ID

7681

Description

CALGB 90802 Follow-Up Form Everolimus With or Without Bevacizumab in Treating Patients With Advanced Kidney Cancer That Progressed After First-Line Therapy NCT01198158 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=87856A36-E884-CA3E-E040-BB89AD431C27

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=87856A36-E884-CA3E-E040-BB89AD431C27

Keywords

Clinical Trial

Kidney Neoplasms

Follow-Up Studies

9/19/12 9/19/12 -
1/8/15 1/8/15 - Martin Dugas
1/9/15 1/9/15 - Martin Dugas

Uploaded on

January 9, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Follow-Up Form Kidney Cancer (NCT01198158)

model
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 complete the form electronically. After entering all data, click the "Print and/or Submit to CALGB" button located at the bottom of the last page of the form. Retain a copy of the form for your records. Submit supporting documentation by fax (919-416-4990) or mail. If data are amended, circle amended items, check the "Yes" box, and submit by fax or mail

1 forms

StudyEvent: CALGB 90802 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 complete the form electronically. After entering all data, click the "Print and/or Submit to CALGB" button located at the bottom of the last page of the form. Retain a copy of the form for your records. Submit supporting documentation by fax (919-416-4990) or mail. If data are amended, circle amended items, check the "Yes" box, and submit by fax or mail

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

Header Module

Item Group

Header Module

C1320722 (UMLS CUI-1)

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 (MM DD YYYY)

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)

Date last contact

Item

Date of Last Contact or Death (last known alive MM DD YYYY)

date

C16960 (NCI Thesaurus ObjectClass)
C0805839 (UMLS CUI-1)
C25461 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

Data amended

Item

Are data amended

boolean

C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)

Patient Initials

Item

Patient Initials (Last First Middle)

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)

Medical Record Number

Item

Patient Hospital No.

text

C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)

Institution Name

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)

Participating Group

Item

Participating Group

text

C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)

Study Number Participating Group

Item

Participating Group Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Trial subject ID Participating Group

Item

Participating Group Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

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 (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)

Research Comments

Item

Comments

text

C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)

Vital Status

Item Group

Vital Status

Patient Status

Item

Patient's Vital Status (Mark one with an X. If the patient is lost, follow instructions on form C-1742 and in the CALGB Policies and Procedures chapter 8 to have Data Operations change a patient's survival status to: "Confirmed lost to follow-up")

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

CL Item

Alive (Alive)

CL Item

Dead (Dead)

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 Other Cause (Due to other cause)

CL Item

Due To Protocol Treatment (Due to protocol treatment)

CL Item

Due To This Disease (Due to this disease)

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)

KarnofskyPerformanceStatusScore

Item

Karnofsky Performance Status Score (Mark one with an X.)

text

C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

CL.4

Code List

Karnofsky Performance Status Score (Mark one with an X.)

CL Item

Dead (0)

CL Item

Moribund, Fatal Processes Progressing Rapidly (10)

CL Item

Normal, No Complaints, No Evidence Of Disease (100)

CL Item

Very Sick, Hospitalization Indicated. Death Not Imminent (20)

CL Item

Severely Disabled, Hospitalization Indicated. Death Not Imminent (30)

CL Item

Disabled, Requires Special Care And Assistance (40)

CL Item

Requires Considerable Assistance And Frequent Medical Care (50)

CL Item

Requires Occasional Assistance, But Is Able To Care For Most Of His/her Needs (60)

CL Item

Cares For Self, Unable To Carry On Normal Activity Or To Do Active Work (70)

CL Item

Normal Activity With Effort; Some Signs Or Symptoms Of Disease (80)

CL Item

Able To Carry On Normal Activity; Minor Signs Or Symptoms Of Disease (90)

Disease Assessment

Item Group

Disease Follow-up Status

Documented clinical assessment for this cancer

Item

Has the patient had a documented clinical assessment for this cancer? (since submission of the previous follow-up form)

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)

Follow-Up Date

Item

Date of Last Clinical Assessment (MM DD YYYY)

date

C9305 (NCI Thesaurus ObjectClass)
C3694716 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C25365 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

DiagnosticImagingProcedureMostRecentDate

Item

Most recent CT/MRI scan date (MM DD YYYY)

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)

Patient Weight

Item

Patient Weight (kg)

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

On Study, On Protocol Treatment (On study, on protocol treatment)

CL Item

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

Measurable Disease Response

Item Group

Measurable Disease Response

TumorResponseType

Item

Response Status at This Assessment (Mark one with an X.)

