PACCT-1 TAILORx Follow-up Form NCT00310180

PACCT-1 TAILORx Follow-up Form NCT00310180 Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=05DF4324-6BB2-192D-E044-0003BA3F9857

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  1. StudyEvent: PACCT-1 TAILORx Follow-up Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
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)
Item Group
Follow-up Report Period
Item
Follow-up Report Period (since registration - Choose one x)
text
C0030705 (NCI Metathesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C16033 (NCI Thesaurus Property-2)
C1522577 (UMLS 2011AA Property-2)
C25207 (NCI Thesaurus Property-3)
C0040223 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Follow-up Report Period (since registration - Choose one x)
CL Item
6 Months (6 months post registration)
CL Item
12 Months (12 months post registration)
CL Item
18 Months (18 months post registration)
CL Item
2 Years (24 Months post registration)
CL Item
30 Months (30 months post registration)
CL Item
3 Years (36 months post registration)
CL Item
42 Months Post Registration (42 Months Post Registration)
CL Item
4 Years (48 months post registration)
CL Item
54 Months Post Registration (54 Months Post Registration)
CL Item
5 Years (60 months post registration)
CL Item
6 Years (72 months post registration)
CL Item
84 Months Post Registration (84 months post registration)
CL Item
8 Years (96 months post registration)
CL Item
9 Years (108 months post registration)
CL Item
10 Years (120 months post registration)
CL Item
11 Years Post Registration (132 Months Post Registration)
CL Item
12 Years Post Registration (144 Months Post Registration)
CL Item
13 Years Post Registration (156 Months Post Registration)
CL Item
14 Years Post Registration (168 Months Post Registration)
CL Item
15 Years Post Registration (180 Months Post Registration)
CL Item
16 Years Post Registration (192 Months Post Registration)
CL Item
17 Years Post Registration (204 Months Post Registration)
CL Item
18 Years Post Registration (216 Months Post Registration)
CL Item
19 Years Post Registration (228 Months Post Registration)
CL Item
20 Years Post Registration (240 Months Post Registration)
Item Group
Reporting period
Reporting Period Start Date
Item
Reporting Period Start Date (mm/dd/yyy)
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/yyy)
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
Item Group
Breast: Vital Status
Item
Patient 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 Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Date last contact
Item
Date of Last Contact or Death (mm/dd/yyy)
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 Cardiovascular Disease (Due to cardiovascular disease)
CL Item
Due To Other Chronic Disease (Due to other chronic disease)
CL Item
Due To Second Primary Or Other Malignancy (Due to second primary or other malignancy)
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
Breast: Disease Follow-up Status
Follow-Up Date
Item
Date of Last Clinical Assessment (only provide date if assessment since submission of previous follow-up form)
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)
AssessmentMethodText
Item
Not done (Check here and skip the rest of Section II if a more recent clinical assessment was not done.)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
Item Group
Breast: Notice Of Progression - Advanced Disease
RecurrentIpsilateralBreastNeoplasmDiagnosisInd-2
Item
Has the patient been diagnosed with first ipsilateral breast tumor recurrence (since submission of the last follow-up form)
boolean
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C14173 (NCI Thesaurus ObjectClass-3)
C2945760 (UMLS 2011AA ObjectClass-3)
C25308 (NCI Thesaurus ObjectClass-4)
C0441989 (UMLS 2011AA ObjectClass-4)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
RecurrentIpsilateralBreastNeoplasmDiagnosisDate
Item
Date of first ipsilateral breast tumor recurrence (If yes:)
date
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C14173 (NCI Thesaurus ObjectClass-3)
C2945760 (UMLS 2011AA ObjectClass-3)
C25308 (NCI Thesaurus ObjectClass-4)
C0441989 (UMLS 2011AA ObjectClass-4)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15220 (NCI Thesaurus ValueDomain-2)
C0011900 (UMLS 2011AA ValueDomain-2)
Item
Method of Diagnosis (For contralateral breast primaries:)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C15220 (NCI Thesaurus ObjectClass)
C0011900 (UMLS 2011AA ObjectClass)
Code List
Method of Diagnosis (For contralateral breast primaries:)
CL Item
Radiologic (Radiologic)
CL Item
Histology (Histologic)
C16681 (NCI Thesaurus)
C0019638 (UMLS 2011AA)
C16681 (NCI Thesaurus-3)
C0019638 (UMLS 2011AA-4)
CL Item
Radiologic And Histologic (Radiologic and Histologic)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
DiagnosisMethodSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C15220 (NCI Thesaurus ObjectClass)
C0011900 (UMLS 2011AA ObjectClass)
Item
IBTR histology (NOTE: See TAILORx Forms Completion Guidelines for IBTR definitions)
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C14173 (NCI Thesaurus ObjectClass-3)
C2945760 (UMLS 2011AA ObjectClass-3)
C25308 (NCI Thesaurus ObjectClass-4)
C0441989 (UMLS 2011AA ObjectClass-4)
C16681 (NCI Thesaurus Property)
C0019638 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property-2)
C0008902 (UMLS 2011AA Property-2)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
