ID

11056

Description

E2108 Optimal Systemic Therapy Summary Form NCT01242800 Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=91E1D8B2-2FF5-DD0A-E040-BB89AD434391

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=91E1D8B2-2FF5-DD0A-E040-BB89AD434391

Keywords

  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 6/16/15 6/16/15 -
Uploaded on

June 16, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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E2108 Optimal Systemic Therapy Summary Form NCT01242800

INSTRUCTIONS: After patient is off treatment, complete this form for each required follow-up report period (see forms submission schedule).

ECOG clinical trial administrative data
Description

ECOG clinical trial administrative data

ECOG Patient ID
Description

Patient ID ECOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
DCI Name
Description

Generic drug form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C3242750
NCI Thesaurus Property
C19464
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus ObjectClass-2
C25452
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 (Last, First)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Participating Group Protocol Number
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
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
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
Report Period
Description

Report Period

Reporting Period
Description

Clinical Trial Period

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2347804
NCI Thesaurus ObjectClass
C25214
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass-2
C25651
Data amendment
Description

Data amendment

Please mark an 'X' if data have been amended. (Please circle amended items in red)
Description

Data amended

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Date data amended (M D Y)
Description

Data amended date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25416
NCI Thesaurus ValueDomain-2
C25367
Arm A And Arm B
Description

Arm A And Arm B

Date Systemic Therapy Began
Description

SystemicTherapyAdministeredBeginDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15698
UMLS 2011AA ObjectClass
C1515119
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Date Systemic Therapy Ended
Description

SystemicTherapyAdministeredEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15698
UMLS 2011AA ObjectClass
C1515119
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain-2
C25496
UMLS 2011AA ValueDomain-2
C2746065
Vital Status
Description

Vital Status

Patient's 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
Date of Last Contact or Death
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
Primary Cause of Death (if applicable)
Description

Primary Cause of Death

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C0007465
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C28554
NCI Thesaurus ValueDomain-2
C25251
Describe cause of death
Description

Cause of Death, specify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C0007465
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1521902
NCI Thesaurus Property
C28554
Therapy Administered - Chemotherapy
Description

Therapy Administered - Chemotherapy

Has the patient received any chemotherapy during this reporting period? (as part of optimal systemic therapy)
Description

ChemotherapyAdministeredInd

Data type

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
Chemotherapy Course 1
Description

ChemotherapyFirstCycleAgentName

Data type

text

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25472
UMLS 2011AA Property
C1511572
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus Property-3
C1708
UMLS 2011AA Property-3
C0450442
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Chemotherapy Course 2
Description

ChemotherapySecondCycleAgentName

Data type

text

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25472
UMLS 2011AA Property
C1511572
NCI Thesaurus Property-2
C25666
UMLS 2011AA Property-2
C0205436
NCI Thesaurus Property-3
C1708
UMLS 2011AA Property-3
C0450442
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Chemotherapy Course 3
Description

ChemotherapyThirdCycleAgentName

Data type

text

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25472
UMLS 2011AA Property
C1511572
NCI Thesaurus Property-2
C1708
UMLS 2011AA Property-2
C0450442
NCI Thesaurus Property-3
C25260
UMLS 2011AA Property-3
C0205437
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Specify
Description

ChemotherapyAgentSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ValueDomain-2
C15368
NCI Thesaurus Property
C1708
UMLS 2011AA Property
C0450442
Therapy Administered - Hormone Therapy
Description

Therapy Administered - Hormone Therapy

Has the patient received any hormone therapy during this reporting period? (as part of optimal systemic therapy)
Description

HormoneTherapyReportPeriodAdministeredInd-3

Data type

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
Hormone Therapy Course 1
Description

EndocrineTherapyFirstCycleAgentName

Data type

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25472
UMLS 2011AA Property
C1511572
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus Property-3
C1708
UMLS 2011AA Property-3
C0450442
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Hormone Therapy Course 2
Description

