sdtm_ae.Rd
Adverse Events data frame - One record per adverse event per subject
sdtm_ae
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