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Forms Instruction Manual - 1
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 an international center, has consented to participate in research,
and has been assigned to the TED track by the Form Selection Algorithm.
• Recipient receives a transplant at a United States center designated as Comprehensive Report Form
center and has been assigned to the TED track by the Form Selection Algorithm.
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• Recipient receives an allogeneic transplant at a United States center designated as Comprehensive
Report Form center, but has not consented to participate in research.
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 General Instructions, Center Type and Data Collection Forms.
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. The Post-TED is considered past due
120 days after each of these time points.
*
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.
*
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.
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 your center’s CIBMTR CRC if the subsequent Pre-TED does not come due automatically.
Lost to Follow-Up:
Occasionally, centers may lose contact with recipients for a variety of reasons, including the recipient’s
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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,
contacting the hospital billing department, or beginning a search request with the CIBMTR. If your center
receives documented information that a recipient is alive or dead, the form should be filled out with the
recipient survival status. If no documentation exists and several unsuccessful attempts have been made to
contact the recipient, they are considered lost to follow-up and the center should indicate this status in
FormsNet for each reporting period in which no contact exists.
Q1-7: 100 Day Report Only
Q8-11: Initial ANC Recovery
Q12-14: Initial Platelet Recovery
Q15-18: Graft versus Host Disease
Q19-61: New Malignancy, Lymphoproliferative or Myeloproliferative Disorder
Q62-74: Survival
Q75-77: Post-HCT Therapy
Q78: HCT for Non-Malignant Disease Only
Q79-81: Malignant Disease Evaluation for this HCT
Q82-91: First Relapse or Progression after HCT
Q92-95: Additional Treatment
Q96-107: Method of Latest Disease Assessment
Q110-145: Donor Cellular Infusion
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.
Add/
Remove/ Description
Modify
Date
Manual
Section
4/6/
16
2450:
Modify
Post-TED
Changed the wording in questions 66-73 to reflect the possibility of multiple
causes of death (i.e., select all that apply), rather than a single primary cause of
death.
2/9/
16
2450:
Modify
Post-TED
Modified pediatric acute GVHD Gut guidelines to question 15. See table for
details.
1/
22/
16
2450:
Modify
Post-TED
Updated footnote 4 below acute GVHD staging and grading table:
Persistent nausea with or without histologic evidence of GVHD in the stomach or
duodenum.
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12/
3/15
9/
27/
15
Forms Instruction Manual - 1
2450:
Modify
Post-TED
Updated description of DLI indication reporting in Questions 118-119:
From the list provided, indicate the reason the cells were infused. If there was
more than one reason for the DCI, check all applicable indications. If the recipient
received multiple DCIs for more than one indication, report the DCI and the new
indication in the second DCI section.
If multiple DCIs were given within the 10-week period, check all applicable
indications.
2450:
Pre-TED
Modify
language to question 65:
Cause of death is considered the main disease, complication, or injury that leads
to death. Do not report the mode of death (e.g., cardiopulmonary arrest). Only one
primary cause of death may be specified; however, under “HSCT-related
causes,” multiple contributing causes may be listed if relevant.
9/
27/
15
2450:
Pre-TED
Remove
Removed the following phrase from “Subsequent Transplant” for clarification
purposes. This does not change the intention of the question; if a recipient
receives an autologous rescue, new forms should not come due:
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, and is therefore not considered a
subsequent HCT.
6/
26/
15
2450:
Pre-TED
Modify
Added warnings to GVHD section that state autologous and sygeneic HCTs
should skip the section.
6/
12/
15
Manualwide
Modify
Language relating to the Lost-to-Follow-Up (2802) has been removed.
6/
12/
15
2450:
Pre-TED
Add
Added explanatory text to question 106:
The date reported should be that of the most disease-specific assessment within
a reasonable timeframe of the date of contact (approximately 30 days). Indicate
the date the sample was collected for examination for pathological and laboratory
evaluations; enter the date the imaging took place for radiographic assessments,
or the date of physical examination.
6/5/
15
2450:
Add
Post-TED
Added pediatric acute GVHD Gut guidelines to question 15. See table for details.
Q1-7: 100 Day Report Only
*
Question numbers correspond to the FormsNet3 SM application. Questions 1-7
should only be answered for the 100 day reporting period.
Question 1: Is “Date of HCT” the same as the date given on Pre-TED?
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If the HCT occurred on the date reported on the Pre-TED (question 2, Date of this HCT), check “yes” and
continue with question 2.
If the HCT did not occur on the date reported on the Pre-TED, you must update the HCT date you reported
on the Pre-TED or, in the case of a subsequent transplant, on the form that you reported the subsequent
transplant on. The correction of the HCT date must be completed before the Post-TED is started.
If the HCT did not occur, check “no” and continue with question 2.
Question 2: Was HCT infusion given?
If the HCT infusion was given, check “yes” and continue with question 8 (do not answer questions 3-7). If
the HCT infusion was not given, check “no” and continue with question 3.
Question 3: At least one dose of the preparative regimen was given?
If at least one dose of the preparative regimen was administered (includes radiation and/or chemotherapy),
check “yes” and continue with question 4. If the preparative regimen was not started, check “no” and
continue with question 5.
Question 4: Patient died during preparative regimen?
If the recipient died after the start of the preparative regimen, but prior to the HCT infusion, check “yes” and
continue with question 62. If “no,” continue with question 5.
*
Questions 5-6
If the HCT did not occur, and the patient did not die during the preparative regimen,
either question 5 or question 6 must be answered “yes.”
Question 5: This HCT is cancelled?
If the HCT was cancelled, check “yes,” and continue with question 62, and submit the form. If “no,” continue
with question 6.
Question 6: This HCT is postponed?
If this HCT was postponed, check “yes” and continue with question 7. The “no” should never be chosen for
this question, as the HCT will either have been cancelled (question 5) or postponed.
Question 7: New estimated date:
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Enter the new estimated date of the HCT, complete questions 62-74, and submit the form. A postponed
HCT does not count as an HCT event. If the postponed event is re-scheduled and completed, then another
Pre-TED will be requested and the follow-up process will start with the subsequent Pre-TED.
Do not change the date on the previously submitted Pre-TED via the error correction process. A new
Pre-TED must be completed for the re-scheduled HCT.
For more information regarding reporting partial or unknown dates, see General Instructions, General
Guidelines for Completing Forms.
Q8-11: Initial ANC Recovery
*
Initial ANC Recovery
Recovery, as reported in this section, does not distinguish between allogeneic
engraftment (blood and stem cells of donor origin) and autologous engraftment
(blood and stem cells of host origin). To demonstrate engraftment for allogeneic
recipients, particularly non-myeloablative or reduced intensity approaches,
chimerism tests must be done. These measure the quantity of donor cells relative
to the quantity of host (recipient) cells. While ANC usually represents donor cells in
allogeneic HCT, it cannot be proven without chimerism studies.
ANC recovery is defined as an absolute neutrophil count (ANC) of ≥ 0.5 × 109/L (500/mm3) for three
consecutive laboratory values obtained on different days. Date of ANC recovery is the date of the first of
three consecutive laboratory values where the ANC is ≥ 0.5 × 109/L. At some institutions, the laboratory
reports display the ANC value once there are sufficient white blood cells to perform a differential count. At
other institutions, the laboratory reports do not display the ANC, and it must be calculated from the white
blood cell count (WBC) and the percent of segmented and band neutrophils (if the differential was
performed on a machine, the percent neutrophils will include both segmented and band neutrophils). If the
laboratory report displays an automated ANC value of exactly 0.5, the actual ANC value should be
calculated from the manual differential if available. The calculated value from the manual differential will
determine ANC recovery. If your institution’s laboratory reports do not display the ANC value, use the
following calculation to determine the ANC:
Example 1. Calculating Absolute Neutrophil Count (ANC)
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Traditionally, the definition of ANC recovery required selecting the first date of three consecutive days in
which the recipient’s ANC was ≥ 0.5×109/L (500/mm3). For various reasons it may not be possible to obtain
daily laboratory values. Under those circumstances, report ANC recovery based upon three consecutive
laboratory values (drawn more than a day apart) as long as the ANC remains ≥ 0.5×109/L (500/mm3).
