2100: Post-Infusion Follow-Up

A transplant center designated as a Comprehensive Report Form center will submit data on the Pre-TED and Pre-TED Disease Classification Forms, followed by either the Post-TED Form or the Comprehensive Report Forms. The type of follow-up forms required for a specific recipient is determined by the CIBMTR’s form selection algorithm.

The Post-Infusion Form (2100) must be completed at the following time points: 100 days, 6 months, annually for 6 years post-HCT, and biennially thereafter. This form should be completed as closely to these time points as possible. The following recipient data should be collected from an actual examination (or other recipient contact) by the transplant center physician or the local physician who is following the recipient post-HCT: vital status, hematopoietic reconstitution post-HCT, neutrophil recovery, platelet recovery, current hematologic findings, immune reconstitution, chimerism studies, engraftment syndrome, acute Graft-versus-Host Disease (GVHD), chronic GVHD, infections, organ function, new malignancy, functional status, and subsequent HCT.

Subsequent HCT
If a recipient receives a subsequent HCT between time points (100 day, 6 months, annually), the CRF form sequence will start over again with another Pre-TED.

However, if the recipient receives an autologous HCT as a result of a poor graft or graft failure, the CRF form sequence will not start over again. Generally, this type of infusion (autologous rescue) is used to treat the recipient’s poor graft response, rather than to treat the recipient’s disease, and is, therefore, not considered a subsequent HCT for reporting purposes.

Contact CIBMTR Center Support if the subsequent Pre-TED does not come due automatically.

*If the recipient received a subsequent transplant (excluding an autologous rescue), the answers to all questions should reflect the clinical status of the recipient the day prior to the start of the preparative regimen or, if no preparative regimen was given, the answers to all questions should reflect the clinical status of the recipient the day prior to HCT infusion.

Lost to Follow Up
Occasionally, centers may lose contact with recipients for a variety of reasons, including the recipient moving, changing physicians, or death. If contact with a recipient appears lost, please consider calling the recipient at home or work, sending a letter, communicating with the treating or referring physician, or contacting the hospital billing department. If no documentation exists and several unsuccessful attempts have been made to contact the recipient, they are considered lost to follow-up and the form may be marked as such using the Lost to Follow-Up Tool in FormsNet3 for each reporting period in which no contact exists.

Links to Sections of Form

Q1 – 9: Vital Status
Q10 – 16: Granulopoiesis / Neutrophil Recovery
Q17 – 20: Megakaryopoiesis / Platelet Recovery
Q21 – 29: Growth Factor and Cytokine Therapy
Q30 – 39: Current Hematologic Findings
Q40 – 55: Immune Reconstitution
Q56: Gene Therapy Persistence Testing
Q57 – 74: Chimerism Studies
Q75 – 85: Engraftment Syndrome
Q86 – 134: Acute Graft vs. Host Disease
Q135 – 204: Chronic Graft vs. Host Disease
Q205 – 211: Current GVHD Status
Q212 – 227: Infection Prophylaxis
Q228 – 249: Infection
Q250 – 382: Organ Function
Q383: New Malignancy, Lymphoproliferative or Myeloproliferative Disease / Disorder
Q384 – 408: Functional Status
Q409 – 412: Subsequent HCT

Manual Updates
Sections of the Forms Instruction Manual are frequently updated. The most recent updates to the manual can be found below. For additional information, select the manual section and review the updated text.

If you need to reference the historical Manual Change History for this form, please review the table below or reference the retired manual section on the Retired Forms Manuals webpage.

