ID

7317

Description

S1007 Off-Protocol Notice Form - Step 1 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=90DE3C1B-9D8D-FBC6-E040-BB89AD4313C7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=90DE3C1B-9D8D-FBC6-E040-BB89AD4313C7

Keywords

Versions (2)
  1. 8/27/12 8/27/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

January 9, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT01272037 Off Treatment - S1007 Off-Protocol Notice Form - Step 1 - 3141184v1.0

English

Instructions: Submit this form if the patient will not continue on study and register to Step 2, within 2 weeks after the decision not to proceed. All dates are MONTH, DAY, YEAR. Explain any blank fields or blank dates in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED at the top of the form

1 forms  
Header
Description

Header

SWOG Patient ID
Description

Trial subject ID SWOG

Data type

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.
Description

Protocol ID SWOG

Data type

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
Description

Registration Number

Data type

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)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Institution/Affiliate
Description

Institution Name

Data type

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
Description

Investigator Name

Data type

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
Description

Participating Group

Data type

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.
Description

Study Number Participating Group

Data type

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
Description

Trial subject ID Participating Group

Data type

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
Oncotype Dx Recurrence Score
Description

Oncotype Dx Recurrence Score

Was the Oncotype DX Recurrence Score obtained
Description

LaboratoryProcedureOncotypeDXBreastCancerAssayResultIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C52159
UMLS 2011AA Property-2
C1709318
Oncotype DX Recurrence Score
Description

LaboratoryProcedureOncotypeDXBreastCancerAssayResultScore

Data type

float

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C52159
UMLS 2011AA Property-2
C1709318
NCI Thesaurus ValueDomain
C25338
UMLS 2011AA ValueDomain
C0449820
Oncotype DX ER Score
Description

LaboratoryProcedureOncotypeDXBreastCancerAssayEstrogenReceptorStatusResultScore

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C52159
UMLS 2011AA Property-2
C1709318
NCI Thesaurus Property-3
C16150
UMLS 2011AA Property-3
C1516974
NCI Thesaurus ValueDomain
C25338
UMLS 2011AA ValueDomain
C0449820
Oncotype DX PR Score
Description

LaboratoryProcedureOncotypeDXBreastCancerAssayProgesteroneReceptorStatusResultScore

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C52159
UMLS 2011AA Property-2
C1709318
NCI Thesaurus Property-3
C16149
UMLS 2011AA Property-3
C1514471
NCI Thesaurus ValueDomain
C25338
UMLS 2011AA ValueDomain
C0449820
Oncotype DX HER2 Score
Description

LaboratoryProcedureOncotypeDXBreastCancerAssayHER2ResultScore

Data type

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C17756
UMLS 2011AA Property-2
C0242957
NCI Thesaurus Property-3
C52159
UMLS 2011AA Property-3
C1709318
NCI Thesaurus ValueDomain
C25338
UMLS 2011AA ValueDomain
C0449820
Requisition Number
Description

PatientOncotypeDXBreastCancerAssayIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C52159
UMLS 2011AA Property-2
C1709318
Off Protocol Reason
Description

Off Protocol Reason

Off Protocol Reason (select one)
Description

BreastCarcinomaOfftreatmentReason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus ObjectClass-2
C4872
UMLS 2011AA ObjectClass-2
C0678222
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Specify reason
Description

Off-TreatmentPatientReasonSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C25638
UMLS 2011AA Property
C0392360
NCI Thesaurus Property-2
C16960
UMLS 2011AA Property-2
C0030705
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
Recurrence Score <=25 and patient withdrawal/refusal, specify
Description

PatientProtocolTherapyRefuseSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25320
UMLS 2011AA Property
C1507394
NCI Thesaurus Property-2
C49161
UMLS 2011AA Property-2
C1705116
NCI Thesaurus Property-3
C15368
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Sites
Description

Off-TreatmentDiseaseProgressionAnatomicSiteSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C13717
UMLS 2011AA Property
C1515974
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus ObjectClass-2
C17747
UMLS 2011AA ObjectClass-2
C0242656
Other specify
Description

Off Treatment Reason, specify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
UMLS CUI-3
C1521902
Off Protocol Date (Date of decision not to continue on study MM DD YYYY)
Description

ProtocolOff-TreatmentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus ObjectClass-2
C42651
UMLS 2011AA ObjectClass-2
C0442711
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Planned Treatment
Description

Planned Treatment

What treatment is planned for the patient (select all that apply)
Description

BreastProtocolPlannedTreatmentType

Data type

text

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus ObjectClass-2
C12971
UMLS 2011AA ObjectClass-2
C0006141
NCI Thesaurus Property
C15368
NCI Thesaurus Property-2
C25619
UMLS 2011AA Property
C1301732
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Specify
Description

SystemicTherapyTypeSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15698
UMLS 2011AA ObjectClass
C1515119
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
For Patients Participating In The Quality Of Life And Economic Analysis Substudy
Description

For Patients Participating In The Quality Of Life And Economic Analysis Substudy

For patients participating in the Quality of Life and Economic Analysis substudy, was the S1007 Health-Related Quality of Life Questionnaire: Observational Study Form completed per protocol section 14.8?
Description

QualityofLifeCompleteProtocolAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C17047
UMLS 2011AA ObjectClass
C0518214
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property-2
C25367
NCI Thesaurus Property-3
C42651
UMLS 2011AA Property-2
C0442711
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
No, specify reason
Description

QualityofLifeCompleteProtocolAssessmentSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C17047
UMLS 2011AA ObjectClass
C0518214
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property-2
C25367
NCI Thesaurus Property-3
C42651
UMLS 2011AA Property-2
C0442711
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Status
Description

