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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