Submassive Pulmonary Embolism
Conditions
Brief summary
An exploratory, multicenter, randomized, placebo-controlled, double blind, dose escalation study comparing a standard therapy for submassive pulmonary embolism (Enoxaparin sodium) to a combined therapy of Drotrecogin alfa (activated) plus Enoxaparin sodium.
Interventions
6 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
DRUGEnoxaparin
1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target International Normalized Ratio (INR) is reached, minimum of 5 days
DRUGPlacebo
intravenous (IV), one infusion, over 12 hours
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients with symptoms of acute pulmonary embolism (PE), without an indication for fibrinolytic therapy but with echocardiographic evidence of right ventricular dysfunction (submassive PE) within 48 hours of onset of symptoms Inclusion Criteria: * Clinical symptoms of Pulmonary embolism for less than 48 hours
Exclusion criteria
* Patients with symptoms of Pulmonary embolism for more than 48 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Major Bleeding Events | baseline through day 6 | Number of patients with major bleeding events, defined as: Reduction in hemoglobin of 2 to 5 grams per deciliter (g/dL) within 24 hours; Transfusion of 2 to 4 units of packed red blood cells within 24 hours; Hematoma requiring prolonged hospitalization or surgical intervention; Intracranial or retroperitoneal hemorrhage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios | baseline, day 6, day 90 | Change of right ventricular function measured as difference of right ventricular enddiastolic area/left ventricular enddiastolic area (RVEDA/LVEDA) ratios by echocardiography |
| Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | baseline and day 90 (follow-up) | Scores in each of the 4 domains (dyspnea, fatigue, emotional, and mastery) ranged from 1 (maximum impairment) to 7 (no impairment). |
| Difference in Pulmonary Artery (PA) Pressure | baseline, day 6, day 90 | Investigator decided estimate of pulmonary artery pressure by echocardiography would not be useful and no data on pulmonary artery pressure were collected. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Drotrecogin Alfa (Activated) - 6 Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days | 6 |
| Drotrecogin Alfa (Activated) - 12 Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days | 9 |
| Drotrecogin Alfa (Activated) - 18 Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days | 9 |
| Drotrecogin Alfa (Activated) - 24 Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days | 8 |
| Placebo Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days | 15 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 | 0 | 2 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Drotrecogin Alfa (Activated) - 6 | Drotrecogin Alfa (Activated) - 12 | Drotrecogin Alfa (Activated) - 18 | Drotrecogin Alfa (Activated) - 24 | Placebo | Total |
|---|---|---|---|---|---|---|
| Age Continuous | 70.8 years STANDARD_DEVIATION 4.4 | 65.7 years STANDARD_DEVIATION 8.9 | 51.9 years STANDARD_DEVIATION 16.5 | 45.6 years STANDARD_DEVIATION 22.6 | 60.7 years STANDARD_DEVIATION 21.9 | 58.7 years STANDARD_DEVIATION 18.9 |
| Body Weight | 76.0 kilograms STANDARD_DEVIATION 9.7 | 93.9 kilograms STANDARD_DEVIATION 13.3 | 85.2 kilograms STANDARD_DEVIATION 17.6 | 86.4 kilograms STANDARD_DEVIATION 13.8 | 85.7 kilograms STANDARD_DEVIATION 18.6 | 86.0 kilograms STANDARD_DEVIATION 16 |
| Medical History - Acute Coronary Syndrome/Myocardial Infarction Acute Coronary Syndrome/MI - No | 6 participants | 8 participants | 9 participants | 8 participants | 13 participants | 44 participants |
| Medical History - Acute Coronary Syndrome/Myocardial Infarction Acute Coronary Syndrome/MI - Unknown | 0 participants | 0 participants | 0 participants | 0 participants | 2 participants | 2 participants |
| Medical History - Acute Coronary Syndrome/Myocardial Infarction Acute Coronary Syndrome/MI - Yes | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants |
| Medical History - Chronic Obstructive Pulmonary Disease Chronic Obstructive Pulmonary Disease - No | 5 participants | 7 participants | 9 participants | 8 participants | 13 participants | 42 participants |
| Medical History - Chronic Obstructive Pulmonary Disease Chronic Obstructive Pulmonary Disease - Unknown | 1 participants | 0 participants | 0 participants | 0 participants | 2 participants | 3 participants |
| Medical History - Chronic Obstructive Pulmonary Disease Chronic Obstructive Pulmonary Disease - Yes | 0 participants | 2 participants | 0 participants | 0 participants | 0 participants | 2 participants |
| Medical History - Deep Vein Thrombosis Deep Vein Thrombosis - No | 2 participants | 7 participants | 8 participants | 6 participants | 13 participants | 36 participants |
| Medical History - Deep Vein Thrombosis Deep Vein Thrombosis - Unknown | 3 participants | 0 participants | 0 participants | 0 participants | 0 participants | 3 participants |
| Medical History - Deep Vein Thrombosis Deep Vein Thrombosis - Yes | 1 participants | 2 participants | 1 participants | 2 participants | 2 participants | 8 participants |
| Medical History - Ischemic Stroke Ischemic Stroke - No | 4 participants | 8 participants | 9 participants | 8 participants | 12 participants | 41 participants |
| Medical History - Ischemic Stroke Ischemic Stroke - Unknown | 1 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants |
| Medical History - Ischemic Stroke Ischemic Stroke - Yes | 1 participants | 1 participants | 0 participants | 0 participants | 3 participants | 5 participants |
| Medical History - Pulmonary Embolism Pulmonary Embolism - No | 3 participants | 7 participants | 9 participants | 7 participants | 15 participants | 41 participants |
| Medical History - Pulmonary Embolism Pulmonary Embolism - Unknown | 2 participants | 0 participants | 0 participants | 0 participants | 0 participants | 2 participants |
| Medical History - Pulmonary Embolism Pulmonary Embolism - Yes | 1 participants | 2 participants | 0 participants | 1 participants | 0 participants | 4 participants |
| Medical History - Venous Thromboembolism Venous Thromboembolism - No | 3 participants | 7 participants | 8 participants | 7 participants | 12 participants | 37 participants |
| Medical History - Venous Thromboembolism Venous Thromboembolism - Unknown | 3 participants | 0 participants | 0 participants | 1 participants | 2 participants | 6 participants |
| Medical History - Venous Thromboembolism Venous Thromboembolism - Yes | 0 participants | 2 participants | 1 participants | 0 participants | 1 participants | 4 participants |
| Race/Ethnicity Caucasian | 6 participants | 9 participants | 8 participants | 7 participants | 15 participants | 45 participants |
| Race/Ethnicity Other | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity Unknown | 0 participants | 0 participants | 1 participants | 0 participants | 0 participants | 1 participants |
| Region of Enrollment Germany | 6 participants | 9 participants | 9 participants | 8 participants | 15 participants | 47 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 5 Participants | 3 Participants | 11 Participants | 25 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 4 Participants | 5 Participants | 4 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / — | 8 / — | 8 / — | 6 / — | 11 / — |
| serious Total, serious adverse events | 1 / — | 1 / — | 1 / — | 2 / — | 2 / — |
Outcome results
Primary
Number of Participants With Major Bleeding Events
Number of patients with major bleeding events, defined as: Reduction in hemoglobin of 2 to 5 grams per deciliter (g/dL) within 24 hours; Transfusion of 2 to 4 units of packed red blood cells within 24 hours; Hematoma requiring prolonged hospitalization or surgical intervention; Intracranial or retroperitoneal hemorrhage.
Time frame: baseline through day 6
Population: The population analyzed was all randomized patients who received any amount of study drug \[drotrecogin alfa (activated) or placebo\].
