This form must be completed for all recipients who are randomized to the Comprehensive Report Form (CRF) track and whose primary disease is reported on the Pre-TED Disease Classification Form (Form 2402) as “Myelodysplastic Syndrome (MDS) (50)” The Myelodysplastic Syndrome (MDS) Post-HCT Data (Form 2114) must be completed in conjunction with each Post-HCT follow-up form completed (Form 2100). The form is designed to capture specific data occurring within the timeframe of each reporting period (i.e., between day 0 and day 100, between day 100 and the six-month date of contact, between the date of contact for the six-month follow up and the date of contact for the one-year follow up, etc.).
For recipients who had MDS that transformed to AML prior to transplant, only Form 2014 (Myelodysplastic Syndrome Pre-HCT Data) must be completed to obtain MDS data pre-HCT. Form 2114 (Myelodysplastic Syndrome Post-HCT Data) is not required for these recipients post-HCT.
Q1-72: Disease Assessment at the Time of Best Response to HCT or Cellular Therapy
Q73-87: Post-HCT / Post-Infusion Therapy
Q88-171: Disease Detection Since the Date of Last Report
Q172-236: Disease Status at the Time of Evaluation for this Reporting Period
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 Forms Manuals/Documents/2114.MDS Pre-HCT Data Manual Change History through 3.31.15.pdf or reference the retired manual section on the Retired Forms Manuals Forms Manuals/pages/index.aspx .
|10/5/2020||MDS Post-HCT||Add|| Clarification added on when to report “yes” and “no” for question 172:
|8/18/2020||MDS Post-HCT||Add||Red warning box added above questions 219-220 to clarify the instruction text is currently incorrect but will be updated with the next revision of the form: The question text for questions 219 – 220 are incorrect. Currently, the question reads “Was disease detected via bone marrow examination;” however, the question should say “Was disease assessed via bone marrow examination.” This question will be updated with the next revision of this form.|
|5/9/2020||MDS Post-HCT||Modify||Version 3 of the 2114: MDS Post-HCT section of the Forms Instruction Manual released. Version 3 corresponds to revision 4 of the Form 2114.|
|3/19/18||Comprehensive Disease Specific Manuals||Add|| Added the following instruction for applicable post-infusion disease-specific forms where current disease status is asked (2110, 2111, 2112, 2113, 2114, 2115, 2116, 2118, 2119).
The center does not need to repeat all disease-specific assessments (biopsies, scans, labs) each reporting period in order to complete current disease status data fields. Once a particular disease status is achieved, the center can continue reporting that disease status (based on labs / clinical assessments) until there is evidence of relapse / progression.
|2/24/17||Comprehensive Disease-Specific Manuals||Modify||Updated explanations of triggers for disease inserts to refer to the primary disease reported on the Pre-TED Disease Classification Form (Form 2402) instead of the Pre-TED Form (Form 2400)|
|6/26/15||2114: MDS/MPN Post-HCT||Modify||Modified text of Question 30 to include the following concept:
Progression to AML: ≥ 20% blasts in the blood or bone marrow
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