ID

8082

Descripción

CALGB: 30801 Respiratory On-Study Form Gemcitabine Hydrochloride or Pemetrexed Disodium and Carboplatin With or Without Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6AF26CA3-DD74-EEE0-E040-BB89AD436D54

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6AF26CA3-DD74-EEE0-E040-BB89AD436D54

Palabras clave

Versiones (3)
  1. 19/9/12 19/9/12 -
  2. 11/8/14 11/8/14 - Martin Dugas
  3. 9/1/15 9/1/15 - Martin Dugas
Subido en

9 de enero de 2015

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0 Legacy
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Lung Cancer NCT01041781 On-Study - CALGB: 30801 Respiratory On-Study Form - 2891327v1.0

Inglés

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. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice...

1 formularios  
Ccrr Module For Calgb 90202: Skeletal Survey Form
Descripción

Ccrr Module For Calgb 90202: Skeletal Survey Form

CALGB Form
Descripción

Form ID CALGB

Tipo de datos

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.
Descripción

Protocol ID CALGB

Tipo de datos

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
Descripción

Trial subject ID CALGB

Tipo de datos

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
Treatment Begin Date (MM DD YYYY)
Descripción

Treatment Begin Date

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25431
UMLS CUI-1
C3173309
NCI Thesaurus Property-2
C25275
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Are data amended
Descripción

Data amended

Tipo de datos

boolean

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

Patient Initials

Tipo de datos

text

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

Medical Record Number

Tipo de datos

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
Descripción

Institution Name

Tipo de datos

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
Descripción

Participating Group

Tipo de datos

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.
Descripción

Study Number Participating Group

Tipo de datos

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
Descripción

Trial subject ID Participating Group

Tipo de datos

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
Disease Status
Descripción

Disease Status

MedDRA Code (disease)
Descripción

MedDRACode

Tipo de datos

float

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
Histologic Type (Mark one with an X.)
Descripción

Histologic Type

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS CUI-1
C0449574
NCI Thesaurus ObjectClass-2
C12468
NCI Thesaurus Property
C25526
NCI Thesaurus Property-2
C25161
NCI Thesaurus ValueDomain
C25372
NCI Thesaurus ValueDomain-2
C25526
Other specify
Descripción

Histologic Type, other

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1299220
NCI Thesaurus ObjectClass
C3262
NCI Thesaurus Property
C25526
NCI Thesaurus Property-2
C25161
Medical History (Does the patient have any of the following)
Descripción

ConcomitantDiseasePersonalMedicalHistoryType

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass-2
C25730
UMLS 2011AA ObjectClass-2
C0521115
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Smoking History (Mark one with an X.)
Descripción

Smoking history

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1519384
NCI Thesaurus ObjectClass
C17934
NCI Thesaurus Property
C18772
Number pack years smoked (If former or current smoker Pack year = number of packs smoked/day x number of years smoked)
Descripción

CigaretteSmokingHistoryPackYearAmount

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C17934
UMLS 2011AA ObjectClass
C0453996
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
NCI Thesaurus ValueDomain
C25417
Vital Status
Descripción

Vital Status

Performance Status (Mark one with an X.)
Descripción

ECOG Performance Status

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Prior Therapy
Descripción

Prior Therapy

Prior radiation therapy
Descripción

PriorRTHistoryInd-3

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Prior radiation therapy stop date (MM DD YYYY)
Descripción

PriorRadiationTherapyAdministeredEndDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15313
UMLS 2011AA ObjectClass
C1522449
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Prior chemotherapy, immunotherapy or systemic treatment for NSCLC
Descripción

PriorChemotherapyImmunotherapySystemicTherapyNon-SmallCellLungCancerAdministeredInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C15698
UMLS 2011AA ObjectClass-2
C1515119
NCI Thesaurus ObjectClass-3
C15262
UMLS 2011AA ObjectClass-3
C0021083
NCI Thesaurus ObjectClass-4
C25629
UMLS 2011AA ObjectClass-4
C0332152
NCI Thesaurus Property
C2926
UMLS 2011AA Property
C0007131
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Prior Surgery
Descripción

