sdtmchecks (version 1.0.0)

check_ae_aeout: Check for inconsistency between AE outcome (AEOUT) and death date (AEDTHDTC)

Description

This check looks for AEs with Death date(AEDTHDTC) but outcome (AEOUT) is not FATAL and conversely AEs with no death date (AEDTHDTC) but outcome (AEOUT) is fatal

Usage

check_ae_aeout(AE, preproc = identity, ...)

Value

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

Arguments

AE

Adverse Events SDTM dataset with variables USUBJID, AEDTHDTC, AEOUT

preproc

An optional company specific preprocessing script

...

Other arguments passed to methods

Author

Shumei Chi

Examples

AE <- data.frame(
    USUBJID = 1:8,
    AEDTHDTC = c(NA, "NA", "2015-03-12", "2017-01-22", "1999-11-07","",NA, "2020-01-01"),
    AEOUT = c("", "", "","FATAL","RECOVERED/RESOLVED","FATAL","FATAL", NA),
    AESPID = "FORMNAME-R:13/L:13XXXX",
    stringsAsFactors = FALSE
)

check_ae_aeout(AE)
check_ae_aeout(AE,preproc=roche_derive_rave_row)

AE$AEDTHDTC <- NULL
check_ae_aeout(AE)

AE$AEOUT <- NULL
check_ae_aeout(AE)