Instructions: For registration step 1, submit this form within 2 weeks after going off study, if patient is off study without randomization to extended vs. standard LND. List treatments that the patient received. Systemic Therapy: List regimens, start and end dates. For multidrug regimens, do not list individual drugs separately; end date would be the date all drugs in the regimen were discontinued. Surgery: List type of surgery, and in the "end date" column, the date of surgery. Radiation: List sites, start and end dates (inclusive of boosts and implants)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Trial subject ID SWOG
Item
SWOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
Protocol ID SWOG
Item
SWOG Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Patient Initials
Item
Patient Initials (L, F M)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Investigator Name
Item
Physician
text
C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)
Participating Group
Item
Participating Group Name
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item Group
Treatment Information
C0087111 (UMLS CUI-1)
Treatment
Item
Did the patient receive any treatment (on this registration step)
boolean
C38148 (NCI Thesaurus ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C0087111 (UMLS CUI-1)
Treatment Begin Date
Item
Treatment Start Date (MM DD YYYY)
date
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus Property)
C3173309 (UMLS CUI-1)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Treatment End Date
Item
Treatment End Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C1531784 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C25496 (NCI Thesaurus Property-2)
ProcedureLocationText
Item
Regimen or Procedure or Site(s)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25218 (NCI Thesaurus ObjectClass)
C1948041 (UMLS 2011AA ObjectClass)
Item Group
Off Treatment Reason
C1518544 (UMLS CUI-1)
C0566251 (UMLS CUI-2)
Item
Off Study Reason (select one)
text
C25196 (NCI Thesaurus ObjectClass)
C25601 (NCI Thesaurus ObjectClass-2)
C25629 (NCI Thesaurus ObjectClass-3)
C25365 (NCI Thesaurus Property)
C25638 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C0566251 (UMLS CUI-2)
CL.2
Code List
Off Study Reason (select one)
CL Item
Ineligible For Randomization To Extended Vs. Standard Lnd Due To Extent Of Disease At The Time Of Surgery (1)
CL Item
Adverse Event/side Effects/complications (2)
CL Item
Patient Withdrawal/refusal (3)
CL Item
Disease Progression (4)
CL Item
Death On Study (5)
CL Item
Other (6)
Off-TreatmentAdverseEventReasonSpecify
Item
Adverse event/side effects/complications specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25638 (NCI Thesaurus Property)
C0392360 (UMLS 2011AA Property)
C41331 (NCI Thesaurus Property-2)
C0877248 (UMLS 2011AA Property-2)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
Off-TreatmentPatientReasonSpecify
Item
Patient withdrawal/refusal, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25638 (NCI Thesaurus Property)
C0392360 (UMLS 2011AA Property)
C16960 (NCI Thesaurus Property-2)
C0030705 (UMLS 2011AA Property-2)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
Off-TreatmentDiseaseProgressionAnatomicSiteSpecify
Item
Sites
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C13717 (NCI Thesaurus Property)
C1515974 (UMLS 2011AA Property)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C17747 (NCI Thesaurus ObjectClass-2)
C0242656 (UMLS 2011AA ObjectClass-2)
Off Treatment Reason, specify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
C1521902 (UMLS CUI-3)
Off-TreatmentStudyFollow-UpEndDate
Item
Off Study Date (MM DD YYYY Date of progression, death or decision to discontinue)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C15206 (NCI Thesaurus ObjectClass-2)
C0008972 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item Group
Additional Treatment
C1706712 (UMLS CUI-1)
Item
Will patient receive further treatment?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25519 (NCI Thesaurus ObjectClass-2)
C1517331 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.3
Code List
Will patient receive further treatment?
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)
FurtherTreatmentSpecify
Item
Yes, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25519 (NCI Thesaurus ObjectClass-2)
C1517331 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item Group
Vital Status
C1148433 (UMLS CUI-1)
Date last contact
Item
Date of Last Contact or Death (MM DD YYYY)
date
C16960 (NCI Thesaurus ObjectClass)
C0805839 (UMLS CUI-1)
C25461 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Vital Status
text
C16960 (NCI Thesaurus ObjectClass)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25717 (NCI Thesaurus Property)
C3846084 (UMLS CUI-1)
CL.4
Code List
Vital Status
CL Item
Alive (Alive)
C2584946 (UMLS CUI-1)
CL Item
Dead (Dead)
C0011065 (UMLS CUI-1)
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