INSTRUCTIONS: After patient is off treatment, complete this form for each required follow-up report period (see forms submission schedule).

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
ECOG clinical trial administrative data
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Generic drug form
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (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
Participating Group 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)
Item Group
Data amendment
Data amended
Item
Please mark an 'X' if data have been amended
text
C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Data amended date
Item
Date data amended
date
C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Cycle number
Item
On Treatment Report Period
text
C25284 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25616 (NCI Thesaurus Property-2)
C15368 (NCI Thesaurus ObjectClass)
Code List
On Treatment Report Period
CL Item
End Of Cycle 2 (End of Cycle 2)
CL Item
End Of Cycle 4 (End of Cycle 4)
CL Item
End Of Cycle 6 (End of Cycle 6)
CL Item
End Of Cycle 8 (End of Cycle 8)
CL Item
Recurrence (Recurrence)
C3352 (NCI Thesaurus)
C0034897 (UMLS 2011AA)
Item
Off Treatment Report Period
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25601 (NCI Thesaurus Property-2)
C1518544 (UMLS 2011AA Property-2)
C25207 (NCI Thesaurus Property-3)
C0040223 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Off Treatment Report Period
CL Item
54 Months Post Registration (54 Months Post Registration)
CL Item
42 Months Post Registration (42 Months Post Registration)
CL Item
9 Years (108 months post registration)
CL Item
12 Months (12 months post registration)
CL Item
10 Years (120 months post registration)
CL Item
15 Months (15 months post registration)
CL Item
18 Months (18 months post registration)
CL Item
21 Months Post Registration (21 months post registration)
CL Item
24 Months (24 months post registration)
CL Item
3 Months (3 months post registration)
CL Item
30 Months (30 months post registration)
CL Item
36 Months (36 months post registration)
CL Item
4 Years (48 months post registration)
CL Item
6 Months (6 months post registration)
CL Item
5 Years (60 months post registration)
CL Item
6 Years (72 months post registration)
CL Item
84 Months Post Registration (84 months post registration)
CL Item
9 Months (9 months post registration)
CL Item
8 Years (96 months post registration)
Item Group
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)
Code List
Has the patient had a documented clinical assessment for this cancer (since submission of the previous follow-up form)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CancerUnknownFollow-upAssessmentSpecify
Item
If unknown, please explain
text
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C17998 (NCI Thesaurus Property-2)
C0439673 (UMLS 2011AA Property-2)
C16033 (NCI Thesaurus Property-3)
C1522577 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Follow-Up Date
Item
Date of last clinical assessment (If yes)
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
Notice Of Recurrence
DiseaseRecurrenceInd-3
Item
Recurrent disease
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C3352 (NCI Thesaurus Property)
C0034897 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
RecurrentDiseaseFirstDiagnosisDate
Item
Date of First Recurrence (If yes)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
Item
How was recurrence discovered
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3352 (NCI Thesaurus ObjectClass)
C0034897 (UMLS 2011AA ObjectClass)
C25737 (NCI Thesaurus Property)
C0205396 (UMLS 2011AA Property)
Code List
How was recurrence discovered
CL Item
Clinical Evaluation (Clinical evaluation)
CL Item
Development Of Symptoms (Development of symptoms)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Routine Radiologic Evaluation (Routine radiologic evaluation)
RecurrenceIdentifiedSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C3352 (NCI Thesaurus ObjectClass)
C0034897 (UMLS 2011AA ObjectClass)
C25737 (NCI Thesaurus Property)
C0205396 (UMLS 2011AA Property)
Item
Site of recurrence
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C9385 (NCI Thesaurus ObjectClass)
C0007134 (UMLS 2011AA ObjectClass)
Code List
Site of recurrence
CL Item
Central Nervous System (Central nervous system)
C12438 (NCI Thesaurus)
C3714787 (UMLS 2011AA)
CL Item
Liver (Liver)
C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)
CL Item
Lung (Lung)
C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Other Organs (Other organs)
CL Item
Renal Bed (Renal bed)
CL Item
Skeletal (Skeletal)
CL Item
Subcutaneous And Lymph Node Recurrence (Subcutaneous and lymph node recurrence)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
RenalCellCarcinomaRecurrentDiseaseSpecify
Item
Explain other or unknown
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C9385 (NCI Thesaurus ObjectClass)
C0007134 (UMLS 2011AA ObjectClass)
Item
Biopsy done
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
Code List
Biopsy done
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)
Biopsy Date
Item
Date of Biopsy
date
C25164 (NCI Thesaurus ValueDomain)
C0005558 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C15189 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
Item
Biopsy Result
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
Code List
Biopsy Result
CL Item
Atypical/indeterminate (Atypical/indeterminate)
CL Item
Benign (Benign)
C14172 (NCI Thesaurus)
C0205183 (UMLS 2011AA)
CL Item
Malignant (Malignant)
C14143 (NCI Thesaurus)
C0205282 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
BiopsyResultSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
Item
Did a physician make a formal diagnosis of recurrence
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
Code List
Did a physician make a formal diagnosis of recurrence
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
PhysicianRecurrentDiseaseDiagnosisSpecify
Item
Specify basis of recurrence (If no or unknown)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
Item
Was the recurrence treated by surgery
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C15368 (NCI Thesaurus Property-2)
Code List
Was the recurrence treated by surgery
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item Group
Comments
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Investigator Signature Date
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)

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