coronary artery occlusion, blood creatine phosphokinase increase, and electrocardiogram
Q wave abnormal. So if a patient was reported to have experienced any of these 30
preferred terms they would be counted in this myocardial infarction SMQ and would be
counted as having had a myocardial infarction.
different users could select different sets of preferred terms when they are trying to
retrieve cases related to a particular safety issue. To try and get around this, the
MedDRA folks have developed what is known as standardized MedDRA queries, which
is a grouping of preferred terms potentially related to a defined medical condition of
interest, and SMQs have been developed to standardize the sets of preferred terms that
should be included when evaluating a particular safety signal. So let’s take an example.
The myocardial infarction SMQ, and here I am working of a MedDRA version 11.1,
consists of 30 preferred terms.
safety endpoints that FDA requested. When I use the term MACE, here that’s shorthand
for Major Adverse Cardiovascular Events. There is a broad SMQ MACE and a custom
SMQ MACE. The broad SMQ MACE is a composite of cardiovascular death, preferred
Now, because of MedDRA’s size and complexity you can imagine that
Four examples are shown on the slide; acute myocardial infarction,
Scribes, LLC Toll Free 1-800-675-8846 www.scribesllc.com
could be consistent with myocardial infarction, there may be another explanation in some
patients. Take, for example, blood creatine phosphokinase increase. That could be due
to exercise, trauma, and medications. In other words, conditions not related to
Now, it’s important to realize that although some of these preferred terms
With that background, I want to now talk about the two cardiovascular