Adjuvant Treatment of Pulmonary Embolism With Drotrecogin... | NCT00191724 | Trialant
NCT00191724
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Jun 24, 2009Estimated
Enrollment
47Actual
Phase
Phase 2
Conditions
Submassive Pulmonary Embolism
Interventions
Drotrecogin Alfa (Activated)
Enoxaparin
Placebo
Drotrecogin Alfa (Activated)
Drotrecogin Alfa (Activated)
Drotrecogin Alfa (Activated)
Countries
Germany
Protocol Section
Identification Module
NCT ID
NCT00191724
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
8354
Secondary IDs
ID
Type
Description
Link
F1K-MC-O014
Brief Title
Adjuvant Treatment of Pulmonary Embolism With Drotrecogin Alfa (Activated): Phase II Exploratory Study
Official Title
Drotrecogin Alfa (Activated) (LY203638)] Exploratory, Safety Study, Multi-Center, Randomized, Placebo-Controlled, Dose Escalating Study Design, Comparing a Standard Therapy (Enoxaparin Sodium) for Submassive Pulmonary Embolism to a Combined Therapy of Drotrecogin Alfa (Activated) Plus Enoxaparin Sodium.
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jun 2009
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2004
Primary Completion Date
Jan 2008Actual
Completion Date
Jan 2008Actual
First Submitted Date
Sep 12, 2005
First Submission Date that Met QC Criteria
Sep 12, 2005
First Posted Date
Sep 19, 2005Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 14, 2009
Results First Submitted that Met QC Criteria
Apr 28, 2009
Results First Posted Date
Jun 17, 2009Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 16, 2009
Last Update Posted Date
Jun 24, 2009Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Submassive Pulmonary Embolism
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
47Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Experimental
Drug: Drotrecogin Alfa (Activated)
Drug: Enoxaparin
2
Experimental
Drug: Enoxaparin
Drug: Drotrecogin Alfa (Activated)
3
Experimental
Drug: Enoxaparin
Drug: Drotrecogin Alfa (Activated)
4
Experimental
Drug: Enoxaparin
Drug: Drotrecogin Alfa (Activated)
5
Placebo Comparator
Drug: Enoxaparin
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Drotrecogin Alfa (Activated)
Drug
6 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
baseline through day 6
Secondary Outcomes
Measure
Description
Time Frame
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
baseline, day 6, day 90
Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada)
Other Outcomes
Not provided
Eligibility Module
Eligibility 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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
80 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Dempfle CE, Elmas E, Link A, Suvajac N, Liebe V, Janes J, Borggrefe M. Endogenous plasma activated protein C levels and the effect of enoxaparin and drotrecogin alfa (activated) on markers of coagulation activation and fibrinolysis in pulmonary embolism. Crit Care. 2011;15(1):R23. doi: 10.1186/cc9968. Epub 2011 Jan 17.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Xigris, LY203638
Enoxaparin
Drug
1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target International Normalized Ratio (INR) is reached, minimum of 5 days
1
2
3
4
5
Placebo
Drug
intravenous (IV), one infusion, over 12 hours
5
Drotrecogin Alfa (Activated)
Drug
12 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
2
Xigris, LY203638
Drotrecogin Alfa (Activated)
Drug
18 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
3
Xigris, LY203638
Drotrecogin Alfa (Activated)
Drug
24 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
4
Xigris, LY203638
Scores in each of the 4 domains (dyspnea, fatigue, emotional, and mastery) ranged from 1 (maximum impairment) to 7 (no impairment).
baseline and day 90 (follow-up)
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.