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Drotrecogin Alfa (Activated) - 6 | Number of Participants With Major Bleeding Events | Reduction in Hemoglobin | 0 participants |
| Drotrecogin Alfa (Activated) - 6 | Number of Participants With Major Bleeding Events | Intracranial Hemorrhage | 1 participants |
| Drotrecogin Alfa (Activated) - 6 | Number of Participants With Major Bleeding Events | Hematoma | 0 participants |
| Drotrecogin Alfa (Activated) - 6 | Number of Participants With Major Bleeding Events | Transfusion | 0 participants |
| Drotrecogin Alfa (Activated) - 12 | Number of Participants With Major Bleeding Events | Intracranial Hemorrhage | 0 participants |
| Drotrecogin Alfa (Activated) - 12 | Number of Participants With Major Bleeding Events | Reduction in Hemoglobin | 0 participants |
| Drotrecogin Alfa (Activated) - 12 | Number of Participants With Major Bleeding Events | Transfusion | 0 participants |
| Drotrecogin Alfa (Activated) - 12 | Number of Participants With Major Bleeding Events | Hematoma | 0 participants |
| Drotrecogin Alfa (Activated) - 18 | Number of Participants With Major Bleeding Events | Reduction in Hemoglobin | 0 participants |
| Drotrecogin Alfa (Activated) - 18 | Number of Participants With Major Bleeding Events | Transfusion | 0 participants |
| Drotrecogin Alfa (Activated) - 18 | Number of Participants With Major Bleeding Events | Intracranial Hemorrhage | 0 participants |
| Drotrecogin Alfa (Activated) - 18 | Number of Participants With Major Bleeding Events | Hematoma | 0 participants |
| Drotrecogin Alfa (Activated) - 24 | Number of Participants With Major Bleeding Events | Reduction in Hemoglobin | 0 participants |
| Drotrecogin Alfa (Activated) - 24 | Number of Participants With Major Bleeding Events | Transfusion | 0 participants |
| Drotrecogin Alfa (Activated) - 24 | Number of Participants With Major Bleeding Events | Intracranial Hemorrhage | 0 participants |
| Drotrecogin Alfa (Activated) - 24 | Number of Participants With Major Bleeding Events | Hematoma | 0 participants |
| Placebo | Number of Participants With Major Bleeding Events | Reduction in Hemoglobin | 1 participants |
| Placebo | Number of Participants With Major Bleeding Events | Intracranial Hemorrhage | 0 participants |
| Placebo | Number of Participants With Major Bleeding Events | Hematoma | 0 participants |
| Placebo | Number of Participants With Major Bleeding Events | Transfusion | 0 participants |
Secondary
Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada)
Scores in each of the 4 domains (dyspnea, fatigue, emotional, and mastery) ranged from 1 (maximum impairment) to 7 (no impairment).
Time frame: baseline and day 90 (follow-up)
Population: Population was all randomized patients who received any study drug \[drotrecogin alfa (activated) or placebo\]. Patients who had no postbaseline assessment were excluded from the analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Drotrecogin Alfa (Activated) - 6 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Dyspnea - Baseline | 5.0 units on a scale | Standard Deviation 1.8 |
| Drotrecogin Alfa (Activated) - 6 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Emotional - Baseline | 4.0 units on a scale | Standard Deviation 1.2 |
| Drotrecogin Alfa (Activated) - 6 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Fatigue - 90 Day Follow-Up | 4.8 units on a scale | Standard Deviation 1.3 |
| Drotrecogin Alfa (Activated) - 6 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Mastery - Baseline | 5.1 units on a scale | Standard Deviation 0.8 |
| Drotrecogin Alfa (Activated) - 6 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Dyspnea - 90 Day Follow-Up | 4.8 units on a scale | Standard Deviation 1.4 |
| Drotrecogin Alfa (Activated) - 6 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Mastery - 90 Day Follow-Up | 5.0 units on a scale | Standard Deviation 1.2 |
| Drotrecogin Alfa (Activated) - 6 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Emotional - 90 Day Follow-Up | 4.7 units on a scale | Standard Deviation 1.1 |
| Drotrecogin Alfa (Activated) - 6 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Fatigue - Baseline | 4.5 units on a scale | Standard Deviation 1.5 |
| Drotrecogin Alfa (Activated) - 12 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Fatigue - Baseline | 3.6 units on a scale | Standard Deviation 1.4 |
| Drotrecogin Alfa (Activated) - 12 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Dyspnea - 90 Day Follow-Up | 5.1 units on a scale | Standard Deviation 1.7 |
| Drotrecogin Alfa (Activated) - 12 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Emotional - Baseline | 4.1 units on a scale | Standard Deviation 1 |
| Drotrecogin Alfa (Activated) - 12 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Fatigue - 90 Day Follow-Up | 4.1 units on a scale | Standard Deviation 1 |
| Drotrecogin Alfa (Activated) - 12 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Dyspnea - Baseline | 4.5 units on a scale | Standard Deviation 1.5 |
