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  1. StudyEvent: E1900 On-Study Form
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
ECOG clinical trial administrative data
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGPatientID
Item
ECOG Patient ID
text
RegistrationStep
Item
Registration Step
text
Patient'sName
Item
Patient?s Name
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
ParticipatingGroupPatientID
Item
Participating Group Patient ID
text
MainMemberInstitution/Affiliate
Item
Institution/Affiliate
text
AmendedDataInd
Item
Are data amended?
boolean
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
Item Group
Disease Description
InitialDiagnosisDate
Item
Date of initial pathologic diagnosis
date
Item
Leukemia Classification (Choose one)
text
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C3161 (NCI Thesaurus ObjectClass)
C0023418 (UMLS 2011AA ObjectClass)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
CL.2
Code List
Leukemia Classification (Choose one)
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 Is A Mixed Lineage Acute Leukemia (Mixed lineage acute leukemia)
CL Item
Disease Classified As Specified Other Leukemia (Other, specify)
LeukemiaClassification,Other
Item
Other, specify (leukemia classification)
text
Item
Clinical Onset of AML (Choose one)
text
CL.3
Code List
Clinical Onset of AML (Choose one)
CL Item
Aml Without Prior Clinical History Of Mds Or Potentially Leukemogenic Treatment (de novo)
CL Item
Aml Related To/associated With Prior Clinical History Of Potentially Leukemogenic Treatment (treatment related)
CL Item
Aml Related To/associated With Prior Clinical History Of Mds (MDS-related)
CNSSiteInd
Item
Central Nervous System
boolean
PeripheralNervousSystemSiteInd
Item
Peripheral Nervous System
boolean
GingivalHypertrophySiteInd
Item
Gingival Hypertrophy
boolean
MediastinalMassSiteInd
Item
Mediastinal Mass
boolean
SkinSiteInd
Item
Skin
boolean
OtherSiteInd
Item
Other
boolean
ExtramedullaryDisease,OtherSite
Item
Other, specify (extramedullary disease involvement)
text
Item Group
Baseline Evaluation Data
PatientHeight
Item
Patient Height (cm)
float
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)
Lab,Hematology,SampleCollectionDate
Item
Date Hematology Sample Obtained (Bone marrow biopsy/aspirate)
date
BoneMarrowBiopsyDate
Item
Date of bone Marrow Biopsy
date
Lab,Hematology,WBC
Item
Peripheral WBC count (/mm 3 ) (x1000)
float
Lab,Hematology,Platelets
Item
Peripheral platelet count (/mm 3 ) (x1000)
float
Lab,Hematology,Blasts,CellPercentage
Item
Peripheral Blasts (%)
float
Lab,Hematology,Neutrophils,CellPercentage
Item
Peripheral Neutrophils (%)
float
Lab,Hematology,Hemoglobin
Item
Hemoglobin (g/dl)
float
BoneMarrow,CellularityPercentage
Item
Marrow Cellularity (%)
float
CD33%byflowcytometry
Item
CD33 % by flow cytometry
text
CD33%byflowcytometry(ifdrytaporinaspirable)
Item
CD33 % by flow cytometry (if dry tap or inaspirable)
text
Item
Marrow Cellularity Status (Choose one)
text
CL.10
Code List
Marrow Cellularity Status (Choose one)
CL Item
Cellularity Status Of Bone Marrow Is Aplasitc (severely Hypocellular) (aplastic (severly 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)
Item
Performance status
text
CL.11
Code List
Performance status
CL Item
0 (Fully active, able to carry on all pre-disease performance without restriction (Karnofsky 90-100))
C0919414 (NCI Metathesaurus)
CL Item
1 (Restricted in physically strenuous activity but ambulatory (K 70-80))
CL Item
2 (Ambulatory and capable of all selfcare but unable to carry out any work activities (K 50-60))
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours (K 30-40))
CL Item
4 (completely disabled (K 10-20))
Comments
Item
Comments
text
InvestigatorSignature
Item
Investigator Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Date
date
Item Group
Ccrr Module For E1900 On-study Form
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