ID

6762

Beschreibung

CALGB: 30610 Treatment and Response Form Three Different Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3C3834F7-372A-2795-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3C3834F7-372A-2795-E044-0003BA3F9857

Stichworte

Versionen (2)
  1. 19.09.12 19.09.12 -
  2. 08.01.15 08.01.15 - Martin Dugas
Hochgeladen am

8. Januar 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy
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Lung Cancer NCT00632853 Treatment - CALGB: 30610 Treatment and Response Form - 2688627v1.0

Englisch

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted.

1 Formulare  
Ccrr Module For Calgb 90202: Skeletal Survey Form
Beschreibung

Ccrr Module For Calgb 90202: Skeletal Survey Form

CALGB Form (C-1244)
Beschreibung

Form ID CALGB

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3262252
NCI Thesaurus ObjectClass
C19464
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass-2
C25442
CALGB Study No.
Beschreibung

Protocol ID CALGB

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
CALGB Patient ID
Beschreibung

Trial subject ID CALGB

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
Reporting Period Start Date
Beschreibung

Reporting Period Start Date

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25616
UMLS CUI-1
C2361257
NCI Thesaurus Property-2
C25651
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Reporting Period End Date
Beschreibung

Reporting Period End Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2361259
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25651
Are data amended
Beschreibung

Data amended

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Patient Initials (Last, First Middle)
Beschreibung

Patient Initials

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Patient Hospital No.
Beschreibung

Medical Record Number

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Institution/Affiliate
Beschreibung

Institution Name

Datentyp

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
Beschreibung

Participating Group

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Participating Group Study No.
Beschreibung

Study Number Participating Group

Datentyp

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
Participating Group Patient ID
Beschreibung

Trial subject ID Participating Group

Datentyp

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
Survival Date
Beschreibung

Survival Date

Vital Status (Mark one with an X.)
Beschreibung

Patient Status

Datentyp

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
Beschreibung

Date last contact

Datentyp

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
Treatment Data
Beschreibung

Treatment Data

Reporting Period
Beschreibung

Clinical Trial Period

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2347804
NCI Thesaurus ObjectClass
C25214
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass-2
C25651
BSA
Beschreibung

Body Surface Area

Datentyp

float

Maßeinheiten
  • m2
Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C0005902
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus Property
C25157
m2
Number of cycles given (this reporting period)
Beschreibung

TherapyCourseAdministeredCount

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Total dose of cisplatin administered this reporting period (mg)
Beschreibung

CisplatinAgentDuringReportingPeriodAdministeredDose

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C376
UMLS 2011AA ObjectClass
C0008838
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25651
UMLS 2011AA Property-2
C0700287
NCI Thesaurus Property-3
C25382
UMLS 2011AA Property-3
C1521801
NCI Thesaurus Property-4
C25490
UMLS 2011AA Property-4
C0347984
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
Total dose of etoposide administered this reporting period (mg)
Beschreibung

EtoposideAgentDuringReportingPeriodAdministeredDose

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C491
UMLS 2011AA ObjectClass-2
C0015133
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25651
UMLS 2011AA Property-2
C0700287
NCI Thesaurus Property-3
C25382
UMLS 2011AA Property-3
C1521801
NCI Thesaurus Property-4
C25490
UMLS 2011AA Property-4
C0347984
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
Total dose of radiation therapy administered during this reporting period
Beschreibung

RadiationTherapyReportPeriodAdministeredDose

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
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
C25488
UMLS 2011AA ValueDomain
C0178602
Were there any dose modifications or additions/omissions to protocol treatment? (Radiation therapy)
Beschreibung

Dose Modification

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25256
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain-2
C25572
Were there any dose modifications or additions/omissions to protocol treatment? (Radiation therapy)
Beschreibung

Dose Modification

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25256
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain-2
C25572
Reason Treatment Ended
Beschreibung

Off Treatment Reason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
Alternative Therapy
Beschreibung

Off-treatmentAlternativeReasonSpecify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus Property
C25415
UMLS 2011AA Property
C1523987
NCI Thesaurus Property-2
C25365
UMLS 2011AA Property-2
C0678257
Other specify
Beschreibung

Off Treatment Reason, specify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
UMLS CUI-3
C1521902
Response Data
Beschreibung

Response Data

Date of Last Clinical Assessment
Beschreibung

Follow-Up Date

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C9305
UMLS CUI-1
C3694716
NCI Thesaurus Property
C16033
NCI Thesaurus Property-2
C25365
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Best Overall Response to date
Beschreibung

