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  1. StudyEvent: Off Protocol Therapy Follow-up (OPTF) Report (Master) [ADVL0212]
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Institution Name
Item
Institution
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
CRAName
Item
CRA Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25465 (NCI Thesaurus ObjectClass)
C1516627 (UMLS 2011AA ObjectClass)
PatientCOGIdentifierNumber
Item
COG Number
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)
C39353 (NCI Thesaurus Property-2)
C1516477 (UMLS 2011AA Property-2)
Protocol ID COG
Item
Study Number (All studies for which the patient has registered will appear on the RDE Screen.)
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516477 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Form Completion Date
Item
Today's date
date
C19464 (NCI Thesaurus ObjectClass)
C1549507 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
DataEnteredDate
Item
Date worksheet entered into RDE
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C37949 (NCI Thesaurus Property)
C1521975 (UMLS 2011AA Property)
Item Group
Patient Status Information
PatientPriorContactDate
Item
Date of Previous Contact (If the patient's records reflect a date of last contact which disagrees with the displayed date of previous contact,)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25461 (NCI Thesaurus Property)
C0337611 (UMLS 2011AA Property)
PatientPriorContactRecordDate
Item
enter the date of previous contact according to the patient's records (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25461 (NCI Thesaurus Property)
C0337611 (UMLS 2011AA Property)
PatientPriorContactText
Item
Please provide some text to explain the possible nature of the disagrement.
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25461 (NCI Thesaurus Property)
C0337611 (UMLS 2011AA Property)
Date last contact
Item
Date of Last Contact (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0805839 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25461 (NCI Thesaurus Property)
Item
Life Status at the Date of Last Contact
text
C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25365 (NCI Thesaurus Property)
CL.1
Code List
Life Status at the Date of Last Contact
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Item
Disease Status at the end of the reporting period (Select one)
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.2
Code List
Disease Status at the end of the reporting period (Select one)
CL Item
Residual Disease After Prior Therapy (No disease present)
CL Item
Eradicated But Recurred Locally And Distantly (Disease present)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Non-protocolTherapyAdministeredInd-3
Item
Has patient received anti-cancer therapy since the last OPTF report submission? (If the patient received anti-cancer therapy during this reporting period,)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
select the type of treatment from this list (If the patient received anti-cancer therapy during this reporting period,)
text
C15368 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.4
Code List
select the type of treatment from this list (If the patient received anti-cancer therapy during this reporting period,)
CL Item
Chemotherapy (Chemotherapy)
C15632 (NCI Thesaurus)
C0392920 (UMLS 2011AA)
CL Item
Transplant (Transplant)
C0040733 (NCI Metathesaurus)
CL Item
External Beam Radiation (XRT)
CL Item
Surgery (Surgery)
C17173 (NCI Thesaurus)
C0038894 (UMLS 2011AA)
CL Item
Extensive Radiation (Extensive Radiation)
C16230 (NCI Thesaurus)
C1517030 (UMLS 2011AA)
CL Item
Limited Radiation (Limited Radiation)
CL Item
Radiation (nos) (Radiation (NOS))
CL Item
Prior Therapy (nos) (Prior Therapy (NOS))
CL Item
Other Therapy (Other)
C15645 (NCI Thesaurus)
C0418967 (UMLS 2011AA)
CL Item
Immunotherapy (Immunotherapy)
C15262 (NCI Thesaurus)
C0021083 (UMLS 2011AA)
CL Item
Stem Cell Transplant (Stem Cell Transplant)
CL Item
Gene Therapy (Gene Therapy)
C15238 (NCI Thesaurus)
C0017296 (UMLS 2011AA)
CL Item
No Prior Therapy (No Prior Therapy)
C15903 (NCI Thesaurus)
C1518341 (UMLS 2011AA)
CL Item
Bone Marrow Transplant (Bone Marrow Transplant)
CL Item
Anti-retroviral Therapy (Anti-retroviral Therapy)
CL Item
Antisense (Antisense)
CL Item
Oncolytic Virotherapy (Oncolytic Virotherapy)
CL Item
Vaccine (Vaccine)
C923 (NCI Thesaurus)
C0042210 (UMLS 2011AA)
CL Item
Chemotherapy Non-cytotoxic (Chemotherapy Non-cytotoxic)
Non-protocolTherapyAdministeredText
Item
describe [anti-cancer therapy]
text
C15368 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item Group
Events Of Interest
Item
Did the patient relapse or experience disease progression during the reporting period? (If yes,)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
CL.5
Code List
Did the patient relapse or experience disease progression during the reporting period? (If yes,)
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)
DiseaseProgressionDate
Item
date of relapse or progression (mm/dd/ccyy)
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
Did the patient experience a second malignant neoplasm during the reporting period? (If yes,)
text
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)
CL.6
Code List
Did the patient experience a second malignant neoplasm during the reporting period? (If yes,)
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)
NewCancerDiagnosisDate
Item
date of second malignant neoplasm (mm/dd/ccyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
PatientWithdrawFollow-upConsentInd-2
Item
Did the patient withdraw consent for follow-up at the end of the reporting period? (Note: Withdrawal of consent is to be coded only when the patient no longer wants to participate in the study and asks data no longer be submitted.)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property-2)
C38061 (NCI Thesaurus Property-3)
C2349954 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientLostFollow-upInd-2
Item
Was the patient confirmed lost to follow-up at the end of the reporting period?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25560 (NCI Thesaurus Property)
C0745777 (UMLS 2011AA Property)
C16033 (NCI Thesaurus Property-2)
C1522577 (UMLS 2011AA Property-2)
PatientOtherEnrollmentInd-2
Item
Was the patient enrolled on another COG therapeutic study at the end of the reporting period? (If disease status was evaluated during this interval,)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
Item
what was the patient's response?
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25605 (NCI Thesaurus ObjectClass-2)
C1561607 (UMLS 2011AA ObjectClass-2)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
CL.10
Code List
what was the patient's response?
CL Item
Complete Response (Complete Response)
CL Item
Partial Response (Partial Response)
C18212 (NCI Thesaurus)
CL Item
Stable Disease (Stable Disease)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Partial Response (Progressive Disease)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
C18212 (NCI Thesaurus-3)
CL Item
Insufficient Evaluation (Not Evaluable)
CL Item
Death Prior To Completion Of Protocol Criteria (Early death)
CL Item
Progressive Disease (PD)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
RadiationTherapyReportingPeriodReceivedInd-3
Item
Did patient receive radiation therapy during this reporting period? (If yes,)
boolean
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
C25651 (NCI Thesaurus Property-3)
C0700287 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Radiation Therapy Body Site
Item
specify sites [radiation therapy]
text
C25191 (NCI Thesaurus ValueDomain)
C1997599 (UMLS CUI-1)
C25341 (NCI Thesaurus Property)
C15313 (NCI Thesaurus ObjectClass)
PBSCTransfusionReceivedInd-2
Item
Did patient receive PBSC transfusion? (If yes,)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C15408 (NCI Thesaurus ObjectClass)
PBSCTransfusionReceivedDate
Item
what date(s) did the transfusion(s) take place?
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C15408 (NCI Thesaurus ObjectClass)
Research Comments
Item
COMMENT
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item Group
Ccrr Module For Off Protocol Therapy Follow-up (optf) Report (master) [advl0212]
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