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Summary Report and Cover Letter Memo

Dear TACL T2016-002 Study Investigator:

As investigators participating in a clinical trial using the investigational medicinal product (IMP) nivolumab, Bristol-Myers Squib has issued safety reports referenced in the memos found below.  The details of these adverse events/safety issues can be found in the "Detailed Individual SUSAR/CIOMS Report" page.  Each safety report has been independently reviewed and assessed by Dr. Anupam Verma (TACL Study Chair) and/or Dr. Nobuko Hijiya and Dr. Deepa Bhojwani (Vice-Chairs) for T2016-002 study.

WHAT THE INVESTIGATOR NEEDS TO DO WITH THIS INFORMATION:

  • Review each external adverse event associated with the use of Nivolumab as described in the T2016-002 Nivolumab External SUSAR summary report independent of study chair's determination
  • Evaluate each external adverse event to determine if it meets your local IRB/IEC reporting requirements
  • If Iocal IRB/IEC reporting requirements are met, submit it within the required timeframe 
  • Even if local IRB/IEC reporting requirements are not met, submission may be necessary per TACL Study Chair's determination
  • Copy and attach the summary reports to your Investigator's Brochure for the T2016-002 Nivolumab study protocol
  • Retain a copy of the memos in your site's study regulatory files

 

 Summary Reports    Cover Letter Memos
T2016-002 Nivolumab External SUSAR summary_July 2020   T2016-002 External SUSAR cover letter - 07.06.2020
T2016-002 Nivolumab External SUSAR summary_August 2020   T2016-002 External SUSAR cover letter - August 2020
T2016-002 Nivolumab External SUSAR summary_September-October 2020   T2016-002 External SUSAR cover letter - September-October 2020
T2016-002 Nivolumab External SUSAR summary_November 2020   T2016-002 External SUSAR cover letter - November 2020
T2016-002 Nivolumab External SUSAR summary_January 2021   T2016-002 External SUSAR cover letter - January 2021
T2016-002 Nivolumab External SUSAR summary_February 2021   T2016-002 External SUSAR cover letter - February 2021
T2016-002 Nivolumab External SUSAR summary_March 2021   T2016-002 External SUSAR cover letter - March 2021
T2016-002 Nivolumab External SUSAR summary_April 2021   T2016-002 External SUSAR cover letter - April 2021
T2016-002 Nivolumab External SUSAR summary_May 2021   T2016-002 External SUSAR cover letter - May 2021
T2016-002 Nivolumab External SUSAR summary_June 2021   T2016-002 External SUSAR cover letter - June 2021
T2016-002 Nivolumab External SUSAR summary_July-August 2021   T2016-002 External SUSAR cover letter - July-August 2021
T2016-002 Nivolumab External SUSAR summary_October-November 2021