Contents

Purpose

 

Chronic GVHD - Activity Assessment Patient Self Reported 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
Severity of Symptom - Skin itching   10 characters
Severity of Symptom - Mouth dryness   10 characters 
Severity of Symptom - Mouth Pain   10 characters
Severity of Symptom - Mouth Sensitivity   10 characters
Severity of Symptom - What is your main complaint with regard to your eyes?   200 characters
Severity of Symptom - Eye Symptoms   10 characters
Vulvovaginal Symptoms - Do you have any burning, pain or discomfort?

 

  • N/A - NOT APPLICABLE
  • NO - NO
  • YES - YES
 Use pick list
Vulvovaginal Symptoms - Comments   200 characters
Patient Global Rating- Severity of cGVHD

 

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

Code

Description

Resolutions

  There are no validations.  

Code

Field Name

Description

  There are no derivations.