Check for consistency between DV and AE for COVID-19 events

If a patient has a DV record indicating COVID-19 then they should also have COVID-related AE where AE.AEDECOD matches covid.REFTERM.

check_dv_ae_aedecod_covid(AE, DV, covid_df = NULL)

Arguments

AE

Adverse Events SDTM dataset with variables USUBJID, AEDECOD

DV

Protocol Deviation SDTM dataset with variables USUBJID, DVREAS

covid_df

Dataframe of AE terms identify COVID-19, contains variable REFTERM

Value

boolean value if check returns 0 obs, otherwise return subset dataframe.

See also

Other COVID: check_ae_aeacn_ds_disctx_covid(), check_ae_aeacnoth_ds_stddisc_covid(), check_dv_covid()

Author

Natalie Springfield

Examples

covid_df = data.frame(REFTERM = c("COVID-19",
                                  "CORONAVIRUS POSITIVE"
                                  )
                     )

AE <- data.frame(
 USUBJID = 1:6,
 AEDECOD = c("covid-19", "covid-19","some AE","some AE","CORONAVIRUS POSITIVE","UNMAPPED")
)

DV <- data.frame(
 USUBJID = 1:6,
 DVREAS=c("SUSPECTED EPIDEMIC/PANDEMIC INFECTION",
          "UNKNOWN",
          "SUSPECTED EPIDEMIC/PANDEMIC INFECTION",
          "OTHER",
          "SUSPECTED EPIDEMIC/PANDEMIC INFECTION",
          "SUSPECTED EPIDEMIC/PANDEMIC INFECTION")
)

check_dv_ae_aedecod_covid(AE,DV,covid_df)
#> [1] FALSE
#> attr(,"msg")
#> [1] "Found 2 patient(s) with COVID-related Protocol Deviation, but no AE record with COVID terms. "
#> attr(,"data")
#>   USUBJID                                DVREAS AEDECOD
#> 2       3 SUSPECTED EPIDEMIC/PANDEMIC INFECTION    <NA>
#> 4       6 SUSPECTED EPIDEMIC/PANDEMIC INFECTION    <NA>