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Trial Outcomes & Findings for Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery (NCT NCT00838383)

NCT ID: NCT00838383

Last Updated: 2022-09-08

Results Overview

PVR in participants was derived from mean pulmonary artery pressure (PAP) (millimeter of mercury \[mmHg\]), pulmonary capillary wedge pressure (PCWP \[mmHg\]) and cardiac output (CO \[litres per minute\]). It was calculated using the following formula: (\[mean PAP-PCWP\] divided by CO)\*80, where CO= stroke volume (SV)\*heart rate (HR). Post-separation from CPB was the time immediately following cross-clamp release in CPB. Percent change in PVR at 0.5 hour post-separation from CPB in participants were summarized and reported.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

29 participants

Primary outcome timeframe

0 hour, 0.5 hour post-separation from CPB

Results posted on

2022-09-08

Participant Flow

Participant milestones

Participant milestones
Measure
Sitaxsentan (1 mg/kg)
Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB).
Sitaxsentan (2 mg/kg)
Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB.
Placebo
Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB.
Overall Study
STARTED
9
10
10
Overall Study
COMPLETED
9
10
10
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Sitaxsentan (1 mg/kg)
n=9 Participants
Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB).
Sitaxsentan (2 mg/kg)
n=10 Participants
Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB.
Placebo
n=10 Participants
Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB.
Total
n=29 Participants
Total of all reporting groups
Age, Continuous
62.3 years
STANDARD_DEVIATION 8.86 • n=39 Participants
68.5 years
STANDARD_DEVIATION 8.81 • n=41 Participants
67.2 years
STANDARD_DEVIATION 6.56 • n=35 Participants
66.1 years
STANDARD_DEVIATION 8.26 • n=31 Participants
Sex: Female, Male
Female
2 Participants
n=39 Participants
0 Participants
n=41 Participants
1 Participants
n=35 Participants
3 Participants
n=31 Participants
Sex: Female, Male
Male
7 Participants
n=39 Participants
10 Participants
n=41 Participants
9 Participants
n=35 Participants
26 Participants
n=31 Participants

PRIMARY outcome

Timeframe: 0 hour, 0.5 hour post-separation from CPB

Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Here, "number of participants analyzed" signifies participants who were evaluable for this outcome measure.

PVR in participants was derived from mean pulmonary artery pressure (PAP) (millimeter of mercury \[mmHg\]), pulmonary capillary wedge pressure (PCWP \[mmHg\]) and cardiac output (CO \[litres per minute\]). It was calculated using the following formula: (\[mean PAP-PCWP\] divided by CO)\*80, where CO= stroke volume (SV)\*heart rate (HR). Post-separation from CPB was the time immediately following cross-clamp release in CPB. Percent change in PVR at 0.5 hour post-separation from CPB in participants were summarized and reported.

Outcome measures

Outcome measures
Measure
Sitaxsentan (1 mg/kg)
n=9 Participants
Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB).
Sitaxsentan (2 mg/kg)
n=9 Participants
Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB.
Placebo
n=10 Participants
Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB.
Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5 Hour Post-separation From Cardiopulmonary Bypass (CPB)
-7.75 percent change
Standard Deviation 55.277
-10.94 percent change
Standard Deviation 37.967
62.22 percent change
Standard Deviation 260.172

PRIMARY outcome

Timeframe: 0 hour, 6 hour post-separation from CPB

Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Here, "number of participants analyzed" signifies participants who were evaluable for this outcome measure.

PVR in participants was derived from mean PAP (mmHg), PCWP (mmHg) and CO (litres per minute). It was calculated using the following formula: (\[mean PAP-PCWP\] divided by CO)\*80, where CO= SV \* HR. Percent change in PVR at 6 hour in participants were summarized and reported.

Outcome measures

Outcome measures
Measure
Sitaxsentan (1 mg/kg)
n=9 Participants
Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB).
Sitaxsentan (2 mg/kg)
n=9 Participants
Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB.
Placebo
n=9 Participants
Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB.
Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 6 Hour Post-separation From Cardiopulmonary Bypass (CPB)
39.36 percent change
Standard Deviation 61.615
-12.01 percent change
Standard Deviation 39.561
173.68 percent change
Standard Deviation 511.269

PRIMARY outcome

Timeframe: 0 hour, 12 hour post-separation from CPB

Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Here, "number of participants analyzed" signifies participants who were evaluable for this outcome measure.

