This form will generate automatically for Day 7 through Day 100 reporting periods. This form will subsequently come due in Day 180-Day 365 reporting periods if “Did acute GVHD develop, recur or persist since last reported for the study?” on the previous reporting period Acute GVHD form is answered Yes.
If Acute GVHD resolves and then reoccurs within a reporting period, report each occurrence of Acute GVHD separately. If Acute GVHD resolves and a new instance of Acute GVHD involving new organs occurs within this reporting period, report the resolution and the new instance separately. Click +New Section to report additional occurrences.
Changes in Acute GVHD staging or grading should NOT be reported as new log lines. Only reoccurrences, persisting or new Acute GVHD diagnoses should be reported
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.
Acute GVHD will be graded according to the guidelines described in platform protocol Appendix E, utilizing the Mount Sinai Acute GvHD International Consortium (MAGIC).
Training on acute GVHD is available here for site personnel: https://network-bethematch-greenlight.silkroad.com/student/default.aspx?parms=1&launchitem=catalog&launchargs=i:886
To access the course, please create a new user account or log into your existing account, should you have one. Once logged in, you will be able to access the Site Facing Acute GVHD Training and begin the course.
Reporting GVHD in Veeva EDC:
GVHD should be recorded with regard to reporting period. 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 01-JAN. Subject is diagnosed with GVHD on 14-FEB (Day +44). GVHD should be reported in the Day 49 visit folder, because it was diagnosed within the Day 49 reporting period. While the date of diagnosis is in the day +42 visit window, because the day +42 visit had already occurred when GVHD was diagnosed, it is reported in the following reporting period –
| Visit | Visit Window | Reporting Period |
|---|---|---|
| Day 42 Occurred 12-FEB |
+/-3 days: 9-FEB through 15-FEB |
Day +36 through Day +42 post-transplant: 6-FEB through 12-FEB |
| Day 49 Occurred 19-FEB |
+/-3 days: 16-FEB through 22-FEB |
Day +43 through Day +49 post-transplant: 13-FEB through 19-FEB |
If GVHD occurs later in the study and between visits with longer periods of time between, for example at day +120 (between the day +100 and day +180 visit windows), please complete the following:
- 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.
- Click “Save” to confirm the date. If the date is a future date, a query will fire. A response to the query can be added to indicate aGVHD occurred prior to the next visit:
- Once the 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.
Grading acute GVHD as a 3-Step Process
- Determine organ involvement and maximum stage per organ
- Attribute confidence levels to each organ
- Determine the overall clinical grade, based on organ stages_
Did acute GVHD develop, recur or persist since last reported for the study?:
Confirm whether a new instance of acute GVHD was diagnosed since last reported for the study, if a previously-reported instance persisted into this report period, or if there was a flare of a previously-reported instance. If the response is “No,” select “No” and save the form; the form is then complete. If the response is “Yes,” select “Yes” to generate the “Acute GVHD” log line section of the form.
Once log line section of form is generated, click the “+ New Section” button to create a new log line. This form allows for 999 log lines to be added.
Date of acute GVHD diagnosis:
Report the date of diagnosis of acute GVHD in DD/MMM/YYYY format, if initially diagnosed within the reporting period (since the last visit). If onset of acute GVHD occurred in prior reporting period, leave this field blank and complete the following field.
Report the date of clinical diagnosis of acute GVHD. The clinical diagnosis date may not necessarily be the date the symptoms began (example: the subject developed a rash one week prior to the physician clinically diagnosing acute skin GVHD). If the clinical diagnosis is documented, but the diagnosis date is unclear, obtain documentation from the primary physician confirming the clinical diagnosis date.
If there were multiple occurrences of GVHD within a reporting period, please report each instance in the order of diagnosis.
Date of acute GVHD diagnosis previously reported:
Check this field if this instance of acute GVHD was diagnosed in a previous reporting period. This field should not be checked at Day 7. If the previous instance of aGVHD resolved before the start of this reporting period, and the instance being reported now is a new one, please enter the new diagnosis date above and do not select this field.
Was there acute skin GVHD involvement for this occurrence in this reporting period?:
Select “Yes” or “No” to indicate whether there was skin involvement for this occurrence in this reporting period. Skin involvement ranges from reddening to a maculopapular rash (skin eruption of flat or raised lesions) often found on hands, soles of feet, ears, shoulders, back and/or chest. Features may include:
• Pruritus or dysesthesia: itching or abnormal sensation
• Erythroderma: inflammation and reddening of the skin
• Desquamation: peeling of skin
• Bullae: fluid-filled sacs or lesions on the skin (large blister)
Stage of acute skin GVHD for this occurrence in this reporting period:
This field will only appear if the preceding question was answered “Yes.” Select the skin feature score observed at the time of the maximum GVHD severity in this reporting period:
• Stage 0: No active (erythematous) GVHD rash
• Stage 1: Maculopapular rash <25% BSA
• Stage 2: Maculopapular rash 25-50% BSA
• Stage 3: Maculopapular rash >50% BSA
• Stage 4: Generalize erythrodema (>50% BSA) plus bullous formation and desquamation >5% BSA
Was there acute liver GVHD involvement for this occurrence in this reporting period?:
Select “Yes” or “No” to indicate whether there was liver involvement for this occurrence in this reporting period.
