X hits on this document

465 views

0 shares

0 downloads

0 comments

92 / 170

9

elevated - when they analyze people with elevated CPKs, most of them did not have

10

another event, if I understood that correctly, which isn’t really directly answering the

11

question that they have an event when we are analyzing them. It makes a big difference

12

in the analysis whether you focus on the custom MACE or the broad MACE, or the broad

13

SMQ. So could you speak a little more about the CPKs and were there any other

14

evidence that these people actually had heart disease at the time?

3

understand exactly. I would like a little more discussion of the elevated CPK, because

4

although other things certainly can elevate, other conditions can elevate CPK, in this

5

circumstance, usually it's going to be a myocardial infarction or at least some sort of

6

cardiac damage, so much of the difference between the broad SMQ and a custom MACE

7

related to people with elevated CPKs.

21

analyzed or they came in the hospital for chest pain, or how - what were the clinical

22

circumstances of an elevated CPK?

8

I believe it was Dr. Mele who presented data that said, if someone had an

1

(No response.)

2

I have one question for the FDA, which is a general one. I am not sure I

16

answer your question that it didn’t have to just be a subsequent event. It's just did they

17

have an event that was other than just a CPK, but these are first events. So the CPK

18

would be the first event that was observed and then you would have to look for

19

subsequent events.

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

91

15

DR. MELE: I just want to clarify about that analysis. Dr. Lowy will

20

DR. BURMAN: This was an elevated CPK when people just were

23

24

DR. LOWY: So, just to reiterate, these trials were not prospectively

designed to pick up these events. So a lot of the information that we had regarding these

Document info
Document views465
Page views465
Page last viewedTue Dec 06 13:22:21 UTC 2016
Pages170
Paragraphs7975
Words54271

Comments