ID

1124

Description

CALGB 40601 FOLLOW-UP FORM Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3A098B5D-E41F-1055-E044-0003BA3F9857

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3A098B5D-E41F-1055-E044-0003BA3F9857

Mots-clés

D001943

Verlaufsstudien

Téléchargé le

27 août 2012

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0 Legacy

Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires

Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Breast Cancer NCT00770809 Follow-Up - CALGB 40601 FOLLOW-UP FORM - 2681705v1.0

model
Détails

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 Formulaires

StudyEvent: CALGB 40601 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

Type

Description | Question | Decode (Coded Value)

Type de données

Alias

Unnamed1

Item Group

Unnamed1

CALGBFormIdentifierNumber

Item

CALGB Form

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus ObjectClass)
C1516238 (UMLS 2011AA ObjectClass)

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)

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)

TreatmentReportingPeriodEndDate

Item

Reporting Period End Date (date of last contact or death)

date

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

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)

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)

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)

ProtocolParticipatingIdentifierNumber

Item

Participating Group Study 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)

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)

VITAL STATUS

Item Group

Vital Status

PatientVitalStatus

Item

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

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)
C25717 (NCI Thesaurus Property)
C1148433 (UMLS 2011AA Property)

CL.2

Code List

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

CL Item

Alive (Alive)

CL Item

Dead (Dead)

PatientDeathPrimaryReason

Item

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

text

C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
C25251 (NCI Thesaurus ValueDomain)
C0205225 (UMLS 2011AA ValueDomain)

CL.3

Code List

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

CL Item

Due To This Disease (Due to this disease)

CL Item

Due To Protocol Treatment (Due to protocol treatment)

CL Item

Due To Other Cause (Due to other cause)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PatientDeathSpecify

Item

Describe cause of death

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)

NeoadjuvantTherapyFollow-upCyclophosphamideDoxorubicinAdministrationInd-2

Item

Did the patient continue treatment with AC?

text

C16033 (NCI Thesaurus ObjectClass)
C1522577 (UMLS 2011AA ObjectClass)
C15665 (NCI Thesaurus ObjectClass)
C0600558 (UMLS 2011AA ObjectClass)
C456 (NCI Thesaurus Property)
C0013089 (UMLS 2011AA Property)
C405 (NCI Thesaurus Property)
C0010583 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.4

Code List

Did the patient continue treatment with AC?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

TherapeuticProcedureRegimenType

Item

Treatment Regimen

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49236 (NCI Thesaurus ObjectClass)
C0087111 (UMLS 2011AA ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)

CL.5

Code List

Treatment Regimen

CL Item

Classical (Classical)

CL Item

Dose Dense (Dose dense)

NeoadjuvantTherapyFollow-upTrastuzumabAdministrationInd-2

Item

Did the patient continue treatment with trastuzumab?

text

C16033 (NCI Thesaurus ObjectClass)
C1522577 (UMLS 2011AA ObjectClass)
C15665 (NCI Thesaurus ObjectClass)
C0600558 (UMLS 2011AA ObjectClass)
C1647 (NCI Thesaurus Property)
C0338204 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.6

Code List

Did the patient continue treatment with trastuzumab?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

NeoadjuvantTherapyFollow-upTrastuzumabAdministrationBeginDate

Item

Treatment start date

date

C16033 (NCI Thesaurus ObjectClass)
C1522577 (UMLS 2011AA ObjectClass)
C15665 (NCI Thesaurus ObjectClass)
C0600558 (UMLS 2011AA ObjectClass)
C1647 (NCI Thesaurus Property)
C0338204 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)

NeoadjuvantTherapyFollow-upTrastuzumabAdministrationEndDate

Item

Treatment end date

date

C16033 (NCI Thesaurus ObjectClass)
C1522577 (UMLS 2011AA ObjectClass)
C15665 (NCI Thesaurus ObjectClass)
C0600558 (UMLS 2011AA ObjectClass)
C1647 (NCI Thesaurus Property)
C0338204 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