Tracking the date of ANC recovery may not always be straightforward. In some cases the ANC may
fluctuate for a period of time before the recipient fully recovers. In other cases the ANC may remain above
0.5 × 109/L for several days immediately post-HCT and then fall below 0.5 ×10 9/L. Do not begin counting
ANC values of ≥ 0.5 × 10 9/L towards recovery until the ANC has dropped to the lowest level (nadir)
post-HCT. If the recipient was transplanted using a non-myeloablative (NST) or reduced intensity (RIC)
regimen, or was transplanted for an immunodeficiency (e.g., SCID, WAS), the recipient’s ANC may never
drop below 0.5 × 109/L. If this is the case, an ANC recovery date will not be reported, and the “never below”
option should be chosen. However, if the recipient’s ANC drops below 0.5×109/L for even one day, this
should be considered the nadir and “never below” should not be chosen. See the following example for
more information regarding tracking the date of ANC recovery.
Example 2: Tracking ANC Recovery Transplant Date = May 6
Date
WBC %Neutrophils ANC
May 7
900
0.6
540
May 8
850
0.59
502
May 9
720
0.7
504
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May 10 300
0.45
135
May 11 15
No differential
—
May 12 30
No differential
—
May 13 50
No differential
—
May 14 250
0.4
100
May 15 800
0.7
560
May 16 1050 0.8
840
May 17 1000 0.7
700
May 18 1800 0.6
1080
May 19 2000 0.55
1100
May 20 2500 0.53
1325
May 21 2250 0.43
968
May 22 1500 0.45
675
Date of first recovery: ANC ≥ 0.5×109/L
Question 8: Was ≥ 0.5 × 109/L achieved for 3 consecutive labs?
Indicate whether or not there was evidence of initial ANC recovery following this HCT.
Check only one response:
• If “yes,” continue with question 9.
• If “no,” continue with question 10.
• Check “never below,” if the recipient’s ANC never dropped below 0.5 × 10 9/L at any time post-HCT.
• Check “previously reported” if this is the six-month or annual follow-up, and the initial ANC recovery
has already been reported.
• Check “unknown” if there is no documentation of ANC recovery and/or laboratory reports cannot be
obtained. This answer should rarely be used, as ANC recovery is fundamental to a successful HCT. It
is imperative that every effort be made to report this data.
Question 9: First date of 3 consecutive labs:
Enter the first date of the three consecutive laboratory values obtained on different days where the ANC
was ≥ 0.5 × 109/L. For an example of tracking ANC recovery, see Example 2.
For more information regarding reporting partial or unknown dates, see General Instructions, General
Guidelines for Completing Forms.
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Question 10: Date of last assessment:
If ANC of ≥ 0.5 × 109/L was not achieved for three or more consecutive days, enter the date of the last
laboratory report.
For more information regarding reporting partial or unknown dates, see General Instructions, General
Guidelines for Completing Forms.
Question 11: Did graft failure occur?
Graft failure includes persistent neutropenia, < 5% donor chimerism, and ANC < 0.5 × 109/L for three or
more consecutive laboratory values. Graft failure often requires an additional infusion of donor cells. Graft
failure may result from the use of specific drugs, infection (especially CMV), GVHD, and other etiologies.
If the recipient meets the criteria of graft failure, check “yes.”
Q12-14: Initial Platelet Recovery
!
Transfusions
Currently there is an error on the Form 2450 regarding the date of platelet
recovery. The form should read: “date platelet greater than or equal to (≥) 20 ×
109/L.”
The following questions refer to initial platelet recovery following the HCT for which this form is being
completed. All dates should reflect no platelet transfusions administered for seven consecutive days.
Report the date of the first of three consecutive laboratory values ≥ 20 × 10 9/L obtained on different days,
as shown in example 3 below. Note that platelet recovery may take place well after the recipient has
returned to the referring physician for care. It is essential that information and laboratory values be obtained
from the referring physician.
Transfusions temporarily increase blood cell counts. When the data is later used for analysis, it is important
to be able to distinguish between a recipient whose own body was creating the cells and a recipient who
required transfusions to support the counts.
The following example illustrates the procedure to follow for reporting platelet recovery.
Example: Reporting Platelet Recovery
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Transfusion
Day
0
1
2
3
4
5
6
7
8
9
10
Platelet
10,000
Count
35,000 30,000 25,000 10,000 15,000 19,000 23,000 25,000 40,000 50,000
Date
1/2/
2008
1/1/2008
1/3/
2008
1/4/
2008
1/5/
2008
1/6/
2008
1/7/
2008
1/8/
2008
1/9/
2008
1/10/
2008
1/11/
2008
1st of
3
Report 1/8/08 as date platelet count ≥ 20 × 10 9/L
Question 12: Initial platelet recovery
Indicate whether or not there was evidence of initial platelet recovery following this HCT.
Check only one response:
• If “yes,” continue with question 13.
• If “no,” continue with question 14.
• Check “never below,” if the recipient’s platelets never dropped below 20 × 10 9/L at any time post-HCT
and a platelet transfusion was never required. If the recipient’s platelet count drops below 20 × 10 9/L
and/or the recipient received a platelet transfusion even once, do not use this option.
• Check “previously reported” if this is the six-month or annual follow-up, and initial platelet recovery
has already been reported on a previous form.
• Check “unknown” if there is no documentation of platelet recovery and/or laboratory reports cannot be
obtained.
Question 13: Date platelet ≥ 20 × 109/L
Enter the first date of three consecutive laboratory values obtained on different days where the platelet
count was ≥ 20 × 109/L. Ensure that no platelet transfusions were administered for seven days immediately
preceding this date. Include day seven, as shown in Example 3 above, when determining the recovery date.
If three laboratory values were not obtained on consecutive days, but a sequential rise of ≥ 20 × 10 9/L is
demonstrated, follow the examples below when determining an estimated date.
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Example 1 The recipient is being seen in the outpatient clinic and receives a platelet transfusion on
January 1. The platelet count is ≥ 20 × 10 9/L on January 2, January 3, and January 4. The recipient does
not come into the clinic for evaluation until one month later. The recipient has not received any more
platelet transfusions and the platelet count is well above 20 × 10 9/L. Report January 8 (day seven postplatelet transfusion) for the date of platelet recovery.
Example 2 The recipient is being seen in the outpatient clinic and receives a platelet transfusion on
January 1. The platelet count is ≥ 20 × 10 9/L on January 2, January 3, and January 4. The recipient is
then discharged back to their primary care physician. The transplant center receives a follow-up note from
the primary care physician that states “recipient recovered their platelets in January of 2011.” Report the
day of the month as the 15th. If the 15th does not make logical sense in relation to the dates of the
platelet counts obtained, use either the 1st or 30th. Report month and year as documented.
For more information regarding reporting partial or unknown dates, see General Instructions, General
Guidelines for Completing Forms.
Question 14: Date of last assessment
If a platelet count of ≥ 20 × 10 9/L was not achieved; enter the date of the last laboratory report.
For more information regarding reporting partial or unknown dates, see General Instructions, General
Guidelines for Completing Forms.
Q15-18: Graft versus Host Disease
(Allogeneic Only)
!
Autologous and Syngeneic Transplants
If this was an autologous or syngeneic HCT, continue with the New Malignancy
section at question 19.
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. Very rarely, GVHD may occur due to autologous reactivity (autologous GVHD),
third party transfusions, or with identical twin transplantation. Due to the rarity of this occurrence, the GVHD
section should only be completed for allogeneic transplants. For autologous HCT, leave questions 15-18
blank.
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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. 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, or liver. Other sites, such as the lung, may be involved.
Question 15: Maximum Grade of Acute GVHD
The acute GVHD grading scale is based on clinical evidence (physician observation), not histology. If there
is a difference in the clinical grade recorded by the physician and a histologic report, use the data from the
clinical documentation. Biopsy of affected organs allows for more precise diagnosis as to the presence or
absence of GVHD. 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 table below.
