ID

10905

Beschreibung

CALGB: 80303 ON-STUDY FORM NCT00088894 Gemcitabine With or Without Bevacizumab in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D6006B65-CAFE-728C-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D6006B65-CAFE-728C-E034-0003BA12F5E7

Stichworte

Versionen (3)
  1. 19.09.12 19.09.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
  3. 12.06.15 12.06.15 -
Hochgeladen am

12. Juni 2015

DOI

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Lizenz

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CALGB: 80303 ON-STUDY FORM NCT00088894

Englisch

No Instruction available.

1 Formulare  
  1. StudyEvent: CALGB: 80303 ON-STUDY FORM
    1. No Instruction available.
Header
Beschreibung

Header

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
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 demographics
Beschreibung

Patient demographics

Patient Initials
Beschreibung

Patient Initials

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
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
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
Participating Group Protocol 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
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 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
Treatment begin
Beschreibung

Treatment begin

Treatment start date
Beschreibung

Treatment Begin Date

Datentyp

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
Patient Description
Beschreibung

Patient Description

Height (cm)
Beschreibung

Patient Height

Datentyp

float

Maßeinheiten
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0489786
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
cm
Weight (kg)
Beschreibung

Patient Weight

Datentyp

float

Maßeinheiten
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
BSA (m^2)
Beschreibung

Body Surface Area

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005902
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25157
Performance Status
Beschreibung

PerformanceStatusScale

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C25361
UMLS 2011AA ObjectClass
C0597198
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Has the patient had any prior cancer diagnosed?
Beschreibung

PriorCancerDiagnosisInd-3

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
specify type of cancer
Beschreibung

PriorCancerType

Datentyp

text

date of diagnosis
Beschreibung

PriorCancerDiagnosisDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Laboratory Data At Study Entry
Beschreibung

Laboratory Data At Study Entry

Absolute neutrophil count (1000/mcL)
Beschreibung

Neutrophil count

Datentyp

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
Platelets (1000/mcL)
Beschreibung

Platelets

Datentyp

float

Maßeinheiten
  • 1000/uL
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0005821
NCI Thesaurus Property-2
C12520
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
1000/uL
Total Bilirubin (1000/mcL)
Beschreibung

LaboratoryProcedureTotalBilirubinResultSpecifiedValue

Datentyp

float

Maßeinheiten
  • 1000/uL
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C38037
UMLS 2011AA Property-2
C0201913
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C38024
UMLS 2011AA ValueDomain-2
C0205369
1000/uL
Bilirubin ULN
Beschreibung

HepaticBilirubinLabUpperLimitNormalValue

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C305
UMLS 2011AA Property-2
C0005437
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
SGOT (U/L)
Beschreibung

SGOT (AST)

Datentyp

float

Maßeinheiten
  • U/L
Alias
NCI Thesaurus Property
C25202
UMLS CUI-1
C0201899
NCI Thesaurus Property-2
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
U/L
SGOT ULN
Beschreibung

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Datentyp

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
PT INR
Beschreibung

INR

Datentyp

float

Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0525032
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property-2
C25352
NCI Thesaurus ValueDomain
C25712
Serum Creatinine (mg/dL)
Beschreibung

RenalCreatinineLabSpecifiedValue

Datentyp

float

Maßeinheiten
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25225
UMLS 2011AA ObjectClass
C0022646
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus Property-2
C25294
UMLS 2011AA Property-2
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
CA 19-9
Beschreibung

TumorMarkerCA-19-9TestValue

Datentyp

float

Alias
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus ObjectClass
C17220
UMLS 2011AA ObjectClass
C0041365
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property-2
C327
UMLS 2011AA Property-2
C0006613
Urine protein
Beschreibung

UrineProtein

Datentyp

text

Alias
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ObjectClass
C17243
UMLS 2011AA ObjectClass
C0042077
24-hour urine collection (grams protein/24 hours)
Beschreibung

