sdtmchecks (version 1.0.0)

check_ae_aeacnoth: 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, ...)

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, AEACNOTH, AEACNOT1/2, AESPID (optional)

preproc

An optional company specific preprocessing script

...

Other arguments passed to methods

Author

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AE$AEACNOT2[2] = "DRUG WITHDRAWN"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AE$AEACNOT2[4] = "DRUG WITHDRAWN"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)