ID

6689

Beschrijving

S1007 Treatment Form (TX1007) Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=90CA1C57-43D2-A228-E040-BB89AD43458D

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=90CA1C57-43D2-A228-E040-BB89AD43458D

Trefwoorden

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

8 januari 2015

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0 Legacy
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Breast Cancer NCT01272037 Treatment - S1007 Treatment Form (TX1007) - 3140038v1.0

Engels

Instructions: Please complete this form at 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 4 years, and 5 years after randomization. All dates are MONTH, DAY, YEAR. Explain any blank dates or fields in a Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across the top of the form

1 Formulieren  
Header
Beschrijving

Header

SWOG Patient ID
Beschrijving

Trial subject ID SWOG

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1519429
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25699
SWOG Study No.
Beschrijving

Protocol ID SWOG

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1519429
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25699
Registration Step
Beschrijving

Registration Number

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Patient Initials (L, F M)
Beschrijving

Patient Initials

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Reporting Period
Beschrijving

Clinical Trial Period

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2347804
NCI Thesaurus ObjectClass
C25214
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass-2
C25651
Institution/Affiliate
Beschrijving

Institution Name

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Physician
Beschrijving

Investigator Name

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2826892
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C17089
NCI Thesaurus ObjectClass-2
C25644
Participating Group Name
Beschrijving

Participating Group

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Participating Group Study No.
Beschrijving

Study Number Participating Group

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Patient ID
Beschrijving

Trial subject ID Participating Group

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Status
Beschrijving

Status

Vital Status
Beschrijving

Patient Status

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C3846084
NCI Thesaurus ValueDomain
C18003
NCI Thesaurus ValueDomain-2
C25688
NCI Thesaurus Property
C25717
Date of Last Contact or Death (MM DD YYYY)
Beschrijving

Date last contact

Datatype

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C0805839
NCI Thesaurus Property
C25461
NCI Thesaurus Property-2
C25551
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Has the patient progressed per the definition in Section 10.0 of the protocol
Beschrijving

Tumor Progression

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0178874
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25320
NCI Thesaurus Property-2
C19987
Treatment For This Cycle
Beschrijving

Treatment For This Cycle

Assigned Treatment Arm
Beschrijving

Protocol Treatment Arm

Datatype

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C42651
UMLS CUI-1
C1522541
NCI Thesaurus Property
C32141
NCI Thesaurus Property-2
C25426
NCI Thesaurus ValueDomain
C25284
Was the patient treated on the assigned arm during this reporting period
Beschrijving

ProtocolTreatmentArmAssignmentInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C42651
UMLS 2011AA ObjectClass
C0442711
NCI Thesaurus Property
C32141
UMLS 2011AA Property
C1140618
NCI Thesaurus Property-2
C25426
UMLS 2011AA Property-2
C1516050
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Reporting Period Start Date (MM DD YYYY)
Beschrijving

Reporting Period Start Date

Datatype

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25616
UMLS CUI-1
C2361257
NCI Thesaurus Property-2
C25651
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Reporting Period End Date (MM DD YYYY)
Beschrijving

Reporting Period End Date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2361259
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25651
Weight (kg)
Beschrijving

Patient Weight

Datatype

float

Maateenheden
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Has the patient received any chemotherapy during this reporting period?
Beschrijving

ChemotherapyAdministeredInd

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Section Iv - Treatment
Beschrijving

Section Iv - Treatment

Has the patient received any endocrine therapy during this reporting period
Beschrijving

HormoneTherapyReportPeriodAdministeredInd-3

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25375
UMLS 2011AA Property-2
C0684224
NCI Thesaurus Property-3
C25382
UMLS 2011AA Property-3
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Did patient switch type of endocrine therapy during this reporting period
Beschrijving

AdjuvantHormoneTherapyChangeInd-3

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25446
UMLS 2011AA Property
C0392747
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
Specify reason for switch in endocrine therapy (If yes)
Beschrijving

AdjuvantHormoneTherapyChangeReason

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25446
UMLS 2011AA Property
C0392747
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
Other, specify
Beschrijving

AdjuvantHormoneTherapyChangeSpecify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25446
UMLS 2011AA Property
C0392747
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
Start date of new endocrine therapy (MM DD YYYY)
Beschrijving

