ID

10743

Beschreibung

CALGB: 90401 FOLLOW-UP FORM NCT00110214 Docetaxel and Prednisone With or Without Bevacizumab in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=EFB2FF09-853B-4EB3-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=EFB2FF09-853B-4EB3-E034-0003BA3F9857

Stichworte

Klinische Studie [Dokumenttyp]

Treatment Form

Prostatatumoren

Hochgeladen am

8. Juni 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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CALGB: 90401 FOLLOW-UP FORM NCT00110214

Modell
Details

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..

1 Formulare

StudyEvent: CALGB: 90401 FOLLOW-UP FORM
1. 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..

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Header

Item Group

Header

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)

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 demographics

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)

Patient Hospital No

Item

Patient Hospital No

text

C25337 (NCI Thesaurus ValueDomain)
C0421459 (UMLS CUI-1)
C16960 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
C16696 (NCI Thesaurus ObjectClass)

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)

VITAL STATUS

Item Group

Vital Status

Patient Status

Item

Patient's 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

Patient's vital status (Mark one with an X.)

CL Item

Alive (Alive)

CL Item

Dead (Dead)

CL Item

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

Primary Cause of Death

Item

Primary cause of death (Mark one with an X.)

text

C25638 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C28554 (NCI Thesaurus Property)
C25251 (NCI Thesaurus ValueDomain-2)

CL.3

Code List

Primary cause of death (Mark one with an X.)

CL Item

Due To Protocol Treatment (Due to protocol treatment)

CL Item

Due To This Disease (Due to this disease)

CL Item

Due To Other Cause (Due to other cause)

Cause of Death, specify

Item

Describe cause of death

text

C25685 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C28554 (NCI Thesaurus Property)

ECOG Performance Status

Item

ECOG Performance Status

text

C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)

CL.4

Code List

ECOG Performance Status

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)

CL Item

Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)

CL Item

Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)

CL Item

Dead (5)

Patient Weight

Item

Patient Weight (current)

float

C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)

Treatment Status

Item

TREATMENT STATUS (Mark one with an X.)

text

C15368 (NCI Thesaurus ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0749659 (UMLS CUI-1)
C25365 (NCI Thesaurus Property)

CL.5

Code List

TREATMENT STATUS (Mark one with an X.)

CL Item

Protocol Therapy (Protocol therapy)

CL Item

Follow-up, Off Protocol Therapy (Follow-up, off protocol therapy)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

TreatmentDescriptionSpecify

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

Disease Assessment

Item Group

Disease Assessment

Documented clinical assessment for this cancer

Item

Has the patient had a documented clinical assessment for this cancer?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1522577 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C0006826 (UMLS CUI-2)
C9305 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property-2)

PatientPhysicalExaminationMostRecentDate

Item

Date of most recent physical exam

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25577 (NCI Thesaurus ValueDomain-2)
C1513491 (UMLS 2011AA ValueDomain-2)

SurgicalProcedureAdministeredMostRecentDate

Item

Date of most recent biopsy or surgery

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25577 (NCI Thesaurus ValueDomain-2)
C1513491 (UMLS 2011AA ValueDomain-2)

DiagnosticImagingProcedureMostRecentDate

Item

Most recent CT/MRI scan date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C25218 (NCI Thesaurus Property)
C1948041 (UMLS 2011AA Property)
C25577 (NCI Thesaurus ValueDomain-2)
C1513491 (UMLS 2011AA ValueDomain-2)

BoneScanMedicalImagingAssessmentMostRecentDate

Item

Most recent bone scan date

date

C17646 (NCI Thesaurus ObjectClass)
C0203668 (UMLS 2011AA ObjectClass)
C16831 (NCI Thesaurus ObjectClass-2)
C25367 (NCI Thesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25577 (NCI Thesaurus ValueDomain-2)
C1513491 (UMLS 2011AA ValueDomain-2)

BoneLesionBoneScanDocumentedIdentifiedValue

Item

Number of new bone lesions documented since baseline

text

C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C12366 (NCI Thesaurus ObjectClass-2)
C0262950 (UMLS 2011AA ObjectClass-2)
C17646 (NCI Thesaurus Property)
C0203668 (UMLS 2011AA Property)
C25737 (NCI Thesaurus Property-2)
C0205396 (UMLS 2011AA Property-2)
C25356 (NCI Thesaurus Property-3)
C1301725 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

CL.7

Code List

Number of new bone lesions documented since baseline

CL Item

None (0)

C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)