PVR in participants was derived from mean PAP (mmHg), PCWP (mmHg) and CO (litres per minute). It was calculated using the following formula: (\[mean PAP-PCWP\] divided by CO)\*80, where CO= SV \* HR. Percent change in PVR at 12 hour in participants were summarized and reported.

Outcome measures

Outcome measures
Measure
Sitaxsentan (1 mg/kg)
n=9 Participants
Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB).
Sitaxsentan (2 mg/kg)
n=9 Participants
Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB.
Placebo
n=10 Participants
Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB.
Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 12 Hour Post-separation From Cardiopulmonary Bypass (CPB)
31.42 percent change
Standard Deviation 67.887
-12.32 percent change
Standard Deviation 37.517
98.03 percent change
Standard Deviation 283.333

PRIMARY outcome

Timeframe: 0 hour, 24 hour post-separation from CPB

Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Here, "number of participants analyzed" signifies participants who were evaluable for this outcome measure.

PVR in participants was derived from mean PAP (mmHg), PCWP (mmHg) and CO (litres per minute). It was calculated using the following formula: (\[mean PAP-PCWP\] divided by CO)\*80, where CO= SV \* HR. Percent change in PVR at 24 hour in participants were summarized and reported.

Outcome measures

Outcome measures
Measure
Sitaxsentan (1 mg/kg)
n=9 Participants
Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB).
Sitaxsentan (2 mg/kg)
n=8 Participants
Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB.
Placebo
n=9 Participants
Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB.
Percent Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 24 Hour Post-separation From Cardiopulmonary Bypass (CPB)
18.06 percent change
Standard Deviation 63.362
-15.99 percent change
Standard Deviation 41.604
195.64 percent change
Standard Deviation 522.379

PRIMARY outcome

Timeframe: During surgery, initial hospitalization period (up to 29 days for 1 mg/kg group, up to 44 days for 2 mg/kg dose group, up to 19 days for placebo group)

Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study.

Number of participants who died during surgery or during initial hospitalization are reported here.

Outcome measures

Outcome measures
Measure
Sitaxsentan (1 mg/kg)
n=9 Participants
Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB).
Sitaxsentan (2 mg/kg)
n=10 Participants
Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB.
Placebo
n=10 Participants
Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB.
Mortality: Number of Participants Died During Surgery and Initial Hospitalization
During surgery
0 participants
0 participants
0 participants
Mortality: Number of Participants Died During Surgery and Initial Hospitalization
During initial hospitalization
2 participants
1 participants
0 participants

PRIMARY outcome

Timeframe: Initial hospitalization period (up to 44 days)

Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study.

Number of participants with following incidents: myocardial infarction (Q and non-Q wave); stroke or cerebrovascular event (acute ischemia, hemorrhagic stroke or infarction, or a transient ischemia attack); hemodynamic collapse (requiring ventricular assistance devices) and re-operation (participants who returned to the operating room) during the initial hospitalization were reported.

Outcome measures

Outcome measures
Measure
Sitaxsentan (1 mg/kg)
n=9 Participants
Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB).
Sitaxsentan (2 mg/kg)
n=10 Participants
Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB.
Placebo
n=10 Participants
Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB.
Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation
Myocardial Infarction
1 participants
0 participants
0 participants
Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation
Stroke or Cerebrovascular event
0 participants
0 participants
0 participants
Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation
Hemodynamic collapse
1 participants
2 participants
0 participants
Number of Participants With Myocardial Infarction, Cerebrovascular Event, Hemodynamic Collapse and Re-operation
Re-operation
0 participants
0 participants
0 participants

SECONDARY outcome

Timeframe: Immediately after cross-clamp removal up to 24 hours post-separation from CPB

Population: Data was not collected, since this outcome was not analyzed as per Sponsor's discretion.

Participants were considered for inotropic requirements/therapy in case of either severe right ventricular failure or high pulmonary artery pressure, or if cardiac output was not maintained with epinephrine.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0, 0.5, 6, 12, 24 hours post-separation from CPB

Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the last observation carried forward (LOCF) method.

CO was calculated by multiplying stroke volume (SV) with heart rate (HR). It was used to evaluate the hemodynamic profile of each participant.

