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FDA Toxicity Grading Scale for Preventive Vaccine Trials: Renal Reactions

Description

The Food and Drug Administration (FDA) has developed grading scales for reactions to vaccines during clinical trials. One of these scales deals with the kidneys and urine production.


 

Patient selection: renal reaction after the vaccination

 

Renal reactions may include:

(1) serum BUN

(2) serum creatinine

(3) urine protein

(4) urine glucose

(5) urine blood

 

Reduced urine output is not included as a measure.

Reaction

Grade

none

0

mild

1

moderate

2

severe

3

potentially life threatening

4

 

 

Renal Parameter

Finding

Grade

BUN

23 to 26 mg/dL

1

 

27 to 31 mg/dL

2

 

> 31 mg/dL

3

 

requires dialysis

4

creatinine

1.5 to 1.7 mg/dL

1

 

1.8 to 2.0 mg/dL

2

 

2.1 to 2.5 mg/dL

3

 

> 2.5 mg/dL

4

 

requires dialysis

4

urine protein

trace

1

 

1+

2

 

2+

3

 

hospitalized or requires dialysis

4

urine glucose

trace

1

 

1+

2

 

2+

3

 

hospitalization for hyperglycemia

4

urine blood

1 to 10 RBC per hpf

1

 

11 to 50 RBC per hpf

2

 

> 50 per hpf

3

 

gross blood

3

 

hospitalized

4

 

blood transfusion

4

 


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