ID

2152

Beschrijving

CALGB: 30607 Treatment and Response Form Sunitinib as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Treated With Combination Chemotherapy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=35681A7B-54DB-54F0-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=35681A7B-54DB-54F0-E044-0003BA3F9857

Trefwoorden

D008175

Treatment Form

Geüploaded op

19 september 2012

DOI

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Creative Commons BY-NC 3.0 Legacy

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Lung Cancer NCT00693992 Treatment - CALGB: 30607 Treatment and Response Form - 2664196v1.0

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.

1 Formulieren

StudyEvent: CALGB: 30607 Treatment and Response 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.

Name

Type

Description | Question | Decode (Coded Value)

Datatype

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)

TreatmentLastDoseEndDate

Item

Date of Last dose for this reporting period

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property)
C1265611 (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

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 (Last, First Middle)

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)

HospitalPatientIdentifierNumber

Item

Patient Hospital No

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C16696 (NCI Thesaurus ObjectClass)
C0019994 (UMLS 2011AA ObjectClass)

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)

Survival Date

Item Group

Survival Date

PatientVitalStatus

Item

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

Vital Status (Mark one with an X.)

CL Item

Alive (Alive)

CL Item

Dead (Dead)

PatientDeathPatientDeathPrimaryReason

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 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)

PrimaryCauseDeathOtherReasonSpecify

Item

Due to other cause, specify

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C0007465 (NCI Metathesaurus ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

Treatment Data

Item Group

Unnamed Module 5

AgentReportPeriodBeginQuantityDose

Item

Dose level received on reporting period start date

text

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)

CL.4

Code List

Dose level received on reporting period start date

CL Item

37.5 Mg (37.5 mg)

CL Item

25 Mg (25 mg)

CL Item

25 Mg For 4 Of 6 Weeks (25 mg for 4 of 6 weeks)

SunitinibMalatePlaceboAgentReceivedDose

Item

Total dose of sunitinib/ placebo received during this reporting period

double

C753 (NCI Thesaurus ObjectClass)
C0032042 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C26673 (NCI Thesaurus ObjectClass)
C1698963 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)

DoseModificationInd

Item

Were there any dose modifications or additions/omissions to protocol treatment? (during this reporting period)

text

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

CL.5

Code List

Were there any dose modifications or additions/omissions to protocol treatment? (during this reporting period)

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)

TreatmentLastDoseEndDate

Item

Date of Last dose for this reporting period

date

Off-treatmentReason

Item

Off treatment reason (if applicable Mark one with an X.)

text

C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.6

Code List

Off treatment reason (if applicable Mark one with an X.)

CL Item

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

CL Item

Adverse Event/side Effects/complications (Adverse event/side effects/complications)

CL Item

Death On Study (Death on study)

CL Item

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

CL Item

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

CL Item

Alternative Therapy (Alternative therapy)

CL Item

Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

Off-TreatmentAlternativeTherapyAdministeredReason

Item

Alternative therapy, specify (Mark one with an X.)

text

C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C25415 (NCI Thesaurus ObjectClass)
C1523987 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)

CL.7

Code List

Alternative therapy, specify (Mark one with an X.)

CL Item

Removed To Undergo Surgical Resection (Removed to undergo surgical resection)

CL Item

Removed To Receive Non-protocol Chemotherapy And/or Biologic Therapy (Removed to receive non-protocol chemotherapy and/or biologic therapy)

Off-treatmentReasonSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

Response Data

Item Group

Response Data

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)

BestOverallNeoplasmResponseType

Item

Best Overall Response to date

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25605 (NCI Thesaurus ObjectClass)
C1561607 (UMLS 2011AA ObjectClass)
C25432 (NCI Thesaurus ObjectClass)
C1522427 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.8

Code List

Best Overall Response to date

CL Item

Complete Response (CR)

CL Item

Partial Response (PR)

C18212 (NCI Thesaurus)

CL Item

Stable Disease (SD)

C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)

CL Item

Progressive Disease (PD)

C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)

CL Item

Not An Approved Recist Value (NED)

CompleteResponseFirstObservedDate

Item

Complete Response (CR) First Observed Date

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

Partial Response (PR) First Observed Date

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)

ProgressionObservedDate

Item

Progressive Disease (PD) Observed Date

date

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

ProgressionSite

Item

Sites of progression

text

C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25331 (NCI Thesaurus ObjectClass)

CL.9

Code List

Sites of progression

CL Item

Lung, Nos (Lung)

C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)

CL Item

Contralateral Lung (Opposite lung)

CL Item

Pleura (Pleura)

C12469 (NCI Thesaurus)
C0032225 (UMLS 2011AA)

CL Item

Regional Lymph Nodes (Regional lymph nodes)

CL Item

Distant Lymph Nodes (Distant lymph nodes)

CL Item

Liver (Liver)

C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)

CL Item

Bone (Bone)

C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)

CL Item

Central Nervous System (Central Nervous System)

C12438 (NCI Thesaurus)
C0927232 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

ProgressionSiteSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25331 (NCI Thesaurus ObjectClass)

ResponsiblePersonName

Item

Completed by

text

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

FormOriginalCompleteDate

Item

Date form originally completed

date

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

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Lung Cancer NCT00693992 Treatment - CALGB: 30607 Treatment and Response Form - 2664196v1.0

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.

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