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CTC NOTICE OF MODIFICATIONS

Version 2.0 Publish Date: April 30, 1999

Appendix V (Continued)

BMT-Specific Adverse Events

Summary of BMT-Specific Adverse Events that may be used if specified by the protocol. These differ from the standard CTC and may be more relevant to the transplant setting. They are listed here for the convenience of investigators writing transplant protocols. They are also included in the CTC document.

Grade

Adverse Event

  • 0

    1

2

3

4

Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies.

Transfusion: Platelets for BMT studies.

Transfusion: pRBCs for BMT studies.

Transfusion: pRBCs for Pediatric BMT studies.

Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTP or hemolytic uremic syndrome/HUS) for BMT studies.

Weight gain associated with Veno-Occlusive Disease (VOD) for BMT studies.

Cancer Therapy Evaluation Program Common Toxicity Criteria, Version 2.0 DCTD, NCI, NIH, DHHS March 1998

34

Revised March 23, 1998

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