SAE | Arm A: 20 ml/kg (Number = 82) | Arm B: 30 ml/kg (Number = 78) | Total |
---|---|---|---|
Clinician defined SAEs | Â | Â | Â |
Allergic reaction/transfusion reaction | 0 | 1a | 1 |
Deaths | Â | Â | Â |
 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 | Â | Â | Â |
Fatal events relationship to transfusion c | Â | Â | Â |
Definitely | 0 | - | Â |
Probably | 0 | - | Â |
Possibly | 3 | - | Â |
Not related | 3 | 1b | Â |
unknown | 0 | - | Â |