Graft vs. 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. Very rarely, GVHD may occur due to autologous reactivity (autologous GVHD), third party transfusions, or with identical twin (syngeneic) transplantation.
Factors influencing the severity of GVHD are related to three main categories: 1) donor or graft, 2) recipient, and 3) treatment. Influential risk factors include the degree of genetic disparity between the donor and the recipient (HLA match), female donor to male recipient, donor parity, older donors, and T-cell dose, graft type and GVHD prophylaxis. The occurrence of acute GVHD becomes a risk factor for the development of chronic GVHD. Recipient age and prior infections are also factors. 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 the time since HCT, so determination of acute or chronic should rest on clinical and histological features. However, organ staging, and overall grade should only be calculated from the clinical picture, not histology. Acute GVHD usually begins between 10 and 40 days after HCT but can appear earlier or later. The organs most commonly affected by acute GVHD are the skin, gut, and / or liver. Other sites, such as the lung, may be involved.
Questions 86 – 94: Select specific therapy used after the start of the preparative regimen to prevent acute GVHD. (Check all that apply) (Note: do not include growth factors reported in questions 20 – 28, or ex vivo T-cell depletion reported on the Product Insert. Do not include drugs given as part of the preparative regimen)
Following an allogeneic HCT, specific immunosuppressive therapy may be administered to prevent GVHD or to immunosuppress the host marrow. Most transplant centers have specific GVHD prophylaxis protocols and graft rejection protocols. Any agent a recipient receives as a result of these protocols should be included in this section. The type of acute GVHD prophylaxis is included in almost every analysis of allogeneic transplantation.
The prophylactic drug options listed on the form are intended to be systemic (IV or oral administration).
The Post-Infusion Follow-Up (2100) Form lists the generic immune suppression drug names. The following website provides the trade names under which generic drugs are manufactured: http://www.rxlist.com/drugs/alpha_a.htm.
If GVHD prophylaxis is used for a syngeneic (monozygotic or identical twin) or autologous HCT, upload documentation in FormsNet3 using the attachment feature. Contact CIBMTR Center Support with questions.
Specify the therapy given after the start of the preparative regimen to prevent acute GVHD or graft rejection. Check all that apply. If acute GVHD prophylaxis was not given, report None.
- Abatacept (Orencia): Immunomodulator that works to block the activity of T-cells.
- Alemtuzumab (Campath): Monoclonal antibody that targets common antigens found on B-cells and T-cells (part of the body’s immune system). If this drug was given as acute GVHD prophylaxis and report the total ordered dose administered in milligrams.
- ALG (Anti-Lymphocyte Globulin), ALS (Anti-Lymphocyte Serum), ATG (Anti-Thymocyte Globulin) ATS (Anti-Thymocyte Serum): Serum or gamma globulin preparations containing polyclonal immunoglobulins directed against lymphocytes. These drugs are usually prepared from horse or rabbits immunized against human lymphocytes. Also report the animal source. If Other is selected, specify the source.
- Blinded randomized trial: If the recipient is on a blinded randomized trial, specify agent being studied in the trial in question 86. Additionally, update the Post-Infusion Follow-Up (2100) once the trial is over to specify whether the recipient received the trial drug or placebo.
- Corticosteroids (systemic) (e.g., prednisone, dexamethasone): Usually combined with cyclosporine when used for prophylaxis. Only report systemic steroids in this section.
- Cyclophosphamide (Cytoxan): Given in high doses near the date of infusion as prophylaxis. Continue with question 87 and report the total administered dose in milligrams. See the GVHD Prophylaxis note above for additional instructions on how to report this drug.
- Cyclosporine (CSA, Neoral, Sandimmune, Gengraf): Calcineurin inhibitor which decreases cytokine production by T-cells. Usually given for ≥ 3 months.
- In vivo immunotoxin: Antibody preparations linked to a toxin that is infused in the recipient following HCT. Specify the in vivo immunotoxin.
- Methotrexate (MTX) (Amethopterin): Inhibits the metabolism of folic acid. It is most often used with calcineurin inhibitors and is usually for a short duration of time.
- Mycophenolate mofetil (MMF) (CellCept, Myfortic): Inhibits the de novo pathway used for lymphocyte proliferation and activation.
- Sirolimus (Rapamycin, Rapamune): Inhibits the response to interleukin-2, blocking the activation of T-cells.
- Tacrolimus (Prograf): Inhibits the production of interleukin-2 by T-cells.