EndocrineTherapySecondCycleAgentName

Data type

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25472
UMLS 2011AA Property
C1511572
NCI Thesaurus Property-2
C25666
UMLS 2011AA Property-2
C0205436
NCI Thesaurus Property-3
C1708
UMLS 2011AA Property-3
C0450442
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Hormone Therapy Course 3
Description

EndocrineTherapyThirdCycleAgentName

Data type

text

Alias
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus Property
C25472
UMLS 2011AA Property
C1511572
NCI Thesaurus Property-2
C1708
UMLS 2011AA Property-2
C0450442
NCI Thesaurus Property-3
C25260
UMLS 2011AA Property-3
C0205437
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Specify
Description

EndocrineTherapyAgentSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ValueDomain-2
C15368
NCI Thesaurus Property
C1708
UMLS 2011AA Property
C0450442
Therapy Administered - New Progression
Description

Therapy Administered - New Progression

Has the patient been diagnosed with a new progression? (while receiving systemic therapy)
Description

DiseaseNewProgressionInd-2

Data type

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
Basis for Progressive Disease
Description

DiseaseorDisorderNewDiseaseProgressionDiagnosisType

Data type

text

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25586
UMLS 2011AA Property
C0205314
NCI Thesaurus Property-2
C17747
UMLS 2011AA Property-2
C0242656
NCI Thesaurus Property-3
C15220
UMLS 2011AA Property-3
C0011900
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Date of Progression
Description

DiseaseProgressionDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Comments
Description

Comments

Investigator Signature
Description

Investigator Signature

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
Investigator Signature Date
Description

Investigator Signature Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089

Similar models

INSTRUCTIONS: After patient is off treatment, complete this form for each required follow-up report period (see forms submission schedule).

