Trial Outcomes & Findings for Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Septic Shock (NCT NCT00604214)
NCT ID: NCT00604214
Last Updated: 2012-09-18
Results Overview
Expressed as percentage of participants who died from any cause at Day 28 endpoint.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1696 participants
Primary outcome timeframe
Day 28
Results posted on
2012-09-18
Participant Flow
Participant milestones
| Measure |
Drotrecogin Alfa (Activated)
24 microgram/kilogram/hour, intravenous, 96 hours
|
Placebo
0.9% sodium chloride, intravenous, 96 hours
|
|---|---|---|
|
Baseline to Day 28
STARTED
|
851
|
845
|
|
Baseline to Day 28
Received Study Drug
|
833
|
833
|
|
Baseline to Day 28
COMPLETED
|
623
|
632
|
|
Baseline to Day 28
NOT COMPLETED
|
228
|
213
|
|
Day 29 to Day 90
STARTED
|
623
|
632
|
|
Day 29 to Day 90
COMPLETED
|
555
|
553
|
|
Day 29 to Day 90
NOT COMPLETED
|
68
|
79
|
|
Day 91 to Day 180
STARTED
|
555
|
553
|
|
Day 91 to Day 180
COMPLETED
|
529
|
521
|
|
Day 91 to Day 180
NOT COMPLETED
|
26
|
32
|
Reasons for withdrawal
| Measure |
Drotrecogin Alfa (Activated)
24 microgram/kilogram/hour, intravenous, 96 hours
|
Placebo
0.9% sodium chloride, intravenous, 96 hours
|
|---|---|---|
|
Baseline to Day 28
Death
|
223
|
202
|
|
Baseline to Day 28
Lost to Follow-up
|
2
|
4
|
|
Baseline to Day 28
Withdrawal by Subject
|
3
|
7
|
|
Day 29 to Day 90
Death
|
64
|
67
|
|
Day 29 to Day 90
Lost to Follow-up
|
4
|
6
|
|
Day 29 to Day 90
Withdrawal by Subject
|
0
|
6
|
|
Day 91 to Day 180
Death
|
19
|
23
|
|
Day 91 to Day 180
Lost to Follow-up
|
6
|
8
|
|
Day 91 to Day 180
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Septic Shock
Baseline characteristics by cohort
| Measure |
Drotrecogin Alfa (Activated)
n=851 Participants
24 microgram/kilogram/hour, intravenous, 96 hours
|
Placebo
n=845 Participants
0.9% sodium chloride, intravenous, 96 hours
|
Total
n=1696 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
63.42 years
STANDARD_DEVIATION 15.42 • n=5 Participants
|
62.70 years
STANDARD_DEVIATION 16.41 • n=7 Participants
|
63.06 years
STANDARD_DEVIATION 15.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
360 Participants
n=5 Participants
|
379 Participants
n=7 Participants
|
739 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
491 Participants
n=5 Participants
|
466 Participants
n=7 Participants
|
957 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Aboriginal/Torres Strait Islander
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African
|
30 participants
n=5 Participants
|
27 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
740 participants
n=5 Participants
|
721 participants
n=7 Participants
|
1461 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
East Asian/Pacific
|
21 participants
n=5 Participants
|
10 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
21 participants
n=5 Participants
|
32 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
West Asian (Indian Subcontinent)
|
34 participants
n=5 Participants
|
45 participants
n=7 Participants
|
79 participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
78 participants
n=5 Participants
|
82 participants
n=7 Participants
|
160 participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
45 participants
n=5 Participants
|
42 participants
n=7 Participants
|
87 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
87 participants
n=5 Participants
|
84 participants
n=7 Participants
|
171 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
44 participants
n=5 Participants
|
49 participants
n=7 Participants
|
93 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
54 participants
n=5 Participants
|
53 participants
n=7 Participants
|
107 participants
n=5 Participants
|
|
Region of Enrollment
India
|
40 participants
n=5 Participants
|
41 participants
n=7 Participants
|
81 participants
n=5 Participants
|
|
Region of Enrollment
France
|
235 participants
n=5 Participants
|
229 participants
n=7 Participants
|
464 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
30 participants
n=5 Participants
|
24 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
36 participants
n=5 Participants
|
43 participants
n=7 Participants
