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Clarification regarding AE tables Email, October 05, 2009 - Laviv
From: Jeanne Novak [firstname.lastname@example.org]
Sent: Monday, October 05, 2009 4:43 PM
To: Haudenschild, Changting
Cc: Tull, Lori; Dana Weinberger; Jeanne Novak
Subject: Clarification regarding AE tables
As you know, we originally emailed draft tables regarding rare (<1%) related
adverse events to Dr. Zhu on 9/30/09, and we emailed revised, final versions to
Dr. Zhu on 10/2/09. We also made a formal submission (BLA 125348; Amendment 13)
of these AE tables for delivery to the document control room tomorrow.
You also emailed draft slides that you prepared on this topic on Oct. 1st, and
we discussed the impact of changes made to the tables on the draft slides by
phone on Oct. 2nd. Further to the discussion on Oct. 2nd, we wanted to note
that the following changes were made to Table 1: events for the preferred terms
?erythema?, ?post procedural dizziness?, and ?post procedural headache? were
added to the final version relative to the original draft version. Only the
event of ?post procedural headache? occurred in Studies IT-R-005 or IT-R-006
(the other two did not occur in these studies). Post procedural headache was
reported for subject -b(6)-. As such, we think that the addition of the event
of ?post procedural headache? may have an impact on the draft slides regarding
AEs in Studies IT-R-005 and IT-R-006 that you provided.
We hope this information helps your review. Please feel free to contact me with
any questions or requests.
Jeanne M. Novak, Ph.D.
Owner and Principal Consultant
CBR International Corp.?
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