ID

10186

Description

CALGB: 40101 TREATMENT SUMMARY SUBSET FORM Four Versus Six Cycles of Cyclophosphamide/Doxorubicin or Paclitaxel in Adjuvant Breast Cancer NCT00041119 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A46C8094-22BA-26B0-E034-080020C9C0E0

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A46C8094-22BA-26B0-E034-080020C9C0E0

Keywords

  1. 8/26/12 8/26/12 -
  2. 4/24/15 4/24/15 - Martin Dugas
Uploaded on

April 24, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer Treatment CALGB 40101 NCT00041119

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 Statistical Center, Data Operations. 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

Cycle start date
Description

CourseBeginDate

Data type

date

Cycle end date (M)
Description

Cycleenddate

Data type

text

Amended data?
Description

Amended data?

Data type

boolean

Alias
UMLS CUI-1
C0680532
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

Completed By (Print or Type Name)
Description

CompletedBy

Data type

text

Date Completed (M)
Description

DateCompleted

Data type

date

Breast cancer treatment
Description

Breast cancer treatment

Alias
UMLS CUI-1
C1511300
Current cycle number
Description

Current cycle number

Data type

integer

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2045829
BSA
Description

BSA

Data type

text

Total dosage for this cycle, Doxorubicin
Description

Totaldosageforthiscycle,Doxorubicin

Data type

float

Measurement units
  • mg
Alias
UMLS CUI-1
C0013089
UMLS CUI-2
C0178602
mg
Total dosage for this cycle, Cyclophosphamide
Description

Totaldosageforthiscycle,Cyclophosphamide

Data type

float

Measurement units
  • mg
Alias
UMLS CUI-1
C0010583
UMLS CUI-2
C0178602
mg
Total dosage for this cycle, Paclitaxel
Description

Totaldosageforthiscycle,Paclitaxel

Data type

float

Measurement units
  • mg
Alias
UMLS CUI-1
C0144576
UMLS CUI-2
C0178602
mg
Dose adjustments (mark one with an X)
Description

Dose adjustments (mark one with an X)

Data type

text

Alias
UMLS CUI-1
C2826232
Reason for adjustment (Reasons for dose adjustment)
Description

Reasonforadjustment

Data type

text

Alias
UMLS CUI-1
C2826286
Specify (reason for adjustment) (if applicable)
Description

Specify(reasonforadjustment)

Data type

text

Alias
UMLS CUI-1
C2826286

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 Statistical Center, Data Operations. 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
CourseBeginDate
Item
Cycle start date
date
Cycleenddate
Item
Cycle end date (M)
text
Amended data
Item
Amended data?
boolean
C0680532 (UMLS CUI-1)
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
CompletedBy
Item
Completed By (Print or Type Name)
text
DateCompleted
Item
Date Completed (M)
date
Item Group
Breast cancer treatment
C1511300 (UMLS CUI-1)
Current cycle number
Item
Current cycle number
integer
C25337 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
BSA
Item
BSA
text
Doxorubicin dosage
Item
Total dosage for this cycle, Doxorubicin
float
C0013089 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
Cyclophosphamide dosage
Item
Total dosage for this cycle, Cyclophosphamide
float
C0010583 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
Paclitaxel dosage
Item
Total dosage for this cycle, Paclitaxel
float
C0144576 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
Item
Dose adjustments (mark one with an X)
text
C2826232 (UMLS CUI-1)
Code List
Dose adjustments (mark one with an X)
CL Item
Reduced (1)
C0392756 (UMLS CUI-1)
CL Item
Delayed (2)
C0205421 (UMLS CUI-1)
CL Item
Reduced And Delayed (3)
C0392756 (UMLS CUI-1)
C0205421 (UMLS CUI-2)
Item
Reason for adjustment (Reasons for dose adjustment)
text
C2826286 (UMLS CUI-1)
Code List
Reason for adjustment (Reasons for dose adjustment)
CL Item
Not Satisfactorily Recovered From Hematologic Toxicity (1)
CL Item
Grade 3 Or 4 Fatigue (2)
C1556364 (UMLS CUI-1)
C1556365 (UMLS CUI-2)
CL Item
Grade 2 Or 3 Anaphylaxis/hypersensitivity (3)
C1560129 (UMLS CUI-1)
C1560130 (UMLS CUI-2)
CL Item
Grade 3 Or 4 Diarrhea/nausea (4)
C1559310 (UMLS CUI-1)
C1559311 (UMLS CUI-2)
CL Item
Grade 3 Or 4 Mucositis (5)
CL Item
Grade 2 Or Higher Neuropathy (6)
CL Item
Grade 3 Or Higher Cardiac Toxicity (7)
CL Item
Grade 3 Or Higher Infection (8)
C1560948 (UMLS CUI-1)
C1560949 (UMLS CUI-2)
C1560950 (UMLS CUI-3)
CL Item
Grade 3 Or 4 Other Non-hematologic Toxicity (9)
CL Item
Holiday/vacation (10)
CL Item
Other (11)
C0205394 (UMLS CUI-1)
Reason for dose adjustment, specify
Item
Specify (reason for adjustment) (if applicable)
text
C2826286 (UMLS CUI-1)

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