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 based on the Preferred Term
(PT) level but also including the hierarchy above.
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.
To learn more about how the Pediatric Adverse Event Term List has been developed, please click here.
If you wish to provide feedback or recommendations on how to improve
the “Pediatric Adverse Event Term List,” please
click here.
Gender Specific Adverse Event Term Lists
The MSSO developed a “Gender Specific Adverse Event Term List” of MedDRA terms with 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).
To learn more about how the Gender Specific Adverse Event Term List has been developed, please
click here.
If you wish to provide feedback or recommendations on how to improve
the “Gender Specific Adverse Event Term List,” please
click here.
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