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:
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
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BMS-2020-035784-Haemolytic anaemia G2
SUSAR Date: 11 May 2020 |
BMS-2020-040314-Encephalitis G5
SUSAR Date: 18 Jun 2020 |