ID

9449

Descrizione

CALGB: 90104 Treatment and Follow-up Form Combination Chemotherapy in Treating Patients With Bladder Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BE1B6072-F2CE-7116-E034-0003BA12F5E7

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=BE1B6072-F2CE-7116-E034-0003BA12F5E7

Keywords

Clinical Trial

Treatment Form

C67.9

Caricato su

9 gennaio 2015

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0 Legacy

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Bladder Cancer NCT00014534 Treatment - CALGB: 90104 Treatment and Follow-up Form - 2169531v3.0

model
Dettagli

No Instruction available.

1 moduli

StudyEvent: CALGB: 90104 Treatment and Follow-up Form
1. No Instruction available.

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

CCRR MODULE

Item Group

Ccrr Module For Calgb: 90104 Treatment And Follow-up Form

CALGB Form

Item

CALGB Form

text

C3262252 (UMLS CUI-1)
C1516238 (UMLS CUI-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

From

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

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

Amended data?

text

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

CL.1

Code List

Amended data?

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus-3)
C1705108 (UMLS 2011AA-4)

Patient Initials

Item

Patient Initials

text

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

Participating Group

Item

Participating Group

text

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

Medical Record Number

Item

Patient Medical Record Number

text

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

Study Number Participating Group

Item

Participating Group Protocol Number

text

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

Institution Name

Item

Institute/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)

Patient Status

Item

Patient's vital status

text

C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25365 (NCI Thesaurus Property)

CL.2

Code List

Patient's vital status

CL Item

Alive (Alive-NED)

CL Item

Alive (Alive with disease)

CL Item

Dead (Dead)

PatientDeathPrimaryReason

Item

Primary cause of death

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)
C28554 (NCI Thesaurus ValueDomain-2)
C0011065 (UMLS 2011AA ValueDomain-2)

CL.3

Code List

Primary cause of death

CL Item

Due To This Disease (due to this disease)

CL Item

Due To Protocol Treatment (due to protocol treatment)

CL Item

Unknown (unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Due To Other Cause, Specify (due to other cause)

Cause of Death, specify

Item

Due to other cause, specify

text

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

Date last contact

Item

Date of last contact or death

date

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

RecombinantGranulocyteColonyStimulatingFactorReceivedInd-2

Item

GCSF administered?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C1287 (NCI Thesaurus ObjectClass)
C0376562 (UMLS 2011AA ObjectClass)

Ifyes,specifywhy(GCSFadministered)

Item

If yes, specify why (GCSF administered)

text

Protocol Treatment Arm

Item

Treatment

text

C25337 (NCI Thesaurus ValueDomain)
C1522541 (UMLS CUI-1)
C32141 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)

CL.5

Code List

Treatment

CL Item

Arm A (Arm A)

CL Item

Arm B (Arm B)

TreatmentDiscontinuedType

Item

Reason treatment ended

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)

CL.6

Code List

Reason treatment ended

CL Item

Treatment Completed Per Protocol Criteria (Treatment completed per protocol)

CL Item

Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)

CL Item

Disease Progression, Relapse Prior To Beginning Protocol Therapy (Disease progression, relapse prior to beginning protocol therapy)

CL Item

Toxicity/side Effects/complications (Toxicity/side effects/complications)

CL Item

Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal or refusal after beginning protocol therapy)

CL Item

Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal or refusal prior to beginning protocol therapy)

CL Item

disease recurrence (disease recurrence)

CL Item

Death After Beginning Protocol Therapy (death after beginning protocol therapy)

CL Item

Death Prior To Beginning Protocol Therapy (death prior to beginning protocol therapy)

CL Item

Alternative Therapy (alternative therapy)

CL Item

Other (other complicating disease)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Other (Other, specify)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

OffTreatmentReason,Other

Item

Other, specify (off treatment reason)

text

Dose Modification

Item

Were there any dose modifications or additions/omissions to protocol treatment?

text

C25180 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25256 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain-2)

CL.7

Code List

Were there any dose modifications or additions/omissions to protocol treatment?

CL Item

No (no)

C49487 (NCI Thesaurus)
C1298908 (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)

CL Item

Unknown (unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

DoseModificationText

Item

If yes, specify (modification)

text

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

Lab,Renal,CreatinineClearance

Item

Calculated creatinine clearance

float

Lab,Hematology,WBC

Item

WBC

float

LaboratoryProcedureNeutrophilResultSpecifiedValue

Item

ANC

float

C12533 (NCI Thesaurus Property)
C0027950 (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)

HepaticSGOT(AST)LabUnspecifiedValue

Item

AST

float

C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property-2)
C0022877 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

Platelets

Item

Platelet count

float

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

Blood Urea Nitrogen

Item

BUN

float

C20200 (NCI Thesaurus Property)
C0005845 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C61019 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)

LaboratoryProcedureBloodUreaNitrogenResultUpperLimitNormalValue

Item

BUN, ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C61019 (NCI Thesaurus Property-2)
C0005845 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

Lab,Hepatic,Bilirubin

Item

Bilirubin

float

HepaticBilirubinLabUpperLimitNormalValue

Item

Bilirubin, ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property-2)
C0005437 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

RenalCreatinineLabSpecifiedValue

Item

Serum creatinine

float

C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

Lab,Hepatic,AlkalinePhosphatase

Item

alkaline phosphatase

float

Alkaline Phosphatase ULN

Item

Alkaline phlosphatase, ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0151420 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C16276 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)