CL Item

1 Bone Lesion (1)

CL Item

2 Bone Lesions (2)

CL Item

3 Or More Bone Lesions (3 or more)

CL Item

Bone Scan Not Done (Bone scan not done)

DISEASE RESPONSE

Item Group

Disease Response

TumorResponseType

Item

Response Status at This Assessment

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)

CL.8

Code List

Response Status at This Assessment

CL Item

Complete Response (CR)

CL Item

Insufficient Evaluation (Insufficient evaluation to determine response status)

CL Item

Progressive Disease (PD)

C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)

CL Item

Partial Response (PR)

C18212 (NCI Thesaurus)

CL Item

Stable Disease (SD)

C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)

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)

ProgressionFirstObservedDate

Item

Progressive Disease First Observed Date (per CT/MRI)

date

C25331 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property-2)
C1441672 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

DiseaseResponseSite

Item

Sites of response (Mark all that apply with an X.)

text

C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C25341 (NCI Thesaurus Property-2)
C0450429 (UMLS 2011AA Property-2)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

CL.9

Code List

Sites of response (Mark all that apply with an X.)

CL Item

Lymph Nodes (Lymph nodes)

CL Item

Liver (Liver)

C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)

CL Item

Lung (Lung)

C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)

CL Item

Pleura (Pleura)

C12469 (NCI Thesaurus)
C0032225 (UMLS 2011AA)

CL Item

Cns/brain (CNS/Brain)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

ProstateDiseaseProgressionSiteSpecify

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C17747 (NCI Thesaurus Property-2)
C0242656 (UMLS 2011AA Property-2)

CompleteResponseObservedInd-2

Item

Complete response

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus ObjectClass-2)
C0205197 (UMLS 2011AA ObjectClass-2)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)

DISEASE PROGRESSION

Item Group

Disease Progression

DiseaseProgressionInd-3

Item

Has patient developed a first progression that has not been previously reported? (or relapse)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

ProstateDiseaseProgressionSite

Item

Sites of progression during this reporting period (Mark one with an X.)

text

C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C12410 (NCI Thesaurus ObjectClass)
C0033572 (UMLS 2011AA ObjectClass)
C17747 (NCI Thesaurus Property-2)
C0242656 (UMLS 2011AA Property-2)

CL.12

Code List

Sites of progression during this reporting period (Mark one with an X.)

CL Item

Biochemical Progression (Biochemical progression)

CL Item

Bone (Bone)

C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)

CL Item

Lymph Nodes (Lymph nodes)

CL Item

Liver (Liver)

C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)

CL Item

Lung (Lung)

C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)

CL Item

Pleura (Pleura)

C12469 (NCI Thesaurus)
C0032225 (UMLS 2011AA)

CL Item

Cns/brain (CNS/Brain)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

BiochemicalProgressionFirstDate

Item

Biochemical progression first date (PSA)

date

C25331 (NCI Thesaurus ObjectClass)
C25434 (NCI Thesaurus ObjectClass-2)
C0205474 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25509 (NCI Thesaurus ValueDomain-2)
C1279901 (UMLS 2011AA ValueDomain-2)

BiochemicalProgressionConfirmedDate

Item

Biochemical progression confirmed date (PSA)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C25331 (NCI Thesaurus ObjectClass)
C25434 (NCI Thesaurus ObjectClass-2)
C0205474 (UMLS 2011AA ObjectClass)

ProstateDiseaseProgressionSiteSpecify

Item

Other, specify

text

CancerProgressionBoneObservedDate

Item

Date of bone progression

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12366 (NCI Thesaurus Property)
C0262950 (UMLS 2011AA Property)
C19987 (NCI Thesaurus ObjectClass)
C0242656 (UMLS 2011AA ObjectClass)
C25599 (NCI Thesaurus Property-2)
C1441672 (UMLS 2011AA Property-2)

ResponseSymptomaticDeteriorationInd-3

Item

Is there symptomatic deterioration of the patient's health status requiring discontinuation of treatment?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25269 (NCI Thesaurus Property)
C0231220 (UMLS 2011AA Property)
C25751 (NCI Thesaurus Property-2)
C0868945 (UMLS 2011AA Property-2)

ResponseSymptomaticDeteriorationDate

Item

Symptomatic deterioration date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25269 (NCI Thesaurus Property)
C0231220 (UMLS 2011AA Property)
C25751 (NCI Thesaurus Property-2)
C0868945 (UMLS 2011AA Property-2)