NewAdjuvantHormoneTherapyAdministeredDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass-2
C15445
UMLS 2011AA ObjectClass-2
C0279025
NCI Thesaurus ObjectClass-3
C2140
UMLS 2011AA ObjectClass-3
C0001552
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Specify new type of endocrine therapy given
Beschrijving

AdjuvantHormoneTherapyChangeType

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25446
UMLS 2011AA Property
C0392747
NCI Thesaurus ObjectClass-2
C2140
UMLS 2011AA ObjectClass-2
C0001552
Other, specify
Beschrijving

NewAdjuvantHormoneTherapyAdministeredSpecify

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass-2
C15445
UMLS 2011AA ObjectClass-2
C0279025
NCI Thesaurus ObjectClass-3
C2140
UMLS 2011AA ObjectClass-3
C0001552
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Specify which Aromatase Inhibitor was given (If Aromatase Inhibitor)
Beschrijving

AdjuvantAromataseInhibitorHormoneTherapyChangeType

Datatype

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C1740
UMLS 2011AA ObjectClass-2
C0593802
NCI Thesaurus ObjectClass-3
C2140
UMLS 2011AA ObjectClass-3
C0001552
NCI Thesaurus Property
C25446
UMLS 2011AA Property
C0392747
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other, specify
Beschrijving

AdjuvantAromataseInhibitorHormoneTherapyChangeSpecify

Datatype

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C1740
UMLS 2011AA ObjectClass-2
C0593802
NCI Thesaurus ObjectClass-3
C2140
UMLS 2011AA ObjectClass-3
C0001552
NCI Thesaurus Property
C25446
UMLS 2011AA Property
C0392747
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Tamoxifen (If no, Answer Yes or No for each of the following therapies the patient consistently took during this reporting period)
Beschrijving

HormoneTherapyTamoxifenReceivedInd-3

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C855
UMLS 2011AA Property
C0039286
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property-2
C25639
UMLS 2011AA Property-2
C1514756
Aromatase Inhibitor (If no, Answer Yes or No for each of the following therapies the patient consistently took during this reporting period)
Beschrijving

AromataseInhibitorReceivedInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ObjectClass
C1740
UMLS 2011AA ObjectClass
C0593802
Specify which Aromatase Inhibitor was given
Beschrijving

AromataseInhibitorReceivedType

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ObjectClass
C1740
UMLS 2011AA ObjectClass
C0593802
Specify
Beschrijving

AromataseInhibitorReceivedSpecify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ObjectClass
C1740
UMLS 2011AA ObjectClass
C0593802
Other
Beschrijving

HormoneTherapyOtherReceivedInd-3

Datatype

boolean

Alias
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property-2
C25639
UMLS 2011AA Property-2
C1514756
Specify (If yes,)
Beschrijving

HormoneTherapyOtherReceivedSpecify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property-2
C25639
UMLS 2011AA Property-2
C1514756
If the patient was premenopausal at registration, is she currently having regular menstrual periods
Beschrijving

MenstrualCycleAssessmentInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C16838
UMLS 2011AA ObjectClass
C0025329
Did patient receive Ovarian Function Suppression (OFS) during this reporting period
Beschrijving

OvarianAntiestrogenHormoneTherapyAdministeredInd-3

Datatype

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C15757
UMLS 2011AA ObjectClass-2
C0854638
NCI Thesaurus ObjectClass-3
C28047
UMLS 2011AA ObjectClass-3
C0205065
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Ovarian Function Suppression Type (If yes)
Beschrijving

OvarianAntiestrogenHormoneTherapyAdministeredType

Datatype

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C15757
UMLS 2011AA ObjectClass-2
C0854638
NCI Thesaurus ObjectClass-3
C28047
UMLS 2011AA ObjectClass-3
C0205065
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other, specify
Beschrijving

OvarianAntiestrogenHormoneTherapyAdministeredSpecify

Datatype

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C15757
UMLS 2011AA ObjectClass-2
C0854638
NCI Thesaurus ObjectClass-3
C28047
UMLS 2011AA ObjectClass-3
C0205065
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Was all endocrine therapy discontinued this reporting period
Beschrijving

