ID

10628

Beschreibung

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

Link

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

Stichworte

Versionen (3)
  1. 26.08.12 26.08.12 -
  2. 22.05.15 22.05.15 -
  3. 03.06.15 03.06.15 -
Hochgeladen am

3. Juni 2015

DOI

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Lizenz

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

Englisch

No Instruction available.

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

CALGB clinical trial administrative data

CALGB Form
Beschreibung

CALGBForm

Datentyp

text

CALGB Study No
Beschreibung

CALGBProtocolNumber

Datentyp

text

CALGB Patient ID
Beschreibung

CALGBPatientID

Datentyp

text

From
Beschreibung

From

Datentyp

text

To
Beschreibung

To

Datentyp

text

Amended data?
Beschreibung

AmendedDataInd

Datentyp

text

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

Patient clinical trial data

Patient's Name
Beschreibung

Patient'sName

Datentyp

text

Participating Group
Beschreibung

ParticipatingGroup

Datentyp

text

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

PatientHospitalNumber

Datentyp

text

Participating Group Protocol No.
Beschreibung

ParticipatingGroupProtocolNo.

Datentyp

text

Main Member Institution/Adjunct
Beschreibung

MainMemberInstitution/Adjunct

Datentyp

text

Participating Group Patient No.
Beschreibung

ParticipatingGroupPatientNo.

Datentyp

text

Treatment Plan
Beschreibung

Treatment Plan

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

Initialdoseofweek1orweek7

Datentyp

text

Last date protocol therapy was given
Beschreibung

ProtocolTreatmentAdministeredEndDate

Datentyp

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
Beschreibung

NumberofcompletedweeksofPaclitaxelduringthisreportingperiod

Datentyp

text

Reason Treatment Ended (mark one with an X)
Beschreibung

TreatmentDiscontinuedType

Datentyp

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
Beschreibung

ReasonTreatmentEndedOther,specify

Datentyp

text

Treatment Schedule - Systemic Therapy
Beschreibung

Treatment Schedule - Systemic Therapy

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

Werethereanydosemodificationsoradditions/omissionstoprotocoltreatment?

Datentyp

text

Treatment Schedule - Other Therapy
Beschreibung

Treatment Schedule - Other Therapy

Were any optional protocol therapies given?
Beschreibung

Wereanyoptionalprotocoltherapiesgiven?

Datentyp

text

Optional Protocol Therapy Name
Beschreibung

OptionalProtocolTherapyName

Datentyp

text

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

Wereanynon-protocoltherapiesgivenduringprotocoltreatment?

Datentyp

text

Concurrent Non-Protocol Chemotherapy?
Beschreibung

ConcurrentNon-ProtocolChemotherapyInd

Datentyp

text

Concurrent Non-Protocol Hormonal Therapy?
Beschreibung

ConcurrentNon-ProtocolHormonalTherapyInd

Datentyp

text

Concurrent Non-Protocol Biologic Response Modifier Therapy?
Beschreibung

ConcurrentNon-ProtocolBRMInd

Datentyp

text

Concurrent Non-Protocol Radiation Therapy?
Beschreibung

ConcurrentNon-ProtocolRTInd

Datentyp

text

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

ConcurrentNon-ProtocolHDC/ASCTInd

Datentyp

text

Comments
Beschreibung

Comments

Comments
Beschreibung

Comments

Datentyp

text

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No Instruction available.

1 Formulare
  1. StudyEvent: CALGB: 49808 TREATMENT SUMMARY FORM PACLITAXEL + HERCEPTIN (T+H)
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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