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Listed below are the details for the data element.

1.7
Element Type
Common Data Element
Adverse event MedDRA lower level term code
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
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
DiseaseDomainSub-Domain
Epilepsy Safety Data Adverse Events
General (For all diseases) Safety Data Adverse Events

Classification

Epilepsy :
Supplemental
General (For all diseases) :
Supplemental
Keywords
AE_Mapped , Adverse_Event , See_also , Knowledge_graph
Labels
Effective Date
Until Date
Last Change Date
2020-05-18
See Also
AdvrsEvntDuringStudyInd;AdvrsEvntSeverScale;AdvrsEvntStartDateTime;AdverseEvntEndDateTime;AdvrsEvntVerbatimTermText;SeriousAdvrsEvntInd;AdvrsEvntCTCAELowLvlTermName;InjElapsedTime
Submitting Organization Name
NIH/NINDS
Submitting Contact Name
NINDSCDE
Submitting Contact Information
NINDSCDE@emmes.com
Steward Organization Name
NIH/NINDS
Steward Contact Name
NINDSCDE
Steward Contact Information
NINDSCDE@emmes.com
NINDS ID

Change History