Generic drug form
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)
Registration Number
Item
Registration Step (Place ID Label Here)
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Patient Initials
Item
Patient Initials (Last, First)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Study Number Participating Group
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group 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)
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)
Item
On Treatment Report Period
text
C25284 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25616 (NCI Thesaurus Property-2)
C15368 (NCI Thesaurus ObjectClass)
Code List
On Treatment Report Period
CL Item
Cycle 1 - Induction (Cycle 1 - Induction)
CL Item
Cycle 2 - Induction (Cycle 2 - Induction)
CL Item
Cycle 1 - Consolidation (Cycle 1 - Consolidation)
CL Item
Cycle 2 - Consolidation (Cycle 2 - Consolidation)
CL Item
Cycle 1 - Step 3 (Cycle 1 - Step 3)
CL Item
Cycle 2 - Step 3 (Cycle 2 - Step 3)
CL Item
Cycle 3 - Step 3 (Cycle 3 - Step 3)
CL Item
Cycle 4 - Step 3 (Cycle 4 - Step 3)
CL Item
Cycle 5 - Step 3 (Cycle 5 - Step 3)
CL Item
Cycle 6 - Step 3 (Cycle 6 - Step 3)
CL Item
Cycle 7 - Step 3 (Cycle 7 - Step 3)
CL Item
Cycle 8 - Step 3 (Cycle 8 - Step 3)
CL Item
Cycle 9 - Step 3 (Cycle 9 - Step 3)
CL Item
Cycle 10 - Step 3 (Cycle 10 - Step 3)
CL Item
Cycle 11 - Step 3 (Cycle 11 - Step 3)
CL Item
Cycle 12 - Step 3 (Cycle 12 - Step 3)
CL Item
Cycle 13 - Step 3 (Cycle 13 - Step 3)
CL Item
At Transplant (At Transplant)
Item
Off Treatment Report Period (since registration to Step 1 If this form covers an Off Treatment Report Period Choose one)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25601 (NCI Thesaurus Property-2)
C1518544 (UMLS 2011AA Property-2)
C25207 (NCI Thesaurus Property-3)
C0040223 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Off Treatment Report Period (since registration to Step 1 If this form covers an Off Treatment Report Period Choose one)
CL Item
3 Months (3 Months Post Registration)
CL Item
6 Months (6 Months Post Registration)
CL Item
9 Months (9 Months Post Registration)
CL Item
12 Months (12 Months Post Registration)
CL Item
15 Months (15 Months Post Registration)
CL Item
18 Months (18 Months Post Registration)
CL Item
21 Months Post Registration (21 Months Post Registration)
CL Item
2 Years (24 Months Post Registration)
CL Item
30 Months (30 Months Post Registration)
CL Item
3 Years (36 Months Post Registration)
CL Item
42 Months (42 Months Post Registration)
CL Item
4 Years (48 Months Post Registration)
CL Item
54 Months (54 Months Post Registration)
CL Item
5 Years (60 Months Post Registration)
Data amended
Item
Please mark an 'X' if data have been amended. (Please circle amended items in red)
text
C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Data amended date
Item
Date data amended (s M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Was bone marrow biopsy done (/aspirate obtained for this reporting period)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
Code List
Was bone marrow biopsy done (/aspirate obtained for this reporting period)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
BoneMarrowBiopsyDate
Item
Date of Bone Marrow Biopsy (second /aspirate if done M D Y Submit copy of bone marrow report with E2906 Source Document Tracking Coversheet attached)
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)
BoneMarrowBiopsyDate
Item
Date of Bone Marrow Biopsy (second /aspirate if done M D Y Submit copy of bone marrow report with E2906 Source Document Tracking Coversheet attached)
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)
DataUnknownText
Item
Mark an 'X' if not done (second bone marrow biopsy/aspirate)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C17998 (NCI Thesaurus Property)
C0439673 (UMLS 2011AA Property)
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)
LaboratoryProcedureCytogeneticAnalysisCellLineOutcomeInd-2
Item
Are all cell lines maturing
boolean
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C18280 (NCI Thesaurus Property)
C0752095 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C16403 (NCI Thesaurus Property-3)
C0007600 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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
Are auer rods present?
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)
C25287 (NCI Thesaurus Property-3)
C0333828 (UMLS 2011AA Property-3)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
Code List
Are auer rods present?