Date	Manual Section	Add/Remove/Modify	Description
7/26/2024	7/26/2024	2100:Post-Infusion Follow-Up Form	Subsequent HCT and Cellular Therapy red warning box added above Q4: Subsequent HCT and Cellular Therapy: The following questions are disabled as of July 26, 2024: Did the recipient receive a subsequent HCT?, Has the recipient received a cellular therapy?, Was this infusion a donor lymphocyte infusion (DLI)?, Number of DLIs in this reporting period, Are any of the products, associated with the course of cellular therapy, genetically modified?, Date of cellular therapy; and will be removed with the next revision of this form. All subsequent infusions are reported in the question above Did the recipient receive a subsequent infusion?
7/26/2024	2100:Post-Infusion Follow-Up Form	Modify	Subsequent HCT red warning box above Q409 updated: Complete this section only if the recipient received a subsequent HCT. The data reported in this section should reflect the clinical status immediately prior to the start of the preparative regimen for the subsequent HCT. A new Pre-TED (2400), Disease Classification (2402), and Recipient Baseline (2000) form must be completed for the subsequent HCT. The exception to this is an autologous HCT performed for graft failure / insufficient hematopoietic recovery. The cells used for this subsequent autologous HCT would have been collected prior to the previous HCT. For more information on how to distinguish infusion types (i.e., HCT vs DCI), see Appendix D The Subsequent HCT section is disabled as of July26, 2024 due to the new infusion reporting process and will be removed with the next revision of this form.
7/26/2024	2100:Post-Infusion Follow-Up Form	Modify	Instruction overhaul for reporting organ impairments in Q250 – 377.
7/26/2024	2100:Post-Infusion Follow-Up Form	Add	Instructions for counting number of inpatient days updated in Q389: Enter the total number of inpatient days (including day 0). If the recipient was discharged and readmitted during the first 100 days, the total should include days hospitalized after being readmitted. In the scenario of readmission, when counting the total number of inpatient days, count either the day of admission or the day of discharge; do not count both.
4/19/2024	2100:Post-Infusion Follow-Up Form	Modify	The COVID-19 Vaccine red box updated above Q245 to clarify these questions are now disabled.
4/9/2024	2100:Post-Infusion Follow-Up Form	Add	Example 1 added to the intro of the infection prophylaxis section: Example 1: A recipient is admitted for transplant on day -6, 1/2/2022, with the transplant occurring on 1/8/2022. The recipient receives the following medications based on the medication administration record: Ciprofloxacin started on 1/07/22 Ciprofloxacin is discontinued on 1/14/22, and the recipient begins treatment for a neutropenic fever with Cefepime and Vancomycin on the same day. Valacyclovir started on 1/7/2022. Fluconazole started on 1/7/2022. Fluconazole is discontinued on 1/16/22, and the recipient begins Micafungin due to a toxicity on the same day. Bactrim given from 1/2/22 to 1/6/22 and again at discharge. In this scenario, the infection prophylaxes would be reported as the following: Antibacterial prophylaxis: Ciprofloxacin Cefepime and vancomycin were empiric treatments (not prophylaxis) for a neutropenic fever and thus would not be reported as the antibacterial prophylactic drugs. Antiviral prophylaxis: Valacyclovir Antifungal prophylaxis: Fluconazole Micafungin was the second antifungal administered and likely still served as prophylaxis. However, the switch from Fluconazole to Micafungin was due to the recipient’s increase in liver function tests (AST, ALT, etc.), and thus is not reported as an antifungal prophylaxis since only the first prophylactic drug administered during the reporting period is reported. Anti-PJP prophylaxis: Bactrim
4/9/2024	2100:Post-Infusion Follow-Up Form	Add	Instructions updated to further clarify the intent of this question is to capture the first prophylaxis in Q212: Report the first antibacterial drug administered for prophylaxis and closest to the start of the preparative regimen / infusion and started no later than day +45. This may include antibacterial drugs started prior to the start of the preparative regimen as long as they were continued at the start of the preparative regimen.
4/9/2024	2100:Post-Infusion Follow-Up Form	Add	Instructions updated to further clarify the intent of this question is to capture the first prophylaxis for Q217: Report the first antiviral drug administered for prophylaxis and closest to the start of the preparative regimen / infusion and started no later than day +45. This may include antiviral drugs started prior to the start of the preparative regimen as long as they were continued at the start of the preparative regimen. If the start date is prior to the start of the preparative regimen and the start date is unknown, report the date as seven days prior the start of the preparative regimen. Only one antiviral drug may be reported.
4/9/2024	2100:Post-Infusion Follow-Up Form	Add	Instructions updated to further clarify the intent of this question is to capture the first prophylaxis in Q222: Report the first antifungal drug administered for prophylaxis and closest to the start of the preparative regimen / infusion and started no later than day +45. This may include antifungal drugs started as prophylaxis prior to the start of the preparative regimen as long as they were continued at the start of the preparative regimen. Only one antifungal drug may be reported. If the start date is prior to the start of the preparative regimen and the start date is unknown, report the date as seven days prior to the start of the preparative regimen.