- Other in vivo monoclonal antibody: Antibody preparations that are infused for GVHD prophylaxis. Specify if an in vivo monoclonal antibody other than Alemtuzumab (Campath) or an in vivo immunotoxin was used.
- Other agent: If the drug is not listed on the form, select this option and specify the other agent being given as GVHD prophylaxis.
Do not report the following:
- Ex vivo T-cell depletion
- Report ex vivo T-cell depletion on the HCT Infusion Form (Form 2006).
- Agents used to prevent infection
- Report infection prophylaxis agents in the Infection section
- Topical corticosteroids or ursodeoxycholic acid (ursodiol, actigal).
Question 95: Did acute GVHD develop?
Questions Did acute GVHD develop and Did acute GVHD persist on the Post-HCT Follow-Up Data (2100) Form are meant to capture whether the recipient had active symptoms of acute GVHD during the reporting period. Acute GVHD is one of the main outcomes reported in allogeneic transplantation. If the recipient had active acute GVHD during the reporting period, either Did acute GVHD develop OR Did acute GVHD persist must be answered Yes unless there has been a prior / concurrent diagnosis of chronic GVHD (refer to the Acute/Chronic GVHD blue box above). There will not be a situation where Yes is reported for both Did acute GVHD develop and Did acute GVHD persist. If Did acute GVHD develop is answered Yes and a diagnosis date has been reported, Did acute GVHD persist will be disabled in FormsNet3SM. Centers should report Yes for Did acute GVHD develop to indicate the recipient developed acute GVHD in the following scenarios:
- Acute GVHD is diagnosed for the first time during the reporting period.
- An acute GVHD flare is diagnosed during the current reporting period and all of the following conditions are met:
- The recipient’s prior acute GVHD symptoms did not persist from the prior reporting period into the beginning of the current reporting period.
- The flare is diagnosed after at least 30 days without any active acute GVHD symptoms.
- The recipient was not diagnosed with chronic GVHD on or before the date of the flare (see Acute/Chronic GVHD blue box above).
If the recipient has active acute GVHD during the reporting period, but does not match either of the scenarios above, the center will likely need to report No for Did acute GVHD develop and Yes for Did acute GVHD persist. Did acute GVHD persist is intended to capture acute GVHD which has continued from a prior reporting period. This includes any flares which do not meet the above conditions. The intent of classifying GVHD episodes as newly developed or persistent is to avoid having centers re-report diagnosis information which has been captured on a prior form. Refer to the Acute GVHD Diagnosis Scenarios below to see examples of how to answer Did acute GVHD develop and Did acute GVHD persist.
Report No for questions Did acute GVHD develop and Did acute GVHD persist if the recipient had no active acute GVHD symptoms during the reporting period OR all acute GVHD signs / symptoms during the reporting period occurred after a diagnosis of chronic GVHD (see Acute/Chronic GVHD blue box above).
Indicate Unknown if there is no information about the recipient’s GVHD status for the reporting period. This option should be used sparingly and only when no judgment can be made about the presence or absence of GVHD in the reporting period.
Acute GVHD Diagnosis Scenarios:
A. A recipient receives a HCT on 1/1/2015 and develops acute GVHD which is clinically diagnosed on 2/1/2015. At least one of their symptoms, attributed to acute GVHD, persists beyond the 100-day date of contact which is 4/5/2015. Treatment continues and symptoms completely resolve on 5/1/2015. Immunosuppression is tapered until a flare of acute GVHD is diagnosed on 5/25/2015. Immunosuppression is given and symptoms quickly resolve with no active acute GVHD beginning 6/10/2015. The six-month date of contact is 6/20/2015. Another flare of acute GVHD is clinically diagnosed on 8/15/2015.
100 Day Post-Infusion Data Form:
Did acute GVHD develop: Report Yes to indicate a new clinical diagnosis of acute GVHD.
Date of acute GVHD diagnosis: Report the initial date of diagnosis (2/1/2015).
Did acute GVHD persist: Leave blank. This question will be skipped whenever an acute diagnosis date has been entered.
Biopsy and organ staging at diagnosis questions: Answer these questions based on the assessments performed at the time of diagnosis (2/1/2015).
Six Month Post-Infusion Data Form:
Did acute GVHD develop: Report No to indicate acute GVHD persists from a previous report. Note, the flare of acute GVHD was < 30 days from symptoms resolution so it doesn’t count as a new reportable episode.
Date of acute GVHD diagnosis: Leave blank. This question will be skipped whenever Did acute GVHD develop is answered No.
