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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
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
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
Off protocol treatment period
Item
Off Treatment Report Period (since initial registration)
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)
CL.1
Code List
Off Treatment Report Period (since initial registration)
CL Item
3 Months (3 Months Post Registration)
CL Item
6 Months (6 Months Post Registration)
CL Item
9 Months (9 Months Post Registration)
CL Item
12 Months (12 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
2 Years (24 Months Post Registration)
CL Item
30 Months (30 Months Post Registration)
CL Item
3 Years (36 Months Post Registration)
CL Item
42 Months (42 Months Post Registration)
CL Item
4 Years (48 Months Post Registration)
CL Item
54 Months (54 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
8 Years (96 Months Post-Registration)
CL Item
9 Years (108 Months Post-Registration)
CL Item
10 Years (120 Months Post-Registration)
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
Vital Status
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.2
Code List
Patient Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
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
Primary Cause of Death (if applicable)
text
C25638 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C28554 (NCI Thesaurus Property)
C25251 (NCI Thesaurus ValueDomain-2)
CL.3
Code List
Primary Cause of Death (if applicable)
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)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
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
Section II - Reporting Period
Reporting Period Start Date
Item
Reporting Period Start Date
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Reporting Period End Date
Item
Reporting Period End Date
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
Item Group
Notice Of New Primary (including Second Colon Primary)
Item
Has a new primary cancer or MDS been diagnosed that has not been previously reported (MDS)
text
C25180 (NCI Thesaurus ValueDomain)
C0751623 (UMLS CUI-1)
C25586 (NCI Thesaurus ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C15220 (NCI Thesaurus Property)
CL.4
Code List
Has a new primary cancer or MDS been diagnosed that has not been previously reported (MDS)
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)
NewCancerSiteText
Item
Site of New Primary (s)
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
Section V - Last Cycle Of Protocol Therapy
HeartMUGATestInd-3
Item
Was a MUGA performed (this reporting period?)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C38073 (NCI Thesaurus Property)
C0521317 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
HeartMUGATestDate
Item
Date of assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C38073 (NCI Thesaurus Property)
C0521317 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
HeartEchocardiogramTestInd-3
Item
Was an Echocardiogram (ECHO) performed (this reporting period?)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C37945 (NCI Thesaurus Property)
C2243117 (UMLS 2011AA Property)
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
EchocardiogramDate
Item
Date of assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C37945 (NCI Thesaurus ObjectClass)
C2243117 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
HeartLVEFTestPercentageValue
Item
Left Ventricular Ejection Fraction at Rest
float
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property-2)
C2700377 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
HeartLVEFTestPercentageValue
Item
Left Ventricular Ejection Fraction at Rest
float
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property-2)
C2700377 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
HeartLVEFTestPercentageLowerLimitofNormalValue
Item
LVEF Institutional Lower Limit of Normal
float
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property-2)
C2700377 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
C1518030 (UMLS 2011AA ValueDomain-3)
HeartLVEFTestPercentageLowerLimitofNormalValue
Item
LVEF Institutional Lower Limit of Normal
float
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property-2)
C2700377 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
C1518030 (UMLS 2011AA ValueDomain-3)
Item Group
Disease Follow-up Status
Item
Has the patient had a documented clinical assessment for this cancer (this reporting period)
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.7
Code List
Has the patient had a documented clinical assessment for this cancer (this reporting period)
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
Adverse Events
Item
Has the patient experienced any severe long term toxicity that has not been previously reported (prior to diagnosis of recurrence Grade >4 hematologic, Grade >3 non-hematologic NOTE: Do not report adverse events occurring after start of non-protocol therapy.)
text
C19778 (NCI Thesaurus ObjectClass)
C1514695 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass-2)
C0877248 (UMLS 2011AA ObjectClass-2)
C18265 (NCI Thesaurus Property)
C25375 (NCI Thesaurus Property-2)
C0684224 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.8
Code List
Has the patient experienced any severe long term toxicity that has not been previously reported (prior to diagnosis of recurrence Grade >4 hematologic, Grade >3 non-hematologic NOTE: Do not report adverse events occurring after start of non-protocol therapy.)
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
Has the patient received any non-protocol cancer therapy prior to first recurrence (not previously reported)
text
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C3352 (NCI Thesaurus Property)
C0034897 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.9
Code List
Has the patient received any non-protocol cancer therapy prior to first recurrence (not previously reported)
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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