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StudyEvent: Phase II Breast Cancer - End of Treatment Summary Form
1. No Instruction available.

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

CRF Header

Item Group

Crf Header

Protocol ID Coordinating Group

Item

Coordinating Group Protocol No.

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1711341 (UMLS CUI-2)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Coordinating Group Code

Item

Coordinating Group Code

text

C25162 (NCI Thesaurus ValueDomain)
C1711341 (UMLS CUI-1)
C17005 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25462 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)

Protocol Title

Item

Protocol Title

text

C25191 (NCI Thesaurus ValueDomain)
C2986303 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C42774 (NCI Thesaurus Property)

Patient Study ID

Item

Patient Study ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Registering Group Code

Item

Registering Group Code

text

C25162 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C17005 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25645 (NCI Thesaurus ObjectClass-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)

Registering Institution Code

Item

Registering Institution Code

text

C25162 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25645 (NCI Thesaurus ObjectClass-2)

Patient Initials

Item

Patient Initials

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)

Form Administration

Item Group

Lung: Adverse Events

Person Completing Form

Item

Person Completing Form

text

C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)

Data amended

Item

Are data amended (If data are amended, please circle in red when using paper form)

boolean

C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)

Breast: Treatment Plan

Item Group

Lung: Treatment Plan

Treatment Start Date

Item

First Date (any modality of) protocol therapy was given

date

C15368 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus ObjectClass-2)
C3173309 (UMLS CUI-1)
C25431 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)

Treatment End Date

Item

Last Date (any modality of) protocol therapy was given

date

C25164 (NCI Thesaurus ValueDomain)
C1531784 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C25496 (NCI Thesaurus Property-2)

Off Treatment Reason

Item

Reason Treatment Ended

text

C25638 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)

CL.2

Code List

Reason Treatment Ended

CL Item

Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)

CL Item

Disease Progression Before Active Treatment (Disease Progression before active treatment)

CL Item

Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)

CL Item

Death On Study (Death on study)

CL Item

Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)

CL Item

Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal/refusal prior to beginning protocol therapy)

CL Item

Alternative Therapy (Alternative therapy)

CL Item

Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)

CL Item

Lost To Follow-up (Lost to follow-up)

CL310949 (NCI Metathesaurus)

CL Item

Cytogenetic Resistance (Cytogenetic Resistance)

CL Item

Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)

CL Item

No Treatment, Per Protocol Criteria (No treatment, per protocol criteria)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

Off-treatmentAlternativeReasonSpecify

Item

Alternative Therapy (Specify)

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25415 (NCI Thesaurus Property)
C1523987 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)

Off Treatment Reason, specify

Item

Complicating Disease (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)
C25455 (NCI Thesaurus Property-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)

Breast: Treatment Schedule ¿ Systemic Therapy

Item Group

Lung: Treatment Schedule ¿ Radiation Therapy

Total number of cycles

Item

Total Number of Cycles given

float

C25304 (NCI Thesaurus Property)
C2045831 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C25379 (NCI Thesaurus Property-2)

Dose Modification

Item

Were there any dose modifications or additions/omissions to protocol treatment?

text

C25180 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25256 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain-2)

CL.3

Code List

Were there any dose modifications or additions/omissions to protocol treatment?

CL Item

Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned)

CL Item

Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

Breast: Treatment Schedule ¿ Radiation Therapy

Item Group

Lung: Treatment Schedule ¿ Radiation Therapy

Total Dose to Lung

Item

Total Dose to Lung (cGy)

float

C15313 (NCI Thesaurus ObjectClass)
C2169193 (UMLS CUI-1)
C12468 (NCI Thesaurus Property)
C0024109 (UMLS CUI-2)
C25382 (NCI Thesaurus Property-2)
C25304 (NCI Thesaurus ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)

Unscheduled Interruptions in Radiation Therapy

Item

Were there any unscheduled interruptions in radiation therapy?

text

C25180 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C1512900 (UMLS CUI-2)
C25542 (NCI Thesaurus Property)

CL.4

Code List

Were there any unscheduled interruptions in radiation therapy?

CL Item

Yes, Due To Toxicity (Yes, due to toxicity)

CL Item

Yes, For Other Reasons, Specify (Yes, for other reasons, specify)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

Radiation Therapy Interruption Reason

Item

Specify RT interruption reason

text

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS CUI-1)
C25594 (NCI Thesaurus Property)
C3538832 (UMLS CUI-2)
C25211 (NCI Thesaurus Property-2)
C25542 (NCI Thesaurus Property-3)
C25685 (NCI Thesaurus ValueDomain)

Breast: Off-Study Follow-up

Item Group

Lung: Off-study Follow-up

PatientProtocolEndPointFollow-upInd-3

Item

Is the patient currently being followed for study endpoints? (whether on or off treatment)

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C16033 (NCI Thesaurus Property-2)
C1522577 (UMLS 2011AA Property-2)
C25212 (NCI Thesaurus Property-3)
C2349179 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

Off-TreatmentStudyFollow-UpReason

Item

Off Study Reason (If no,)

text

C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C15206 (NCI Thesaurus ObjectClass-2)
C0008972 (UMLS 2011AA ObjectClass-2)

CL.6

Code List

Off Study Reason (If no,)

CL Item

Protocol-defined Follow-up Completed (Protocol-defined follow-up completed)

CL Item

Patient Refused Follow-up (Patient refused follow-up)

CL Item

Lost To Follow-up (Patient lost to follow-up)

CL310949 (NCI Metathesaurus)

CL Item

Death (Death)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

Off-TreatmentStudyFollow-UpEndDate

Item

Off Study Date

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)

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)

Comments

Item Group

Comments

Research Comments

Item

Comments

text

C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)

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