sdtm_ae: sdtm_ae

In safetyData: Clinical Trial Data

Description

Adverse Events data frame - One record per adverse event per subject

Usage

sdtm_ae

Format

a data frame with 1191 rows and 35 columns. See https://github.com/SafetyGraphics/safetyData/blob/main/data-raw/sdtm/README.md for more details and full data specification. Columns:

STUDYID

text - Study Identifier

DOMAIN

text - Domain Abbreviation

USUBJID

text - Unique Subject Identifier

AESEQ

integer - Sequence Number

AESPID

text - Sponsor-Defined Identifier

AETERM

text - Reported Term for the Adverse Event

AELLT

text - Lowest Level Term

AELLTCD

integer - Lowest Level Term Code

AEDECOD

text - Dictionary-Derived Term

AEPTCD

integer - Preferred Term Code

AEHLT

text - High Level Term

AEHLTCD

integer - High Level Term Code

AEHLGT

text - High Level Group Term

AEHLGTCD

integer - High Level Group Term Code

AEBODSYS

text - Body System or Organ Class

AEBDSYCD

integer - Body System or Organ Class Code

AESOC

text - Primary System Organ Class

AESOCCD

integer - Primary System Organ Class Code

AESEV

text - Severity/Intensity

AESER

text - Serious Event

AEACN

text - Action Taken with Study Treatment

AEREL

text - Causality

AEOUT

text - Outcome of Adverse Event

AESCAN

text - Involves Cancer

AESCONG

text - Congenital Anomaly or Birth Defect

AESDISAB

text - Persist or Signif Disability/Incapacity

AESDTH

text - Results in Death

AESHOSP

text - Requires or Prolongs Hospitalization

AESLIFE

text - Is Life Threatening

AESOD

text - Occurred with Overdose

AEDTC

date - Date/Time of Collection

AESTDTC

date - Start Date/Time of Adverse Event

AEENDTC

date - End Date/Time of Adverse Event

AESTDY

integer - Study Day of Start of Adverse Event

AEENDY

integer - Study Day of End of Adverse Event

safetyData documentation built on Jan. 19, 2021, 5:09 p.m.