Trial Outcomes & Findings for Evaluate Protein C Levels in Severe Sepsis Patients on Drotrecogin Alfa (Activated) (NCT NCT00386425)
NCT ID: NCT00386425
Last Updated: 2010-12-16
Results Overview
Mean change in protein C from Study Day 1 to Study Day 7 was tested using an unadjusted two-sample t-test with a two-sided alpha of 0.05. To be included in the primary analysis, Intention-to-Treat (ITT) patients must have at least 1 protein C value available at 24 hours or earlier and at least 1 protein C value at a post-24-hour timepoint.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
486 participants
Primary outcome timeframe
Day 1, Day 7
Results posted on
2010-12-16
Participant Flow
Efficacy results are only provided for the intent-to-treat (ITT) population (patients who actually received the randomized treatment after the 24 hour pretreatment period).
Participant milestones
| Measure |
Standard Therapy
24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
|
Alternative Therapy
Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
|
Randomized Non-ITT Population
Participants were randomized to either the Standard or Alternative Therapy and received 24 mcg/kg/hr during the first 24 hours (common therapy period); however, they did not continue on to receive the actual randomized therapy.
|
|---|---|---|---|
|
Overall Study
STARTED
|
227
|
206
|
53
|
|
Overall Study
Received Study Drug
|
227
|
206
|
53
|
|
Overall Study
COMPLETED
|
224
|
205
|
53
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
0
|
Reasons for withdrawal
| Measure |
Standard Therapy
24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
|
Alternative Therapy
Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
|
Randomized Non-ITT Population
Participants were randomized to either the Standard or Alternative Therapy and received 24 mcg/kg/hr during the first 24 hours (common therapy period); however, they did not continue on to receive the actual randomized therapy.
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
3
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Evaluate Protein C Levels in Severe Sepsis Patients on Drotrecogin Alfa (Activated)
Baseline characteristics by cohort
| Measure |
Standard Therapy
n=227 Participants
24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
|
Alternative Therapy
n=206 Participants
Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
|
Randomized Non-ITT Population
n=53 Participants
|
Total
n=486 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
62.31 years
STANDARD_DEVIATION 16.11 • n=5 Participants
|
61.91 years
STANDARD_DEVIATION 14.44 • n=7 Participants
|
66.63 years
STANDARD_DEVIATION 12.82 • n=5 Participants
|
62.61 years
STANDARD_DEVIATION 15.12 • n=4 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
186 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
137 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
300 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
204 Participants
n=5 Participants
|
189 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
444 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
West Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
27 participants
n=5 Participants
|
23 participants
n=7 Participants
|
6 participants
n=5 Participants
|
56 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
22 participants
n=5 Participants
|
21 participants
n=7 Participants
|
4 participants
n=5 Participants
|
47 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
14 participants
n=5 Participants
|
12 participants
n=7 Participants
|
1 participants
n=5 Participants
|
27 participants
n=4 Participants
|
|
Region of Enrollment
Finland
|
29 participants
n=5 Participants
|
30 participants
n=7 Participants
|
2 participants
n=5 Participants
|
61 participants
n=4 Participants
|
|
Region of Enrollment
France
|
37 participants
n=5 Participants
|
33 participants
n=7 Participants
|
9 participants
n=5 Participants
|
79 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Puerto Rico
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
0 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
19 participants
n=5 Participants
|
16 participants
n=7 Participants
|
12 participants