Code List
IBTR histology (NOTE: See TAILORx Forms Completion Guidelines for IBTR definitions)
CL Item
Invasive Carcinoma (Invasive Carcinoma)
C9480 (NCI Thesaurus)
C1334274 (UMLS 2011AA)
CL Item
Ductal Carcinoma In Situ (Ductal carcinoma in situ)
CL Item
Both Invasive Carcinoma And Ductal Carcinoma In Situ (Both invasive carcinoma and DCIS)
Item Group
Iib - Local-regional Recurrence
RecurrentDiseaseCancerProgressionFirstLocal-RegionalDiagnosisIndicator
Item
Has the patient been diagnosed with first local-regional recurrence or progression (since submission of the last follow-up form)
boolean
C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C25388 (NCI Thesaurus Property)
C1947913 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C19987 (NCI Thesaurus Property-4)
C0242656 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
RecurrentDiseaseFirstLocal-RegionalDiagnosisDate
Item
Date of First Local-Regional Recurrence (If yes: - mm/dd/yyyy)
date
C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C25388 (NCI Thesaurus Property)
C1947913 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Site of first local-regional recurrence (s check all that apply; all sites refer to the same side as the original primary)
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25388 (NCI Thesaurus Property)
C1947913 (UMLS 2011AA Property)
C38155 (NCI Thesaurus Property-2)
C0277556 (UMLS 2011AA Property-2)
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
Code List
Site of first local-regional recurrence (s check all that apply; all sites refer to the same side as the original primary)
CL Item
Ipsilateral Axillary Lymph Nodes And/or Soft Tissue (Ipsilateral axillary lymph nodes and/or soft tissue)
CL Item
Ipsilateral Internal Mammary Nodes (Ipsilateral internal mammary nodes)
CL Item
Ipsilateral Infraclavicular Nodes (Ipsilateral infraclavicular nodes)
CL Item
Ipsilateral Supraclavicular Nodes (Ipsilateral supraclavicular nodes)
CL Item
Ipsilateral Chest Wall (Ipsilateral chest wall)
Item
Method of Diagnosis (For contralateral breast primaries:)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C15220 (NCI Thesaurus ObjectClass)
C0011900 (UMLS 2011AA ObjectClass)
Code List
Method of Diagnosis (For contralateral breast primaries:)
CL Item
Radiologic (Radiologic)
CL Item
Histology (Histologic)
C16681 (NCI Thesaurus)
C0019638 (UMLS 2011AA)
C16681 (NCI Thesaurus-3)
C0019638 (UMLS 2011AA-4)
CL Item
Radiologic And Histologic (Radiologic and Histologic)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
DiagnosisMethodSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C15220 (NCI Thesaurus ObjectClass)
C0011900 (UMLS 2011AA ObjectClass)
Item Group
Iic - Distance Recurrence
Neoplasm recurrence, Distal
Item
Has the patient been diagnosed with first distant recurrence/progression? (since submission of the last follow-up form)
boolean
C19987 (NCI Thesaurus ObjectClass)
C0027627 (UMLS CUI-1)
C25321 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C15220 (NCI Thesaurus Property-3)
C25180 (NCI Thesaurus ValueDomain)
RecurrentDiseaseFirstDistantDiagnosisDate
Item
Date of First Distant Recurrence (mm/dd/yyyy)
date
C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C25321 (NCI Thesaurus Property)
C0443203 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
Site(s) of First Distant Recurrence (Indicate - check all that apply at the completion of the metastatic workup)
text
C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C25321 (NCI Thesaurus Property)
C0443203 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
Code List
Site(s) of First Distant Recurrence (Indicate - check all that apply at the completion of the metastatic workup)
CL Item
Bone (Bone(s))
C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)
CL Item
Central Nervous System (Central Nervous System (e.g., brain, meninges))
C12438 (NCI Thesaurus)
C3714787 (UMLS 2011AA)
CL Item
Liver (Liver)
C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)
CL Item
Lung (Lung(s))
C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)
CL Item
Positive Lymph Node (Non-regional lymph node(s))
C27296 (NCI Thesaurus)
C0746319 (UMLS 2011AA)
CL Item
Pleura (Pleura (pleural effusion))
C12469 (NCI Thesaurus)
C0032225 (UMLS 2011AA)
CL Item
Skin (Skin (excluding ipsilateral chest wall))
C12470 (NCI Thesaurus)
C1123023 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
RecurrentDiseaseFirstDistantDiagnosisSpecify
Item
Other specify
text
C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C25321 (NCI Thesaurus Property)
C0443203 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Method of Diagnosis (For contralateral breast primaries:)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C15220 (NCI Thesaurus ObjectClass)
C0011900 (UMLS 2011AA ObjectClass)
Code List
Method of Diagnosis (For contralateral breast primaries:)
CL Item
Radiologic (Radiologic)
CL Item
Histology (Histologic)
C16681 (NCI Thesaurus)
C0019638 (UMLS 2011AA)
C16681 (NCI Thesaurus-3)
C0019638 (UMLS 2011AA-4)
CL Item
Radiologic And Histologic (Radiologic and Histologic)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
DiagnosisMethodSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C15220 (NCI Thesaurus ObjectClass)
C0011900 (UMLS 2011AA ObjectClass)
Item Group
Section Iii - New Primary Cancers
Item
Has a new primary cancer or MDS been diagnosed that has not been previously reported?