baseline, day 6, day 90
Germany
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
FG002
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
FG003
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
FG004
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
FG0006 subjects
FG0019 subjects
FG0029 subjects
FG0038 subjects
FG00415 subjects
COMPLETED
FG0005 subjects
FG0018 subjects
FG0028 subjects
FG0035 subjects
FG00412 subjects
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0033 subjects
FG0043 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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
BG001
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
BG002
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
BG003
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
BG004
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
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0019
BG0029
BG0038
BG00415
BG00547
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00070.8± 4.4
BG00165.7± 8.9
BG00251.9± 16.5
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0013
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Germany
Title
Measurements
BG0006
BG0019
BG002
Medical History - Acute Coronary Syndrome/Myocardial Infarction
Number
participants
Title
Denominators
Categories
Acute Coronary Syndrome/MI - Yes
Title
Measurements
BG0000
BG0011
BG002
Medical History - Chronic Obstructive Pulmonary Disease
Number
participants
Title
Denominators
Categories
Chronic Obstructive Pulmonary Disease - Yes
Title
Measurements
BG0000
BG0012
BG002
Medical History - Deep Vein Thrombosis
Number
participants
Title
Denominators
Categories
Deep Vein Thrombosis - Yes
Title
Measurements
BG0001
BG0012
BG002
Medical History - Ischemic Stroke
Number
participants
Title
Denominators
Categories
Ischemic Stroke - Yes
Title
Measurements
BG0001
BG0011
BG002
Medical History - Pulmonary Embolism
Number
participants
Title
Denominators
Categories
Pulmonary Embolism - Yes
Title
Measurements
BG0001
BG0012
BG002
Medical History - Venous Thromboembolism
Number
participants
Title
Denominators
Categories
Venous Thromboembolism - Yes
Title
Measurements
BG0000
BG0012
BG002
Race/Ethnicity
Number
participants
Title
Denominators
Categories
Caucasian
Title
Measurements
BG0006
BG0019
BG002
Body Weight
Mean
Standard Deviation
kilograms
Title
Denominators
Categories
Title
Measurements
BG00076.0± 9.7
BG00193.9± 13.3
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
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.
The population analyzed was all randomized patients who received any amount of study drug [drotrecogin alfa (activated) or placebo].
Posted
Number
participants
baseline through day 6
ID
Title
Description
OG000
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
OG001
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
OG002
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
OG003
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
OG004
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
Units
Counts
Participants
OG0005
OG0018
OG0028
OG003
Title
Denominators
Categories
Intracranial Hemorrhage
Title
Measurements
OG0001
OG0010
OG0020
OG003
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
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.
Posted
Mean
Standard Deviation
ratio
baseline, day 6, day 90
ID
Title
Description
OG000
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
OG001
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
OG002
Drotrecogin Alfa (Activated) - 18
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).
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.
Posted
Mean
Standard Deviation
units on a scale
baseline and day 90 (follow-up)
ID
Title
Description
OG000
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
OG001
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
OG002
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
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.
Data were not collected.
Posted
Mean
Standard Deviation
mm Hg
baseline, day 6, day 90
ID
Title
Description
OG000
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
OG001
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
OG002
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
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
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
1
3
EG001
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
1
8
EG002
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
1
8
EG003
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
2
6
EG004
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
2
11
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected15 at risk
Accidental overdose
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Atrial flutter
Cardiac disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Bradycardia
Cardiac disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Cardiac arrest
Cardiac disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Deep vein thrombosis
Vascular disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Oedema peripheral
General disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Prothrombin time prolonged
Investigations
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Splenomegaly
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected15 at risk
Palpitations
Cardiac disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected9 at risk
EG003
Tachycardia
Cardiac disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Vertigo