Prior Surgery

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0744961
NCI Thesaurus Property
C38000
NCI Thesaurus ObjectClass
C15329
NCI Thesaurus ObjectClass-2
C25629
Date of prior surgery (MM DD YYYY)
Descripción

PriorSurgeryDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15329
UMLS 2011AA ObjectClass
C0543467
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Stage (Indicate extent of disease prior to surgery Mark one with an X.)
Descripción

PriorTherapeuticProcedureLungStageExtentType

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C12468
UMLS 2011AA ObjectClass
C0024109
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus ObjectClass-3
C49236
UMLS 2011AA ObjectClass-3
C0087111
NCI Thesaurus Property
C16899
UMLS 2011AA Property
C1300072
NCI Thesaurus Property-2
C25332
UMLS 2011AA Property-2
C0439792
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Stage (Indicate extent of disease prior to surgery Mark one with an X.)
Descripción

PriorTherapeuticProcedureLungStageExtentType

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C12468
UMLS 2011AA ObjectClass
C0024109
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus ObjectClass-3
C49236
UMLS 2011AA ObjectClass-3
C0087111
NCI Thesaurus Property
C16899
UMLS 2011AA Property
C1300072
NCI Thesaurus Property-2
C25332
UMLS 2011AA Property-2
C0439792
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Prior steroid therapy for CNS metastases
Descripción

PriorSteroidTherapyCentralNervousSystemMetastasisAdministeredInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C15370
UMLS 2011AA ObjectClass-2
C0149783
NCI Thesaurus Property
C19151
UMLS 2011AA Property
C0027627
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Metathesaurus Property
C0007679
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Steroid Therapy End Date (MM DD YYYY)
Descripción

PriorSteroidTherapyCentralNervousSystemMetastasisAdministeredEndDate

Tipo de datos

date

Alias
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus ObjectClass-2
C15370
UMLS 2011AA ObjectClass-2
C0149783
NCI Thesaurus Property
C19151
UMLS 2011AA Property
C0027627
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Metathesaurus Property
C0007679
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Lab Data At Protocol Entry
Descripción

Lab Data At Protocol Entry

WBC (10^3/microL)
Descripción

Leukocytes (WBC)

Tipo de datos

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0023508
NCI Thesaurus Property
C12529
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Granulocytes (%)
Descripción

LaboratoryProcedureGranulocyteResultPercentageValue

Tipo de datos

float

Unidades de medida
  • %
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C12530
UMLS 2011AA Property-2
C0018183
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
%
ANC (10^3/microL)
Descripción

Neutrophil count

Tipo de datos

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0200633
NCI Thesaurus Property
C12533
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C25304
NCI Thesaurus ValueDomain-2
C25712
Platelet count (10^3/microL)
Descripción

Platelets

Tipo de datos

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0005821
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C12520
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Estimated creatinine clearance (calculated ml/min)
Descripción

LaboratoryProcedureCreatinineClearanceOutcomeEstimateValue

Tipo de datos

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C25747
UMLS 2011AA Property-2
C0373595
NCI Thesaurus ValueDomain
C25498
UMLS 2011AA ValueDomain
C0750572
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
Bilirubin (mg/dL)
Descripción

LaboratoryProcedureTotalBilirubinResultValue

Tipo de datos

float

Unidades de medida
  • mg/dL
Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property-2
C38037
UMLS 2011AA Property-2
C0201913
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
SGOT (AST) (U/L)
Descripción

SGOT (AST)

Tipo de datos

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201899
NCI Thesaurus Property
C25202
NCI Thesaurus Property-2
C20200
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
SGOT (AST) ULN (U/L)
Descripción

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Tipo de datos

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
SGPT (ALT) (U/L)
Descripción

SGPT (ALT)

Tipo de datos

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201836
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C25293
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
SGPT (ALT) ULN (U/L)
Descripción

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

Tipo de datos

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C25293
UMLS 2011AA Property-2
C0376147
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
Albumin (g/dL)
Descripción

LaboratoryProcedureAlbuminResultUnspecifiedValue

Tipo de datos

float

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C214
UMLS 2011AA Property-2
C0001924
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Tnm Staging
Descripción