n=5 Participants
|
47 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
32 participants
n=5 Participants
|
29 participants
n=7 Participants
|
10 participants
n=5 Participants
|
71 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
36 participants
n=7 Participants
|
8 participants
n=5 Participants
|
86 participants
n=4 Participants
|
|
Recent Surgery
Yes
|
68 participants
n=5 Participants
|
61 participants
n=7 Participants
|
25 participants
n=5 Participants
|
154 participants
n=4 Participants
|
|
Recent Surgery
No
|
159 participants
n=5 Participants
|
144 participants
n=7 Participants
|
28 participants
n=5 Participants
|
331 participants
n=4 Participants
|
|
Recent Surgery
Unknown
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Number of organ dysfunctions
|
3.08 organ dysfunctions
STANDARD_DEVIATION 0.86 • n=5 Participants
|
3.08 organ dysfunctions
STANDARD_DEVIATION 0.84 • n=7 Participants
|
3.28 organ dysfunctions
STANDARD_DEVIATION 0.93 • n=5 Participants
|
3.10 organ dysfunctions
STANDARD_DEVIATION 0.86 • n=4 Participants
|
|
Time of onset of Second organ dysfunction to start of drug infusion
|
15.3 hours
STANDARD_DEVIATION 7.0 • n=5 Participants
|
15.0 hours
STANDARD_DEVIATION 7.0 • n=7 Participants
|
15.8 hours
STANDARD_DEVIATION 7.2 • n=5 Participants
|
15.3 hours
STANDARD_DEVIATION 7.0 • n=4 Participants
|
|
Total Sequential Organ Failure Assessment (SOFA) score
|
8.38 units on a scale
STANDARD_DEVIATION 2.83 • n=5 Participants
|
8.65 units on a scale
STANDARD_DEVIATION 2.70 • n=7 Participants
|
9.09 units on a scale
STANDARD_DEVIATION 2.25 • n=5 Participants
|
8.57 units on a scale
STANDARD_DEVIATION 2.72 • n=4 Participants
|
|
Acute Physiology And Chronic Health Evaluation (APACHE) II Score
|
26.34 units on a scale
STANDARD_DEVIATION 7.70 • n=5 Participants
|
26.15 units on a scale
STANDARD_DEVIATION 7.31 • n=7 Participants
|
28.26 units on a scale
STANDARD_DEVIATION 8.05 • n=5 Participants
|
26.47 units on a scale
STANDARD_DEVIATION 7.59 • n=4 Participants
|
|
Use of vasopressor
Yes
|
190 participants
n=5 Participants
|
183 participants
n=7 Participants
|
51 participants
n=5 Participants
|
424 participants
n=4 Participants
|
|
Use of vasopressor
No
|
37 participants
n=5 Participants
|
23 participants
n=7 Participants
|
2 participants
n=5 Participants
|
62 participants
n=4 Participants
|
|
Mechanical ventilation
Yes
|
178 participants
n=5 Participants
|
158 participants
n=7 Participants
|
44 participants
n=5 Participants
|
380 participants
n=4 Participants
|
|
Mechanical ventilation
No
|
49 participants
n=5 Participants
|
48 participants
n=7 Participants
|
9 participants
n=5 Participants
|
106 participants
n=4 Participants
|
|
Protein C level
|
44 Percent Protein C Activity
STANDARD_DEVIATION 19 • n=5 Participants
|
41 Percent Protein C Activity
STANDARD_DEVIATION 20 • n=7 Participants
|
30 Percent Protein C Activity
STANDARD_DEVIATION 18 • n=5 Participants
|
42 Percent Protein C Activity
STANDARD_DEVIATION 20 • n=4 Participants
|
|
Central laboratory protein C class
Severe deficiency
|
97 participants
n=5 Participants
|
100 participants
n=7 Participants
|
31 participants
n=5 Participants
|
228 participants
n=4 Participants
|
|
Central laboratory protein C class
Moderate deficiency
|
94 participants
n=5 Participants
|
76 participants
n=7 Participants
|
9 participants
n=5 Participants
|
179 participants
n=4 Participants
|
|
Central laboratory protein C class
Normal
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
0 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Central laboratory protein C class
Unknown
|
27 participants
n=5 Participants
|
21 participants
n=7 Participants
|
13 participants
n=5 Participants
|
61 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1, Day 7Population: Intent to Treat (ITT) Last Observation Carried Forward (LOCF) population.
Mean change in protein C from Study Day 1 to Study Day 7 was tested using an unadjusted two-sample t-test with a two-sided alpha of 0.05. To be included in the primary analysis, Intention-to-Treat (ITT) patients must have at least 1 protein C value available at 24 hours or earlier and at least 1 protein C value at a post-24-hour timepoint.
