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

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Header
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)
Item Group
Reporting Period
Item
On Treatment Report Period (Maintenance 1 cycle = 3 weeks)
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 (Maintenance 1 cycle = 3 weeks)
CL Item
Cycle 5 (Cycle 5)
CL Item
Cycle 8 (cycle 8)
CL Item
Cycle 24 (Cycle 24)
CL Item
Cycle 40 (Cycle 40)
CL Item
Cycle 56 (Cycle 56)
CL Item
Cycle 72 (Cycle 72)
CL Item
End Of Treatment (End of Treatment)
Item
On Treatment Report Period (Maintenance 1 cycle = 3 weeks)
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 (Maintenance 1 cycle = 3 weeks)
CL Item
Cycle 5 (Cycle 5)
CL Item
Cycle 8 (cycle 8)
CL Item
Cycle 24 (Cycle 24)
CL Item
Cycle 40 (Cycle 40)
CL Item
Cycle 56 (Cycle 56)
CL Item
Cycle 72 (Cycle 72)
CL Item
End Of Treatment (End of Treatment)
Item Group
Patient demographics
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 Initials
Item
Patient Initials (Last, First)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
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)
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 (Please circle amended items in red)
text
C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Data amended date
Item
Date data amended (M D Y)
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
Additional Concerns
Item
I feel fatigued
text
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C3036 (NCI Thesaurus Property-2)
C0015672 (UMLS 2011AA Property-2)
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ValueDomain-2)
C0518214 (UMLS 2011AA ValueDomain-2)
Code List
I feel fatigued
CL Item
Not At All (Not at all)
C91213 (NCI Thesaurus)
C91213 (NCI Thesaurus-2)
C70543 (NCI Thesaurus-3)
C2003901 (UMLS 2011AA)
CL Item
A Little Bit (A little bit)
CL Item
Somewhat (Somewhat)
C91215 (NCI Thesaurus)
CL Item
Quite A Bit (Quite a bit)
C91216 (NCI Thesaurus)
C91216 (NCI Thesaurus-2)
CL Item
Very Much (Very much)
C91217 (NCI Thesaurus)
C91217 (NCI Thesaurus-2)
Item
I feel weak all over
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C27961 (NCI Thesaurus ObjectClass-2)
C0235032 (UMLS 2011AA ObjectClass-2)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C0151786 (NCI Metathesaurus Property)
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ValueDomain-2)
C0518214 (UMLS 2011AA ValueDomain-2)
Code List
I feel weak all over
CL Item
Not At All (Not at all)
C91213 (NCI Thesaurus)
C91213 (NCI Thesaurus-2)
C70543 (NCI Thesaurus-3)
C2003901 (UMLS 2011AA)
CL Item
A Little Bit (A little bit)
CL Item
Somewhat (Somewhat)
C91215 (NCI Thesaurus)
CL Item
Quite A Bit (Quite a bit)
C91216 (NCI Thesaurus)
C91216 (NCI Thesaurus-2)
CL Item
Very Much (Very much)
C91217 (NCI Thesaurus)
C91217 (NCI Thesaurus-2)
Item
I feel listless ("washed out")
text
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C50412 (NCI Thesaurus Property-2)
C0023380 (UMLS 2011AA Property-2)
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ValueDomain-2)
C0518214 (UMLS 2011AA ValueDomain-2)
Code List
I feel listless ("washed out")
CL Item
Not At All (Not at all)
C91213 (NCI Thesaurus)
C91213 (NCI Thesaurus-2)
C70543 (NCI Thesaurus-3)
C2003901 (UMLS 2011AA)
CL Item
A Little Bit (A little bit)
CL Item
Somewhat (Somewhat)
C91215 (NCI Thesaurus)
CL Item
Quite A Bit (Quite a bit)
C91216 (NCI Thesaurus)
C91216 (NCI Thesaurus-2)
CL Item
Very Much (Very much)
C91217 (NCI Thesaurus)
C91217 (NCI Thesaurus-2)
Item
I feel tired
text
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C3036 (NCI Thesaurus Property-2)
