ID

10633

Description

CALGB: 49808 TREATMENT SUMMARY FORM DOXORUBICIN + CYCLOPHOSPHAMIDE + ZINECARD (AC+Z) 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-89CA-227A-E034-080020C9C0E0 NCT00016276

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9E35395C-89CA-227A-E034-080020C9C0E0

Keywords

  1. 8/26/12 8/26/12 -
  2. 5/22/15 5/22/15 -
  3. 6/3/15 6/3/15 - Julian Varghese
  4. 6/3/15 6/3/15 -
Uploaded on

June 3, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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CALGB: 49808 TREATMENT SUMMARY FORM DOXORUBICIN + CYCLOPHOSPHAMIDE + ZINECARD (AC+Z) NCT00016276

No Instruction available.

  1. StudyEvent: CALGB: 49808 TREATMENT SUMMARY FORM DOXORUBICIN + CYCLOPHOSPHAMIDE + ZINECARD (AC+Z)
    1. No Instruction available.
CALGB clinical trial administrative data
Description

CALGB clinical trial administrative data

CALGB Form
Description

CALGBForm

Data type

text

CALGB Study No
Description

CALGBProtocolNumber

Data type

text

CALGB Patient ID
Description

CALGBPatientID

Data type

text

From
Description

From

Data type

text

To
Description

To

Data type

text

Amended data?
Description

AmendedDataInd

Data type

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Patient demographics
Description

Patient demographics

Patient's Name
Description

Patient'sName

Data type

text

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

Treatment Plan
Description

Treatment Plan

Initial dose of Cycle 1 or Cycle 3
Description

InitialdoseofCycle1orCycle3

Data type

text

Last date protocol therapy was given
Description

ProtocolTreatmentAdministeredEndDate

Data type

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 cycles completed this reporting period
Description

Numberofcyclescompletedthisreportingperiod

Data type

text

Reason Treatment Ended
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?
Description

Werethereanydosemodificationsoradditions/omissionstoprotocoltreatment?

Data type

text

Treatment Schedule - Other Therapy
Description

Treatment Schedule - Other Therapy

Were any optional protocol therapies given?
Description

Wereanyoptionalprotocoltherapiesgiven?

Data type

text

Optional Protocol Therapy Name
Description

OptionalProtocolTherapyName

Data type

text

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

Wereanynon-protocoltherapiesgivenduringprotocoltreatment?

Data type

text

Concurrent Non-Protocol Chemotherapy?
Description

ConcurrentNon-ProtocolChemotherapyInd

Data type

text

Concurrent Non-Protocol Hormonal Therapy?
Description

ConcurrentNon-ProtocolHormonalTherapyInd

Data type

text

Concurrent Non-Protocol Biologic Response Modifier Therapy?
Description

ConcurrentNon-ProtocolBRMInd

Data type

text

Concurrent Non-Protocol Radiation Therapy?
Description

ConcurrentNon-ProtocolRTInd

Data type

text

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

ConcurrentNon-ProtocolHDC/ASCTInd

Data type

text

Disease Assessment
Description

Disease Assessment

Disease Assessment
Description

DiseaseAssessment

Data type

text

Primary Tumor Size
Description

PrimaryTumorSize

Data type

double

Comments
Description

Comments

Comments
Description

Comments

Data type

text

Similar models

No Instruction available.

  1. StudyEvent: CALGB: 49808 TREATMENT SUMMARY FORM DOXORUBICIN + CYCLOPHOSPHAMIDE + ZINECARD (AC+Z)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
CALGB clinical trial administrative data
CALGBForm
Item
CALGB Form
text
CALGBProtocolNumber
Item
CALGB Study No
text
CALGBPatientID
Item
CALGB Patient ID
text
From
Item
From
text
To
Item
To
text
Item
Amended data?
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
Code List
Amended data?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Patient demographics
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
Initial dose of Cycle 1 or Cycle 3
text
Code List
Initial dose of Cycle 1 or Cycle 3
CL Item
Doxorubicin (Doxorubicin)
C456 (NCI Thesaurus)
C0013089 (UMLS 2011AA)
CL Item
Cyclophosphamide (Cyclophosphamide)
C405 (NCI Thesaurus)
C0010583 (UMLS 2011AA)
CL Item
Zinecard (Zinecard)
C0728750 (NCI Metathesaurus)
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)
Numberofcyclescompletedthisreportingperiod
Item
Number of cycles completed this reporting period
text
Item
Reason Treatment Ended
text
Code List
Reason Treatment Ended
CL Item
Not Applicable (Not applicable)
C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)
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?
text
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 (Yes, planned)
CL Item
Yes, Unplanned (Yes, unplanned)
Item Group
Treatment Schedule - Other Therapy
Item
Were any optional protocol therapies given?
text
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
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
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
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
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
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
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 Group
Disease Assessment
Item
Disease Assessment
text
Code List
Disease Assessment
CL Item
Physical Exam (Physical Exam)
CL Item
Mammogram (Mammogram)
C20178 (NCI Thesaurus)
C0024671 (UMLS 2011AA)
CL Item
Ultrasound (Ultrasound)
C64384 (NCI Thesaurus)
C1456803 (UMLS 2011AA)
PrimaryTumorSize
Item
Primary Tumor Size
double
Item Group
Comments
Comments
Item
Comments
text

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