03
|
-0.4 mmHg
Standard Deviation 4.04
|
0.3 mmHg
Standard Deviation 13.47
|
-4.0 mmHg
Standard Deviation 8.39
|
-10.3 mmHg
Standard Deviation 9.65
|
-7.7 mmHg
Standard Deviation 15.61
|
3.6 mmHg
Standard Deviation 7.47
|
|
Change From Baseline in Mean Partial Pressure of Oxygen (PaO2) and Carbon Dioxide (PaCO2) at Hour 1 and 4 Post Dose
PaCO2: Change at Hour 4
|
-0.7 mmHg
Standard Deviation 1.36
|
1.0 mmHg
Standard Deviation 2.48
|
-1.9 mmHg
Standard Deviation 4.44
|
-1.6 mmHg
Standard Deviation 3.59
|
-3.3 mmHg
Standard Deviation 2.91
|
0.6 mmHg
Standard Deviation 3.68
|
0.8 mmHg
Standard Deviation 10.55
|
SECONDARY outcome
Timeframe: 1, 2, 3, 4, 5, 6, 8 hours post-dose on Day 1, follow up (Day 3 to 5)Population: Data was not reported for this outcome measure because the study was terminated and as per change in planned analysis, the pharmacokinetic parameters were not to be summarized.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-00489791 1 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
PF-00489791 2 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-00489791 4 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-00489791 10 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
PF-00489791 20 mg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Sildenafil
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=6 participants at risk
Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 1 mg
n=6 participants at risk
Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 2 mg
n=7 participants at risk
Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 4 mg
n=6 participants at risk
Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 10 mg
n=6 participants at risk
Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 20 mg
n=7 participants at risk
Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
Sildenafil
n=6 participants at risk
Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Haemorrhoids
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
General disorders
Chest pain
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
General disorders
Oedema peripheral
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/4
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/4
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/3
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
20.0%
1/5
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/4
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
Other adverse events
| Measure |
Placebo
n=6 participants at risk
Single oral dose of 2 placebo matched to PF-00489791 tablet along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 1 mg
n=6 participants at risk
Single oral dose of 1 PF-00489791 1 milligram (mg) tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 2 mg
n=7 participants at risk
Single oral dose of 1 PF-00489791 2 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 4 mg
n=6 participants at risk
Single oral dose of 2 PF-00489791 2 mg tablet (equivalent to PF-00489791 4 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 10 mg
n=6 participants at risk
Single oral dose of 1 PF-00489791 10 mg tablet along with 1 placebo matched to PF-00489791 tablet and 1 placebo matched to sildenafil tablet on Day 1.
|
PF-00489791 20 mg
n=7 participants at risk
Single oral dose of 2 PF-00489791 10 mg tablet (equivalent to PF-00489791 20 mg) along with 1 placebo matched to sildenafil tablet on Day 1.
|
Sildenafil
n=6 participants at risk
Single oral dose of 1 sildenafil 20 mg tablet along with 2 placebo matched to PF-00489791 tablet on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Eosinophilia
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Eye disorders
Eye irritation
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
33.3%
2/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
General disorders
Asthenia
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
General disorders
Axillary pain
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
General disorders
Chest discomfort
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
General disorders
Chest pain
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
General disorders
Oedema
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
General disorders
Pyrexia
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Investigations
Bacterial test positive
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Investigations
Blood bilirubin unconjugated increased
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Investigations
Blood glucose increased
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Investigations
Blood urea increased
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Investigations
Urinary sediment present
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Nervous system disorders
Headache
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
33.3%
2/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Vascular disorders
Haematoma
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
33.3%
2/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
14.3%
1/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Vascular disorders
Hot flush
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
16.7%
1/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/7
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
0.00%
0/6
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
|
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