Tnm Staging

Clinical T Stage (Mark one with an X.)
Descripción

T Stage clinical

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS CUI-1
C0475455
NCI Thesaurus ObjectClass-2
C12468
UMLS CUI-2
C0205210
NCI Thesaurus Property
C25398
NCI Thesaurus Property-2
C25728
NCI Thesaurus ValueDomain
C16899
Clinical N Stage (Mark one with an X.)
Descripción

N Stage clinical

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS CUI-1
C0456532
NCI Thesaurus ObjectClass-2
C12468
UMLS CUI-2
C0205210
NCI Thesaurus Property
C25398
NCI Thesaurus Property-2
C25580
NCI Thesaurus ValueDomain
C16899
Clinical M Stage (Mark one with an X.)
Descripción

M Stage clinical

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS CUI-1
C0456533
NCI Thesaurus ObjectClass-2
C12468
UMLS CUI-2
C0205210
NCI Thesaurus Property
C25398
NCI Thesaurus Property-2
C25727
NCI Thesaurus ValueDomain
C16899
Footer
Descripción

Footer

Completed by (Last name, First name)
Descripción

Person Completing Form

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date Form Completed (MM DD YYYY)
Descripción

Date Form Completed

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
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. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice...

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Ccrr Module For Calgb 90202: Skeletal Survey Form
Form ID CALGB
Item
CALGB Form
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)
Treatment Begin Date
Item
Treatment Begin 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)
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
Disease Status
MedDRACode
Item
MedDRA Code (disease)
float
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
Item
Histologic Type (Mark one with an X.)
text
C3262 (NCI Thesaurus ObjectClass)
C0449574 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C25526 (NCI Thesaurus Property)
C25161 (NCI Thesaurus Property-2)
C25372 (NCI Thesaurus ValueDomain)
C25526 (NCI Thesaurus ValueDomain-2)
CL.2
Code List
Histologic Type (Mark one with an X.)
CL Item
Adenocarcinoma (Adenocarcinoma)
C2852 (NCI Thesaurus)
C0001418 (UMLS 2011AA)
CL Item
Squamous Cell Carcinoma (Squamous cell carcinoma)
C2929 (NCI Thesaurus)
C0007137 (UMLS 2011AA)
CL Item
Large Cell Carcinoma (Large cell carcinoma)
C3780 (NCI Thesaurus)
C0206704 (UMLS 2011AA)
CL Item
Bronchoalveolar (bac) (Bronchoalveolar carcinoma (BAC))
CL Item
Other (Other specify)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C17649 (NCI Thesaurus-3)
C0205394 (UMLS 2011AA-4)
Histologic Type, other
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1299220 (UMLS CUI-1)
C3262 (NCI Thesaurus ObjectClass)
C25526 (NCI Thesaurus Property)
C25161 (NCI Thesaurus Property-2)
Item
Medical History (Does the patient have any of the following)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
CL.3
Code List
Medical History (Does the patient have any of the following)
CL Item
Untreated Cns Metastases (Untreated CNS metastases)
CL Item
Known Hypersensitivity To Aspirin, Nsaid Or Sulfonamides (Known hypersensitivity to aspirin, NSAID or sulfonamides)
CL Item
Active Ulcer Disease (Active ulcer disease)
CL Item
Prior Treatment With Other Investigational Therapy (Prior treatment with other investigational therapy)
CL Item
Using Current Regimen Of Another Nsaid (Using current regimen of another NSAID)
Item
Smoking History (Mark one with an X.)
text
C25180 (NCI Thesaurus ValueDomain)
C1519384 (UMLS CUI-1)
C17934 (NCI Thesaurus ObjectClass)
C18772 (NCI Thesaurus Property)
CL.4
Code List
Smoking History (Mark one with an X.)
CL Item
Never Smoked (Never smoked)
CL Item
Smoked In The Past (Smoked in the past)
CL Item
Currently Smoking (Currently smoking)
CigaretteSmokingHistoryPackYearAmount
Item
Number pack years smoked (If former or current smoker Pack year = number of packs smoked/day x number of years smoked)
text
C17934 (NCI Thesaurus ObjectClass)
C0453996 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C25417 (NCI Thesaurus ValueDomain)
Item Group
Vital Status
Item
Performance Status (Mark one with an X.)
