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Detailed Individual SUSAR/CIOMS Report

Dear TACL T2016-002 Nivolumab Study Investigator:

As investigators participating in a clinical trial using the investigational medicinal product (IMP) Nivolumab, Bristol-Myers Squibb has issued the following safety reports below.  The details of these adverse events/safety issues are being reported in compliance with regulations.

What The Investigator Needs To Do With This Information:

  • Evaluate the adverse events associated with the use of Nivolumab for reporting to your local IRB, and if required, submit it within the required timeframe 
BMS-2019-118520-Fulminant type 1 diabetes_Acute kidney failure_Acidosis G4

SUSAR Date: 14 Apr 2020

BMS-2020-032436-Cardiac function decreased_Platelet count_Pneumonia_G5

SUSAR Date: 13 May 2020

SUSAR Date: 12 Jun 2020 
BMS-2020-035784-Haemolytic anaemia G2

SUSAR Date: 11 May 2020

BMS-2020-040314-Encephalitis G5

SUSAR Date: 18 Jun 2020