ID

6208

Beschrijving

North Central Cancer Treatment Group N0577 Event Monitoring Form Radiation Therapy or Radiation Therapy and Temozolomide or Temozolomide Alone in Treating Patients With Newly Diagnosed Anaplastic Glioma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4C090D31-BB06-2FAA-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=4C090D31-BB06-2FAA-E044-0003BA3F9857

Trefwoorden

Versies (3)
  1. 18-12-14 18-12-14 - Martin Dugas
  2. 08-01-15 08-01-15 - Martin Dugas
  3. 09-01-15 09-01-15 - Martin Dugas
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18 december 2014

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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Event Monitoring Form N0577

Engels

No Instruction available.

1 Formulieren  
  1. StudyEvent: North Central Cancer Treatment Group N0577 Event Monitoring Form
    1. No Instruction available.
Header
Beschrijving

Header

Alias
UMLS CUI-1
C1320722
Protocol Number
Beschrijving

ProtocolNorthCentralCancerTreatmentGroupIdentifierNumber

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25581
UMLS 2011AA Property
C1518419
Patient ID
Beschrijving

PatientNorthCentralCancerTreatmentGroupIdentifierNumber

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25581
UMLS 2011AA Property
C1518419
Patient Initials (L F M)
Beschrijving

PatientInitialsName

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Institution Number
Beschrijving

InstitutionIdentifierNumber

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Institution
Beschrijving

InstitutionName

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Are data amended (If yes, highlight amended areas)
Beschrijving

DataAmendedInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Were you able to obtain any information about the patient since the last report (If this is the first event monitoring form check yes, enter assessment date and complete the rest of the form.)
Beschrijving

PatientInformationCurrentFollow-upCollectedInd-2

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass
C48191
UMLS 2011AA ObjectClass
C1533716
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus Property
C16033
UMLS 2011AA Property
C1522577
NCI Thesaurus Property
C25452
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date of last attempt to contact patient (If No, mm/dd/yyyy)
Beschrijving

PatientLastAttemptContactDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25461
UMLS 2011AA Property
C0337611
NCI Thesaurus Property
C25551
UMLS 2011AA Property
C1517741
NCI Thesaurus Property
C39769
UMLS 2011AA Property
C1516084
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Vital Status
Beschrijving

Vital Status

Vital Status
Beschrijving

PatientVitalStatus

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C18003
UMLS 2011AA ValueDomain
C0442732
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property
C25717
UMLS 2011AA Property
C1148433
Date of Last Contact or Death (mm/dd/yyyy)
Beschrijving

PatientLastContactDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25461
UMLS 2011AA Property
C0337611
NCI Thesaurus Property
C25551
UMLS 2011AA Property
C1517741
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Primary Cause of Death
Beschrijving

PatientDeathPatientDeathPrimaryReason

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C28554
UMLS 2011AA Property
C0011065
NCI Thesaurus ValueDomain
C25251
UMLS 2011AA ValueDomain
C0205225
Due to other cause, specify
Beschrijving

PrimaryCauseDeathOtherReasonSpecify

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass
C25251
UMLS 2011AA ObjectClass
C0205225
NCI Metathesaurus ObjectClass
C0007465
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Disease Follow-up Status
Beschrijving

Disease Follow-up Status

Has the patient had a documented clinical assessment for this cancer? (since submission of the last event monitoring form)
Beschrijving

CancerFollow-upStatusInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C16033
UMLS 2011AA Property
C1522577
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Cancer Follow-up Status Date (If yes,)
Beschrijving

CancerFollow-UpStatusDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C16033
UMLS 2011AA Property
C1522577
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Notice Of First Relapse/progression In The Event Monitoring Phase
Beschrijving

Notice Of First Relapse/progression In The Event Monitoring Phase

Has the patient developed a first relapse or progression that has not been previously reported
Beschrijving

DiseaseRelapseProgressionInd-3

Datatype

text

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C38155
UMLS 2011AA Property
C0277556
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus Property
C19987
UMLS 2011AA Property
C0242656
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Date of Relapse or Progression (If yes,)
Beschrijving

DiseaseRecurrentDiseaseCancerProgressionDiagnosisDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C38155
UMLS 2011AA Property
C0277556
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus Property
C19987
UMLS 2011AA Property
C0242656
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Site of relapse/progression (s)
Beschrijving

MetastaticMalignantNeoplasmtotheBrainRelapseProgressionSite

Datatype

text

Alias
NCI Thesaurus ObjectClass
C3813
UMLS 2011AA ObjectClass
C0220650
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property
C18265
NCI Thesaurus Property
C25331
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
Other, specify
Beschrijving

MetastaticMalignantNeoplasmtotheBrainRelapseProgressionLocationSpecify

Datatype

text

Alias
NCI Thesaurus ObjectClass
C3813
UMLS 2011AA ObjectClass
C0220650
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property
C18265
NCI Thesaurus Property
C25331
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Method of Evaluation
Beschrijving

