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Listed below are the details for the data element.

1.8
Element Type
Common Data Element
Adverse event CTCAE low level term name
AdvrsEvntCTCAELowLvlTermName
Short Description
Text that represents the Common Terminology Criteria for Adverse Events (CTCAE) low level term name for an adverse event.
Definition
Text that represents the Common Terminology Criteria for Adverse Events (CTCAE) low level term name for an adverse event.
 

Biomedical Terminologies and Standards

Notes
CDISC SDTM variables: In studies using toxicity grade according to a standard toxicity scale such as Common Terminology Criteria for Adverse Events v3.0 (CTCAE), published by the NCI (National Cancer Institute) at http://ctep.cancer.gov/reporting/ctc.html)), AETOXGR should be used instead of AESEV. In most cases, either AESEV or AETOXGR is populated but not both. There may be cases when a sponsor may need to populate both variables. The sponsor is expected to provide the dictionary name and version used to map the terms utilizing the define.xml external codelist attributes
Creation Date
Historical Notes
Adverse event CTCAE low level term name
References
EPILEPSY/GENERAL: Common Terminology Criteria for Adverse Events (CTCAE) v4.0 (http: //evs.nci.nih.gov/ftp1/CTCAE/About.html)

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 Common Terminology Criteria for Adverse Events (CTCAE) low level term name. CTCAE is a freely available standard terminology for adverse event data.
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 , COVID19
Labels
Effective Date
Until Date
Last Change Date
2020-05-18
See Also
AdvrsEvntDuringStudyInd;AdvrsEvntSeverScale;AdvrsEvntStartDateTime;AdverseEvntEndDateTime;AdvrsEvntVerbatimTermText;SeriousAdvrsEvntInd;AdvEvntMedDRALowerLvlTermCode;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