ID

9994

Description

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

Link

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

Keywords

Versions (2)
  1. 8/26/12 8/26/12 -
  2. 3/12/15 3/12/15 - Martin Dugas
Uploaded on

March 12, 2015

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0 Legacy
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Breast Cancer NCT00016276 Treatment - CALGB: 49808 TREATMENT SUMMARY FORM HERCEPTIN VS OBSERVATION - 2032660v3.0

English

No Instruction available.

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

Header

CALGB Form
Description

CALGBForm

Data type

text

CALGB Study No
Description

CALGBProtocolNumber

Data type

text

CALGB Patient ID
Description

CALGBPatientID

Data type

text

Amended data?
Description

Amended data?

Data type

boolean

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

Patient's Name

Data type

text

Alias
UMLS CUI-1
C1299487
Participating Group
Description

ParticipatingGroup

Data type

text

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

PatientHospitalNumber

Data type

text

Participating Group Protocol No.
Description

ParticipatingGroupProtocolNo.

Data type

text

Main Member Institution/Adjunct
Description

MainMemberInstitution/Adjunct

Data type

text

Participating Group Patient No.
Description

ParticipatingGroupPatientNo.

Data type

text

Comments
Description

Comments

Data type

text

Treatment Plan
Description

Treatment Plan

Is patient taking Herceptin?
Description

Is patient taking Herceptin?

Data type

boolean

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

Initialdosethisreportingperiod

Data type

text

Last date protocol therapy was given
Description

ProtocolTreatmentAdministeredEndDate

Data type

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
Description

Numberofcompletedweeksduringthisreportingperiod

Data type

integer

Reason Treatment Ended (mark one with an X)
Description

ReasonTreatmentEnded

Data type

text

Reason Treatment Ended Other, specify
Description

ReasonTreatmentEndedOther,specify

Data type

text

Treatment Schedule - Systemic Therapy
Description

Treatment Schedule - Systemic Therapy

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

Werethereanydosemodificationsoradditions/omissionstoprotocoltreatment?

Data type

text

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

Wereanyoptionalprotocoltherapiesgiven?

Data type

boolean

Optional Protocol Therapy Name
Description

OptionalProtocolTherapyName

Data type

text

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

Wereanynon-protocoltherapiesgivenduringprotocoltreatment?

Data type

boolean

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

ConcurrentNon-ProtocolChemotherapyInd

Data type

boolean

Concurrent Non-Protocol Hormonal Therapy?
Description

ConcurrentNon-ProtocolHormonalTherapyInd

Data type

boolean

Concurrent Non-Protocol Biologic Response Modifier Therapy?
Description

ConcurrentNon-ProtocolBRMInd

Data type

boolean

Concurrent Non-Protocol Radiation Therapy?
Description

ConcurrentNon-ProtocolRTInd

Data type

boolean

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

ConcurrentNon-ProtocolHDC/ASCTInd

Data type

boolean

Did this patient receive any tamoxifen?
Description

PastTamoxifenInd

Data type

boolean

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

Didpatientbegintakingtamoxifenduringthisreportingperiod?

Data type

boolean

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

IfYes,datetamoxifenstarted

Data type

date

Is the patient still receiving tamoxifen?
Description

CurrentTamoxifenInd

Data type

boolean

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

Ifpatientdiscontinuedtamoxifensincelastfollow-up,givedate.

Data type

date

Back to the top of the page

Similar models

No Instruction available.

1 forms
  1. StudyEvent: CALGB: 49808 TREATMENT SUMMARY FORM HERCEPTIN VS OBSERVATION
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial