Contents

Purpose

 

Chronic GVHD - Characteristics at Enrollment eCRF

Field Name

Description / Instructions

Format

Visit Date

The Visit Date is required.

DD-MMM-YYYY

cGVHD Original Seattle Classification

 

  • EXTENSIVE - Extensive Involvement
  • LIMITED - Limited Involvement
 Use pick list
cGVHD Revised Seattle Classification

 

  • EXTENSIVE - Extensive Involvement
  • LIMITED - Limited Involvement
 Use pick list
Organs Involved Select up to 9 organs involved from the pick list.  Use pick list
Current cGVHD Systemic Therapy?

 

  • NO
  • YES
 Use pick list
Agent Name Select up to 5 generic agents from the pick list if currently under systemic cGVHD therapy. Use pick list
Weight   Number (99.999)
% Change in Last (3) months   Number (99)
Weight Change

 

  • GAIN - Weight Gain
  • LOSS - Weight loss
  • STABLE - Stable Weight
 Use pick list
Date of Biopsy   DD-MMM-YYYY
Organ Select the organ from the picklist. Use pick list
Findings Enter the biopsy finding results. 200 characters
Autoimmune Manifestations List   200 characters 

Legend: (d) derived field, (m) RDC mandatory, (c) for CTEP reporting only.

Validations

Code

Description

Resolutions

  There are no validations.  

Derivations

Code

Field Name

Description

  There are no derivations.