|
79 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
69 participants
n=5 Participants
|
70 participants
n=7 Participants
|
139 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
36 participants
n=5 Participants
|
28 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
22 participants
n=5 Participants
|
23 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
24 participants
n=5 Participants
|
22 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Primary Site of Infection
Abdomen
|
263 participants
n=5 Participants
|
246 participants
n=7 Participants
|
509 participants
n=5 Participants
|
|
Primary Site of Infection
Blood
|
40 participants
n=5 Participants
|
25 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
Primary Site of Infection
Bone
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Primary Site of Infection
Central Nervous System
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Primary Site of Infection
Head
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Primary Site of Infection
Heart
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Primary Site of Infection
Lung
|
369 participants
n=5 Participants
|
375 participants
n=7 Participants
|
744 participants
n=5 Participants
|
|
Primary Site of Infection
Other
|
11 participants
n=5 Participants
|
17 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Primary Site of Infection
Pleura
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Primary Site of Infection
Reproductive Tract
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Primary Site of Infection
Skin or Skin Structure
|
48 participants
n=5 Participants
|
45 participants
n=7 Participants
|
93 participants
n=5 Participants
|
|
Primary Site of Infection
Urinary Tract
|
97 participants
n=5 Participants
|
112 participants
n=7 Participants
|
209 participants
n=5 Participants
|
|
Primary Site of Infection
Unknown
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Cardiovascular Sequential Organ Failure Assessment (SOFA) Score
|
3.91 units on a scale
STANDARD_DEVIATION 0.32 • n=5 Participants
|
3.89 units on a scale
STANDARD_DEVIATION 0.35 • n=7 Participants
|
3.90 units on a scale
STANDARD_DEVIATION 0.33 • n=5 Participants
|
|
Respiratory Sequential Organ Failure Assessment (SOFA) Score
|
2.78 units on a scale
STANDARD_DEVIATION 1.07 • n=5 Participants
|
2.74 units on a scale
STANDARD_DEVIATION 1.08 • n=7 Participants
|
2.76 units on a scale
STANDARD_DEVIATION 1.08 • n=5 Participants
|
|
Renal Sequential Organ Failure Assessment (SOFA) Score
|
1.67 units on a scale
STANDARD_DEVIATION 1.33 • n=5 Participants
|
1.60 units on a scale
STANDARD_DEVIATION 1.34 • n=7 Participants
|
1.63 units on a scale
STANDARD_DEVIATION 1.33 • n=5 Participants
|
|
Coagulation Sequential Organ Failure Assessment (SOFA) Score
|
0.76 units on a scale
STANDARD_DEVIATION 0.97 • n=5 Participants
|
0.71 units on a scale
STANDARD_DEVIATION 0.96 • n=7 Participants
|
0.74 units on a scale
STANDARD_DEVIATION 0.96 • n=5 Participants
|
|
Liver Sequential Organ Failure Assessment (SOFA) Score
|
0.55 units on a scale
STANDARD_DEVIATION 0.85 • n=5 Participants
|
0.53 units on a scale
STANDARD_DEVIATION 0.88 • n=7 Participants
|
0.54 units on a scale
STANDARD_DEVIATION 0.87 • n=5 Participants
|
|
Acute Physiology and Chronic Health Evaluation II (APACHE II) Score
|
25.17 units on a scale
STANDARD_DEVIATION 8.06 • n=5 Participants
|
25.45 units on a scale
STANDARD_DEVIATION 8.14 • n=7 Participants
|
25.31 units on a scale
STANDARD_DEVIATION 8.10 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: All randomized participants with known mortality status at Day 28.
Expressed as percentage of participants who died from any cause at Day 28 endpoint.
Outcome measures
| Measure |
Drotrecogin Alfa (Activated)
n=846 Participants
24 microgram/kilogram/hour, intravenous, 96 hours
|
Placebo
n=834 Participants
0.9% sodium chloride, intravenous, 96 hours
|
|---|---|---|
|
28-Day All-Cause Mortality
|
26.4 percentage of participants
|
24.2 percentage of participants
|
SECONDARY outcome
Timeframe: Day 28Population: All randomized participants with severe protein C deficiency at Baseline with known mortality status at Day 28.
