Common Data Element: Adverse event end date and time
Listed below are the details for the data element.
FITBIR
1.10
Element Type
Common Data Element
Adverse event end date and time
AdverseEvntEndDateTime
Short Description
Date (and time, if applicable and known) on which the adverse event discontinued/stopped
Definition
Date (and time, if applicable and known) on which the adverse event discontinued/stopped
Notes
CDISC SDTM variables: AESTDTC Start Date/Time of Adverse Event
Creation Date
Historical Notes
Adverse event end date and time
References
No references available
Data Type
Date or Date & Time
Input Restrictions
Free-Form Entry
Population
Adult and Pediatric
Guidelines/Instructions
GENERAL: Record the date (and time) the adverse event stopped or worsened. The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.) and in the format acceptable to the study database. If an AE worsens, record an end date/time and create a new AE record with a new start date/time and severity.
EPILEPSY: Record the date (and time) the adverse event stopped or worsened. If an AE worsens, record an end date and create a new AE record with a new start date and severity. Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http: //www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).
Preferred Question Text
End Date
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
COVID19
Knowledge_graph
Labels
