ID

9994

Beskrivning

Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer NCT00016276 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9E35395C-8C3D-227A-E034-080020C9C0E0

Länk

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

Nyckelord

Versioner (2)
  1. 2012-08-26 2012-08-26 -
  2. 2015-03-12 2015-03-12 - Martin Dugas
Uppladdad den

12 mars 2015

DOI

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Licens

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

Engelsk

No Instruction available.

1 Formulär  
  1. StudyEvent: CALGB: 49808 TREATMENT SUMMARY FORM HERCEPTIN VS OBSERVATION
    1. No Instruction available.
Header
Beskrivning

Header

CALGB Form
Beskrivning

CALGBForm

Datatyp

text

CALGB Study No
Beskrivning

CALGBProtocolNumber

Datatyp

text

CALGB Patient ID
Beskrivning

CALGBPatientID

Datatyp

text

Amended data?
Beskrivning

Amended data?

Datatyp

boolean

Alias
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
UMLS CUI-1
C0680532
Patient's Name
Beskrivning

Patient's Name

Datatyp

text

Alias
UMLS CUI-1
C1299487
Participating Group
Beskrivning

ParticipatingGroup

Datatyp

text

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

PatientHospitalNumber

Datatyp

text

Participating Group Protocol No.
Beskrivning

ParticipatingGroupProtocolNo.

Datatyp

text

Main Member Institution/Adjunct
Beskrivning

MainMemberInstitution/Adjunct

Datatyp

text

Participating Group Patient No.
Beskrivning

ParticipatingGroupPatientNo.

Datatyp

text

Comments
Beskrivning

Comments

Datatyp

text

Treatment Plan
Beskrivning

Treatment Plan

Is patient taking Herceptin?
Beskrivning

Is patient taking Herceptin?

Datatyp

boolean

Alias
UMLS CUI-1
C0338204
Initial dose this reporting period (Total dose in mg Herceptin if randomized)
Beskrivning

Initialdosethisreportingperiod

Datatyp

text

Last date protocol therapy was given
Beskrivning

ProtocolTreatmentAdministeredEndDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C42651
NCI Thesaurus Property
C25382
UMLS CUI-1
C1531784
Number of completed weeks during this reporting period
Beskrivning

Numberofcompletedweeksduringthisreportingperiod

Datatyp

integer

Reason Treatment Ended (mark one with an X)
Beskrivning

ReasonTreatmentEnded

Datatyp

text

Reason Treatment Ended Other, specify
Beskrivning

ReasonTreatmentEndedOther,specify

Datatyp

text

Treatment Schedule - Systemic Therapy
Beskrivning

Treatment Schedule - Systemic Therapy

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

Werethereanydosemodificationsoradditions/omissionstoprotocoltreatment?

Datatyp

text

Alias
UMLS CUI-1
C1705236
Were any optional protocol therapies given?
Beskrivning

Wereanyoptionalprotocoltherapiesgiven?

Datatyp

boolean

Optional Protocol Therapy Name
Beskrivning

OptionalProtocolTherapyName

Datatyp

text

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

Wereanynon-protocoltherapiesgivenduringprotocoltreatment?

Datatyp

boolean

Alias
UMLS CUI-1
C1518384
UMLS CUI-2
C0087111
Concurrent Non-Protocol Chemotherapy?
Beskrivning

ConcurrentNon-ProtocolChemotherapyInd

Datatyp

boolean

Concurrent Non-Protocol Hormonal Therapy?
Beskrivning

ConcurrentNon-ProtocolHormonalTherapyInd

Datatyp

boolean

Concurrent Non-Protocol Biologic Response Modifier Therapy?
Beskrivning

ConcurrentNon-ProtocolBRMInd

Datatyp

boolean

Concurrent Non-Protocol Radiation Therapy?
Beskrivning

ConcurrentNon-ProtocolRTInd

Datatyp

boolean

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

ConcurrentNon-ProtocolHDC/ASCTInd

Datatyp

boolean

Did this patient receive any tamoxifen?
Beskrivning

PastTamoxifenInd

Datatyp

boolean

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

Didpatientbegintakingtamoxifenduringthisreportingperiod?

Datatyp

boolean

Alias
UMLS CUI-1
C0039286
If Yes, date tamoxifen started
Beskrivning

IfYes,datetamoxifenstarted

Datatyp

date

Is the patient still receiving tamoxifen?
Beskrivning

CurrentTamoxifenInd

Datatyp

boolean

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

Ifpatientdiscontinuedtamoxifensincelastfollow-up,givedate.

Datatyp

date

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Similar models

No Instruction available.

1 Formulär
  1. StudyEvent: CALGB: 49808 TREATMENT SUMMARY FORM HERCEPTIN VS OBSERVATION
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Header
CALGBForm
Item
CALGB Form
text
CALGBProtocolNumber
Item
CALGB Study No
text
CALGBPatientID
Item
CALGB Patient ID
text
Data amended
Item
Amended data?
boolean
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
C0680532 (UMLS CUI-1)
Patient Name
Item
Patient's Name
text
C1299487 (UMLS CUI-1)
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
Comments
Item
Comments
text
Item Group
Treatment Plan
Herceptin
Item
Is patient taking Herceptin?
boolean
C0338204 (UMLS CUI-1)
Initialdosethisreportingperiod
Item
Initial dose this reporting period (Total dose in mg Herceptin if randomized)
text
Therapy end date
Item
Last date protocol therapy was given
date
C25164 (NCI Thesaurus ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1531784 (UMLS CUI-1)
Number of completed weeks
Item
Number of completed weeks during this reporting period
integer
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
C1705236 (UMLS CUI-1)
CL.4
Code List
Were there any dose modifications or additions/ omissions to protocol treatment? (mark one with an X)
CL Item
No (0)
C1298908 (UMLS CUI-1)
CL Item
Yes, planned (1)
C1705108 (UMLS CUI-1)
C1301732 (UMLS CUI-2)
CL Item
Yes, Unplanned (2)
Optional protocol therapies
Item
Were any optional protocol therapies given?
boolean
OptionalProtocolTherapyName
Item
Optional Protocol Therapy Name
text
Non-protocol Therapy
Item
Were any non-protocol therapies given during protocol treatment?
boolean
C1518384 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
ConcurrentNon-ProtocolChemotherapyInd
Item
Concurrent Non-Protocol Chemotherapy?
boolean
ConcurrentNon-ProtocolHormonalTherapyInd
Item
Concurrent Non-Protocol Hormonal Therapy?
boolean
ConcurrentNon-ProtocolBRMInd
Item
Concurrent Non-Protocol Biologic Response Modifier Therapy?
boolean
ConcurrentNon-ProtocolRTInd
Item
Concurrent Non-Protocol Radiation Therapy?
boolean
ConcurrentNon-ProtocolHDC/ASCTInd
Item
Concurrent Non-Protocol High Dose Chemotherapy/Autologous Stem Cell Transplant?
boolean
PastTamoxifenInd
Item
Did this patient receive any tamoxifen?
boolean
Tamoxifen
Item
Did patient begin taking tamoxifen during this reporting period? (If Yes)
boolean
C0039286 (UMLS CUI-1)
Tamoxifen start date
Item
If Yes, date tamoxifen started
date
CurrentTamoxifenInd
Item
Is the patient still receiving tamoxifen?
boolean
Tamoxifen discontinuation date
Item
If patient discontinued tamoxifen since last follow-up, give date.
date
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