Instructions: This form is to be completed if the patient received bone active medication, non-steroidal, anti-inflammatory drug or extended adjuvant therapy during this follow-up period. Use minus one (-1) to indicate that an answer is unknown, unobtainable or not done

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
C1320722 (UMLS CUI-1)
Hospital Admission Ordinal Number
Item
Visit number
integer
C25337 (NCI Thesaurus ValueDomain)
C16696 (NCI Thesaurus ObjectClass)
C25385 (NCI Thesaurus Property)
C1549755 (UMLS CUI [1])
International Breast Cancer Study Group Identifier Number
Item
IBCSG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25530 (NCI Thesaurus Property-2)
C4037772 (UMLS CUI [1,1])
C1512890 (UMLS CUI [1,2])
Protocol International Breast Cancer Study Group Identifier Number
Item
IBCSG Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25530 (NCI Thesaurus Property-2)
C1507394 (UMLS CUI [1,1])
C1512890 (UMLS CUI [1,2])
RandomizationNumber
Item
Randomization No.
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus ValueDomain)
C0600091 (UMLS 2011AA ValueDomain)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
Institution Identifier Number
Item
Institution Code Number
text
C25337 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C1301943 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
InstitutionName
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C0018704 (UMLS 2011AA ValueDomain-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Item Group
Long Term Follow-up Medication
C1517942 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
Item
Did the patient receive bone active medication other than calcium or vitamin D during this follow-up period (e.g., bisphosphonates)
text
C25180 (NCI Thesaurus ValueDomain)
C3298 (NCI Thesaurus Property)
C459 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property-2)
C0029456 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
CL.1
Code List
Did the patient receive bone active medication other than calcium or vitamin D during this follow-up period (e.g., bisphosphonates)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS CUI-1)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS CUI-1)
CL Item
Continuing (Continuing)
C1553904 (UMLS CUI-1)
Item
If yes or continuing
integer
C25284 (NCI Thesaurus ValueDomain)
C3298 (NCI Thesaurus Property)
C459 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property-2)
C0029456 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
CL.2
Code List
If yes or continuing
CL Item
Biphosphonate Therapy (1)
C0012544 (UMLS CUI-1)
CL Item
Other (2)
C0205394 (UMLS CUI-1)
Medication Osteoporosis, specify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C3298 (NCI Thesaurus Property)
C459 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property-2)
C0029456 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item
Did the patient receive glucocorticosteroids during this follow-up period
text
C459 (NCI Thesaurus ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C2322 (NCI Thesaurus Property)
C25382 (NCI Thesaurus Property-2)
C25180 (NCI Thesaurus ValueDomain)
C0001617 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
CL.3
Code List
Did the patient receive glucocorticosteroids during this follow-up period
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS CUI-1)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS CUI-1)
CL Item
Continuing (Continuing)
C1553904 (UMLS CUI-1)
Concomitant Medication OtherCorticosteroid
Item
Specify (If yes or continuing, medication)
text
C459 (NCI Thesaurus ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C17649 (NCI Thesaurus Property)
C2322 (NCI Thesaurus Property-2)
C25382 (NCI Thesaurus Property-3)
C25685 (NCI Thesaurus ValueDomain)
C0013227C0001617 (UMLS CUI [1])
Item
Did the patient receive continuous, non-steroidal, anti-inflammatory drug during this follow-up period (e.g., COX-2 inhibitors, aspirin, Ibuprofen)
text
C16960 (NCI Thesaurus ObjectClass)
C18772 (NCI Thesaurus Property)
C257 (NCI Thesaurus Property-2)
C25340 (NCI Thesaurus Property-3)
C25647 (NCI Thesaurus Property-4)
C25180 (NCI Thesaurus ValueDomain)
C0003211 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
CL.4
Code List
Did the patient receive continuous, non-steroidal, anti-inflammatory drug during this follow-up period (e.g., COX-2 inhibitors, aspirin, Ibuprofen)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS CUI-1)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS CUI-1)
CL Item
Continuing (Continuing)
C1553904 (UMLS CUI-1)
Nonsteroidal Antiinflammatory Drug Medication
Item
Specify (If yes or continuing, medication)
text
C459 (NCI Thesaurus ObjectClass)
C257 (NCI Thesaurus ObjectClass-2)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus Property-2)
C25685 (NCI Thesaurus ValueDomain)
C0013227 (UMLS CUI [1,1])
C0003211 (UMLS CUI [1,2])
Item
Did patient receive extended adjuvant endocrine therapy for primary breast cancer during this follow-up period (If treatment was given for breast cancer recurrence, do not record)
text
C25180 (NCI Thesaurus ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C2367461 (UMLS CUI [1])
CL.5
Code List
Did patient receive extended adjuvant endocrine therapy for primary breast cancer during this follow-up period (If treatment was given for breast cancer recurrence, do not record)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS CUI-1)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS CUI-1)
CL Item
Continuing (Continuing)
C1553904 (UMLS CUI-1)
Adjuvant Hormone Therapy Begin Date
Item
Begin date (If yes or continuing day month year)
date
C15445 (NCI Thesaurus ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C25431 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C2367461 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Adjuvant Hormone Therapy End Date
Item
End date (day month year)
date
C15445 (NCI Thesaurus ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C25275 (NCI Thesaurus Property)
C25496 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C2367461 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Adjuvant Hormonal Therapy Administered Type (Extended)
integer
C25284 (NCI Thesaurus ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C2367461 (UMLS CUI [1])
CL.6
Code List
Adjuvant Hormonal Therapy Administered Type (Extended)
CL Item
Letrozole (1)
C0246421 (UMLS CUI-1)
CL Item
Tamoxifen (2)
C0039286 (UMLS CUI-1)
CL Item
Anastrozole (3)
C0290883 (UMLS CUI-1)
CL Item
Exemestane (4)
C0851344 (UMLS CUI-1)
CL Item
Other (5)
C0205394 (UMLS CUI-1)
New Adjuvant Hormone Therapy, specify
Item
Other, specify
text
C25586 (NCI Thesaurus ObjectClass)
C15445 (NCI Thesaurus ObjectClass-2)
C2140 (NCI Thesaurus ObjectClass-3)
C25382 (NCI Thesaurus Property)
C25685 (NCI Thesaurus ValueDomain)
C2367461 (UMLS CUI [1])
Item
Reason Stopped (If extended treatment stopped, what was the reason)
integer
C25638 (NCI Thesaurus ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25484 (NCI Thesaurus Property)
C4288399 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
CL.7
Code List
Reason Stopped (If extended treatment stopped, what was the reason)
CL Item
Completed Treatment (1)
C0580352 (UMLS CUI-1)
CL Item
Physician Decision (2)
C1709536 (UMLS CUI-1)
CL Item
Adverse Event (3)
C0877248 (UMLS CUI-1)
CL Item
Disease progression or second malignancy (4)
C0242656 (UMLS CUI-1)
C0085183 (UMLS CUI-3)
CL Item
Other (5)
C0205394 (UMLS CUI-1)
Off-treatment Reason
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property)
C1518544 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Item Group
Footer Module
C2825232 (UMLS CUI-1)
Investigator Signature
Item
Investigator/Designee Signature
text
C25704 (NCI Thesaurus ValueDomain)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25479 (NCI Thesaurus Property-2)
C2346576 (UMLS CUI [1])
Investigator Signature Date
Item
Signature date
date
C25164 (NCI Thesaurus ValueDomain)
C25678 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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