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Fout:
ID
768
Beschrijving
CALGB: 49903 ADVANCED TREATMENT SUMMARY FORM; All Patients Trastuzumab With or Without Tamoxifen in Treating Women With Progressive Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A73D1CA4-8ADF-4761-E034-0003BA0B1A09
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Versies (2)
- 26-08-12 26-08-12 -
- 20-03-14 20-03-14 - Martin Dugas
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26 augustus 2012
DOI
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Licentie
Creative Commons BY-NC 3.0 Legacy
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Breast Cancer NCT00053339 Treatment - CALGB: 49903 ADVANCED TREATMENT SUMMARY FORM; All Patients - 2054479v3.0
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)
Datatype
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
TreatmentEndDate
Item
Last date protocol therapy was given (M)
date
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
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
AffiliateName
Item
Main Member Institution/Adjunct
text
ParticipatingGroupPatientID
Item
Participating Group Patient No.
text
AgentTotalDose(percourse)
Item
Total Dose of Drugs for this Regimen (mg)
double
AgentName
Item
Agent Name
text
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
Patient Off-treatment For 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 (Other, specify)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C0205394 (UMLS 2011AA)
OffTreatmentReason,Other
Item
Other, specify (reason treatment ended)
text
Item
Were there any dose modifications or additions/ omissions to protocol treatment? (mark one with an X)
text
Code List
Were there any dose modifications or additions/ omissions to protocol treatment? (mark one with an X)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1298908 (UMLS 2011AA)
CL Item
(i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned)
CL Item
(i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
C0439673 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
OptionalProtocolTherapyName
Item
optional protocol therapy name(s)
text
Item
Was any concurrent non-protocol therapy given during protocol treatment?
text
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
Item
indicate below (concurrent non-protocol therapy given during protocol treatment) (mark all that apply with an X)
text
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)
Comments
Item
Comments
text
PersonCompletingForm,FirstName
Item
Completed By (Print or Type Name)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
FormCompletionDate,Original
Item
Date Completed
date