4/9/2024	2100:Post-Infusion Follow-Up Form	Add	Instructions updated to further clarify the intent of this question is to capture the first prophylaxis in Q225: Report the first anti-pneumocystis (PJP) drug administered for prophylaxis and closest to the start of the preparative regimen / infusion and started no later than day +45. This may include anti-pneumocystis (PJP) drugs started prior to the start of the preparative regimen as long as they were continued at the start of the preparative regimen. Only one anti-pneumocystis (PJP) drug may be reported.
4/3/2024	2100:Post-Infusion Follow-Up Form	Add	Further clarification added to Q186 to explain the clinician’s score should be reported: Report the maximum chronic GVHD involvement, based on the opinion of the clinician. (i.e., clinical grade), since the date of the last report. The intent of this question is to capture the maximum grade based on the best clinical judgment. If both the global severity and the score based on the clinician’s opinion is documented, report the clinician score. If the maximum clinical grade is not documented, request documentation from the recipient’s primary care provider. Guidelines on how to report the maximum grade of chronic GVHD are outlined below: Mild: Signs and symptoms of chronic GVHD do not interfere substantially with function and do not progress once appropriately treated with local therapy or standard systemic therapy (e.g., corticosteroids and/or cyclosporine or FK 506) Moderate: Signs and symptoms of chronic GVHD interfere somewhat with function despite appropriate therapy or are progressive through first line systemic therapy (e.g., corticosteroids and/or cyclosporine or FK 506) Severe: Signs and symptoms of chronic GVHD limit function substantially despite appropriate therapy or are progressive through second line therapy 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.
3/13/2024	2100:Post-Infusion Follow-Up Form	Add	Instructions added on when to use the medication toxicity for liver impairment in Q275: Medication toxicity: If the liver abnormality (i.e., abnormal LFT values) is associated with drug initiation, abnormalities improve with cessation, and / or there are no other causes for the changes.
2/13/2024	2100:Post-Infusion Follow-Up Form	Remove	Update the Corticosteroids blue note box above Q121 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 are inhaled or ingested, but are not absorbed and are therefore considered topical. Examples include beclomethasone and budesonide. If these treatments are given for acute GI GVHD during the reporting period, report Yes for Corticosteroids. If these treatments were given for other organ involvement of GVHD, contact the CIBMTR Customer Service Center to determine the best option for reporting this therapy. Systemic Treatments: Systemic administration of corticosteroids, including use of prednisone and dexamethasone, should be reported in Select systemic treatment used to treat acute GVHD).
1/26/2024	2100:Post-Infusion Follow-Up Form	Add	Example 7 added to Q1: Example 7. The recipient had a subsequent auto transplant for graft failure: The recipient has their first auto transplant on 3/1/23 and a subsequent auto transplant for the indication of graft failure/insufficient hematopoietic recovery on 4/15/23. What to report: 100 Day Date of Contact: The date of contact reported will be appropriate to the reporting period since a new Pre-TED (2400) / Disease Classification (2402) is not required for auto rescues.
12/19/2023	2100:Post-Infusion Follow-Up Form	Modify	Q1 instructions update to clarify the contact date for the 1Y reporting period must be greater than day 365: Reporting the 1-Year Date of Contact: If this form is being completed for the 1-year reporting period, ensure the reported contact date is > ≥ Day 365. Review the 1-Year Date of Contact instructions below for additional information.
12/9/2023	2100:Post-Infusion Follow-Up Form	Add	Immunosuppressive Agents blue box added above Q209: Immunosuppressive Agents As of December 9, 2023, questions regarding if the recipient is still taking immunosuppressive agents are required to be answered for all allogeneic infusions, regardless of if GVDH developed.
11/17/2023	2100:Post-Infusion Follow-Up Form	Add	Instructions added on how to report the resolution date for cardiomyopathy: _Indicate if the cardiac impairment / disorder resolved during the reporting period. If Yes, report the resolution date. For all cardiac impairment / disorders, except for cardiomyopathy, the resolution date is the date when the notes specify the condition as resolved and / or medications to treat the condition were completed. For cardiomyopathy, report the resolution date as the first date when the echocardiogram normalized, and the recipient is no longer receiving cardiomyopathy treatment. If an echocardiogram was not performed to assess the cardiomyopathy status, report the resolution date as the first date when treatment is no longer required and in the physician’s opinion, cardiomyopathy resolved.
10/27/2023	2100:Post-Infusion Follow-Up Form	Modify	Version 9 of the 2100: Post-Infusion Follow-Up section of the Forms Instructions Manual released. Version 9 corresponds to revision 9 of the Form 2100

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