| Drotrecogin Alfa (Activated) - 12 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Mastery - 90 Day Follow-Up | 4.9 units on a scale | Standard Deviation 2.1 |
| Drotrecogin Alfa (Activated) - 12 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Mastery - Baseline | 4.1 units on a scale | Standard Deviation 1.2 |
| Drotrecogin Alfa (Activated) - 12 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Emotional - 90 Day Follow-Up | 4.8 units on a scale | Standard Deviation 1.3 |
| Drotrecogin Alfa (Activated) - 18 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Fatigue - 90 Day Follow-Up | 5.2 units on a scale | Standard Deviation 1.1 |
| Drotrecogin Alfa (Activated) - 18 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Dyspnea - Baseline | 4.8 units on a scale | Standard Deviation 1.6 |
| Drotrecogin Alfa (Activated) - 18 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Dyspnea - 90 Day Follow-Up | 6.7 units on a scale | Standard Deviation 0.7 |
| Drotrecogin Alfa (Activated) - 18 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Fatigue - Baseline | 4.2 units on a scale | Standard Deviation 1.2 |
| Drotrecogin Alfa (Activated) - 18 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Mastery - 90 Day Follow-Up | 6.1 units on a scale | Standard Deviation 1.2 |
| Drotrecogin Alfa (Activated) - 18 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Emotional - Baseline | 4.8 units on a scale | Standard Deviation 1.2 |
| Drotrecogin Alfa (Activated) - 18 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Emotional - 90 Day Follow-Up | 5.5 units on a scale | Standard Deviation 1 |
| Drotrecogin Alfa (Activated) - 18 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Mastery - Baseline | 4.7 units on a scale | Standard Deviation 1.7 |
| Drotrecogin Alfa (Activated) - 24 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Dyspnea - 90 Day Follow-Up | 4.8 units on a scale | Standard Deviation 2.1 |
| Drotrecogin Alfa (Activated) - 24 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Emotional - Baseline | 6.1 units on a scale | Standard Deviation 0.9 |
| Drotrecogin Alfa (Activated) - 24 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Dyspnea - Baseline | 5.0 units on a scale | Standard Deviation 2.4 |
| Drotrecogin Alfa (Activated) - 24 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Mastery - 90 Day Follow-Up | 4.9 units on a scale | Standard Deviation 1.7 |
| Drotrecogin Alfa (Activated) - 24 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Mastery - Baseline | 5.8 units on a scale | Standard Deviation 1.4 |
| Drotrecogin Alfa (Activated) - 24 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Fatigue - 90 Day Follow-Up | 4.0 units on a scale | Standard Deviation 1.3 |
| Drotrecogin Alfa (Activated) - 24 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Emotional - 90 Day Follow-Up | 4.4 units on a scale | Standard Deviation 1.5 |
| Drotrecogin Alfa (Activated) - 24 | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Fatigue - Baseline | 4.7 units on a scale | Standard Deviation 1 |
| Placebo | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Fatigue - Baseline | 4.1 units on a scale | Standard Deviation 1.3 |
| Placebo | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Mastery - Baseline | 4.8 units on a scale | Standard Deviation 1.4 |
| Placebo | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Emotional - Baseline | 4.4 units on a scale | Standard Deviation 1.1 |
| Placebo | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Dyspnea - 90 Day Follow-Up | 6.5 units on a scale | Standard Deviation 0.6 |
| Placebo | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Mastery - 90 Day Follow-Up | 6.1 units on a scale | Standard Deviation 0.9 |
| Placebo | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Emotional - 90 Day Follow-Up | 5.2 units on a scale | Standard Deviation 0.9 |
| Placebo | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Dyspnea - Baseline | 4.8 units on a scale | Standard Deviation 1.7 |
| Placebo | Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) | Fatigue - 90 Day Follow-Up | 5.0 units on a scale | Standard Deviation 0.7 |
p-value: 0.72Regression, Linear
p-value: 0.481Regression, Linear
p-value: 0.161Regression, Linear
p-value: 0.068Regression, Linear
p-value: 0.985Regression, Linear
p-value: 0.018Regression, Linear
p-value: 0.281Regression, Linear
p-value: 0.273Regression, Linear
p-value: 0.848Regression, Linear
p-value: 0.841Regression, Linear
p-value: 0.797Regression, Linear
p-value: 0.963Regression, Linear
p-value: 0.149Regression, Linear
p-value: 0.141Regression, Linear
p-value: 0.774Regression, Linear
p-value: 0.394Regression, Linear
Secondary
Difference in Pulmonary Artery (PA) Pressure
Investigator decided estimate of pulmonary artery pressure by echocardiography would not be useful and no data on pulmonary artery pressure were collected.
