ID

6527

Descripción

CALGB 40302 TREATMENT AND RESPONSE SUMMARY FORM (SUBSET OF PATIENTS) Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive NCT00390455 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F5BC1727-9755-553F-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F5BC1727-9755-553F-E034-0003BA3F9857

Palabras clave

Versiones (2)
  1. 26/8/12 26/8/12 -
  2. 8/1/15 8/1/15 - Martin Dugas
Subido en

8 de enero de 2015

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0 Legacy
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TREATMENT AND RESPONSE SUMMARY FORM Breast Cancer (NCT00390455)

Inglés

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink.

1 formularios  
Header
Descripción

Header

CALGB Form
Descripción

Form ID CALGB

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3262252
NCI Thesaurus ObjectClass
C19464
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass-2
C25442
CALGB Study No
Descripción

Protocol ID CALGB

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
CALGB Patient ID
Descripción

Trial subject ID CALGB

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
Last date of reporting period
Descripción

Reporting Period End Date

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2361259
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25651
Patient Initials
Descripción

Patient Initials

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Patient Hospital No
Descripción

Patient Hospital No

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C0421459
NCI Thesaurus Property
C16960
NCI Thesaurus Property-2
C25364
NCI Thesaurus ObjectClass
C16696
Institution/Affiliate
Descripción

Institution Name

Tipo de datos

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
Participating Group
Descripción

Participating Group

Tipo de datos

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 Protocol No
Descripción

Study Number Participating Group

Tipo de datos

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
Descripción

Trial subject ID Participating Group

Tipo de datos

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
Date of last clinical assessment
Descripción

Follow-Up Date

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C9305
UMLS CUI-1
C3694716
NCI Thesaurus Property
C16033
NCI Thesaurus Property-2
C25365
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Are data amended
Descripción

Data amended

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Lapatinib/placebo
Descripción

Lapatinib/placebo

Current cycle number
Descripción

Cycle Number Chemotherapeutics

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2045829
NCI Thesaurus Property
C25471
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25379
Cycle start date
Descripción

Chemotherapy Cycle Start Date

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1302181
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI-2
C3173309
NCI Thesaurus Property
C25379
Cycle end date
Descripción

Chemotherapy Cycle End Date

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1302181
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
UMLS CUI-2
C0806020
Number of tablets issued
Descripción

PillsReceivedCount

Tipo de datos

text

Alias
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ObjectClass
C25394
UMLS 2011AA ObjectClass
C0994475
Prescribed dose
Descripción

Agent dose prescribed

Tipo de datos

float

Alias
NCI Thesaurus ObjectClass
C28180
UMLS CUI-1
C0678766
NCI Thesaurus ObjectClass-2
C1708
UMLS CUI-2
C0278329
NCI Thesaurus Property
C25256
NCI Thesaurus ValueDomain
C25488
NCI Thesaurus ValueDomain-2
C1708
Number of tablets remaining
Descripción

PillsRemainingCount

Tipo de datos

float

Alias
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ObjectClass
C25394
UMLS 2011AA ObjectClass
C0994475
NCI Thesaurus Property
C25649
UMLS 2011AA Property
C1527428
Actual Dose
Descripción

AgentActualDose

Tipo de datos

float

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus ObjectClass-2
C25274
UMLS 2011AA ObjectClass-2
C0237400
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Dose Modification (Change)
Descripción

Dose Modification

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25256
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain-2
C25572
Modified Dose
Descripción

DoseModificationAmount

Tipo de datos

float

Alias
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus ValueDomain
C25417
NCI Thesaurus Property
C25572
Specify reason for modification
Descripción

PlannedDoseModificationSpecify

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C25619
UMLS 2011AA ObjectClass
C1301732
NCI Thesaurus ObjectClass-2
C25488
UMLS 2011AA ObjectClass-2
C0178602
NCI Thesaurus Property
C25572
Were there any delays in dose administration
Descripción

DoseDelayedInd-3

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25477
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
Number of days delayed
Descripción

Treatment delay duration

Tipo de datos

float

Alias
NCI Thesaurus ValueDomain
C25301
UMLS CUI-1
C0087111
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain-2
C25463
UMLS CUI-2
C2985752
NCI Thesaurus Property
C25476
Specify reason for delay
Descripción

