Adverse event severity scale : 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 severity scale

Variable Name

AdvrsEvntSeverScale

Short Description

Scale of the severity or intensity of the adverse event

Definition

Scale of the severity or intensity of the adverse event

Biomedical Terminologies and Standards

Notes

CDISC SDTM variables: AESEV

Creation Date

Historical Notes

Adverse event severity scale

References

EPILEPSY/GENERAL/PD: Common Terminology Criteria for Adverse Events (CTCAE) v4.0 (http: //evs.nci.nih.gov/ftp1/CTCAE/About.html)

Data Type

Alphanumeric

Input Restrictions

Single Pre-Defined Value Selected

Pre-Defined Values

External Schema Permissible Value Mapping

Population

Adult and Pediatric

Guidelines/Instructions

GENERAL: Choose the one severity that best describes the investigator's assessment of the intensity of the AE. The five severity grades are from the Common Terminology Criteria for Adverse Events v4.0 (CTCAE). Severe events interrupt the participant's/subject's normal daily activities and generally require systemic drug therapy or other treatment; they are usually incapacitating. Consequently, a change in severity may constitute a new reportable AE. Severity is not synonymous with seriousness. A severe rash is not likely to be an SAE. Likewise, a severe headache is not necessarily an SAE. However, mild chest pain may result in a day's hospitalization and thus is an SAE. It is helpful to define the severity categories in the protocol or Manual of Operations to obtain consistency in reporting across sites. PD: Choose the one severity that best describes the investigator's assessment of the intensity of the AE. The five severity grades are from the Common Terminology Criteria for Adverse Events v4.0 (CTCAE). Severe events interrupt the participant's/subject's normal daily activities and generally require systemic drug therapy or other treatment; they are usually incapacitating. Consequently, a change in severity may constitute a new reportable AE. Severity is not synonymous with seriousness. A severe rash is not likely to be an SAE. Likewise, a severe headache is not necessarily an SAE. However, mild chest pain may result in a day's hospitalization and thus is an SAE. It is helpful to define the severity categories in the protocol or Manual of Operations to obtain consistency in reporting across sites. EPILEPSY: Choose the one severity that best describes the investigator's assessment of the intensity of the AE. The five severity grades are from the Common Terminology Criteria for Adverse Events v4.0 (CTCAE). Severe events interrupt the participant's/subject's normal daily activities and generally require systemic drug therapy or other treatment; they are usually incapacitating. Consequently, a change in severity may constitute a new reportable AE. Severity is not synonymous with seriousness. A severe rash is not likely to be an SAE. Likewise, a severe headache is not necessarily an SAE. However, mild chest pain may result in a day's hospitalization and thus is an SAE. It is helpful to define the severity categories in the protocol or Manual of Operations to obtain consistency in reporting across sites.

Preferred Question Text

Severity

Category Groups and Classifications

Disease	Domain	Sub-Domain
Epilepsy	Safety Data	Adverse Events
Parkinson's Disease	Treatment/Intervention Data	Surgeries and Other Procedures
General (For all diseases)	Safety Data	Adverse Events

Classification

Parkinson's Disease :

Supplemental

General (For all diseases) :

Supplemental

Epilepsy :

Supplemental

Keywords

AE_Mapped , Adverse_Event , See_also , Knowledge_graph , COVID19

Labels

Effective Date

Until Date

Last Change Date

Wed Apr 24 16:42:59 EDT 2024

Change History