Outcome measures

Outcome measures
Measure
Sitaxsentan (1 mg/kg)
n=9 Participants
Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB).
Sitaxsentan (2 mg/kg)
n=10 Participants
Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB.
Placebo
n=10 Participants
Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB.
Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
At 0 hour post-separation from CPB
5.48 liters per minute
Standard Deviation 2.036
5.51 liters per minute
Standard Deviation 1.211
4.83 liters per minute
Standard Deviation 1.158
Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 0.5 hours post-separation from CPB
0.22 liters per minute
Standard Deviation 0.696
-0.36 liters per minute
Standard Deviation 0.973
0.16 liters per minute
Standard Deviation 0.532
Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 6 hours post-separation from CPB
0.38 liters per minute
Standard Deviation 2.138
0.61 liters per minute
Standard Deviation 2.088
0.43 liters per minute
Standard Deviation 1.299
Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 12 hours post-separation from CPB
1.32 liters per minute
Standard Deviation 1.552
0.00 liters per minute
Standard Deviation 1.505
0.52 liters per minute
Standard Deviation 1.045
Change From 0 Hour in Cardiac Output (CO) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 24 hours post-separation from CPB
1.40 liters per minute
Standard Deviation 2.636
0.21 liters per minute
Standard Deviation 1.782
0.48 liters per minute
Standard Deviation 1.403

SECONDARY outcome

Timeframe: 0, 0.5, 6, 12, 24 hours post-separation from CPB

Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method. Here, "number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure
Sitaxsentan (1 mg/kg)
n=9 Participants
Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB).
Sitaxsentan (2 mg/kg)
n=10 Participants
Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB.
Placebo
n=9 Participants
Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB.
Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)
At 0 hour post-separation from CPB
9.89 millimeters of mercury (mmHg)
Standard Deviation 8.724
8.10 millimeters of mercury (mmHg)
Standard Deviation 5.425
9.22 millimeters of mercury (mmHg)
Standard Deviation 5.518
Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)
Change at 0.5 hours post-separation from CPB
2.11 millimeters of mercury (mmHg)
Standard Deviation 2.804
0.40 millimeters of mercury (mmHg)
Standard Deviation 1.578
0.33 millimeters of mercury (mmHg)
Standard Deviation 4.301
Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)
Change at 6 hours post-separation from CPB
0.78 millimeters of mercury (mmHg)
Standard Deviation 10.146
5.70 millimeters of mercury (mmHg)
Standard Deviation 6.750
1.44 millimeters of mercury (mmHg)
Standard Deviation 6.540
Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)
Change at 12 hours post-separation from CPB
0.00 millimeters of mercury (mmHg)
Standard Deviation 9.220
3.80 millimeters of mercury (mmHg)
Standard Deviation 5.846
3.11 millimeters of mercury (mmHg)
Standard Deviation 7.044
Change From 0 Hour in Central Venous Pressure (CVP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)
Change at 24 hours post-separation from CPB
1.89 millimeters of mercury (mmHg)
Standard Deviation 9.649
3.90 millimeters of mercury (mmHg)
Standard Deviation 6.740
0.78 millimeters of mercury (mmHg)
Standard Deviation 7.311

SECONDARY outcome

Timeframe: 0, 0.5, 6, 12, 24 hours post-separation from CPB

Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method.

The hematocrit is percentage of the volume of whole blood that is made up of red blood cells (RBCs).

Outcome measures

Outcome measures
Measure
Sitaxsentan (1 mg/kg)
n=9 Participants
Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB).
Sitaxsentan (2 mg/kg)
n=10 Participants
Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB.
Placebo
n=10 Participants
Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB.
Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
0 hour post-separation from CPB
25.56 percentage of red blood cells in blood
Standard Deviation 4.157
26.46 percentage of red blood cells in blood
Standard Deviation 1.984
25.30 percentage of red blood cells in blood
Standard Deviation 2.541
Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 0.5 hours post-separation from CPB
1.77 percentage of red blood cells in blood
Standard Deviation 2.422
3.29 percentage of red blood cells in blood
Standard Deviation 2.804
2.30 percentage of red blood cells in blood
Standard Deviation 2.541
Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 6 hours post-separation from CPB
9.64 percentage of red blood cells in blood
Standard Deviation 4.081
6.82 percentage of red blood cells in blood
Standard Deviation 5.310
7.55 percentage of red blood cells in blood
Standard Deviation 5.204
Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 12 hours post-separation from CPB
8.93 percentage of red blood cells in blood
Standard Deviation 4.013
5.52 percentage of red blood cells in blood
Standard Deviation 3.862
7.68 percentage of red blood cells in blood
Standard Deviation 4.757
Change From 0 Hour in Hematocrit at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 24 hours post-separation from CPB
7.07 percentage of red blood cells in blood
Standard Deviation 4.060
5.77 percentage of red blood cells in blood
Standard Deviation 4.098
8.25 percentage of red blood cells in blood
Standard Deviation 3.925

SECONDARY outcome

Timeframe: 0, 0.5, 6, 12, 24 hours post-separation from CPB

Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method.