HormoneTherapyDiscontinuedInd-2

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
Date any endocrine therapy last given (If yes MM DD YYYY)
Beschrijving

HormoneTherapyLastAdministeredDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25551
UMLS 2011AA Property
C1517741
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Concurrent Medications/clinical Trials
Beschrijving

Concurrent Medications/clinical Trials

Did the patient receive bisphosphonates during this reporting period (select all that apply)
Beschrijving

Bisphosphonates type

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C0012544
NCI Thesaurus ObjectClass
C443
UMLS CUI-2
C0683312
NCI Thesaurus ObjectClass-2
C37902
NCI Thesaurus Property
C25382
Is the patient currently co-enrolled on another CTEP or NCI-sponsored clinical trial for breast cancer
Beschrijving

OtherClinicalTrialsCooperativeGroupPatientEnrollmentInd-2

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C17649
UMLS 2011AA ObjectClass
C0205394
NCI Thesaurus ObjectClass-2
C16960
UMLS 2011AA ObjectClass-2
C0030705
NCI Thesaurus ObjectClass-3
C18205
UMLS 2011AA ObjectClass-3
C1521808
NCI Thesaurus Property
C37948
UMLS 2011AA Property
C1516879
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Specify
Beschrijving

OtherStudyEnrollmentSpecify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15206
UMLS 2011AA ObjectClass
C0008972
NCI Thesaurus Property
C37948
UMLS 2011AA Property
C1516879
Date of enrollment (MM DD YYYY)
Beschrijving

PatientEnrollmentDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
Comments
Beschrijving

Comments

Comments
Beschrijving

Research Comments

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Terug naar het begin van de pagina

Similar models

Instructions: Please complete this form at 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 4 years, and 5 years after randomization. All dates are MONTH, DAY, YEAR. Explain any blank dates or fields in a Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across the top of the form

