| |
Fibrinogen concentrate arm
|
Placebo arm
|
|---|
|
Subjects
|
|
Number of participants in receipt of the study intervention
|
20
|
19
|
|
Number of participants experiencing at least one SAEa
|
13
|
11
|
|
Number of SAEs
|
29
|
21
|
|
Symptomatic thrombotic events
|
3
|
2
|
|
Arterial
|
|
MI
|
0
|
0
|
|
Stroke
|
1
|
1
|
|
Other (arterial thrombus)
|
0
|
1
|
|
Venous
|
|
DVT
|
0
|
0
|
|
PE
|
2
|
0
|
|
Sepsis
|
4
|
6
|
|
Organ failure
|
10
|
2
|
|
Multiple organ failure
|
4
|
1
|
|
Single organ failure
|
6
|
1
|
|
New-onset major bleeding
|
1
|
3
|
|
Uncontrolled major bleedingb
|
2
|
1
|
|
Other SAEs
|
9
|
7
|
|
Death
|
|
All deathsc
|
8
|
3
|
|
Death due to bleeding
|
2 (25%)
|
1 (33%)
|
- Abbreviations: DVT Deep venous thrombosis, MI Myocardial infarction, PE Pulmonary embolus, SAE Serious adverse event
- Safety data were collected for only the 39 participants who were administered the study intervention
- aEleven participants experienced more than one SAE
- bMajor bleeding that was not controlled at any time from admission
- cIncludes all cases of multi-organ failure, all cases of uncontrolled bleeding, one case of single organ failure in the active treatment arm and two other SAEs (one in the active treatment arm and one in the placebo arm)
