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Vaccines, Blood & Biologics

UNSOL_AE Dataset Narratives - Cervarix, July 18, 2007

To: Mr. Matt Whitman
File: STN 125259/0 - Cervarix®
RE: UNSOL_AE Dataset Narratives
Date: July 18, 2007

We have the following comments:

In review of the UNSOL_AE datasets, subjects with potentially autoimmune diseases were identified (as per GSK AID designation and by CBER reviewer*). A list of the subject identification numbers is noted below.

Please submit narratives for these subjects to the BLA. If narratives have already been submitted to the BLA for some of these subjects, please indicate their location within the BLA.

PID Numbers
13143
13518
71903
16584
8523
6393
12692
15900
677
21505
8416
*11150
85619
14118
86676
7706
7736
*2371
*7141
*5225
*4101
*2775
1441
*5471
7669
11937
*37
169
6838
40
8347
18876
14339
16130
70167
9301
73824
16955
6297
254
160
57
5018
*1063
*731
*237
19518
2241
8281
16813
71902
108
17450
5520
21875
10842
1009
10876
20305
17284
3064
4
6603
12718
12908
1702

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