Heart rate was assessed as one of the hemodynamic profile assessments at the specified time points.

Outcome measures

Outcome measures
Measure
Sitaxsentan (1 mg/kg)
n=9 Participants
Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB).
Sitaxsentan (2 mg/kg)
n=10 Participants
Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB.
Placebo
n=10 Participants
Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB.
Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
0 hour post-separation from CPB
80.11 beats per minute (bpm)
Standard Deviation 13.851
84.50 beats per minute (bpm)
Standard Deviation 16.298
77.80 beats per minute (bpm)
Standard Deviation 9.102
Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 6 hours post-separation from CPB
5.00 beats per minute (bpm)
Standard Deviation 21.593
1.10 beats per minute (bpm)
Standard Deviation 16.980
-2.00 beats per minute (bpm)
Standard Deviation 11.804
Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 12 hours post-separation from CPB
8.11 beats per minute (bpm)
Standard Deviation 12.098
0.00 beats per minute (bpm)
Standard Deviation 18.868
0.70 beats per minute (bpm)
Standard Deviation 21.474
Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 24 hours post-separation from CPB
11.56 beats per minute (bpm)
Standard Deviation 17.350
1.40 beats per minute (bpm)
Standard Deviation 13.074
0.80 beats per minute (bpm)
Standard Deviation 18.408
Change From 0 Hour in Heart Rate at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 0.5 hours post-separation from CPB
-1.56 beats per minute (bpm)
Standard Deviation 9.580
-1.70 beats per minute (bpm)
Standard Deviation 11.225
-2.80 beats per minute (bpm)
Standard Deviation 8.351

SECONDARY outcome

Timeframe: 0, 0.5, 6, 12, 24 hours post-separation from CPB

Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method.

mPAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position. It was used to evaluate the hemodynamic profile of each participant.

Outcome measures

Outcome measures
Measure
Sitaxsentan (1 mg/kg)
n=9 Participants
Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB).
Sitaxsentan (2 mg/kg)
n=10 Participants
Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB.
Placebo
n=10 Participants
Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB.
Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)
At 0 Hour post-separation from CPB
19.27 mmHg
Standard Deviation 7.224
26.02 mmHg
Standard Deviation 10.392
20.81 mmHg
Standard Deviation 6.978
Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)
Change at 0.5 hours post-separation from CPB
-1.14 mmHg
Standard Deviation 4.765
-3.51 mmHg
Standard Deviation 7.321
-0.41 mmHg
Standard Deviation 6.276
Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)
Change at 6 hours post-separation from CPB
3.12 mmHg
Standard Deviation 7.576
2.41 mmHg
Standard Deviation 7.834
2.41 mmHg
Standard Deviation 9.676
Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)
Change at 12 hours post-separation from CPB
2.88 mmHg
Standard Deviation 6.468
0.41 mmHg
Standard Deviation 8.832
3.80 mmHg
Standard Deviation 7.246
Change From 0 Hour in Mean Pulmonary Artery Pressure (MPAP) at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)
Change at 24 hours post-separation from CPB
4.92 mmHg
Standard Deviation 7.253
0.22 mmHg
Standard Deviation 10.727
1.96 mmHg
Standard Deviation 9.046

SECONDARY outcome

Timeframe: 0, 0.5, 6, 12, 24 hours post-separation from CPB

Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method. Here, "number of participants analyzed" signifies participants who were evaluable for this outcome measure.

PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure. It was used to evaluate the hemodynamic profile of each participant.

