Informationen:
Fehler:
ID
10181
Beschreibung
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
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Stichworte
Versionen (2)
- 26.08.12 26.08.12 -
- 22.04.15 22.04.15 - Martin Dugas
Hochgeladen am
22. April 2015
DOI
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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.
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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
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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)
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)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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)
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)
C0011008 (UMLS 2011AA ValueDomain)
C25509 (NCI Thesaurus ValueDomain-2)
C1279901 (UMLS 2011AA ValueDomain-2)
Comments
Item
Comments
text
Total dose
Item
Total Dose of Drugs for Cycle 1
float
C2986497 (UMLS CUI-1)
CL Item
Cyclophosphamide (Cyclophosphamide)
C405 (NCI Thesaurus)
C0010583 (UMLS CUI-1)
C0010583 (UMLS CUI-1)
CL Item
Methotrexate (Methotrexate)
C642 (NCI Thesaurus)
C0025677 (UMLS CUI-1)
C0025677 (UMLS CUI-1)
CL Item
Fluorouracil (Fluorouracil)
C505 (NCI Thesaurus)
C0016360 (UMLS CUI-1)
C0016360 (UMLS CUI-1)
CL Item
Adriamycin (Adriamycin)
C0085752 (UMLS CUI-1)
CL Item
Capecitabine (Capecitabine)
C1794 (NCI Thesaurus)
C0671970 (UMLS CUI-1)
C0671970 (UMLS CUI-1)
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)
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)
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)
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)