ID

7396

Beschrijving

NSABP-B-47 Treatment Discontinuation Form (Form OFF) A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women With Node- Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=955983BD-6DF9-0939-E040-BB89AD430554

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=955983BD-6DF9-0939-E040-BB89AD430554

Trefwoorden

Versies (2)
  1. 27-08-12 27-08-12 -
  2. 09-01-15 09-01-15 - Martin Dugas
Geüploaded op

9 januari 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT01275677 Off Treatment - NSABP-B-47 Treatment Discontinuation Form (Form OFF) - 3161872v1.0

Engels

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 Formulieren  
Header
Beschrijving

Header

Patient Initials (Last First Middle)
Beschrijving

Patient Initials

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
NSABP Patient ID
Beschrijving

Patient ID NSABP

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1513905
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C15818
Time Point
Beschrijving

Time Point

Time point
Beschrijving

AssessmentPeriodType

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
Header Module
Beschrijving

Header Module

Did the patient begin any protocol drug
Beschrijving

AnyClinicalStudyProtocolTherapyAdministeredInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C81168
UMLS 2011AA ObjectClass-2
C1552551
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Last treatment cycle any protocol drug was given (If yes, TC/AC cycle WP dose)
Beschrijving

LastCycleTherapyAdministeredCount

Datatype

float

Alias
NCI Thesaurus ObjectClass
C25472
UMLS 2011AA ObjectClass
C1511572
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C25551
UMLS 2011AA ObjectClass-2
C1517741
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Agent Name
Beschrijving

Agent

Datatype

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Was this agent ever started
Beschrijving

AgentBeginAdministeredInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25431
UMLS 2011AA Property
C0439659
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Primary reason agent was stopped or never started (Choose from list below)
Beschrijving

NationalSurgicalAdjuvantBreastandBowelProjectTreatmentNotAdministeredReason

Datatype

text

Alias
NCI Thesaurus ObjectClass
C15818
UMLS 2011AA ObjectClass
C1513905
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Header Module
Beschrijving

Header Module

Did the patient receive trastuzumab?
Beschrijving

ImmunotherapyTrastuzumabReceivedInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C1647
UMLS 2011AA Property
C0338204
NCI Thesaurus ObjectClass
C15262
UMLS 2011AA ObjectClass
C0021083
NCI Thesaurus Property-2
C25639
UMLS 2011AA Property-2
C1514756
Last treatment cycle any trastuzumab was given (If yes, any TC cycle Group 2A only WP dose Group 2B only Post-chemotherapy PC dose)
Beschrijving

LastCycleTherapyTrastuzumabAdministeredCount

Datatype

float

Alias
NCI Thesaurus ObjectClass
C25472
UMLS 2011AA ObjectClass
C1511572
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus ObjectClass-3
C25551
UMLS 2011AA ObjectClass-2
C1517741
NCI Thesaurus Property
C1647
UMLS 2011AA Property
C0338204
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Primary reason agent was stopped or never started (Choose from list below)
Beschrijving

NationalSurgicalAdjuvantBreastandBowelProjectTreatmentNotAdministeredReason

Datatype

text

Alias
NCI Thesaurus ObjectClass
C15818
UMLS 2011AA ObjectClass
C1513905
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Footer
Beschrijving

Footer

Comments (optional)
Beschrijving

Research Comments

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Person Completing Form
Beschrijving

Person Completing Form

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date Form Completed (MM DD YYYY)
Beschrijving

Date Form Completed

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367
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Similar models

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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