check_ae_withdr_ds_discon: Check if an AE leading to drug being withdrawn is reflected...

In sdtmchecks: Data Quality Checks for Study Data Tabulation Model (SDTM) Datasets

Check if an AE leading to drug being withdrawn is reflected in DS

Description

This checks that if there is an AE with AEACN="DRUG WITHDRAWN" then there should be a treatment discontinuation record indicated by DS.DSSCAT

Usage

check_ae_withdr_ds_discon(AE, DS, TS, preproc = identity, ...)

Arguments

AE	Adverse Events SDTM dataset with variables USUBJID, AEACN
DS	Disposition SDTM dataset with variables USUBJID, DSCAT, DSSCAT
TS	Trial Summary SDTM dataset with variables TSPARMCD, TSVAL
preproc	An optional company specific preprocessing script
...	Other arguments passed to methods

Value

boolean value if check failed or passed with 'msg' attribute if the test failed

Author(s)

Yuliia Bahatska

Examples

AE <- data.frame(
 USUBJID = 1:6,
 AEACN = c("DRUG WITHDRAWN",NA,NA,NA,NA,NA),
 AETOXGR = c(NA,NA,NA,NA,"5",NA),
 AEDECOD=c("NAUSEA","HEADACHE"),
 AESPID = "FORMNAME-R:5/L:5XXXX"
)
DS <- data.frame(
 USUBJID = 1:3,
 DSCAT="DISPOSITION EVENT",
 DSSCAT="STUDY TREATMENT",
 DSDECOD=c("COMPLETED","ADVERSE EVENT","DEATH")
)

 TS <- data.frame(
 TSPARMCD="TRT",
 TSVAL="CHECK"
)

check_ae_withdr_ds_discon(AE,DS,TS)
check_ae_withdr_ds_discon(AE,DS,TS,preproc=roche_derive_rave_row)

DS$DSSCAT = NULL

check_ae_withdr_ds_discon(AE,DS,TS)

sdtmchecks documentation built on Sept. 11, 2024, 9:34 p.m.