sdtmchecks (version 1.0.0)

check_ae_death: Check for Grade 5 AE death variable consistency

Description

Checks for grade 5 AEs not marked fatal (AEOUT), death not indicated (AESDTH), or no death date (AESDTHDTC)

Usage

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

Value

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

Arguments

AE

Adverse Event dataframe with variables USUBJID,AETOXGR,AEOUT,AEDTHDTC,AESDTH

preproc

An optional company specific preprocessing script

...

Other arguments passed to methods

Author

Iris Zhao

Examples

 AE <- data.frame(
 USUBJID = 1:10,
 AETOXGR = c(1:5,5,5,5,5,5),
 AEDTHDTC = c(rep(NA,4),rep("2020-01-01",6)),
 AESDTH = c(rep(NA,4),rep("Y",6)),
 AEOUT = c(rep(NA,4),rep("FATAL",6)),
  AESPID = "FORMNAME-R:13/L:13XXXX"
)

check_ae_death(AE)
check_ae_death(AE,preproc=roche_derive_rave_row)

AE$AEDTHDTC[5]="NA"
AE$AEDTHDTC[6]=NA
AE$AEDTHDTC[7]=""
AE$AESDTH[8]=NA
AE$AEOUT[9]=NA

check_ae_death(AE)
check_ae_death(AE,preproc=roche_derive_rave_row)