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CTC NOTICE OF MODIFICATIONS

Grade

Adverse Event

0

1

2

COAGULATION

Note: See the HEMORRHAGE...

DIC (disseminated intravascular coagulation)

Also consider Platelets. Note: Must have… Fibrinogen

The word grade was replaced with the word consider.

For leukemia studies or bone marrow infiltrative/ myelophthisic process, if specified in the protocol.

G2

Partial thromboplastin time (PTT)

Phlebitis is graded... Prothrombin time (PT) Thrombosis/embolism is graded...

The spelling for the word Phlebitis was corrected.

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

For BMT studies, if specified in the protocol.

G3

Also consider Hemoglobin... Note: Must have...

Coagulation - Other (Specify, __________)

CONSTITUTIONAL SYMPTOMS

Fatigue (lethargy, malaise, asthenia)

Note: See Appendix III...

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

7

3

Version 2.0 Publish Date: April 30, 1999

4

The Grade 4 value for Fibrinogen for leukemia studies or bone marrow infiltrative/ myelophthisic process was changed to <50mg (“%” was deleted).

Revised March 23, 1998

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