How can I use Maternal Fetal Adverse Event Terminology

This terminology helps to define Adverse Events and then to decide their severity using a grading system.

The terminology can be used in clinical trials as described below. It can also be used to provide a standardised comprehensive assessment of medical occurrences in observational studies, audits and quality improvement projects.

PDF file - MFAET Version 1.1 with instructions for use  

Excel file Version 1.1 including MedDRA numerical codes  

 

AEs in clinical trials

During clinical trials, Adverse Events are reviewed to determine:

(1) whether the AE meets the definition of ‘serious’2:

  • Results in death
  • Is life-threatening
  • Requires inpatient hospitalisation or results in prolongation of existing hospitalisation
  • Results in persistent or significant disability/incapacity
  • Is a congenital anomaly/birth defect
  • Is a medically important event or reaction

(2) whether it is possibly, probably or definitely related to the intervention (i.e. is a reaction). The event is then classified as:

 

 

Serious

Reaction

Adverse event (AE)

No

No

Adverse reaction (AR)

No

Yes

Serious adverse event (SAE)

Yes

No

Serious adverse reaction (SAR)

Yes

Yes

Grading Adverse Events

AEs are graded from 1 to 5:

Grade 1: mild

Grade 2: moderate

Grade 3: severe or medically significant

Grade 4: life-threatening

Grade 5: death

If an AE fulfils the criteria for more than one grade of severity, the highest applicable grade should be used. Grading the severity of AEs provides additional safety information. It does not replace the regulatory requirements for AE assessment described above.