Graft-versus-host disease (GVHD) is an immunological phenomenon resulting from the reaction of donor immune cells against major or minor histocompatibility antigens of the recipient. GVHD is primarily caused by donor-derived T-cells. Factors influencing the severity of GVHD are related to three main categories: 1) donor or graft, 2) recipient, and 3) treatment. The most influential donor/graft factor is the degree of genetic disparity between the donor and the recipient (HLA match), but other risk factors include female donor to male recipient, donor parity, older donors, and T-cell dose. The occurrence of acute GVHD becomes a risk factor for the development of chronic GVHD. Recipient age and prior infections are also factors. Treatment- related factors include a myeloablative preparative regimen and inadequate post-HCT immune suppression (GVHD prophylaxis).
In the past, GVHD was classified as acute or chronic based on its time to diagnosis following transplant, and other clinical and histological (biopsy or post-mortem) features. Today, there has been increased recognition that acute and chronic GVHD are not dependent upon time since HCT, so determination of acute or chronic should rest on clinical and histologic features. The organs most commonly affected by acute GVHD are the skin, gut, or liver. Other sites, such as the lung, may be involved.
Chronic GVHD will be diagnosed and graded according to the guidelines described in protocol Appendix F, utilizing the NIH Consensus Criteria.
Reporting GVHD in Veeva EDC:
cGVHD should be recorded with regard to reporting period, with the exception of cGVHD that occurs prior to Day 100. The first timepoint where the Chronic or Overlap GVHD form comes due is at D100. cGVHD that occurs prior to the D100 visit (e.g., cGVHD detected between D0 and D100) can wait to be reported until the Day 100 event date.
Reporting periods begin one day after the last visit, and run through the date of the current visit. Please see the example below, and use the reporting periods provided in the table above to determine which folder GVHD would be reported in.
Example: Subject receives a transplant on 31-JAN. Subject is diagnosed with GVHD on 20-MAY. GVHD should be reported in the Day 180 visit folder, because it was diagnosed within the Day 180 reporting period –
| Visit | Visit Window | Reporting Period |
|---|---|---|
| Day 100 Occurred 11-MAY |
+/- 7 days: 04-MAY through 18-MAY |
Day +0 through Day +100 post-transplant: 31-JAN through 11-MAY |
| Day 180 Occurred 30-JUL |
+/- 14 days: 16-JUL through 13-AUG |
Day +101 through Day +180 post-transplant: 12-MAY through 30-JUL |
For the above example, cGVHD should be reported in the Day 180 visit folder in real-time. Follow the below steps to report prior to the occurrence of the occurrence of the Day 180 visit:
- In Veeva EDC, record the projected visit date as the visit’s Event Date to trigger the next visit forms. This should be within the expected date range for the next visit/event:
- Once the D180 study visit occurs, revise the event date if needed. Select the ellipses to the right of the date, then click “Edit Event Date”. Enter the study date, then select Reason for Change (Updated Information). This date should match the Date of Evaluation on the follow-up form.
- Click Save
Did chronic GVHD develop, occur or persist since last reported for the study?:
Report if chronic GVHD developed, occurred, or persisted since last reported for the study. If yes, click +New Section to report each re-occurrence or new diagnoses. The system allows for maximum number of repeats of 999 for new sections.
If answered yes, additional fields appear below to complete.
Date of chronic GVHD diagnosis:
Report the date of clinical diagnosis of chronic GVHD in DD/MMM/YYYY format. The clinical diagnosis date may not necessarily be the date the symptoms began (example: the subject developed dry eyes one week prior to the physician documenting the dry eyes as a manifestation of chronic GVHD). If the clinical diagnosis date is not documented, then report the date of histological confirmation. If onset of chronic GVHD occurred in prior reporting period, leave this field blank and complete the following field.
If the subject developed more than one episode of chronic GVHD in the same reporting period, report the date of onset of the first episode of chronic GVHD.
If the date of chronic GVHD has previously been reported, leave this field blank and check the following field. This field will be removed.
Date of chronic GVHD diagnosis previously reported:
Check the box if date of chronic GVHD diagnosis was previously reported. This field should not be completed at Day 100 (first instance of this form). If box is checked, the preceding field (Date of chronic GVHD diagnosis) disappears.
