Example SDTM Adverse Events Data

Example SDTM Adverse Events Data

Usage

sdtm_example_dataverse_ae

Format

A data frame with 18 variables and 16 observations:

STUDYID

Study Identifier, character

DOMAIN

Domain Abbreviation, character

USUBJID

Unique Subject Identifier, character

AESEQ

Sequence Number, numeric

AESPID

Sponsor-Defined Identifier, character

AETERM

Reported Term for the Adverse Event, character

AEMODIFY

Modified Reported Term, character

AEDECOD

Dictionary-Derived Term, character

AEBODSYS

Body System or Organ Class, character

AESEV

Severity/Intensity, character

AESER

Serious Event, character

AEACN

Action Taken with Study Treatment, character

AEREL

Causality, character

AESTDTC

Start Date/Time of Adverse Event, character, ISO8601

AEENDTC

End Date/Time of Adverse Event, character, ISO8601

AESTDY

Study Day of Start of Adverse Event, numeric

AEENDY

Study Day of End of Adverse Event, numeric

AEENRF

End Relative to Reference Period, character

Source

https://doi.org/10.7910/DVN/51B6NK

See also

Other SDTM example data: sdtm_example_dataverse_dm, sdtm_example_dataverse_eg, sdtm_example_dataverse_lb, sdtm_example_dataverse_mh, sdtm_example_dataverse_pe, sdtm_example_dataverse_vs, sdtm_example_theoph_ex, sdtm_example_theoph_pc