Acute Myeloid Leukemia (AML)Myelodysplastic Syndrome (MDS) - On-Study Form - RelapseRefractory Treatment 2019378_v3_0
Acute Myeloid Leukemia (AML)/Myelodysplastic Syndrome (MDS) - On-Study Form - Relapse/Refractory Treatment Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1B24FD93-54A8-51C5-E044-0003BA3F9857

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  1. StudyEvent: Acute Myeloid Leukemia (AML)/Myelodysplastic Syndrome (MDS) - On-Study Form - Relapse/Refractory Treatment
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Crf Header
Protocol ID Coordinating Group
Item
Coordinating Group Protocol No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1711341 (UMLS CUI-2)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Coordinating Group Code
Item
Coordinating Group Code
text
C25162 (NCI Thesaurus ValueDomain)
C1711341 (UMLS CUI-1)
C17005 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25462 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Protocol Title
Item
Protocol Title
text
C25191 (NCI Thesaurus ValueDomain)
C2986303 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C42774 (NCI Thesaurus Property)
Patient Study ID
Item
Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Trial subject ID Participating Group
Item
Other Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
ParticipatingGroupIdentifierCode
Item
Participating Group Code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C1257890 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
RegistrationSequenceType
Item
Registration Type
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C25673 (NCI Thesaurus Property)
C1519249 (UMLS 2011AA Property)
Item Group
Leukemia/mds: Form Administration
Person Completing Form
Item
Person Completing Form
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Data amended
Item
Are data amended (If data are amended, please circle in red when using paper form)
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Aml: Disease Description, Previously Untreated
Item
Leukemia/MDS Classification (*Alternately, the CDE WHO Diagnosis can be used.)
text
C3161 (NCI Thesaurus ObjectClass)
C0023418 (UMLS 2011AA ObjectClass)
C43854 (NCI Thesaurus Property)
C1556084 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property-2)
C0008902 (UMLS 2011AA Property-2)
C0596227 (NCI Metathesaurus Property)
C0596070 (NCI Metathesaurus Property-2)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
Code List
Leukemia/MDS Classification (*Alternately, the CDE WHO Diagnosis can be used.)
CL Item
Disease Classified As Undifferentiated Acute Myeloid Leukemia (FAB M0) (Undifferentiated acute myeloid leukemia (FAB M0))
CL Item
Disease Classified As Acute Myeloid Leukemia w/o Maturation (FAB M1) (Acute myeloid leukemia w/o maturation (FAB M1))
CL Item
Disease Classified As Acute Myeloid Leukemia w/ Maturation (FAB M2) (Acute myeloid leukemia w/ maturation (FAB M2))
CL Item
Disease Classified As Acute Promyelocytic Leukemia (FAB M3) (Acute promyelocytic leukemia (FAB M3))
CL Item
Disease Classified As Acute Myelomonocytic Leukemia (fab M4) (Acute myelomonocytic leukemia (FAB M4))
CL Item
Disease Classified As Acute Monocytic Leukemia (fab M5) (Acute monocytic leukemia (FAB M5))
CL Item
Disease Classified As Acute Erythroblastic Leukemia (fab M6) (Acute erythroblastic leukemia (FAB M6))
CL Item
Disease Classified As Acute Megakaryoblastic Leukemia (fab M7) (Acute megakaryoblastic leukemia (FAB M7))
CL Item
Disease Classified As Aml, Not Otherwise Specified (NOS) (AML, not otherwise specified (NOS))
CL Item
Disease Is An Unclassifiable Acute Leukemia (Unclassifiable acute leukemia)
CL Item
Disease Classified As Acute Undifferentiated Leukemia (AUL) (Acute undifferentiated leukemia (AUL))
CL Item
Disease Classified As Refractory Anemia (RA) (Refractory anemia (RA))
CL Item
Disease Classified As Refractory Anemia w/ Ring Sideroblasts (RARS) (Refractory anemia w/ ring sideroblasts (RARS))
CL Item
Disease Classified As Refractory Anemia w/excess Blasts (RAEB) (Refractory anemia w/excess blasts (RAEB))
CL Item
Disease Classified As Refractory Anemia w/ Excess Blasts In Transformation (RAEB-t) (Refractory anemia w/ excess blasts in transformation (RAEB-t))
CL Item
Disease Classified As Chronic Myelomonocytic Leukemia (CMML) (Chronic myelomonocytic leukemia (CMML))
CL Item
Disease Classified As Myelodysplastic Syndrome (MDS) NOS (Myelodysplastic syndrome (MDS) NOS)
CL Item
Disease Classified As Myeloproliferative Syndrome NOS (Myeloproliferative syndrome NOS)
CL Item
Disease Is A Mixed Lineage Acute Leukemia (Mixed lineage acute leukemia)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
LeukemiaFrench-American-BritishClassificationSpecify
Item
Other specify
text
C3161 (NCI Thesaurus ObjectClass)
C0023418 (UMLS 2011AA ObjectClass)
C43854 (NCI Thesaurus Property)
C1556084 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property-2)
C0008902 (UMLS 2011AA Property-2)
C0596227 (NCI Metathesaurus Property)
C0596070 (NCI Metathesaurus Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Disease Status
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C13324 (NCI Thesaurus ObjectClass-2)
C0229601 (UMLS 2011AA ObjectClass-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
Disease Status
CL Item
