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Table 4 Serious adverse events (including fatal events)

From: Phase II trial of standard versus increased transfusion volume in Ugandan children with acute severe anemia

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

-

 
  1. 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.