Outcome measures
| Measure |
Standard Therapy
n=227 Participants
24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
|
Alternative Therapy
n=206 Participants
Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
|
Alternative Therapy - Severe Deficiency
Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
|
Alternative Therapy - Moderate Deficiency
Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours
|
|---|---|---|---|---|
|
Mean Change in Protein C Levels From Day 1 to Day 7
Protein C Day 1, n=226, n=205
|
55 Percent Protein C Activity
Standard Deviation 24
|
52 Percent Protein C Activity
Standard Deviation 24
|
—
|
—
|
|
Mean Change in Protein C Levels From Day 1 to Day 7
Protein C Day 7, n=221, n=203
|
79 Percent Protein C Activity
Standard Deviation 33
|
83 Percent Protein C Activity
Standard Deviation 35
|
—
|
—
|
|
Mean Change in Protein C Levels From Day 1 to Day 7
Change in Protein C, Day 1 to Day 7, n=221, n=202
|
24 Percent Protein C Activity
Standard Deviation 29
|
31 Percent Protein C Activity
Standard Deviation 29
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 7Population: ITT moderately deficient population, ITT severely deficient population
Moderate Protein C Deficiency: A protein C level greater than half the lower limit of normal. Severe Protein C Deficiency: A protein C level less than or equal to half the lower limit of normal.
Outcome measures
| Measure |
Standard Therapy
n=227 Participants
24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
|
Alternative Therapy
n=206 Participants
Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
|
Alternative Therapy - Severe Deficiency
Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
|
Alternative Therapy - Moderate Deficiency
Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours
|
|---|---|---|---|---|
|
Mean Change in Protein C Level From Study Day 1 to Study Day 7 in Patients With Moderate and Severe Protein C Deficiency
Moderate n=175, n=171
|
24 Percent Protein C Activity
Standard Deviation 28
|
30 Percent Protein C Activity
Standard Deviation 29
|
—
|
—
|
|
Mean Change in Protein C Level From Study Day 1 to Study Day 7 in Patients With Moderate and Severe Protein C Deficiency
Severe n=46, n=31
|
25 Percent Protein C Activity
Standard Deviation 32
|
38 Percent Protein C Activity
Standard Deviation 27
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 through Day 28Population: ITT population
Outcome measures
| Measure |
Standard Therapy
n=224 Participants
24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
|
Alternative Therapy
n=205 Participants
Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
|
Alternative Therapy - Severe Deficiency
Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
|
Alternative Therapy - Moderate Deficiency
Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours
|
|---|---|---|---|---|
|
Day 28 All-Cause Mortality
Alive at Day 28
|
83.9 percentage of participants
|
75.1 percentage of participants
|
—
|
—
|
|
Day 28 All-Cause Mortality
Deceased at Day 28
|
16.1 percentage of participants
|
24.9 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 to hospital discharge or Day 90Population: ITT population
Outcome measures
| Measure |
Standard Therapy
n=224 Participants
24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
|
Alternative Therapy
n=205 Participants
Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
|
Alternative Therapy - Severe Deficiency
Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
|
Alternative Therapy - Moderate Deficiency
Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours
|
|---|---|---|---|---|
|
Hospital Mortality (up to Day 90)
Discharged Alive
|
79.5 Percentage of participants
|
72.2 Percentage of participants
|
—
|
—
|
|
Hospital Mortality (up to Day 90)
Deceased
|
20.5 Percentage of participants
|
27.8 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0, Day 28Population: ITT population
The presence of 5 organ dysfunctions (cardiovascular, respiratory, renal, hepatic, coagulation) was assessed using a Sequential Organ Failure Assessment (SOFA) score. Each organ has a possible dysfunction score of 0 to 4, for a total SOFA score range of 0 (no organ dysfunction) to 20 (all organs with dysfunction). SOFA scores were time-averaged.