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
ECOG clinical trial administrative data
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Generic drug form
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-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 (Last, First)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Protocol Number
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)
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)
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
Report Period
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)
Code List
Reporting Period
CL Item
End Of Treatment - Step 1 (End of Treatment - Step 1)
Item Group
Data amendment
Data amended
Item
Please mark an 'X' if data have been amended. (Please circle amended items in red)
text
C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Data amended date
Item
Date data amended (M D Y)
date
C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Arm A And Arm B
SystemicTherapyAdministeredBeginDate
Item
Date Systemic Therapy Began
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15698 (NCI Thesaurus ObjectClass)
C1515119 (UMLS 2011AA ObjectClass)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
SystemicTherapyAdministeredEndDate
Item
Date Systemic Therapy Ended
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15698 (NCI Thesaurus ObjectClass)
C1515119 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25496 (NCI Thesaurus ValueDomain-2)
C2746065 (UMLS 2011AA ValueDomain-2)
Item Group
Vital Status
Item
Patient's Vital Status
text
C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25717 (NCI Thesaurus Property)
Code List
Patient's Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Date last contact
Item
Date of Last Contact or Death
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
Primary Cause of Death (if applicable)
text
C25638 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C28554 (NCI Thesaurus Property)
C25251 (NCI Thesaurus ValueDomain-2)
Code List
Primary Cause of Death (if applicable)
CL Item
Due To Protocol Treatment (Due to protocol treatment)
CL Item
Due To This Disease (Due to this disease)
CL Item
Due To Other Cause (Due to other cause)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Cause of Death, specify
Item
Describe cause of death
text
C25685 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C28554 (NCI Thesaurus Property)
Item Group
Therapy Administered - Chemotherapy
Item
Has the patient received any chemotherapy during this reporting period? (as part of optimal systemic therapy)
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)
Code List
Has the patient received any chemotherapy during this reporting period? (as part of optimal systemic therapy)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
CL Item
Yes, Chemotherapy Completed (Yes, chemotherapy completed)
CL Item
Yes, Chemotherapy Continuing (Yes, chemotherapy continuing)
Item
Chemotherapy Course 1
text
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25472 (NCI Thesaurus Property)
C1511572 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C1708 (NCI Thesaurus Property-3)
C0450442 (UMLS 2011AA Property-3)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
Code List
Chemotherapy Course 1
CL Item
Albumin-bound Paclitaxel (Albumin-bound paclitaxel)
CL Item
Bevacizumab (Bevacizumab)
C2039 (NCI Thesaurus)
C0796392 (UMLS 2011AA)
CL Item
Capecitabine (Capecitabine)
C1794 (NCI Thesaurus)
C0671970 (UMLS 2011AA)
CL Item
Carboplatin (Carboplatin)
C1282 (NCI Thesaurus)
C0079083 (UMLS 2011AA)
CL Item
Cisplatin (Cisplatin)
C376 (NCI Thesaurus)
C0008838 (UMLS 2011AA)
CL Item
Cyclophosphamide (Cyclophosphamide)
C405 (NCI Thesaurus)
C0010583 (UMLS 2011AA)
CL Item
Docetaxel (Docetaxel)
C1526 (NCI Thesaurus)
