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BiMo Request-Clarification - Cervarix, May 16, 21, 2007

Sullivan, Helen M
May 21 Request
Monday, May 21, 2007 6:52:48 PM
"We request that you submit a table which includes a complete list of all protocol deviations reported for Study HPV-008. We request that the table include the following information for each deviation:
• Subject number
• Center
• Date
• Type of Deviation
• Code for deviation
• Study Cohort(s) impacted by the deviation (i.e., safety, and/or immunogenecity, and/or efficacy)"

To: Ms. Sharon Shapowal (GSK)
File: STN #125259
Re: Datasets
Date: May 16, 2007
We have the following comments regarding datasets included in the BLA:
1. In the dataset "reaccod" (solicited adverse events), we note that Center number is not
included as a variable. Please provide this dataset with all Grade 3 solicited adverse events, and include within that table information regarding the study site where each Grade 3 adverse event was reported.
2. We analyzed the serious adverse event (SAE) data for certain centers as provided in the dataset "wconc" and compared them to the SAE information provided in the dataset "wunsol". We noted discrepancies between the two datasets. For example, for PID=19506, 19518, 19773, and 19914 (Center 3891), AE_SER = 'Y' in "wunsol" but AE_SER = ' ' in "wconc". We request that you clarify these discrepancies. Specifically, please explain the definition of serious adverse in each dataset.
In your reply to this memo, we recommend that you restate each item and follow it with your explanation or clarification. Use of this format helps organize the relevant information and provides a self-contained document that facilitates future reference.