MedDRA is a standardized medical dictionary for coding an adverse event (AE) in clinical research. The Neonatal Adverse Event Severity Scale (NAESS) is a validated scale developed by the International Neonatal Consortium (INC) to standardize AE severity reporting in neonates.
NAESS includes AE-specific criteria for common neonatal AEs (NAESS AE terms) and generic severity criteria for other AEs (non-NAESS AE terms). The NAESS AE terms have been linked to corresponding AE terms in MedDRA.
Using the tool to select the appropriate neonatal severity grade:
- Enter an AE term for the correct neonatal term in the search field.
- Use the filter icon to the right of the search field to filter the various NAESS AE terms and non-NAESS AE terms.
- Choose the appropriate neonatal severity grade based on the severity criteria.
Please note that additional information or considerations to be included in the SAE narrative have been provided below the severity criteria.
IMPORTANT: If your AE term is
not one of the neonatology terms listed within this app, please select the Neonatology Generic Severity Scale
HERE.