NeoadjuvantTherapyFollow-upEndocrineTherapyAdministrationInd-2

Item

Did the patient continue treatment with endocrine therapy for ER/PgR positive disease?

text

C16033 (NCI Thesaurus ObjectClass)
C1522577 (UMLS 2011AA ObjectClass)
C15665 (NCI Thesaurus ObjectClass)
C0600558 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus Property)
C0279025 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.7

Code List

Did the patient continue treatment with endocrine therapy for ER/PgR positive disease?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

NeoadjuvantTherapyFollow-upEndocrineTherapyAdministrationBeginDate

Item

Treatment start date

date

C16033 (NCI Thesaurus ObjectClass)
C1522577 (UMLS 2011AA ObjectClass)
C15665 (NCI Thesaurus ObjectClass)
C0600558 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus Property)
C0279025 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)

NeoadjuvantTherapyFollow-upEndocrineTherapyAdministrationEndDate

Item

Treatment end date

date

C16033 (NCI Thesaurus ObjectClass)
C1522577 (UMLS 2011AA ObjectClass)
C15665 (NCI Thesaurus ObjectClass)
C0600558 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus Property)
C0279025 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

CancerFollow-upStatusInd-3

Item

Has the patient had a documented clinical assessment for this cancer

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.8

Code List

Has the patient had a documented clinical assessment for this cancer

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CancerFollow-UpStatusDate

Item

Date of Last Clinical Assessment

date

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

BreastNewStageInd-3

Item

Was patient restaged during this time period (If Yes, complete the following questions and submit C-817 Follow-Up Solid Tumor Measurement Form)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C16899 (NCI Thesaurus Property)
C1300072 (UMLS 2011AA Property)

CL.9

Code List

Was patient restaged during this time period (If Yes, complete the following questions and submit C-817 Follow-Up Solid Tumor Measurement Form)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

OverallTumorResponseType

Item

Overall Tumor Response

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25605 (NCI Thesaurus ObjectClass)
C1561607 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)

CL.10

Code List

Overall Tumor Response

CL Item

Complete Response (CR)

CL Item

Partial Response (PR)

C18212 (NCI Thesaurus)

CompleteResponseFirstObservedDate

Item

CR First Observed Date (MM DD YYYY)

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

PR First Observed Date (MM DD YYYY)

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)

NOTICE OF PROGRESSION

Item Group

Notice Of Progression

CancerProgressionFirstLocal-RegionalDiagnosisInd-3

Item

Has the patient been diagnosed with a first local-regional progression (since submission of the last follow-up form?)

text

C19987 (NCI Thesaurus ObjectClass)
C0242656 (UMLS 2011AA ObjectClass)
C25388 (NCI Thesaurus Property)
C1947913 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.11

Code List

Has the patient been diagnosed with a first local-regional progression (since submission of the last follow-up form?)

CL Item

No (NO)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (YES)

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

Local-RegionalProgressionFirstDate

Item

Date of First Local-Regional Progression

date

C25331 (NCI Thesaurus ObjectClass)
C25388 (NCI Thesaurus ObjectClass)
C1947913 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25509 (NCI Thesaurus ValueDomain)
C1279901 (UMLS 2011AA ValueDomain)

BreastFirstProgressionLocal-RegionalSite

Item

Site of First Local-Regional Progression

text

C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)

CL.12

Code List

Site of First Local-Regional Progression

CL Item

Ipsilateral Breast (Ipsilateral breast)

CL Item

Axillary Nodes (Axillary nodes)

CL Item

Supraclavicular Nodes (Supraclavicular nodes)

CL Item

Infraclavicular Nodes (Infraclavicular nodes)

CL Item

Chest Wall (Chest wall)

CL035093 (NCI Metathesaurus)
C62484 (NCI Thesaurus)
C0205076 (UMLS 2011AA)

CL Item

Internal Mammary Nodes (Internal mammary nodes)

CL Item

Axilla (Axilla)

C12674 (NCI Thesaurus)
C0004454 (UMLS 2011AA)

CancerProgressionDistantFirstDistantDiagnosisInd

Item

Has the patient been diagnosed with first distant progression?

