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CTC NOTICE OF MODIFICATIONS

Version 2.0 Publish Date: April 30, 1999

Grade

Adverse Event

  • 0

    1

2

3

4

Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)

Rectal bleeding/ hematochezia

Vaginal bleeding

Hemorrhage - Other (Specify site, ___________)

HEPATIC

Alkaline phosphatase Bilirubin

Bilirubin associated with graft versus host disease (GVHD) for BMT studies, if specified in the protocol.

G2

GGT (- Glutamyl transpeptidase)

Hepatic enlargement Note: Grade Hepatic... Hypoalbuminemia

Liver dysfunction/ failure (clinical)

G1

The rows for Hepatic enlargement and its Note were shaded to indicate the relationship between VOD and BMT.

The Note for Hepatic enlargement was revised to Grade Hepatic enlargement only for treatment related adverse event including Veno-Occlusive Disease.

Portal vein flow

The Note for Liver dysfunction/failure (clinical) was deleted.

SGOT (AST) (serum glutamic oxaloacetic transaminase)

SGPT (ALT) (serum glutamic pyruvic transaminase)

Hepatic - Other (Specify, __________)

INFECTION/FEBRILE NEUTROPENIA

Catheter-related infection

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

15

Revised March 23, 1998

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