C0246415 (UMLS 2011AA)
CL Item
Doxorubicin (Doxorubicin)
C456 (NCI Thesaurus)
C0013089 (UMLS 2011AA)
CL Item
Epirubicin (Epirubicin)
C62028 (NCI Thesaurus)
C0014582 (UMLS 2011AA)
CL Item
Fluorouracil (Fluorouracil Cl)
C505 (NCI Thesaurus)
C0016360 (UMLS 2011AA)
CL Item
Gemcitabine (Gemcitabine)
C66876 (NCI Thesaurus)
C0045093 (UMLS 2011AA)
CL Item
Ixabepilone (Ixabepilone)
C37452 (NCI Thesaurus)
C0879430 (UMLS 2011AA)
CL Item
Lapatinib (Lapatinib)
C26653 (NCI Thesaurus)
C1173538 (UMLS 2011AA)
CL Item
Methotrexate (Methotrexate)
C642 (NCI Thesaurus)
C0025677 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Paclitaxel (Paclitaxel)
C1411 (NCI Thesaurus)
C0144576 (UMLS 2011AA)
CL Item
Pegylated Liposomal Doxorubicin (Pegylated liposomal doxorubicin)
CL Item
Trastuzumab (Trastuzumab)
C1647 (NCI Thesaurus)
C0338204 (UMLS 2011AA)
CL Item
Vinorelbine (Vinorelbine)
C1275 (NCI Thesaurus)
C0078257 (UMLS 2011AA)
Item
Chemotherapy Course 2
text
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25472 (NCI Thesaurus Property)
C1511572 (UMLS 2011AA Property)
C25666 (NCI Thesaurus Property-2)
C0205436 (UMLS 2011AA Property-2)
C1708 (NCI Thesaurus Property-3)
C0450442 (UMLS 2011AA Property-3)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
Code List
Chemotherapy Course 2
CL Item
Albumin-bound Paclitaxel (Albumin-bound paclitaxel)
CL Item
Bevacizumab (Bevacizumab)
C2039 (NCI Thesaurus)
C0796392 (UMLS 2011AA)
CL Item
Capecitabine (Capecitabine)
C1794 (NCI Thesaurus)
C0671970 (UMLS 2011AA)
CL Item
Carboplatin (Carboplatin)
C1282 (NCI Thesaurus)
C0079083 (UMLS 2011AA)
CL Item
Cisplatin (Cisplatin)
C376 (NCI Thesaurus)
C0008838 (UMLS 2011AA)
CL Item
Cyclophosphamide (Cyclophosphamide)
C405 (NCI Thesaurus)
C0010583 (UMLS 2011AA)
CL Item
Docetaxel (Docetaxel)
C1526 (NCI Thesaurus)
C0246415 (UMLS 2011AA)
CL Item
Doxorubicin (Doxorubicin)
C456 (NCI Thesaurus)
C0013089 (UMLS 2011AA)
CL Item
Epirubicin (Epirubicin)
C62028 (NCI Thesaurus)
C0014582 (UMLS 2011AA)
CL Item
Fluorouracil (Fluorouracil Cl)
C505 (NCI Thesaurus)
C0016360 (UMLS 2011AA)
CL Item
Gemcitabine (Gemcitabine)
C66876 (NCI Thesaurus)
C0045093 (UMLS 2011AA)
CL Item
Ixabepilone (Ixabepilone)
C37452 (NCI Thesaurus)
C0879430 (UMLS 2011AA)
CL Item
Lapatinib (Lapatinib)
C26653 (NCI Thesaurus)
C1173538 (UMLS 2011AA)
CL Item
Methotrexate (Methotrexate)
C642 (NCI Thesaurus)
C0025677 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Paclitaxel (Paclitaxel)
C1411 (NCI Thesaurus)
C0144576 (UMLS 2011AA)
CL Item
Pegylated Liposomal Doxorubicin (Pegylated liposomal doxorubicin)
CL Item
Trastuzumab (Trastuzumab)
C1647 (NCI Thesaurus)
C0338204 (UMLS 2011AA)
CL Item
Vinorelbine (Vinorelbine)
C1275 (NCI Thesaurus)
C0078257 (UMLS 2011AA)
Item
Chemotherapy Course 3
text
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25472 (NCI Thesaurus Property)
C1511572 (UMLS 2011AA Property)
C1708 (NCI Thesaurus Property-2)
C0450442 (UMLS 2011AA Property-2)
C25260 (NCI Thesaurus Property-3)
C0205437 (UMLS 2011AA Property-3)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
Code List
Chemotherapy Course 3
CL Item
Albumin-bound Paclitaxel (Albumin-bound paclitaxel)
CL Item
Bevacizumab (Bevacizumab)
C2039 (NCI Thesaurus)
C0796392 (UMLS 2011AA)
CL Item
Capecitabine (Capecitabine)
C1794 (NCI Thesaurus)
C0671970 (UMLS 2011AA)
CL Item
Carboplatin (Carboplatin)
C1282 (NCI Thesaurus)
C0079083 (UMLS 2011AA)
CL Item
Cisplatin (Cisplatin)
C376 (NCI Thesaurus)
C0008838 (UMLS 2011AA)
CL Item
Cyclophosphamide (Cyclophosphamide)
C405 (NCI Thesaurus)
C0010583 (UMLS 2011AA)
CL Item
Docetaxel (Docetaxel)
C1526 (NCI Thesaurus)
C0246415 (UMLS 2011AA)
CL Item
Doxorubicin (Doxorubicin)
C456 (NCI Thesaurus)
C0013089 (UMLS 2011AA)
CL Item
Epirubicin (Epirubicin)
C62028 (NCI Thesaurus)
C0014582 (UMLS 2011AA)