Outcome measures
| Measure |
Standard Therapy
n=227 Participants
24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
|
Alternative Therapy
n=206 Participants
Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
|
Alternative Therapy - Severe Deficiency
Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
|
Alternative Therapy - Moderate Deficiency
Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours
|
|---|---|---|---|---|
|
28-Day Time Averaged Sequential Organ Failure (SOFA) Score
Liver
|
0.78 Units on a scale
Standard Deviation 1.22
|
0.89 Units on a scale
Standard Deviation 1.21
|
—
|
—
|
|
28-Day Time Averaged Sequential Organ Failure (SOFA) Score
Total
|
5.96 Units on a scale
Standard Deviation 5.21
|
6.62 Units on a scale
Standard Deviation 5.23
|
—
|
—
|
|
28-Day Time Averaged Sequential Organ Failure (SOFA) Score
Cardiovascular
|
1.28 Units on a scale
Standard Deviation 1.21
|
1.41 Units on a scale
Standard Deviation 1.26
|
—
|
—
|
|
28-Day Time Averaged Sequential Organ Failure (SOFA) Score
Respiratory
|
2.22 Units on a scale
Standard Deviation 0.99
|
2.38 Units on a scale
Standard Deviation 0.88
|
—
|
—
|
|
28-Day Time Averaged Sequential Organ Failure (SOFA) Score
Renal
|
0.92 Units on a scale
Standard Deviation 1.28
|
1.04 Units on a scale
Standard Deviation 1.31
|
—
|
—
|
|
28-Day Time Averaged Sequential Organ Failure (SOFA) Score
Hematology
|
0.80 Units on a scale
Standard Deviation 1.16
|
0.93 Units on a scale
Standard Deviation 1.20
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 through Day 28Population: Randomized participants who received randomized therapy (intention to treat population).
Serious bleeding events (SBE): intracranial hemorrhage, life-threatening or fatal bleed, or bleeding event assessed as an SAE. Patients may have multiple events with onset in different time periods. SAEs include SBEs. The 3 SBEs in Alternative-Moderate Deficiency arm (days 5-8) occurred after completion of study drug infusion. One event (pleural haemorrhage) occurred same day of completion of infusion and 2 events (cerebral haemorrhage, shock haemorrhagic) occurred day after completion.
Outcome measures
| Measure |
Standard Therapy
n=51 Participants
24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
|
Alternative Therapy
n=176 Participants
Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
|
Alternative Therapy - Severe Deficiency
n=33 Participants
Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
|
Alternative Therapy - Moderate Deficiency
n=173 Participants
Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours
|
|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAE) and Serious Bleeding Events (SBE) by Time Period
Serious Bleeding Events: Study Days 5 through 8
|
1 number of patients with at least 1 event
|
0 number of patients with at least 1 event
|
0 number of patients with at least 1 event
|
3 number of patients with at least 1 event
|
|
Number of Participants With Serious Adverse Events (SAE) and Serious Bleeding Events (SBE) by Time Period
Serious Adverse Events: Study Days 0 through 4
|
0 number of patients with at least 1 event
|
10 number of patients with at least 1 event
|
5 number of patients with at least 1 event
|
17 number of patients with at least 1 event
|
|
Number of Participants With Serious Adverse Events (SAE) and Serious Bleeding Events (SBE) by Time Period
Serious Adverse Events: Study Days 5 through 8
|
2 number of patients with at least 1 event
|
4 number of patients with at least 1 event
|
1 number of patients with at least 1 event
|
8 number of patients with at least 1 event
|
|
Number of Participants With Serious Adverse Events (SAE) and Serious Bleeding Events (SBE) by Time Period
Serious Adverse Events: Study Days 9 through 28
|
3 number of patients with at least 1 event
|
8 number of patients with at least 1 event
|
4 number of patients with at least 1 event
|
14 number of patients with at least 1 event
|
|
Number of Participants With Serious Adverse Events (SAE) and Serious Bleeding Events (SBE) by Time Period
Serious Bleeding Events: Study Days 0 through 4
|
0 number of patients with at least 1 event
|
2 number of patients with at least 1 event
|
0 number of patients with at least 1 event
|
9 number of patients with at least 1 event
|
|
Number of Participants With Serious Adverse Events (SAE) and Serious Bleeding Events (SBE) by Time Period
Serious Bleeding Events: Study Days 9 through 28
|
0 number of patients with at least 1 event
|
1 number of patients with at least 1 event
|
0 number of patients with at least 1 event
|
1 number of patients with at least 1 event
|
SECONDARY outcome
Timeframe: 28 daysPopulation: ITT Population - All patients who are randomly assigned to treatment and receive any amount of randomized therapy
Normalization was defined as having 2 consecutive protein C measurements above the lower limit of normal through Study Day 7.