AssessmentMethodType

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
Other Specify
Beschrijving

AssessmentMethodSpecify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C16847
UMLS 2011AA Property
C0449851
Notice Of First Subsequent Treatment
Beschrijving

Notice Of First Subsequent Treatment

Has the patient received subsequent treatment for this cancer that has not been previously reported
Beschrijving

AdditionalTreatmentProgressionInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25406
UMLS 2011AA ObjectClass
C1524062
Date of Subsequent Treatment (If yes mm/dd/yyyy)
Beschrijving

AdditionalTreatmentProgressionDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25406
UMLS 2011AA ObjectClass
C1524062
NCI Thesaurus Property
C25331
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Subsequent Treatment Type
Beschrijving

AdditionalTreatmentProgressionText

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25406
UMLS 2011AA ObjectClass
C1524062
Notice Of New Primary
Beschrijving

Notice Of New Primary

Has a new primary cancer or MDS been diagnosed that has not been previously reported? (myelodyplastic syndrome)
Beschrijving

NewCancerDiagnosisInd-3

Datatype

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
New Primary Cancer Date (If yes,)
Beschrijving

NewCancerDiagnosisDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
Site of New Primary
Beschrijving

NewCancerSiteText

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
Description Of Primary Disease
Beschrijving

Description Of Primary Disease

Has the patient experienced (prior to treatment for progression or relapse or a second primary, and prior to non-protocol treatment) any severe (grade >=3) long term toxicity that has not been previously reported?
Beschrijving

AdverseEventPriorCancerProgressionRecurrentNeoplasmPresentInd-3

Datatype

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property
C25629
UMLS 2011AA Property
C0332152
NCI Thesaurus Property
C19987
UMLS 2011AA Property
C0242656
NCI Thesaurus Property
C4798
UMLS 2011AA Property
C0521158
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
CTC Adverse Event Term
Beschrijving

CommonToxicityCriteriaAdverseEventTermType

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C45559
UMLS 2011AA Property
C1705313
MedDRA Code (primary tumor site: Metastases to brain parenchyma)
Beschrijving

MedDRACode

Datatype

double

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
CTC Adverse Event Grade (Highest Grade)
Beschrijving

CommonToxicityCriteriaAdverseEventGrade

Datatype

double

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
CTC AE Attribution Code
Beschrijving

CTCAdverseEventAttributionScale

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
Late Adverse Event Onset Date (mm/dd/yyyy)
Beschrijving

LateAdverseEventOnsetDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25279
UMLS 2011AA Property
C0332162
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1 Formulieren
  1. StudyEvent: North Central Cancer Treatment Group N0577 Event Monitoring Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
ProtocolNorthCentralCancerTreatmentGroupIdentifierNumber
Item
Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25581 (NCI Thesaurus Property)
C1518419 (UMLS 2011AA Property)
PatientNorthCentralCancerTreatmentGroupIdentifierNumber
Item
Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25581 (NCI Thesaurus Property)
C1518419 (UMLS 2011AA Property)
PatientInitialsName
Item
Patient Initials (L F M)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
InstitutionIdentifierNumber
Item
Institution Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
InstitutionName
Item
Institution
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Item
Are data amended (If yes, highlight amended areas)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
CL.1
Code List
Are data amended (If yes, highlight amended areas)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Were you able to obtain any information about the patient since the last report (If this is the first event monitoring form check yes, enter assessment date and complete the rest of the form.)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C48191 (NCI Thesaurus ObjectClass)
C1533716 (UMLS 2011AA ObjectClass)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C25452 (NCI Thesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.2
Code List
Were you able to obtain any information about the patient since the last report (If this is the first event monitoring form check yes, enter assessment date and complete the rest of the form.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
PatientLastAttemptContactDate
Item
Date of last attempt to contact patient (If No, mm/dd/yyyy)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25461 (NCI Thesaurus Property)
C0337611 (UMLS 2011AA Property)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C39769 (NCI Thesaurus Property)
C1516084 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Vital Status
Item
Vital Status
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18003 (NCI Thesaurus ValueDomain)
C0442732 (UMLS 2011AA ValueDomain)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25717 (NCI Thesaurus Property)
C1148433 (UMLS 2011AA Property)
CL.3
Code List
Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
PatientLastContactDate
Item
Date of Last Contact or Death (mm/dd/yyyy)
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25461 (NCI Thesaurus Property)
C0337611 (UMLS 2011AA Property)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
Item
Primary Cause of Death
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
C25251 (NCI Thesaurus ValueDomain)
C0205225 (UMLS 2011AA ValueDomain)
CL.4
Code List
Primary Cause of Death
CL Item
Due To Protocol Treatment (Due to protocol treatment)
CL Item
Due To This Disease (Due to this disease)
CL Item
Due To Other Cause (Due to other cause)
PrimaryCauseDeathOtherReasonSpecify
Item
Due to other cause, specify
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C0007465 (NCI Metathesaurus ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item Group
Disease Follow-up Status
Item
Has the patient had a documented clinical assessment for this cancer? (since submission of the last event monitoring form)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.5
Code List
Has the patient had a documented clinical assessment for this cancer? (since submission of the last event monitoring form)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CancerFollow-UpStatusDate
Item
Cancer Follow-up Status Date (If yes,)
date
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
Item Group
Notice Of First Relapse/progression In The Event Monitoring Phase
Item
Has the patient developed a first relapse or progression that has not been previously reported
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C19987 (NCI Thesaurus Property)
C0242656 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.6
Code List
Has the patient developed a first relapse or progression that has not been previously reported
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
DiseaseRecurrentDiseaseCancerProgressionDiagnosisDate
Item
Date of Relapse or Progression (If yes,)
date
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C19987 (NCI Thesaurus Property)
C0242656 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Site of relapse/progression (s)
text
C3813 (NCI Thesaurus ObjectClass)
C0220650 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C18265 (NCI Thesaurus Property)
C25331 (NCI Thesaurus Property)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
CL.7
Code List
Site of relapse/progression (s)
CL Item
Local Brain Failure (Local brain failure)
CL Item
Distant Brain Failure (Distant brain failure)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
MetastaticMalignantNeoplasmtotheBrainRelapseProgressionLocationSpecify
Item
Other, specify
text
C3813 (NCI Thesaurus ObjectClass)
C0220650 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C18265 (NCI Thesaurus Property)
C25331 (NCI Thesaurus Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Method of Evaluation
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
CL.8
Code List
Method of Evaluation
CL Item
Clinical (Clinical)
C25398 (NCI Thesaurus)
C0205210 (UMLS 2011AA)
CL Item
Radiology (Radiologic)
C17059 (NCI Thesaurus)
C0034599 (UMLS 2011AA)
C17059 (NCI Thesaurus)
C0034599 (UMLS 2011AA)
CL Item
Pathologic (Pathologic)
C25610 (NCI Thesaurus)
C1521733 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
AssessmentMethodSpecify
Item
Other Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
Item Group
Notice Of First Subsequent Treatment
Item
Has the patient received subsequent treatment for this cancer that has not been previously reported
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25406 (NCI Thesaurus ObjectClass)
C1524062 (UMLS 2011AA ObjectClass)
CL.9
Code List
Has the patient received subsequent treatment for this cancer that has not been previously reported
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)
AdditionalTreatmentProgressionDate
Item
Date of Subsequent Treatment (If yes mm/dd/yyyy)
date
C15368 (NCI Thesaurus ObjectClass)
C25406 (NCI Thesaurus ObjectClass)
C1524062 (UMLS 2011AA ObjectClass)
C25331 (NCI Thesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
AdditionalTreatmentProgressionText
Item
Subsequent Treatment Type
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25406 (NCI Thesaurus ObjectClass)
C1524062 (UMLS 2011AA ObjectClass)
Item Group
Notice Of New Primary
Item
Has a new primary cancer or MDS been diagnosed that has not been previously reported? (myelodyplastic syndrome)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
CL.10
Code List
Has a new primary cancer or MDS been diagnosed that has not been previously reported? (myelodyplastic syndrome)
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)
NewCancerDiagnosisDate
Item
New Primary Cancer Date (If yes,)
date
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
NewCancerSiteText
Item
Site of New Primary
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
Item Group
Description Of Primary Disease
Item
Has the patient experienced (prior to treatment for progression or relapse or a second primary, and prior to non-protocol treatment) any severe (grade >=3) long term toxicity that has not been previously reported?
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C19987 (NCI Thesaurus Property)
C0242656 (UMLS 2011AA Property)
C4798 (NCI Thesaurus Property)
C0521158 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.11
Code List
Has the patient experienced (prior to treatment for progression or relapse or a second primary, and prior to non-protocol treatment) any severe (grade >=3) long term toxicity that has not been previously reported?
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)
CommonToxicityCriteriaAdverseEventTermType
Item
CTC Adverse Event Term
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
MedDRACode
Item
MedDRA Code (primary tumor site: Metastases to brain parenchyma)
double
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
Item
CTC Adverse Event Grade (Highest Grade)
double
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.12
Code List
CTC Adverse Event Grade (Highest Grade)
CL Item
Severe Adverse Event (3)
C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)
CL Item
Life-threatening Or Disabling Adverse Event (4)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
Item
CTC AE Attribution Code
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
CL.13
Code List
CTC AE Attribution Code
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
LateAdverseEventOnsetDate
Item
Late Adverse Event Onset Date (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25279 (NCI Thesaurus Property)
C0332162 (UMLS 2011AA Property)
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