Did acute GVHD persist: Report Yes to indicate GVHD persists from a previous report.
Biopsy and organ staging at diagnosis questions: Leave blank. Answering Yes for question 93 prevents the center from re-reporting diagnosis information already captured on the 100-day form.
One Year Post-Infusion Data Form:
Did acute GVHD develop: Report Yes to indicate a flare of acute GVHD occurred at least 30 days after resolving during a prior reporting period.
Date of acute GVHD diagnosis: Report the diagnosis date of the flare occurring during the reporting period (8/15/2015).
Did acute GVHD persist: Leave blank. This question will be skipped whenever an acute diagnosis date has been entered.
Biopsy and organ staging at diagnosis questions: Answer these questions based on the assessments performed at the time of diagnosis of the flare of acute GVHD (8/15/2015).
B. A recipient receives a HCT on 1/1/2015 and develops acute skin GVHD on 2/1/2015 and then chronic eye GVHD on 3/1/2015. Both acute and chronic symptoms resolve by the 100-day date of contact (4/5/2015). While tapering their immunosuppression, the recipient has a flare of their acute skin GVHD on 5/30/2015. Treatment continues and symptoms completely resolve by the six-month date of contact (6/20/2015).
100 Day Post-Infusion Data Form:
Did acute GVHD develop: Report Yes to indicate a new clinical diagnosis of acute GVHD.
Date of acute GVHD diagnosis: Report the initial date of diagnosis (2/1/2015).
Did acute GVHD persist: Leave blank. This question will be skipped whenever an acute diagnosis date has been entered.
Biopsy and organ staging at diagnosis questions: Answer these questions based on the assessments performed at the time of diagnosis (2/1/2015).
Maximum organ involvement and treatment questions: Answer these questions based on any symptoms and treatment documented from the onset of acute GVHD (2/1/2015) up to the diagnosis of chronic GVHD (3/1/2015). This instruction is provided in the Acute / Chronic GVHD blue note box above.
Six Month Post-Infusion Data Form:
Did acute GVHD develop: Report No to indicate acute GVHD did not develop during the reporting period.
Date of acute GVHD diagnosis: Leave blank. This question will be skipped whenever Did acute GVHD develop is answered No.
Did acute GVHD persist: Report No to indicate acute GVHD did not persist from a previous report.
If chronic GVHD has been diagnosed in a prior reporting period, report No for Did acute GVHD develop and Did acute GVHD persist. Any new or persistent acute GVHD symptoms occurring after the onset of chronic GVHD must be reported in the chronic GVHD section of the form. Do not include any signs, symptoms, or treatment occurring on or after the onset of chronic GVHD when completing the acute GVHD section. This instruction has been provided in the Acute / Chronic GVHD blue note box above.
Question 96: Date of acute GVHD diagnosis
The date of acute GVHD diagnosis is important as CIBMTR tries to analyze GVHD as a time-to-event endpoint, for which a date is required. This type of analysis can then adjust for recipients who relapse or die before Day 100.
Report the date of clinical diagnosis of acute GVHD. The clinical diagnosis date may not necessarily be the date the symptoms began (example: the recipient 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 the recipient developed more than one episode of acute GVHD in the same reporting period, report the date of onset of the first episode of acute GVHD.
If the exact clinical diagnosis date is unknown, but the treatment start date is known, report the date treatment started as the date of acute GVHD diagnosis.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
Question 97: Did acute GVHD persist?
This question will only be enabled in FormsNet3SM if the center has reported No for the question Did acute GVHD develop? and, therefore, has not reported a date of acute GVHD diagnosis. If prompted to answer this question, report Yes if acute GVHD was diagnosed in a prior reporting period and any of the following conditions are met:
- The recipient’s acute GVHD symptoms have been active since diagnosis and continue to be active during the current reporting period (i.e., no period of resolution or quiescence since diagnosis).
- The recipient’s acute GVHD symptoms had resolved before the first day of the current reporting period, but a flare occurred within 30 days of symptom resolution / quiescence.
- The recipient was not diagnosed with chronic GVHD on or before the date of the flare (see note above question 91).
Report No for Did acute GVHD develop and Did acute GVHD persist if the recipient had no active acute GVHD symptoms during the reporting period OR all acute GVHD signs / symptoms during the reporting period occurred after a diagnosis of chronic GVHD (see Acute / Chronic GVHD blue note box above).