Onset of chronic GVHD:
Indicate whether the onset of chronic GVHD was:
• Progressive (acute GVHD present within 2 weeks prior to onset of chronic GVHD)
• Interrupted (acute GVHD resolved, then chronic GVHD developed)
• De novo (acute GVHD never developed)
If the onset of chronic GVHD has previously been reported, leave this field blank and check the following field. This field will be removed.
Onset of chronic GVHD was previously reported:
Check this field, if chronic GVHD was diagnosed in a previous reporting period. This field should not be checked at Day 100.
Were signs of acute GVHD present at the time of chronic GVHD diagnosis (overlap syndrome):
Chronic GVHD can be separated into two different categories; classical chronic GVHD and overlap syndrome. Overlap syndrome is a condition where there are features of both acute and chronic GVHD at the time of diagnosis. Indicate whether signs of acute GVHD were present at the time of diagnosis of chronic GVHD (overlap syndrome) as Yes or No.
If overlap of chronic GVHD has previously been reported, leave this field blank and check the following field. This field will be removed.
Overlap GHVD was previously reported:
Check this field, if chronic GVHD was diagnosed in a previous reporting period. This field should not be checked at Day 100.
Was functional status assessed:
Report if functional (performance) status was assessed within the reporting period as Yes or No.
Karnofsky Performance Scale:
Report the performance status score observed at the time of maximum chronic GVHD severity in this reporting period (example provided below). Options are as follows:
o 100% – Normal, no complaints, no evidence of disease
o 90% – Able to carry on normal activity
o 80% – Normal activity with effort
o 70% – Cares for self, unable to carry on normal activity or to do active work
o 60% – Requires occasional assistance but is able to care for most needs
o 50% – Requires considerable assistance and frequent medical care
o 40% – Disabled, requires special care and assistance
o 30% – Severely disabled, hospitalization indicated, although death not imminent
o 20% – Very sick, hospitalization necessary
o 10% – Moribund, fatal process progressing rapidly
If ECOG performance status was collected instead of Karnofsky, clinician should convert score to Karnofsky and addend progress note in the EMR to add this data post-visit.
Example: Between the D56 and D100 visit, the subject experiences the following changes to GVHD severity and performance status:
| Date | Chronic GVHD Maximum Grade | Performance Status Score |
|---|---|---|
| 02-FEB (day +71) | Moderate cGVHD | 70% |
| 22-FEB (day+91) | Mild cGVHD | 80% |
- Maximum grade of chronic GVHD according to best clinical judgment since last reported for the study = Moderate
- Karnofsky Performance Scale = 70%
If “Was functional status assessed” = No, use the Intentionally Left Blank functionality.
Chronic or Overlap GVHD organ involvement
Was there chronic skin GVHD involvement for this occurrence in this reporting period?:
Indicate if chronic skin GVHD involvement occurred during this reporting period as Yes or No.
Chronic GVHD skin body surface area (BSA) score:
This field will only appear in EDC if “Was there chronic skin GVHD involvement for this occurrence in this reporting period?” is answered Yes. Select the skin score observed at the time of the maximum GVHD severity in this reporting period. GVHD features to be scored by BSA include maculopapular rash/erythema, lichen planus-like features, sclerotic features, papulosquamous lesions or ichthyosis, keratosis pilaris-like GVHD.
• Score 0 – No BSA involved
• Score 1 – 1-18% BSA
• Score 2 – 19-50% BSA,
• Score 3 – >50% BSA
Skin GVHD features present to be scored by BSA (select all that apply)
The following fields will only appear in EDC if “Was there chronic skin GVHD involvement for this occurrence in this reporting period?” is answered Yes. Indicate if skin features were present.
Maculopapular rash / erythema:
Check this field if the subject experienced reddish skin with small confluent bumps / redness.
Lichen planus-like features:
Check this field if the subject experienced whitish lacy patches.
Sclerotic features:
Check this field if the subject experienced thickening of the skin, which may cause loss of suppleness.