Best Overall Response

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS CUI-1
C2986560
NCI Thesaurus ObjectClass-2
C25605
NCI Thesaurus ObjectClass-3
C25432
NCI Thesaurus Property
C25755
NCI Thesaurus ValueDomain
C25284
Complete Response (CR) First Observed Date
Beschreibung

Complete Response First Observed Date

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C25755
UMLS CUI-1
C0677874
NCI Thesaurus ObjectClass-2
C25250
UMLS CUI-2
C1115465
NCI Thesaurus Property
C25509
NCI Thesaurus Property-2
C25599
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Partial Response (PR) First Observed Date
Beschreibung

Partial Response First Observed Date

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C25755
UMLS CUI-1
C1521726
NCI Thesaurus ObjectClass-2
C25378
UMLS CUI-2
C1115465
NCI Thesaurus Property
C25509
NCI Thesaurus Property-2
C25599
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Progressive Disease (PD) Observed Date
Beschreibung

Progressive Disease Observed Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1335499
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus Property
C25599
UMLS CUI-2
C0011008
Sites of Progression
Beschreibung

Progression Site

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS CUI-1
C0242656
NCI Thesaurus Property
C25341
UMLS CUI-2
C1515974
NCI Thesaurus ObjectClass
C25331
Other specify
Beschreibung

Progression Site, specify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C0242656
NCI Thesaurus Property
C25341
UMLS CUI-2
C1515974
NCI Thesaurus ObjectClass
C25331
Site of progression with regard to RT fields
Beschreibung

RadiationFieldCancerProgressionAnatomicSite

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus ObjectClass
C54648
UMLS 2011AA ObjectClass
C1882536
NCI Thesaurus Property
C19987
UMLS 2011AA Property
C0242656
Footer
Beschreibung

Footer

Completed by (Last name, First name)
Beschreibung

Person Completing Form

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date Form Originally Completed
Beschreibung

Form Completion Date

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C19464
UMLS CUI-1
C1549507
NCI Thesaurus Property
C25250
NCI Thesaurus Property-2
C25604
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
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INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted.