BladderTreatmentDelayedCycleReason

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C12414
UMLS 2011AA ObjectClass
C0005682
NCI Thesaurus ObjectClass-2
C15368
NCI Thesaurus Property
C25477
NCI Thesaurus Property-2
C25472
UMLS 2011AA Property
C1511572
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Fluvestrant
Descripción

Fluvestrant

Dose day 1
Descripción

FulvestrantAgentFirstDayAdministeredDose

Tipo de datos

float

Alias
NCI Thesaurus ObjectClass
C1379
UMLS 2011AA ObjectClass
C0701491
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25301
UMLS 2011AA Property
C0439228
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus Property-3
C25382
UMLS 2011AA Property-3
C1521801
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
Dose day 15 cycle 1 (cycle 1 only)
Descripción

FulvestrantAgentFirstCourseAdministeredDose

Tipo de datos

float

Alias
NCI Thesaurus ObjectClass
C1379
UMLS 2011AA ObjectClass
C0701491
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C25379
UMLS 2011AA Property-2
C0750729
NCI Thesaurus Property-3
C25382
UMLS 2011AA Property-3
C1521801
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
Specify reason for delay
Descripción

TreatmentDelayedReasonText

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Laboratory Values
Descripción

Laboratory Values

Heart LVEF Test Percentage Value (%)
Descripción

HeartLVEFTestPercentageValue

Tipo de datos

float

Unidades de medida
  • %
Alias
NCI Thesaurus ObjectClass
C12727
UMLS 2011AA ObjectClass
C0018787
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus Property-2
C37946
UMLS 2011AA Property-2
C2700377
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
%
Lab, Hematology, INR
Descripción

INR

Tipo de datos

float

Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0525032
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property-2
C25352
NCI Thesaurus ValueDomain
C25712
Peripheral Granulocytes Count
Descripción

LaboratoryProcedureGranulocyteResultCount

Tipo de datos

float

Unidades de medida
  • 1000/uL
Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C12530
UMLS 2011AA Property-2
C0018183
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
1000/uL
Peripheral Platelet Count
Descripción

HematologyPlateletLabUnspecifiedValue

Tipo de datos

float

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Creatinine
Descripción

RenalCreatinineLabSpecifiedValue

Tipo de datos

float

Unidades de medida
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25225
UMLS 2011AA ObjectClass
C0022646
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus Property-2
C25294
UMLS 2011AA Property-2
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
Bilirubin
Descripción

HepaticBilirubinLabValue

Tipo de datos

float

Unidades de medida
  • mg/dL
Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C305
UMLS 2011AA Property-2
C0005437
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
Lab, Hepatic, SGOT
Descripción

HepaticSGOT(AST)LabUnspecifiedValue

Tipo de datos

float

Alias
NCI Thesaurus ObjectClass
C13308
UMLS 2011AA ObjectClass
C0205054
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property-2
C37984
UMLS 2011AA Property-2
C0022877
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
Lab, Hepatic, SGPT
Descripción

HepaticSGPT(ALT)LabUnspecifiedValue

Tipo de datos

float

Alias
NCI Thesaurus ObjectClass
C13308
UMLS 2011AA ObjectClass
C0205054
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus Property-2
C25293
UMLS 2011AA Property-2
C0376147
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
Response Assessment
Descripción

Response Assessment

Has the patient achieved a response?
Descripción

TumorResponseInd-3

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
NCI Thesaurus ValueDomain-2
C25755
UMLS 2011AA ValueDomain-2
C0871261
Partial response first observed date (PR)
Descripción

Partial Response First Observed Date

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C25755
UMLS CUI-1
C1521726
NCI Thesaurus ObjectClass-2
C25378
UMLS CUI-2
C1115465
NCI Thesaurus Property
C25509
NCI Thesaurus Property-2
C25599
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Complete response first observed date (CR)
Descripción

Complete Response First Observed Date

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C25755
UMLS CUI-1
C0677874
NCI Thesaurus ObjectClass-2
C25250
UMLS CUI-2
C1115465
NCI Thesaurus Property
C25509
NCI Thesaurus Property-2
C25599
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Has the patient been diagnosed with a new progression (during this reporting period not previously reported?)
Descripción

DiseaseNewProgressionInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25586
UMLS 2011AA Property
C0205314
NCI Thesaurus Property-2
C25331
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
No, specify
Descripción

SpecimenNotSubmittedSpecify

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus Property-2
C25695
UMLS 2011AA Property-2
C1515023
Date response last documented
Descripción

ResponseLastDocumentedDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus Property
C25551
UMLS 2011AA Property
C1517741
NCI Thesaurus Property-2
C25356
UMLS 2011AA Property-2
C1301725
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Yes, specify
Descripción

Yes,specify

Tipo de datos

text

Progressive disease first observed date (PD)
Descripción

ProgressionFirstObservedDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C25599
UMLS 2011AA Property-2
C1441672
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Progressive disease documentation (Mark one with an X.)
Descripción

ProgressionCriteriaType

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus Property
C25466
UMLS 2011AA Property
C0243161
Other, specify
Descripción

ProgressionAssessmentSpecify

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C25331
Completed by (Last name, First name)
Descripción

Person Completing Form

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date form completed
Descripción

Date Form Completed

Tipo de datos

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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INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink.

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Header
Form ID CALGB
Item
CALGB Form
text
C25337 (NCI Thesaurus ValueDomain)
C3262252 (UMLS CUI-1)
C19464 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)
Protocol ID CALGB
Item
CALGB Study No
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Trial subject ID CALGB
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Reporting Period End Date
Item
Last date of reporting period
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient Hospital No
Item
Patient Hospital No
text
C25337 (NCI Thesaurus ValueDomain)
C0421459 (UMLS CUI-1)
C16960 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
C16696 (NCI Thesaurus ObjectClass)
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)
Participating Group
Item
Participating Group
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 Protocol 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)
Follow-Up Date
Item
Date of last clinical assessment
date
C9305 (NCI Thesaurus ObjectClass)
C3694716 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C25365 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Data amended
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Lapatinib/placebo
Cycle Number Chemotherapeutics
Item
Current cycle number
text
C25337 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25471 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property-2)
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)
Chemotherapy Cycle End Date
Item
Cycle end date
date
C25164 (NCI Thesaurus ValueDomain)
C1302181 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0806020 (UMLS CUI-2)
PillsReceivedCount
Item
Number of tablets issued
text
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25394 (NCI Thesaurus ObjectClass)
C0994475 (UMLS 2011AA ObjectClass)
Agent dose prescribed
Item
Prescribed dose
float
C28180 (NCI Thesaurus ObjectClass)
C0678766 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass-2)
C0278329 (UMLS CUI-2)
C25256 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ValueDomain-2)
PillsRemainingCount
Item
Number of tablets remaining
float
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25394 (NCI Thesaurus ObjectClass)
C0994475 (UMLS 2011AA ObjectClass)
C25649 (NCI Thesaurus Property)
C1527428 (UMLS 2011AA Property)
AgentActualDose
Item
Actual Dose
float
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25274 (NCI Thesaurus ObjectClass-2)
C0237400 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Dose Modification (Change)
text
C25180 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25256 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain-2)
CL.2
Code List
Dose Modification (Change)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes)
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
DoseModificationAmount
Item
Modified Dose
float
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25417 (NCI Thesaurus ValueDomain)
C25572 (NCI Thesaurus Property)
PlannedDoseModificationSpecify
Item
Specify reason for modification
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25619 (NCI Thesaurus ObjectClass)
C1301732 (UMLS 2011AA ObjectClass)
C25488 (NCI Thesaurus ObjectClass-2)
C0178602 (UMLS 2011AA ObjectClass-2)
C25572 (NCI Thesaurus Property)
DoseDelayedInd-3
Item
Were there any delays in dose administration
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25477 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
Treatment delay duration
Item
Number of days delayed
float
C25301 (NCI Thesaurus ValueDomain)
C0087111 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain-2)