First Relapse (Relapse: 1st)
CL Item
Second Relapse (Relapse: 2nd)
CL Item
Third Or Greater Relapse (Relapse: 3rd+)
CL Item
Relapse (relapse NOS)
C18265 (NCI Thesaurus)
CL Item
Refractory To First Induction (Refractory to 1st induction)
CL Item
Refractory To Reinduction After Complete Response (Refractory to reinduction after CR)
CL Item
Refractory (refractory NOS)
C38014 (NCI Thesaurus)
C0205269 (UMLS 2011AA)
CL Item
Other, Specify (Other)
DiseaseStatusSpecify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item
What was the duration of the preceding response? (For relapsed AML/MDS,)
text
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C18265 (NCI Thesaurus Property)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25330 (NCI Thesaurus ValueDomain)
C0449238 (UMLS 2011AA ValueDomain)
Code List
What was the duration of the preceding response? (For relapsed AML/MDS,)
CL Item
Duration Of Response Less Than 6 Months (< 6 months)
CL Item
Duration Of Response Greater Than Or Equal To 6 Months (> or = 6 months)
CL Item
Duration Of Response Unknown (Unknown)
HematologySpecimenCollectedDate
Item
Date Hematology (Blood) Sample Obtained (Peripheral Blood mm dd yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C25452 (NCI Thesaurus Property)
LaboratoryProcedureLeukocyteResultSpecifiedValue
Item
White Blood Cell Count (x 10^3/mcL)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12529 (NCI Thesaurus Property)
C0023516 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C0205369 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureNeutrophilResultPercentageValue
Item
Peripheral Neutrophils/Bands (%)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12533 (NCI Thesaurus Property)
C0027950 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureBlastCellOutcomePercentageValue
Item
Peripheral Blasts (%)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12918 (NCI Thesaurus Property-2)
C0368761 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
BoneMarrowBiopsyDate
Item
Date of Bone Marrow Biopsy (Bone Marrow Biopsy/Aspirate mm dd yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
LaboratoryProcedureBoneMarrowCellularityOutcomePercentageValue
Item
Marrow Cellularity (%)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C37923 (NCI Thesaurus Property-3)
C1516377 (UMLS 2011AA Property-3)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureBoneMarrowBlastCellOutcomePercentageValue
Item
Marrow Blasts (%)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C12918 (NCI Thesaurus Property-3)
C0368761 (UMLS 2011AA Property-3)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Item
Marrow Cellularity Status
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12431 (NCI Thesaurus Property)
C0005953 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C37923 (NCI Thesaurus Property-3)
C1516377 (UMLS 2011AA Property-3)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
Code List
Marrow Cellularity Status
CL Item
Cellularity Status Of Bone Marrow Is Aplasitc (severely Hypocellular) (Aplastic (severely hypocellular))
CL Item
Cellularity Status Of Bone Marrow Is Hypocellular (Hypocellular)
CL Item
Cellularity Status Of Bone Marrow Is Normocellular (Normocellular)
CL Item
Cellularity Status Of Bone Marrow Is Hypercellular (Hypercellular)
CL Item
Cellularity Status Of Bone Marrow Is Packed (intensely Hypercellular) (Packed (intensely hypercellular))
CL Item
Cellularity Status Of Bone Marrow Unknown, Procedure Resulted In No Material To Analyze (Dry tap or inaspirable)
PriorBMSCTAdministeredInd-3
Item
Prior bone marrow or peripheral blood stem cell transplant?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C25437 (NCI Thesaurus ObjectClass-2)
C0842093 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Type of Bone Marrow or Peripheral Blood Stem Cell (PBSC) Transplant
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25437 (NCI Thesaurus ObjectClass)
C0842093 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
Type of Bone Marrow or Peripheral Blood Stem Cell (PBSC) Transplant
CL Item
Bone Marrow Stem Cells Used For Transplant Obtained From Antigen-matched Sibling Or Family Member Of Recipient (Bone marrow from matched sibling or family member)
CL Item
Peripheral Blood Stem Cells Used For Transplant Obtained From Antigen-matched Sibling Or Family Member Of Recipient (PBSC from matched sibling or family member)
CL Item
Bone Marrow Stem Cells Used For Transplant Obtained From Antigen-matched Individual Unrelated To Recipient (Bone marrow from matched unrelated donor)
CL Item
Peripheral Blood Stem Cells Used For Transplant Obtained From Antigen-matched Individual Unrelated To Recipient (PBSC from matched unrelated donor)
CL Item
Bone Marrow Stem Cells Used For Transplant Obtained From Recipient Him/herself (Autologous bone marrow)
CL Item
Peripheral Blood Stem Cells Used For Transplant Obtained From Recipient Him/herself (Autologous PBSC)
CL Item
Other Specify (Other)
BMSCTDescriptionOtherSpecify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus ValueDomain-2)
C0205394 (UMLS 2011AA ValueDomain-2)
C25437 (NCI Thesaurus ObjectClass)
C0842093 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item Group
Allows Documentation Of Any Additional Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)