Status

Date of Last Contact or Death (MM DD YYYY)
Description

Date last contact

Data type

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
Vital Status
Description

Patient Status

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C3846084
NCI Thesaurus ValueDomain
C18003
NCI Thesaurus ValueDomain-2
C25688
NCI Thesaurus Property
C25717
Comments
Description

Comments

Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
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Instructions: Submit this form if the patient will not continue on study and register to Step 2, within 2 weeks after the decision not to proceed. All dates are MONTH, DAY, YEAR. Explain any blank fields or blank dates in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED at the top of the form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
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
Oncotype Dx Recurrence Score
Item
Was the Oncotype DX Recurrence Score obtained
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C52159 (NCI Thesaurus Property-2)
C1709318 (UMLS 2011AA Property-2)
CL.1
Code List
Was the Oncotype DX Recurrence Score obtained
CL Item
No, Patient Refused (No, patient refused)
CL Item
No, Assay Could Not Be Performed (No, assay could not be performed)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
LaboratoryProcedureOncotypeDXBreastCancerAssayResultScore
Item
Oncotype DX Recurrence Score
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C52159 (NCI Thesaurus Property-2)
C1709318 (UMLS 2011AA Property-2)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
LaboratoryProcedureOncotypeDXBreastCancerAssayEstrogenReceptorStatusResultScore
Item
Oncotype DX ER Score
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C52159 (NCI Thesaurus Property-2)
C1709318 (UMLS 2011AA Property-2)
C16150 (NCI Thesaurus Property-3)
C1516974 (UMLS 2011AA Property-3)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
LaboratoryProcedureOncotypeDXBreastCancerAssayProgesteroneReceptorStatusResultScore
Item
Oncotype DX PR Score
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C52159 (NCI Thesaurus Property-2)
C1709318 (UMLS 2011AA Property-2)
C16149 (NCI Thesaurus Property-3)
C1514471 (UMLS 2011AA Property-3)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
LaboratoryProcedureOncotypeDXBreastCancerAssayHER2ResultScore
Item
Oncotype DX HER2 Score
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17756 (NCI Thesaurus Property-2)
C0242957 (UMLS 2011AA Property-2)
C52159 (NCI Thesaurus Property-3)
C1709318 (UMLS 2011AA Property-3)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
PatientOncotypeDXBreastCancerAssayIdentifierNumber
Item
Requisition Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C52159 (NCI Thesaurus Property-2)
C1709318 (UMLS 2011AA Property-2)
Item Group
Off Protocol Reason
Item
Off Protocol Reason (select one)
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C4872 (NCI Thesaurus ObjectClass-2)
C0678222 (UMLS 2011AA ObjectClass-2)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.2
Code List
Off Protocol Reason (select one)
CL Item
Recurrence Score >25 (Recurrence Score >25)
CL Item
Recurrence Score Not Obtained (Recurrence Score not obtained)
CL Item
Recurrence Score <=25 And Patient Withdrawal/refusal (Recurrence Score <=25 and patient withdrawal/refusal)
CL Item
Disease Progression Or Distant Recurrence Or New Primary Invasive Cancer (Disease progression or distant recurrence or new primary invasive cancer)
CL Item
Death (Death)
C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Off-TreatmentPatientReasonSpecify
Item
Specify reason
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25638 (NCI Thesaurus Property)
C0392360 (UMLS 2011AA Property)
C16960 (NCI Thesaurus Property-2)
C0030705 (UMLS 2011AA Property-2)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
PatientProtocolTherapyRefuseSpecify
Item
Recurrence Score <=25 and patient withdrawal/refusal, specify
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C49161 (NCI Thesaurus Property-2)
C1705116 (UMLS 2011AA Property-2)
C15368 (NCI Thesaurus Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Off-TreatmentDiseaseProgressionAnatomicSiteSpecify
Item
Sites
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C13717 (NCI Thesaurus Property)
C1515974 (UMLS 2011AA Property)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C17747 (NCI Thesaurus ObjectClass-2)
C0242656 (UMLS 2011AA ObjectClass-2)
Off Treatment Reason, specify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
C1521902 (UMLS CUI-3)
ProtocolOff-TreatmentDate
Item
Off Protocol Date (Date of decision not to continue on study MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C42651 (NCI Thesaurus ObjectClass-2)
C0442711 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item Group
Planned Treatment
Item
What treatment is planned for the patient (select all that apply)
text
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus Property)
C25619 (NCI Thesaurus Property-2)
C1301732 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.3
Code List
What treatment is planned for the patient (select all that apply)
CL Item
Endocrine Therapy (Endocrine Therapy)
C15445 (NCI Thesaurus)
C0279025 (UMLS 2011AA)
CL Item
Chemotherapy (Chemotherapy)
C15632 (NCI Thesaurus)
C0392920 (UMLS 2011AA)
CL Item
Other Therapy (Other Therapy)
C15645 (NCI Thesaurus)
C0418967 (UMLS 2011AA)
SystemicTherapyTypeSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15698 (NCI Thesaurus ObjectClass)
C1515119 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item Group
For Patients Participating In The Quality Of Life And Economic Analysis Substudy
QualityofLifeCompleteProtocolAssessmentInd-2
Item
For patients participating in the Quality of Life and Economic Analysis substudy, was the S1007 Health-Related Quality of Life Questionnaire: Observational Study Form completed per protocol section 14.8?
boolean
C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus Property-2)
C42651 (NCI Thesaurus Property-3)
C0442711 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
QualityofLifeCompleteProtocolAssessmentSpecify
Item
No, specify reason
text
C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus Property-2)
C42651 (NCI Thesaurus Property-3)
C0442711 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item Group
Status
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)
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.5
Code List
Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
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