CL Item
Fluorouracil (Fluorouracil Cl)
C505 (NCI Thesaurus)
C0016360 (UMLS 2011AA)
CL Item
Gemcitabine (Gemcitabine)
C66876 (NCI Thesaurus)
C0045093 (UMLS 2011AA)
CL Item
Ixabepilone (Ixabepilone)
C37452 (NCI Thesaurus)
C0879430 (UMLS 2011AA)
CL Item
Lapatinib (Lapatinib)
C26653 (NCI Thesaurus)
C1173538 (UMLS 2011AA)
CL Item
Methotrexate (Methotrexate)
C642 (NCI Thesaurus)
C0025677 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Paclitaxel (Paclitaxel)
C1411 (NCI Thesaurus)
C0144576 (UMLS 2011AA)
CL Item
Pegylated Liposomal Doxorubicin (Pegylated liposomal doxorubicin)
CL Item
Trastuzumab (Trastuzumab)
C1647 (NCI Thesaurus)
C0338204 (UMLS 2011AA)
CL Item
Vinorelbine (Vinorelbine)
C1275 (NCI Thesaurus)
C0078257 (UMLS 2011AA)
ChemotherapyAgentSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus Property)
C0450442 (UMLS 2011AA Property)
Item Group
Therapy Administered - Hormone Therapy
HormoneTherapyReportPeriodAdministeredInd-3
Item
Has the patient received any hormone therapy during this reporting period? (as part of optimal systemic therapy)
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)
Item
Hormone Therapy Course 1
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25472 (NCI Thesaurus Property)
C1511572 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C1708 (NCI Thesaurus Property-3)
C0450442 (UMLS 2011AA Property-3)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
Code List
Hormone Therapy Course 1
CL Item
Anastrozole (Anastrozole)
C1607 (NCI Thesaurus)
C0290882 (UMLS 2011AA)
CL Item
Aromatase Inhibitor - Anastrazole (arimidex) (Aromatase Inhibitor - Anastrazole (Arimidex))
CL Item
Aromatase Inhibitor - Exemestane (aromasin) (Aromatase Inhibitor - Exemestane (Aromasin))
CL Item
Aromatase Inhibitor - Letrozole (femara) (Aromatase Inhibitor - Letrozole (Femara))
CL Item
Ethinyl Estradiol (Ethinyl Estradiol)
C486 (NCI Thesaurus)
C0015011 (UMLS 2011AA)
CL Item
Exemestane (Exemestane)
C1097 (NCI Thesaurus)
C0060116 (UMLS 2011AA)
CL Item
Fluoxymesterone (Fluoxymesterone)
C507 (NCI Thesaurus)
C0016366 (UMLS 2011AA)
CL Item
Fulvestrant (Fulvestrant)
C1379 (NCI Thesaurus)
C0701491 (UMLS 2011AA)
CL Item
Letrozole (Letrozole)
C1527 (NCI Thesaurus)
C0246421 (UMLS 2011AA)
CL Item
Megestrol Acetate (Megestrol Acetate)
C1156 (NCI Thesaurus)
C0065879 (UMLS 2011AA)
CL Item
Other (Other)
CL Item
Ovarian Function Suppression (ofs) - Medical Suppression (Ovarian Function Suppression (OFS) - Medical suppression)
CL Item
Ovarian Function Suppression (ofs) - Oophorectomy (Ovarian Function Suppression (OFS) - Oophorectomy)
CL Item
Ovarian Function Suppression (ofs) - Ovarian Radiation (Ovarian Function Suppression (OFS) - Ovarian radiation)
CL Item
Tamoxifen (Tamoxifen)
C855 (NCI Thesaurus)
C0039286 (UMLS 2011AA)
CL Item
Toremifene (Toremifene)
C1256 (NCI Thesaurus)
C0076836 (UMLS 2011AA)
Item
Hormone Therapy Course 2
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25472 (NCI Thesaurus Property)
C1511572 (UMLS 2011AA Property)
C25666 (NCI Thesaurus Property-2)
C0205436 (UMLS 2011AA Property-2)
C1708 (NCI Thesaurus Property-3)
C0450442 (UMLS 2011AA Property-3)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
Code List
Hormone Therapy Course 2
CL Item
Anastrozole (Anastrozole)
C1607 (NCI Thesaurus)
C0290882 (UMLS 2011AA)
CL Item
Aromatase Inhibitor - Anastrazole (arimidex) (Aromatase Inhibitor - Anastrazole (Arimidex))
CL Item
Aromatase Inhibitor - Exemestane (aromasin) (Aromatase Inhibitor - Exemestane (Aromasin))
CL Item
Aromatase Inhibitor - Letrozole (femara) (Aromatase Inhibitor - Letrozole (Femara))
CL Item
Ethinyl Estradiol (Ethinyl Estradiol)
C486 (NCI Thesaurus)
C0015011 (UMLS 2011AA)
CL Item
Exemestane (Exemestane)
C1097 (NCI Thesaurus)
C0060116 (UMLS 2011AA)
CL Item
Fluoxymesterone (Fluoxymesterone)