Outcome measures

Outcome measures
Measure
Sitaxsentan (1 mg/kg)
n=8 Participants
Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB).
Sitaxsentan (2 mg/kg)
n=7 Participants
Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB.
Placebo
n=8 Participants
Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB.
Change From 0 Hour in Pulmonary Capillary Wedge Pressure (PCWP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
0 Hour post-separation from CPB
10.38 mmHg
Standard Deviation 7.652
14.43 mmHg
Standard Deviation 4.962
12.50 mmHg
Standard Deviation 5.292
Change From 0 Hour in Pulmonary Capillary Wedge Pressure (PCWP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 0.5 hours post-separation from CPB
0.25 mmHg
Standard Deviation 3.694
-0.43 mmHg
Standard Deviation 1.618
-0.88 mmHg
Standard Deviation 2.232
Change From 0 Hour in Pulmonary Capillary Wedge Pressure (PCWP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 6 hours post-separation from CPB
0.38 mmHg
Standard Deviation 6.823
2.71 mmHg
Standard Deviation 4.152
-0.63 mmHg
Standard Deviation 4.868
Change From 0 Hour in Pulmonary Capillary Wedge Pressure (PCWP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 12 hours post-separation from CPB
-0.75 mmHg
Standard Deviation 7.005
3.57 mmHg
Standard Deviation 4.826
0.00 mmHg
Standard Deviation 6.949
Change From 0 Hour in Pulmonary Capillary Wedge Pressure (PCWP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 24 hours post-separation from CPB
-0.25 mmHg
Standard Deviation 7.265
2.86 mmHg
Standard Deviation 5.146
-2.25 mmHg
Standard Deviation 6.519

SECONDARY outcome

Timeframe: 0, 0.5, 6, 12, 24 hours post-separation from CPB

Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method. Here, "number of participants analyzed" signifies participants who were evaluable for this outcome measure.

PVR in participants was derived from mean PAP (mmHg), PCWP (mmHg) and CO (litres per minute). It was calculated using the following formula: (\[mean PAP-PCWP\] divided by CO)\*80, where CO= SV \* HR.

Outcome measures

Outcome measures
Measure
Sitaxsentan (1 mg/kg)
n=9 Participants
Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB).
Sitaxsentan (2 mg/kg)
n=10 Participants
Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB.
Placebo
n=9 Participants
Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB.
Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
At 0 Hour post-separation from CPB
125.28 (dynes*second) per centimeter^5
Standard Deviation 74.325
166.22 (dynes*second) per centimeter^5
Standard Deviation 81.090
112.79 (dynes*second) per centimeter^5
Standard Deviation 59.363
Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 0.5 hours post-separation from CPB
-31.32 (dynes*second) per centimeter^5
Standard Deviation 71.465
-33.47 (dynes*second) per centimeter^5
Standard Deviation 94.027
-4.04 (dynes*second) per centimeter^5
Standard Deviation 52.134
Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 6 hours post-separation from CPB
19.31 (dynes*second) per centimeter^5
Standard Deviation 66.920
-33.53 (dynes*second) per centimeter^5
Standard Deviation 95.697
33.99 (dynes*second) per centimeter^5
Standard Deviation 89.573
Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 12 hours post-separation from CPB
7.40 (dynes*second) per centimeter^5
Standard Deviation 58.674
-29.66 (dynes*second) per centimeter^5
Standard Deviation 98.021
28.49 (dynes*second) per centimeter^5
Standard Deviation 58.749
Change From 0 Hour in Pulmonary Vascular Resistance (PVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 24 hours post-separation from CPB
0.21 (dynes*second) per centimeter^5
Standard Deviation 68.221
-33.60 (dynes*second) per centimeter^5
Standard Deviation 87.893
55.33 (dynes*second) per centimeter^5
Standard Deviation 80.563

SECONDARY outcome

Timeframe: 0, 0.5, 6, 12, 24 hours post-separation from CPB

Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method. Here, "number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Venous oxygen saturation is the percentage of oxygen bound to hemoglobin in blood returning to the right side of the heart. It reflects the amount of oxygen "left over" after the tissues consumption.