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
CL.5
Code List
Performance Status (Mark one with an X.)
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
Item Group
Prior Therapy
PriorRTHistoryInd-3
Item
Prior radiation therapy
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
PriorRadiationTherapyAdministeredEndDate
Item
Prior radiation therapy stop date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
PriorChemotherapyImmunotherapySystemicTherapyNon-SmallCellLungCancerAdministeredInd-2
Item
Prior chemotherapy, immunotherapy or systemic treatment for NSCLC
boolean
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C15698 (NCI Thesaurus ObjectClass-2)
C1515119 (UMLS 2011AA ObjectClass-2)
C15262 (NCI Thesaurus ObjectClass-3)
C0021083 (UMLS 2011AA ObjectClass-3)
C25629 (NCI Thesaurus ObjectClass-4)
C0332152 (UMLS 2011AA ObjectClass-4)
C2926 (NCI Thesaurus Property)
C0007131 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Prior Surgery
Item
Prior Surgery
boolean
C38148 (NCI Thesaurus ValueDomain)
C0744961 (UMLS CUI-1)
C38000 (NCI Thesaurus Property)
C15329 (NCI Thesaurus ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
PriorSurgeryDate
Item
Date of prior surgery (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item
Stage (Indicate extent of disease prior to surgery Mark one with an X.)
text
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C49236 (NCI Thesaurus ObjectClass-3)
C0087111 (UMLS 2011AA ObjectClass-3)
C16899 (NCI Thesaurus Property)
C1300072 (UMLS 2011AA Property)
C25332 (NCI Thesaurus Property-2)
C0439792 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.10
Code List
Stage (Indicate extent of disease prior to surgery Mark one with an X.)
CL Item
I (I)
CL Item
Ii (II)
CL Item
Iiia (IIIA)
CL Item
Iiib (IIIB)
CL Item
Iv (IV)
Item
Stage (Indicate extent of disease prior to surgery Mark one with an X.)
text
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C49236 (NCI Thesaurus ObjectClass-3)
C0087111 (UMLS 2011AA ObjectClass-3)
C16899 (NCI Thesaurus Property)
C1300072 (UMLS 2011AA Property)
C25332 (NCI Thesaurus Property-2)
C0439792 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.10
Code List
Stage (Indicate extent of disease prior to surgery Mark one with an X.)
CL Item
I (I)
CL Item
Ii (II)
CL Item
Iiia (IIIA)
CL Item
Iiib (IIIB)
CL Item
Iv (IV)
PriorSteroidTherapyCentralNervousSystemMetastasisAdministeredInd-2
Item
Prior steroid therapy for CNS metastases
boolean
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15370 (NCI Thesaurus ObjectClass-2)
C0149783 (UMLS 2011AA ObjectClass-2)
C19151 (NCI Thesaurus Property)
C0027627 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C0007679 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PriorSteroidTherapyCentralNervousSystemMetastasisAdministeredEndDate
Item
Steroid Therapy End Date (MM DD YYYY)
date
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15370 (NCI Thesaurus ObjectClass-2)
C0149783 (UMLS 2011AA ObjectClass-2)
C19151 (NCI Thesaurus Property)
C0027627 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C0007679 (NCI Metathesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Lab Data At Protocol Entry
Leukocytes (WBC)
Item
WBC (10^3/microL)
float
C25294 (NCI Thesaurus ObjectClass)
C0023508 (UMLS CUI-1)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureGranulocyteResultPercentageValue
Item
Granulocytes (%)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12530 (NCI Thesaurus Property-2)
C0018183 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Neutrophil count
Item
ANC (10^3/microL)
float
C25294 (NCI Thesaurus ObjectClass)
C0200633 (UMLS CUI-1)
C12533 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25304 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Platelets
Item
Platelet count (10^3/microL)
float
C25294 (NCI Thesaurus ObjectClass)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C12520 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureCreatinineClearanceOutcomeEstimateValue
Item
Estimated creatinine clearance (calculated ml/min)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25747 (NCI Thesaurus Property-2)