LHRH Agonist

Item Group

Lhrh Agonist

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationInd-3

Item

Is patient receiving on-going LH-RH agonist therapy

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C1910 (NCI Thesaurus Property-2)
C1518041 (UMLS 2011AA Property-2)

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistNegationAdministrationReason

Item

Select reason (If no,)

text

C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property-2)
C1533734 (UMLS 2011AA Property-2)
C1910 (NCI Thesaurus Property-3)
C1518041 (UMLS 2011AA Property-3)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)

CL.15

Code List

Select reason (If no,)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Prior Orchiectomy (Prior orchiectomy)

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistNegationAdministrationSpecify

Item

Other, specify

text

C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property-2)
C1533734 (UMLS 2011AA Property-2)
C1910 (NCI Thesaurus Property-3)
C1518041 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

HormoneTherapyLuteinizingHormone-releasingHormoneAgonistAdministrationEndDate

Item

LHRH agonist end date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C1910 (NCI Thesaurus Property-2)
C1518041 (UMLS 2011AA Property-2)

Notice of New Primary

Item Group

Notice Of New Primary

New primary cancer

Item

Has a new primary cancer or MDS been diagnosed that has not been previously reported?

boolean

C25180 (NCI Thesaurus ValueDomain)
C0751623 (UMLS CUI-1)
C25586 (NCI Thesaurus ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C15220 (NCI Thesaurus Property)

NewCancerDiagnosisDate

Item

New Primary Cancer Date

date

C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

SecondPrimaryMalignantNeoplasmAnatomicSiteText

Item

Site of new primary (s)

text

C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C25666 (NCI Thesaurus ObjectClass-3)
C0205436 (UMLS 2011AA ObjectClass-3)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25421 (NCI Thesaurus Property-2)
C0002808 (UMLS 2011AA Property-2)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)

PrimaryTumorNewHistologicCategory

Item

New Primary, Histologic type

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property-2)
C0008902 (UMLS 2011AA Property-2)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain-2)
C0205462 (UMLS 2011AA ValueDomain-2)

LONG-TERM TOXICITY

Item Group

Long-term Toxicity

RTOGAdverseEventReportInd-3

Item

Has the patient experienced (prior to diagnosis of recurrence or second primary) any severe (Grade > 3), long-term toxicity that has not been previously reported?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C19778 (NCI Thesaurus ObjectClass)
C1514695 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass-2)
C0877248 (UMLS 2011AA ObjectClass-2)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)

NotAML/MDSSecondaryMalignantNeoplasmText

Item

If non-AML/MDS secondary malignancy occurs, specify type and/or site

text

C25594 (NCI Thesaurus ObjectClass)
C1518422 (UMLS 2011AA ObjectClass)
C9441 (NCI Thesaurus ObjectClass-2)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C25667 (NCI Thesaurus Property-2)
C0175668 (UMLS 2011AA Property-2)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)

NON-PROTOCOL THERAPY

Item Group

Non-protocol Therapy

Non-ProtocolTherapyPriorCancerProgressionAdministrationInd-3

Item

Has the patient received any non-protocol cancer therapy (not previously reported?)

boolean

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C19987 (NCI Thesaurus Property-2)
C0242656 (UMLS 2011AA Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

Non-protocolTherapyAdministeredType

Item

NON-PROTOCOL THERAPY

text

C15368 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.19

Code List

NON-PROTOCOL THERAPY

CL Item

Non-protocol Hormonal Therapy (Non-protocol hormonal therapy)

CL Item

Non-protocol Radiation Therapy (Non-protocol radiation therapy)

CL Item

Non-protocol Chemotherapy (Non-protocol chemotherapy)

CL Item

Non-protocol Surgery (Non-protocol surgery)

CL Item

Other Non-protocol Therapy (Other non-protocol therapy)

Non-ProtocolHormoneTherapyAdministeredSpecify

Item

Non-protocol hormonal therapy, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

Non-ProtocolRadiationTherapyAdministeredSpecify

Item

Non-protocol radiation therapy, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

Non-ProtocolChemotherapyAdministeredSpecify

Item

Non-protocol chemotherapy, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

Non-ProtocolSurgeryAdministeredSpecify

Item

Non-protocol surgery, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

Non-protocolTherapyOtherAdministeredName

Item

Other non-protocol therapy, specify

text

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)

Non-protocolTherapyAdministeredBeginDate

Item

Non-protocol therapy start date (or date performed)

date

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)

Non-protocolTherapyAdministeredEndDate

Item

Non-protocol therapy end date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

