Scale of the severity or intensity of the adverse event

CDISC SDTM variables: AESEV

Adverse event severity scale

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

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.

Severity