ID

801

Description

CALGB: 40101 TREATMENT SUMMARY SUBSET FORM Four Versus Six Cycles of Cyclophosphamide/Doxorubicin or Paclitaxel in Adjuvant Breast Cancer 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

August 26, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00041119 Treatment - CALGB: 40101 TREATMENT SUMMARY SUBSET FORM - 2037407v3.0

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.

Unnamed1
Description

Unnamed1

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

Amendeddata?

Data type

text

Unnamed2
Description

Unnamed2

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

Unnamed3
Description

Unnamed3

Current cycle number
Description

Currentcyclenumber

Data type

double

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
BSA
Description

BSA

Data type

text

Unnamed4
Description

Unnamed4

Total dosage for this cycle, Doxorubicin (mg)
Description

Totaldosageforthiscycle,Doxorubicin

Data type

text

Total dosage for this cycle, Cyclophosphamide (mg)
Description

Totaldosageforthiscycle,Cyclophosphamide

Data type

text

Total dosage for this cycle, Paclitaxel (mg)
Description

Totaldosageforthiscycle,Paclitaxel

Data type

text

Dose adjustments (mark one with an X)
Description

Doseadjustments

Data type

text

Reason for adjustment (Reasons for dose adjustment)
Description

Reasonforadjustment

Data type

text

Specify (reason for adjustment) (if applicable)
Description

Specify(reasonforadjustment)

Data type

text

Unnamed5
Description

Unnamed5

Completed By (Print or Type Name)
Description

CompletedBy

Data type

text

Date Completed (M)
Description

DateCompleted

Data type

date

Ccrr Module For Calgb: 40101 Treatment Summary Subset Form
Description

Ccrr Module For Calgb: 40101 Treatment Summary Subset Form

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
Unnamed1
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
Item
Amended data?
text
Code List
Amended data?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Unnamed2
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
Unnamed3
Currentcyclenumber
Item
Current cycle number
double
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
BSA
Item
BSA
text
Item Group
Unnamed4
Totaldosageforthiscycle,Doxorubicin
Item
Total dosage for this cycle, Doxorubicin (mg)
text
Totaldosageforthiscycle,Cyclophosphamide
Item
Total dosage for this cycle, Cyclophosphamide (mg)
text
Totaldosageforthiscycle,Paclitaxel
Item
Total dosage for this cycle, Paclitaxel (mg)
text
Item
Dose adjustments (mark one with an X)
text
Code List
Dose adjustments (mark one with an X)
CL Item
Reduced (Reduced)
C25640 (NCI Thesaurus)
C0392756 (UMLS 2011AA)
CL Item
Delayed (Delayed)
C25477 (NCI Thesaurus)
CL Item
Reduced And Delayed (Reduced and delayed)
Item
Reason for adjustment (Reasons for dose adjustment)
text
Code List
Reason for adjustment (Reasons for dose adjustment)
CL Item
Not Satisfactorily Recovered From Hematologic Toxicity (Not satisfactorily recovered from hematologic toxicity)
CL Item
Grade 3 Or 4 Fatigue (Grade 3 or 4 fatigue)
CL Item
Grade 2 Or 3 Anaphylaxis/hypersensitivity (Grade 2 or 3 anaphylaxis/hypersensitivity)
CL Item
Grade 3 Or 4 Diarrhea/nausea (Grade 3 or 4 diarrhea/nausea)
CL Item
Grade 3 Or 4 Mucositis (Grade 3 or 4 mucositis)
CL Item
Grade 2 Or Higher Neuropathy (Grade 2 or higher neuropathy)
CL Item
Grade 3 Or Higher Cardiac Toxicity (Grade 3 or higher cardiac toxicity)
CL Item
Grade 3 Or Higher Infection (Grade 3 or higher infection)
CL Item
Grade 3 Or 4 Other Non-hematologic Toxicity (Grade 3 or 4 other non-hematologic toxicity)
CL Item
Holiday/vacation (Holiday/vacation)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Specify(reasonforadjustment)
Item
Specify (reason for adjustment) (if applicable)
text
Item Group
Unnamed5
CompletedBy
Item
Completed By (Print or Type Name)
text
DateCompleted
Item
Date Completed (M)
date
Item Group
Ccrr Module For Calgb: 40101 Treatment Summary Subset Form

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