check_ae_aeacnoth {sdtmchecks}

Check for null AEACNOT1/2 when AEACNOTH = 'MULTIPLE'

Description

Flag if patient has a record with null values of AEACNOT1 and AEACNOT2 but AEACNOTH = 'MULTIPLE', so a likely mapping issue

Usage

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

Arguments

AE

Adverse Events SDTM dataset with variables USUBJID, AETERM, AESTDTC, AEACNOTH, AEACNOT1/2, AESPID (optional)

preproc

An optional company specific preprocessing script

...

Other arguments passed to methods

Value

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

Author(s)

Ross Farrugia

Examples

AE <- data.frame(
 USUBJID = 1:7,
 AETERM = 1:7,
 AESTDTC = 1:7,
 AEACNOTH = 1:7,
 AEACNOT1 = 1:7,
 AEACNOT2 = 1:7,
 AESPID = "FORMNAME-R:13/L:13XXXX"
)

# pass
check_ae_aeacnoth(AE)

AE$AEACNOTH[1] = ""
AE$AEACNOT1[1] = ""
AE$AEACNOT2[1] = ""
AE$AEACNOTH[2] = "MULTIPLE"
AE$AEACNOT1[2] = "DOSE REDUCED"
AE$AEACNOT2[2] = "DRUG WITHDRAWN"
AE$AEACNOTH[3] = "MULTIPLE"
AE$AEACNOT1[3] = "DOSE REDUCED"
AE$AEACNOT2[3] = ""
AE$AEACNOTH[4] = "MULTIPLE"
AE$AEACNOT1[4] = ""
AE$AEACNOT2[4] = "DRUG WITHDRAWN"
AE$AEACNOTH[5] = "MULTIPLE"
AE$AEACNOT1[5] = ""
AE$AEACNOT2[5] = ""

# fail
check_ae_aeacnoth(AE)
check_ae_aeacnoth(AE,preproc=roche_derive_rave_row)

AE$AEACNOTH[1] = NA
AE$AEACNOT1[1] = NA
AE$AEACNOT2[1] = NA
AE$AEACNOT2[3] = NA 
AE$AEACNOT1[4] = NA 
AE$AEACNOT1[5] = NA
AE$AEACNOT2[5] = NA

# fail
check_ae_aeacnoth(AE)
check_ae_aeacnoth(AE,preproc=roche_derive_rave_row)


AE$AEACNOTH <- NULL
AE$AEACNOT1 <- NULL
AE$AEACNOT2 <- NULL
AE$AESPID <- NULL
check_ae_aeacnoth(AE)