Pediatric and Gender Adverse Event Term Lists

With the endorsement of the MedDRA Management Board, the MSSO has developed a set of MedDRA term lists to meet user needs. These lists could be used to improve data quality of adverse event reporting and for specific pharmacovigilance practices. They are potentially useful to users at regulatory authorities, pharmaceutical companies, and sponsors of clinical trials.

Unlike SMQs, these lists are not intended to identify a medical condition or area of interest. Similar to SMQs, these lists will be maintained by input from subscribers and updated with each version of MedDRA.

These lists are intended as recommendations only and are not part of any regulatory requirement. They provide the basis for a common understanding, and leave organizations the option to modify the lists – either adding or deleting terms – according to their own specific needs.

Pediatric Adverse Event Term List

The MSSO has developed a Pediatric Adverse Event Term List of MedDRA Preferred Terms (PT) terms.

Medicinal products may affect physical and cognitive growth and development, and the adverse event profile may differ in pediatric patients. Because developing systems may respond differently than mature adult organs, some adverse events and drug interactions that occur in pediatric patients may not be identified in adult studies and therefore need specific monitoring. In addition, the dynamic processes of growth and development may not manifest adverse events acutely, but at a later stage of growth and maturation and therefore also require monitoring.

Learn more about the Pediatric Adverse Event Term List (.pdf) and how has it been developed.

To provide feedback or recommendations on how to improve the Pediatric Adverse Event Term List, please contact the MSSO Help Desk.

Pediatric Adverse Event Term List (MedDRA 14.1) (.xlsx)

Gender Specific Adverse Event Term Lists

The MSSO developed a Gender Specific Adverse Event Term List of MedDRA Preferred Terms (PT) terms. These are separate lists for male and female terms.

Besides a potential use in monitoring gender-specific adverse events, the gender term lists are also intended as a query to validate coding at the data entry level by highlighting reports that include gender inconsistencies (e.g., female patients with prostate cancer).

Learn more about the Gender Specific Adverse Event Term List (.pdf) and how it has been developed.

If you wish to provide feedback or recommendations on how to improve the Gender Specific Adverse Event Term List, please email to the MSSO Help Desk.

Gender Specific Adverse Event Term Lists (MedDRA Version 14.1) (.xlsx)