ID

10181

Description

CALGB: 49907 ADJUVANT TREATMENT SUMMARY FORM; All Patients Comparison of Combination Chemotherapy Regimens in Treating Older Women Who Have Undergone Surgery for Breast Cancer NCT00024102 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A50D76F4-2138-330D-E034-080020C9C0E0

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A50D76F4-2138-330D-E034-080020C9C0E0

Keywords

  1. 8/26/12 8/26/12 -
  2. 4/22/15 4/22/15 - Martin Dugas
Uploaded on

April 22, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer ADJUVANT TREATMENT CALGB 49907 NCT00024102

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. Circle amended items and check "Amended data" box to the right. If submitting by mail, retain a copy for your records and send the original to the CALGB Data Management Center. If faxing, use an original form for maximum clarity in transmission and fax to 919-416-4990. If submitting electronically, click the Send button when you have completed the PDF version of the form.

Header
Description

Header

Alias
UMLS CUI-1
C1320722
CALGB Form
Description

CALGBForm

Data type

text

CALGB Study No
Description

CALGBStudyNo

Data type

text

CALGB Patient ID
Description

CALGBPatientID

Data type

text

First date protocol therapy was given
Description

TreatmentBeginDate

Data type

date

Last date protocol therapy was given (M)
Description

ProtocolTreatmentAdministeredEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C42651
UMLS 2011AA ObjectClass
C0442711
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Amended data?
Description

Amendeddata?

Data type

text

Completed By (Print or Type Name)
Description

CompletedBy

Data type

text

Date Completed
Description

DateCompleted

Data type

date

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

First Date (Treatment Schedule - Systemic Therapy)
Description

FirstDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25509
UMLS 2011AA ValueDomain-2
C1279901
Comments
Description

Comments

Data type

text

Treatment Cycle Information
Description

Treatment Cycle Information

Total Dose of Drugs for Cycle 1
Description

TotalDoseofDrugsforCycle1

Data type

float

Measurement units
  • mg
Alias
UMLS CUI-1
C2986497
mg
Agent Name
Description

Agent Name

Data type

text

Alias
UMLS CUI-1
C0450442
Reason Treatment Ended (mark one with an X)
Description

ReasonTreatmentEnded

Data type

text

Other, specify (reason treatment ended)
Description

Other,specify(reasontreatmentended)

Data type

text

Were there any dose modifications or additions/ omissions to protocol treatment? (Treatment Schedule - Other Therapy)
Description

Werethereanydosemodificationsoradditions/omissionstoprotocoltreatment?

Data type

text

Alias
UMLS CUI-1
C1707811
Were any optional protocol therapies given?
Description

Wereanyoptionalprotocoltherapiesgiven?

Data type

boolean

optional protocol therapy name(s)
Description

optionalprotocoltherapyname(s)

Data type

text

Was any concurrent non-protocol therapy given during protocol treatment?
Description

Wasanyconcurrentnon-protocoltherapygivenduringprotocoltreatment?

Data type

boolean

Alias
UMLS CUI-1
C1518384
UMLS CUI-2
C0087111
indicate below (concurrent non-protocol therapy given during protocol treatment) (mark all that apply with an X)
Description

indicate below (concurrent non-protocol therapy given during protocol treatment) (mark all that apply with an X)

Data type

text

Alias
UMLS CUI-1
C1518384
UMLS CUI-2
C0087111

Similar models

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. Circle amended items and check "Amended data" box to the right. If submitting by mail, retain a copy for your records and send the original to the CALGB Data Management Center. If faxing, use an original form for maximum clarity in transmission and fax to 919-416-4990. If submitting electronically, click the Send button when you have completed the PDF version of the form.

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
CALGBForm
Item
CALGB Form
text
CALGBStudyNo
Item
CALGB Study No
text
CALGBPatientID
Item
CALGB Patient ID
text
TreatmentBeginDate
Item
First date protocol therapy was given
date
ProtocolTreatmentAdministeredEndDate
Item
Last date protocol therapy was given (M)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass-2)
C0442711 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Amended data?
text
Code List
Amended data?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CompletedBy
Item
Completed By (Print or Type Name)
text
DateCompleted
Item
Date Completed
date
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
FirstDate
Item
First Date (Treatment Schedule - Systemic Therapy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25509 (NCI Thesaurus ValueDomain-2)
C1279901 (UMLS 2011AA ValueDomain-2)
Comments
Item
Comments
text
Item Group
Treatment Cycle Information
Total dose
Item
Total Dose of Drugs for Cycle 1
float
C2986497 (UMLS CUI-1)
Item
Agent Name
text
C0450442 (UMLS CUI-1)
Code List
Agent Name
CL Item
Cyclophosphamide (Cyclophosphamide)
C405 (NCI Thesaurus)
C0010583 (UMLS CUI-1)
CL Item
Methotrexate (Methotrexate)
C642 (NCI Thesaurus)
C0025677 (UMLS CUI-1)
CL Item
Fluorouracil (Fluorouracil)
C505 (NCI Thesaurus)
C0016360 (UMLS CUI-1)
CL Item
Adriamycin (Adriamycin)
C0085752 (UMLS CUI-1)
CL Item
Capecitabine (Capecitabine)
C1794 (NCI Thesaurus)
C0671970 (UMLS CUI-1)
Item
Reason Treatment Ended (mark one with an X)
text
Code List
Reason Treatment Ended (mark one with an X)
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
Other Complicating Disease (Other complicating disease)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal or refusal prior to beginning protocol therapy)
CL Item
Other, Specify: (Other, specify)
Other,specify(reasontreatmentended)
Item
Other, specify (reason treatment ended)
text
Item
Were there any dose modifications or additions/ omissions to protocol treatment? (Treatment Schedule - Other Therapy)
text
C1707811 (UMLS CUI-1)
Code List
Were there any dose modifications or additions/ omissions to protocol treatment? (Treatment Schedule - Other Therapy)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned (Yes, planned)
CL Item
Yes, Unplanned (Yes, unplanned)
CL Item
Unknown (Unknown)
Optional protocol therapies
Item
Were any optional protocol therapies given?
boolean
optionalprotocoltherapyname(s)
Item
optional protocol therapy name(s)
text
Non-Protocol Therapy
Item
Was any concurrent non-protocol therapy given during protocol treatment?
boolean
C1518384 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
Item
indicate below (concurrent non-protocol therapy given during protocol treatment) (mark all that apply with an X)
text
C1518384 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
Code List
indicate below (concurrent non-protocol therapy given during protocol treatment) (mark all that apply with an X)
CL Item
Concurrent Non-protocol Chemotherapy (Concurrent non-protocol chemotherapy)
CL Item
Concurrent Non-protocol Hormonal Therapy (Concurrent non-protocol hormonal therapy)
CL Item
Concurrent Non-protocol Biologic Response Modifier Therapy (Concurrent non-protocol biologic response modifier therapy)
CL Item
Concurrent Non-protocol Radiation Therapy (Concurrent non-protocol radiation therapy)
CL Item
Concurrent Non-protocol High Dose Chemotherapy/autologous Stem Cell Transplant (Concurrent non-protocol high dose chemotherapy/ autologous stem cell transplant)

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