Outcome measures

Outcome measures
Measure
Sitaxsentan (1 mg/kg)
n=7 Participants
Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB).
Sitaxsentan (2 mg/kg)
n=8 Participants
Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB.
Placebo
n=9 Participants
Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB.
Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
At 0 hour post-separation from CPB
75.14 percentage of oxygen saturation
Standard Deviation 14.949
73.25 percentage of oxygen saturation
Standard Deviation 10.053
72.44 percentage of oxygen saturation
Standard Deviation 22.305
Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 0.5 hours post-separation from CPB
0.14 percentage of oxygen saturation
Standard Deviation 6.644
0.88 percentage of oxygen saturation
Standard Deviation 4.086
2.44 percentage of oxygen saturation
Standard Deviation 7.055
Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 6 hours post-separation from CPB
-4.29 percentage of oxygen saturation
Standard Deviation 12.459
-8.50 percentage of oxygen saturation
Standard Deviation 7.191
-0.44 percentage of oxygen saturation
Standard Deviation 8.719
Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 12 hours post-separation from CPB
-3.00 percentage of oxygen saturation
Standard Deviation 11.328
-8.75 percentage of oxygen saturation
Standard Deviation 4.803
-1.22 percentage of oxygen saturation
Standard Deviation 8.059
Change From 0 Hour in Venous Oxygen Saturation (SV02/02) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 24 hours post-separation from CPB
-5.14 percentage of oxygen saturation
Standard Deviation 11.006
-14.38 percentage of oxygen saturation
Standard Deviation 9.591
-0.78 percentage of oxygen saturation
Standard Deviation 6.815

SECONDARY outcome

Timeframe: 0, 0.5, 6, 12, 24 hours post-separation from CPB

Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method.

SVR was calculated using formula: (\[mean systemic arterial pressure - mean right atrial pressure\] divided by CO)\*80, where CO= SV \* HR.

Outcome measures

Outcome measures
Measure
Sitaxsentan (1 mg/kg)
n=9 Participants
Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB).
Sitaxsentan (2 mg/kg)
n=10 Participants
Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB.
Placebo
n=10 Participants
Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB.
Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
At 0 hour post-separation from CPB
978.37 (dynes*second) per centimeter^5
Standard Deviation 490.306
959.89 (dynes*second) per centimeter^5
Standard Deviation 281.280
1155.39 (dynes*second) per centimeter^5
Standard Deviation 521.235
Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 0.5 hours post-separation from CPB
-117.39 (dynes*second) per centimeter^5
Standard Deviation 229.848
1.14 (dynes*second) per centimeter^5
Standard Deviation 214.493
-20.25 (dynes*second) per centimeter^5
Standard Deviation 255.252
Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 6 hours post-separation from CPB
89.96 (dynes*second) per centimeter^5
Standard Deviation 511.943
-139.23 (dynes*second) per centimeter^5
Standard Deviation 330.787
-77.92 (dynes*second) per centimeter^5
Standard Deviation 673.047
Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 12 hours post-separation from CPB
-216.84 (dynes*second) per centimeter^5
Standard Deviation 407.566
-63.12 (dynes*second) per centimeter^5
Standard Deviation 343.174
-193.43 (dynes*second) per centimeter^5
Standard Deviation 562.028
Change From 0 Hour in Systemic Vascular Resistance (SVR) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 24 hours post-separation from CPB
-80.49 (dynes*second) per centimeter^5
Standard Deviation 358.157
26.74 (dynes*second) per centimeter^5
Standard Deviation 384.919
-8.37 (dynes*second) per centimeter^5
Standard Deviation 663.864

SECONDARY outcome

Timeframe: 0, 0.5, 6, 12, 24 hours post-separation from CPB

Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method.

Outcome measures

Outcome measures
Measure
Sitaxsentan (1 mg/kg)
n=9 Participants
Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB).
Sitaxsentan (2 mg/kg)
n=10 Participants
Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB.
Placebo
n=10 Participants
Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB.
Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
At 0 hour post-separation from CPB
69.01 mmHg
Standard Deviation 13.887
71.90 mmHg
Standard Deviation 12.768
72.55 mmHg
Standard Deviation 11.760
Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 0.5 hours post-separation from CPB
-5.80 mmHg
Standard Deviation 15.467
-3.70 mmHg
Standard Deviation 11.658
2.21 mmHg
Standard Deviation 13.509
Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 6 hours post-separation from CPB
6.30 mmHg
Standard Deviation 15.133
1.97 mmHg
Standard Deviation 12.846
3.04 mmHg
Standard Deviation 14.554
Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 12 hours post-separation from CPB
1.15 mmHg
Standard Deviation 15.240
0.73 mmHg
Standard Deviation 11.124
0.39 mmHg
Standard Deviation 17.768
Change From 0 Hour in Mean Systemic Blood Pressure (MSBP) at 0.5, 6, 12, and 24 Hours Post-Separation From Cardiopulmonary Bypass (CPB)
Change at 24 hours post-separation from CPB
11.93 mmHg
Standard Deviation 13.039
8.20 mmHg
Standard Deviation 14.764
8.00 mmHg
Standard Deviation 20.338