Ear and labyrinth disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected9 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Colonic polyp
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Diarrhoea
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Dyspepsia
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Gastritis
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Intra-abdominal haematoma
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Nausea
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0023 events3 affected9 at risk
EG003
Reflux oesophagitis
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Vomiting
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected9 at risk
EG003
Catheter site oedema
General disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Catheter site pain
General disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Catheter site related reaction
General disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Chest pain
General disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected9 at risk
EG003
Discomfort
General disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Fatigue
General disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Inflammation
General disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Injection site haemorrhage
General disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Oedema peripheral
General disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Polyp
General disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Vessel puncture site haematoma
General disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Pyrexia
General disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0023 events3 affected9 at risk
EG003
Hepatic cyst
Hepatobiliary disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0022 events2 affected9 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Portal hypertensive gastropathy
Hepatobiliary disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Drug hypersensitivity
Immune system disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Bronchitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Clostridium difficile colitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Cystitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Eye infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Influenza
Infections and infestations
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Nasopharyngitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Pneumonia
Infections and infestations
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Pyelonephritis
Infections and infestations
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Urethritis
Infections and infestations
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Overdose
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Postoperative wound complication
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
C-reactive protein increased
Investigations
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Haemoglobin decreased
Investigations
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0022 events1 affected9 at risk
EG003
Akathisia
Nervous system disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Dementia
Nervous system disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Headache
Nervous system disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Migraine
Nervous system disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events1 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Neuropathy peripheral
Nervous system disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Partial seizures
Nervous system disorders
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Presyncope
Nervous system disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Agoraphobia
Psychiatric disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Confusional state
Psychiatric disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Insomnia
Psychiatric disorders
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Oliguria
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Renal cyst
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Renal pain
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Atrophic vulvovaginitis
Reproductive system and breast disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Dsypnoea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Orthopnoea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Painful respiration
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0022 events1 affected9 at risk
EG003
Angiodysplasia
Vascular disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Haematoma
Vascular disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Hypertension
Vascular disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected9 at risk
EG0021 events1 affected9 at risk
EG003
Phlebitis
Vascular disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
Vasodilatation
Vascular disorders
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected9 at risk
EG003
This study was stopped early after 47 patients had been enrolled (planned enrollment was 48 patients). Study was stopped early due to slow enrollment.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Chief Medical Officer
Eli Lilly and Company
1-800-545-5979
ID
Term
C421124
drotrecogin alfa activated
D017984
Enoxaparin
Ancestor Terms
ID
Term
D006495
Heparin, Low-Molecular-Weight
D006493
Heparin
D006025
Glycosaminoglycans
D011134
Polysaccharides
