ID

675

Beschrijving

CALGB: 49808 TREATMENT SUMMARY FORM HERCEPTIN VS OBSERVATION Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9E35395C-8C3D-227A-E034-080020C9C0E0

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9E35395C-8C3D-227A-E034-080020C9C0E0

Trefwoorden

Versies (2)
  1. 26-08-12 26-08-12 -
  2. 12-03-15 12-03-15 - Martin Dugas
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26 augustus 2012

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00016276 Treatment - CALGB: 49808 TREATMENT SUMMARY FORM HERCEPTIN VS OBSERVATION - 2032660v3.0

Engels

No Instruction available.

1 Formulieren  
  1. StudyEvent: CALGB: 49808 TREATMENT SUMMARY FORM HERCEPTIN VS OBSERVATION
    1. No Instruction available.
Unnamed1
Beschrijving

Unnamed1

CALGB Form
Beschrijving

CALGBForm

Datatype

text

CALGB Study No
Beschrijving

CALGBProtocolNumber

Datatype

text

CALGB Patient ID
Beschrijving

CALGBPatientID

Datatype

text

Amended data?
Beschrijving

AmendedDataInd

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Unnamed2
Beschrijving

Unnamed2

Patient's Name
Beschrijving

Patient'sName

Datatype

text

Participating Group
Beschrijving

ParticipatingGroup

Datatype

text

Alias
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Patient Hospital Number
Beschrijving

PatientHospitalNumber

Datatype

text

Participating Group Protocol No.
Beschrijving

ParticipatingGroupProtocolNo.

Datatype

text

Main Member Institution/Adjunct
Beschrijving

MainMemberInstitution/Adjunct

Datatype

text

Participating Group Patient No.
Beschrijving

ParticipatingGroupPatientNo.

Datatype

text

Treatment Plan
Beschrijving

Treatment Plan

Is patient taking Herceptin?
Beschrijving

IspatienttakingHerceptin?

Datatype

text

Initial dose this reporting period (Total dose in mg Herceptin if randomized)
Beschrijving

Initialdosethisreportingperiod

Datatype

text

Last date protocol therapy was given
Beschrijving

ProtocolTreatmentAdministeredEndDate

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C42651
UMLS 2011AA ObjectClass
C0442711
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Number of completed weeks during this reporting period
Beschrijving

Numberofcompletedweeksduringthisreportingperiod

Datatype

text

Reason Treatment Ended (mark one with an X)
Beschrijving

ReasonTreatmentEnded

Datatype

text

Reason Treatment Ended Other, specify
Beschrijving

ReasonTreatmentEndedOther,specify

Datatype

text

Treatment Schedule - Systemic Therapy
Beschrijving

Treatment Schedule - Systemic Therapy

Were there any dose modifications or additions/ omissions to protocol treatment? (mark one with an X)
Beschrijving

Werethereanydosemodificationsoradditions/omissionstoprotocoltreatment?

Datatype

text

Were any optional protocol therapies given?
Beschrijving

Wereanyoptionalprotocoltherapiesgiven?

Datatype

text

Optional Protocol Therapy Name
Beschrijving

OptionalProtocolTherapyName

Datatype

text

Were any non-protocol therapies given during protocol treatment?
Beschrijving

Wereanynon-protocoltherapiesgivenduringprotocoltreatment?

Datatype

text

Concurrent Non-Protocol Chemotherapy?
Beschrijving

ConcurrentNon-ProtocolChemotherapyInd

Datatype

text

Concurrent Non-Protocol Hormonal Therapy?
Beschrijving

ConcurrentNon-ProtocolHormonalTherapyInd

Datatype

text

Concurrent Non-Protocol Biologic Response Modifier Therapy?
Beschrijving

ConcurrentNon-ProtocolBRMInd

Datatype

text

Concurrent Non-Protocol Radiation Therapy?
Beschrijving

ConcurrentNon-ProtocolRTInd

Datatype

text

Concurrent Non-Protocol High Dose Chemotherapy/Autologous Stem Cell Transplant?
Beschrijving

ConcurrentNon-ProtocolHDC/ASCTInd

Datatype

text

Did this patient receive any tamoxifen?
Beschrijving

PastTamoxifenInd

Datatype

text

Did patient begin taking tamoxifen during this reporting period? (If Yes)
Beschrijving

Didpatientbegintakingtamoxifenduringthisreportingperiod?