LaboratoryProcedureTotalUrineProteinOutcomeUnspecifiedValue

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25304
UMLS 2011AA Property
C0439810
NCI Thesaurus Property-2
C13283
UMLS 2011AA Property-2
C0042036
NCI Thesaurus Property-3
C20200
UMLS 2011AA Property-3
C1274040
NCI Thesaurus Property-4
C17021
UMLS 2011AA Property-4
C0033684
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Examination Data At Study Entry
Beschreibung

Examination Data At Study Entry

Evaluation method
Beschreibung

Evaluation method

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C16847
UMLS CUI-1
C2911685
Other, specify
Beschreibung

Evaluation method, specify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C2911685
NCI Thesaurus ObjectClass
C20989
UMLS CUI-2
C1521902
NCI Thesaurus Property
C16847
Prior Therapy Data
Beschreibung

Prior Therapy Data

Has the patient had prior chemotherapy or immunotherapy for the following target areas? Pancreatic cancer
Beschreibung

Hasthepatienthadpriorchemotherapyorimmunotherapyforthefollowingtargetareas?Pancreaticcancer

Datentyp

text

Yes, specify
Beschreibung

Agent

Datentyp

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
End date
Beschreibung

Medication End Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
UMLS CUI-2
C0806020
NCI Thesaurus Property
C25275
Has the patient had prior chemotherapy or immunotherapy for the following target areas? Resected
Beschreibung

Hasthepatienthadpriorchemotherapyorimmunotherapyforthefollowingtargetareas?Resected

Datentyp

text

Has the patient had prior chemotherapy or immunotherapy for the following target areas? Metastatic disease - unresected
Beschreibung

Hasthepatienthadpriorchemotherapyorimmunotherapyforthefollowingtargetareas?Metastaticdisease-unresected

Datentyp

text

Has the patient had prior chemotherapy or immunotherapy for the following target areas? Other cancer, specify
Beschreibung

Hasthepatienthadpriorchemotherapyorimmunotherapyforthefollowingtargetareas?Othercancer,specify

Datentyp

text

Other cancer, specify
Beschreibung

Othercancer,specify

Datentyp

text

Has the patient had prior radiotherapy for the following target areas? Pancreatic cancer
Beschreibung

Hasthepatienthadpriorradiotherapyforthefollowingtargetareas?Pancreaticcancer

Datentyp

text

Has the patient had prior radiotherapy for the following target areas? Resected
Beschreibung

Hasthepatienthadpriorradiotherapyforthefollowingtargetareas?Resected

Datentyp

text

Has the patient had prior radiotherapy for the following target areas? Metastatic disease - unresected
Beschreibung

Hasthepatienthadpriorradiotherapyforthefollowingtargetareas?Metastaticdisease-unresected

Datentyp

text

Yes, specify
Beschreibung

Yes,specify

Datentyp

text

End date
Beschreibung

Enddate

Datentyp

text

Has the patient had prior radiotherapy for the following target areas? Other cancer, specify
Beschreibung

Hasthepatienthadpriorradiotherapyforthefollowingtargetareas?Othercancer,specify

Datentyp

text

Yes, specify
Beschreibung

Yes,specify

Datentyp

text

Other cancer, specify
Beschreibung

Othercancer,specify

Datentyp

text

End date
Beschreibung

Enddate

Datentyp

text

Has the patient had any invasive surgical procedures?
Beschreibung

Hasthepatienthadanyinvasivesurgicalprocedures?

Datentyp

boolean

specify date
Beschreibung

specifydate

Datentyp

text

Is the patient on full-dose anticoagulants?
Beschreibung

Isthepatientonfull-doseanticoagulants?

Datentyp

boolean

specify reason
Beschreibung

specifyreason

Datentyp

text

Has the patient taken a thrombolytic agent within 1 month prior to registration?
Beschreibung

Hasthepatienttakenathrombolyticagentwithin1monthpriortoregistration?

Datentyp

boolean

Patient Medical History
Beschreibung

Patient Medical History

Does the patient have clinically significant cardiovascular disease?
Beschreibung

Doesthepatienthaveclinicallysignificantcardiovasculardisease?

Datentyp

boolean

Does the patient have a serious or non-healing wound, ulcer or bone fracture?
Beschreibung

Doesthepatienthaveaseriousornon-healingwound,ulcerorbonefracture?

