Trial Outcomes & Findings for Adjuvant Treatment of Pulmonary Embolism With Drotrecogin Alfa (Activated): Phase II Exploratory Study (NCT NCT00191724)
NCT ID: NCT00191724
Last Updated: 2009-06-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
baseline through day 6
Results posted on
2009-06-24
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
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
|
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
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
9
|
9
|
8
|
15
|
|
Overall Study
COMPLETED
|
5
|
8
|
8
|
5
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
3
|
3
|
Reasons for withdrawal
| Measure |
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
|
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
|
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
|
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
|
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
|
|---|---|---|---|---|---|
|
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
Adjuvant Treatment of Pulmonary Embolism With Drotrecogin Alfa (Activated): Phase II Exploratory Study
Baseline characteristics by cohort
| Measure |
Drotrecogin Alfa (Activated) - 6
n=6 Participants
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
|
Drotrecogin Alfa (Activated) - 12
n=9 Participants
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
|
Drotrecogin Alfa (Activated) - 18
n=9 Participants
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
|
Drotrecogin Alfa (Activated) - 24
n=8 Participants
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
|
Placebo
n=15 Participants
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
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Medical History - Acute Coronary Syndrome/Myocardial Infarction
Acute Coronary Syndrome/MI - Yes
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
|
Medical History - Acute Coronary Syndrome/Myocardial Infarction
Acute Coronary Syndrome/MI - No
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
8 participants
n=4 Participants
|
13 participants
n=21 Participants
|
44 participants
n=8 Participants
|
|
Medical History - Acute Coronary Syndrome/Myocardial Infarction
Acute Coronary Syndrome/MI - Unknown
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
2 participants
n=8 Participants
|
|
Medical History - Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease - Yes
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=8 Participants
|
|
Age Continuous
|
70.8 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
65.7 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
51.9 years
STANDARD_DEVIATION 16.5 • n=5 Participants
|
45.6 years
STANDARD_DEVIATION 22.6 • n=4 Participants
|
60.7 years
STANDARD_DEVIATION 21.9 • n=21 Participants
|
58.7 years
STANDARD_DEVIATION 18.9 • n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
|
Region of Enrollment
Germany
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
8 participants
n=4 Participants
|
15 participants
n=21 Participants
|
47 participants
n=8 Participants
|
|
Medical History - Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease - No
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
8 participants
n=4 Participants
|
13 participants
n=21 Participants
|
42 participants
n=8 Participants
|
|
Medical History - Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease - Unknown
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
3 participants
n=8 Participants
|
|
Medical History - Deep Vein Thrombosis
Deep Vein Thrombosis - Yes
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
8 participants
n=8 Participants
|
|
Medical History - Deep Vein Thrombosis
Deep Vein Thrombosis - No
|
2 participants
n=5 Participants
|
7 participants
n=7 Participants
|
8 participants
n=5 Participants
|
6 participants
n=4 Participants
|
13 participants
n=21 Participants
|
36 participants
n=8 Participants
|
|
Medical History - Deep Vein Thrombosis
Deep Vein Thrombosis - Unknown
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
3 participants
n=8 Participants
|
|
Medical History - Ischemic Stroke
Ischemic Stroke - Yes
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
5 participants
n=8 Participants
|
|
Medical History - Ischemic Stroke
Ischemic Stroke - No
|
4 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
8 participants
n=4 Participants
|
12 participants
n=21 Participants
|
41 participants
n=8 Participants
|
|
Medical History - Ischemic Stroke
Ischemic Stroke - Unknown
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
|
Medical History - Pulmonary Embolism
Pulmonary Embolism - Yes
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
4 participants
n=8 Participants
|
|
Medical History - Pulmonary Embolism
Pulmonary Embolism - No
|
3 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
7 participants
n=4 Participants
|
15 participants
n=21 Participants
|
41 participants
n=8 Participants
|
|
Medical History - Pulmonary Embolism
Pulmonary Embolism - Unknown
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=8 Participants
|
|
Medical History - Venous Thromboembolism
Venous Thromboembolism - Yes
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
4 participants
n=8 Participants
|
|
Medical History - Venous Thromboembolism
Venous Thromboembolism - No
|
3 participants
n=5 Participants
|
7 participants
n=7 Participants
|
8 participants
n=5 Participants
|
7 participants
n=4 Participants
|
12 participants
n=21 Participants
|
37 participants
n=8 Participants
|
|
Medical History - Venous Thromboembolism
Venous Thromboembolism - Unknown
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
6 participants
n=8 Participants
|
|
Race/Ethnicity
Caucasian
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
8 participants
n=5 Participants
|
7 participants
n=4 Participants
|
15 participants
n=21 Participants
|
45 participants
n=8 Participants
|
|
Race/Ethnicity
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
|
Race/Ethnicity
Unknown
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
|
Body Weight
|
76.0 kilograms
STANDARD_DEVIATION 9.7 • n=5 Participants
|
93.9 kilograms
STANDARD_DEVIATION 13.3 • n=7 Participants
|
85.2 kilograms
STANDARD_DEVIATION 17.6 • n=5 Participants
|
86.4 kilograms
STANDARD_DEVIATION 13.8 • n=4 Participants
|
85.7 kilograms
STANDARD_DEVIATION 18.6 • n=21 Participants
|
86.0 kilograms
STANDARD_DEVIATION 16.0 • n=8 Participants
|
PRIMARY outcome
Timeframe: baseline through day 6Population: The population analyzed was all randomized patients who received any amount of study drug \[drotrecogin alfa (activated) or placebo\].