COMPLETE SECTION BELOW UNTIL PROGRESSION

Item Group

Complete Section Below Until Progression

OpiateAgentAdministeredName

Item

Agent code

text

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C1657 (NCI Thesaurus ObjectClass-2)
C0376196 (UMLS 2011AA ObjectClass-2)
C0027365 (NCI Metathesaurus ValueDomain)

CL.20

Code List

Agent code

CL Item

Codeine (Codeine)

CL Item

Dihydrocode (synalgos) (Dihydrocode)

CL Item

Fentanyl (duragesic, Sublimaze, Actiq) (Fentanyl)

CL Item

Hydrocodone (Hydrocodone)

CL Item

Hydromorphone (dilaudid) (Hydromorphone)

CL Item

Levorphanol (levodromoran) (Levorphanol)

CL Item

Methadone (Methadone)

CL Item

Morphine (Morphine)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Oxymorphone (numorphone) (Oxymorphone)

CL Item

Propoxyphene (Propoxyphene)

OpiateAgentAdministeredText

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C1657 (NCI Thesaurus ObjectClass-2)
C0376196 (UMLS 2011AA ObjectClass-2)

Concomitant Medication Daily Dose

Item

Agent Total Dose (per day)

float

C25473 (NCI Thesaurus ObjectClass)
C2826638 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass-2)
C25304 (NCI Thesaurus Property)
C25256 (NCI Thesaurus Property-2)
C25488 (NCI Thesaurus ValueDomain)
C1708 (NCI Thesaurus ValueDomain-2)

Units

Item

Units

text

C1708 (NCI Thesaurus ObjectClass)
C1519795 (UMLS CUI-1)
C25256 (NCI Thesaurus Property)
C25709 (NCI Thesaurus ValueDomain)

CL.21

Code List

Units

CL Item

Gram (g)

C0439208 (NCI Metathesaurus)

CL Item

International Unit (IU)

C28255 (NCI Thesaurus)

CL Item

Liter (L)

CL Item

Microgram (mcg)

CL Item

Milligram (mg)

C28253 (NCI Thesaurus)
C0439210 (UMLS 2011AA)

CL Item

Milliliter (mL)

C28254 (NCI Thesaurus)
C0439242 (UMLS 2011AA)

CL Item

Unit (unit)

C44278 (NCI Thesaurus)
C0439148 (UMLS 2011AA)

Drug Administration Route

Item

Route

text

C25284 (NCI Thesaurus ValueDomain)
C0013153 (UMLS CUI-1)
C459 (NCI Thesaurus ObjectClass)
C25409 (NCI Thesaurus ObjectClass-2)
C25169 (NCI Thesaurus Property)

CL.22

Code List

Route

CL Item

Intravenous (IV)

X-MO-6794 (MGED)
X-MO-6794 (MGED-2)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Oral (PO)

C25311 (NCI Thesaurus)
C0442027 (UMLS 2011AA)
C25311 (NCI Thesaurus-3)
C0442027 (UMLS 2011AA-4)

CL Item

Subcutaneous (SC)

C13353 (NCI Thesaurus)
C0443315 (UMLS 2011AA)
C13353 (NCI Thesaurus-3)
C0443315 (UMLS 2011AA-4)

CL Item

Topical (TOP)

C13344 (NCI Thesaurus)
C0332237 (UMLS 2011AA)
C13344 (NCI Thesaurus-3)
C0332237 (UMLS 2011AA-4)

Concomitant Medication Start Date

Item

Agent Start Date

date

C25164 (NCI Thesaurus ValueDomain)
C2826734 (UMLS CUI-1)
C25431 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)

Concomitant Medication End Date

Item

Agent End Date

date

C25164 (NCI Thesaurus ValueDomain)
C2826744 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)

AgentAdministeredFrequency

Item

Frequency

text

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25515 (NCI Thesaurus ValueDomain)
C0439603 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.23

Code List

Frequency

CL Item

Intermittent (Intermittent or as needed)

AdministeredAgentIntentType

Item

Indication for use

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus ObjectClass-2)
C1521801 (UMLS 2011AA ObjectClass-2)
C25725 (NCI Thesaurus Property)
C1283828 (UMLS 2011AA Property)

CL.24

Code List

Indication for use

CL Item

Curative Treatment (Curative)

CL282358 (NCI Metathesaurus)

CL Item

Prevention (Prophylaxis)

C15405 (NCI Thesaurus)

Footer

Item Group

Footer

Person Completing Form

Item

Completed by

text

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

Date Form Completed

Item

Date Form Completed

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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CALGB: 90401 FOLLOW-UP FORM NCT00110214

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..

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