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CTC NOTICE OF MODIFICATIONS

Version 2.0 Publish Date: April 30, 1999

Appendix I

Adverse Event Module

G1

To be implemented at the request of the study sponsor or principal investigator in the protocol or by protocol amendment when more detailed information is considered pertinent.

Adverse Event: Date of onset: Date of first change in grade: Date of next change in grade: Date of next change in grade: Date of next change in grade: Date of next change in grade: Date of next change in grade:

Date of Treatment:

G1

Course Number: Grade at onset: Grade: Grade: Grade: Grade: Grade: Grade:

Did adverse event resolve? If so, date of resolution of adverse event:

Yes

______

No

______

Date of last observation (if prior to recovery):

Reason(s) observations stopped (if prior to recovery):

Was patient retreated?

Yes

______

No

______

If yes, was treatment delayed for recovery?

Yes

______

No

______

Date of next treatment? Dose reduced for next treatment?

Yes

No

______

______

Additional Comments: ________________________________________________________________________________________________________

___________________________________________________________

_______________________________________

G1

If module is being activated for new adverse event not currently in CTC, please provide definitions for adverse event grading:

Grade 0 = Grade 1 = Grade 2 = Grade 3 = Grade 4 =

______________________ ______________________

G7

_________________________________________ _________________________________________

____________________________________________________________________ ____________________________________________________________________ ____________________________________________________________________

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

28

Revised March 23, 1998

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