2450: Post-TED

Transplant centers participating in the CIBMTR must submit a Post-TED Form for recipients who meet any of the following criteria:

• Recipient receives a transplant at a United States center designated as a TED-only center.
• Recipient receives a transplant at a United States center designated as Comprehensive Report Form center, but has been assigned to the TED track by the Form Selection Algorithm.
• Recipient receives an allogeneic transplant at a United States center designated as Comprehensive Report Form center, but has not consented to participate in research.
• Recipient receives a transplant at an international center, has consented to participate in research, and has been assigned to the TED track by the Form Selection Algorithm.

The Post-TED fulfills the requirements of the SCTOD for recipients meeting any of the above criteria. For more information regarding the SCTOD, see General Instructions, Stem Cell Therapeutics Outcomes Database.

For more information, including information on the TED and Comprehensive Report Form Selection Algorithm, see Section 1 in the Center Reference Guide.

The Post-TED must be completed at the following time points: 100 days, six months, and annually post-HCT. These forms should be completed as closely to these time points as possible. The structure of the TED Forms is such that each form should fit on a timeline with distinct start and stop dates that do not overlap any other forms, except in the case of a subsequent HCT.

*If the Post-TED form is being completed for a six-month or annual evaluation, the answers to all questions should reflect the clinical status of the recipient since the last report.

Subsequent HCT:
If a recipient receives a subsequent HCT between Post-TED time points (100 day, six months, annually), the TED 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 TED 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.

Contact the CIBMTR Customer Service Center 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.

Non-Malignant Diseases
If the HCT being reported was given to treat a non-malignant disease (as reported on the Pre-TED Disease Classification Form {Form 2402}), do not complete the following sections of the Post-TED Form:

• Q73 – 95: Disease Assessment at the Time of Best Response to HCT
• 96 – 104: Post-HCT Therapy
• Q105 – 115: Relapse or Progression Post-HCT
• Q116 – 118: Current Disease Status
  

Lost to Follow-Up:
Occasionally, centers may lose contact with recipients for a variety of reasons, including the recipient’s 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^SM for each reporting period in which no contact exists.

Links to Sections in Manual:
Q1 – 2: Survival
Q3 – 12: Subsequent Transplant
Q13 – 15: Initial ANC Recovery
Q16 – 17: Initial Platelet Recovery
Q18 – 43: Graft-Versus-Host Disease
Q44 – 46: Liver Toxicity Prophylaxis
Q47 – 48: Veno-occlusive disease (VOD) / Sinusoidal obstruction syndrome (SOS)
Q49 – 55: Infection
Q56: New Malignancy, Lymphoproliferative or Myeloproliferative Disorder
Q57 – 74: Chimerism Studies
Q75 – 97: Disease Assessment at the Time of Best Response to HCT
Q98 – 106: Post-HCT Therapy
Q107 – 117: Relapse or Progression Post-HCT
Q118 – 120: Current Disease Status

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 click here or reference the retired manual section on the Retired Forms Manuals webpage.

