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