Contents

Purpose

 

Chronic GVHD - Treatment History eCRF

Field Name

Description / Instructions

Format

Visit Date

The Visit Date is required.

DD-MMM-YYYY

Date of GVHD Diagnosis   DD-MMM-YYYY
Biopsy Proven?

 

  • NO
  • YES
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If Biopsy Proven, Date Obtained   DD-MMM-YYY 
GVHD Type

 

  • CLASSIC CGVHD - Chronic Craft versus Host Disease (GVHD) without features characteristic of acute GVHD
  • LATE ACUTE GVHD - Features of classic acute Graft versus Host Disease (GVHD) without diagnostic or distinctive manifestations of chronic GVHD occurring beyond 100 days of transplantation or Donor Lymphocyte Infusion (D
  • OVERLAP CGVHD - Features of chronic and acute Graft versus Host Disease (GVHD) appear together
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Late Acute GVHD subtype

 

  • DELAYED - Delayed acute GVHD manifestations presenting for the first time after Day 100 of transplantation or Donor Lymphocyte Infusion (DLI)
  • PROLONGED - Prolonged acute GVHD manifestations that started before Day 100 and continue beyond Day 100
  • RECURRENT - Recurrent acute GVHD manifestations after Day 100 that reappear after resolution of any prior acute GVHD
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Intensity of current immunosuppression

 

  • HIGH - High (2 or more agents/modalities +/- prednisone >= 0.5 mg/kg/day)
  • MILD - Mild (single agent prednisone <0.5 mg/kg/day)
  • MODERATE - Moderate (prednisone  >= 0.5 mg/kg/day and/or any single agent/modality)
  • NONE - None
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Therapeutic intent at time of clinic visit

 

  • ALTER SYSTEMIC THERAPY DUE TO ITS TOXICITY
  • DECREASE SYSTEMIC THERAPY B/C CGVHD IS BETTER
  • INCREASE SYSTEMIC THERAPY B/C CGVHD IS WORSE
  • NO CHANGE TO CURRENT SYSTEMIC THERAPY B/C CGVHD IS STABLE
  • NOT APPLICABLE
  • SUBSTITUTE SYSTEMIC THERAPY DUE TO LACK OF RESPONSE
  • WITHDRAW SYSTEMIC THERAPY DUE TO LACK OF RESPONSE
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Clinician's impression of activity

 

  • ACTIVE, IRRESPECTIVE OF THE LEVEL OF CURRENT THERAPY
  • HIGHLY ACTIVE, IRRESPECTIVE OF THE LEVEL OF CURRENT THERAPY
  • INACTIVE, OFF SYSTEMIC THERAPY OR TOPICAL IMMUNOSUPPRESSION
  • INACTIVE, ON SYSTEMIC THERAPY OR TOPICAL IMMUNOSUPPRESSION
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cGVHD Biopsy Proven Organ Involvement

 

  • EYE
  • GENITAL TRACT
  • GI
  • JOINTS AND FASCIA
  • LIVER
  • LUNG
  • MOUTH
  • SKIN
  • VULVOVAGINAL
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Biopsy Proven?

 

  • NO
  • YES
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Prior Systemic Therapy

 

  • NO
  • YES
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Prior Systemic Therapy - Agent Name   Use pick list
Current Systemic Therapy - Agent Name   Use pick list
Current Systemic Therapy - Comments   200 characters
Type of Onset of cGVHD relative to aGVHD

 

  • DE NOVO
  • PROGRESSIVE
  • QUIESCENT
 Pre-defined
Yes/No

 

  • NO
  • YES
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Documented infections since cGVHD Diagnosis?

 

  • NO
  • YES
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List infections since cGVHD Diagnosis

 

  • ACTIVE CHICKEN POX, HERPES ZOSTER, OR VARICELLA ZOSTER (VZV, SHINGLES)
  • ACTIVE CMV (CYTOMEGALOVIRUS)
  • ACTIVE HERPES SIMPLEX VIRUS (HSV)
  • BACTERIAL INFECTION IN THE BLOOD
  • BRONCHITIS
  • CATHETER INFECTION
  • CELLULITIS
  • CONJUNCTIVITIS OR EYE INFECTION
  • EAR INFECTION
  • FUNGUS (YEAST OR MOLD)
  • HEAD COLD OR SINUS INFECTION
  • HEMOPHILUS INFLUENZA
  • HEPATITIS
  • HPV/CERVICAL DYSPLASIA
  • INFLUENZA A
  • MENINGITIS
  • MYCOBACTERIUM AVIUM-INTRACELLULARE INFECTION (MAI)
  • PNEUMOCYSTIS CARINII (PCP)
  • PNEUMONIA
  • RESPIRATORY SYNCTIAL VIRUS (RSV)
  • SINUSITIS
  • STAPHYLOCOCCUS AUREUS
  • UPPER RESPIRATORY INFECTION (URI)
  • URINARY TRACT INFECTION (URI)
  • YEAST INFECTION IN THE MOUTH
  • YEAST INFECTION IN THE VAGINA
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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.  
Last updated by Fontinha, Marcelo (NIH/OD) [E] on Jul 30, 2013