Adverse event verbatim term text : FITBIR : Federal Interagency Traumatic Brain Injury Research Informatics System

Listed below are the details for the data element.

Version

1.10

Element Type

Common Data Element

Title

Adverse event verbatim term text

Variable Name

AdvrsEvntVerbatimTermText

Short Description

Adverse event verbatim term text

Definition

Text that describes the adverse event word for word as described by the participant/subject

Biomedical Terminologies and Standards

Notes

CDISC SDTM variables: AETERM

Creation Date

Historical Notes

Adverse event verbatim term text

References

No references available

Data Type

Alphanumeric

Input Restrictions

Free-Form Entry

Maximum Character Quantity

4000

External Schema Permissible Value Mapping

Population

Adult and Pediatric

Guidelines/Instructions

GENERAL: Any untoward medical occurrence in a study participant/subject that does not necessarily have a causal relationship with the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study intervention or study procedure, whether or not related to the study intervention or procedure. Each AE should be listed on a separate line. Any worsening of a baseline condition or reoccurrence of a baseline condition that had previously ended for a time should be listed as an AE. Events, such as nausea and vomiting are considered two events, and therefore should be listed on separate lines. A participant/subject may experience an unexpected AE. An unexpected adverse reaction has a nature or severity of which is not consistent with the study intervention description (e.g. Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product). The unexpected AE must be reported, whether related to the study intervention or not, with as much detail as is available. See the Data Dictionary for additional information on coding the adverse events using either the Common Terminology Criteria for Adverse Events (CTCAE) or the Medical Dictionary for Regulatory Activities (MedDRA). EPILEPSY: Any untoward medical occurrence in a study participant/subject that does not necessarily have a causal relationship with the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study intervention or study procedure, whether or not related to the study intervention or procedure. Each AE should be listed on a separate line. Any worsening of a baseline condition or reoccurrence of a baseline condition that had previously ended for a time should be listed as an AE. Events, such as nausea and vomiting are considered two events, and therefore should be listed on separate lines. A participant/subject may experience an unexpected AE. An unexpected adverse reaction has a nature or severity of which is not consistent with the study intervention description (e.g. Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product). The unexpected AE must be reported, whether related to the study intervention or not, with as much detail as is available.

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 , COVID21 , Knowledge_graph

Labels

Effective Date

Until Date

Last Change Date

Wed Apr 24 16:43:16 EDT 2024

Change History