Table 1: GVHD Grading and Staging
Stage Skin
Liver
Gut
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
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
1
2
Grade5
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I
Stage 1-2
None
None
II
Stage 3 or
Stage 1 or
Stage 1
III
—
Stage 2-3 or
Stages 2-4
IV6
Stage 4
Stage 4
—
1
Use “Rule of Nines” (Table 2) 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 histologic 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
*
Pediatric Recipients
Diarrhea in pediatric recipients is assessed in mL/m 2 rather than mL/kg since the
recipient’s weight may fluctuate due to cardiac failure, renal failure, or severe
diarrhea.
Table 2: 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%
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Indicate the maximum grade of acute GVHD present during this reporting period [including acute GVHD that
persists from a previous HCT or donor cellular infusion (DCI)].
If acute GVHD was present, but the maximum grade was not documented nor is it able to be determined
from the grading and staging table, check “present (but) grade unknown.”
Example 1: 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 using
Table 1.
Example 2: A recipient developed acute liver GVHD with elevated LFTs with no total bilirubin
manifestation. The progress notes indicate stage 1 (grade II overall) acute GVHD of the liver. In this case,
the clinical manifestations do not fit the criteria used in Table 1; “present, grade unknown” would be the
best option to report.
If the recipient did not develop acute GVHD, check “0.”
*
Reporting Chronic GVHD, Date of Diagnosis, and Continuation From Last
Report (Questions 16, 17, & 18)
Question 16 is intended to capture the maximum extent of chronic GVHD during
the reporting period.
Question 17 is intended to capture the date of onset of chronic GVHD or flare of
chronic GHVD if the previous episode has resolved for at least 30 days.
Question 18 is intended to capture if the chronic GVHD episode has continued
from the last post-TED form (Form 2450).
Question 16: Maximum extent of Chronic GVHD during this period
Chronic GVHD can occur following acute GVHD or without prior evidence of acute GVHD (de novo). Chronic
GVHD affects 25-50% of long-term survivors of allogeneic transplants and usually develops after day 100. It
has been documented as occurring as early as day 60 and as late as day 400 post-HCT. In chronic GVHD,
the mechanism of tissue damage differs from acute GVHD and a greater variety of organs may be affected.
The staging system for chronic GVHD is divided into two categories: limited and extensive.
*
Reporting Stage of Chronic GVHD (Sullivan KM, Blood 1981; 57:267.)
Limited: Localized skin involvement resembling localized scleroderma with or
without liver involvement; no other organ involvement.
Extensive: Generalized skin and/or multiple organ involvement.
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Indicate the maximum grade of chronic GVHD present during this reporting period. If the recipient did not
develop chronic GVHD, check “none” and continue with question 19.
Report “limited” if chronic GVHD includes only localized skin involvement and/or liver dysfunction. Continue
with question 17.
Report “extensive” if any of the following symptoms are attributed to chronic GVHD:
• Generalized skin involvement and/or liver dysfunction
• Liver histology showing chronic aggressive hepatitis, bridging necrosis, or cirrhosis
• Involvement of the eye
• Involvement of the salivary glands or oral mucous membranes
• Involvement of any other target organ
Continue with question 17.
If chronic GVHD was present, but the maximum extent was not documented, check “unknown” and continue
with question 19.
Example 1. A recipient developed stage 1 acute skin GVHD in the 100 day reporting period that
persisted into the 6 month reporting period. During the 6 month reporting period, the acute skin GVHD
progressed into limited chronic skin GVHD. The chronic skin GVHD was in remission by the end of the
6 month reporting period, and there was no subsequent episode of chronic GVHD in the 1 year
reporting period.
Reporting
Period
Maximum Extent
(Question 16)
Date of Diagnosis (Question
17)
Continued From Last Report
(Question 18)
100 day
None
—
—
6 month
Limited
Date acute progressed to
chronic GVHD
—
1 year
None
—
—
Example 2. A recipient developed de novo chronic oral GHVD in the 100 day reporting period, which
persisted into the 6 month reporting period. There was no subsequent chronic GVHD through the 1
year reporting period.
Reporting
Period
Maximum Extent
(Question 16)
Date of Diagnosis
(Question 17)
Continued From Last Report
(Question 18)
100 day
Extensive
Date of clinical diagnosis
—
6 month
Extensive
Leave blank
Yes
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1 year
Forms Instruction Manual - 1
None
—
—
Example 3. A recipient developed stage 1 acute skin GVHD in the 100 day reporting period which was in
remission by the date of contact for the 100 day form. Towards the end of the 6 month reporting period,
the recipient developed limited, chronic GVHD of the skin, which persisted into the 1 year reporting
period.
Reporting
Period
Maximum Extent
(Question 16)
Date of Diagnosis
(Question 17)
Continued From Last Report
(Question 18)
100 day
None
—
—
6 month
Limited
Date of clinical diagnosis
No
1 year
Limited
Leave blank
Yes
Example 4. A recipient developed de novo extensive gastrointestinal (GI) chronic GVHD in the 6 month
reporting period. The chronic GI GVHD is in remission on the date of contact for the 6 month reporting
period. Two months into the 1 year reporting period, the recipient developed a flare of the extensive GI
GVHD.
Reporting
Period
Maximum Extent
(Question 16)
Date of Diagnosis (Question 17)
Continued From Last Report
(Question 18)
100 day
None
—
—
6 month
Extensive
Date of clinical diagnosis in the
6-month reporting period
No
1 year
Extensive
Date of clinical diagnosis in the 1-year
reporting period
Yes
Example 5. A recipient developed stage 2 acute GVHD of the skin in the 100 day reporting period, which
persisted into the 6 month reporting period; and subsequently progressed into limited, chronic GVHD
of the skin. Limited chronic GVHD of the skin persisted through the 6 month reporting period and into
the 1 year reporting period. The chronic GVHD of the skin cleared for the last two months in the 1 year
reporting period. However, the recipient developed extensive chronic oral GVHD near the end of the 1
year reporting period.
Reporting
Period
Maximum Extent
(Question 16)
Date of Diagnosis (Question
17)
Continued From Last Report
(Question 18)
100 day
None
—
—
6 month
Limited
Date of progression from acute
to chronic
No
1 year
Extensive
Date of oral GVHD onset
Yes
Question 17: Date of diagnosis of chronic GVHD
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Report the date of clinical diagnosis of chronic GVHD. The clinical diagnosis date may not necessarily be
the date the symptoms began. If the clinical diagnosis date is not documented, then report the date of
histologic confirmation.
If this form is being completed for the six-month or annual follow-up time point, and the recipient had a
previous onset of chronic GVHD that subsequently resolved for at least 30 days and then reactivated
(“flare”), report the flare as a new episode and list the new date of diagnosis.
If chronic GVHD progressed directly from acute GVHD, the date of onset should be reported as the date the
recipient’s symptoms progressed from acute to chronic.
For more information regarding reporting partial or unknown dates, see General Instructions, General
Guidelines for Completing Forms.
Question 18: Continued from last report (answer is only valid on > day 100 evaluation)
Indicate whether the chronic GVHD episode has continued from the last Post-TED form. This question is not
intended to capture when acute GVHD progresses to chronic GVHD.
Q19-61: New Malignancy, Lymphoproliferative
or Myeloproliferative Disorder
Question 19: Did a new malignancy, lymphoproliferative or myeloproliferative disorder
occur?
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.
A new malignancies, lymphoproliferative disorder, or myeloproliferative disorder 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)
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The following should not be reported as new malignancy:
• Recurrence of primary disease (report as relapse or disease progression)
• Relapse of malignancy from recipient’s pre-HCT medical history
• Breast cancer found in other (i.e., opposite) breast (report as relapse)
• Post-HCT cytogenetic abnormalities associated with the pre-HCT diagnosis (report as relapse)
• Transformation of MDS to AML post-HCT (report as disease progression)
*
Skin Cancers
For most malignancies, one does 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 in the “New Malignancy” section.
However, in the case of a basal cell or squamous cell skin cancer, one needs to
report each discrete episode. For example, a recipient had a basal cell skin cancer
diagnosed on the neck four months post-HCT and six months later had another
basal cell located on the nose. The lesion on the nose is not considered a
metastasis from the neck, but a new discrete lesion.
