This process screens Standard
MedDRA
Query terms by performing a
Cochran-Mantel-Haenszel exact test
on all 2 x 2 tables constructed from event incidence and treatment
arm
. Output is a table of multiplicity-adjusted
p-values
, an accompanying
volcano plot
of relative risk and a SAS data set of indicator
variables
that can be used as input for other processes.
This process requires
AE
and either
DM
or
ADSL
. Required variables include
USUBJID
and
AEDECOD
.
AELLT
is desirable, but optional.
In addition, several text files defining MedDRA terms are required. These include:
mq_content.asc
(lists preferred and lower level terms associated with the queries),
smq_list.asc
( list of
SMQs
),
pt.asc
(lists
preferred terms
and codes), and
llt.asc
(lists lower-level terms and codes).
The output generated by this process is summarized in a tabbed report. Refer to the
Standardized MedDRA Queries Incidence Screen
output documentation for detailed descriptions and guides to interpreting your results.