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CTC NOTICE OF MODIFICATIONS

Grade

Adverse Event Dehydration

  • 0

    1

2

3

Also consider Diarrhea...

Diarrhea Patients without colostomy:

The Also Consider for Dehydration was changed to Diarrhea, Vomiting, Stomatitis/pharyngitis (oral/ pharyngeal mucositis), Hypotension (“Hypotension” moved to the end of the sentence).

Patients with a colostomy:

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

The event Diarrhea for BMT studies was changed to Diarrhea associated with graft versus host disease (GVHD) for BMT studies, if specified in the protocol.

For Pediatric BMT studies, if specified in the protocol.

G3

Also consider Hemorrhage...

The Also Consider for Diarrhea was changed by removing the row shading to indicate that it relates to all four (4) Diarrhea adverse events.

Duodenal ulcer (requires radiographic or endoscopic documentation)

Dyspepsia/heartburn

Dysphagia, esophagitis, odynophagia (painful swallowing)

Note: If the adverse event i

G1

G7

Dysphagia-esophageal related to radiation

Also consider Pain Note: Fistula is...

Dysphagia-pharyngeal related to radiation

Also consider Pain due... Note: Fistula is graded... Fistula-esophageal Fistula-intestinal

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

11

Version 2.0 Publish Date: April 30, 1999

4

Revised March 23, 1998

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