Time frame: baseline, day 6, day 90
Population: Data were not collected.
Secondary
Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios
Change of right ventricular function measured as difference of right ventricular enddiastolic area/left ventricular enddiastolic area (RVEDA/LVEDA) ratios by echocardiography
Time frame: baseline, day 6, day 90
Population: Population is all randomized patients who received any amount of study drug \[drotrecogin alfa (activated) or placebo\]. Patients who had no postbaseline measure at Day 6 or Day 90 were excluded from the analysis of change from baseline to day 6 or day 90, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Drotrecogin Alfa (Activated) - 6 | Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios | RVEDA/LVEDA at Day 0 | 0.8 ratio | Standard Deviation 0.3 |
| Drotrecogin Alfa (Activated) - 6 | Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios | RVEDA/LVEDA at Day 90 | 0.5 ratio | Standard Deviation 0.1 |
| Drotrecogin Alfa (Activated) - 6 | Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios | RVEDA/LVEDA at Day 6 | 0.7 ratio | Standard Deviation 0.3 |
| Drotrecogin Alfa (Activated) - 12 | Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios | RVEDA/LVEDA at Day 6 | 0.7 ratio | Standard Deviation 0.2 |
| Drotrecogin Alfa (Activated) - 12 | Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios | RVEDA/LVEDA at Day 0 | 1.0 ratio | Standard Deviation 0.3 |
| Drotrecogin Alfa (Activated) - 12 | Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios | RVEDA/LVEDA at Day 90 | 0.5 ratio | Standard Deviation 0.1 |
| Drotrecogin Alfa (Activated) - 18 | Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios | RVEDA/LVEDA at Day 6 | 0.8 ratio | Standard Deviation 0.3 |
| Drotrecogin Alfa (Activated) - 18 | Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios | RVEDA/LVEDA at Day 0 | 1.0 ratio | Standard Deviation 0.4 |
| Drotrecogin Alfa (Activated) - 18 | Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios | RVEDA/LVEDA at Day 90 | 0.6 ratio | Standard Deviation 0.1 |
| Drotrecogin Alfa (Activated) - 24 | Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios | RVEDA/LVEDA at Day 0 | 0.9 ratio | Standard Deviation 0.4 |
| Drotrecogin Alfa (Activated) - 24 | Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios | RVEDA/LVEDA at Day 90 | 0.5 ratio | Standard Deviation 0.1 |
| Drotrecogin Alfa (Activated) - 24 | Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios | RVEDA/LVEDA at Day 6 | 0.6 ratio | Standard Deviation 0.2 |
| Placebo | Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios | RVEDA/LVEDA at Day 6 | 0.7 ratio | Standard Deviation 0.2 |
| Placebo | Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios | RVEDA/LVEDA at Day 0 | 1.1 ratio | Standard Deviation 0.5 |
| Placebo | Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios | RVEDA/LVEDA at Day 90 | 0.6 ratio | Standard Deviation 0.2 |
p-value: 0.528Regression, Linear
p-value: 0.23Regression, Linear