Information request for BLA 125478/0, January 10, 2014 - RAGWITEK

(System Info - 260782 RIVERS KATIE 01/17/2014 08:21:55 RIVERSK)
From: Rivers, Katie
Sent: Friday, January 10, 2014 9:07 AM
To: 'Greenfeder, Scott'
Subject: Information request for BLA 125478/0
 Dear Scott,
 We have the following information request (IR) for your BLA, STN 125478/0:
1.Please provide a summary of the data for treatment interruptions. Specifically, provide the number of subjects who experienced a treatment interruption, the reason for each interruption, and the length of time the treatment was interrupted.
2.We note that you have separated adverse events that are synonymous (i.e., tongue swelling and tongue edema). Please clarify the reason that these events were defined differently (i.e., investigator determination) and not combined in your analysis. Also, please provide data that combines the synonymous adverse events.
3.Please provide a summary of the data for subjects that experienced multiple adverse events that appear to be similar (i.e., tongue edema and mouth edema or vomiting and esophageal pain).

Please reply to this request by Friday, January 17, 2014. Please let me know if you have any questions.
 Thank you,
 Katie