CancerFollow-upStatusInd-3

Item

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

boolean

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

CancerFollow-UpStatusDate

Item

Date of last clinical assessment

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

ChestX-RayAssessmentDate

Item

chest x-ray assessment date

date

ChestX-RayResult

Item

Chest x-ray result

text

CL.9

Code List

Chest x-ray result

CL Item

Negative (negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Equivocal (equivocal)

C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)

Abdominal/PelvicCTAssessmentDate

Item

abdominal/pelvic CT assessment date

text

Abdominal/pelvicCTresult

Item

Abdominal/pelvic CT result

text

CL.10

Code List

Abdominal/pelvic CT result

CL Item

Not Done (not done)

CL281691 (NCI Metathesaurus)

CL Item

Normal (normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)

CL Item

Equivocal (equivocal)

C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)

CL Item

Abnormal-disease Related (abnormal-disease related)

CL Item

Abnormal-not Disease Related (abnormal-not disease related)

CL Item

Unknown (unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

DiseaseAdvancedProgressionInd-3

Item

Has the patient been diagnosed with a local recurrence that has not been previously reported?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C25411 (NCI Thesaurus Property-2)
C0205179 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

ProgressionDate,FirstLocal

Item

Date of first local progression

date

ProgressionSite,FirstLocal

Item

Site(s) of first local progression

text

CL.12

Code List

Site(s) of first local progression

CL Item

Local Progression To The Abdominal Wall (abdominal wall)

CL Item

Local Progression To The Pelvic Wall (pelvic wall)

CL Item

Local Spread To Peritoneal Tissue (peritoneum)

CL Item

Spread Of Cancer To Skin Or Subcutaneous Tissue Near To The Bladder (skin)

CL Item

Local Spread To The Vagina (vagina)

CL Item

Local Spread To The Urethra (urethra)

CL Item

Progression To Another Site, Specify Site (other, specify)

CL Item

Progression To Another Site, Specify Site (Other, specify)

LocalLymphNodeProgressionInd-3

Item

Has the patient been diagnosed with a local-regional lymph node recurrence that has not been previously reported?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25388 (NCI Thesaurus ObjectClass-2)
C1947913 (UMLS 2011AA ObjectClass-2)

ProgressionDate,FirstLocalNode

Item

Date of first local-regional lymph node progression

date

ProgressionSite,FirstLocalNode

Item

Site(s) of first local-regional lymph node progression

text

CL.14

Code List

Site(s) of first local-regional lymph node progression

CL Item

Disease Is Present In The Internal Iliac Lymph Nodes (internal iliac)

CL Item

Disease Is Present In The External Iliac Lymph Nodes (external iliac)

CL Item

Disease Is Present In The Common Iliac Lymph Nodes (common iliac)

CL Item

Disease Is Present In The Hypogastric Lymph Nodes (hypogastric)

CL Item

Disease Is Present In The Para-aortic Lymph Nodes (para-aortic)

CL Item

Disease Is Present In Another Local-regional Lymph Nodes, Specify (other, specify)

CL Item

Disease Is Present In Another Local-regional Lymph Nodes, Specify (Other, specify)

DistantMetastasisProgressionInd-3

Item

Has the patient been diagnosed with a distant metastatic progression that has not been previously reported?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C25321 (NCI Thesaurus ObjectClass)
C0443203 (UMLS 2011AA ObjectClass)
C19151 (NCI Thesaurus ObjectClass-2)
C0027627 (UMLS 2011AA ObjectClass-2)

ProgressionDate,FirstDistant

Item

Date of first distant progression

date

ProgressionSite,FirstDistant

Item

Site(s) of first local (distant) progression

text

CL.16

Code List

Site(s) of first local (distant) progression

CL Item

Bone (bone)

C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)

CL Item

Liver (liver)

C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)

CL Item

Lung (lung)

C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)

CL Item

Peritoneum (peritoneum)

C12770 (NCI Thesaurus)
C0031153 (UMLS 2011AA)

CL Item

Pleura (pleura)

C12469 (NCI Thesaurus)
C0032225 (UMLS 2011AA)

CL Item

Skin (skin)

C12470 (NCI Thesaurus)
C1123023 (UMLS 2011AA)

CL Item

Central Nervous System Or Brain (central nervous system/brain)

CL Item

Distant Lymph Nodes (distant nodes)

CL Item

Other, Specify (other)

LymphNodes,DistantLocation

Item

distant nodes, specify

text

MetastaticSite,Other

Item

other, specify

text

NewCancerDiagnosisInd-3

Item

Has a new primary cancer or myelodysplatsic syndrome 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

Date of first local progression (new primary)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

NewCancerSiteText

Item

Site(s) of new primary

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)

LateAdverseEventInd

Item

Has the patient experienced any severe, long-term toxicity that has not been previously reported?

boolean

RTOGAdverseEventTermText

Item

late adverse event term

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C19778 (NCI Thesaurus ObjectClass)
C1514695 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass-2)
C0877248 (UMLS 2011AA ObjectClass-2)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)

RTOGAdverseEventGrade

Item

late adverse event grade

float

C19778 (NCI Thesaurus ObjectClass)
C1514695 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass-2)
C0877248 (UMLS 2011AA ObjectClass-2)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

LateAdverseEventOnsetDate

Item

date of onset of long-term toxicity

date

Research Comments

Item

comments

text

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

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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versioni (4)

Caricato su

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Bladder Cancer NCT00014534 Treatment - CALGB: 90104 Treatment and Follow-up Form - 2169531v3.0

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