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CTC NOTICE OF MODIFICATIONS

Version 2.0 Publish Date: April 30, 1999

Grade

Adverse Event

0

1

2

3

4

HEMORRHAGE

G6

Notes: Transfusion in this... For any bleeding with...

G7

The Note beginning with “For any bleeding with…” was revised to …in addition to grading severity by grading the site or type of bleeding.

If the site or type of Hemorrhage...

If the platelet...

Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia

Also consider Platelets...

G7

The Also consider for Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia was revised to Platelets, Hemoglobin, Transfusion-platelets, Transfusion- p R B C s s i t e o r t y p e o f b l e e d i n g . I f t h e s i t e i s n o t l i s t e d , g r a d e a s H e m o r r h a g e -

Other (Specify site, _______).

Note: This adverse event must...

G1

Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia

Also consider Platelets... Note: Bleeding in... CNS hemorrhage/bleeding

G7

The Note for Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia was revised by deleting the sentence “Also grade the site or type of hemorrhage/ bleeding. If the site is not listed, grade as Other in the HEMORRHAGE category”.

The Also consider for Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia

w a s r e v i s e d b y a d d i n g H e m o r r h a g e - O t h e r ( S p e c i f y s i t e

, _________

)

.

Epistaxis

Hematemesis

Hematuria (in the absence of vaginal bleeding)

Hemoptysis

Hemorrhage/bleeding associated with surgery

Note: Expected blood loss... Melena/GI bleeding

G1

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

14

Revised March 23, 1998

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