|
SAE
|
Arm A: 20 ml/kg (Number = 82)
|
Arm B: 30 ml/kg (Number = 78)
|
Total
|
|---|
|
Clinician defined SAEs
| | | |
|
Allergic reaction/transfusion reaction
|
0
|
1a
|
1
|
|
Deaths
| | | |
|
Cardio respiratory arrest
|
1
|
0
|
1
|
|
Respiratory arrest
|
1
|
0
|
1
|
|
Multiple organ failure
|
0
|
1b
|
1
|
|
Other deaths
|
4
|
0
|
4
|
|
Total
|
6
|
2
|
8
|
|
Adjudication by endpoint committee
| | | |
|
Fatal events relationship to transfusion
c
| | | |
|
Definitely
|
0
|
-
| |
|
Probably
|
0
|
-
| |
|
Possibly
|
3
|
-
| |
|
Not related
|
3
|
1b
| |
|
unknown
|
0
|
-
| |
-
aMedian rate of transfusion at the time of reaction, 0.95 ml/minute, no events judged to have any relationship to volume of transfusions; boccurred four days after discharge (day 12 post-admission); csee Table S1 in Additional file 2 for further details of the deaths.