Expressed as percentage of participants who died from any cause at Day 28 endpoint. Participants with severe protein C deficiency are those who had a protein C level ≤ half the lower limit of normal (LLN) (≤40%).
Outcome measures
| Measure |
Drotrecogin Alfa (Activated)
n=342 Participants
24 microgram/kilogram/hour, intravenous, 96 hours
|
Placebo
n=331 Participants
0.9% sodium chloride, intravenous, 96 hours
|
|---|---|---|
|
28-Day All-Cause Mortality in Participants With Severe Protein C Deficiency
|
28.7 percentage of participants
|
30.8 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 28Population: All randomized participants with any post-baseline data on Day 1 through Day 28. For those days when a participant is alive, but no data are available, last observation carried forward (LOFC) is used to impute the missing data. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.
Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing cardiovascular dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.
Outcome measures
| Measure |
Drotrecogin Alfa (Activated)
n=837 Participants
24 microgram/kilogram/hour, intravenous, 96 hours
|
Placebo
n=828 Participants
0.9% sodium chloride, intravenous, 96 hours
|
|---|---|---|
|
Average Cardiovascular Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28
|
1.92 units on a scale
Standard Deviation 1.31
|
1.84 units on a scale
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: Day 1 through Day 28Population: All randomized participants with any post-baseline data on Day 1 through Day 28. For those days when a participant is alive, but no data are available, last observation carried forward (LOFC) is used to impute the missing data. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.
Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing respiratory dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.
Outcome measures
| Measure |
Drotrecogin Alfa (Activated)
n=817 Participants
24 microgram/kilogram/hour, intravenous, 96 hours
|
Placebo
n=806 Participants
0.9% sodium chloride, intravenous, 96 hours
|
|---|---|---|
|
Average Respiratory Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28
|
2.31 units on a scale
Standard Deviation 1.05
|
2.29 units on a scale
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: Day 1 through Day 28Population: All randomized participants with any post-baseline data on Day 1 through Day 28. For those days when a participant is alive, but no data are available, last observation carried forward (LOFC) is used to impute the missing data. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.
Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing renal dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.
Outcome measures
| Measure |
Drotrecogin Alfa (Activated)
n=836 Participants
24 microgram/kilogram/hour, intravenous, 96 hours
|
Placebo
n=827 Participants
0.9% sodium chloride, intravenous, 96 hours
|
|---|---|---|
|
Average Renal Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28
|
1.38 units on a scale
Standard Deviation 1.42
|
1.28 units on a scale
Standard Deviation 1.40
|
SECONDARY outcome
Timeframe: Day 90Population: All randomized participants with known mortality status at Day 90.
Expressed as percentage of participants who died from any cause at Day 90 endpoint.
Outcome measures
| Measure |
Drotrecogin Alfa (Activated)
n=842 Participants
24 microgram/kilogram/hour, intravenous, 96 hours
|
Placebo
n=822 Participants
0.9% sodium chloride, intravenous, 96 hours
|
|---|---|---|
|
90-Day Mortality
|
34.1 percentage of participants
|
32.7 percentage of participants
|
SECONDARY outcome
Timeframe: Day 180Population: All randomized participants with known mortality status at Day 180.
Expressed as percentage of participants who died from any cause at Day 180 endpoint.
Outcome measures
| Measure |
Drotrecogin Alfa (Activated)
n=835 Participants
24 microgram/kilogram/hour, intravenous, 96 hours
|
Placebo
n=813 Participants
0.9% sodium chloride, intravenous, 96 hours
|
|---|---|---|
|
180-Day Mortality
|
36.6 percentage of participants
|
35.9 percentage of participants
|
SECONDARY outcome
Timeframe: Day 180Population: All randomized participants excluding those with unknown mortality status at Day 180.
Outcome measures
| Measure |
Drotrecogin Alfa (Activated)
n=835 Participants
24 microgram/kilogram/hour, intravenous, 96 hours
|
Placebo
n=813 Participants
0.9% sodium chloride, intravenous, 96 hours
|
|---|---|---|
|
Median Survival Time
|
NA days
Median value was not calculated due to less than 50% of participants reaching mortality endpoint at Day 180.
|
NA days
Median value was not calculated due to less than 50% of participants reaching mortality endpoint at Day 180.
|
SECONDARY outcome
Timeframe: Baseline and Days 28 and 90 and 180Population: All randomized participants with EQ-5D VAS data at the specified time points.