Papulosquamous lesions or ichthyosis:
Check this field if the subject experienced dry, scaly, or thickened skin.
Keratosis pilaris-like GVHD:
Check this field if the subject experienced small acne-like bumps and rough patches.
Skin features score:
Select the skin feature score observed at the time of the maximum GVHD severity in this reporting period:
• Score 0 – No sclerotic features
• Score 2 – Superficial sclerotic features “not hidebound” (able to pinch)
• Score 3 – Deep sclerotic features, hidebound (unable to pinch), impaired mobility, or ulceration
Other skin GVHD features (NOT scored by BSA) (select all that apply)
Hyperpigmentation:
This field will only appear in EDC if “Was there chronic skin GVHD involvement for this occurrence in this reporting period?” is answered Yes. Hyperpigmentation results in patches of skin which are darker in color than surrounding skin due to hyperproduction of melanin. Indicate if skin feature was present.
Hypopigmentation:
This field will only appear in EDC if “Was there chronic skin GVHD involvement for this occurrence in this reporting period?” is answered Yes. Hypopigmentation results in patches of skin which are lighter in color than surrounding skin due to an absence of melanin. Indicate if skin feature was present.
Poikiloderma:
This field will only appear in EDC if “Was there chronic skin GVHD involvement for this occurrence in this reporting period?” is answered Yes. Poikiloderma results in mottled, patchy skin often reddish-brown and present on the neck, upper check and cheeks. Indicate if skin feature was present.
Severe or generalized pruritus:
This field will only appear in EDC if “Was there chronic skin GVHD involvement for this occurrence in this reporting period?” is answered Yes. Pruritus refers to itchy skin (either limited to an area or widespread). Indicate if skin feature was present.
Hair involvement:
This field will only appear in EDC if “Was there chronic skin GVHD involvement for this occurrence in this reporting period?” is answered Yes. Hair involvement refers hair disturbances such as hair loss. Indicate if skin feature was present.
Nail involvement:
This field will only appear in EDC if “Was there chronic skin GVHD involvement for this occurrence in this reporting period?” is answered Yes. Nail involvement refers to scarring of the nail bed or alterations in appearance (i.e., ridging). Indicate if skin feature was present.
Skin abnormality present but explained entirely by non-GVHD documented cause:
This field will only appear in EDC if “Was there chronic skin GVHD involvement for this occurrence in this reporting period?” is answered Yes. Indicate if there were any skin abnormalities present but were entirely explained by non-GVHD documented causes. If “Yes,” continue with the next question.
Specify cause of skin abnormality:
This field will only appear in EDC if “Skin abnormality present but explained entirely by non-GVHD documented cause” is answered Yes. Please report the cause in this free textbox (up to 200 characters).
Skin evaluation by biopsy (histology):
This field will only appear in EDC if “Was there chronic skin GVHD involvement for this occurrence in this reporting period?” is answered Yes. Indicate the results of the skin biopsy (histology), by selecting one of the following options:
• Positive
• Suggestive
• Negative
• Inconclusive / equivocal
• Not done
Was there chronic mouth GVHD involvement for this occurrence in this reporting period?:
Indicate if mouth involvement was occurred during this reporting period as Yes or No.
Chronic GVHD mouth score:
This field will only appear in EDC if “Was there chronic mouth GVHD involvement for this occurrence in this reporting period?” is answered Yes. Select the mouth score observed at the time of the maximum GVHD severity in this reporting period:
• Score 0 – No symptoms
• Score 1 – Mild symptoms with disease signs but not limiting oral intake significantly
• Score 2 – Moderate symptoms with disease signs with partial limitation of oral intake
• Score 3 – Severe symptoms with disease signs on examination with major limitation of oral intake
Lichen planus-like features:
This field will only appear in EDC if “Was there chronic mouth GVHD involvement for this occurrence in this reporting period?” is answered Yes. Lichen planus-like features include white, lacy patches; swollen tissue or open sores. Indicate if feature was present.
Mouth abnormality present but explained entirely by non-GVHD documented cause:
This field will only appear in EDC if “Was there chronic mouth GVHD involvement for this occurrence in this reporting period?” is answered Yes. Indicate if there were any mouth abnormalities present but were entirely explained by non-GVHD documented causes. If “Yes,” continue with the next question.