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.7

Code List

Response Status at This Assessment (Mark one with an X.)

CL Item

Complete Response (CR)

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)

CL Item

Insufficient Evaluation (Insufficient evaluation to determine response status)

Complete Response First Observed Date

Item

Complete Response (CR) First Observed Date (MM DD YYYY)

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 (MM DD YYYY)

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 (MM DD YYYY)

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)

Progression Site

Item

Sites of Progression (during this reporting period Mark all that apply with an X.)

text

C13717 (NCI Thesaurus ValueDomain)
C0242656 (UMLS CUI-1)
C25341 (NCI Thesaurus Property)
C1515974 (UMLS CUI-2)
C25331 (NCI Thesaurus ObjectClass)

CL.8

Code List

Sites of Progression (during this reporting period Mark all that apply with an X.)

CL Item

Bladder (Bladder)

C12414 (NCI Thesaurus)
C0005682 (UMLS 2011AA)

CL Item

Bone (Bone)

C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)

CL Item

Central Nervous System/brain (CNS/Brain)

CL Item

Liver (Liver)

C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)

CL Item

Lung, Nos (Lung)

C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)

CL Item

Lymph Nodes, Specify (Lymph nodes)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C17649 (NCI Thesaurus-3)
C0205394 (UMLS 2011AA-4)

CL Item

Pleura (Pleura)

C12469 (NCI Thesaurus)
C0032225 (UMLS 2011AA)

CL Item

Urothelial Tract (Urothelial Tract)

Progression Site, specify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C0242656 (UMLS CUI-1)
C25341 (NCI Thesaurus Property)
C1515974 (UMLS CUI-2)
C25331 (NCI Thesaurus ObjectClass)

LABORATORY DATA

Item Group

Baseline Lab Values (hematologic)

Leukocytes (WBC)

Item

WBC (x10^3 microL)

float

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

Neutrophil count

Item

ANC (x10^3 microL)

float

C25294 (NCI Thesaurus ObjectClass)
C0200633 (UMLS CUI-1)
C12533 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25304 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

Platelets

Item

Platelets (PLT) (x10^3 microL)

float

C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)

LaboratoryProcedureHemoglobinResultSpecifiedValue

Item

Hemoglobin (g/dL)

float

C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureHemoglobinResultUpperLimitofNormalValue

Item

Hemoglobin, ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C16676 (NCI Thesaurus Property)
C0019046 (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)

Creatinine, Serum

Item

Serum creatinine (mg/dl)

float

C20200 (NCI Thesaurus Property)
C0201976 (UMLS CUI-1)
C399 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)

LaboratoryProcedureCreatinineClearanceOutcomeEstimateValue

Item

Calculated creatinine clearance (mL/min)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25747 (NCI Thesaurus Property-2)
C0373595 (UMLS 2011AA Property-2)
C25498 (NCI Thesaurus ValueDomain)
C0750572 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

SGOT (AST)

Item

SGOT (AST)

float

C25294 (NCI Thesaurus ObjectClass)
C0201899 (UMLS CUI-1)
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Item

SGOT (AST) ULN

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)

Bilirubin, Total

Item

Total Bilirubin (mg/dl)

float

C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C38037 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

Bilirubin, Total ULN

Item

Bilirubin ULN (mg/dl)

float

C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C38037 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedureFastingPlasmaGlucoseMeasurementOutcomeValue

Item

Fasting serum glucose (mg/dL)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C41376 (NCI Thesaurus Property-2)
C0202042 (UMLS 2011AA Property-2)
C63663 (NCI Thesaurus Property-3)
C0015663 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