Datatype

text

If Yes, date tamoxifen started
Beschrijving

IfYes,datetamoxifenstarted

Datatype

text

Is the patient still receiving tamoxifen?
Beschrijving

CurrentTamoxifenInd

Datatype

text

If patient discontinued tamoxifen since last follow-up, give date.
Beschrijving

Ifpatientdiscontinuedtamoxifensincelastfollow-up,givedate.

Datatype

text

Comments
Beschrijving

Comments

Comments
Beschrijving

Comments

Datatype

text

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Similar models

No Instruction available.

1 Formulieren
  1. StudyEvent: CALGB: 49808 TREATMENT SUMMARY FORM HERCEPTIN VS OBSERVATION
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Unnamed1
CALGBForm
Item
CALGB Form
text
CALGBProtocolNumber
Item
CALGB Study No
text
CALGBPatientID
Item
CALGB Patient ID
text
Item
Amended data?
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
CL.1
Code List
Amended data?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Unnamed2
Patient'sName
Item
Patient's Name
text
ParticipatingGroup
Item
Participating Group
text
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientHospitalNumber
Item
Patient Hospital Number
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
MainMemberInstitution/Adjunct
Item
Main Member Institution/Adjunct
text
ParticipatingGroupPatientNo.
Item
Participating Group Patient No.
text
Item Group
Treatment Plan
Item
Is patient taking Herceptin?
text
CL.2
Code List
Is patient taking Herceptin?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Initialdosethisreportingperiod
Item
Initial dose this reporting period (Total dose in mg Herceptin if randomized)
text
ProtocolTreatmentAdministeredEndDate
Item
Last date protocol therapy was given
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass)
C0442711 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Numberofcompletedweeksduringthisreportingperiod
Item
Number of completed weeks during this reporting period
text
Item
Reason Treatment Ended (mark one with an X)
text
CL.3
Code List
Reason Treatment Ended (mark one with an X)
CL Item
Not applicable (Not applicable)
CL Item
Treatment completed per protocol criteria (Treatment completed per protocol criteria)
CL Item
Disease progression/relapse during active treatment (Disease progression/relapse during active treatment)
CL Item
Toxicity/side effects/complications (Toxicity/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 prior to beginning protocol therapy (Patient withdrawal or refusal prior to beginning protocol therapy)
CL Item
Alternative therapy (Alternative therapy)
CL Item
Other complicating disease (Other complicating disease)
CL Item
Other, specify (Other, specify)
ReasonTreatmentEndedOther,specify
Item
Reason Treatment Ended Other, specify
text
Item Group
Treatment Schedule - Systemic Therapy
Item
Were there any dose modifications or additions/ omissions to protocol treatment? (mark one with an X)
text
CL.4
Code List
Were there any dose modifications or additions/ omissions to protocol treatment? (mark one with an X)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned (Yes, planned)
CL Item
Yes, Unplanned (Yes, unplanned)
Item
Were any optional protocol therapies given?
text
CL.5
Code List
Were any optional protocol therapies given?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
OptionalProtocolTherapyName
Item
Optional Protocol Therapy Name
text
Item
Were any non-protocol therapies given during protocol treatment?
text
CL.6
Code List
Were any non-protocol therapies given during protocol treatment?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Concurrent Non-Protocol Chemotherapy?
text
CL.7
Code List
Concurrent Non-Protocol Chemotherapy?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Concurrent Non-Protocol Hormonal Therapy?
text
CL.8
Code List
Concurrent Non-Protocol Hormonal Therapy?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Concurrent Non-Protocol Biologic Response Modifier Therapy?
text
CL.9
Code List
Concurrent Non-Protocol Biologic Response Modifier Therapy?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Concurrent Non-Protocol Radiation Therapy?
text
CL.10
Code List
Concurrent Non-Protocol Radiation Therapy?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Concurrent Non-Protocol High Dose Chemotherapy/Autologous Stem Cell Transplant?
text
CL.11
Code List
Concurrent Non-Protocol High Dose Chemotherapy/Autologous Stem Cell Transplant?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Did this patient receive any tamoxifen?
text
CL.12
Code List
Did this patient receive any tamoxifen?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Did patient begin taking tamoxifen during this reporting period? (If Yes)
text
CL.13
Code List
Did patient begin taking tamoxifen during this reporting period? (If Yes)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
IfYes,datetamoxifenstarted
Item
If Yes, date tamoxifen started
text
Item
Is the patient still receiving tamoxifen?
text
CL.14
Code List
Is the patient still receiving tamoxifen?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Ifpatientdiscontinuedtamoxifensincelastfollow-up,givedate.
Item
If patient discontinued tamoxifen since last follow-up, give date.
text
Item Group
Comments
Comments
Item
Comments
text
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