Indicate Unknown if there is no information about the recipient’s GVHD status for the reporting period. This option should be used sparingly and only when no judgment can be made about the presence or absence of GVHD in the reporting period.
Question 98: Was acute GVHD evaluated by biopsy (histology)? (at diagnosis)
Histological tests may be performed to confirm the clinical diagnosis of GVHD; however, the staging and grading of GVHD should be based on clinical evidence, not histological results.
Indicate Yes or No if a biopsy was used to diagnose acute GVHD. If biopsy was not performed or unknown if performed at diagnosis, report No.
Questions 99 – 105: Specify result(s)
For each organ listed, indicate the test result documented on the pathology report as either Positive, Suggestive, Negative, Inconclusive / equivocal, or Not done.
Suggestive or Inconclusive / equivocal should be reported if in the final diagnosis or comments section of the pathology report, those words are used.
Biopsy report may use the term “consistent with GVHD” which could be interpreted as either Positive or Suggestive, depending on the comments listed in the report.
If the biopsy was performed on an “other site,” specify the site biopsied.
Additionally, indicate whether documentation was submitted to the CIBMTR (e.g., pathology report). For further instructions on how to attach documents in FormsNet3, refer to the FormsNet3 Training Guide.
Question 106: Overall grade of acute GVHD at diagnosis
Indicate the overall grade of acute GVHD at the time of diagnosis. For reporting purposes, “at diagnosis” is defined as the period between onset of signs / symptoms and the initiation of therapy to treat GVHD (topical or systemic). The acute GVHD grading scale is based on clinical evidence (physician observation), not histology. Pathology reports sometimes list a histologic grade of GVHD. Do not report the histologic grade. Biopsy of affected organs allows for more precise diagnosis as to the presence or absence of GVHD, not its severity. However, overall grading remains clinical and is based on the criteria published by Przepiorka et al., Bone Marrow Transplant 1995; 15(6):825-8, see the GVHD Grading and Staging table below.
If acute GVHD was present, but the grade at diagnosis was not documented and it cannot be determined from the grading and staging table, report Not applicable. Examples may include:
- Any other organ involvement without skin, liver, or gut symptoms attributable to GVHD
- Lower intestinal tract involvement where the stage cannot be determined in select scenarios. See lower intestinal tract involvement description below.
GVHD Grading and Staging
| Extent of Organ Involvement | |||
|---|---|---|---|
| Stage | Skin | Liver | Gut |
| 1 | Rash on <25% of skin1 | Bilirubin 2-3 mg/dl2 | Diarrhea > 500 ml/day3 or persistent nausea4 Pediatric: 280-555 ml/m2/day or 10-19.9 mL/kg/day |
| 2 | Rash on 25-50% of skin | Bilirubin 3-6 mg/dl | Diarrhea >1000 ml/day Pediatric: 556-833 ml/m2/day or 20-30 mL/kg/day |
| 3 | Rash on >50% of skin | Bilirubin 6-15 mg/dl | Diarrhea >1500 ml/day Pediatric: >833 ml/m2/day or > 30 mL/kg/day |
| 4 | Generalized erythroderma with bullous formation | Bilirubin >15 mg/dl | Severe abdominal pain, with or without ileus, and / or grossly blood stool |
| Grade5 | |||
|---|---|---|---|
| I | Stage 1-2 | None | None |
| II | Stage 3 | Stage 1 | Stage 1 |
| III | — | Stage 2-3 | Stages 2-4 |
| IV6 | Stage 4 | Stage 4 | — |
| 1. Use “Rule of Nines” (Table 4) or burn chart to determine extent of rash. 2. Range given as total bilirubin. Downgrade one stage if an additional cause of elevated bilirubin has been documented. 3. Volume of diarrhea applies to adults. For pediatric patients, the volume of diarrhea should be based on body surface area. Downgrade one stage if an additional cause of diarrhea has been documented. 4. Persistent nausea with or without histological evidence of GVHD in the stomach or duodenum. 5. Criteria for grading given as minimum degree of organ involvement required to confer that grade. 6. Grade IV may also include lesser organ involvement with an extreme decrease in performance status. |
|||
Questions 107 – 112: Indicate the stage for each organ involvement at time of diagnosis of acute GVHD
Report the stage of each organ at diagnosis. For reporting purposes, “at diagnosis” is defined as the period between onset of signs / symptoms and the initiation of therapy to treat GVHD (topical or systemic).
Reporting each organ staging is important as this will allow CIBMTR to recalculate the overall acute GVHD grade, based on difference schemes, if necessary.
