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COMMON TOXICITY CRITERIA (CTC) Version 2.0

NOTICE OF MODIFICATIONS Modifications made between January 30, 1998 and April 30, 1999

This document provides a description of the modifications made to the Common Toxicity Criteria Version 2.0 document between January 30, 1998 and April 30, 1999. The majority of the modifications are editorial adjustments that add clarity, consistency or correct typographical errors.

This document describes each modification within a rectangle which points to the location of the modification. Bold text within the rectangle indicates the new value or text. Modifications that are repeated throughout the document are presented with a numeric annotation (see below) to prevent redundancy. Item-specific modifications are described at the point of the modification.

Please note that all grading criteria, Notes and Also consider details are deleted from this publication to simplify the viewing of this document. The Adverse Event names and the document formatting remain intact to allow for comparisons between this document and CTC document published April 30, 1999.

NUMERIC ANNOTATIONS (Global Modifications)

Used for identifying modifications made for consistency purposes throughout the CTC V2.0 document.

Annotation Number

G1 G2

Modification Description The word toxicity was replaced with the term adverse event.

Information now provided within the Adverse Event column was originally presented as a Note relating to the adverse event. Both the adverse event name and the Note were consolidated to condense the information. The phrase if specified in the protocol was also added.

G3

The phrase if specified in the protocol was added to the adverse event name.

G4 G5 G6 G7

A comma was added to values exceeding four digits. The unit of measure cc was changed to mL. Note: changed to Notes: where two or more notes appear consecutively.

Minor editorial changes (i.e., punctuation, capitalization and lowercase corrections, replacement of hyphens with colons, etc).

i

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