sdtmchecks (version 1.0.0)

check_ae_aeout_aeendtc_nonfatal: Check for non-fatal AEs with inconsistent AEOUT and AEENDTC

Description

Check for inconsistency between AE outcome (AEOUT) and AE end date (AEENDTC) for non-fatal AEs (based on AEOUT). AE flagged if AEENDTC not populated when AEOUT is "RECOVERED/RESOLVED", "RECOVERED/RESOLVED WITH SEQUELAE". AE also flagged if AEENDTC is populated when AEOUT is "UNKNOWN", "NOT RECOVERED/NOT RESOLVED", "RECOVERING/RESOLVING".

Usage

check_ae_aeout_aeendtc_nonfatal(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, AETERM, AESTDTC, AEENDTC, AEOUT

preproc

An optional company specific preprocessing script

...

Other arguments passed to methods

Author

Jennifer Lomax

Examples

AE <- data.frame(
USUBJID = 1:10,
AETERM  = "AE",
AESTDTC = c(NA, "NA", "2015-03-09", "2010-10", "2017-01-20",   "1999-11-02",
        "",     NA,                   "2017-08-20",          "2014-12-01"),
AEENDTC = c(NA, "NA", "2015-03-12", "2010-10", "2017-01-22",   "1999-11-07",
        "",     NA,                   "2017-09-01",          "2015-01-01"),
AEOUT   = c("", "",   "",           "",        "NOT RECOVERED",
"RECOVERED/RESOLVED","FATAL","RECOVERED/RESOLVED", "RECOVERING/RESOLVING","UNKNOWN"),
AESPID  = "FORMNAME-R:13/L:13XXXX",
stringsAsFactors = FALSE
)

check_ae_aeout_aeendtc_nonfatal(AE)
check_ae_aeout_aeendtc_nonfatal(AE,preproc=roche_derive_rave_row)

AE$AEENDTC <- NULL
check_ae_aeout_aeendtc_nonfatal(AE)

AE$AEOUT <- NULL
check_ae_aeout_aeendtc_nonfatal(AE)