This paper worksheet may be completed to facilitate the entry of the information in NSABP Coordinator Online. Partially completed online forms may be saved in Coordinator Online. DO NOT SUBMIT THIS WORKSHEET VIA FAX OR MAIL. Submit the Form OFF when any of the following conditions apply: When it is confirmed that the patient will NOT begin any study drugs. When the patient permanently discontinues or completes all of the study drugs during chemotherapy. Groups 2A and 2B only: When the patient permanently discontinues or completes trastuzumab

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
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)
Item Group
Time Point
Item
Time point
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
CL.1
Code List
Time point
CL Item
Chemotherapy (Chemotherapy)
C15632 (NCI Thesaurus)
C0392920 (UMLS 2011AA)
CL Item
Trastuzumab (Trastuzumab)
C1647 (NCI Thesaurus)
C0338204 (UMLS 2011AA)
Item Group
Header Module
AnyClinicalStudyProtocolTherapyAdministeredInd-2
Item
Did the patient begin any protocol drug
boolean
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C81168 (NCI Thesaurus ObjectClass-3)
C1552551 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
LastCycleTherapyAdministeredCount
Item
Last treatment cycle any protocol drug was given (If yes, TC/AC cycle WP dose)
float
C25472 (NCI Thesaurus ObjectClass)
C1511572 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25551 (NCI Thesaurus ObjectClass-3)
C1517741 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
Agent
Item
Agent Name
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
AgentBeginAdministeredInd-2
Item
Was this agent ever started
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
Item
Primary reason agent was stopped or never started (Choose from list below)
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)
CL.6
Code List
Primary reason agent was stopped or never started (Choose from list below)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
CL Item
Protocol-specified Toxicity/adverse Event (Protocol-specified toxicity/adverse event)
CL Item
Non-protocol-specified Toxicity/adverse Event (Non-protocol-specified toxicity/adverse event)
CL Item
Patient Withdrawal Or Refusal (Patient withdrawal or refusal)
CL Item
Physician Withdrawal (Physician withdrawal)
CL Item
Recurrence Or Second Primary Cancer (Recurrence or second primary cancer)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death (Death)
C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item Group
Header Module
ImmunotherapyTrastuzumabReceivedInd-2
Item
Did the patient receive trastuzumab?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C1647 (NCI Thesaurus Property)
C0338204 (UMLS 2011AA Property)
C15262 (NCI Thesaurus ObjectClass)
C0021083 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
LastCycleTherapyTrastuzumabAdministeredCount
Item
Last treatment cycle any trastuzumab was given (If yes, any TC cycle Group 2A only WP dose Group 2B only Post-chemotherapy PC dose)
float
C25472 (NCI Thesaurus ObjectClass)
C1511572 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25551 (NCI Thesaurus ObjectClass-3)
C1517741 (UMLS 2011AA ObjectClass-2)
C1647 (NCI Thesaurus Property)
C0338204 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
Item
Primary reason agent was stopped or never started (Choose from list below)
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)
CL.6
Code List
Primary reason agent was stopped or never started (Choose from list below)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
CL Item
Protocol-specified Toxicity/adverse Event (Protocol-specified toxicity/adverse event)
CL Item
Non-protocol-specified Toxicity/adverse Event (Non-protocol-specified toxicity/adverse event)
CL Item
Patient Withdrawal Or Refusal (Patient withdrawal or refusal)
CL Item
Physician Withdrawal (Physician withdrawal)
CL Item
Recurrence Or Second Primary Cancer (Recurrence or second primary cancer)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death (Death)
C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item Group
Footer
Research Comments
Item
Comments (optional)
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Person Completing Form
Item
Person Completing Form
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
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