Date	Manual Section	Add/Remove/Modify	Description
4/3/2024	2450: Post-TED	Add	Further clarification added to Q39 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.
1/26/2024	2450: Post-TED	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	2450: Post-TED	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.
12/19/2023	2450: Post-TED	Add	Q110 instructions updated to clarify relapse / progression therapy is not reported when treatment begins in the reporting period after which relapse / progression was first reported in: Indicate whether therapy was given during the reporting period for persistent or relapsed / progressive disease. Do not include therapy given for maintenance or planned post-transplant consolidation. Any post-transplant therapy included as part of the initial transplant protocol should not be reported in this area of the form. If treatment for relapse / progression started after the reporting period in which relapse / progression was first reported in, the _intervention for relapse / persistent / progressive disease data fields are disabled and relapse / progression treatment is not captured. See the Intervention reporting scenarios provided below for further clarification._
10/27/2023	2450: Post-TED	Modify	Red warning box regarding reporting maximum organ staging was added: Due to further clarification provided, the instructions for reporting the maximum organ staging were updated with the Fall 2023 Quarterly Release. The intent of the maximum organ staging questions is to capture the maximum stage of each organ involved with acute GVHD in the reporting period; not at the time of the maximum overall grade, despite what the question text states. The question text will be revised with the next revision of the Post-Infusion Follow-Up (2100) Form. Additionally. instructions were updated to clarify the maximum stage in the reporting period should be reported, not the maximum stage at the time of the maximum grade of GVHD
9/15/2023	2450: Post-TED	Modify	Instructions updated to clarify reporting the date of maximum grade of acute GVHD when there is organ staging variation: 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. However, if the same maximum overall grade was achieved, but the specific organ staging varied, report the date of the maximum organ staging which is consistent with the overall grade reported in Maximum overall grade of acute GVHD question. For further clarification, review Acute GVHD grading scenario E above has been provided for further clarification.
9/15/2023	“2450: Post-TED	Modify	Updated Acute GVHD Grading Scenario E to reflect updated instructions of reporting the date of maximum grade when there is organ staging variation: E. 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 steroids. Later in the reporting period, on 2/14/2019, they have a flare of the skin GVHD, this time at stage 2 3, along with GI stage 1 (overall grade II). In this case, grade II would be reported in question 29 as the Maximum overall grade of acute GVHD with the date of diagnosis of the more severe flare maximum date reported as 1/1/2019, the First date of maximum overall grade of acute GVHD. Additionally, the skin symptoms would be reported as stage 2 in question 31.when reporting the organ staging at the time of maximum overall grade, skin stage 1 and liver stage 1 should be reported. Skin stage 3 and GI stage 1 will not be captured.
7/20/2023	2450: Post-TED	Add	Clarification added on how to report haplo cords chimerism in Q60-74: When reporting chimerism studies for multiple donors, there should be one instance for each donor for each chimerism test results. For haplo cords, (i.e., haplo donor PBSC and CBU), there should be an instance for both the CBU and the PBSC.
7/19/2023	2450: Post-TED	Modify	Blue PTLD info box added to Q56: Post-Transplant Lymphoproliferative Disorder (PTLD): PTLD should be reported as a new malignancy if it was confirmed via a biopsy (treatment not required) or suspected to be PTLD and treated.
7/19/2023	2450: Post-TED	Modify	Clarified in Q56 which option to select for PTLD: Indicate whether a new or secondary malignancy, lymphoproliferative disorder, or myeloproliferative disorder has developed. Do not report recurrence, progression, or transformation of the recipient’s primary disease (disease for which the transplant was performed), or relapse of a prior malignancy. New malignancies, lymphoproliferative disorders, or myeloproliferative disorders include but are not limited to: Skin cancers (basal, squamous, melanoma) New leukemia New myelodysplasia Solid tumors PTLD (post-transplant lymphoproliferative disorder) (report as lymphoma or lymphoproliferative disease NHL )
5/1/2023	2450: Post-TED	Modify	The Diagnosis of COVID-19 after the start of the preparative regimen blue box above Q49 was updated: Any COVID-19 infections diagnosed after the start of the preparative regimen should be reported in the development of COVID-19 questions on the Post-TED (2450) form. An associated Respiratory Virus Post-Infusion Data (2149) form will be generated. Effective November 18, 2022, the Respiratory Virus Post-Infusion Data (2149) form for transplants on the TED track will no longer be required. Additionally, an unscheduled Respiratory Virus Post-Infusion (2149) form can not be created for these recipients.