Specify cause of mouth abnormality:
This field will only appear in EDC if “Mouth abnormality present but explained entirely by non-GVHD documented cause” is answered Yes. Please report the cause in this free textbox (up to 200 characters).
Was there chronic eye GVHD involvement for this occurrence in this reporting period?:
Indicate if eye involvement occurred during this reporting period as Yes or No.
Chronic GVHD eyes score:
This field will only appear in EDC if “Was there chronic eye GVHD involvement for this occurrence in this reporting period?” is answered Yes. Select the eyes score observed at the time of the maximum GVHD severity in this reporting period:
• Score 0 – No symptoms
• Score 1 – Mild dry eye symptoms not affecting ADL (requirement of lubricant eye drops ≤ 3x per day)
• Score 2 – Moderate dry eye symptoms partially affecting ADL (requiring lubricant eye drops >3x per day or punctal plugs), WITHOUT new vision impairment due to KCS
• Score 3 – Severe dry eye symptoms significantly affecting ADL (special eyewear to relieve pain) OR unable to work because of ocular symptoms OR loss of vision due to KCS
Keratoconjunctivitis sicca (KCS) confirmed by ophthalmologist:
This field will only appear in EDC if “Was there chronic eye GVHD involvement for this occurrence in this reporting period?” is answered Yes. Keratoconjunctivitis sicca (KCS) is a dry eye condition which must be confirmed by an ophthalmologist. Indicate if feature was present.
Eye abnormality present but explained entirely by non-GVHD documented cause:
This field will only appear in EDC if “Was there chronic eye GVHD involvement for this occurrence in this reporting period?” is answered Yes. Indicate if there were any eye abnormalities present but were entirely explained by non-GVHD documented causes. If “Yes,” continue with the next question.
Specify cause of eye abnormality:
This field will only appear in EDC if “Eye abnormality present but explained entirely by non-GVHD documented cause” is answered Yes. Please report the cause in this free textbox (up to 200 characters).
Was there chronic gastrointestinal (GI) GVHD involvement for this occurrence in this reporting period?:
Indicate if Gastrointestinal (GI) tract involvement occurred during this reporting period as Yes or No.
Chronic GVHD gastrointestinal (GI) score:
This field will only appear in EDC if “Was there chronic gastrointestinal (GI) GVHD involvement for this occurrence in this reporting period?” is answered Yes. Select the GI tract score observed at the time of the maximum GVHD severity in this reporting period:
• Score 0 – No symptoms
• Score 1 – Symptoms without significant weight loss (<5%)
• Score 2 – Symptoms associated with mild to moderate weight loss (5-15%) OR moderate diarrhea without significant interference with daily living
• Score 3 – Symptoms associated with significant weight loss (>15%), requires nutritional supplementation for most calorie needs OR esophageal dilation OR severe diarrhea with significant interference with daily living
GI GVHD features present (check all that apply)
Esophageal web/proximal stricture or ring:
This field will only appear in EDC if “Was there chronic gastrointestinal (GI) GVHD involvement for this occurrence in this reporting period?” is answered Yes. Esophageal rings and webs are thin structures that partially occlude the esophageal lumen. Indicate if feature was present.
Dysphagia:
This field will only appear in EDC if “Was there chronic gastrointestinal (GI) GVHD involvement for this occurrence in this reporting period?” is answered Yes. Dysphagia is a medical term for difficulty swallowing. Indicate if feature was present.
Anorexia:
This field will only appear in EDC if “Was there chronic gastrointestinal (GI) GVHD involvement for this occurrence in this reporting period?” is answered Yes. Indicate if feature was present.
Nausea:
This field will only appear in EDC if “Was there chronic gastrointestinal (GI) GVHD involvement for this occurrence in this reporting period?” is answered Yes. Indicate if feature was present.
Vomiting:
This field will only appear in EDC if “Was there chronic gastrointestinal (GI) GVHD involvement for this occurrence in this reporting period?” is answered Yes. Indicate if feature was present.