HematologySerumTotalCholesterolLaboratoryResultValueinmg/dL

Item

Serum cholesterol (mg/dL)

float

C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C13325 (NCI Thesaurus Property-2)
C0229671 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus Property-3)
C0022885 (UMLS 2011AA Property-3)
C369 (NCI Thesaurus Property-4)
C0008377 (UMLS 2011AA Property-4)
C28253 (NCI Thesaurus ValueDomain)
C0439210 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus ValueDomain-2)
C1274040 (UMLS 2011AA ValueDomain-2)
C37984 (NCI Thesaurus ValueDomain-3)
C0022877 (UMLS 2011AA ValueDomain-3)
C25712 (NCI Thesaurus ValueDomain-4)
C1522609 (UMLS 2011AA ValueDomain-4)

HematologySerumTriglyceridesLaboratoryResultValueinmg/dL

Item

Trigylcerides (mg/dL)

float

C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C13325 (NCI Thesaurus Property)
C0229671 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C906 (NCI Thesaurus Property-3)
C0041004 (UMLS 2011AA Property-3)
C28253 (NCI Thesaurus ValueDomain)
C0439210 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus ValueDomain-2)
C1274040 (UMLS 2011AA ValueDomain-2)
C37984 (NCI Thesaurus ValueDomain-3)
C0022877 (UMLS 2011AA ValueDomain-3)
C25712 (NCI Thesaurus ValueDomain-4)
C1522609 (UMLS 2011AA ValueDomain-4)

LaboratoryProcedureCorrectedSerumCalciumMeasurementOutcomeValue

Item

Corrected serum calcium (mg/dL Calculated by: Serum calcium - [0.707Serum albumin-3.4])

float

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C74950 (NCI Thesaurus Property-2)
C0455288 (UMLS 2011AA Property-2)

Notice of New Primary

Item Group

Notice Of New Primary

NewCancerDiagnosisInd-3

Item

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

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
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)

NewCancerDiagnosisDate

Item

New Primary Cancer Date (MM DD YYYY)

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)

NewCancerSiteText

Item

Site of New Primary (s)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)

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

Long-TermAdverseEventFollow-upInd-3

Item

Has the patient experienced post diagnosis of progression or new primary, any severe (Grade > 3), long-term toxicity that has not been previously reported

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C25322 (NCI Thesaurus ObjectClass-2)
C0443252 (UMLS 2011AA ObjectClass-2)

Non-Protocol Therapy

Item Group

Non-protocol Therapy

Non-protocolTherapyCurrentPeriodAdministeredInd-2

Item

Has the patient received any non-protocol cancer therapy during this reporting period?

boolean

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

Non-ProtocolTherapyAdministeredType

Item

Specify (If yes, Mark all that apply with an X below.)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.12

Code List

Specify (If yes, Mark all that apply with an X below.)

CL Item

Radiation Therapy (Radiation therapy)

C15313 (NCI Thesaurus)
C1522449 (UMLS 2011AA)

CL Item

Chemotherapy (Chemotherapy)

C15632 (NCI Thesaurus)
C0392920 (UMLS 2011AA)

CL Item

Surgery (Surgery)

C17173 (NCI Thesaurus)
C0038894 (UMLS 2011AA)

CL Item

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

Non-ProtocolRadiationTherapyAdministeredSpecify

Item

Specify (Radiation therapy)

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-ProtocolSystemicChemotherapyAdministeredSpecify

Item

Specify (Chemotherapy)

text

C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C13310 (NCI Thesaurus ObjectClass-2)
C0205373 (UMLS 2011AA ObjectClass-2)
C25590 (NCI Thesaurus ObjectClass-3)
C1518384 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

Non-ProtocolSurgeryAdministeredSpecify

Item

Specify (Surgery)

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-ProtocolTherapyOtherAdministeredSpecify

Item

Specify (Other non-protocol therapy)

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)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

Non-protocolTherapyAdministeredBeginDate

Item

Non-protocol Therapy Start Date (MM DD YYYY 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)

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Item comments for :

Follow-Up Form Kidney Cancer (NCT01198158)

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