EQ-5D VAS assesses caregiver's impression of participant's overall health state. Scores range from 0 (worst health state) to 100 (best health state), with higher scores indicating a better health state.
Outcome measures
| Measure |
Drotrecogin Alfa (Activated)
n=851 Participants
24 microgram/kilogram/hour, intravenous, 96 hours
|
Placebo
n=845 Participants
0.9% sodium chloride, intravenous, 96 hours
|
|---|---|---|
|
EuroQoL Questionnaire-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Scores at Baseline, Days 28, 90 and 180
Baseline (n=685, 679)
|
54.21 units on a scale
Standard Deviation 26.99
|
54.37 units on a scale
Standard Deviation 27.95
|
|
EuroQoL Questionnaire-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Scores at Baseline, Days 28, 90 and 180
Day 28 (n=500, 476)
|
54.78 units on a scale
Standard Deviation 23.46
|
55.24 units on a scale
Standard Deviation 22.89
|
|
EuroQoL Questionnaire-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Scores at Baseline, Days 28, 90 and 180
Day 90 (n=474, 469)
|
64.41 units on a scale
Standard Deviation 21.00
|
65.18 units on a scale
Standard Deviation 20.15
|
|
EuroQoL Questionnaire-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Scores at Baseline, Days 28, 90 and 180
Day 180 (n=456, 443)
|
68.94 units on a scale
Standard Deviation 20.19
|
69.08 units on a scale
Standard Deviation 20.50
|
SECONDARY outcome
Timeframe: Baseline and Days 28 and 90 and 180Population: All randomized participants with EQ-5D total score data at the specified time points.
The EQ-5D is used to assess participant's overall health. Consists of 5 items: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item has 3 severity levels (no, some, severe problems). Calculated from EQ-5D, total scores (United States \[US\] Index Score) range from 0 (worst quality of life) to 1.00 (best quality of life).
Outcome measures
| Measure |
Drotrecogin Alfa (Activated)
n=851 Participants
24 microgram/kilogram/hour, intravenous, 96 hours
|
Placebo
n=845 Participants
0.9% sodium chloride, intravenous, 96 hours
|
|---|---|---|
|
EuroQoL Questionnaire-5 Dimensions (EQ-5D) Total Scores at Baseline, Days 28, 90 and 180
Baseline (n=702, 705)
|
0.60 units on a scale
Standard Deviation 0.35
|
0.60 units on a scale
Standard Deviation 0.35
|
|
EuroQoL Questionnaire-5 Dimensions (EQ-5D) Total Scores at Baseline, Days 28, 90 and 180
Day 28 (n=509, 486)
|
0.51 units on a scale
Standard Deviation 0.33
|
0.53 units on a scale
Standard Deviation 0.33
|
|
EuroQoL Questionnaire-5 Dimensions (EQ-5D) Total Scores at Baseline, Days 28, 90 and 180
Day 90 (n=480, 473)
|
0.71 units on a scale
Standard Deviation 0.27
|
0.71 units on a scale
Standard Deviation 0.28
|
|
EuroQoL Questionnaire-5 Dimensions (EQ-5D) Total Scores at Baseline, Days 28, 90 and 180
Day 180 (n=458, 448)
|
0.77 units on a scale
Standard Deviation 0.23
|
0.76 units on a scale
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: Baseline and Days 28 and 90 and 180Population: All randomized participants with SF-12 score data at the specified time points.
SF-12 was used as an instrument to measure participants' physical wellbeing (physical component) and mental wellbeing (mental component). Scores for each component range from 0-100, with 0= lowest wellbeing, and 100=highest wellbeing.