2/16/2023	2450: Post-TED	Modify	Examples updated for Q1: Example 8. The recipient had a subsequent non-genetically modified cellular therapy. The recipient has their first transplant on 1/21/15 and a non-genetically modified (e.g. DLI) (excludes DLI) cellular therapy infusion on 2/15/15. There was no lymphodepleting therapy administered. Example 9. The recipient had a subsequent Donor Lymphocyte Infusion (DLI). The recipient has their first transplant on 1/21/2215 and receives a DLI on 2/27/2022. There was no lymphodepleting therapy administered prior to the DLI. What to report: 100 Day Date of Contact: The date of contact reported will be appropriate to the reporting period. Do not complete the follow up form early. Combined follow up will not be applied, a single F2199 is required for each DLI in the reporting period, then HCT reporting continues.
2/15/2023	2450: Post-TED	Add	The ‘No Documentation of Contact Date’ red warning box added above Q1: No Documentation of Contact Date The contact date data field cannot be left blank and is required to be reported. In cases where the recipient passed away and there is no documentation to report the date of death, the guidelines for reporting estimated dates must be used.
2/15/2023	2450: Post-TED	Add	Instruction updated to include a radiologic assessment may be reported for the current disease stats assessment date: If the current disease status is Complete remission, report the date of the most disease specific clinical / hematologic or radiologic assessment performed within approximately 30 days of the contact date. If the current disease status is Not in complete remission – disease detected, report the most recent clinical / hematologic or radiologic assessment performed in the reporting period that detects disease. If the current disease status is Not in complete remission – no disease detected but incomplete evaluation to establish CR, report the last clinical / hematologic (color-red) or radiologic assessment performed in the reporting period.
2/14/2023	2450: Post-TED	Modify	Clarification added on when to use the Previously reported option for new malignancy: The Previously reported option should only be used if the same malignancy has already been reported on a Subsequent Neoplasms (3500) form that was made do on demand. See examples below. If it is unclear whether or not to use of this option, contact CIBMTR Center Support if there are questions. Example 1. A recipient developed a new malignancy at Day +68 and is reported at the time the Day 100 Post-Infusion Follow-up (2450) form is completed. In this scenario, report Yes, the recipient developed a new malignancy, and a Subsequent Neoplasms (3500) form will be completed to report the new malignancy information. For all future reporting periods, select No. Example 2. A recipient developed a new malignancy during the seven-year reporting period and the transplant center decided to create the Subsequent Neoplasms (3500) form as an unscheduled form in FormsNet3SM to report the new malignancy information immediately since a Post-Infusion Follow-Up for seven-year reporting period will not come due. When the eight-year Post-Infusion Follow-Up (2450) form is completed, Previously reported, will be reported since a prior Subsequent Neoplasms (3500) form has already been submitted for the new malignancy. Example 3. A recipient was diagnosed with basal cell skin cancer on the neck in the one-year reporting period and two months later, within the same reporting period, there was a diagnosis of basal cell located on the nose. The lesion on the nose is not considered a metastasis from the neck, but a new discreet lesion. Report Yes, there was a new malignancy on the Post-HCT Follow-Up (2450), and a single Subsequent Neoplasms (3500) form will come due to report one of the basal cell malignancies. Create a second Subsequent Neoplasms (3500) form to report the other basal cell malignancy as these are discreet episodes. If the new malignancy, lymphoproliferative disorder, or myeloproliferative disorder was reported in a prior reporting period, select Previously reported.
1/27/2023	2450: Post-TED	Add	Red warning box regarding reporting persistent GVHD for the Day 100 reporting added for Q38: Persistent GVHD and Day 100 Reporting Period: Previously, reporting Yes for Did chronic GVHD persist since the date of last report was not an applicable option for the Day 100 reporting period. However, if there was a prior infusion, the recipient developed chronic GVHD in the last reporting period of the previous infusion and chronic GVHD persisted into the Day 100 reporting period of the current infusion, report Yes, chronic GVHD persisted since the date of last report.
1/27/2023	2450: Post-TED	Add	Red warning box regarding reporting persistent GVHD for the Day 100 reporting added for Q19: Persistent GVHD and Day 100 Reporting Period: Previously, reporting Yes for Did acute GVHD persist since the date of last report was not an applicable option for the Day 100 reporting period. However, if there was a prior infusion, the recipient developed acute GVHD in the last reporting period of the previous infusion and acute GVHD persisted into the Day 100 reporting period of the current infusion, report Yes, acute GVHD persisted since the date of last report.
9/23/2022	2450: Post-TED	Modify	Version 6 of the 2450: Post-TED section of the Forms Instruction Manual released. Version 6 corresponds to revision 7 of the Form 2450.

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