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CTC NOTICE OF MODIFICATIONS

Version 2.0 Publish Date: April 30, 1999

Appendix V

BMT-Specific Adverse Events

The BMT-Specific Adverse Events was added to summarize all BMT events included in the CTC v2.0.

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

Bilirubin associated with graft versus host disease for BMT studies.

Diarrhea associated with graft versus host disease (GVHD) for BMT studies.

Diarrhea for Pediatric BMT studies.

Hepatic enlargement

Leukocytes (total WBC) for BMT studies.

Leukocytes (total WBC) for pediatric BMT studies (using age, race and sex normal values).

Lymphopenia for pediatric BMT studies (using age, race and sex normal values).

Neutrophils/granulocytes (ANC/AGC) for BMT studies.

Platelets for BMT studies.

Rash/dermatitis associated with high-dose chemotherapy or BMT studies.

Rash/desquamation associated with graft versus host disease (GVHD) for BMT studies.

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

33

Revised March 23, 1998

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