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CTC NOTICE OF MODIFICATIONS

Version 2.0 Publish Date: April 30, 1999

Appendix II Infection Module

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.

  • 1.

    Use the Common Toxicity Criteria definitions to grade the severity of the infection.

  • 2.

    Specify type of infection from the following (CHOOSE ONE):

BACTERIAL

FUNGAL

PROTOZOAL

VIRAL

UNKNOWN

  • 3.

    Specify site of infection from the following (CHOOSE ALL THAT APPLY): BLOOD CULTURE POSITIVE BONE INFECTION CATHETER (intravenous) CATHETER (intravenous), tunnel infection CENTRAL NERVOUS SYSTEM INFECTION EAR INFECTION EYE INFECTION GASTROINTESTINAL INFECTION ORAL INFECTION PNEUMONIA SKIN INFECTION UPPER RESPIRATORY INFECTION URINARY TRACT INFECTION VAGINAL INFECTION INFECTION, not otherwise specified (Specify site, __________)

  • 4.

    Specify organism, if known: _______________.

  • 5.

    Prophylactic antibiotic, antifungal, or antiviral therapy administration Yes_______ No_______ If prophylaxis was given prior to infection, please specify below: Antibiotic prophylaxis _____________________________________________________ Antifungal prophylaxis ____________________________________________________ Antiviral prophylaxis ______________________________________________________ Other prophylaxis ________________________________________________________

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

29

Revised March 23, 1998

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