Diarrhea:
This field will only appear in EDC if “Was there chronic gastrointestinal (GI) GVHD involvement for this occurrence in this reporting period?” is answered Yes. Indicate if feature was present.
Weight loss ≥ 5%:
This field will only appear in EDC if “Was there chronic gastrointestinal (GI) GVHD involvement for this occurrence in this reporting period?” is answered Yes. Indicate if feature was present.
Failure to thrive:
This field will only appear in EDC if “Was there chronic gastrointestinal (GI) GVHD involvement for this occurrence in this reporting period?” is answered Yes. Failure to thrive describes a syndrome of global decline, marked by weight loss, decrease in appetite and other physical manifestations. Indicate if feature was present.
GI abnormality present but explained entirely by non-GVHD documented cause:
This field will only appear in EDC if “Was there chronic gastrointestinal (GI) GVHD involvement for this occurrence in this reporting period?” is answered Yes. Indicate if there were any GI abnormalities present but were entirely explained by non-GVHD documented causes. If “Yes,” continue with the next question.
Specify cause of GI abnormality:
This field will only appear in EDC if “GI abnormality present but explained entirely by non-GVHD documented cause” is answered Yes. Please report the cause in this free textbox (up to 200 characters).
GI evaluation by biopsy (histology):
This field will only appear in EDC if “Was there chronic gastrointestinal (GI) GVHD involvement for this occurrence in this reporting period?” is answered Yes. Indicate the results of the biopsy (histology), by selecting one of the following options:
• Positive
• Suggestive
• Negative
• Inconclusive / equivocal
• Not done
Was there chronic liver GVHD involvement for this occurrence in this reporting period?:
Indicate if liver involvement occurred during this reporting period as Yes or No (assessed via total bilirubin).
Chronic GVHD liver score:
This field will only appear in EDC if “Was there chronic liver GVHD involvement for this occurrence in this reporting period?” is answered Yes. Select the liver score observed at the time of the maximum GVHD severity in this reporting period:
• Score 0 – Normal total bilirubin and ALT or AP <3 x uln
• Score 1 – Normal total bilirubin with ALT ≥3 to 5 x ULN or AP ≥3 x ULN
• Score 2 – Elevated total bilirubin but ≤3 mg/dL or ALT >5 ULN
• Score 3 – Elevated total bilirubin > 3 mg/dL
Liver abnormality present but explained entirely by non-GVHD documented cause:
This field will only appear in EDC if “Was there chronic liver GVHD involvement for this occurrence in this reporting period?” is answered Yes. Indicate if there were any liver abnormalities present but were entirely explained by non-GVHD documented causes. If “Yes,” continue with the next question.
Specify cause of liver abnormality:
This field will only appear in EDC if “Liver abnormality present but explained entirely by non-GVHD documented cause” is answered Yes. Please report the cause in this free textbox (up to 200 characters).
Liver evaluation by biopsy (histology):
This field will only appear in EDC if “Was there chronic liver GVHD involvement for this occurrence in this reporting period?” is answered Yes. Indicate the results of the biopsy (histology), by selecting one of the following options:
• Positive
• Suggestive
• Negative
• Inconclusive / equivocal
• Not done
Was there chronic lung GVHD involvement for this occurrence in this reporting period?:
Indicate if lung involvement occurred during this reporting period as Yes or No.
Chronic GVHD lung symptom score:
This field will only appear in EDC if “Was there chronic lung GVHD involvement for this occurrence in this reporting period?” is answered Yes. Select the lung score observed at the time of the maximum GVHD severity in this reporting period:
• Score 0 – No symptoms
• Score 1 – Mild symptoms (shortness of breath after climbing one flight of steps)
• Score 2 – Moderate symptoms (shortness of breath after walking on flat ground)
• Score 3 – Severe symptoms (shortness of breath at rest; requiring oxygen)
Were pulmonary function tests performed:
This field will only appear in EDC if “Was there chronic lung GVHD involvement for this occurrence in this reporting period?” is answered Yes. Indicate if pulmonary function tests (PFTs) were performed as “Yes” or “No.” If indicated “Yes,” continue with PFT-related question.
