Contents

Purpose

 

 

Chronic GVHD - Activity Assessment Clinician eCRF

Field Name

Description / Instructions

Format

Visit Date

The Visit Date is required.

DD-MMM-YYYY

Data Collected? Indicate if data was collected or not. Use pick list.
Assessment Date Enter the Assessment Date.

DD-MMM-YYYY

Reason if Data Not Collected Enter the reason data was not collected. 200 characters 
Skin- erythematous rash of any sort (%BSA)   Number (99.999)
Skin- Moveable sclerosis (%BSA)   Number (99.999)
Skin- Non-moveable sclerosis or subcutaneous   Number (99.999)
Skin- Ulcers (largest ulceration lesion) Location   100 characters
Skin- Ulcers (largest ulceration lesion) Dimension (cm)   Number (99.99)
Eye- Right

 

  • NOT APPLICABLE
  • NOT ASSESSED
  • NOT ASSESSED DUE TO AGE RESTRICTION
  • PARTIALLY ASSESSED DUE TO AGE RESTRICTION
 Use pick list
Eye- Left  
  • NOT APPLICABLE
  • NOT ASSESSED
  • NOT ASSESSED DUE TO AGE RESTRICTION
  • PARTIALLY ASSESSED DUE TO AGE RESTRICTION
 Use pick list 
Mouth- Mucosal Change Erythema

 

  • 0 - None
  • 1 - Mild
  • 2 - Moderate
  • 3 - Severe
  • NOT APPLICABLE - Not Applicable
  • NOT ASSESSED - Not Assessed
  • PARTIALLY ASSESSED - Partial Assessment
  Use pick list
Mouth- Mucosal Change Lichenoid

 

  • 0 - None
  • 1 - Mild
  • 2 - Moderate
  • 3 - Severe
  • NOT APPLICABLE - Not Applicable
  • NOT ASSESSED - Not Assessed
  • PARTIALLY ASSESSED - Partial Assessment
 Use pick list
Mouth - Mucosal Change Ulcers

 

  • 0 - None
  • 1 - Mild
  • 2 - Moderate
  • 3 - Severe
  • NOT APPLICABLE - Not Applicable
  • NOT ASSESSED - Not Assessed
  • PARTIALLY ASSESSED - Partial Assessment
 Use pick list  
Mouth- Mucosal Change Mucoceles

 

  • 0 - None
  • 1 - Mild
  • 2 - Moderate
  • 3 - Severe
  • NOT APPLICABLE - Not Applicable
  • NOT ASSESSED - Not Assessed
  • PARTIALLY ASSESSED - Partial Assessment
 Use pick list
Mouth - Total Score   Number (99)
Upper GI

 

  • 0 - None
  • 1 - Occasional
  • 2 - Intermittent
  • 3 - Severe
  • NOT APPLICABLE - Not Applicable
  • NOT ASSESSED - Not Assessed
  • PARTIALLY ASSESSED - Partially Assessed
 Use pick list
Esophageal

 

  • 0 - None
  • 1 - Occasional
  • 2 - Intermittent
  • 3 - Severe
  • NOT APPLICABLE - Not Applicable
  • NOT ASSESSED - Not Assessed
  • PARTIALLY ASSESSED - Partially Assessed
 Use pick list
Lower GI- Diarrhea

 

  • 0 - None
  • 1 - Occasional
  • 2 - Intermittent
  • 3 - Severe
  • NOT APPLICABLE - Not Applicable
  • NOT ASSESSED - Not Assessed
  • PARTIALLY ASSESSED - Partially Assessed
 Use pick list
Health Care Provider Global Rating- Severity of cGVHD

 

  • 0 - None
  • 1 - Mild_
  • 2 - Moderate_
  • 3 - Severe_
 Use pick list
Health Care Provider Global Rating- Severity Scale Enter a number between 0 and 10. Number (99)
Health Care Provider Global Rating- Past Month Status

 

  • -1 - A Little Worse
  • -2 - Moderately Worse
  • -3 - Very Much Worse
  • 0 - About the Same
  • +1 - A Little Better
  • +2 - Moderately Better
  • +3 - Very Much Better

Use pick list

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.