C507 (NCI Thesaurus)
C0016366 (UMLS 2011AA)
CL Item
Fulvestrant (Fulvestrant)
C1379 (NCI Thesaurus)
C0701491 (UMLS 2011AA)
CL Item
Letrozole (Letrozole)
C1527 (NCI Thesaurus)
C0246421 (UMLS 2011AA)
CL Item
Megestrol Acetate (Megestrol Acetate)
C1156 (NCI Thesaurus)
C0065879 (UMLS 2011AA)
CL Item
Other (Other)
CL Item
Ovarian Function Suppression (ofs) - Medical Suppression (Ovarian Function Suppression (OFS) - Medical suppression)
CL Item
Ovarian Function Suppression (ofs) - Oophorectomy (Ovarian Function Suppression (OFS) - Oophorectomy)
CL Item
Ovarian Function Suppression (ofs) - Ovarian Radiation (Ovarian Function Suppression (OFS) - Ovarian radiation)
CL Item
Tamoxifen (Tamoxifen)
C855 (NCI Thesaurus)
C0039286 (UMLS 2011AA)
CL Item
Toremifene (Toremifene)
C1256 (NCI Thesaurus)
C0076836 (UMLS 2011AA)
Item
Hormone Therapy Course 3
text
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25472 (NCI Thesaurus Property)
C1511572 (UMLS 2011AA Property)
C1708 (NCI Thesaurus Property-2)
C0450442 (UMLS 2011AA Property-2)
C25260 (NCI Thesaurus Property-3)
C0205437 (UMLS 2011AA Property-3)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
Code List
Hormone Therapy Course 3
CL Item
Anastrozole (Anastrozole)
C1607 (NCI Thesaurus)
C0290882 (UMLS 2011AA)
CL Item
Aromatase Inhibitor - Anastrazole (arimidex) (Aromatase Inhibitor - Anastrazole (Arimidex))
CL Item
Aromatase Inhibitor - Exemestane (aromasin) (Aromatase Inhibitor - Exemestane (Aromasin))
CL Item
Aromatase Inhibitor - Letrozole (femara) (Aromatase Inhibitor - Letrozole (Femara))
CL Item
Ethinyl Estradiol (Ethinyl Estradiol)
C486 (NCI Thesaurus)
C0015011 (UMLS 2011AA)
CL Item
Exemestane (Exemestane)
C1097 (NCI Thesaurus)
C0060116 (UMLS 2011AA)
CL Item
Fluoxymesterone (Fluoxymesterone)
C507 (NCI Thesaurus)
C0016366 (UMLS 2011AA)
CL Item
Fulvestrant (Fulvestrant)
C1379 (NCI Thesaurus)
C0701491 (UMLS 2011AA)
CL Item
Letrozole (Letrozole)
C1527 (NCI Thesaurus)
C0246421 (UMLS 2011AA)
CL Item
Megestrol Acetate (Megestrol Acetate)
C1156 (NCI Thesaurus)
C0065879 (UMLS 2011AA)
CL Item
Other (Other)
CL Item
Ovarian Function Suppression (ofs) - Medical Suppression (Ovarian Function Suppression (OFS) - Medical suppression)
CL Item
Ovarian Function Suppression (ofs) - Oophorectomy (Ovarian Function Suppression (OFS) - Oophorectomy)
CL Item
Ovarian Function Suppression (ofs) - Ovarian Radiation (Ovarian Function Suppression (OFS) - Ovarian radiation)
CL Item
Tamoxifen (Tamoxifen)
C855 (NCI Thesaurus)
C0039286 (UMLS 2011AA)
CL Item
Toremifene (Toremifene)
C1256 (NCI Thesaurus)
C0076836 (UMLS 2011AA)
EndocrineTherapyAgentSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus Property)
C0450442 (UMLS 2011AA Property)
Item Group
Therapy Administered - New Progression
DiseaseNewProgressionInd-2
Item
Has the patient been diagnosed with a new progression? (while receiving systemic therapy)
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)
Item
Basis for Progressive Disease
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C17747 (NCI Thesaurus Property-2)
C0242656 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Basis for Progressive Disease
CL Item
Enlargement Of Existing Sites By 20% Or More (Enlargement of existing sites by 20% or more)
CL Item
New Sites Of Disease (New sites of disease)
CL Item
Symptomatic Deterioration In The Presence Of Radiographic Evidence Of Disease (Symptomatic deterioration in the presence of radiographic evidence of disease)
DiseaseProgressionDate
Item
Date of Progression
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
Item Group
Comments
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Investigator Signature Date
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)

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