These discrete episodes should be reported in the “Other skin malignancy”
questions on the Post-TED forms (questions 47-49).
If a new malignancy, lymphoproliferative disorder, or myeloproliferative disorder has occurred following the
HCT, check “yes” and continue with question 20. If not, check “no” and continue with question 62.
*
New Malignancy, Lymphoproliferative or Myeloproliferative Disorder
Paper submission of new malignancy: if more than one new malignancy occurred in
a single reporting period and each malignancy had a different diagnosis date, copy
the page and report each malignancy separately, labeling them 1st, 2nd, 3rd, etc. If
multiple malignancies occurred with the same diagnosis date, report all
malignancies from that diagnosis date on the same page.
Question 20: For all new malignancies except “other skin malignancy (basal cell,
squamous),” was testing performed to determine the cell of origin?
Indicate if testing was performed to determine the cell of origin of the new malignancy. If testing was
performed, check “yes” and continue with question 21. If not, check “no” and continue with question 23.
Question 21: Specify the cell origin of the new malignancy
Indicate the cell origin of the new malignancy.
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Question 22: Is a copy of the cell origin evaluation (VNTR, cytogenetics, FISH) attached?
Attaching a copy of the evaluation for the cell origin of the new malignancy reduces the need for later data
queries.
If “yes,” complete the Log of Appended Documents Form (Form 2800) and attach the pathology report. Do
not attach the pathology report to the 2450. For more information regarding the Form 2800, see the Log of
Appended Documents manual section.
*
Questions 23-60
FormsNet3SM application: Check either “yes” or “no” for each option listed, and
enter the “date of diagnosis,” if applicable.
Paper form submission: Check all that apply.
Question 23-60: Specify which new disease(s) occurred
Indicate the disease classification(s) at diagnosis.
Question 27: Other leukemia (including ALL) – Specify
If the disorder is “other leukemia,” specify the type. Do not report AML/ANLL in this category.
Question 44: Is the tumor EBV positive?
If the disorder is lymphoma or lymphoproliferative disease, indicate if the tumor is EBV positive.
Question 60: Other malignancy – Specify
If the disorder does not fit one of the categories listed, specify the type.
Question 61: Is a pathology/autopsy report or other documentation attached?
Attaching a copy of the diagnostic pathology report for the new malignancy assists in disease confirmation
and reduces the need for later data queries.
If “yes,” complete the Log of Appended Documents Form (Form 2800) and attach the pathology report. Do
not attach the pathology report to the 2450. For more information regarding the Form 2800, see the Log of
Appended Documents manual section.
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Q62-74: Survival
The latest follow-up date is based on a medical evaluation conducted by a transplant center physician,
referring physician, or other physician currently assuming responsibility for the recipient’s care. Report the
date of the medical evaluation performed closed to the designated time period of the form (e.g., day 100,
six-month, or annual follow-up visit). Recipients are not always seen within the time windows used for
reporting follow-up dates and some discretion is required when determining which date to report. In that
case, report the date closest to the date of contact within reason. If this Post-TED Form is being completed
for the day 100 time period, the answers to all questions should reflect the clinical status of the recipient
between the HCT infusion date and the latest follow-up date. If this Post-TED Form is being completed for
the six-month or annual time period, the answers to all questions should reflect the clinical status of the
recipient between follow-up dates of the most recent Post-TED completed and the current Post-TED. If the
recipient has not been seen by a physician but the survival status is known, submit the Post-TED reporting
only the survival status.
If this form reports a subsequent stem cell infusion, report the date of contact as the day before the
preparative regimen began for the subsequent HCT. If no preparative regimen is given, report the date of
contact as the day before the subsequent HCT.
Paper submission of Post-TED: For survival status, include the date of latest follow-up, date of death, or last
known date alive in the “latest follow-up” space.
For more information regarding reporting partial or unknown dates, see General Instructions, General
Guidelines for Completing Forms.
Question 62: Survival status at latest follow-up
Indicate the clinical status of the recipient on the date of actual contact for follow-up evaluation. If the
recipient is alive, continue with question 63. If the recipient has died, continue with question 64.
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Reporting Latest Follow-up
When reporting the date of latest follow-up prior to a subsequent HCT, report the
date specified above regardless whether there is actual patient contact on the date.
This is an exception to standard date of follow-up reporting to ensure all dates are
captured within the sequence of forms.
It is important to note that the date latest follow-up for the Form 2450 being
completed should be before the date of a subsequent HCT. Also, even if the
subsequent transplant date falls outside of the reporting period for this form, the
answer to “did the recipient receive a subsequent HCT” must be “yes” (question
949 in the key fields).
Questions 63-64: Latest follow-up
Enter the date of actual contact with recipient to determine medical status for this follow-up report.
Acceptable evaluations include those from the transplant center, referring physician, or other physician
currently assuming responsibility for the recipient’s care. If an evaluation was not performed at Day 100, at
six months, or on the HCT anniversary, choose the date of the visit closest to the actual time point.
If the recipient has not been seen by a physician but the survival status is known, submit the Post-TED
reporting only the survival status.
In general, the date of contact should be reported as close to the 100 day, six month, or annual anniversary
to transplant as possible. Report the date of actual contact with the recipient to evaluate medical status for
the reporting period. Preferred evaluations include those from the transplant center physician, referring
physician, or other physician currently assuming responsibility for the recipient’s care. In the absence of
contact with a physician, other types of contact may include a documented phone call with the recipient, a
laboratory evaluation, or any other documented recipient interaction on the date reported. If there was no
contact on the exact time point, choose the date of contact closest to the actual time point. Below, the
guidelines show an ideal approximate range for reporting each post-transplant time point:
Form
Time Point
Approximate Range
100 days
+/- 15 days (Day 85-115)
Post-TED (Form 2450) 6 Months
+/- 30 days (Day 150-210)
1 Year, 2 Year, 3 Year, etc. +/- 30 days (Months 11-13, 23-25, 35-37, etc)
Recipients are not always seen within the approximate ranges and some discretion is required when
determining the date of contact to report. In that case, report the date closest to the date of contact within
reason. The examples below assume that efforts were undertaken to retrieve outside medical records from
the primary care provider, but source documentation was available.
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Example 1. The 100 day date of contact doesn’t fall within the ideal approximate range.
The autologous recipient was transplanted on 1/1/13 and is seen regularly until 3/1/13. After that, the
recipient was referred home and not seen again until 7/1/13 for a restaging exam and 7/5/13 for a meeting
to discuss the results.
What to report:
100 Day Date of Contact: 3/1/13 (Since there was no contact closer to the ideal date of 4/11/13, this date
is acceptable)
6 Month Date of Contact: 7/5/13 (note the latest disease assessment would likely be reported as 7/1/13)
Example 2. The 100 day date of contact doesn’t fall within the ideal approximate range and the
recipient wasn’t seen again until 1 year post-HCT.
The autologous recipient was transplanted on 1/1/12 and is seen regularly until 3/1/12. After that, the
recipient was referred home and not seen again until 1/1/13 for a restaging exam and 1/4/13 for a meeting
to discuss the results.
What to report:
100 Day Date of Contact: 3/1/13 (Since there was no contact closer to the ideal date of 4/11/13, this date
is acceptable)
6 Month Form: Indicate the recipient is lost to follow-up in FormsNet
1 Year Date of Contact: 1/4/13 (note the latest disease assessment would likely be reported as 1/1/13)
Additional Information
• A date of contact should never be used multiple times for the same recipient’s forms.
◦ For example, 6/1/13 should not be reported for both the 6 month and 1 year form. Instead,
determine the best possible date of contact for each reporting period; if there is not a suitable
date of contact for a reporting period, this may indicate that the recipient was lost to follow-up
and a Loss to Follow-Up Declaration (Form 2802) may need to be completed.
• If the recipient has a disease evaluation just after the ideal date of contact, capturing that data on the
form may be beneficial.
◦ For example, if the recipient’s 90 day restaging exam was delayed until day 115 and the
physician had contact with the recipient on day 117, the restaging exams can be reported as
the latest disease assessment and day 117 would be the ideal date of contact, even though it is
just slightly after the ideal approximate range for the date of contact.