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Header
Trial subject ID SWOG
Item
SWOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
Protocol ID SWOG
Item
SWOG Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-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 (L, F M)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Item
Reporting Period
text
C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)
CL.1
Code List
Reporting Period
CL Item
6 Months (6 months)
CL Item
12 Months (12 months)
CL Item
18 Months (18 months)
CL Item
24 Months (24 months)
CL Item
30 Months (30 months)
CL Item
36 Months (36 months)
CL Item
48 Months (48 months)
CL Item
60 Months (60 months)
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)
Investigator Name
Item
Physician
text
C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)
Participating Group
Item
Participating Group Name
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Study No.
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)
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
Status
Item
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
Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Date last contact
Item
Date of Last Contact or Death (MM DD YYYY)
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)
Tumor Progression
Item
Has the patient progressed per the definition in Section 10.0 of the protocol
boolean
C38147 (NCI Thesaurus ValueDomain)
C0178874 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25320 (NCI Thesaurus Property)
C19987 (NCI Thesaurus Property-2)
Item Group
Treatment For This Cycle
Item
Assigned Treatment Arm
text
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass-2)
C1522541 (UMLS CUI-1)
C32141 (NCI Thesaurus Property)
C25426 (NCI Thesaurus Property-2)
C25284 (NCI Thesaurus ValueDomain)
CL.4
Code List
Assigned Treatment Arm
CL Item
Arm 1: Chemotherapy + Endocrine Therapy (Arm 1: Chemotherapy + endocrine therapy)
CL Item
Arm 2: Endocrine Therapy Only (Arm 2: Endocrine therapy only)
ProtocolTreatmentArmAssignmentInd-2
Item
Was the patient treated on the assigned arm during this reporting period
boolean
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass-2)
C0442711 (UMLS 2011AA ObjectClass)
C32141 (NCI Thesaurus Property)
C1140618 (UMLS 2011AA Property)
C25426 (NCI Thesaurus Property-2)
C1516050 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Reporting Period Start Date
Item
Reporting Period Start Date (MM DD YYYY)
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 (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
Patient Weight
Item
Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Item
Has the patient received any chemotherapy during this reporting period?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.6
Code List
Has the patient received any chemotherapy during this reporting period?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Chemotherapy Continuing (Yes, chemotherapy continuing)
CL Item
Yes, Chemotherapy Completed (Yes, chemotherapy completed)
Item Group
Section Iv - Treatment
HormoneTherapyReportPeriodAdministeredInd-3
Item
Has the patient received any endocrine therapy during this reporting period
boolean
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25375 (NCI Thesaurus Property-2)
C0684224 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
AdjuvantHormoneTherapyChangeInd-3
Item
Did patient switch type of endocrine therapy during this reporting period
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25446 (NCI Thesaurus Property)
C0392747 (UMLS 2011AA Property)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
Item
Specify reason for switch in endocrine therapy (If yes)
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25446 (NCI Thesaurus Property)
C0392747 (UMLS 2011AA Property)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
CL.9
Code List
Specify reason for switch in endocrine therapy (If yes)
CL Item
Planned Switch For Therapeutic Reason (Planned switch for therapeutic reason)
CL Item
Adverse Events From Prior Endocrine Therapy (Adverse events from prior endocrine therapy)
CL Item
Both Planned Switch For Therapeutic Reason And For Adverse Events From Prior Hormonal Therapy (Both)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
AdjuvantHormoneTherapyChangeSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25446 (NCI Thesaurus Property)
C0392747 (UMLS 2011AA Property)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
NewAdjuvantHormoneTherapyAdministeredDate
Item
Start date of new endocrine therapy (MM DD YYYY)
date
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus ObjectClass-2)
C0279025 (UMLS 2011AA ObjectClass-2)
C2140 (NCI Thesaurus ObjectClass-3)
C0001552 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Specify new type of endocrine therapy given
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25446 (NCI Thesaurus Property)
C0392747 (UMLS 2011AA Property)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
CL.10
Code List
Specify new type of endocrine therapy given
CL Item
Tamoxifen (Tamoxifen)
C855 (NCI Thesaurus)
C0039286 (UMLS 2011AA)
CL Item
Aromatase Inhibitor (Aromatase Inhibitor)
C1740 (NCI Thesaurus)
C0593802 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
NewAdjuvantHormoneTherapyAdministeredSpecify
Item
Other, specify
text
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus ObjectClass-2)
C0279025 (UMLS 2011AA ObjectClass-2)
C2140 (NCI Thesaurus ObjectClass-3)
C0001552 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Specify which Aromatase Inhibitor was given (If Aromatase Inhibitor)
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C1740 (NCI Thesaurus ObjectClass-2)
C0593802 (UMLS 2011AA ObjectClass-2)