Outcome measures
| Measure |
Drotrecogin Alfa (Activated)
n=851 Participants
24 microgram/kilogram/hour, intravenous, 96 hours
|
Placebo
n=845 Participants
0.9% sodium chloride, intravenous, 96 hours
|
|---|---|---|
|
Quality of Life Short Form-12 (SF-12) Scores at Baseline, Days 28, 90 and 180
Physical Component at Baseline (n=683, 696)
|
39.14 units on a scale
Standard Deviation 12.04
|
39.22 units on a scale
Standard Deviation 12.10
|
|
Quality of Life Short Form-12 (SF-12) Scores at Baseline, Days 28, 90 and 180
Physical Component at Day 28 (n=484, 465)
|
31.14 units on a scale
Standard Deviation 10.29
|
31.13 units on a scale
Standard Deviation 9.84
|
|
Quality of Life Short Form-12 (SF-12) Scores at Baseline, Days 28, 90 and 180
Physical Component at Day 90 (n=474, 459)
|
38.09 units on a scale
Standard Deviation 11.17
|
40.03 units on a scale
Standard Deviation 11.23
|
|
Quality of Life Short Form-12 (SF-12) Scores at Baseline, Days 28, 90 and 180
Physical Component at Day 180 (n=450, 444)
|
42.26 units on a scale
Standard Deviation 10.80
|
41.59 units on a scale
Standard Deviation 11.28
|
|
Quality of Life Short Form-12 (SF-12) Scores at Baseline, Days 28, 90 and 180
Mental Component at Baseline (n=683, 696)
|
45.44 units on a scale
Standard Deviation 13.07
|
46.03 units on a scale
Standard Deviation 12.88
|
|
Quality of Life Short Form-12 (SF-12) Scores at Baseline, Days 28, 90 and 180
Mental Component at Day 28 (n=484, 465)
|
40.57 units on a scale
Standard Deviation 13.12
|
41.45 units on a scale
Standard Deviation 12.59
|
|
Quality of Life Short Form-12 (SF-12) Scores at Baseline, Days 28, 90 and 180
Mental Component at Day 90 (n=474, 459)
|
47.53 units on a scale
Standard Deviation 12.08
|
48.52 units on a scale
Standard Deviation 12.36
|
|
Quality of Life Short Form-12 (SF-12) Scores at Baseline, Days 28, 90 and 180
Mental Component at Day 180 (n=450, 444)
|
50.42 units on a scale
Standard Deviation 11.50
|
50.55 units on a scale
Standard Deviation 11.70
|
SECONDARY outcome
Timeframe: Baseline through Day 28Population: Participants who received study drug.
Outcome measures
| Measure |
Drotrecogin Alfa (Activated)
n=833 Participants
24 microgram/kilogram/hour, intravenous, 96 hours
|
Placebo
n=833 Participants
0.9% sodium chloride, intravenous, 96 hours
|
|---|---|---|
|
Percentage of Participants Discontinued Due to Adverse Events Any Time From Baseline Through Day 28 Endpoint
|
4.4 percentage of participants
|
3.0 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through Day 28Population: Participants who received study drug.
Percentage of participants who experienced serious bleeding events are reported by System Organ Class (SOC) term based on MedDRA 14.0. For a bleeding to qualify as a serious event, it would have to meet the standard definition of a serious adverse event or be a central nervous system bleeding or a bleeding event that lead to administration of ≥3 units packed red blood cells/day for 2 consecutive days.
Outcome measures
| Measure |
Drotrecogin Alfa (Activated)
n=833 Participants
24 microgram/kilogram/hour, intravenous, 96 hours
|
Placebo
n=833 Participants
0.9% sodium chloride, intravenous, 96 hours
|
|---|---|---|
|
Percentage of Participants With Serious Bleeding Events Within System Organ Class Any Time From Baseline Through Day 28
with ≥1 event
|
2.4 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants With Serious Bleeding Events Within System Organ Class Any Time From Baseline Through Day 28
Gastrointestinal Disorders
|
1.1 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With Serious Bleeding Events Within System Organ Class Any Time From Baseline Through Day 28
Injury, Poisoning And Procedural Complications
|
0 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants With Serious Bleeding Events Within System Organ Class Any Time From Baseline Through Day 28
Nervous System Disorders
|
0.4 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Serious Bleeding Events Within System Organ Class Any Time From Baseline Through Day 28
Renal And Urinary Disorders
|
0.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Serious Bleeding Events Within System Organ Class Any Time From Baseline Through Day 28
Respiratory, Thoracic And Mediastinal Disorders
|
0.4 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Serious Bleeding Events Within System Organ Class Any Time From Baseline Through Day 28
Vascular Disorders
|
0.5 percentage of participants
|
1.0 percentage of participants
|
Adverse Events
Drotrecogin Alfa (Activated)
Serious events: 119 serious events
Other events: 151 other events
Deaths: 0 deaths
Placebo
Serious events: 96 serious events
Other events: 119 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Drotrecogin Alfa (Activated)
n=833 participants at risk
24 microgram/kilogram/hour, intravenous, 96 hours
|
Placebo
n=833 participants at risk
0.9% sodium chloride, intravenous, 96 hours
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.24%
2/833 • Number of events 4 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 3 • Day 0 to Day 28
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Cardiac disorders
Acute myocardial infarction
|
0.36%
3/833 • Number of events 6 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Cardiac disorders
Arrhythmia
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Cardiac disorders
Atrial fibrillation
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
|
Cardiac disorders
Bradycardia
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Cardiac disorders
Cardiac arrest
|
1.6%
13/833 • Number of events 15 • Day 0 to Day 28
|
0.96%
8/833 • Number of events 8 • Day 0 to Day 28
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/833 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/833 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
|
Cardiac disorders
Myocardial infarction
|
0.48%
