ID

2928

Description

CALGB: 80303 FOLLOW-UP FORM 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=D5EC9696-FBE6-0D66-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D5EC9696-FBE6-0D66-E034-0003BA12F5E7

Keywords

Uploaded on

September 19, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Pancreatic Cancer NCT00088894 Follow-Up - CALGB: 80303 FOLLOW-UP FORM - 2271365v3.0

model
Details

No Instruction available.

1 forms

StudyEvent: CALGB: 80303 FOLLOW-UP FORM
1. No Instruction available.

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

Unnamed1

Item Group

Unnamed1

ProtocolCALGBIdentifierNumber

Item

CALGB Study No

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)

ProtocolCALGBIdentifierNumber

Item

CALGB Study No

text

PatientCALGBIdentifierNumber

Item

CALGB Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)

TreatmentReportingPeriodBeginDate

Item

Reporting period start date

date

C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)

PatientLastContactDate

Item

To (Date of last contact)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C25461 (NCI Thesaurus Property)
C0337611 (UMLS 2011AA Property)

DataAmendedInd-3

Item

Are data amended?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)

CL.1

Code List

Are data amended?

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Unnamed2

Item Group

Unnamed2

PatientInitialsName

Item

Patient Initials

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)

ParticipatingGroupName

Item

Participating Group

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PatientMedicalRecordNumber

Item

Patient Hospital No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25198 (NCI Thesaurus Property)
C0034869 (UMLS 2011AA Property)

ProtocolParticipatingIdentifierNumber

Item

Participating Group Protocol No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

CombinedInstitutionName

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)

PatientParticipatingIdentifierNumber

Item

Participating Group Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

Unnamed3

Item Group

Unnamed3

PatientVitalStatus

Item

Survival status

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18003 (NCI Thesaurus ValueDomain)
C0442732 (UMLS 2011AA ValueDomain)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.2

Code List

Survival status

CL Item

Alive (Alive)

CL Item

Dead (Dead)

CL Item

Lost to follow-up (Lost to follow-up)

PerformanceStatusScale

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.3

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))

TREATMENT DATA

Item Group

Treatment Data

ProtocolTreatmentCurrentReceivedInd-2

Item

Treatment type

text

C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass)
C0442711 (UMLS 2011AA ObjectClass)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.4

Code List

Treatment type

CL Item

Yes (Patient is receiving protocol therapy)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (Patient is in post-treatment follow-up)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

TreatmentTotalCourseCount

Item

Number of cycles given during this time period

double

C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)

PatientOff-treatmentInd-3

Item

Status of assigned treatment

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25601 (NCI Thesaurus Property)
C1518544 (UMLS 2011AA Property)

CL.5

Code List

Status of assigned treatment

CL Item

Yes (Therapy has been terminated permanently)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (Therapy is being continued)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

TreatmentEndDate

Item

Date treatment ended or date of last dose given

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25496 (NCI Thesaurus Property)
C2746065 (UMLS 2011AA Property)

DoseModificationInd

Item

Was protocol treatment modified or delayed during this time period?

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus ObjectClass)
C1265611 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain)

CL.6

Code List

Was protocol treatment modified or delayed during this time period?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (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)

DoseModificationText

Item

specify

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus ObjectClass)
C1265611 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)

Non-protocolTherapyOtherAdministeredInd-3

Item

Has the patient received non-protocol therapy for cancer during the follow-up period?

text

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.7

Code List

Has the patient received non-protocol therapy for cancer during the follow-up period?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Non-protocolTherapyOtherAdministeredName

Item

specify

text

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)

AnticoagulantAgentAdministeredind-3

Item

Is the patient on full-dose anticoagulants?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C263 (NCI Thesaurus ObjectClass)
C0003280 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.8

Code List

Is the patient on full-dose anticoagulants?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

AnticoagulantAgentAdministeredReason

Item

specify reason

text

C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C263 (NCI Thesaurus ObjectClass)
C0003280 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

Unnamed4

Item Group

Unnamed4

ProtocolCALGBIdentifierNumber

Item

CALGB Study No

text

ProtocolCALGBIdentifierNumber

Item

CALGB Study No

text

PatientCALGBIdentifierNumber

Item

CALGB Patient ID

text

TreatmentReportingPeriodBeginDate

Item

Reporting period start date

date

Unnamed5

Item Group

Unnamed5

PatientInitialsName

Item

Patient Initials

text

EXAMINATION DATA

Item Group

Examination Data

AssessmentMethodType

Item

Unnamed question

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)

CL.9

Code List

Unnamed question

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)

CL Item

CA 19-9 (CA 19-9)

AssessmentMethodSpecify

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)

TumorMarkerCA-19-9TestValue

Item

CA 19-9 Results, Value

double

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)
C0006613 (UMLS 2011AA Property)

TumorMarkerCA-19-9TestDate

Item

CA 19-9 Results, Date collected

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C17220 (NCI Thesaurus ObjectClass)
C0041365 (UMLS 2011AA ObjectClass)
C327 (NCI Thesaurus Property)
C0006613 (UMLS 2011AA Property)

TUMOR RESPONSE DATA

Item Group

Tumor Response Data

MyelomaResponseBestDocumentedType

Item

Best overall tumor response to date

text

C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C3242 (NCI Thesaurus ObjectClass)
C0026764 (UMLS 2011AA ObjectClass)
C25432 (NCI Thesaurus Property)
C1522427 (UMLS 2011AA Property)
C25356 (NCI Thesaurus Property)
C1301725 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.10

Code List

Best overall tumor response to date

CL Item

Complete Response (Complete response)

CL Item

Partial Response (Partial response)

C18212 (NCI Thesaurus)

CL Item

Stable Disease (Stable disease)

C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)

CL Item

Progressive Disease (Progression)

C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)

CL Item

Unevaluable (Unevaluable)

C62222 (NCI Thesaurus)
C1883425 (UMLS 2011AA)

CompleteResponseConfirmedInd-3

Item

CR confirmed

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus ObjectClass)
C0205197 (UMLS 2011AA ObjectClass)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)

CL.11

Code List

CR confirmed

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PartialResponseConfirmedInd-3

Item

PR confirmed

text

C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25378 (NCI Thesaurus ObjectClass)
C0728938 (UMLS 2011AA ObjectClass)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ValueDomain)
C0871261 (UMLS 2011AA ValueDomain)

CL.12

Code List

PR confirmed

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

StableDiseaseConfirmedInd-3

Item

SD confirmed

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus ValueDomain)
C0871261 (UMLS 2011AA ValueDomain)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)

CL.13

Code List

SD confirmed

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CompleteResponseFirstObservedDate

Item

Date of CR onset

date

C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus ObjectClass)
C0205197 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

PartialResponseFirstObservedDate

Item

Date of PR onset

date

C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25378 (NCI Thesaurus ObjectClass)
C0728938 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

DiseaseProgressionDate

Item

Date of progression

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

ResponsiblePersonName

Item

Completed by

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

FormOriginalCompleteDate

Item

Date form completed

date

C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25604 (NCI Thesaurus Property)
C0205313 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

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Model comments :

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Item comments for :

Pancreatic Cancer NCT00088894 Follow-Up - CALGB: 80303 FOLLOW-UP FORM - 2271365v3.0

No Instruction available.

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