C0373595 (UMLS 2011AA Property-2)
C25498 (NCI Thesaurus ValueDomain)
C0750572 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureTotalBilirubinResultValue
Item
Bilirubin (mg/dL)
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
SGOT (AST)
Item
SGOT (AST) (U/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0201899 (UMLS CUI-1)
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
Item
SGOT (AST) ULN (U/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
SGPT (ALT)
Item
SGPT (ALT) (U/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0201836 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C25293 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue
Item
SGPT (ALT) ULN (U/L)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureAlbuminResultUnspecifiedValue
Item
Albumin (g/dL)
float
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C214 (NCI Thesaurus Property-2)
C0001924 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item Group
Tnm Staging
Item
Clinical T Stage (Mark one with an X.)
text
C3262 (NCI Thesaurus ObjectClass)
C0475455 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C0205210 (UMLS CUI-2)
C25398 (NCI Thesaurus Property)
C25728 (NCI Thesaurus Property-2)
C16899 (NCI Thesaurus ValueDomain)
CL.12
Code List
Clinical T Stage (Mark one with an X.)
CL Item
Primary Tumor Cannot Be Assessed, Or Tumor Proven By The Presence Of Malignant Cells In Sputum Or Bronchial Washings But Not Visualized By Imaging Or Bronchoscopy (Tx)
CL Item
No Evidence Of Primary Tumor (T0)
CL Item
Carcinoma In Situ (Tis)
C2917 (NCI Thesaurus)
C0007099 (UMLS 2011AA)
CL Item
Tumor 3 Cm Or Less In Greatest Dimension, Surrounded By Lung Or Visceral Pleura, Invasion More Proximal Than The Lobar Bronchus, (i.e., Not In The Main Bronchus) (T1)
CL Item
Tumor With Any Of The Following Features Of Size Or Extent: More Than 3cm In Greatest Dimension; Invades The Visceral Pleura; Associated With Atelectasis Or Obstructive Pneumonitis That Extends To The Hilar Region But Does Not Involve The Entire Lung (T2)
CL Item
Tumor Of Any Size That Directly Invades Any Of The Following: Chest Wall (including Superior Sulcus Tumors), Diaphragm, Mediastinal Pleura, Parietal Pericardium; Or Tumor In The Main Bronchus Less Than 2 Cm Distal To The Carina, But Without Involvement O* (T3)
CL Item
Tumor Of Any Size That Directly Invades Any Of The Following: Chest Wall (including Superior Sulcus Tumors), Diaphragm, Mediastinal Pleura, Parietal Pericardium; Or Tumor In The Main Bronchus Less Than 2 Cm Distal To The Carina, But Without Involvement O* (T4)
Item
Clinical N Stage (Mark one with an X.)
text
C3262 (NCI Thesaurus ObjectClass)
C0456532 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C0205210 (UMLS CUI-2)
C25398 (NCI Thesaurus Property)
C25580 (NCI Thesaurus Property-2)
C16899 (NCI Thesaurus ValueDomain)
CL.13
Code List
Clinical N Stage (Mark one with an X.)
CL Item
Regional Lymph Nodes Cannot Be Assessed (NX)
CL Item
No Regional Lymph Node Metastasis (N0)
CL Item
Metastasis To Ipsilateral Peribronchial And/or Ipsilateral Hilar Lymph Nodes, And Intrapulmonary Nodes Including Involvement By Direct Extension Of The Primary Tumor (N1)
CL Item
Metastasis To Ipsilateral Mediastinal And/or Subcarinal Lymph Node(s) (N2)
CL Item
Metastasis To Contralateral Mediastinal, Contralateral Hilar, Ipsilateral Or Contralateral Scalene, Or Supraclavicular Lymph Node(s) (N3)
Item
Clinical M Stage (Mark one with an X.)
text
C3262 (NCI Thesaurus ObjectClass)
C0456533 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C0205210 (UMLS CUI-2)
C25398 (NCI Thesaurus Property)
C25727 (NCI Thesaurus Property-2)
C16899 (NCI Thesaurus ValueDomain)
CL.14
Code List
Clinical M Stage (Mark one with an X.)
CL Item
Distant Metastasis Cannot Be Assessed (MX)
CL Item
No Distant Metastasis (M0)
CL Item
Distant Metastasis Present (M1)
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)
Date Form Completed
Item
Date Form Completed (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
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