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Detailed Individual SUSAR/CIOMS Report

Dear TACL T2017-002 Ixazomib Study Investigator:

As investigators participating in a clinical trial using the investigational medicinal product (IMP) ixazomib, PPD Global 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 
PPD Ref: Batch 622 MLN9708 20201012
PPD Ref: Batch 621 MLN9708 20201005
PPD Ref: Batch 619 MLN9708 20200917
PPD Ref: Batch 618 MLN9708 20200910
PPD Ref: Batch 617 MLN9708 20200903
PPD Ref: Batch 616 MLN9708 20200825
PPD Ref: Batch 615 MLN9708 20200819
PPD Ref: Batch 614 MLN9708 20200814
PPD Ref: Batch 613 MLN9708 20200813
PPD Ref: Batch 612 MLN9708 20200728
PPD Ref: Batch 611 MLN9708 20200717
PPD Ref: Batch 610 MLN9708 20200709
PPD Ref: Batch 609 MLN9708 20200701
PPD Ref: Batch 608 MLN9708 20200626
PPD Ref: Batch 607 MLN9708 20200617