Specify FEV1 percent (%):
This field will only appear in EDC if “Were pulmonary function tests performed” is answered Yes. Specify the FEV1 percent documented on the pulmonary function test results in %. This field allows up to five characters.
Lung abnormality present but explained entirely by non-GVHD documented cause:
This field will only appear in EDC if “Was there chronic lung GVHD involvement for this occurrence in this reporting period?” is answered Yes. Indicate if there were any lung abnormalities present but were entirely explained by non-GVHD documented causes. If “Yes,” continue with the next question.
Specify cause of lung abnormality:
This field will only appear in EDC if “Lung abnormality present but explained entirely by non-GVHD documented cause” is answered Yes. Please report the cause in this free textbox (up to 200 characters).
Lung evaluation by biopsy:
This field will only appear in EDC if “Was Liver assessed” is answered Yes. Indicate the results of the biopsy (histology), by selecting one of the following options:
• Positive
• Suggestive
• Negative
• Inconclusive / equivocal
• Not done
Was there chronic joint and fascia GVHD involvement for this occurrence in this reporting period?:
Indicate if joints and fascia involvement occurred during this reporting period as Yes or No.
Chronic GVHD joint and fascia score:
This field will only appear in EDC if “Was there chronic joint and fascia GVHD involvement for this occurrence in this reporting period?” is answered Yes. Select the score observed at the time of the maximum GVHD severity in this reporting period:
• Score 0 – No symptoms
• Score 1 – Mild tightness of arms or legs, normal or mild decreased range of motion (ROM) AND not affecting ADL
• Score 2 – Tightness of arms or legs OR joint contractures, erythema thought due to fasciitis, moderate decrease ROM AND mild to moderate limitation of ADL
• Score 3 – Contractures WITH significant decrease ROM AND significant limitation of ADL (e.g. unable to tie shoes, button shirts, dress self, etc.)
• Not applicable – abnormality present but explained entirely by non-GVHD documented cause
Was P-ROM score assessed:
This field will only appear in EDC if “Were joints and fascia assessed” is answered Yes. Indicate if Photographic Range of Motion (P-ROM) was assessed during this reporting period as Yes or No.
List P-ROM score for areas listed below
This section will only appear in EDC if “Was P-ROM score assessed” is answered Yes.
Report the P-ROM score for areas listed below:
Shoulder (1-7)
Elbow (1-7)
Wrist/finger (1-7)
Ankle (1-4)
Joint or fascia abnormality present but explained entirely by non-GVHD documented cause:
This field will only appear in EDC if “Was there chronic joint and fascia GVHD involvement for this occurrence in this reporting period?” is answered Yes. Indicate if there were any Joint or fascia abnormalities present but were entirely explained by non-GVHD documented causes. If “Yes,” continue with the next question.
Specify cause of joint or fascia abnormality:
This field will only appear in EDC if “Joint or fascia abnormality present but explained entirely by non-GVHD documented cause” is answered Yes. Please report the cause in this free textbox (up to 200 characters).
Was there chronic genital tract GVHD involvement for this occurrence in this reporting period?:
Indicate if genital tract involvement occurred during this reporting period as Yes or No.
Chronic GVHD genital tract score:
This field will only appear in EDC if “Was there chronic genital tract GVHD involvement for this occurrence in this reporting period?” is answered Yes. Select the score observed at the time of the maximum GVHD severity in this reporting period:
• Score 0 – No signs
• Score 1 – Mild signs and females with or without discomfort on exam
• Score 2 – Moderate signs and may have symptoms with discomfort on exam
• Score 3 – Severe signs with or without symptoms
Currently sexually active:
This field will only appear in EDC if “Was there chronic genital tract GVHD involvement for this occurrence in this reporting period?” is answered Yes. Report if the subject is currently sexually active as Yes, No, or Unknown (not asked / not disclosed).
Genital tract abnormality present but explained entirely by non-GVHD documented cause:
This field will only appear in EDC if “Was there chronic genital tract GVHD involvement for this occurrence in this reporting period?” is answered Yes. Indicate if any genital tract abnormalities were present but explained by non-GVHD documented causes in “Yes” or “No.” If “Yes,” continue with the next question.