Date of Contact & Death
In the case of recipient death, the date of contact is also carefully chosen. If the recipient dies, the date of
death should be reported as the date of contact regardless of the time until the ideal date of contact. The
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date of death should be reported no matter where the death took place (inpatient at the transplant facility, at
an outside hospital, in a hospice setting, or within the recipient’s home).
Example 3. The recipient has died before their six month anniversary.
The recipient is transplanted on 1/1/13, was seen regularly through the first 100 days. They had restaging
exams on 4/4/13 and was seen on 4/8/13, and then died on 5/13/13 in the hospital emergency room.
What to report:
100 Day Date of Contact: 4/8/13 (note the latest disease assessment would likely be reported as 4/4/13)
6 Month Date of Contact: 5/13/13 (though the death does not occur within the ideal approximate range for
6 months)
Example 4. The recipient has died after their six month anniversary.
The recipient is transplanted on 1/1/13, was seen regularly through the first 100 days. They had restaging
exams on 4/22/13 and was seen on 4/23/13. Based on findings in the restaging exam, the recipient was
admitted for additional treatment. The disease was found to be refractory on a 6/25/13 restaging exam,
and the recipient was discharged to hospice on 7/8/13. The hospital was notified via telephone that the
recipient died on 7/16/13.
What to report:
100 Day Date of Contact: 4/23/13 (note the latest disease assessment would likely be reported as 4/22/
13)
6 Month Date of Contact: 7/16/13 (note the latest disease assessment would likely be reported as 6/25/
13)
Date of Contact & Subsequent Transplant
If the recipient has a subsequent HCT, report the date of contact as the day before the preparative regimen
begins for the subsequent HCT. If no preparative regimen is given, report the date of contact as the day
before the subsequent HCT. In these cases, actual contact on that day is not required, and the day prior to
the initiation of the preparative regimen (or infusion, if no preparative regimen) should be reported. This
allows every day to be covered by a reporting period, but prevents overlap between transplant events.
Example 5. The recipient had a 2nd transplant with a preparative regimen.
The recipient has their first transplant on 1/1/13 and a planned second transplant on 2/1/13. The recipient
was admitted on and received their first dose of chemotherapy for the preparative regimen for HCT #2 on
1/28/13.
What to report:
100 Day Date of Contact: 1/27/13 (regardless of actual contact on that date)
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Example 6. The recipient had a subsequent transplant without a preparative regimen.
Following their first transplant on 1/1/13, a recipient with SCID required a subsequent allogeneic
transplant due to poor graft function. The recipient has remained inpatient following the first transplant.
The physician planned the second transplant for 5/31/13, and proceeded without a preparative regimen.
What to report:
100 Day Date of Contact: 4/11/13 (+/- 15 days)
6 Month Date of Contact: 5/30/13
For more information regarding reporting partial or unknown dates, see General Instructions, General
Guidelines for Completing Forms.
Question 65: Main cause of death
Cause of death is considered the main disease, complication, or injury that leads to death. Do not report the
mode of death (e.g., cardiopulmonary arrest). Only one primary cause of death may be specified; however,
under “HSCT-related causes,” multiple contributing causes may be listed if relevant.
Primary cause of death is separated into three main categories: relapse or recurrence of disease for which
the HCT occurred, HCT-related causes, and new malignancies (not transformation or progression).
Typically, one of these three categories applies, but if not, the “other” option may be used. Report the
recipient’s primary cause of death as one of the following:
• Relapse / Progression / Persistent disease: Primary cause of death is attributed to persistence or
recurrence of the underlying disease for which the HCT was performed. Post-HCT disease evaluation
must reflect the presence of disease. If this option is chosen, questions 96-106 should also reflect the
disease relapse/recurrence.
*
Aplastic Anemia
If the recipient received an HCT for aplastic anemia, and the primary cause of
death is attributed to relapse/recurrence of disease, report “HCT related causes”
and select “Rejection/Poor graft function” as the cause of death.
• HCT-related causes: See the detailed instructions for questions 66-73 below. If the recipient’s
primary cause of death is HCT-related, questions 66-73 must be completed.
• New malignancy: Primary cause of death is attributed to the onset of a new malignancy after HCT. If
the malignancy was diagnosed prior to this HCT, report the disease as “other” and specify the disease
in question 72. The new malignancy must differ from the disease for which the HCT was performed.
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Examples include de novo leukemia, and AML diagnosed many years after a transplant for ALL. If the
recipient received an HCT for MDS, and post-transplant MDS transformed into AML, this would be
considered progression of disease, not a new malignancy.
• Other: See the detailed instructions for question 74 below.
• Unknown: This option should be used only when there is no documentation of the recipient’s cause
of death and all methods to try to obtain documentation have been utilized.
*
Questions 66-73
FormsNet3SM application: Check either “yes” or “no” for each option listed
Paper form submission: Check all that apply
Include all complications, including those only detected at autopsy.
Question 66: GVHD
Check “yes” if a cause of death is attributed to acute and/or chronic GVHD. If “yes” is answered for this
question, there must also be data reported in the GVHD section of the form (questions 15-18).
Question 67: Cardiac toxicity
Check “yes” if cardiac toxicity was a cause of death. Examples of cardiac toxicity include: heart failure,
congestive heart failure, non-infectious pericarditis, and/ or cardiac tamponade.
Question 68: Infection
Check “yes” if a fungal, bacterial, and/or viral infection (documented or suspected) was a cause of death.
Examples of infection include: viral pneumonia and viral infection of other organs.
Interstitial pneumonia (in the absence of viral infection or pneumocystis) should be reported as “pulmonary
toxicity.”
Question 69: Pulmonary toxicity
Check “yes” if a pulmonary toxicity was a cause of death. An example of pulmonary toxicity is non-infectious
lung failure, which can include ARDS, pulmonary hemorrhage, radiation pneumonia, etc. If bronchiolitis
obliterans is a part of chronic GVHD, it can also be reported here.
Question 70: Rejection/Poor graft function
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Check “yes” if rejection/poor graft function was a cause of death. This may also be recorded as bone
marrow failure or aplasia. Rejection/poor graft function should be reported if one of the following conditions
is met and the recipient has not relapsed.
• ANC < 0.5 × 109/L after day 28 post-HCT and bone marrow biopsy with < 5% cellularity.
• ANC sustained > 0.5 × 109/L for three or more consecutive days with subsequent decrease to < 0.5 ×
109/L and bone marrow examination with < 5% cellularity.
Question 71: Veno-Occlusive Disease (Hepatic)
Check “yes” if Veno-Occlusive Disease (VOD) was a cause of death. VOD is often caused by chemotherapy
and/or radiation therapy. VOD is characterized by endothelial damage, micro-thrombosis of the hepatic
venules, and sinusoidal fibrosis. VOD is more common in allogeneic than in autologous HCT and typically
occurs within 3 weeks of transplant. In the absence of a histological diagnosis, recipients must fulfill the
criteria below for a diagnosis of VOD.
Clinical Criteria for Veno-Occlusive Disease Of Liver 12:
Recipients reported as having VOD based only on clinical signs and symptoms must have two or more of
the following, and no other identifiable cause for liver disease:
• Jaundice (bilirubin ≥ 2 mg/dL or > 34 μmol/L)
• Hepatomegaly with right upper quadrant pain
• Ascites and/or weight gain (> 5% over baseline, as generally accepted)
1
McDonald GB, et al., Hepatology 1984;4:116-122.
2
Jones RJ, et al., Transplantation 1987;778-783.
Questions 72-73: Other, specify (HCT-related)
Check “yes” if the cause of death is not one of the listed HCT-related options. Examples of other causes of
death include but are limited to multi-organ failure, stroke, and hemorrhage.
Question 74: Other, specify (primary cause of death)
This option should only be used if the primary cause of death does not fit one of the categories listed (e.g.,
suicide, sudden death, etc.).
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Q75-77: Post-HCT Therapy
*
Post-HCT Therapy
This section collects data on specific therapies for current CIBMTR studies. It is not
intended to collect every type of possible post-HCT therapy.
