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CTC NOTICE OF MODIFICATIONS

Grade

Adverse Event Transfusion: pRBCs

0

1

2

3

For BMT studies, if specified in the protocol.

G5

G3

For pediatric BMT studies, if specified in the protocol

The values for Transfusion: pRBCs for Pediatric BMT studies were separated from Transfusion: pRBCs BMT values (above) creating a new Adverse Event row.

Also consider Hemoglobin.

Blood/Bone Marrow - Other (Specify, __________)

CARDIOVASCULAR (ARRHYTHMIA)

Conduction abnormality/ Atrioventricular heart block

Nodal/junctional arrhythmia/dysrhythmia

Palpitations Note: Grade palpitations...

Prolonged QTc interval (QTc > 0.48 seconds)

Sinus bradycardia

Sinus tachycardia

Supraventricular arrhythmias (SVT/atrial fibrillation/ flutter)

Syncope (fainting) is... Vasovagal episode

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

4

Version 2.0 Publish Date: April 30, 1999

4

The Grade 2 value for Transfusion: pRBCs for Pediatric BMT studies was modified by adding a hyphen to designate a range of values.

Revised March 23, 1998

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