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.
Outcome measures
| Measure |
Drotrecogin Alfa (Activated) - 6
n=5 Participants
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
|
Drotrecogin Alfa (Activated) - 12
n=8 Participants
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
|
Drotrecogin Alfa (Activated) - 18
n=8 Participants
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
|
Drotrecogin Alfa (Activated) - 24
n=5 Participants
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
|
Placebo
n=12 Participants
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
|
|---|---|---|---|---|---|
|
Number of Participants With Major Bleeding Events
Intracranial Hemorrhage
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Major Bleeding Events
Transfusion
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Major Bleeding Events
Reduction in Hemoglobin
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Major Bleeding Events
Hematoma
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: baseline, day 6, day 90Population: 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.
Change of right ventricular function measured as difference of right ventricular enddiastolic area/left ventricular enddiastolic area (RVEDA/LVEDA) ratios by echocardiography
Outcome measures
| Measure |
Drotrecogin Alfa (Activated) - 6
n=6 Participants
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
|
Drotrecogin Alfa (Activated) - 12
n=9 Participants
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
|
Drotrecogin Alfa (Activated) - 18
n=9 Participants
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
|
Drotrecogin Alfa (Activated) - 24
n=8 Participants
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
|
Placebo
n=15 Participants
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
|
|---|---|---|---|---|---|
|
Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios
RVEDA/LVEDA at Day 0
|
0.8 ratio
Standard Deviation 0.3
|
1.0 ratio
Standard Deviation 0.3
|
1.0 ratio
Standard Deviation 0.4
|
0.9 ratio
Standard Deviation 0.4
|
1.1 ratio
Standard Deviation 0.5
|
|
Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios
RVEDA/LVEDA at Day 6
|
0.7 ratio
Standard Deviation 0.3
|
0.7 ratio
Standard Deviation 0.2
|
0.8 ratio
Standard Deviation 0.3
|
0.6 ratio
Standard Deviation 0.2
|
0.7 ratio
Standard Deviation 0.2
|
|
Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios
RVEDA/LVEDA at Day 90
|
0.5 ratio
Standard Deviation 0.1
|
0.5 ratio
Standard Deviation 0.1
|
0.6 ratio
Standard Deviation 0.1
|
0.5 ratio
Standard Deviation 0.1
|
0.6 ratio
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: 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.
Scores in each of the 4 domains (dyspnea, fatigue, emotional, and mastery) ranged from 1 (maximum impairment) to 7 (no impairment).
Outcome measures
| Measure |
Drotrecogin Alfa (Activated) - 6
n=5 Participants
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
|
Drotrecogin Alfa (Activated) - 12
n=8 Participants
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
|
Drotrecogin Alfa (Activated) - 18
n=8 Participants
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
|
Drotrecogin Alfa (Activated) - 24
n=5 Participants
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
|
Placebo
n=13 Participants
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
|
|---|---|---|---|---|---|
|
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
|
5.1 units on a scale
Standard Deviation 1.7
|
6.7 units on a scale
Standard Deviation 0.7
|
4.8 units on a scale
Standard Deviation 2.1
|
6.5 units on a scale
Standard Deviation 0.6
|
|
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
|
3.6 units on a scale
Standard Deviation 1.4
|
4.2 units on a scale
Standard Deviation 1.2
|
4.7 units on a scale
Standard Deviation 1.0
|
4.1 units on a scale
Standard Deviation 1.3
|
|
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
|
4.9 units on a scale
Standard Deviation 2.1
|
6.1 units on a scale
Standard Deviation 1.2
|
4.9 units on a scale
Standard Deviation 1.7
|
6.1 units on a scale
Standard Deviation 0.9
|
|
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
|
4.5 units on a scale
Standard Deviation 1.5
|
4.8 units on a scale
Standard Deviation 1.6
|
5.0 units on a scale
Standard Deviation 2.4
|
4.8 units on a scale
Standard Deviation 1.7
|
|
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
|
4.1 units on a scale
Standard Deviation 1.0
|
5.2 units on a scale
Standard Deviation 1.1
|
4.0 units on a scale
Standard Deviation 1.3
|
5.0 units on a scale
Standard Deviation 0.7
|
|
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
|
4.1 units on a scale
Standard Deviation 1.0
|
4.8 units on a scale
Standard Deviation 1.2
|
6.1 units on a scale
Standard Deviation 0.9
|
4.4 units on a scale
Standard Deviation 1.1
|
|
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
|
4.8 units on a scale
Standard Deviation 1.3
|
5.5 units on a scale
Standard Deviation 1.0
|
4.4 units on a scale
Standard Deviation 1.5
|
5.2 units on a scale
Standard Deviation 0.9
|
|
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
|
4.1 units on a scale
Standard Deviation 1.2
|
4.7 units on a scale
Standard Deviation 1.7
|
5.8 units on a scale
Standard Deviation 1.4
|
4.8 units on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: baseline, day 6, day 90Population: Data were not collected.