text
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C9305 (NCI Thesaurus ObjectClass-3)
C0006826 (UMLS 2011AA ObjectClass-3)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
Code List
Has a new primary cancer or MDS been diagnosed that has not been previously reported?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Ductal Carcinoma In Situ Of Contralateral Breast (Yes, ductal carcinoma in situ of contralateral breast)
CL Item
Yes, Invasive Disease In Contralateral Breast (Yes, invasive disease in contralateral breast)
CL Item
Yes, Ductal Carcinoma In Situ Of Ipsilateral Breast (Yes, DCIS of ipsilateral breast)
CL Item
Yes, All Other Sites (Yes, all other sites)
NewCancerSiteText
Item
Site of New Primary (Recommended term - CRF shows "specify sites")
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
NewCancerDiagnosisDate
Item
Date of diagnosis (If yes: - )
date
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Method of Diagnosis (For contralateral breast primaries:)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C15220 (NCI Thesaurus ObjectClass)
C0011900 (UMLS 2011AA ObjectClass)
Code List
Method of Diagnosis (For contralateral breast primaries:)
CL Item
Radiologic (Radiologic)
CL Item
Histology (Histologic)
C16681 (NCI Thesaurus)
C0019638 (UMLS 2011AA)
C16681 (NCI Thesaurus-3)
C0019638 (UMLS 2011AA-4)
CL Item
Radiologic And Histologic (Radiologic and Histologic)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
DiagnosisMethodSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C15220 (NCI Thesaurus ObjectClass)
C0011900 (UMLS 2011AA ObjectClass)
Item Group
Section Iv - Treatment
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)
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)
CL Item
Not Applicable (Not Applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
HormoneTherapyReportPeriodAdministeredInd-3
Item
Has the patient received any hormone 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 hormonal therapy during this report 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)
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 Hormonal Therapy (Adverse events from prior hormonal 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 hormonal therapy
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 hormonal 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)
Code List
Specify new type of hormonal therapy given
CL Item
Aromatase Inhibitor (Aromatase Inhibitor)
C1740 (NCI Thesaurus)
C0593802 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Tamoxifen (Tamoxifen)
C855 (NCI Thesaurus)
C0039286 (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)
Code List
Specify which Aromatase Inhibitor was given (If aromatase inhibitor:)
CL Item
Anastrozole (ANASTROZOLE)
C1607 (NCI Thesaurus)
C0290882 (UMLS 2011AA)
CL Item
Exemestane (EXEMESTANE)
C1097 (NCI Thesaurus)
C0060116 (UMLS 2011AA)
CL Item
Letrozole (LETROZOLE)
C1527 (NCI Thesaurus)
C0246421 (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 (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
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)
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, specify)
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)
Item
Did patient receive Ovarian Function Suppression (OFS) during this follow-up 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)
Code List
Did patient receive Ovarian Function Suppression (OFS) during this follow-up 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
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)
Code List
Ovarian Function Suppression Type
CL Item
Medical Suppression Of Ovarian Function (Medical suppression)
CL Item
Bilateral Surgical Oophorectomy (Oophorectomy)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Radiation Therapy (Ovarian radiation)
C15313 (NCI Thesaurus)
C1522449 (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 hormonal therapy discontinued this report 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 hormonal 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
Footer Module
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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