Skin: Select the stage that reflects the body surface area involved with a maculopapular rash attributed to acute GVHD at the time of acute GVHD diagnosis or flare in the reporting period. See the table below to determine the percent of body surface area involved with a rash. Do not report ongoing rash not attributed to acute GVHD at the time of acute GVHD diagnosis or flare.
Percent Body Surfaces
| Body Area | Percent | Total Percentage |
|---|---|---|
| Each Arm | 9% | 18% |
| Each Leg | 18% | 36% |
| Chest & Abdomen | 18% | 18% |
| Back | 18% | 18% |
| Head | 9% | 9% |
| Pubis | 1% | 1% |
Lower intestinal tract (use mL/day for adult recipients and mL/kg/day for pediatric recipients): Select the stage that reflects the volume of diarrhea attributed to acute GVHD at the time of acute GVHD diagnosis or flare in the reporting period. Use mL/day for adult recipients and mL/m2/day for pediatric recipients. Input and output records may be useful in determining the volume of diarrhea. Do not report diarrhea ongoing but not attributed to acute GVHD at the time of acute GVHD diagnosis or flare.
Upper intestinal tract: Select the stage that reflects the presence of persistent nausea or vomiting attributed to acute GVHD at the time of acute GVHD diagnosis or flare in the reporting period. Do not report ongoing nausea or vomiting which is not attributed to acute GVHD at the time of acute GVHD diagnosis or flare.
Liver: Select the stage that reflects the bilirubin level attributed to acute GVHD at the time of acute GVHD diagnosis or flare in the reporting period. Do not report ongoing hyperbilirubinemia which is not attributed to acute GVHD at the time of acute GVHD diagnosis or flare.
Other site(s) involved with acute GVHD: Indicate whether acute GVHD affected an organ other than skin, upper GI, lower GI, or liver manifesting with hyperbilirubinemia. Report only other organ involvement at the time of acute GVHD diagnosis or flare in the reporting period. Do not report ongoing symptoms which are not attributed to acute GVHD at the time of acute GVHD diagnosis or flare. If Yes is reported, specify the other site(s) of involvement.
Question 113: Maximum overall grade of acute GVHD
Indicate the overall maximum grade of acute GVHD since the date of the last report. This is an important data field since most studies are specifically interested in grade II – IV or grade III – IV acute GVHD. Grading is based on clinical evidence (physician observation), not histology. Pathology reports sometimes list a histologic grade of GVHD. Do not report the histologic grade. GVHD scoring and grading is based on clinical severity, not histologic severity. Biopsy of affected organs allows for more precise diagnosis as to the presence or absence of GVHD but is not used for staging or grading. However, overall grading remains clinical and is based on the criteria published by Przepiorka et al., Bone Marrow Transplant 1995; 15(6):825-8, see the GVHD Grading and Staging table above.
Report an overall grade of IV if stage 4 acute skin GVHD, stage 4 acute liver GVHD, or an extreme decrease in performance status is documented at the time point being reported (see GVHD Staging and Grading Table). Report overall grade III if stage 2-3 liver involvement is documented at the time point being reported and there is no evidence of grade IV GVHD.
If chronic GVHD was diagnosed during the reporting period, report the maximum severity of acute GVHD prior to the onset of chronic GVHD. See Did acute GVHD develop for further instructions. Acute GVHD grading scenario D below has been provided for further clarification.
Report the recipient’s maximum acute GVHD grade in the reporting period; this may differ from the grade at diagnosis or may be the same. If acute GVHD was present, but the maximum grade was not documented and it cannot be determined from the grading and staging table, report Not applicable. Examples may include:
- Any other organ involvement without skin, liver, or gut symptoms attributable to GVHD
- Lower intestinal tract involvement where the stage cannot be determined in select scenarios lower intestinal tract involvement description above
Acute GVHD Grading Scenarios:
A. A recipient developed stage 2 skin involvement and elevated liver function tests (LFTs) attributed to acute GVHD; however, there was no total bilirubin manifestation. In this case, overall maximum grade I acute GVHD should be reported since the staging / grading can be determined based on the skin involvement alone.
B. A recipient developed stage 2 skin involvement, which showed improvement in response to topical steroids. However, the recipient then developed hyperbilirubinemia attributed to stage 1 liver involvement; the skin involvement at that time was stage 1. In this case, grade II would be reported (assuming this was the extent of the recipient’s acute GVHD in the reporting period).
