dtlg (version 0.0.2)

aesi: Adverse Events of Special Interest (AESI) example dataset

Description

aesi is a modified version of the random.cdisc.data::cadae dataset, filtered to include only analysis-flagged records (ANL01FL == "Y") and extended with binary indicator variables corresponding to adverse events of special interest (AESIs).

Usage

aesi

Format

A data.frame with a subset of rows from cadae and additional derived columns including:

FATAL

Logical flag for fatal AEs (AESDTH == "Y").

SEV

Logical flag for severe AEs (AESEV == "SEVERE").

SER

Logical flag for serious AEs (AESER == "Y").

SERWD

Serious AE leading to withdrawal (AESER == "Y" & AEACN == "DRUG WITHDRAWN").

SERDSM

Serious AE leading to dose modification/interruption.

RELSER

Serious and related AE.

WD

AE leading to withdrawal.

DSM

AE leading to dose modification/interruption.

REL

Related AE.

RELWD

Related AE leading to withdrawal.

RELDSM

Related AE leading to dose modification/interruption.

Details

These derived flags include seriousness, severity, fatality, relatedness, and treatment consequence (e.g., dose modification or withdrawal), and are used to illustrate key safety summaries in clinical reporting.

Each derived variable is labeled using with_label() for compatibility with tabulation functions.

This dataset is included in {dtlg} to support function testing, usage examples, and reproducible safety analyses.

See Also

random.cdisc.data::cadae, multi_event_true()

Examples

aesi