ID

2005

Beskrivning

E1900 On-Study Form Combination Chemotherapy With or Without Monoclonal Antibody Therapy Followed by Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A7294479-6D5C-2FC8-E034-0003BA0B1A09

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A7294479-6D5C-2FC8-E034-0003BA0B1A09

Nyckelord

  1. 2012-09-19 2012-09-19 -
  2. 2015-05-28 2015-05-28 -
  3. 2015-06-03 2015-06-03 -
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19 september 2012

DOI

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Creative Commons BY-NC 3.0 Legacy

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Leukemia NCT00049517 On-Study - E1900 On-Study Form - 2054051v3.0

No Instruction available.

  1. StudyEvent: E1900 On-Study Form
    1. No Instruction available.
Unnamed1
Beskrivning

Unnamed1

Registration Step
Beskrivning

RegistrationStep

Datatyp

text

Patient?s Name
Beskrivning

Patient'sName

Datatyp

text

ECOG Protocol No.
Beskrivning

ECOGProtocolNo.

Datatyp

text

ECOG Protocol No.
Beskrivning

ECOGProtocolNo.

Datatyp

text

ECOG Patient ID
Beskrivning

ECOGPatientID

Datatyp

text

ECOG Patient ID
Beskrivning

ECOGPatientID

Datatyp

text

Participating Group Protocol No.
Beskrivning

ParticipatingGroupProtocolNo.

Datatyp

text

Participating Group Patient ID
Beskrivning

ParticipatingGroupPatientID

Datatyp

text

Institution/Affiliate
Beskrivning

MainMemberInstitution/Affiliate

Datatyp

text

Unnamed2
Beskrivning

Unnamed2

Are data amended?
Beskrivning

AmendedDataInd

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Disease Description
Beskrivning

Disease Description

Date of initial pathologic diagnosis
Beskrivning

InitialDiagnosisDate

Datatyp

date

Leukemia Classification (Choose one)
Beskrivning

Leukemia/MDSClassification

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C3161
UMLS 2011AA ObjectClass
C0023418
NCI Thesaurus Property
C25161
UMLS 2011AA Property
C0008902
Other, specify (leukemia classification)
Beskrivning

LeukemiaClassification,Other

Datatyp

text

Clinical Onset of AML (Choose one)
Beskrivning

Onset,AML

Datatyp

text

Central Nervous System
Beskrivning

CNSSiteInd

Datatyp

text

Peripheral Nervous System
Beskrivning

PeripheralNervousSystemSiteInd

Datatyp

text

Gingival Hypertrophy
Beskrivning

GingivalHypertrophySiteInd

Datatyp

text

Mediastinal Mass
Beskrivning

MediastinalMassSiteInd

Datatyp

text

Skin
Beskrivning

SkinSiteInd

Datatyp

text

Other
Beskrivning

OtherSiteInd

Datatyp

text

Other, specify (extramedullary disease involvement)
Beskrivning

ExtramedullaryDisease,OtherSite

Datatyp

text

Baseline Evaluation Data
Beskrivning

Baseline Evaluation Data

Patient Height (cm)
Beskrivning

PatientHeight

Datatyp

double

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25347
UMLS 2011AA Property
C0489786
Date Hematology Sample Obtained (Bone marrow biopsy/aspirate)
Beskrivning

Lab,Hematology,SampleCollectionDate

Datatyp

date

Date of bone Marrow Biopsy
Beskrivning

BoneMarrowBiopsyDate

Datatyp

date

Peripheral WBC count (/mm 3 ) (x1000)
Beskrivning

Lab,Hematology,WBC

Datatyp

double

Peripheral platelet count (/mm 3 ) (x1000)
Beskrivning

Lab,Hematology,Platelets

Datatyp

double

Peripheral Neutrophils (%)
Beskrivning

Lab,Hematology,Neutrophils,CellPercentage

Datatyp

double

Hemoglobin (g/dl)
Beskrivning

Lab,Hematology,Hemoglobin

Datatyp

double

Marrow Cellularity (%)
Beskrivning

BoneMarrow,CellularityPercentage

Datatyp

double

Peripheral Blasts (%)
Beskrivning

Lab,Hematology,Blasts,CellPercentage

Datatyp

double

Peripheral Blasts (%)
Beskrivning

Lab,Hematology,Blasts,CellPercentage

Datatyp

double

CD33 % by flow cytometry
Beskrivning

CD33%byflowcytometry

Datatyp

text

CD33 % by flow cytometry (if dry tap or inaspirable)
Beskrivning

CD33%byflowcytometry(ifdrytaporinaspirable)

Datatyp

text

Marrow Cellularity Status (Choose one)
Beskrivning

BoneMarrow,CellularityStatus

Datatyp

text

Performance status
Beskrivning

PerformanceStatus

Datatyp

text

Comments
Beskrivning

Comments

Datatyp

text

Investigator Signature
Beskrivning

InvestigatorSignature

Datatyp

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Date
Beskrivning

InvestigatorSignatureDate

Datatyp

date

Ccrr Module For E1900 On-study Form
Beskrivning

Ccrr Module For E1900 On-study Form

Similar models

No Instruction available.

  1. StudyEvent: E1900 On-Study Form
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Unnamed1
RegistrationStep
Item
Registration Step
text
Patient'sName
Item
Patient?s Name
text
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGPatientID
Item
ECOG Patient ID
text
ECOGPatientID
Item
ECOG Patient ID
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
ParticipatingGroupPatientID
Item
Participating Group Patient ID
text
MainMemberInstitution/Affiliate
Item
Institution/Affiliate
text
Item Group
Unnamed2
Item
Are data amended?
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
Code List
Are data amended?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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)
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
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)
Item
Central Nervous System
text
Code List
Central Nervous System
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Peripheral Nervous System
text
Code List
Peripheral Nervous System
CL Item
Null (no)
CL Item
Null (yes)
Item
Gingival Hypertrophy
text
Code List
Gingival Hypertrophy
CL Item
Null (no)
CL Item
Null (yes)
Item
Mediastinal Mass
text
Code List
Mediastinal Mass
CL Item
Null (no)
CL Item
Null (yes)
Item
Skin
text
Code List
Skin
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Other
text
Code List
Other
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
ExtramedullaryDisease,OtherSite
Item
Other, specify (extramedullary disease involvement)
text
Item Group
Baseline Evaluation Data
PatientHeight
Item
Patient Height (cm)
double
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)
double
Lab,Hematology,Platelets
Item
Peripheral platelet count (/mm 3 ) (x1000)
double
Lab,Hematology,Neutrophils,CellPercentage
Item
Peripheral Neutrophils (%)
double
Lab,Hematology,Hemoglobin
Item
Hemoglobin (g/dl)
double
BoneMarrow,CellularityPercentage
Item
Marrow Cellularity (%)
double
Lab,Hematology,Blasts,CellPercentage
Item
Peripheral Blasts (%)
double
Lab,Hematology,Blasts,CellPercentage
Item
Peripheral Blasts (%)
double
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
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
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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