CL Item
Auer Rods Absent From Bone Marrow (Absent)
CL Item
Auer Rods Present In Bone Marrow (Present)
PersistentLeukemiaPhenotypeFlowCytometryFindingInd-2
Item
Was there evidence of persistence of leukemia associated phenotype by flow cytometry
boolean
C3161 (NCI Thesaurus ObjectClass)
C0023418 (UMLS 2011AA ObjectClass)
C43623 (NCI Thesaurus ObjectClass-2)
C0205322 (UMLS 2011AA ObjectClass-2)
C16977 (NCI Thesaurus ObjectClass-3)
C0031437 (UMLS 2011AA ObjectClass-3)
C16585 (NCI Thesaurus Property)
C0016263 (UMLS 2011AA Property)
C3367 (NCI Thesaurus Property-2)
C0037088 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PeripheralBloodBlastCellPresentInd-2
Item
Were there circulating blasts in peripheral blood
boolean
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C25233 (NCI Thesaurus ObjectClass-2)
C0205100 (UMLS 2011AA ObjectClass-2)
C12918 (NCI Thesaurus ObjectClass-3)
C0368761 (UMLS 2011AA ObjectClass-3)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
MorphologicFindingDisease-FreeSurvivalLeukemiaDiagnosisInd-2
Item
Did the patient achieve morphologic leukemia-free state
boolean
C3161 (NCI Thesaurus ObjectClass)
C0023418 (UMLS 2011AA ObjectClass)
C17751 (NCI Thesaurus ObjectClass-2)
C0242793 (UMLS 2011AA ObjectClass-2)
C35867 (NCI Thesaurus ObjectClass-3)
C0700329 (UMLS 2011AA ObjectClass-3)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
MorphologicFindingDisease-FreeSurvivalLeukemiaDiagnosisDate
Item
Date patient achieved morphologic leukemia-free state
date
C3161 (NCI Thesaurus ObjectClass)
C0023418 (UMLS 2011AA ObjectClass)
C17751 (NCI Thesaurus ObjectClass-2)
C0242793 (UMLS 2011AA ObjectClass-2)
C35867 (NCI Thesaurus ObjectClass-3)
C0700329 (UMLS 2011AA ObjectClass-3)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
PartialResponseFirstObservedInd-2
Item
Did patient achieve PR
boolean
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25378 (NCI Thesaurus ObjectClass-2)
C0728938 (UMLS 2011AA ObjectClass-2)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property-2)
C1441672 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PartialResponseConfirmedDate
Item
Date of PR (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C25378 (NCI Thesaurus ObjectClass-2)
C0728938 (UMLS 2011AA ObjectClass-2)
CompleteResponseObservedInd-2
Item
Did patient achieve CR
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus ObjectClass-2)
C0205197 (UMLS 2011AA ObjectClass-2)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)
CompleteResponseOccurrenceDate
Item
Date of CR (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus ObjectClass-2)
C0205197 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
IncompleteBloodCellCountRecoveryCellularMorphologyCompleteRemissionFirstObservedInd-2
Item
Was Complete Remission incomplete (CRi) achieved (If no CR)
boolean
C49160 (NCI Thesaurus ObjectClass)
C0205257 (UMLS 2011AA ObjectClass)
C4870 (NCI Thesaurus ObjectClass-2)
C0677874 (UMLS 2011AA ObjectClass-2)
C17768 (NCI Thesaurus ObjectClass-3)
C2700385 (UMLS 2011AA ObjectClass-3)
C70827 (NCI Thesaurus ObjectClass-4)
C0237820 (UMLS 2011AA ObjectClass-4)
C28133 (NCI Thesaurus ObjectClass-5)
C0009555 (UMLS 2011AA ObjectClass-5)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property-2)
C1441672 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
IncompleteBloodCellCountRecoveryCellularMorphologyCompleteRemissionFirstObservedDate
Item
Date of CRi (M D Y)
date
C49160 (NCI Thesaurus ObjectClass)
C0205257 (UMLS 2011AA ObjectClass)
C4870 (NCI Thesaurus ObjectClass-2)
C0677874 (UMLS 2011AA ObjectClass-2)
C17768 (NCI Thesaurus ObjectClass-3)
C2700385 (UMLS 2011AA ObjectClass-3)
C70827 (NCI Thesaurus ObjectClass-4)
C0237820 (UMLS 2011AA ObjectClass-4)
C28133 (NCI Thesaurus ObjectClass-5)
C0009555 (UMLS 2011AA ObjectClass-5)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property-2)
C1441672 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
PatientExtramedullaryDiseaseAssessmentInd-3
Item
Is there any extramedullary disease
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C25503 (NCI Thesaurus Property-3)
C1517060 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
DiseaseInvolvedSiteSpecify
Item
Specify sites
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25547 (NCI Thesaurus Property-2)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Investigator Signature Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)