Datentyp

boolean

Does the patient have an active infection requiring parental antibiotics?
Beschreibung

Doesthepatienthaveanactiveinfectionrequiringparentalantibiotics?

Datentyp

boolean

Completed by
Beschreibung

Completedby

Datentyp

text

Date form completed
Beschreibung

Dateformcompleted

Datentyp

text

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1 Formulare
  1. StudyEvent: CALGB: 80303 ON-STUDY FORM
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header
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)
Data amended
Item
Are data amended?
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Patient demographics
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
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)
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)
Study Number Participating Group
Item
Participating Group Protocol 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)
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)
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
Treatment begin
Treatment Begin Date
Item
Treatment start date
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)
Item Group
Patient Description
Patient Height
Item
Height (cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
Patient Weight
Item
Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Body Surface Area
Item
BSA (m^2)
float
C25209 (NCI Thesaurus ValueDomain)
C0005902 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)
Item
Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25361 (NCI Thesaurus ObjectClass)
C0597198 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.2
Code List
Performance Status
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction (karnofsky 90 - 100) (ecog - 0 Asymptomatic) (Fully active, able to carry on all pre-disease performance without restriction (ECOG=0))
CL Item
Restricted In Physically Strenuous Activity But Ambulatory (k70 - 80) (ecog - 1 Symptomatic - Fully Ambulatory) (Restricted in physically strenuous activity but ambulatory (ECOG=1))
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities (k 50 - 60) (ecog - 2 Symptomatic; In Bed , 50% Of The Day) (Ambulatory and capable of selfcare, but unable to carry out any work activities (ECOG=2))
CL Item
Capable Of Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (k 30 - 40) (ecog - 3 Symptomatic; In Bed > 50% Of The Day But Not Bedridden) (Capable of limited selfcare, confined to bed or chair more than 50% of waking hours (ECOG=3))
CL Item
Completely Disabled (k10 - 20) (ecog - 4 Bedridden) (Completely disabled (ECOG=4))
PriorCancerDiagnosisInd-3
Item
Has the patient had any prior cancer diagnosed?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
PriorCancerType
Item
specify type of cancer
text
PriorCancerDiagnosisDate
Item
date of diagnosis
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
Item Group
Laboratory Data At Study Entry
Neutrophil count
Item
Absolute neutrophil count (1000/mcL)
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
Platelets (1000/mcL)
float
C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
LaboratoryProcedureTotalBilirubinResultSpecifiedValue
Item
Total Bilirubin (1000/mcL)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C0205369 (UMLS 2011AA ValueDomain-2)
HepaticBilirubinLabUpperLimitNormalValue
Item
Bilirubin ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property-2)
C0005437 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
SGOT (AST)
Item
SGOT (U/L)
float
C25202 (NCI Thesaurus Property)
C0201899 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
Item
SGOT ULN
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)
INR
Item
PT INR
float
C20200 (NCI Thesaurus Property)
C0525032 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25352 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
RenalCreatinineLabSpecifiedValue
Item
Serum Creatinine (mg/dL)
float
C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
TumorMarkerCA-19-9TestValue
Item
CA 19-9
float
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C17220 (NCI Thesaurus ObjectClass)
C0041365 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C327 (NCI Thesaurus Property-2)
C0006613 (UMLS 2011AA Property-2)
Item
Urine protein
text
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C17243 (NCI Thesaurus ObjectClass)
C0042077 (UMLS 2011AA ObjectClass)
CL.4
Code List
Urine protein
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1+ (1+)
CL Item
2+ (2+)
CL Item
3+ (3+)
CL Item
4+ (4+)
LaboratoryProcedureTotalUrineProteinOutcomeUnspecifiedValue