Investigator decided estimate of pulmonary artery pressure by echocardiography would not be useful and no data on pulmonary artery pressure were collected.
Outcome measures
Outcome data not reported
Adverse Events
Drotrecogin Alfa (Activated) - 6
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Drotrecogin Alfa (Activated) - 12
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Drotrecogin Alfa (Activated) - 18
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Drotrecogin Alfa (Activated) - 24
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
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
|
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
|
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
|
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
|
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
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/15
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/15
|
|
General disorders
Oedema peripheral
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/15
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
16.7%
1/6 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/15
|
Other adverse events
| Measure |
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
|
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
|
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
|
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
|
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
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/15
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6
|
0.00%
0/9
|
22.2%
2/9 • Number of events 2
|
0.00%
0/8
|
0.00%
0/15
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/15
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6
|
0.00%
0/9
|
22.2%
2/9 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
13.3%
2/15 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/15
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/15
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
16.7%
1/6 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/15
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
6.7%
1/15 • Number of events 2
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
25.0%
2/8 • Number of events 2
|
13.3%
2/15 • Number of events 2
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/15
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6
|
0.00%
0/9
|
33.3%
3/9 • Number of events 3
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/15
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6
|
0.00%
0/9
|
22.2%
2/9 • Number of events 2
|
0.00%
0/8
|
0.00%
0/15
|
|
General disorders
Catheter site oedema
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Catheter site pain
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/15
|
|
General disorders
Catheter site related reaction
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/15
|
|
General disorders
Chest pain
|
0.00%
0/6
|
0.00%
0/9
|
22.2%
2/9 • Number of events 2
|
0.00%
0/8
|
0.00%
0/15
|
|
General disorders
Discomfort
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/15
|
|
General disorders
Fatigue
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
25.0%
2/8 • Number of events 2
|
0.00%
0/15
|
|
General disorders
Inflammation
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/15
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/15
|
|
General disorders
Oedema peripheral
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
25.0%
2/8 • Number of events 3
|
0.00%
0/15
|
|
General disorders
Polyp
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
33.3%
3/9 • Number of events 3
|
0.00%
0/8
|
0.00%
0/15
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/6
|
0.00%
0/9
|
22.2%
2/9 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Hepatobiliary disorders
Portal hypertensive gastropathy
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/15
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/15
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/15
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/15
|
|
Infections and infestations
Cystitis
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Eye infection
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/15
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/15
|
|
Infections and infestations
Urethritis
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
16.7%
1/6 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
16.7%
1/6 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/15
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/15
|
|
Investigations
Haemoglobin decreased
|
16.7%
1/6 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 2
|
0.00%
0/8
|
0.00%
0/15
|
|
Nervous system disorders
Akathisia
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Dementia
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Nervous system disorders
Migraine
|
0.00%
0/6
|
11.1%
1/9 • Number of events 2
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/15
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/15
|
|
Nervous system disorders
Partial seizures
|
16.7%
1/6 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/15
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/15
|
|
Psychiatric disorders
Agoraphobia
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/15
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/15
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/15
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
6.7%
1/15 • Number of events 2
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/15
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dsypnoea
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
12.5%
1/8 • Number of events 1
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 2
|
0.00%
0/8
|
0.00%
0/15
|
|
Vascular disorders
Angiodysplasia
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Vascular disorders
Haematoma
|
0.00%
0/6
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/8
|
0.00%
0/15
|
|
Vascular disorders
Hypertension
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/15
|
|
Vascular disorders
Phlebitis
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
|
Vascular disorders
Vasodilatation
|
0.00%
0/6
|
0.00%
0/9
|
0.00%
0/9
|
0.00%
0/8
|
6.7%
1/15 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 1-800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60