SECONDARY outcome

Timeframe: 0, 0.5, 6, 12, 24 hours post-separation from CPB

Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method. Here, "number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure
Sitaxsentan (1 mg/kg)
n=9 Participants
Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB).
Sitaxsentan (2 mg/kg)
n=10 Participants
Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB.
Placebo
n=8 Participants
Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB.
Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)
At 0 hour post-separation from CPB
105.56 milliliters (mL)
Standard Deviation 196.365
124.50 milliliters (mL)
Standard Deviation 162.830
107.50 milliliters (mL)
Standard Deviation 117.959
Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)
Change at 0.5 hours post-separation from CPB
-42.11 milliliters (mL)
Standard Deviation 186.162
0.50 milliliters (mL)
Standard Deviation 136.472
-16.88 milliliters (mL)
Standard Deviation 185.817
Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)
Change at 6 hours post-separation from CPB
664.78 milliliters (mL)
Standard Deviation 657.273
334.50 milliliters (mL)
Standard Deviation 325.358
367.50 milliliters (mL)
Standard Deviation 546.083
Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)
Change at 12 hours post-separation from CPB
520.78 milliliters (mL)
Standard Deviation 637.651
358.00 milliliters (mL)
Standard Deviation 485.038
145.63 milliliters (mL)
Standard Deviation 244.298
Change From 0 Hour in Urine Output at 0.5, 6, 12, and 24 Hours Post-separation From Cardiopulmonary Bypass (CPB)
Change at 24 hours post-separation from CPB
611.78 milliliters (mL)
Standard Deviation 785.270
579.80 milliliters (mL)
Standard Deviation 641.390
443.75 milliliters (mL)
Standard Deviation 790.672

SECONDARY outcome

Timeframe: 0 to 24 hours post-separation from CPB

Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study. Missing values were imputed using the LOCF method.

Number of participants with unanticipated perioperative (occurring at or around the time of the surgery) and postoperative (period following the surgery) blood requirements were recorded on case report forms, summarized and reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Sitaxsentan (1 mg/kg)
n=9 Participants
Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB).
Sitaxsentan (2 mg/kg)
n=10 Participants
Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB.
Placebo
n=10 Participants
Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB.
Number of Participants With Unanticipated Perioperative and Postoperative Blood Requirements
0 participants
3 participants
0 participants

SECONDARY outcome

Timeframe: 0 hour up to 24 hours post-separation from CPB

Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study.

Assisted Ventilation time was the time (in hours) between intubation and extubation.

Outcome measures

Outcome measures
Measure
Sitaxsentan (1 mg/kg)
n=9 Participants
Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB).
Sitaxsentan (2 mg/kg)
n=10 Participants
Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB.
Placebo
n=10 Participants
Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB.
Duration of Assisted Ventilation
12 hours
Full Range 23.2 • Interval 9.0 to 72.0
23 hours
Full Range 39.7 • Interval 9.0 to 143.0
21 hours
Full Range 10.6 • Interval 10.0 to 47.0

SECONDARY outcome

Timeframe: 0 hour post-separation from CPB up to 44 days

Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study.

Outcome measures

Outcome measures
Measure
Sitaxsentan (1 mg/kg)
n=9 Participants
Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB).
Sitaxsentan (2 mg/kg)
n=10 Participants
Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB.
Placebo
n=10 Participants
Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB.
Duration of Intensive Care Unit (ICU) Stay
4 days
Full Range 2.5 • Interval 2.0 to 10.0
6 days
Full Range 10.7 • Interval 3.0 to 37.0
5 days
Full Range 2.1 • Interval 4.0 to 10.0

SECONDARY outcome

Timeframe: 0 hour post-separation from CPB up to 44 days

Population: Safety analysis set included all participants who received either sitaxsentan 1 mg/kg, sitaxsentan 2 mg/kg, or placebo during the study.

The duration of initial postoperative hospitalization had been reported.