4/833 • Number of events 5 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Cardiac disorders
Pulseless electrical activity
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Cardiac disorders
Supraventricular tachyarrhythmia
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Cardiac disorders
Ventricular fibrillation
|
0.36%
3/833 • Number of events 4 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Cardiac disorders
Ventricular tachycardia
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
|
Eye disorders
Pupils unequal
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.72%
6/833 • Number of events 6 • Day 0 to Day 28
|
0.36%
3/833 • Number of events 5 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Gastrointestinal ischaemia
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.36%
3/833 • Number of events 4 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Localised intraabdominal fluid collection
|
0.12%
1/833 • Number of events 3 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Melaena
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Peritoneal haematoma
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Peritonitis
|
0.24%
2/833 • Number of events 3 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Rectal perforation
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Sigmoiditis
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Volvulus
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
General disorders
Brain death
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
General disorders
Death
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
|
General disorders
Device dislocation
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
General disorders
General physical health deterioration
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
General disorders
Idiosyncratic drug reaction
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.12%
1/833 • Number of events 3 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Infections and infestations
Abdominal abscess
|
0.36%
3/833 • Number of events 7 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Infections and infestations
Abdominal wall abscess
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Infections and infestations
Bronchopneumonia
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Infections and infestations
Clostridium difficile colitis
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Infections and infestations
Colon gangrene
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Infections and infestations
Device related sepsis
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Infections and infestations
Diabetic gangrene
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Infections and infestations
Enterobacter sepsis
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Infections and infestations
Infection
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Infections and infestations
Meningitis pneumococcal
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Infections and infestations
Periorbital cellulitis
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Infections and infestations
Pneumonia
|
0.60%
5/833 • Number of events 10 • Day 0 to Day 28
|
0.36%
3/833 • Number of events 3 • Day 0 to Day 28
|
|
Infections and infestations
Pneumonia necrotising
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.24%
2/833 • Number of events 3 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Infections and infestations
Septic shock
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Infections and infestations
Superinfection bacterial
|
0.12%
1/833 • Number of events 3 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Infections and infestations
Systemic candida
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Infections and infestations
Urosepsis
|
0.48%
4/833 • Number of events 6 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 5 • Day 0 to Day 28
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Injury, poisoning and procedural complications
Anastomotic fistula
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Injury, poisoning and procedural complications
Biliary anastomosis complication
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.24%
2/833 • Number of events 4 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma necrosis
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Injury, poisoning and procedural complications
Suture rupture
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Injury, poisoning and procedural complications
Tracheal haemorrhage
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.12%
1/833 • Number of events 5 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 3 • Day 0 to Day 28
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/833 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 4 • Day 0 to Day 28
|
|
Investigations
Oxygen saturation decreased
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Investigations
Pulse absent
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Metabolism and nutrition disorders
Hypoglycaemic seizure
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 3 • Day 0 to Day 28
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoproliferative disorder
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mucoepidermoid carcinoma
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Nervous system disorders
Cerebral artery embolism
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/833 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 3 • Day 0 to Day 28
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.24%
2/833 • Number of events 4 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Nervous system disorders
Cerebral infarction
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 4 • Day 0 to Day 28
|
|
Nervous system disorders
Cerebral ischaemia