C2985752 (UMLS CUI-2)
C25476 (NCI Thesaurus Property)
BladderTreatmentDelayedCycleReason
Item
Specify reason for delay
text
C12414 (NCI Thesaurus ObjectClass)
C0005682 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25477 (NCI Thesaurus Property)
C25472 (NCI Thesaurus Property-2)
C1511572 (UMLS 2011AA Property)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
Item Group
Fluvestrant
FulvestrantAgentFirstDayAdministeredDose
Item
Dose day 1
float
C1379 (NCI Thesaurus ObjectClass)
C0701491 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25301 (NCI Thesaurus Property)
C0439228 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
FulvestrantAgentFirstCourseAdministeredDose
Item
Dose day 15 cycle 1 (cycle 1 only)
float
C1379 (NCI Thesaurus ObjectClass)
C0701491 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25379 (NCI Thesaurus Property-2)
C0750729 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
TreatmentDelayedReasonText
Item
Specify reason for delay
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Item Group
Laboratory Values
HeartLVEFTestPercentageValue
Item
Heart LVEF Test Percentage Value (%)
float
C12727 (NCI Thesaurus ObjectClass)
C0018787 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C37946 (NCI Thesaurus Property-2)
C2700377 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
INR
Item
Lab, Hematology, INR
float
C20200 (NCI Thesaurus Property)
C0525032 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25352 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
LaboratoryProcedureGranulocyteResultCount
Item
Peripheral Granulocytes Count
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12530 (NCI Thesaurus Property-2)
C0018183 (UMLS 2011AA Property-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
HematologyPlateletLabUnspecifiedValue
Item
Peripheral Platelet Count
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
RenalCreatinineLabSpecifiedValue
Item
Creatinine
float
C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
HepaticBilirubinLabValue
Item
Bilirubin
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property-2)
C0005437 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
HepaticSGOT(AST)LabUnspecifiedValue
Item
Lab, Hepatic, SGOT
float
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property-2)
C0022877 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
HepaticSGPT(ALT)LabUnspecifiedValue
Item
Lab, Hepatic, SGPT
float
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Item Group
Response Assessment
TumorResponseInd-3
Item
Has the patient achieved a response?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C25755 (NCI Thesaurus ValueDomain-2)
C0871261 (UMLS 2011AA ValueDomain-2)
Partial Response First Observed Date
Item
Partial response first observed date (PR)
date
C25755 (NCI Thesaurus ObjectClass)
C1521726 (UMLS CUI-1)
C25378 (NCI Thesaurus ObjectClass-2)
C1115465 (UMLS CUI-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Complete Response First Observed Date
Item
Complete response first observed date (CR)
date
C25755 (NCI Thesaurus ObjectClass)
C0677874 (UMLS CUI-1)
C25250 (NCI Thesaurus ObjectClass-2)
C1115465 (UMLS CUI-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
DiseaseNewProgressionInd-2
Item
Has the patient been diagnosed with a new progression (during this reporting period not previously reported?)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C25331 (NCI Thesaurus Property-2)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
SpecimenNotSubmittedSpecify
Item
No, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25695 (NCI Thesaurus Property-2)
C1515023 (UMLS 2011AA Property-2)
ResponseLastDocumentedDate
Item
Date response last documented
date
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25356 (NCI Thesaurus Property-2)
C1301725 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Yes,specify
Item
Yes, specify
text
ProgressionFirstObservedDate
Item
Progressive disease first observed date (PD)
date
C25331 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property-2)
C1441672 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Progressive disease documentation (Mark one with an X.)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus ObjectClass)
C25466 (NCI Thesaurus Property)
C0243161 (UMLS 2011AA Property)
CL.7
Code List
Progressive disease documentation (Mark one with an X.)
CL Item
Target Lesions (at Least A 20% Increase In The Sum Of Longest Diameters Of Target Lesions, Taking As Reference The Smallest Sum Recorded Since The Treatment Started) (Target lesions)
CL Item
Nontarget Lesions (unequivocal Progression Of Existing Nontarget Lesions) (Nontarget lesions)
CL Item
Progressive Disease Defined By New Lesions (Appearance of one or more new lesions)
CL Item
Other, Specify (Other)
ProgressionAssessmentSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25331 (NCI Thesaurus ObjectClass)
Person Completing Form
Item
Completed by (Last name, First name)
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date form completed
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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