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Vaccines

Treatment Assignments – HPV-009- Cervarix, August 1, 2007

To: Mr. Matt Whitman

File: STN 125259/0 - CERVARIX

RE: Treatment Assignments – HPV-009

Date: August 1, 2007

 

Regarding the blinded Deaths and Serious Adverse Events reported from HPV-009, we request that you provide treatment assignments for the following subjects in order to evaluate whether these events were equally distributed between the treatment groups. We understand that this study is ongoing, and that you and other personnel in your regulatory office remain blinded to treatment assignment.

 

We therefore request that the study personnel who hold codes for the treatment assignments provide for us, by August 15, 2007, the unblinded treatment assignments and available clinical narratives for the following subjects, identified by their subject numbers:

 

Deaths:

 

Subject 141567: Completed suicide, 5 months postdose 3

Subject 312860: Completed suicide, 5 months postdose 2

Subject 390518: Interstitial lung disease, 16 months postdose 1

Subject 237484: AIDS, 8 months postdose 1

 

Serious Adverse Events:

Congenital:

Subject 470854: Hip dysplasia, 8 months postdose 2

Subject 489258: Dermoid cyst of ovary, 7 days postdose 3

 

Eye Disorder:

Subject 271404: Eye disorder (not specified), 13 months postdose 1

 

GI disorder:

Subject 209832: Irritable bowel syndrome, 17 days postdose 2

Subject 237484: Ascites, 11 months postdose 1

Subject 302971: Inflammatory bowel disease, 87 days postdose 3

 

Metabolism:

Subject 139047: DKA, 52 days postdose 2

 

Musculoskeletal:

Subject 294498: Fibromyalgia, 78 days postdose 2

 

Neoplasms:

Subject 175227: Teratoma, 16 days postdose 3

Subject 196354: Colon cancer, 112 days postdose 3

Subject 389954: Benign teratoma, 108 days postdose 2

Subject 390978: Gestational trophoblastic tumor, 8 months postdose 2

Pregnancy:

Subject 315953: Fetal macrosomia, 10 months postdose 2

 

Psychiatric:

Subject 153683: Suicide attempt, 112 days postdose 2

Subject 170457: Suicide attempt, 4 months postdose 1

Subject 173809: Depression, psychotic disorder, 26 days postdose 1

Subject 225916: Suicide attempt, 51 days postdose 2

Subject 393049: Suicide attempt, 49 days postdose 3

Subject 455037: Suicide attempt, 4 months postdose 2

Subject 460910: Suicide attempt, 16 days postdose 1

 

Respiratory:

Subject 367354: Asthma, bronchospasm, 70 days postdose 2

Subject 462888: Asthmatic crisis, 24 days postdose 2