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Ccrr Module For Calgb 90202: Skeletal Survey Form
Form ID CALGB
Item
CALGB Form (C-1244)
text
C25337 (NCI Thesaurus ValueDomain)
C3262252 (UMLS CUI-1)
C19464 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)
Protocol ID CALGB
Item
CALGB Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Trial subject ID CALGB
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Reporting Period Start Date
Item
Reporting Period Start Date
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
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
Data amended
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Patient Initials
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (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)
Participating Group
Item
Participating Group
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)
Item Group
Survival Date
Item
Vital Status (Mark one with an X.)
text
C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25717 (NCI Thesaurus Property)
CL.2
Code List
Vital Status (Mark one with an X.)
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 Group
Treatment Data
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)
CL.3
Code List
Reporting Period
CL Item
Cycles 1 & 2 (Cycles 1 & 2)
CL Item
Cycles 3 & 4 (Cycles 3 & 4)
Body Surface Area
Item
BSA
float
C25190 (NCI Thesaurus ObjectClass)
C0005902 (UMLS CUI-1)
C25712 (NCI Thesaurus ValueDomain)
C25157 (NCI Thesaurus Property)
TherapyCourseAdministeredCount
Item
Number of cycles given (this reporting period)
float
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
CisplatinAgentDuringReportingPeriodAdministeredDose
Item
Total dose of cisplatin administered this reporting period (mg)
float
C376 (NCI Thesaurus ObjectClass)
C0008838 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C25490 (NCI Thesaurus Property-4)
C0347984 (UMLS 2011AA Property-4)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
EtoposideAgentDuringReportingPeriodAdministeredDose
Item
Total dose of etoposide administered this reporting period (mg)
float
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C491 (NCI Thesaurus ObjectClass-2)
C0015133 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property-2)
C0700287 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C25490 (NCI Thesaurus Property-4)
C0347984 (UMLS 2011AA Property-4)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
RadiationTherapyReportPeriodAdministeredDose
Item
Total dose of radiation therapy administered during this reporting period
float
C15313 (NCI Thesaurus ObjectClass)
C1522449 (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)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
Item
Were there any dose modifications or additions/omissions to protocol treatment? (Radiation therapy)
text
C25180 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25256 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain-2)
CL.5
Code List
Were there any dose modifications or additions/omissions to protocol treatment? (Radiation therapy)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
Item
Were there any dose modifications or additions/omissions to protocol treatment? (Radiation therapy)
text
C25180 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25256 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain-2)
CL.5
Code List
Were there any dose modifications or additions/omissions to protocol treatment? (Radiation therapy)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
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.6
Code List
Reason Treatment Ended
CL Item
Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Death On Study (Death on study)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
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)
Off-treatmentAlternativeReasonSpecify
Item
Alternative Therapy
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
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)
Item Group
Response Data
Follow-Up Date
Item
Date of Last Clinical Assessment
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)
Item
Best Overall Response to date
text
C3262 (NCI Thesaurus ObjectClass)
C2986560 (UMLS CUI-1)
C25605 (NCI Thesaurus ObjectClass-2)
C25432 (NCI Thesaurus ObjectClass-3)
C25755 (NCI Thesaurus Property)
C25284 (NCI Thesaurus ValueDomain)
CL.7
Code List
Best Overall Response to date
CL Item
Complete Response (CR)
CL Item
Partial Response (PR)
C18212 (NCI Thesaurus)
CL Item
Stable Disease (SD)
C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)
CL Item
Progressive Disease (PD)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
CL Item
Insufficient Evaluation (Insufficient evaluation to determine response status)
Complete Response First Observed Date
Item
Complete Response (CR) First Observed Date
date
C25755 (NCI Thesaurus ObjectClass)
C0677874 (UMLS CUI-1)
C25250 (NCI Thesaurus ObjectClass-2)
C1115465 (UMLS CUI-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Partial Response First Observed Date
Item
Partial Response (PR) First Observed Date
date
C25755 (NCI Thesaurus ObjectClass)
C1521726 (UMLS CUI-1)
C25378 (NCI Thesaurus ObjectClass-2)
C1115465 (UMLS CUI-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Progressive Disease Observed Date
Item
Progressive Disease (PD) Observed Date
date
C25164 (NCI Thesaurus ValueDomain)
C1335499 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C25331 (NCI Thesaurus ObjectClass)
C25599 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
Item
Sites of Progression
text
C13717 (NCI Thesaurus ValueDomain)
C0242656 (UMLS CUI-1)
C25341 (NCI Thesaurus Property)
C1515974 (UMLS CUI-2)
C25331 (NCI Thesaurus ObjectClass)
CL.8
Code List
Sites of Progression
CL Item
Bone (Bone)
C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)
CL Item
Brain (Brain)
C12439 (NCI Thesaurus)
C0006104 (UMLS 2011AA)
CL Item
Hilar Lymph Node (Hilar lymph nodes)
C1305372 (NCI Metathesaurus)
CL Item
Liver (Liver)
C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)
CL Item
Lung, Nos (Lung)
C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)
CL Item
Mediastinal Lymph Node (Mediastinal lymph nodes)
C33073 (NCI Thesaurus)
C0588055 (UMLS 2011AA)
CL Item
Contralateral Lung (Opposite lung)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C17649 (NCI Thesaurus-3)
C0205394 (UMLS 2011AA-4)
CL Item
Pleura (Pleura)
C12469 (NCI Thesaurus)
C0032225 (UMLS 2011AA)
Progression Site, specify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C0242656 (UMLS CUI-1)
C25341 (NCI Thesaurus Property)
C1515974 (UMLS CUI-2)
C25331 (NCI Thesaurus ObjectClass)
Item
Site of progression with regard to RT fields
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C54648 (NCI Thesaurus ObjectClass)
C1882536 (UMLS 2011AA ObjectClass)
C19987 (NCI Thesaurus Property)
C0242656 (UMLS 2011AA Property)
CL.9
Code List
Site of progression with regard to RT fields
CL Item
Outside The Rt Field And Outside The Initial (pre-chemotherapy) Tumor Volume (Outside the RT field and outside the initial (pre-chemotherapy) tumor volume)
CL Item
Outside The Rt Field And Within The Initial (pre-chemotherapy) Tumor Volume (Outside the RT field and within the initial (pre-chemotherapy) tumor volume)
CL Item
Within Delivered/intended Low Dose Volume (Within delivered/intended low dose volume)
CL Item
Within The Delivered/intended High Dose Volume (Within the delivered/intended high dose volume)
Item Group
Footer
Person Completing Form
Item
Completed by (Last name, First name)
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Form Completion Date
Item
Date Form Originally Completed
date
C19464 (NCI Thesaurus ObjectClass)
C1549507 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
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