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Nervous system disorders
Cerebrovascular accident
|
0.12%
1/833 • Number of events 4 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Nervous system disorders
Dementia alzheimer's type
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Nervous system disorders
Epilepsy
|
0.24%
2/833 • Number of events 3 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Nervous system disorders
Ischaemic stroke
|
0.48%
4/833 • Number of events 5 • Day 0 to Day 28
|
0.48%
4/833 • Number of events 5 • Day 0 to Day 28
|
|
Nervous system disorders
Neuroleptic malignant syndrome
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 4 • Day 0 to Day 28
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 3 • Day 0 to Day 28
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 3 • Day 0 to Day 28
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Renal and urinary disorders
Haematuria
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Renal and urinary disorders
Renal infarct
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.24%
2/833 • Number of events 4 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.24%
2/833 • Number of events 3 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 3 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.72%
6/833 • Number of events 6 • Day 0 to Day 28
|
0.36%
3/833 • Number of events 3 • Day 0 to Day 28
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Vascular disorders
Air embolism
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Vascular disorders
Arterial thrombosis limb
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Vascular disorders
Haematoma
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 3 • Day 0 to Day 28
|
|
Vascular disorders
Haemorrhage
|
0.12%
1/833 • Number of events 3 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Vascular disorders
Hypotension
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/833 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
|
Vascular disorders
Intra-abdominal haemorrhage
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
0.36%
3/833 • Number of events 5 • Day 0 to Day 28
|
|
Vascular disorders
Peripheral ischaemia
|
0.24%
2/833 • Number of events 4 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Vascular disorders
Shock haemorrhagic
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.36%
3/833 • Number of events 8 • Day 0 to Day 28
|
Other adverse events
| Measure |
Drotrecogin Alfa (Activated)
n=833 participants at risk
24 microgram/kilogram/hour, intravenous, 96 hours
|
Placebo
n=833 participants at risk
0.9% sodium chloride, intravenous, 96 hours
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.36%
3/833 • Number of events 7 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 3 • Day 0 to Day 28
|
|
Blood and lymphatic system disorders
Autoimmune thrombocytopenia
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.24%
2/833 • Number of events 3 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.24%
2/833 • Number of events 3 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.12%
1/833 • Number of events 3 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.4%
12/833 • Number of events 21 • Day 0 to Day 28
|
1.1%
9/833 • Number of events 17 • Day 0 to Day 28
|
|
Cardiac disorders
Acute coronary syndrome
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.36%
3/833 • Number of events 9 • Day 0 to Day 28
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/833 • Day 0 to Day 28
|
0.36%
3/833 • Number of events 4 • Day 0 to Day 28
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Cardiac disorders
Atrial fibrillation
|
0.96%
8/833 • Number of events 16 • Day 0 to Day 28
|
0.60%
5/833 • Number of events 9 • Day 0 to Day 28
|
|
Cardiac disorders
Atrial thrombosis
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/833 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 3 • Day 0 to Day 28
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/833 • Day 0 to Day 28
|
0.36%
3/833 • Number of events 7 • Day 0 to Day 28
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Cardiac disorders
Ventricular tachycardia
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Ear and labyrinth disorders
Deafness bilateral
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Eye disorders
Conjunctival haemorrhage
|
0.48%
4/833 • Number of events 10 • Day 0 to Day 28
|
0.36%
3/833 • Number of events 4 • Day 0 to Day 28
|
|
Eye disorders
Scleral haemorrhage
|
0.12%
1/833 • Number of events 3 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 4 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Abdominal wall haemorrhage
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.72%
6/833 • Number of events 9 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/833 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Gastritis
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.36%
3/833 • Number of events 4 • Day 0 to Day 28
|
0.72%
6/833 • Number of events 7 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Haematemesis
|
0.24%
2/833 • Number of events 3 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Haematochezia
|
0.36%
3/833 • Number of events 3 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Melaena
|
0.36%
3/833 • Number of events 5 • Day 0 to Day 28
|
0.72%
6/833 • Number of events 7 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.36%
3/833 • Number of events 4 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Peritonitis
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Rectal ulcer haemorrhage
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
General disorders
Bloody discharge
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
General disorders
Catheter site haemorrhage
|
1.1%
9/833 • Number of events 9 • Day 0 to Day 28
|
0.48%
4/833 • Number of events 6 • Day 0 to Day 28
|
|
General disorders
Infusion site extravasation