C0015672 (UMLS 2011AA Property-2)
C25376 (NCI Thesaurus Property-3)
C0700321 (UMLS 2011AA Property-3)
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ValueDomain-2)
C0518214 (UMLS 2011AA ValueDomain-2)
Code List
I feel tired
CL Item
Not At All (Not at all)
C91213 (NCI Thesaurus)
C91213 (NCI Thesaurus-2)
C70543 (NCI Thesaurus-3)
C2003901 (UMLS 2011AA)
CL Item
A Little Bit (A little bit)
CL Item
Somewhat (Somewhat)
C91215 (NCI Thesaurus)
CL Item
Quite A Bit (Quite a bit)
C91216 (NCI Thesaurus)
C91216 (NCI Thesaurus-2)
CL Item
Very Much (Very much)
C91217 (NCI Thesaurus)
C91217 (NCI Thesaurus-2)
Item
I have trouble starting things because I am tired
text
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C3036 (NCI Thesaurus Property-2)
C0015672 (UMLS 2011AA Property-2)
C25431 (NCI Thesaurus Property-3)
C0439659 (UMLS 2011AA Property-3)
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ValueDomain-2)
C0518214 (UMLS 2011AA ValueDomain-2)
Code List
I have trouble starting things because I am tired
CL Item
Not At All (Not at all)
C91213 (NCI Thesaurus)
C91213 (NCI Thesaurus-2)
C70543 (NCI Thesaurus-3)
C2003901 (UMLS 2011AA)
CL Item
A Little Bit (A little bit)
CL Item
Somewhat (Somewhat)
C91215 (NCI Thesaurus)
CL Item
Quite A Bit (Quite a bit)
C91216 (NCI Thesaurus)
C91216 (NCI Thesaurus-2)
CL Item
Very Much (Very much)
C91217 (NCI Thesaurus)
C91217 (NCI Thesaurus-2)
Item
I have trouble finishing things because I am tired
text
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C3036 (NCI Thesaurus Property-2)
C0015672 (UMLS 2011AA Property-2)
C25496 (NCI Thesaurus Property-3)
C2746065 (UMLS 2011AA Property-3)
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ValueDomain-2)
C0518214 (UMLS 2011AA ValueDomain-2)
Code List
I have trouble finishing things because I am tired
CL Item
Not At All (Not at all)
C91213 (NCI Thesaurus)
C91213 (NCI Thesaurus-2)
C70543 (NCI Thesaurus-3)
C2003901 (UMLS 2011AA)
CL Item
A Little Bit (A little bit)
CL Item
Somewhat (Somewhat)
C91215 (NCI Thesaurus)
CL Item
Quite A Bit (Quite a bit)
C91216 (NCI Thesaurus)
C91216 (NCI Thesaurus-2)
CL Item
Very Much (Very much)
C91217 (NCI Thesaurus)
C91217 (NCI Thesaurus-2)
Item
I have energy
text
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C48058 (NCI Thesaurus Property-2)
C0542479 (UMLS 2011AA Property-2)
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ValueDomain-2)
C0518214 (UMLS 2011AA ValueDomain-2)
Code List
I have energy
CL Item
Not At All (Not at all)
C91213 (NCI Thesaurus)
C91213 (NCI Thesaurus-2)
C70543 (NCI Thesaurus-3)
C2003901 (UMLS 2011AA)
CL Item
A Little Bit (A little bit)
CL Item
Somewhat (Somewhat)
C91215 (NCI Thesaurus)
CL Item
Quite A Bit (Quite a bit)
C91216 (NCI Thesaurus)
C91216 (NCI Thesaurus-2)
CL Item
Very Much (Very much)
C91217 (NCI Thesaurus)
C91217 (NCI Thesaurus-2)
Item
I am able to do my usual activities
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C43431 (NCI Thesaurus Property-2)
C0441655 (UMLS 2011AA Property-2)
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
Code List
I am able to do my usual activities
CL Item
Not At All (Not at all)
C91213 (NCI Thesaurus)
CL Item
A Little Bit (A little bit)
CL Item
Somewhat (Somewhat)
C91215 (NCI Thesaurus)
CL Item
Quite A Bit (Quite a bit)
C91216 (NCI Thesaurus)
CL Item
Very Much (Very much)
C91217 (NCI Thesaurus)
Item
I need to sleep during the day
text
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C25301 (NCI Thesaurus Property-2)
C0439228 (UMLS 2011AA Property-2)
C28185 (NCI Thesaurus Property-3)
C0035253 (UMLS 2011AA Property-3)