text

C19987 (NCI Thesaurus ObjectClass)
C0242656 (UMLS 2011AA ObjectClass)
C25321 (NCI Thesaurus Property)
C0443203 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.14

Code List

Has the patient been diagnosed with first distant progression?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

DistantProgressionFirstDate

Item

Date of First Distant Progression

date

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

RecurrentDiseaseFirstDistantDiagnosisText

Item

Site of First Distant Recurrence

text

C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C25321 (NCI Thesaurus Property)
C0443203 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)

ProgressionAssessmentSource

Item

How was this progression information obtained?

text

C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25331 (NCI Thesaurus ObjectClass)
C25683 (NCI Thesaurus ValueDomain)
C0449416 (UMLS 2011AA ValueDomain)

CL.15

Code List

How was this progression information obtained?

CL Item

Clinical Assessment (Clinical assessment)

CL Item

Patient Self Report Only (Patient self-report only)

ProgressionAssessmentSource

Item

How was this progression information obtained?

text

C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25331 (NCI Thesaurus ObjectClass)
C25683 (NCI Thesaurus ValueDomain)
C0449416 (UMLS 2011AA ValueDomain)

CL.15

Code List

How was this progression information obtained?

CL Item

Clinical Assessment (Clinical assessment)

CL Item

Patient Self Report Only (Patient self-report only)

LONG TERM ADVERSE EVENTS

Item Group

Expected Adverse Events

TreatmentRelatedAdverseEventReportInd-3

Item

Has the patient experienced any grade >= 2 treatment related adverse event? (prior to diagnosis of recurrence or new malignancy)

text

C25648 (NCI Thesaurus ObjectClass)
C0439849 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C0684224 (NCI Metathesaurus Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.16

Code List

Has the patient experienced any grade >= 2 treatment related adverse event? (prior to diagnosis of recurrence or new malignancy)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

MedDRACode

Item

MedDRA Code

double

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)

CommonToxicityCriteriaAdverseEventTermType

Item

CTC adverse event term

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)

CL.17

Code List

CTC adverse event term

CL Item

Peripheral Motor Neuropathy (Neuropathy: motor)

C3500 (NCI Thesaurus)
C0018995 (UMLS 2011AA)

CL Item

Peripheral Sensory Neuropathy (Neuropathy: sensory)

C3501 (NCI Thesaurus)
C0151313 (UMLS 2011AA)

CommonToxicityCriteriaAdverseEventGrade

Item

CTC AE grade (^2)

double

C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.18

Code List

CTC AE grade (^2)

CL Item

Moderate Adverse Event (2)

C41339 (NCI Thesaurus)
C1513374 (UMLS 2011AA)

CL Item

Severe Adverse Event (3)

C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)

CL Item

Life-threatening Or Disabling Adverse Event (4)

CL Item

Death Related To Adverse Event (5)

C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)

CTCAdverseEventAttributionScale

Item

CTC AE Attribution Code (^2)

text

C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)

CL.19

Code List

CTC AE Attribution Code (^2)

CL Item

Unrelated (unrelated)

C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)

CL Item

Unlikely (unlikely)

CL Item

Possible (possible)

C0332149 (NCI Metathesaurus)

CL Item

Probable (probable)

C0332148 (NCI Metathesaurus)

CL Item

Definite (definite)

CL209464 (NCI Metathesaurus)

CTCAdverseEventOnsetDate

Item

Adverse Event Onset Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25279 (NCI Thesaurus Property)
C0332162 (UMLS 2011AA Property)

COMMENTS

Item Group

Comments

ResearchCommentsText

Item

COMMENTS

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)

ResponsiblePersonName

Item

Completed by (Last name, First name)

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)

FormCompleteDate

Item

Date form completed (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)

Retour au début de la page

ID

Description

Lien

Mots-clés

Versions (4)

Téléchargé le

DOI

Licence

Modèle Commentaires :

Groupe Item commentaires pour :

Item commentaires pour :

Breast Cancer NCT00770809 Follow-Up - CALGB 40601 FOLLOW-UP FORM - 2681705v1.0

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.

Description

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description