ID

10628

Description

CALGB: 49808 TREATMENT SUMMARY FORM PACLITAXEL + HERCEPTIN (T+H) NCT00016276 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-8B6D-227A-E034-080020C9C0E0

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9E35395C-8B6D-227A-E034-080020C9C0E0

Mots-clés

Versions (3)
  1. 26/08/2012 26/08/2012 -
  2. 22/05/2015 22/05/2015 -
  3. 03/06/2015 03/06/2015 -
Téléchargé le

3 juin 2015

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy
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CALGB: 49808 TREATMENT SUMMARY FORM PACLITAXEL + HERCEPTIN (T+H) NCT00016276

Anglais

No Instruction available.

1 Formulaires  
  1. StudyEvent: CALGB: 49808 TREATMENT SUMMARY FORM PACLITAXEL + HERCEPTIN (T+H)
    1. No Instruction available.
CALGB clinical trial administrative data
Description

CALGB clinical trial administrative data

CALGB Form
Description

CALGBForm

Type de données

text

CALGB Study No
Description

CALGBProtocolNumber

Type de données

text

CALGB Patient ID
Description

CALGBPatientID

Type de données

text

From
Description

From

Type de données

text

To
Description

To

Type de données

text

Amended data?
Description

AmendedDataInd

Type de données

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Patient clinical trial data
Description

Patient clinical trial data

Patient's Name
Description

Patient'sName

Type de données

text

Participating Group
Description

ParticipatingGroup

Type de données

text

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

PatientHospitalNumber

Type de données

text

Participating Group Protocol No.
Description

ParticipatingGroupProtocolNo.

Type de données

text

Main Member Institution/Adjunct
Description

MainMemberInstitution/Adjunct

Type de données

text

Participating Group Patient No.
Description

ParticipatingGroupPatientNo.

Type de données

text

Treatment Plan
Description

Treatment Plan

Initial dose of week 1 or week 7 (Total dose in mg)
Description

Initialdoseofweek1orweek7

Type de données

text

Last date protocol therapy was given
Description

ProtocolTreatmentAdministeredEndDate

Type de données

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 of Paclitaxel during this reporting period
Description

NumberofcompletedweeksofPaclitaxelduringthisreportingperiod

Type de données

text

Reason Treatment Ended (mark one with an X)
Description

TreatmentDiscontinuedType

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
Reason Treatment Ended Other, specify
Description

ReasonTreatmentEndedOther,specify

Type de données

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?

Type de données

text

Treatment Schedule - Other Therapy
Description

Treatment Schedule - Other Therapy

Were any optional protocol therapies given?
Description

Wereanyoptionalprotocoltherapiesgiven?

Type de données

text

Optional Protocol Therapy Name
Description

OptionalProtocolTherapyName

Type de données

text

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

Wereanynon-protocoltherapiesgivenduringprotocoltreatment?

Type de données

text

Concurrent Non-Protocol Chemotherapy?
Description

ConcurrentNon-ProtocolChemotherapyInd

Type de données

text

Concurrent Non-Protocol Hormonal Therapy?
Description

ConcurrentNon-ProtocolHormonalTherapyInd

Type de données

text

Concurrent Non-Protocol Biologic Response Modifier Therapy?
Description

ConcurrentNon-ProtocolBRMInd

Type de données

text

Concurrent Non-Protocol Radiation Therapy?
Description

ConcurrentNon-ProtocolRTInd

Type de données

text

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

ConcurrentNon-ProtocolHDC/ASCTInd

Type de données

text

Comments
Description

Comments

Comments
Description

Comments

Type de données

text

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Similar models

No Instruction available.

1 Formulaires
  1. StudyEvent: CALGB: 49808 TREATMENT SUMMARY FORM PACLITAXEL + HERCEPTIN (T+H)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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)
CL.1
Code List
Amended data?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Patient clinical trial data
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 week 1 or week 7 (Total dose in mg)
text
CL.2
Code List
Initial dose of week 1 or week 7 (Total dose in mg)
CL Item
Paclitaxel (Paclitaxel)
C1411 (NCI Thesaurus)
C0144576 (UMLS 2011AA)
CL Item
Herceptin (Herceptin)
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)
NumberofcompletedweeksofPaclitaxelduringthisreportingperiod
Item
Number of completed weeks of Paclitaxel during this reporting period
text
Item
Reason Treatment Ended (mark one with an X)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
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 Group
Treatment Schedule - Other Therapy
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 Group
Comments
Comments
Item
Comments
text
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