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ValueDomain-2)
C0518214 (UMLS 2011AA ValueDomain-2)
Code List
I need to sleep during the day
CL Item
Not At All (Not at all)
C91213 (NCI Thesaurus)
C91213 (NCI Thesaurus-2)
C70543 (NCI Thesaurus-3)
C2003901 (UMLS 2011AA)
CL Item
A Little Bit (A little bit)
CL Item
Somewhat (Somewhat)
C91215 (NCI Thesaurus)
CL Item
Quite A Bit (Quite a bit)
C91216 (NCI Thesaurus)
C91216 (NCI Thesaurus-2)
CL Item
Very Much (Very much)
C91217 (NCI Thesaurus)
C91217 (NCI Thesaurus-2)
Item
I am too tired to eat
text
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C3036 (NCI Thesaurus Property-2)
C0015672 (UMLS 2011AA Property-2)
C28229 (NCI Thesaurus Property-3)
C0232478 (UMLS 2011AA Property-3)
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ValueDomain-2)
C0518214 (UMLS 2011AA ValueDomain-2)
Code List
I am too tired to eat
CL Item
Not At All (Not at all)
C91213 (NCI Thesaurus)
C91213 (NCI Thesaurus-2)
C70543 (NCI Thesaurus-3)
C2003901 (UMLS 2011AA)
CL Item
A Little Bit (A little bit)
CL Item
Somewhat (Somewhat)
C91215 (NCI Thesaurus)
CL Item
Quite A Bit (Quite a bit)
C91216 (NCI Thesaurus)
C91216 (NCI Thesaurus-2)
CL Item
Very Much (Very much)
C91217 (NCI Thesaurus)
C91217 (NCI Thesaurus-2)
Item
I need help doing my usual activities
text
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C43431 (NCI Thesaurus Property-2)
C0441655 (UMLS 2011AA Property-2)
C37902 (NCI Thesaurus Property-3)
C1521721 (UMLS 2011AA Property-3)
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ValueDomain-2)
C0518214 (UMLS 2011AA ValueDomain-2)
Code List
I need help doing my usual activities
CL Item
Not At All (Not at all)
C91213 (NCI Thesaurus)
C91213 (NCI Thesaurus-2)
C70543 (NCI Thesaurus-3)
C2003901 (UMLS 2011AA)
CL Item
A Little Bit (A little bit)
CL Item
Somewhat (Somewhat)
C91215 (NCI Thesaurus)
CL Item
Quite A Bit (Quite a bit)
C91216 (NCI Thesaurus)
C91216 (NCI Thesaurus-2)
CL Item
Very Much (Very much)
C91217 (NCI Thesaurus)
C91217 (NCI Thesaurus-2)
Item
I am frustrated by being too tired to do the things I want to do
text
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C61483 (NCI Thesaurus Property-2)
C0016770 (UMLS 2011AA Property-2)
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ValueDomain-2)
C0518214 (UMLS 2011AA ValueDomain-2)
Code List
I am frustrated by being too tired to do the things I want to do
CL Item
Not At All (Not at all)
C91213 (NCI Thesaurus)
C91213 (NCI Thesaurus-2)
C70543 (NCI Thesaurus-3)
C2003901 (UMLS 2011AA)
CL Item
A Little Bit (A little bit)
CL Item
Somewhat (Somewhat)
C91215 (NCI Thesaurus)
CL Item
Quite A Bit (Quite a bit)
C91216 (NCI Thesaurus)
C91216 (NCI Thesaurus-2)
CL Item
Very Much (Very much)
C91217 (NCI Thesaurus)
C91217 (NCI Thesaurus-2)
Item
I have to limit my social activity because I am tired
text
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C43431 (NCI Thesaurus Property-2)
C0441655 (UMLS 2011AA Property-2)
C3036 (NCI Thesaurus Property-3)
C0015672 (UMLS 2011AA Property-3)
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ValueDomain-2)
C0518214 (UMLS 2011AA ValueDomain-2)
Code List
I have to limit my social activity because I am tired
CL Item
Not At All (Not at all)
C91213 (NCI Thesaurus)
C91213 (NCI Thesaurus-2)
C70543 (NCI Thesaurus-3)
C2003901 (UMLS 2011AA)
CL Item
A Little Bit (A little bit)
CL Item
Somewhat (Somewhat)
C91215 (NCI Thesaurus)
CL Item
Quite A Bit (Quite a bit)
C91216 (NCI Thesaurus)
C91216 (NCI Thesaurus-2)
CL Item
Very Much (Very much)
C91217 (NCI Thesaurus)
C91217 (NCI Thesaurus-2)

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