Specify cause of genital tract abnormality:
This field will only appear in EDC if “Genital tract abnormality present but explained entirely by non-GVHD documented cause” is answered Yes. Please report the cause in this free textbox (up to 200 characters).
Was there other chronic GVHD involvement for this occurrence in this reporting period?:
Indicate if any other organ involvement occurred by selecting “Yes” or “No.” If “Yes,” specify organ involvement in field below.
Specify organ involvement:
This field will only appear in EDC if “Was there other chronic GVHD involvement for this occurrence in this reporting period?” is answered Yes. Please report the other involvement in this free textbox (up to 200 characters).
Specify organ score:
This field will only appear in EDC if “Was there other chronic GVHD involvement for this occurrence in this reporting period?” is answered Yes. Report organ score observed at the time of the maximum GVHD severity in this reporting period:
• Score 0 – None
• Score 1 – Mild
• Score 2 – Moderate
• Score 3 – Severe
Maximum grade of chronic GVHD according to best clinical judgment since last reported for the study:
Report the maximum severity experienced within the reporting period (since the last visit), using the utilizing the NIH Consensus Criteria (see Protocol Appendix F).
• Mild: 1 or 2 organs involved with no more than severity score 1 with NO lung involvement
• Moderate: 3 or more organs involved with no more than severity score 1 OR at least 1 organ (not lung) with severity score 2 OR Lung severity score 1
• Severe: At least 1 organ with severity score 3 OR Lung severity score 2 or 3
Date of maximum grade of chronic GVHD reached:
Report the date the above maximum grade was reached in DD/MMM/YYYY format. If the subject had multiple instances in a reporting period in which GVHD reached the same maximum grade, report the earliest date.
Was systematic immunosuppression therapy given to treat chronic GVHD during this assessment period?:
Indicate if systematic immunosuppression therapy was given to treat chronic GVHD during this assessment period by selecting “Yes” or “No.” If “Yes,” report first therapy given during this assessment period in field below.
First immunosuppression therapy for chronic GVHD:
Report the first immunosuppression therapy given for chronic GVHD since last reported. If “Other agent, specify” is selected, specify in the following field. If multiple immunosuppression therapies were given since last reported, report the first.
• ALS, ALG, ATS, ATG
• Corticosteroids (systemic)
• Corticosteroids (topical)
• Cyclosporine (CSA) (Sandimmune, Neoral)
• ECP (extra-corporeal photopheresis)
• FK 506 (Tacrolimus, Prograf)
• Anti CD25 – Zenapax
• Anti CD25 – Daclizumab
• Anti CD25 – AntiTAC
• Campath
• Etanercept (Enbrel)
• Infliximab (Remicade)
• Other in vivo monoclonal antibody
• In vivo immunotoxin
• Methotrexate (MTX) (Amethopterin)
• Mycophenolate mofetil (MMF) (CellCept)
• Sirolimus (Rapamycin, Rapamune)
• Tocilizumab
• Ursodiol
• Other agent, specify
If Other, specify:
This field will only appear in EDC if “First immunosuppression therapy for chronic GVHD” is answered with Other agent, specify. Please report the other agent in this free textbox (up to 200 characters).
Start date of first immunosuppression therapy:
Report the date this agent was initiated in DD/MMM/YYYY format.
End date of first immunosuppression therapy:
Report the date this agent was last administered in DD/MMM/YYYY format. If therapy is ongoing, use the Intentionally Left Blank functionality and specify therapy is ongoing.
Was any deviation or additional immunosuppression therapy given after the first immunosuppression therapy?:
Indicate if there was any deviation or additional immunosuppression therapy given after the first immunosuppression therapy by selecting “Yes” or “No.” If “Yes,” report additional agent given during this assessment period.
Specify the additional agent:
This field appears if “Was any deviation or additional immunosuppression therapy given after the first immunosuppression therapy?” is answered Yes. Report the additional immunosuppression therapy given for chronic GVHD since last reported. If “Other agent, specify” is selected, specify in the following field.