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
General disorders
Injection site haematoma
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
General disorders
Local swelling
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
General disorders
Mucosal haemorrhage
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
General disorders
Vessel puncture site haemorrhage
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 4 • Day 0 to Day 28
|
|
Infections and infestations
Endocarditis
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Injury, poisoning and procedural complications
Hepatic haematoma
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.48%
4/833 • Number of events 5 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.96%
8/833 • Number of events 9 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Injury, poisoning and procedural complications
Wound evisceration
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.72%
6/833 • Number of events 7 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.3%
11/833 • Number of events 18 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 5 • Day 0 to Day 28
|
|
Investigations
Alanine aminotransferase increased
|
0.12%
1/833 • Number of events 4 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Investigations
Haemoglobin decreased
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Investigations
International normalised ratio increased
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Investigations
Occult blood positive
|
0.24%
2/833 • Number of events 3 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
|
Investigations
Platelet count decreased
|
0.36%
3/833 • Number of events 4 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Investigations
Prothrombin time prolonged
|
0.24%
2/833 • Number of events 5 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Investigations
Prothrombin time shortened
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Investigations
Troponin increased
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.12%
1/833 • Number of events 3 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 3 • Day 0 to Day 28
|
|
Nervous system disorders
Transient ischaemic attack
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Renal and urinary disorders
Haematuria
|
1.3%
11/833 • Number of events 12 • Day 0 to Day 28
|
1.1%
9/833 • Number of events 18 • Day 0 to Day 28
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Renal and urinary disorders
Renal infarct
|
0.12%
1/833 • Number of events 3 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 3 • Day 0 to Day 28
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.12%
1/833 • Number of events 4 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Reproductive system and breast disorders
Scrotal haematocoele
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/833 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 3 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.72%
6/833 • Number of events 7 • Day 0 to Day 28
|
0.48%
4/833 • Number of events 4 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.72%
6/833 • Number of events 6 • Day 0 to Day 28
|
0.36%
3/833 • Number of events 3 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Pleural haemorrhage
|
0.00%
0/833 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 3 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 6 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.24%
2/833 • Number of events 3 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract haemorrhage
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Vascular disorders
Arterial thrombosis
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Vascular disorders
Arterial thrombosis limb
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Vascular disorders
Axillary vein thrombosis
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Vascular disorders
Deep vein thrombosis
|
1.2%
10/833 • Number of events 26 • Day 0 to Day 28
|
0.60%
5/833 • Number of events 17 • Day 0 to Day 28
|
|
Vascular disorders
Haematoma
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
|
Vascular disorders
Haemorrhage
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
|
Vascular disorders
Intra-abdominal haematoma
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Vascular disorders
Intra-abdominal haemorrhage
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
|
Vascular disorders
Jugular vein thrombosis
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 4 • Day 0 to Day 28
|
|
Vascular disorders
Necrosis ischaemic
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 3 • Day 0 to Day 28
|
|
Vascular disorders
Phlebitis
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 3 • Day 0 to Day 28
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 4 • Day 0 to Day 28
|
|
Vascular disorders
Thrombophlebitis
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.24%
2/833 • Number of events 2 • Day 0 to Day 28
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/833 • Day 0 to Day 28
|
0.48%
4/833 • Number of events 10 • Day 0 to Day 28
|
|
Vascular disorders
Thrombosis
|
0.12%
1/833 • Number of events 4 • Day 0 to Day 28
|
0.36%
3/833 • Number of events 6 • Day 0 to Day 28
|
|
Vascular disorders
Vena cava thrombosis
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 4 • Day 0 to Day 28
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/833 • Day 0 to Day 28
|
0.12%
1/833 • Number of events 2 • Day 0 to Day 28
|
|
Vascular disorders
Venous thrombosis limb
|
0.12%
1/833 • Number of events 1 • Day 0 to Day 28
|
0.00%
0/833 • Day 0 to Day 28
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the site PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo. An independent Steering Committee responsible for data analyses and publications did not have an embargo.
- Publication restrictions are in place
Restriction type: OTHER