Questions 75-77 are optional for non-US centers.
Questions 75-77: FGF (velafermin), Imatinib mesylate (Gleevec, Glivec), KGF (palifermin,
Kepivance)?
Check “yes” if FGF (velafermin), Imatinib mesylate (Gleevec, Glivec), and/or KGF (palifermin, Kepivance)
were given as post-HCT therapy.
Check “masked trial” if the recipient is part of a study where the agent the recipient received is not known
(e.g., placebo, drug, or other agent). Use the error correction process to update the data field once the
trial is over and the drug the recipient was given is known.
Check “no” if the recipient was not given FGF (velafermin), Imatinib mesylate (Gleevec, Glivec), and/or KGF
(palifermin, Kepivance) as post-HCT therapy.
Check “unknown” if there is no documentation to indicate whether the recipient did, or did not receive FGF
(velafermin), Imatinib mesylate (Gleevec, Glivec), and/or KGF (palifermin, Kepivance) as post-HCT therapy,
and all methods to try to obtain documentation have been utilized.
Q78: HCT for Non-Malignant Disease Only
!
HCT for Non-Malignant Diseases
This section should only be completed if the primary disease for this HCT is a nonmalignant disease. Disease evaluation is not collected for non-malignant diseases,
as there are no standard criteria for measuring non-malignant disease response.
Non-malignant diseases can be identified by the CIBMTR database code number shown in brackets { } on
the Pre-TED, and are numbered 300 and above, with the exception of “Paroxysmal Nocturnal
Hemoglobinuria (PNH) (56)” and “other disease (900)” (where the disease can be either malignant or nonmalignant).
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FormsNet3SM application: Form 2450, question 78 currently contains an error. If
“yes,” questions 107-109 and 110-146 should be completed. If “no,” questions
107-109 should be completed and the form submitted.
Paper form submission: Form 2450, question 78 currently contains an error. If
“yes,” questions 107-109 and 110-146 should be completed. If “no,” questions
107-109 should be completed and pages one and two will be submitted.
Question 78: DCI given in this period?
A Donor Cellular Infusion (DCI) is a cellular therapy that uses cells obtained from the original HCT donor.
The types of cells used for a DCI include, but are not limited to: lymphocytes, unstimulated peripheral blood,
mononuclear cells, dendritic cells, or mesenchymal cells. For more information regarding DCI, see question
110.
If the recipient received a DCI in this reporting period, check “yes” and continue with question 107 and
complete the DCI section. If the recipient did not receive a DCI in this reporting period, check “no,” continue
with questions 107-109, and submit form.
Q79-81: Malignant Disease Evaluation for this
HCT
!
This section should only be completed if the primary disease for which this
HCT is being completed is a malignant disease.
Malignant diseases can be identified by the CIBMTR database code number shown in brackets on Pre-TED
{ }, and are numbered 299 and below, with the exception of with the exception of “Paroxysmal Nocturnal
Hemoglobinuria (PNH) (56)” and “other disease (900)” (where the disease can be either malignant or nonmalignant).
This section collects the data known as “best response to transplant.” The purpose of this section is to
report the recipient’s best response to the planned course of the HCT. This does not include treatment
given for relapsed or persistent disease that was not planned before the HCT was executed. Best response
is often achieved in the first 100 days. However, for some diseases such as multiple myeloma and CLL, the
best response to HCT may take longer.
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If the recipient relapses/progresses and receives therapy for the disease relapse/progression, the response
to that additional therapy should not be reported in this section. The best response prior to the relapse/
progression should be reported. If the recipient was in complete remission (CR) at the start of the
preparative regimen, the best response is “not applicable,” as CR has already been attained.
*
Reporting Complete Remission (CR) Post-HCT
The disease criteria of the Pre-TED (2400) Manual should be used when
determining the recipient’s CR status.
*
CR undetermined (CRU) is the complete disappearance of all known sites of
disease with the exception of persistent scan abnormalities of unknown
significance. CRU should be reported as “complete remission.”
Question 79: Was a CR ever achieved in response to HCT (including any therapy as of Day
0, excluding any change in therapy in response to disease assessment)?
If the recipient was already in CR at the start of the preparative regimen, check “Recipient already in CR at
start of preparative regimen” and continue with question 82.
If the recipient achieved CR post-HCT (excluding unplanned therapy), check “yes” and continue with
question 80.
If the recipient never achieved CR post-HCT, check “no” and continue with question 81.
If the recipient’s disease status was not evaluated post-HCT, check “not evaluated” and continue with
question 82. This option is not commonly used, as this would indicate that no tests (radiological, laboratory,
or a clinical assessment) were performed to assess the CR status at any time during the reporting period.
Question 80: Date (Yes, post-HCT CR was achieved)
Indicate the date CR was achieved. If CR was reported on a previous Post-TED, check “First CR date
reported previously.” This option should only be chosen for > 100 day Post-TED (i.e., six-month or annual
evaluation).
For more information regarding reporting partial or unknown dates, see General Instructions, General
Guidelines for Completing Forms.
Question 81: Date assessed (No, never in CR from HCT)
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If the recipient never achieved CR post-HCT, indicate the date of latest disease assessment. If the recipient
received unplanned therapy, indicate the date of the latest disease assessment prior to receiving the
therapy.
If the recipient never achieved CR post-HCT and unplanned therapy was reported on a previous Post-TED,
check “best response was previously reported.” This option should only be chosen for > 100 day Post-TED
(i.e., six-month or annual evaluation).
For more information regarding reporting partial or unknown dates, see General Instructions, General
Guidelines for Completing Forms.
Q82-91: First Relapse or Progression after
HCT (in this period, any type, not persistent
disease)
Question 82: First relapse or progression after HCT
The three methods used to evaluate disease status are: molecular, cytogenetic/fluorescent in situ
hybridization (FISH)/flow cytometry, and clinical/ hematological. Any of these three methods can record
relapse or progression, but only the first instance for each method should be reported.
If question 82 is answered “yes,” questions 83, 86, and 89 should be answered.
If question 82 was answered “yes” on a previous Post-TED and there are no new methods which detect
relapse or progression, check “no” and continue to 92.
Molecular
Question 83: Relapse/progression detected by molecular method
Molecular assessment involves determining whether a molecular marker for the disease exists in the blood
or bone marrow. Molecular assessment is the most sensitive method of detection and can indicate known
genetic abnormalities associated with the disease for which the HCT was performed. RFLP testing (with
PCR amplification) is an example of a molecular test method used to detect BCR/ABL.
If molecular markers for relapse/progressive disease were found, check “yes” and continue with question
84.
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If molecular markers for relapse/progressive disease were not found, check “no” and continue with question
85.
If disease was detected and reported on a previous Post-TED follow-up, check “previously reported” and
continue with question 86. This option should only be chosen for > 100 day Post-TED.
If molecular testing was not done, check “not evaluated” and continue with question 86.
Question 84: Date first seen (molecular method)
Indicate the date relapse/progressive disease was determined by molecular method. Continue with question
86.
For more information regarding reporting partial or unknown dates, see General Instructions, General
Guidelines for Completing Forms.
Question 85: Date of assessment (molecular method)
If molecular markers for relapse/progressive disease were not found, indicate the date of latest assessment.
Continue with question 86.
For more information regarding reporting partial or unknown dates, see General Instructions, General
Guidelines for Completing Forms.
Cytogenetic/Fluorescent in situ hybridization (FISH)
Question 86: Relapse/progression detected by cytogenetic/FISH method
*
Flow Cytometry
Flow cytometry is a technique that can be performed on blood, bone marrow, or
tissue preparations where cell surface markers can be quantified on cellular
material. Currently the CIBMTR forms do not contain fields to capture flow
cytometry data. Since the sensitivity of flow cytometry is similar to that of FISH
assays, flow cytometry data should be reported in question 86.
An exception to the note above applies to multiple myeloma. If the flow
cytometry assessment has < 5% malignant plasma cells, this result should not be
reported because the result is not reliable; if no other cytogenetic or FISH
assessments were performed, report “no/not evaluated.” However, if the flow
cytometry assessment found ≥ 5% malignant plasma cells, this should be reported
as evidence of disease.