Outcome measures
| Measure |
Standard Therapy
n=232 Participants
24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
|
Alternative Therapy
n=197 Participants
Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
|
Alternative Therapy - Severe Deficiency
Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
|
Alternative Therapy - Moderate Deficiency
Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours
|
|---|---|---|---|---|
|
Mortality by Protein C Normalized Versus Not-normalized
|
10.3 Percentage of participants
|
32.0 Percentage of participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 Days, up to 90 daysPopulation: ITT Population - All patients who are randomly assigned to treatment and receive any amount of randomized therapy. ITT patients with severe protein C deficiency. Severe deficiency is defined by the 24-hour local laboratory protein C value reported to the Interactive voice response system (IVRS).
Twenty-eight day mortality is the patient's mortality status at the predefined timepoint of 672 hours from the start of study drug infusion. Hospital mortality is the patient's survival status at the end of the hospital stay or study day 90 (if the patient remains in the hospital).
Outcome measures
| Measure |
Standard Therapy
n=51 Participants
24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
|
Alternative Therapy
n=33 Participants
Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
|
Alternative Therapy - Severe Deficiency
Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
|
Alternative Therapy - Moderate Deficiency
Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours
|
|---|---|---|---|---|
|
Mortality for Severe Protein C Deficiency
28 Day Mortality - Deceased at Day 28
|
31.4 Percentage of participants
|
24.2 Percentage of participants
|
—
|
—
|
|
Mortality for Severe Protein C Deficiency
28 Day Mortality - Alive at Day 28
|
68.6 Percentage of participants
|
75.8 Percentage of participants
|
—
|
—
|
|
Mortality for Severe Protein C Deficiency
Hospital Mortality - Deceased
|
33.3 Percentage of participants
|
30.3 Percentage of participants
|
—
|
—
|
|
Mortality for Severe Protein C Deficiency
Hospital Mortality - Discharged Alive
|
66.7 Percentage of participants
|
69.7 Percentage of participants
|
—
|
—
|
POST_HOC outcome
Timeframe: 28 DaysPopulation: ITT Population - ITT Switch-No Population, ITT patients who did not answer yes to the switch question.
Outcome measures
| Measure |
Standard Therapy
n=135 Participants
24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
|
Alternative Therapy
n=142 Participants
Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
|
Alternative Therapy - Severe Deficiency
Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
|
Alternative Therapy - Moderate Deficiency
Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours
|
|---|---|---|---|---|
|
Mortality for Moderate Protein C Deficiency by Infusion Duration
<97 Hours n=65, n=71
|
13.8 percent participants deceased
|
28.2 percent participants deceased
|
—
|
—
|
|
Mortality for Moderate Protein C Deficiency by Infusion Duration
>=97 Hours n=70, n=71
|
11.4 percent participants deceased
|
23.9 percent participants deceased
|
—
|
—
|
Adverse Events
Standard Therapy
Serious events: 33 serious events
Other events: 51 other events
Deaths: 0 deaths
Alternative Therapy
Serious events: 48 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Therapy
n=250 participants at risk
Participants assigned to standard therapy (24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours) who received any amount of study drug.
|
Alternative Therapy
n=236 participants at risk
Participants assigned to alternative therapy (Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours) who received any amount of study drug.
