Download Responsible Adverse Event (AE) Reporting: Finding

Responsible Adverse Event (AE) Reporting:
Finding Appropriate AE Terms
Adverse Events - continued
Documenting Grade
A patient need not exhibit all elements of a Grade
description to be designated that Grade.
Example:
Induration/fibrosis (skin and subcutaneous tissue)
Grade 3:
Dysfunction interfering with ADL; very marked density,
retraction or fixation
Read as “Dysfunction ….. OR very marked……”
Interpretation:
A patient with very marked density, retraction or fixation,
but is able to perform ADLs, is Graded 3.
When a patient exhibits elements of multiple Grades,
the highest Grade is to be assigned.