X hits on this document

432 views

0 shares

0 downloads

0 comments

23 / 170

11

coronary artery occlusion, blood creatine phosphokinase increase, and electrocardiogram

12

Q wave abnormal. So if a patient was reported to have experienced any of these 30

13

preferred terms they would be counted in this myocardial infarction SMQ and would be

14

counted as having had a myocardial infarction.

2

different users could select different sets of preferred terms when they are trying to

3

retrieve cases related to a particular safety issue. To try and get around this, the

4

MedDRA folks have developed what is known as standardized MedDRA queries, which

5

is a grouping of preferred terms potentially related to a defined medical condition of

6

interest, and SMQs have been developed to standardize the sets of preferred terms that

7

should be included when evaluating a particular safety signal. So let’s take an example.

8

The myocardial infarction SMQ, and here I am working of a MedDRA version 11.1,

9

consists of 30 preferred terms.

21

safety endpoints that FDA requested. When I use the term MACE, here that’s shorthand

22

for Major Adverse Cardiovascular Events. There is a broad SMQ MACE and a custom

23

SMQ MACE. The broad SMQ MACE is a composite of cardiovascular death, preferred

1

Now, because of MedDRA’s size and complexity you can imagine that

10

Four examples are shown on the slide; acute myocardial infarction,

22

Scribes, LLC Toll Free 1-800-675-8846 www.scribesllc.com

16

could be consistent with myocardial infarction, there may be another explanation in some

17

patients. Take, for example, blood creatine phosphokinase increase. That could be due

18

to exercise, trauma, and medications. In other words, conditions not related to

19

myocardial necrosis.

15

Now, it’s important to realize that although some of these preferred terms

20

With that background, I want to now talk about the two cardiovascular

Document info
Document views432
Page views432
Page last viewedSun Dec 04 06:25:12 UTC 2016
Pages170
Paragraphs7975
Words54271

Comments