Outcome measures

Outcome measures
Measure
Sitaxsentan (1 mg/kg)
n=9 Participants
Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB).
Sitaxsentan (2 mg/kg)
n=10 Participants
Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB.
Placebo
n=10 Participants
Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB.
Duration of Initial Postoperative Hospitalization
8 days
Full Range 8.2 • Interval 4.0 to 29.0
11 days
Full Range 13.5 • Interval 5.0 to 44.0
10 days
Full Range 3.9 • Interval 6.0 to 19.0

Adverse Events

Sitaxsentan (1 mg/kg)

Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths

Sitaxsentan (2 mg/kg)

Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths

Placebo

Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Sitaxsentan (1 mg/kg)
n=9 participants at risk
Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB).
Sitaxsentan (2 mg/kg)
n=10 participants at risk
Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB.
Placebo
n=10 participants at risk
Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB.
Cardiac disorders
Bradycardia
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders
Cardiac arrest
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders
Cardiac failure congestive
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders
Cardiogenic shock
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders
Cardiovascular disorder
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
20.0%
2/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders
Myocardial infarction
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders
Pericardial effusion
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders
Ventricular tachycardia
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders
Ill-defined disorder
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations
Wound infection
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
20.0%
2/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders
Aspiration
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Other adverse events

Other adverse events
Measure
Sitaxsentan (1 mg/kg)
n=9 participants at risk
Participants received single intravenous (IV) infusion of sitaxsentan 1 milligram per kilogram (mg/kg) immediately following cross-clamp release and at 12 hours post-cardiopulmonary bypass (CPB).
Sitaxsentan (2 mg/kg)
n=10 participants at risk
Participants received single IV infusion of sitaxsentan 2 mg/kg immediately following cross-clamp release and at 12 hours post-CPB.
Placebo
n=10 participants at risk
Participants received placebo (matched to sitaxsentan) immediately following cross-clamp release and at 12 hours post-CPB.
Blood and lymphatic system disorders
Anaemia
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders
Iron deficiency anaemia
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders
Arrhythmia supraventricular
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders
Atrial fibrillation
44.4%
4/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
50.0%
5/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
20.0%
2/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders
Atrial flutter
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders
Bundle branch block left
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders
Cardiac failure
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders
Cardiac tamponade
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders
Pericardial effusion
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders
Right ventricular failure
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders
Sinus bradycardia
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders
Sinus tachycardia
22.2%
2/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders
Ventricular fibrillation
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders
Ventricular tachycardia
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Endocrine disorders
Adrenal insufficiency
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders
Constipation
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
20.0%
2/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
20.0%
2/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders
Diarrhoea
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders
Melaena
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders
Nausea
44.4%
4/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
40.0%
4/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders
Small intestinal obstruction
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders
Vomiting
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders
Adverse drug reaction
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders
Asthenia
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders
Chills
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders
Ill-defined disorder
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders
Oedema
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders
Oedema peripheral
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders
Pyrexia
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations
Clostridium difficile colitis
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations
Pneumonia
22.2%
2/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations
Purulent discharge
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations
Sepsis
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications
Excoriation
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications
Post procedural haemorrhage
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications
Postoperative fever
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications
Postoperative ileus
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications
Procedural pain
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications
Skin laceration
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations
Alanine aminotransferase increased
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations
Aspartate aminotransferase increased
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations
Blood bilirubin increased
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations
Blood potassium increased
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations
Blood pressure systolic increased
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations
Body temperature increased
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
20.0%
2/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations
Electrocardiogram QT prolonged
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations
Haematocrit decreased
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
20.0%
2/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations
Haemoglobin decreased
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations
Heart rate increased
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations
Heart rate irregular
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations
Methicillin-resistant staphylococcal aureus test positive
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations
Oxygen saturation decreased
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations
Platelet count decreased
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations
Red blood cell count decreased
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations
Urine output decreased
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations
Vascular resistance systemic decreased
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations
White blood cell count increased
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders
Diabetes mellitus
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders
Fluid overload
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders
Arthropathy
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders
Pain in extremity
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders
Hypoaesthesia
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders
Agitation
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
20.0%
2/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders
Alcohol withdrawal syndrome
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders
Anxiety
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders
Confusional state
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
30.0%
3/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
20.0%
2/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders
Delirium
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders
Disorientation
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders
Renal failure acute
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
20.0%
2/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders
Urinary retention
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders
Atelectasis
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders
Productive cough
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
20.0%
2/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Decubitus ulcer
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Petechiae
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Rash
11.1%
1/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders
Skin ulcer
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Vascular disorders
Hypotension
22.2%
2/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
20.0%
2/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Vascular disorders
Thrombosis
0.00%
0/9
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
10.0%
1/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
0.00%
0/10
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

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