D002241
Carbohydrates
Browse Leaves
Not provided
Browse Branches
Not provided
3 subjects
0 subjects
45.6
± 22.6
BG00460.7± 21.9
BG00558.7± 18.9
5
BG0033
BG00411
BG00525
Male
BG0003
BG0016
BG0024
BG0035
BG0044
BG00522
9
BG0038
BG00415
BG00547
0
BG0030
BG0040
BG0051
Acute Coronary Syndrome/MI - No
Title
Measurements
BG0006
BG0018
BG0029
BG0038
BG00413
BG00544
Acute Coronary Syndrome/MI - Unknown
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0042
BG0052
0
BG0030
BG0040
BG0052
Chronic Obstructive Pulmonary Disease - No
Title
Measurements
BG0005
BG0017
BG0029
BG0038
BG00413
BG00542
Chronic Obstructive Pulmonary Disease - Unknown
Title
Measurements
BG0001
BG0010
BG0020
BG0030
BG0042
BG0053
1
BG0032
BG0042
BG0058
Deep Vein Thrombosis - No
Title
Measurements
BG0002
BG0017
BG0028
BG0036
BG00413
BG00536
Deep Vein Thrombosis - Unknown
Title
Measurements
BG0003
BG0010
BG0020
BG0030
BG0040
BG0053
0
BG0030
BG0043
BG0055
Ischemic Stroke - No
Title
Measurements
BG0004
BG0018
BG0029
BG0038
BG00412
BG00541
Ischemic Stroke - Unknown
Title
Measurements
BG0001
BG0010
BG0020
BG0030
BG0040
BG0051
0
BG0031
BG0040
BG0054
Pulmonary Embolism - No
Title
Measurements
BG0003
BG0017
BG0029
BG0037
BG00415
BG00541
Pulmonary Embolism - Unknown
Title
Measurements
BG0002
BG0010
BG0020
BG0030
BG0040
BG0052
1
BG0030
BG0041
BG0054
Venous Thromboembolism - No
Title
Measurements
BG0003
BG0017
BG0028
BG0037
BG00412
BG00537
Venous Thromboembolism - Unknown
Title
Measurements
BG0003
BG0010
BG0020
BG0031
BG0042
BG0056
8
BG0037
BG00415
BG00545
Other
Title
Measurements
BG0000
BG0010
BG0020
BG0031
BG0040
BG0051
Unknown
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0040
BG0051
85.2
± 17.6
BG00386.4± 13.8
BG00485.7± 18.6
BG00586.0± 16.0
5
OG00412
0
OG0040
Reduction in Hemoglobin
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
Transfusion
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
Hematoma
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
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
OG003
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
OG004
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
Units
Counts
Participants
OG0006
OG0019
OG0029
OG0038
OG00415
Title
Denominators
Categories
RVEDA/LVEDA at Day 0
Title
Measurements
OG0000.8± 0.3
OG0011.0± 0.3
OG0021.0± 0.4
OG0030.9± 0.4
OG0041.1± 0.5
RVEDA/LVEDA at Day 6
Title
Measurements
OG0000.7± 0.3
OG0010.7± 0.2
OG0020.8± 0.3
OG003
RVEDA/LVEDA at Day 90
Title
Measurements
OG0000.5± 0.1
OG0010.5± 0.1
OG0020.6± 0.1
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
Regression, Linear
0.528
P-value for effect of drotrecogin alfa (activated) dose in right ventricular function at Day 6
95
No
Superiority or Other
OG000
OG001
OG002
OG003
OG004
Regression, Linear
0.230
P-value for effect of drotrecogin alfa (activated) dose on right ventricular function at Day 90
95
No
Superiority or Other
OG003
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
OG004
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
Units
Counts
Participants
OG0005
OG0018
OG0028
OG0035
OG00413
Title
Denominators
Categories
Dyspnea - Baseline
Title
Measurements
OG0005.0± 1.8
OG0014.5± 1.5
OG0024.8± 1.6
OG0035.0± 2.4
OG0044.8± 1.7
Dyspnea - 90 Day Follow-Up
Title
Measurements
OG0004.8± 1.4
OG0015.1± 1.7
OG0026.7± 0.7
OG003
Fatigue - Baseline
Title
Measurements
OG0004.5± 1.5
OG0013.6± 1.4
OG0024.2± 1.2
OG003
Fatigue - 90 Day Follow-Up
Title
Measurements
OG0004.8± 1.3
OG0014.1± 1.0
OG0025.2± 1.1
OG003
Emotional - Baseline
Title
Measurements
OG0004.0± 1.2
OG0014.1± 1.0
OG0024.8± 1.2
OG003
Emotional - 90 Day Follow-Up
Title
Measurements
OG0004.7± 1.1
OG0014.8± 1.3
OG0025.5± 1.0
OG003
Mastery - Baseline
Title
Measurements
OG0005.1± 0.8
OG0014.1± 1.2
OG0024.7± 1.7
OG003
Mastery - 90 Day Follow-Up
Title
Measurements
OG0005.0± 1.2
OG0014.9± 2.1
OG0026.1± 1.2
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Regression, Linear
0.018
P-value for Dyspnea 90-Day Follow-Up.
95
No
Superiority or Other
OG000
Regression, Linear
0.720
P-value for Emotional 90 Day Follow-up.
95
No
Superiority or Other
OG000
Regression, Linear
0.481
P-value for Fatigue 90 Day Follow-Up.
95
No
Superiority or Other
OG000
Regression, Linear
0.161
P-value for Mastery 90 Day Follow-Up.
95
No
Superiority or Other
OG001
Regression, Linear
0.068
P-value for Dyspnea 90 Day Follow-Up.
95
No
Superiority or Other
OG001
Regression, Linear
0.985
P-value for Emotional 90 Day Follow-Up.
95
No
Superiority or Other
OG001
Regression, Linear
0.281
P-value for Fatigue 90 Day Follow-Up
95
No
Superiority or Other
OG001
Regression, Linear
0.273
P-value for Mastery 90 Day Follow-Up
95
No
Superiority or Other
OG002
Regression, Linear
0.848
P-value for Dyspnea 90 Day Follow-Up.
95
No
Superiority or Other
OG002
Regression, Linear
0.841
P-value for Emotional 90 Day Follow-Up.
95
No
Superiority or Other
OG002
Regression, Linear
0.797
P-value for Fatigue 90 Day Follow-Up.
95
No
Superiority or Other
OG002
Regression, Linear
0.963
P-value for Mastery 90 Day Follow-Up.
95
No
Superiority or Other
OG003
Regression, Linear
0.149
P-value for Dyspnea 90 Day Follow-Up.
95
No
Superiority or Other
OG003
Regression, Linear
0.141
P-value for Emotional 90 Day Follow-Up.
95
No
Superiority or Other
OG003
Regression, Linear
0.774
P-value for Fatigue 90 Day Follow-Up.
95
No
Superiority or Other
OG003
Regression, Linear
0.394
P-value for Mastery 90 Day Follow-Up.
95
No
Superiority or Other
OG003
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
OG004
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