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ID
1879
Description
CALGB: OFF TREATMENT NOTICE Daunorubicin and Cytarabine With or Without Oblimersen in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B229F9FE-3D25-514D-E034-0003BA12F5E7
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Versions (2)
- 9/19/12 9/19/12 -
- 7/21/17 7/21/17 - Martin Dugas
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September 19, 2012
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Creative Commons BY-NC 3.0
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Leukemia NCT00085124 Off Treatment - CALGB: OFF TREATMENT NOTICE - 2076876v3.0
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 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
Type
Description | Question | Decode (Coded Value)
Data type
Alias
CALGBForm
Item
CALGB Form
text
CALGBProtocolNumber
Item
CALGB Study No
text
CALGBPatientID
Item
CALGB Patient ID
text
Item
Amended data?
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
Patient'sName
Item
Patient's Name
text
ParticipatingGroupName
Item
Participating Group
text
PatientHospitalNumber
Item
Patient Hospital Number
text
Particip.GroupProtocolNumber
Item
Participating Group Protocol No
double
MainMemberInstitution/Affiliate
Item
Main Member Institution/Adjunct
text
ParticipatingGroupPatientID
Item
Participating Group Patient No
text
Item
REASON OFF TREATMENT (select ONE REASON ONLY by placing an X in the appropriate box)
text
CL Item
Treatment completed per protocol. (Treatment completed per protocol.)
CL Item
Patient had disease progression or relapse during active treatment. (Patient had disease progression or relapse during active treatment.)
CL Item
Patient did not respond to therapy (Patient did not respond to therapy)
CL Item
Adverse event (Adverse event)
CL Item
Patient died during treatment (Patient died during treatment)
CL Item
Patient refused further protocol treatment, but consented to be followed. (Patient refused further protocol treatment, but consented to be followed.)
CL Item
Patient refused further protocol treatment, withdrew consent to be followed. Patient is lost to follow-up. (Patient refused further protocol treatment, withdrew consent to be followed. Patient is lost to follow-up.)
CL Item
Patient developed other disease. (Patient developed other disease.)
CL Item
Treatment never started (Treatment never started)
CL Item
Patient taken off of protocol treatment to receive non-protocol therapy during active protocol treatment. (Patient taken off of protocol treatment to receive non-protocol therapy during active protocol treatment.)
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)
Patientdevelopedotherdisease.Specify
Item
Patient developed other disease. Specify
text
Reasonwhytreatmentwasnotstarted:
Item
Reason why treatment was not started:
text
Non-ProtocolTherapyType
Item
Specify type of non-protocol treatment:
text
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C2167 (NCI Thesaurus ObjectClass)
C1443775 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C1518384 (UMLS 2011AA ObjectClass)
C2167 (NCI Thesaurus ObjectClass)
C1443775 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Other,specify
Item
Other, specify (off treatment reason)
text
TreatmentEndDate
Item
LAST DATE OF PROTOCOL TREATMENT (M D Y)
date
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
CompletedBy
Item
Completed By
text
FormOriginalCompleteDate
Item
Date Completed
date
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25604 (NCI Thesaurus Property)
C0205313 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25604 (NCI Thesaurus Property)
C0205313 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
(PrintorTypeName)
Item
(Print or Type Name)
text