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