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/250
|
0.42%
1/236 • Number of events 3
|
|
Cardiac disorders
Atrial fibrillation
|
0.40%
1/250 • Number of events 1
|
0.42%
1/236 • Number of events 1
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/250
|
0.85%
2/236 • Number of events 2
|
|
Cardiac disorders
Cardiac failure
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Cardiac disorders
Electromechanical dissociation
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.40%
1/250 • Number of events 2
|
0.00%
0/236
|
|
Cardiac disorders
Ventricular fibrillation
|
0.80%
2/250 • Number of events 2
|
0.42%
1/236 • Number of events 1
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.40%
1/250 • Number of events 1
|
0.42%
1/236 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.40%
1/250 • Number of events 1
|
0.85%
2/236 • Number of events 2
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/250
|
0.85%
2/236 • Number of events 2
|
|
General disorders
Death
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.40%
1/250 • Number of events 1
|
0.42%
1/236 • Number of events 1
|
|
Infections and infestations
Abdominal sepsis
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Infections and infestations
Candida pneumonia
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Infections and infestations
Clostridium difficile colitis
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Infections and infestations
Empyema
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Infections and infestations
Endocarditis
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.80%
2/250 • Number of events 2
|
0.42%
1/236 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.80%
2/250 • Number of events 2
|
0.85%
2/236 • Number of events 2
|
|
Infections and infestations
Septic shock
|
0.00%
0/250
|
1.7%
4/236 • Number of events 4
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Injury, poisoning and procedural complications
Anastomotic complication
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
0.40%
1/250 • Number of events 1
|
0.42%
1/236 • Number of events 1
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Injury, poisoning and procedural complications
Overdose
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Injury, poisoning and procedural complications
Urinary bladder rupture
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Investigations
Haemoglobin decreased
|
0.40%
1/250 • Number of events 1
|
0.42%
1/236 • Number of events 1
|
|
Investigations
Platelet count decreased
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Nervous system disorders
Central nervous system lesion
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Nervous system disorders
Cerebral haematoma
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Nervous system disorders
Hypoxic encephalopathy
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Nervous system disorders
Ischaemic stroke
|
0.40%
1/250 • Number of events 1
|
0.85%
2/236 • Number of events 2
|
|
Nervous system disorders
Polyneuropathy
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.80%
2/250 • Number of events 2
|
0.42%
1/236 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Respiratory, thoracic and mediastinal disorders
Pleural haemorrhage
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/250
|
0.85%
2/236 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.80%
2/250 • Number of events 2
|
0.42%
1/236 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fistula
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.40%
1/250 • Number of events 2
|
0.00%
0/236
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Vascular disorders
Air embolism
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Vascular disorders
Haematoma
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Vascular disorders
Ischaemia
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Vascular disorders
Shock
|
0.00%
0/250
|
0.85%
2/236 • Number of events 2
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
Other adverse events
| Measure |
Standard Therapy
n=250 participants at risk
Participants assigned to standard therapy (24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours) who received any amount of study drug.