C2140 (NCI Thesaurus ObjectClass-3)
C0001552 (UMLS 2011AA ObjectClass-3)
C25446 (NCI Thesaurus Property)
C0392747 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.11
Code List
Specify which Aromatase Inhibitor was given (If Aromatase Inhibitor)
CL Item
Anastrozole (ANASTROZOLE)
C1607 (NCI Thesaurus)
C0290882 (UMLS 2011AA)
CL Item
Letrozole (LETROZOLE)
C1527 (NCI Thesaurus)
C0246421 (UMLS 2011AA)
CL Item
Exemestane (EXEMESTANE)
C1097 (NCI Thesaurus)
C0060116 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
AdjuvantAromataseInhibitorHormoneTherapyChangeSpecify
Item
Other, specify
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C1740 (NCI Thesaurus ObjectClass-2)
C0593802 (UMLS 2011AA ObjectClass-2)
C2140 (NCI Thesaurus ObjectClass-3)
C0001552 (UMLS 2011AA ObjectClass-3)
C25446 (NCI Thesaurus Property)
C0392747 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
HormoneTherapyTamoxifenReceivedInd-3
Item
Tamoxifen (If no, Answer Yes or No for each of the following therapies the patient consistently took during this reporting period)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C855 (NCI Thesaurus Property)
C0039286 (UMLS 2011AA Property)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
AromataseInhibitorReceivedInd-2
Item
Aromatase Inhibitor (If no, Answer Yes or No for each of the following therapies the patient consistently took during this reporting period)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C1740 (NCI Thesaurus ObjectClass)
C0593802 (UMLS 2011AA ObjectClass)
Item
Specify which Aromatase Inhibitor was given
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C1740 (NCI Thesaurus ObjectClass)
C0593802 (UMLS 2011AA ObjectClass)
CL.14
Code List
Specify which Aromatase Inhibitor was given
CL Item
Anastrozole (ANASTROZOLE)
C1607 (NCI Thesaurus)
C0290882 (UMLS 2011AA)
CL Item
Letrozole (LETROZOLE)
C1527 (NCI Thesaurus)
C0246421 (UMLS 2011AA)
CL Item
Exemestane (EXEMESTANE)
C1097 (NCI Thesaurus)
C0060116 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
AromataseInhibitorReceivedSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C1740 (NCI Thesaurus ObjectClass)
C0593802 (UMLS 2011AA ObjectClass)
HormoneTherapyOtherReceivedInd-3
Item
Other
boolean
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
HormoneTherapyOtherReceivedSpecify
Item
Specify (If yes,)
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property-2)
C1514756 (UMLS 2011AA Property-2)
MenstrualCycleAssessmentInd-2
Item
If the patient was premenopausal at registration, is she currently having regular menstrual periods
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C16838 (NCI Thesaurus ObjectClass)
C0025329 (UMLS 2011AA ObjectClass)
Item
Did patient receive Ovarian Function Suppression (OFS) during this reporting period
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C15757 (NCI Thesaurus ObjectClass-2)
C0854638 (UMLS 2011AA ObjectClass-2)
C28047 (NCI Thesaurus ObjectClass-3)
C0205065 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.17
Code List
Did patient receive Ovarian Function Suppression (OFS) during 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)
Item
Ovarian Function Suppression Type (If yes)
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C15757 (NCI Thesaurus ObjectClass-2)
C0854638 (UMLS 2011AA ObjectClass-2)
C28047 (NCI Thesaurus ObjectClass-3)
C0205065 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.18
Code List
Ovarian Function Suppression Type (If yes)
CL Item
Radiation Therapy (Ovarian radiation)
C15313 (NCI Thesaurus)
C1522449 (UMLS 2011AA)
CL Item
Bilateral Surgical Oophorectomy (Oophorectomy)
CL Item
Medical Suppression Of Ovarian Function (Medical suppression)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
OvarianAntiestrogenHormoneTherapyAdministeredSpecify
Item
Other, specify
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C15757 (NCI Thesaurus ObjectClass-2)
C0854638 (UMLS 2011AA ObjectClass-2)
C28047 (NCI Thesaurus ObjectClass-3)
C0205065 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
HormoneTherapyDiscontinuedInd-2
Item
Was all endocrine therapy discontinued this reporting period
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
HormoneTherapyLastAdministeredDate
Item
Date any endocrine therapy last given (If yes MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
Item Group
Concurrent Medications/clinical Trials
Item
Did the patient receive bisphosphonates during this reporting period (select all that apply)
text
C25284 (NCI Thesaurus ValueDomain)
C0012544 (UMLS CUI-1)
C443 (NCI Thesaurus ObjectClass)
C0683312 (UMLS CUI-2)
C37902 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
CL.20
Code List
Did the patient receive bisphosphonates during this reporting period (select all that apply)
CL Item
Bisphosphonates For Prevention Of Bone Loss (Bisphosphonates for prevention of bone loss)
CL Item
Bisphosphonates For Breast Cancer Treatment (Bisphosphonates for breast cancer treatment)
OtherClinicalTrialsCooperativeGroupPatientEnrollmentInd-2
Item
Is the patient currently co-enrolled on another CTEP or NCI-sponsored clinical trial for breast cancer
boolean
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus ObjectClass-2)
C0030705 (UMLS 2011AA ObjectClass-2)
C18205 (NCI Thesaurus ObjectClass-3)
C1521808 (UMLS 2011AA ObjectClass-3)
C37948 (NCI Thesaurus Property)
C1516879 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
OtherStudyEnrollmentSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15206 (NCI Thesaurus ObjectClass)
C0008972 (UMLS 2011AA ObjectClass)
C37948 (NCI Thesaurus Property)
C1516879 (UMLS 2011AA Property)
PatientEnrollmentDate
Item
Date of enrollment (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial