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.