|
Alternative Therapy
n=236 participants at risk
Participants assigned to alternative therapy (Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours) who received any amount of study drug.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
3/250 • Number of events 3
|
1.3%
3/236 • Number of events 3
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
5/250 • Number of events 5
|
0.42%
1/236 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Eye disorders
Conjunctival haemorrhage
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.2%
3/250 • Number of events 3
|
0.85%
2/236 • Number of events 2
|
|
Gastrointestinal disorders
Haematemesis
|
0.80%
2/250 • Number of events 2
|
0.42%
1/236 • Number of events 2
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.80%
2/250 • Number of events 2
|
0.42%
1/236 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.40%
1/250 • Number of events 1
|
0.42%
1/236 • Number of events 1
|
|
General disorders
Bloody discharge
|
0.40%
1/250 • Number of events 1
|
0.42%
1/236 • Number of events 1
|
|
General disorders
Catheter site haemorrhage
|
1.6%
4/250 • Number of events 6
|
2.1%
5/236 • Number of events 9
|
|
General disorders
Mucosal haemorrhage
|
0.80%
2/250 • Number of events 2
|
0.85%
2/236 • Number of events 2
|
|
General disorders
Puncture site haemorrhage
|
0.40%
1/250 • Number of events 1
|
0.42%
1/236 • Number of events 1
|
|
General disorders
Vessel puncture site haemorrhage
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Infections and infestations
Abdominal infection
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Infections and infestations
Aspergillosis
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Infections and infestations
Bacteraemia
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Infections and infestations
Candidiasis
|
0.40%
1/250 • Number of events 1
|
0.85%
2/236 • Number of events 2
|
|
Infections and infestations
Catheter sepsis
|
0.80%
2/250 • Number of events 2
|
0.42%
1/236 • Number of events 1
|
|
Infections and infestations
Citrobacter infection
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Infections and infestations
Clostridial infection
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Infections and infestations
Empyema
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Infections and infestations
Enterobacter infection
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Infections and infestations
Enterobacter pneumonia
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Infections and infestations
Enterococcal infection
|
0.40%
1/250 • Number of events 1
|
0.42%
1/236 • Number of events 1
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.40%
1/250 • Number of events 1
|
0.42%
1/236 • Number of events 1
|
|
Infections and infestations
Fungal infection
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Infections and infestations
Gastroenteritis
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Infections and infestations
Infection
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Infections and infestations
Klebsiella infection
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Infections and infestations
Lower respiratory tract infection
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Infections and infestations
Lung infection
|
0.40%
1/250 • Number of events 1
|
0.42%
1/236 • Number of events 1
|
|
Infections and infestations
Lung infection pseudomonal
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Infections and infestations
Morganella infection
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Infections and infestations
Oral herpes
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.80%
2/250 • Number of events 2
|
0.85%
2/236 • Number of events 2
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Infections and infestations
Pseudomembranous colitis
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Infections and infestations
Pseudomonas infection
|
1.2%
3/250 • Number of events 3
|
0.85%
2/236 • Number of events 2
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/250
|
0.85%
2/236 • Number of events 2
|
|
Infections and infestations
Stenotrophomonas infection
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Infections and infestations
Systemic candida
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Infections and infestations
Tracheitis
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Infections and infestations
Urinary tract infection
|
0.40%
1/250 • Number of events 1
|
0.42%
1/236 • Number of events 1
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Infections and infestations
Urinary tract infection fungal
|
0.40%
1/250 • Number of events 1
|
0.42%
1/236 • Number of events 1
|
|
Infections and infestations
Viral infection
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Infections and infestations
Wound infection
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Infections and infestations
Wound infection fungal
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Injury, poisoning and procedural complications
Bloody airway discharge
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.40%
1/250 • Number of events 1
|
0.85%
2/236 • Number of events 2
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.80%
2/250 • Number of events 2
|
0.42%
1/236 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tracheal haemorrhage
|
1.2%
3/250 • Number of events 3
|
0.00%
0/236
|
|
Investigations
Bacteria blood identified
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Investigations
Blood urine present
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Investigations
Haematocrit decreased
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Investigations
Haemoglobin decreased
|
0.40%
1/250 • Number of events 1
|
0.42%
1/236 • Number of events 1
|
|
Investigations
Platelet count decreased
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Investigations
Prothrombin time shortened
|
0.00%
0/250
|
0.85%
2/236 • Number of events 2
|
|
Investigations
Sputum culture positive
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Renal and urinary disorders
Haematuria
|
0.80%
2/250 • Number of events 2
|
2.1%
5/236 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.40%
1/250 • Number of events 1
|
0.42%
1/236 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.40%
1/250 • Number of events 1
|
0.00%
0/236
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.40%
1/250 • Number of events 1
|
0.42%
1/236 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/250
|
0.42%
1/236 • Number of events 1
|
|
Vascular disorders
Haematoma
|
1.2%
3/250 • Number of events 3
|
0.42%
1/236 • Number of events 1
|
|
Vascular disorders
Wound haemorrhage
|
0.80%
2/250 • Number of events 2
|
0.00%
0/236
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60