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  1. StudyEvent: Brain Cancer - Event Monitoring Form
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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 Name
Item
Patient Name (initials acceptable)
text
C25191 (NCI Thesaurus ValueDomain)
C1299487 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Item Group
Brain: Vital Status
Date last contact
Item
Date of Last Contact or Death
date
C16960 (NCI Thesaurus ObjectClass)
C0805839 (UMLS CUI-1)
C25461 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Patient Vital Status
text
C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25717 (NCI Thesaurus Property)
CL.1
Code List
Patient Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Item
Primary Cause of Death
text
C25638 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C28554 (NCI Thesaurus Property)
C25251 (NCI Thesaurus ValueDomain-2)
CL.2
Code List
Primary Cause of Death
CL Item
Due To This Disease (Due to this disease)
CL Item
Due To Protocol Treatment (Due to protocol treatment)
CL Item
Due To Other Cause (Due to other cause)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Type of Cancer (If cancer was primary cause of death, indicate)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C12439 (NCI Thesaurus ObjectClass)
C0006104 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.3
Code List
Type of Cancer (If cancer was primary cause of death, indicate)
CL Item
Brain Cancer (Brain cancer)
CL Item
Cancer At Other Site (Cancer at other site)
Cause of Death, specify
Item
Describe cause of death
text
C25685 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C28554 (NCI Thesaurus Property)
Item Group
Brain: Off Study Reason
Off-TreatmentStudyFollow-UpEndDate
Item
Off Study Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C15206 (NCI Thesaurus ObjectClass-2)
C0008972 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item
Off Study Reason
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C15206 (NCI Thesaurus ObjectClass-2)
C0008972 (UMLS 2011AA ObjectClass-2)
CL.4
Code List
Off Study Reason
CL Item
Protocol-defined Follow-up Completed (Protocol-defined follow-up completed)
CL Item
Lost To Follow-up (Patient lost to follow-up)
CL310949 (NCI Metathesaurus)
CL Item
Patient Refused Follow-up (Patient refused follow-up)
CL Item
Death (Death)
C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)
CL Item
Adverse Event/side Effects/complications (Adverse Event/side effects/complications)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Off-TreatmentStudyFollow-UpSpecify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C15206 (NCI Thesaurus ObjectClass-2)
C0008972 (UMLS 2011AA ObjectClass-2)
Item Group
Brain: Disease Follow-up Status
Item
Has the patient had a documented clinical assessment for this cancer? (since submission of the previous follow-up form)
text
C38148 (NCI Thesaurus ValueDomain)
C1522577 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C0006826 (UMLS CUI-2)
C9305 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property-2)
CL.5
Code List
Has the patient had a documented clinical assessment for this cancer? (since submission of the previous follow-up form)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Follow-Up Date
Item
Date of Last Clinical Assessment (MM DD YYYY)
date
C9305 (NCI Thesaurus ObjectClass)
C3694716 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C25365 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Brain: Notice Of Progression
DiseaseProgressionInd-3
Item
Has the patient developed a first progression (or relapse) that has not been previously reported?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
DiseaseProgressionDate
Item
Date of Progression (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
Item
Basis of Diagnosis
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C15220 (NCI Thesaurus ObjectClass)
C0011900 (UMLS 2011AA ObjectClass)
CL.7
Code List
Basis of Diagnosis
CL Item
Clinical (Clinical)
C25398 (NCI Thesaurus)
C0205210 (UMLS 2011AA)
CL Item
Histology (Histology)
C16681 (NCI Thesaurus)
C0019638 (UMLS 2011AA)
C16681 (NCI Thesaurus-3)
C0019638 (UMLS 2011AA-4)
CL Item
Imaging Only (Imaging only)
Item
Site(s) of Progression (mark all that apply)
