Submit this form when protocol treatment has ended in a Group 2 patient, or when it is certain patient will not receive protocol therapy

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header module
Patient Initials
Item
Patient Initials (Last First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient ID NSABP
Item
NSABP Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1513905 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C15818 (NCI Thesaurus Property-2)
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Affiliate Name
Item
Affiliate Name
text
C21541 (NCI Thesaurus ObjectClass)
C1510825 (UMLS CUI-1)
C25413 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Person Completing Form Last Name
Item
Person Completing Form Last Name
text
C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1301584 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)
Person Completing Form First Name
Item
Person Completing Form First Name
text
C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1443235 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)
Person Completing Form Phone
Item
Person Completing Form Phone
text
C25337 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C1515258 (UMLS CUI-2)
C25657 (NCI Thesaurus ObjectClass-2)
C25395 (NCI Thesaurus Property)
Total number of cycles
Item
Total Number of Cycles Given (0, 1, 2, 3, 4, 5, 6, 7, 8)
float
C25304 (NCI Thesaurus Property)
C2045831 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C25379 (NCI Thesaurus Property-2)
Treatment End Date
Item
Treatment End Date (last dose of last cycle Leave blank if treatment was not begun)
date
C25164 (NCI Thesaurus ValueDomain)
C1531784 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C25496 (NCI Thesaurus Property-2)
Data amended
Item
Are data amended (Check box if yes, and circle amended items)
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Patient Height
Item
Patient Height (cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
Item Group
Assessment of Chemotherapy
Cycle Number
Item
Cycle Number
integer
C25337 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
Chemotherapy Cycle Start Date
Item
Cycle Start Date (*)
date
C25164 (NCI Thesaurus ValueDomain)
C1302181 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ValueDomain-2)
C3173309 (UMLS CUI-2)
C25379 (NCI Thesaurus Property)
Patient Weight
Item
Patient Weight (If unknown, leave boxes blank)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Agent
Item
Agent Name (total mg)
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Agent Total Dose
Item
Agent Total Dose (on each cycle)
float
C25304 (NCI Thesaurus ValueDomain)
C2986497 (UMLS CUI-1)
C25379 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
ProtocolAgentNotCompleteAdministrationAdverseEventInd-2
Item
Was less than full dose administered because of toxicity?
boolean
C41161 (NCI Thesaurus ObjectClass)
C1521826 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25594 (NCI Thesaurus Property-2)
C1518422 (UMLS 2011AA Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ValueDomain-2)
C0877248 (UMLS 2011AA ValueDomain-2)
Item
Why did treatment end or not begin (CAPECITABINE Select primary reason)
text
C15818 (NCI Thesaurus ObjectClass)
C1513905 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
Code List
Why did treatment end or not begin (CAPECITABINE Select primary reason)
CL Item
Adverse Event/side Effects/complications (Adverse event/side effects/complications)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death, Recurrence, Or Second Primary Cancer (Death, recurrence, or second primary cancer)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Withdrawal Or Refusal (Patient withdrawal or refusal)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item
Why did treatment end or not begin (CAPECITABINE Select primary reason)
text
C15818 (NCI Thesaurus ObjectClass)
C1513905 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
Code List
Why did treatment end or not begin (CAPECITABINE Select primary reason)
CL Item
Adverse Event/side Effects/complications (Adverse event/side effects/complications)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death, Recurrence, Or Second Primary Cancer (Death, recurrence, or second primary cancer)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Withdrawal Or Refusal (Patient withdrawal or refusal)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item
Why did treatment end or not begin (CAPECITABINE Select primary reason)
text
C15818 (NCI Thesaurus ObjectClass)
C1513905 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
