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
General information
C1508263 (UMLS CUI-1)
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)
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 (Last, First)
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)
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)
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)
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
Off Treatment Report Period (since 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.3
Code List
Off Treatment Report Period (since registration)
CL Item
3 Months Post Randomization (3 Months Post Randomization)
CL Item
6 Months Post Randomization (6 Months Post Randomization)
CL Item
9 Months Post Randomization (9 Months Post Randomization)
CL Item
12 Months Post Randomization (12 Months Post Randomization)
CL Item
18 Months Post Randomization (18 Months Post Randomization)
CL Item
21 Months Post Randomization (21 Months Post Randomization)
CL Item
24 Months Post Randomization (24 Months Post Randomization)
CL Item
30 Months Post Randomization (30 Months Post Randomization)
CL Item
36 Months Post Randomization (36 Months Post Randomization)
CL Item
42 Months Post Randomization (42 Months Post Randomization)
CL Item
48 Months Post Randomization (48 Months Post Randomization)
CL Item
54 Months Post Randomization (54 Months Post Randomization)
CL Item
60 Months Post Randomization (60 Months Post Randomization)
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
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)
CL.2
Code List
On Treatment Report Period (Maintenance 1 cycle = 3 weeks)
CL Item
Cycle 1 (Cycle 1)
CL Item
Cycle 10 (Cycle 10)
CL Item
Cycle 11 (Cycle 11)
CL Item
Cycle 12 (Cycle 12)
CL Item
Cycle 2 (Cycle 2)
CL Item
Cycle 3 (Cycle 3)
CL Item
Cycle 4 (cycle 4)
CL Item
Cycle 5 (Cycle 5)
CL Item
Cycle 6 (Cycle 6)
CL Item
Cycle 7 (Cycle 7)
CL Item
Cycle 8 (cycle 8)
CL Item
Cycle 9 (Cycle 9)
CL Item
> Cycle 12 (> Cycle 12)
Systolic blood pressure
Item
Systolic
integer
C25209 (NCI Thesaurus ValueDomain)
C25214 (NCI Thesaurus Property)
C25298 (NCI Thesaurus ObjectClass)
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic
integer
C25209 (NCI Thesaurus ValueDomain)
C25214 (NCI Thesaurus Property)
C25299 (NCI Thesaurus ObjectClass)
C0428883 (UMLS CUI [1])
LaboratoryProcedureNotPerformedText
Item
Mark an 'X' if not done (during this reporting period)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Assessment Date
Item
Date of Assessment (most recent)
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
Item
Anti-Hypertensive Drugs
text
C25284 (NCI Thesaurus ValueDomain)
C270 (NCI Thesaurus ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C0003364 (UMLS CUI [1])
CL.4
Code List
Anti-Hypertensive Drugs
CL Item
No Medication Given (No medication given)
C0013227 (UMLS CUI-1)
C0332197 (UMLS CUI-2)
CL Item
Beta Blocker (Beta blockers)
C0001645 (UMLS CUI-1)
CL Item
Diuretic (Diuretics)
C0012798 (UMLS CUI-1)
CL Item
Calcium Channel Blocker (Calcium channel blockers)
C0006684 (UMLS CUI-1)
CL Item
Angiotensin II Receptor Blocker (Angiotensin II inhibitors)
C0521942 (UMLS CUI-1)
CL Item
ACE Inhibitor (ACE inhibitors)
C0003015 (UMLS CUI-1)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS CUI-1)
Antihypertensive Agents
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C270 (NCI Thesaurus ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C0003364 (UMLS CUI [1])
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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