• ALS, ALG, ATS, ATG
• Corticosteroids (systemic)
• Corticosteroids (topical)
• Cyclosporine (CSA) (Sandimmune, Neoral)
• ECP (extra-corporeal photopheresis)
• FK 506 (Tacrolimus, Prograf)
• Anti CD25 – Zenapax
• Anti CD25 – Daclizumab
• Anti CD25 – AntiTAC
• Campath
• Etanercept (Enbrel)
• Infliximab (Remicade)
• Other in vivo monoclonal antibody
• In vivo immunotoxin
• Methotrexate (MTX) (Amethopterin)
• Mycophenolate mofetil (MMF) (CellCept)
• Sirolimus (Rapamycin, Rapamune)
• Tocilizumab
• Ursodiol
• Other agent, specify
If Other, specify:
This field will only appear in EDC if “Specify the additional agent” is answered with Other agent, specify. Please report the other agent in this free textbox (up to 200 characters).
Did patient develop steroid-refractory chronic GVHD during this assessment period?:
Indicate if the patient developed steroid-refractory chronic GVHD during this assessment period by selecting “Yes” or “No.” If “Yes,” report the date of diagnosis steroid-refractory chronic GVHD in field below.
Chronic GVHD should be considered steroid-refractory when there is:
- A lack of response or disease progression after administration of minimum prednisone 1 mg/kg/day for ≥1 week (or equivalent), or
- Disease persistence without improvement despite continued treatment with prednisone at >0.5 mg/kg/day or 1 mg/kg/every other day for ≥4 weeks (or equivalent), or
- Increase to prednisone dose to >0.25 mg/kg/day after two un-successful attempts to taper the dose (or equivalent), or
- Initiation of new line of therapy in response to disease progression or lack of response
Date of steroid-refractory chronic GVHD:
Report the date of clinical diagnosis of steroid-refractory chronic GVHD in DD/MMM/YYYY format.
Did the subject receive additional immunosuppression therapy for refractory chronic GVHD?:
Indicate if the subject received additional immunosuppression therapy for refractory chronic GVHD given during this assessment period by selecting “Yes” or “No.” If “Yes,” report additional agent given during this assessment period.
Specify the additional immunosuppression therapy given for steroid-refractory chronic GVHD:
This field appears if “Did the subject receive additional immunosuppression therapy for refractory chronic GVHD?” is answered Yes. Report the additional immunosuppression therapy given for steroid-refractory chronic GVHD since last reported. If “Other agent, specify” is selected, specify in the following field.
• ALS, ALG, ATS, ATG
• Corticosteroids (systemic)
• Corticosteroids (topical)
• Cyclosporine (CSA) (Sandimmune, Neoral)
• ECP (extra-corporeal photopheresis)
• FK 506 (Tacrolimus, Prograf)
• Anti CD25 – Zenapax
• Anti CD25 – Daclizumab
• Anti CD25 – AntiTAC
• Campath
• Etanercept (Enbrel)
• Infliximab (Remicade)
• Other in vivo monoclonal antibody
• In vivo immunotoxin
• Methotrexate (MTX) (Amethopterin)
• Mycophenolate mofetil (MMF) (CellCept)
• Sirolimus (Rapamycin, Rapamune)
• Tocilizumab
• Ursodiol
• Blinded randomized trial
• Other agent, specify
If Other, specify:
This field will only appear in EDC if “Specify the additional agent” is answered with Other agent, specify. Please report the other agent in this free textbox (up to 200 characters).
Is the patient still on immunosuppression therapy at 1-year?:
Report if the patient is still on any immunosuppression therapy at 1-year. For timepoints prior to the Day 365 visit, select “N/A – Not day 365 visit.”
Did this occurrence of chronic GVHD resolve in this reporting period?:
Report if this occurrence of chronic GVHD revolved in this reported period. If No, ensure instance of chronic GVHD is reported in the next reporting period.
Date of chronic GVHD resolution:
This field appears if “Did this occurrence of chronic GVHD resolve in this reporting period?” is answered Yes. Report the date of chronic GVHD resolution in DD/MMM/YYYY format. If the subject developed more than one episode of chronic GVHD in the same reporting period, report the date of resolution of the last episode of chronic GVHD.
CCG v1.0 | CRF v1.3
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