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CTC NOTICE OF MODIFICATIONS

Version 2.0 Publish Date: April 30, 1999

Grade

Adverse Event

  • 0

    1

2

3

4

Fever (in the absence of neutropenia, where neutropenia is defined as AGC < 1.0 x 109/L)

Also consider Allergic... Note: The temperature... Hot flashes/flushes... Rigors, chills

Sweating (diaphoresis)

The Also consider for Weight gain was changed to include the term Pleural effusion (non-malignant).

Weight gain Also consider Ascites…

Weight gain associated with Veno-Occlusive Disease (VOD) for BMT studies, if specified in the protocol.

G2

G7

Also consider Ascites… Weight loss Also consider Vomiting...

The Also consider Ascites, Edema, Pleural effusion (non-malignant) was added to Weight gain associated with Veno-Occlusive Disease for BMT studies.

The spelling for the word ascites was corrected.

Constitutional Symptoms - Other (Specify, __________)

DERMATOLOGY/SKIN

Alopecia

Bruising (in absence of grade 3 or 4 thrombocytopenia)

Note: Bruising resulting...

Dry skin

The adverse event Dermatitis, focal (associated with high-dose chemotherapy and bone marrow transplant) originally listed between Bruising and Dry skin was renamed Rash/dermatitis and moved to page 9.

Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)

Flushing Hand-foot skin reaction

Injection site reaction

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

8

Revised March 23, 1998

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