C. A recipient developed stage 2 skin involvement which resolved in response to topical steroids. Later in the reporting period, the recipient was diagnosed with mild chronic eye GVHD. Shortly thereafter, they were diagnosed with a stage 3 flare of acute skin GVHD. In this case, grade I would be reported. Do not consider any new or persistent acute GVHD symptoms occurring after the onset of chronic GVHD when completing the acute GVHD section of the form.
D. A recipient developed stage 1 skin involvement and stage 1 liver involvement (overall grade II) on 1/1/2019 which resolved in response to topical steroids and tacrolimus. Later in the reporting period, on 2/14/2019, they have a flare of the skin GVHD, this time at stage 3, along with GI stage 1 (overall grade II). In this case, grade II would be reported as the Maximum overall grade of acute GVHD with the maximum date reported as 1/1/2019 for the first date of maximum overall grade of acute GVHD. Additionally, the organ staging should be reported as skin stage 3, liver stage 1, and GI stage 1. The maximum organ staging during the reporting period is captured, not the maximum organ staging at the time of the maximum overall grade.
Question 114: First date of maximum overall grade of acute GVHD
Report the first date of maximum acute GVHD involvement, based on clinical grade. If the recipient had multiple instances in which their GVHD reached the same maximum grade, report the earliest date, regardless of any variation in the organ staging. For further clarification, review acute GVHD grading scenario D above. If Not applicable was reported for Maximum overall grade of acute GVHD, this question must be left blank.
Questions 115 – 120: Specify organ involvement at time of maximum grade
Report the maximum acute GVHD stage of each organ involved, consistent with the reported maximum overall grade, in the reporting period. The maximum staging does not need to be at the time when the maximum overall grade occurred. Refer to the GVHD Grading and Staging Table above for staging guidelines. Also, review example D above for further information.
Question 121: Corticosteroids (topical GI) (e.g. beclomethasone, budesonide)
Select all topical corticosteroids (beclomethasone and / or budesonide) used to treat GI GVHD. If topical corticosteroids to treat GI GVHD were not given, select None.
Topical therapies used for skin or lung GVHD are not captured in this question. Also, do not report systemic corticosteroids such as prednisone or dexamethasone. Systemic therapies are captured below
Questions 122 – 134: Was specific therapy given for acute GVHD?
Specify the systemic therapy used to treat acute GVHD during the reporting period. Report any prophylactic drugs as therapy for acute GVHD if they were continued after the date of diagnosis.
If systemic therapy was given to treat acute GVHD during the reporting period, specify the drugs given and indicate if the treatment was continued from prophylaxis. If the drug was continued from prophylaxis, select Yes and continue with Specify if the treatment was continued from prophylaxis. If the drug was started in a prior reporting period and continued into the current reporting period, select Previously reported. The Previously reported option is not applicable for the Day 100 reporting period.
If the drug was not continued from prophylaxis and was not started in the prior reporting period and continued into the current reporting period, select No and report the therapy start date. When reporting the date started, report the first day the drug was given on or after the GVHD diagnosis date (reported in Date of acute GVHD diagnosis).
If Alemtuzumab (Campath) is selected, report the total administered dose in milligrams during the reporting period. Do not report the prescribed or daily doses.
If ALG, ALS, ATG, ATS is selected, report the total administered dose in milligrams during the reporting period. Do not report the prescribed or daily doses. In addition, specify the animal (horse or rabbit) source. If Other is selected, specify the source.
If Anti CD25 (Zenapax, Daclizumab, AntiTAC), Blinded randomized trial, In vivo immunotoxin, Other in vivo monoclonal antibody, or Other JAK2 inhibitor is selected, specify the agent.
If the therapy is not listed on the form, select Other agent and specify the therapy.
If no therapy was given, indicate None.
Section Updates:
| Question Number | Date of Change | Add/Remove/Modify | Description | Reasoning (If applicable) |
|---|---|---|---|---|
| Q121 | 2/13/2024 | Remove | Update the Corticosteroids blue note box for clarification: Corticosteroids are captured differently depending on whether they are used topically or systemically. Use the following guidelines when determining how to report corticosteroids used to treat acute GVHD: Topical Creams for Skin: Do not report topical ointments or creams used to treat skin GVHD including corticosteroid creams such as Triamcinolone or Hydrocortisone. Other Topical Treatments: Certain corticosteroid treatments Systemic Treatments: Systemic administration of corticosteroids, including use of prednisone and dexamethasone, should be reported in Select systemic treatment used to treat acute GVHD). |
Removed for clarification |
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