Checks for grade 5 AEs not marked fatal (AEOUT), death not indicated (AESDTH), or no death date (AESDTHDTC)
check_ae_death(AE, preproc = identity, ...)Adverse Event dataframe with variables USUBJID,AETOXGR,AEOUT,AEDTHDTC,AESDTH
An optional company specific preprocessing script
Other arguments passed to methods
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)
#> [1] TRUE
check_ae_death(AE,preproc=roche_derive_rave_row)
#> [1] TRUE
AE$AEDTHDTC[5]="NA"
AE$AEDTHDTC[6]=NA
AE$AEDTHDTC[7]=""
AE$AESDTH[8]=NA
AE$AEOUT[9]=NA
check_ae_death(AE)
#> [1] FALSE
#> attr(,"msg")
#> [1] "Total number of records with grade 5 AEs and inconsistencies among AE death variables is 5. "
#> attr(,"data")
#> USUBJID AETOXGR AEOUT AEDTHDTC AESDTH
#> 1 5 5 FATAL NA Y
#> 2 6 5 FATAL <NA> Y
#> 3 7 5 FATAL Y
#> 4 8 5 FATAL 2020-01-01 <NA>
#> 5 9 5 <NA> 2020-01-01 Y
check_ae_death(AE,preproc=roche_derive_rave_row)
#> [1] FALSE
#> attr(,"msg")
#> [1] "Total number of records with grade 5 AEs and inconsistencies among AE death variables is 5. "
#> attr(,"data")
#> USUBJID AETOXGR AEOUT AEDTHDTC AESDTH RAVE
#> 1 5 5 FATAL NA Y FORMNAME-R:13
#> 2 6 5 FATAL <NA> Y FORMNAME-R:13
#> 3 7 5 FATAL Y FORMNAME-R:13
#> 4 8 5 FATAL 2020-01-01 <NA> FORMNAME-R:13
#> 5 9 5 <NA> 2020-01-01 Y FORMNAME-R:13