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Cytogenetic assessment involves testing blood or bone marrow for the presence of a known cytogenetic
abnormality that reflects the recipient’s disease. FISH is categorized with cytogenetics. Although often used
for finding specific features in DNA, FISH is not as sensitive as molecular methods, even though the
markers identified may be the same.
If cytogenetic/FISH/flow markers for relapse/progressive disease were found, check “yes” and continue with
question 87.
If cytogenetic/FISH/flow markers for relapse/progressive disease were not found, check “no” and continue
with question 88.
If disease was found and reported on a previous Post-TED follow-up, check “previously reported” and
continue with question 89. This option should only be chosen for > 100 day Post-TED.
If cytogenetic/FISH/flow testing was not done, check “not evaluated” and continue with question 89.
Question 87: Date first seen (cytogenetic/FISH method)
Indicate the date relapse/progressive disease was determined by cytogenetic methods (e.g., FISH).
Continue with question 89.
For more information regarding reporting partial or unknown dates, see General Instructions, General
Guidelines for Completing Forms.
Question 88: Date of assessment (cytogenetic/FISH method)
If cytogenetic/FISH/flow markers for relapse/progressive disease were not found, indicate the date of latest
assessment. Continue with question 89.
For more information regarding reporting partial or unknown dates, see General Instructions, General
Guidelines for Completing Forms.
Clinical/Hematologic
Question 89: Relapse/progression detected by clinical/hematologic method
Clinical/hematologic assessment is the least sensitive method of disease detection. Examples include
circulating blasts in the bloodstream for AML, or enlargement of a malignant mass for lymphoma or a solid
tumor, as determined either physically or radiographically. Every recipient who has an evaluation by a
physician has a “clinical” assessment.
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If the recipient dies, and the relapse or progression of disease is discovered by autopsy, the date of
assessment should be reported as the date of death, not the autopsy date.
If clinical/hematologic evidence of relapse/progressive disease was found, check “yes” and continue with
question 90.
If clinical/hematologic evidence of relapse/progressive disease was not found, check “no” and continue with
question 91.
If disease was found and reported on a previous post-TED follow-up, check “previously reported” and
continue with question 57. This option should only be chosen for > 100 day Post-TED.
If clinical/hematological assessment was not done, check “not evaluated” and continue with question 92.
Question 90: Date first seen (clinical/hematologic method)
Indicate the date relapse/progressive disease was determined by clinical/hematological evaluation.
Continue with question 92.
For more information regarding reporting partial or unknown dates, see General Instructions, General
Guidelines for Completing Forms.
Question 91: Date of assessment (clinical/hematologic method)
If clinical/hematological evidence of relapse/progressive disease was not found, indicate the date of latest
assessment. Continue with question 92.
For more information regarding reporting partial or unknown dates, see General Instructions, General
Guidelines for Completing Forms.
Q92-95: Additional Treatment
Question 92: Additional treatment
If additional treatment(s) was given to the recipient post-HCT for the primary disease for transplant, check
“yes” and continue with question 93. Do not report supportive care or treatment for new malignancies or
malignancies that were not the primary indication for transplant.
If the recipient did not receive any additional treatment(s) post-HCT for treatment of disease, check “no” and
continue with question 96.
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Questions 93: Additional treatment – DCI (allo only)
If the recipient received a donor cellular infusion (DCI) following an allogeneic HCT, check “yes” and
complete the DCI section of the Post-TED (questions 110-121).
If the recipient did not receive a DCI, check “no” and continue with question 94.
If the recipient received an autologous transplant, this question should be left blank.
Question 94: Additional treatment – Planned
If the recipient received additional treatment as planned post-HCT per protocol, check “yes.” Planned
treatment is considered part of the treatment plan regardless of the disease status post-HCT. This does not
include treatment given for relapsed, progressive, or persistent disease that was not planned before the
HCT was performed. If post-transplant treatment is given as prophylaxis or maintenance for recipients in
CR, or as preemptive therapy for recipients with minimal residual disease, consider this “planned therapy,”
even if this was not documented prior to the transplant.
If the recipient did not receive planned additional treatment post-HCT, check “no” and continue with
question 95.
Question 95: Additional treatment – Not planned
If the recipient received additional treatment post-HCT, and the treatment was not planned per protocol and
given for relapsed, progressive, or persistent disease, check “yes.”
If the recipient did not receive unplanned additional treatment post-HCT, check “no” and continue with
question 96.
Q96-107: Method of Latest Disease
Assessment
METHOD:
This section should be completed for every malignant disease, and should reflect the recipient’s most recent
disease assessment. Not all diseases have molecular and/or cytogenetic/FISH abnormalities identified to
monitor disease status. If no disease assessments exist, check “not evaluated.” In some circumstances,
disease may be detected by molecular or cytogenetic testing, but may not be considered a relapse or
progression. Test results should still be reported.
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Molecular and cytogenetic assessments are often performed for recipients post-HCT. If the recipient did not
have any identified molecular, cytogenetic, or FISH abnormalities at diagnosis or during their pre-transplant
course, and post-HCT follow-up assessments continue to identify that no abnormalities are detected, report
“No/Not Evaluated” for the molecular and/or cytogenetic/FISH assessment data fields on the Post-TED.
However, if routine post-HCT molecular, cytogenetic and/or FISH assessments identify a new abnormality
associated with the recipients disease process, begin reporting those assessments.
If the recipient had molecular, cytogenetic, and/or FISH abnormalities prior to transplant, ensure that
post-HCT assessments are reported.
DATE:
If more than one test in the same assessment category is done on different days, report the date of the most
definitive diagnostic assessment within a reasonable time frame of the date of contact (approximately 30
days).
Example 1 Leukemia: Blasts appear in the peripheral blood on a CBC, the next day a bone marrow
biopsy is done and reveals relapse of disease. Report the date of the bone marrow biopsy as the date of
latest assessment, as this is a more definitive assessment than a CBC.
Example 2 Lymphoma: A bone marrow biopsy is performed and reveals relapse of disease. The next day
a CT scan is performed, which also reveals relapse of disease. Since both tests reveal the same result,
and the tests are of equal diagnostic relevance, either the date of the bone marrow biopsy or the CT scan
date may be reported.
Example 3 Lymphoma: A PET/CT is done five months prior to the date of contact, which shows no
evidence of disease. On the date of contact, the recipient is seen in clinic with no evidence of
lymphadenopathy upon physical examination. Report the date of clinic visit as the date of latest
assessment.
Example 4 Multiple Myeloma (IgG Kappa): A serum electrophoresis (SPEP), serum immunofixation and
bone marrow biopsy are performed one week prior to the date of contact (i.e., the office visit). The SPEP
shows no evidence of a monoclonal protein (M-spike); however, the immunofixation is still positive. The
bone marrow biopsy shows no evidence of residual disease. Report the date of the SPEP,
immunofixation, and bone marrow biopsy as the date of latest assessment. In this case, it should be
reported that disease was detected since the immunofixation is positive.
Molecular
Question 96: Molecular
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Molecular assessment involves determining whether a molecular marker for the disease exists in the blood
or bone marrow. Molecular assessment is the most sensitive method of detection, and can indicate known
genetic abnormalities associated with the disease for which the HCT was performed. RFLP testing (with
PCR amplification) is an example of a molecular test method used to detect BCR/ABL.
In the FormsNet3SM application, check “yes” if a molecular method was used to determine disease status
for this follow-up time point and continue with question 97. If a molecular method was not used to determine
disease status for this follow-up time point, check “no/not evaluated” and continue with question 100.
This question does not exist on the paper version of the Form.
Question 97: Disease detected? (molecular method)
If molecular markers for disease were found, check “yes” and continue with question 98.
If molecular markers for disease were not found, check “no” and continue with question 99.
Question 98: If yes, was the status considered a disease relapse or progression? (molecular
method)
If the physician believes the test results indicate disease relapse or progression, check “yes.” If the recipient
has a positive test result, but the physician does not believe the result represents relapse or progression
(e.g., a recipient transplanted for CML exhibits a low level of BCR-ABL positivity post-HCT that the
physician does not believe is disease), check “no.” Continue with question 100.