Stage of acute liver GVHD (bilirubin) for this occurrence in this reporting period:
This field will only appear if the preceding question was answered “Yes.” Select the liver (total bilirubin) score observed at the time of the maximum GVHD severity in this reporting period:
• Stage 0: < 2 mg/dl
• Stage 1: 2-3 mg/dl
• Stage 2: 3.1-6 mg/dl
• Stage 3: 6.1-15 mg/dl
• Stage 4: >15 mg/dl
Was there acute upper GI GVHD involvement for this occurrence in this reporting period?:
Select “Yes” or “No” to indicate whether there was upper gastrointestinal (GI) involvement for this occurrence in this reporting period.
Stage of acute upper GI GVHD for this occurrence in this reporting period:
This field will only appear if the preceding question was answered “Yes.” Select the upper GI score observed at the time of the maximum GVHD severity in this reporting period:
• Stage 0: No or intermittent nausea, vomiting or anorexia
• Stage 1: Persistent nausea, vomiting or anorexia
Was there acute lower GI GVHD involvement for this occurrence in this reporting period:
Select “Yes” or “No” to indicate whether there was lower gastrointestinal (GI) involvement for this occurrence in this reporting period.
Stage of acute lower GI GVHD for this occurrence in this reporting period:
This field will only appear if the preceding question was answered “Yes.” Select the lower GI score observed at the time of the maximum GVHD severity in this reporting period:
• Stage 0: < 500 ml/day or 3 episodes/day
• Stage 1: 500-999 ml/day or 3-4 episodes/day
• Stage 2: 1000-1500 ml/day or 5-7 episodes/day
• Stage 3: >1500 ml/day or >7 episodes/day
• Stage 4: Severe abdominal pain with or without ileus, or grossly bloody stool (regardless of stool volume)
Maximum clinical grade of acute GVHD for this occurrence in this reporting period:
This is a derived field, calculated by the system. There is no site data entry possible or required in this field. Please review the Overall Clinical Grade table of Appendix E in the platform protocol for details on which individual organ stages correspond with which overall maximum clinical grade in MAGIC aGVHD grading criteria.
Date maximum clinical grade reached:
Report the date that the maximum overall clinical grade was reached in DD/MMM/YYYY format. This must be a date within the reporting period appropriate for this visit. For example, in this example above where aGVHD was diagnosed on day +44 and reported at day +49, the maximum grade date would have to be a date as early as day +44 and as late as day +49, but could not be day +50, even if acute GVHD persisted past day +49 and achieved a higher clinical grade on day +50.
Was systematic immunosuppression therapy given to treat acute GVHD during this assessment period:
Select “Yes” or “No” to indicate where a systematic immunosuppression therapy was given for the treatment of aGVHD during this reporting period. This may include systemic immunosuppression that was started as prophylaxis before aGVHD was diagnosed.
Please note, prophylactic anti-viral cellular therapies and/or co-enrollment on studies using therapies for the prevention of GVHD is prohibited. Please ensure all prohibited medications are reported on the Concomitant Medication form.
First immunosuppression therapy:
Record the earliest immunosuppressive therapy given during the reporting period current to this visit. If the therapy is not an available option, select “Other agent, specify” and complete the field below.
If Other, specify:
This field will only appear if “Other agent, specify” is selected in the field above. If the therapy was not an available option in the previous field, please enter the name of the other agent. This field allows for up to 200 characters.
Start date of first immunosuppression therapy:
Enter the start date of the first immunosuppression therapy in DD/MMM/YYYY format.
End date of first immunosuppression therapy:
Enter the date that administration of this therapy ended.
Was any deviation or additional immunosuppression therapy given after the first immunosuppression therapy:
Confirm whether an additional therapy was given. If it was, complete the field below.
Specify the additional agent:
If an additional immunosuppressive therapy was given, select the type of therapy from the dropdown menu. If the type of therapy given is not an available option, select “Other agent, specify.”
If Other, specify:
This field will only appear if “Other agent, specify” is selected in the field above. If the therapy was not an available option in the previous field, please enter the name of the other agent. This field allows for up to 200 characters.
Did patient develop steroid-refractory acute GVHD during this assessment period?:
Indicate whether GVHD was identified as steroid-refractory. Acute GVHD is steroid-refractory if there is no response to steroid treatment after 7 days AND either an increase in steroid dose (25% or more) OR a new line of therapy.
Date of steroid-refractory acute GVHD:
This field will generate if the above field is answered yes. Indicate date that patient was confirmed by clinical diagnosis from treating physician to have steroid-refractory acute GVHD, or when new line of therapy is started.
Did the subject receive additional immunosuppression therapy for refractory acute GVHD?:
Indicate whether the patient received additional therapy after GVHD was confirmed to be steroid-refractory.
Specify the additional immunosuppression therapy given for steroid-refractory acute GVHD:
This field will generate if the above field is answered Yes. Select the type of therapy given for steroid-refractory acute GVHD. If the therapy given is not an available option, select “Other agent, specify.”
If Other, specify:
This field will only appear if the above field is answered “Other agent, specify.” If the therapy was not an available option in the previous field, please enter the name of the other agent. This field allows for up to 200 characters.
Did this occurrence of acute GVHD resolve in this reporting period?:
Indicate whether this instance of GVHD resolved within this reporting period. If one or more organs resolved but another organ had persistent GVHD, select “No” and report data on the remainder of the instance of aGVHD at the following visit.
Date of acute GVHD resolution:
This field will only generate if the previous field is answered “Yes.” Report the date of aGVHD resolution per the instructions above. If multiple organs resolved in this reporting period but they resolved at different times, report the last date of resolution.
CCG v1.0 | CRF v1.3
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