HPV-009 Treatment Allocations- Cervarix, October 2, 2007
To: Mr. Matthew Whitman
File: STN 125259/0 CERVARIX
RE: HPV-009 – Treatment Allocations
Date: October 2, 2007
Please refer to study HPV-009. We have previously requested the treatment allocations for four subjects who developed rheumatoid arthritis in HPV-009. In review of the meta-analysis for potentially autoimmune events, there was noted to be five subjects (PID numbers 105646, 123422, 229946, 216829, and 230320) who developed rheumatoid arthritis. In addition, one subject (PID number 185015) developed erythema nodosum, one subject (PID number 302971) developed ulcerative colitis, and two subjects (PID numbers 323356 and 165709) developed inflammatory bowel disease. We acknowledge that the study is ongoing, but please provide the treatment allocations for these subjects by the unblinded statistician as soon as possible.