Question 99: Date latest assessed (molecular method)
Indicate the date of the latest disease assessment. Continue with question 100.
For more information regarding reporting partial or unknown dates, see General Instructions, General
Guidelines for Completing Forms.
Cytogenetic/Fluorescent in situ hybridization (FISH)
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Flow Cytometry
Flow cytometry is a technique that can be performed on blood, bone marrow, or
tissue preparations where cell surface markers can be quantified on cellular
material. Currently the CIBMTR forms do not contain fields to capture flow
cytometry data. Since the sensitivity of flow cytometry is similar to that of FISH
assays, flow cytometry data should be reported in question 100.
An exception to the note above applies to multiple myeloma. If the flow
cytometry assessment has < 5% malignant plasma cells, this result should not be
reported because the result is not reliable; if no other cytogenetic or FISH
assessments were performed, report “not evaluated.” However, if the flow
cytometry assessment found ≥ 5% malignant plasma cells, this should be reported
as evidence of disease.
Question 100: Cytogenetic/FISH
Cytogenetic assessment involves testing blood or bone marrow for the presence of a known cytogenetic
abnormality that reflects the recipient’s disease. FISH is categorized with cytogenetics. Although often used
for finding specific features in DNA, FISH is not as sensitive as molecular methods, even though the
markers identified may be the same.
In the FormsNet3SM application, check “yes” if a cytogenetic method was used to determine disease status
for this follow-up time point and continue with question 101. If a cytogenetic method was not used to
determine disease status for this follow-up time point, check “no/not evaluated” and continue with question
104.
This question does not exist on the paper version of the Form.
Question 101: Disease detected? (cytogenetic/FISH method)
If cytogenetic/FISH/flow markers for disease were found, check “yes” and continue with question 102.
If cytogenetic/FISH/flow markers for were not found, check “no” and continue with question 103.
Question 102: If yes, was the status considered a disease relapse or progression?
(Cytogenetic/FISH method)
If the physician believes the test result indicates disease relapse or progression, check “yes.” If the recipient
has a positive test result, but the physician does not believe the result represents relapse or progression,
check “no.” Continue with question 103.
Question 103: Date latest assessed (Cytogenetic/FISH method)
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Indicate the date of the latest disease assessment. Continue with question 104.
For more information regarding reporting partial or unknown dates, see General Instructions, General
Guidelines for Completing Forms.
Clinical/Hematologic
Question 104: Clinical/Hematologic:
Clinical/hematologic assessment is the least sensitive method of disease detection. Examples include
circulating blasts in the bloodstream for AML, and enlargement of a malignant mass for lymphoma or a solid
tumor, as determined either physically or radiographically. Every recipient who has an evaluation by a
physician has a “clinical” assessment.
In the FormsNet3SM application, check “yes” if a clinical/hematologic assessment was used to determine
disease status for this follow-up time point and continue with question 105. If a clinical/hematologic
assessment was not used to determine disease status for this follow-up time point, check “no/not evaluated”
and continue with question 107.
This question does not exist on the paper version of the Form.
Question 105: Disease detected? (clinical/hematologic method)
If clinical/hematologic evidence of disease was found, check “yes.”
If clinical/hematologic evidence of disease was not found, check “no.”
Question 106: Date latest assessed: (clinical/hematologic method)
Indicate the date of the latest disease assessment and continue with question 107.
The date reported should be that of the most disease-specific assessment within a reasonable timeframe of
the date of contact (approximately 30 days). Indicate the date the sample was collected for examination for
pathological and laboratory evaluations; enter the date the imaging took place for radiographic
assessments, or the date of physical examination.
For more information regarding reporting partial or unknown dates, see General Instructions, General
Guidelines for Completing Forms.
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Questions 107-109
Question 107 appears only in the FormsNet3 SM version of the Post-TED Form. For
the paper version of the Form, if a previous HCT was done for a different malignant
disease than this HCT, indicate the status of the original disease and the date
determined (see Questions 108-109). If a previous HCT was not done for a
different malignant disease, continue to the DCI section or submit the Form.
Questions 107-109 only apply to previous HCTs that were performed for another
malignant disease.
Question 107: Was a previous HCT performed for a different disease than this HCT?
If prior to this HCT, an HCT was performed for a different disease (malignant disease only), check “yes”
and continue with question 108.
If this is the recipient’s first HCT, or a prior HCT was not performed for a different disease (malignant
disease only), check “no” and continue with question 110.
Question 108: Give status of original disease
Indicate the current status of the original malignant disease as either “CR” or “not in CR” and continue with
question 109.
Question 109: Date determined
Indicate the date this disease status was determined.
If a DCI was done during this reporting period, continue with the DCI section of the form. If no DCI was done
during the reporting period, the form is considered complete and may be submitted to the CIBMTR.
For more information regarding reporting partial or unknown dates, see General Instructions, General
Guidelines for Completing Forms.
Q110-145: Donor Cellular Infusion (DCI)
The paper version of Post-TED allows the data manager to report up to three Donor Cellular Infusions (DCI)
events. If more than three DCIs were performed during the reporting period, copy the page and continue to
report the subsequent DCIs. The FormsNet3SM application will allow as many DCI entries as needed.
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A DCI is a form of cellular therapy that involves cells from any donor, and is commonly used to create a
graft-versus-leukemia (GVL) effect. The recipient does not receive a preparative regimen prior to receiving
the donor cells. The types of cells used for a DCI include, but are not limited to: lymphocytes, unstimulated
peripheral blood mononuclear cells, dendritic cells, and/or mesenchymal cells.
A DCI should be reported for a recipient who received cells from any donor without a preparative regimen
for any reason other than those pertaining to the original HCT graft (e.g., no engraftment, partial or poor
engraftment, loss of graft, or late graft failure). If the recipient received an infusion due to the graft,
report as a subsequent HCT, not a DCI.
Recipients may receive a DCI over several days or weeks. A single DCI section should be completed for all
infusions given within a 10-week period. See the illustration below for an example of a recipient receiving
multiple DCIs:
Question 110: Date of first DCI
Indicate the date of the recipient’s first DCI given in this reporting period. Continue with question 111.
For more information regarding reporting partial or unknown dates, see General Instructions, General
Guidelines for Completing Forms.
Question 111: Total # DCI in 10 weeks
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Indicate the total number of DCIs given in a 10-week period. (In example above, the total number is four.)
Continue with question 112.
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Questions 112-117: Type of cell(s)
FormsNet3SM application: Check either “yes” or “no” for each option listed
Paper form submission: Check all that apply
Questions 112-117: Type of cell(s)
From the list provided, indicate the type of cell(s) used for the DCI. The most common type of DCI is the DLI
(Donor Lymphocyte Infusion), but there are other types of cellular therapy as indicated. If the type of cell(s)
used for the DCI is not listed, choose “other” and specify the cell type used. Continue with question 118.
Questions 118-119: Indication
From the list provided, indicate the reason the cells were infused. If there was more than one reason for the
DCI, check all applicable indications.
The “other” option should rarely be used. If the reason the recipient receives an infusion of cells is due to
the graft (e.g., no engraftment, partial or poor engraftment, loss of graft, or late graft failure), then the
infusion should be reported as a subsequent HCT, not a DCI. Continue with question 120.
Question 120: Maximum Grade of Acute Graft Versus Host Disease (GVHD)
DCI can trigger acute GVHD independent of the HCT. If the recipient develops acute GVHD as a result of
the DCI, indicate the maximum grade. See question 15, Table 1 for reporting guidelines.
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Question 121
This question should only be answered if the recipient receives an additional DCI
after the initial 10-week period.
Question 121: If another DCI was received in this reporting period, disease status before
next DCI
Indicate the recipient’s disease status prior to receiving a subsequent DCI as either “CR,” “not in CR,” or
“not assessed.”
Questions 122-133: Date of second DCI
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See the detailed instructions for questions 110-121.
Questions 135-146: Date of third DCI
See the detailed instructions for questions 110-121.
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| File Type | application/pdf |
| File Modified | 2016-04-07 |
| File Created | 2016-04-07 |