Code List
Why did treatment end or not begin (CAPECITABINE Select primary reason)
CL Item
Adverse Event/side Effects/complications (Adverse event/side effects/complications)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death, Recurrence, Or Second Primary Cancer (Death, recurrence, or second primary cancer)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Withdrawal Or Refusal (Patient withdrawal or refusal)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
Item Group
Treatment Group 2. Complications Related To Hai Catheter Or Pump
IntrahepaticInfusionProcedureCatheterPumpComplicationInd-2
Item
Were there any complications related to the HAI catheter or pump (complete table per specifications)
boolean
C15731 (NCI Thesaurus ObjectClass)
C1134564 (UMLS 2011AA ObjectClass)
C17446 (NCI Thesaurus Property)
C0085590 (UMLS 2011AA Property)
C2959 (NCI Thesaurus Property-2)
C0009566 (UMLS 2011AA Property-2)
C17625 (NCI Thesaurus Property-3)
C0182537 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
IntrahepaticInfusionProcedurePumpDefectComplicationInd-2
Item
Pump Malfunction (if yes, complete this row)
boolean
C15731 (NCI Thesaurus ObjectClass)
C1134564 (UMLS 2011AA ObjectClass)
C2959 (NCI Thesaurus Property)
C0009566 (UMLS 2011AA Property)
C43429 (NCI Thesaurus Property-2)
C1457869 (UMLS 2011AA Property-2)
C17625 (NCI Thesaurus Property-3)
C0182537 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
IntrahepaticInfusionProcedureCatheterOcclusionComplicationInd-2
Item
Catheter Occlusion (if yes, complete this row)
boolean
C15731 (NCI Thesaurus ObjectClass)
C1134564 (UMLS 2011AA ObjectClass)
C17446 (NCI Thesaurus Property)
C0085590 (UMLS 2011AA Property)
C2959 (NCI Thesaurus Property-2)
C0009566 (UMLS 2011AA Property-2)
C50678 (NCI Thesaurus Property-3)
C1947917 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
IntrahepaticInfusionProcedurePerfusionDefectComplicationInd-2
Item
Misperfusion (if yes, complete this row)
boolean
C15731 (NCI Thesaurus ObjectClass)
C1134564 (UMLS 2011AA ObjectClass)
C2959 (NCI Thesaurus Property)
C0009566 (UMLS 2011AA Property)
C43429 (NCI Thesaurus Property-2)
C1457869 (UMLS 2011AA Property-2)
C15295 (NCI Thesaurus Property-3)
C0031001 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
IntrahepaticInfusionProcedureActiveHemorrhageComplicationInd-2
Item
Bleeding (if yes, complete this row)
boolean
C15731 (NCI Thesaurus ObjectClass)
C1134564 (UMLS 2011AA ObjectClass)
C26791 (NCI Thesaurus Property)
C0019080 (UMLS 2011AA Property)
C45329 (NCI Thesaurus Property-2)
C0205177 (UMLS 2011AA Property-2)
C2959 (NCI Thesaurus Property-3)
C0009566 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
IntrahepaticInfusionProcedureInfectionComplicationInd-2
Item
Infection (if yes, complete this row)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C15731 (NCI Thesaurus ObjectClass)
C1134564 (UMLS 2011AA ObjectClass)
C2959 (NCI Thesaurus Property-2)
C0009566 (UMLS 2011AA Property-2)
IntrahepaticInfusionProcedureOtherComplicationInd-2
Item
Other (if yes, complete this row)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C15731 (NCI Thesaurus ObjectClass)
C1134564 (UMLS 2011AA ObjectClass)
C2959 (NCI Thesaurus Property-2)
C0009566 (UMLS 2011AA Property-2)
IntrahepaticInfusionProcedureOtherComplicationSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C15731 (NCI Thesaurus ObjectClass)
C1134564 (UMLS 2011AA ObjectClass)
C2959 (NCI Thesaurus Property-2)
C0009566 (UMLS 2011AA Property-2)
Item
Cycle Number (Mark all that apply)
text
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
Code List
Cycle Number (Mark all that apply)
CL Item
1 (1)
CL Item
2 (2)
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5-8 (5-8)
Item
Management of Complication (Mark all that apply)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15731 (NCI Thesaurus ObjectClass)
C1134564 (UMLS 2011AA ObjectClass)
C2959 (NCI Thesaurus Property)
C0009566 (UMLS 2011AA Property)
C61372 (NCI Thesaurus Property-2)
C1273870 (UMLS 2011AA Property-2)
Code List
Management of Complication (Mark all that apply)
CL Item
Removal Of Catheter/pump (Removal of catheter/pump)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
IntrahepaticInfusionProcedureManagementComplicationSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15731 (NCI Thesaurus ObjectClass)
C1134564 (UMLS 2011AA ObjectClass)
C2959 (NCI Thesaurus Property)
C0009566 (UMLS 2011AA Property)
C61372 (NCI Thesaurus Property-2)
C1273870 (UMLS 2011AA Property-2)

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