ae: Adverse Events

In pharmaversesdtm: SDTM Test Data for the 'Pharmaverse' Family of Packages

Adverse Events

Description

An updated SDTM AE dataset that uses the CDISC pilot project

Usage

ae

Format

A data frame with 35 columns:

STUDYID

Study Identifier

DOMAIN

Domain Abbreviation

USUBJID

Unique Subject Identifier

AESEQ

Sequence Number

AESPID

Sponsor-Defined Identifier

AETERM

Reported Term for the Adverse Event

AELLT

Lowest Level Term

AELLTCD

Lowest Level Term Code

AEDECOD

Dictionary-Derived Term

AEPTCD

Preferred Term Code

AEHLT

High Level Term

AEHLTCD

High Level Term Code

AEHLGT

High Level Group Term

AEHLGTCD

High Level Group Term Code

AEBODSYS

Body System or Organ Class

AEBDSYCD

Body System or Organ Class Code

AESOC

Primary System Organ Class

AESOCCD

Primary System Organ Class Code

AESEV

Severity/Intensity

AESER

Serious Event

AEACN

Action Taken with Study Treatment

AEREL

Causality

AEOUT

Outcome of Adverse Event

AESCAN

Involves Cancer

AESCONG

Congenital Anomaly or Birth Defect

AESDISAB

Persist or Signif Disability/Incapacity

AESDTH

Results in Death

AESHOSP

Requires or Prolongs Hospitalization

AESLIFE

Is Life Threatening

AESOD

Occurred with Overdose

AEDTC

Date/Time of Collection

AESTDTC

Start Date/Time of Adverse Event

AEENDTC

End Date/Time of Adverse Event

AESTDY

Study Day of Start of Adverse Event

AEENDY

Study Day of End of Adverse Event

Details

Adverse Events

An updated SDTM AE dataset that uses the CDISC pilot project

Author(s)

Gopi Vegesna

Source

Access the source of the Adverse Events dataset.

pharmaversesdtm documentation built on April 3, 2025, 6:17 p.m.