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C12439 (NCI Thesaurus ObjectClass)
C0006104 (UMLS 2011AA ObjectClass)
CL.8
Code List
Site(s) of Progression (mark all that apply)
CL Item
Frontal (Frontal)
CL Item
Temporal (Temporal)
CL Item
Parietal (Parietal)
C25312 (NCI Thesaurus)
C0442030 (UMLS 2011AA)
CL Item
Occipital (Occipital)
CL Item
Cerebellum (Cerebellum)
C12445 (NCI Thesaurus)
C0007765 (UMLS 2011AA)
CL Item
Cerebellar Peduncle (Cerebellar peduncle)
C0228515 (NCI Metathesaurus)
CL Item
Cerebellar Hemisphere (Cerebellar hemisphere)
C0228465 (NCI Metathesaurus)
CL Item
Cerebellar Vermis (Cerebellar vermis)
CL Item
Brainstem (Brainstem)
CL Item
Midbrain (Midbrain)
C0025462 (NCI Metathesaurus)
CL Item
Pons (Pons)
C0032639 (NCI Metathesaurus)
CL Item
Medulla (Medulla)
CL Item
Dorsal Exophytic Brainstem (Dorsal exophytic brainstem)
CL Item
Spinal Cord (c1 And Below) (Spinal cord)
CL Item
Corpus Callosum (Corpus callosum)
C12446 (NCI Thesaurus)
C0010090 (UMLS 2011AA)
CL Item
Optic Chiasm (Optic chiasm)
C0029126 (NCI Metathesaurus)
CL Item
Hypothalamus (Hypothalamus)
C12458 (NCI Thesaurus)
C0020663 (UMLS 2011AA)
CL Item
Cavernous Sinus (Cavernous sinus)
C12690 (NCI Thesaurus)
C0007473 (UMLS 2011AA)
CL Item
Lateral Ventricle (Lateral ventricle)
C12834 (NCI Thesaurus)
C0152279 (UMLS 2011AA)
CL Item
Third Ventricle (Third ventricle)
C12827 (NCI Thesaurus)
C0149555 (UMLS 2011AA)
CL Item
Fourth Ventricle (Fourth ventricle)
C12828 (NCI Thesaurus)
C0149556 (UMLS 2011AA)
CL Item
Cisterna Magna (Cisterna magna)
C32324 (NCI Thesaurus)
C0008841 (UMLS 2011AA)
CL Item
Basal Ganglia (Basal ganglia)
C12447 (NCI Thesaurus)
C0004781 (UMLS 2011AA)
CL Item
Thalamus (Thalamus)
C12459 (NCI Thesaurus)
C0039729 (UMLS 2011AA)
CL Item
Optic Nerve (Optic nerve)
C12761 (NCI Thesaurus)
C0029130 (UMLS 2011AA)
CL Item
Pineal (Pineal)
CL Item
Aqueduct Of Sylvius (Aqueduct of sylvius)
C32135 (NCI Thesaurus)
C0007769 (UMLS 2011AA)
CL Item
Leptomeningeal (Leptomeningeal)
CL Item
Cervical (Cervical)
C12844 (NCI Thesaurus)
C0205064 (UMLS 2011AA)
CL Item
Thoracic (Thoracic)
C13360 (NCI Thesaurus)
C0817096 (UMLS 2011AA)
CL Item
Lumbar (Lumbar)
CL Item
Conus (Conus)
C0598489 (NCI Metathesaurus)
CL Item
Cauda Equina (Cauda equina)
C12689 (NCI Thesaurus)
C0007458 (UMLS 2011AA)
CL Item
Other Specify (Other specify)
Progression Site, specify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C0242656 (UMLS CUI-1)
C25341 (NCI Thesaurus Property)
C1515974 (UMLS CUI-2)
C25331 (NCI Thesaurus ObjectClass)
Item Group
Brain: Notice Of New Primary
NewCancerDiagnosisInd-3
Item
Has a new primary cancer or MDS been diagnosed that has not been previously reported? (myelodysplastic syndrome)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
NewCancerDiagnosisDate
Item
Date of Diagnosis (MM DD YYYY)
date
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
NewCancerSiteText
Item
Site of New Primary (If new primary site is AML/MDS, please submit NCI AML/MDS form.)
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-2)
C0006826 (UMLS 2011AA ObjectClass-2)
Item Group
Brain: Long-term Toxicity
Item
Has the patient experienced (prior to diagnosis of recurrence or second primary) any severe (Grade >=3), long term toxicity that has not been previously reported
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C19778 (NCI Thesaurus ObjectClass)
C1514695 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass-2)
C0877248 (UMLS 2011AA ObjectClass-2)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
CL.10
Code List
Has the patient experienced (prior to diagnosis of recurrence or second primary) any severe (Grade >=3), long term toxicity that has not been previously reported
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
RTOGAdverseEventTermText
Item
Late Adverse Event Term
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C19778 (NCI Thesaurus ObjectClass)
C1514695 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass-2)
C0877248 (UMLS 2011AA ObjectClass-2)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
RTOGAdverseEventGrade
Item
Late Adverse Event Grade
float
C19778 (NCI Thesaurus ObjectClass)
C1514695 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass-2)
C0877248 (UMLS 2011AA ObjectClass-2)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
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