Adverse event MedDRA lower level term code : FITBIR : Federal Interagency Traumatic Brain Injury Research Informatics System

Listed below are the details for the data element.

Version

1.8

Element Type

Common Data Element

Title

Adverse event MedDRA lower level term code

Variable Name

AdvEvntMedDRALowerLvlTermCode

Short Description

Code that corresponds to the Medical Dictionary for Regulatory Activities (MedDRA) Lower Level Term (LLT) for an adverse event

Definition

Code that corresponds to the Medical Dictionary for Regulatory Activities (MedDRA) Lower Level Term (LLT) for an adverse event

Biomedical Terminologies and Standards

Notes

CDISC SDTM variables: AELLTCD - Lowest Level Term Code MedDRA, may add AELLT - Lowest Level Term MedDRA and possibly AEDECOD - Dictionary-Derived Term MedDRA

Creation Date

Historical Notes

Adverse event MedDRA lower level term code

References

EPILEPSY/GENERAL: Medical Dictionary for Regulatory Activities (http: //www.meddramsso.com/index.asp)

Data Type

Alphanumeric

Input Restrictions

Free-Form Entry

Maximum Character Quantity

255

External Schema Permissible Value Mapping

Population

Adult and Pediatric

Guidelines/Instructions

EPILEPSY/GENERAL: Code the adverse event verbatim text with the Medical Dictionary for Regulatory Activities (MedDRA) Lower Level Term (LLT) codes.

Preferred Question Text

Adverse Event

Category Groups and Classifications

Disease	Domain	Sub-Domain
Epilepsy	Safety Data	Adverse Events
General (For all diseases)	Safety Data	Adverse Events

Classification

General (For all diseases) :

Supplemental

Epilepsy :

Supplemental

Keywords

AE_Mapped , Adverse_Event , See_also , Knowledge_graph

Labels

Effective Date

Until Date

Last Change Date

Wed Apr 24 16:43:13 EDT 2024

Change History