Item
24-hour urine collection (grams protein/24 hours)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C13283 (NCI Thesaurus Property-2)
C0042036 (UMLS 2011AA Property-2)
C20200 (NCI Thesaurus Property-3)
C1274040 (UMLS 2011AA Property-3)
C17021 (NCI Thesaurus Property-4)
C0033684 (UMLS 2011AA Property-4)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item Group
Examination Data At Study Entry
Item
Evaluation method
text
C25284 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
C2911685 (UMLS CUI-1)
CL.5
Code List
Evaluation method
CL Item
Chest X-ray (Chest X-ray)
CL Item
Ct Scan (CT scan - chest)
CL Item
Ct Scan (CT scan abdomen/pelvis)
CL Item
Mri (MRI)
CL Item
Other, Specify (Other, specify)
Evaluation method, specify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C16847 (NCI Thesaurus Property)
Item Group
Prior Therapy Data
Item
Has the patient had prior chemotherapy or immunotherapy for the following target areas? Pancreatic cancer
text
CL.6
Code List
Has the patient had prior chemotherapy or immunotherapy for the following target areas? Pancreatic cancer
CL Item
No (No)
CL Item
Yes, specify (Yes, specify)
Agent
Item
Yes, specify
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Medication End Date
Item
End date
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
Item
Has the patient had prior chemotherapy or immunotherapy for the following target areas? Resected
text
CL.7
Code List
Has the patient had prior chemotherapy or immunotherapy for the following target areas? Resected
CL Item
No (No)
CL Item
Yes, specify (Yes, specify)
Item
Has the patient had prior chemotherapy or immunotherapy for the following target areas? Metastatic disease - unresected
text
CL.8
Code List
Has the patient had prior chemotherapy or immunotherapy for the following target areas? Metastatic disease - unresected
CL Item
No (No)
CL Item
Yes, specify (Yes, specify)
Item
Has the patient had prior chemotherapy or immunotherapy for the following target areas? Other cancer, specify
text
CL.9
Code List
Has the patient had prior chemotherapy or immunotherapy for the following target areas? Other cancer, specify
CL Item
No (No)
CL Item
Yes, specify (Yes, specify)
Othercancer,specify
Item
Other cancer, specify
text
Item
Has the patient had prior radiotherapy for the following target areas? Pancreatic cancer
text
CL.10
Code List
Has the patient had prior radiotherapy for the following target areas? Pancreatic cancer
CL Item
No (No)
CL Item
Yes, specify (Yes, specify)
Item
Has the patient had prior radiotherapy for the following target areas? Resected
text
CL.11
Code List
Has the patient had prior radiotherapy for the following target areas? Resected
CL Item
No (No)
CL Item
Yes, specify (Yes, specify)
Item
Has the patient had prior radiotherapy for the following target areas? Metastatic disease - unresected
text
CL.12
Code List
Has the patient had prior radiotherapy for the following target areas? Metastatic disease - unresected
CL Item
No (No)
CL Item
Yes, specify (Yes, specify)
Yes,specify
Item
Yes, specify
text
Enddate
Item
End date
text
Item
Has the patient had prior radiotherapy for the following target areas? Other cancer, specify
text
CL.13
Code List
Has the patient had prior radiotherapy for the following target areas? Other cancer, specify
CL Item
No (No)
CL Item
Yes, specify (Yes, specify)
Yes,specify
Item
Yes, specify
text
Othercancer,specify
Item
Other cancer, specify
text
Enddate
Item
End date
text
Hasthepatienthadanyinvasivesurgicalprocedures?
Item
Has the patient had any invasive surgical procedures?
boolean
specifydate
Item
specify date
text
Isthepatientonfull-doseanticoagulants?
Item
Is the patient on full-dose anticoagulants?
boolean
specifyreason
Item
specify reason
text
Hasthepatienttakenathrombolyticagentwithin1monthpriortoregistration?
Item
Has the patient taken a thrombolytic agent within 1 month prior to registration?
boolean
Item Group
Patient Medical History
Doesthepatienthaveclinicallysignificantcardiovasculardisease?
Item
Does the patient have clinically significant cardiovascular disease?
boolean
Doesthepatienthaveaseriousornon-healingwound,ulcerorbonefracture?
Item
Does the patient have a serious or non-healing wound, ulcer or bone fracture?
boolean
Doesthepatienthaveanactiveinfectionrequiringparentalantibiotics?
Item
Does the patient have an active infection requiring parental antibiotics?
boolean
Completedby
Item
Completed by
text
Dateformcompleted
Item
Date form completed
text
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