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  1. StudyEvent: CALGB: 80101 TREATMENT FORM
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
CALGB clinical trial administrative data
CALGBForm
Item
CALGB Form
text
CALGBProtocolNumber
Item
CALGB Study No
text
CALGBPatientID
Item
CALGB Patient ID
text
AmendedDataInd
Item
Amended data?
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
PatientName,Last
Item
Patient's Name
text
ParticipatingGroupCode
Item
Participating Group
text
PatientMedicalRecordNumber
Item
Patient Hospital Number
text
Particip.GroupProtocolNumber
Item
Participating Group Protocol No.
float
InstitutionName
Item
Main Member Institution/Adjunct
text
PatientStudyID,ParticipatingGroup
Item
Participating Group Patient No.
text
Item Group
Treatment Summary
CourseIdentification
Item
Cycle Number
text
FirstTreatmentStartDate
Item
Start date of first treatment
date
LastTreatmentDate
Item
Date of last treatment
date
Item
Were there any dose modifications or additions/omissions to protocol treatment?
text
Code List
Were there any dose modifications or additions/omissions to protocol treatment?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, planned per protocol (Yes, planned per protocol)
CL Item
(i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
Item
Reason for therapy modification
text
Code List
Reason for therapy modification
CL Item
Adverse Event Or Toxicity (Adverse event or toxicity (including death))
CL Item
Parient Refusal/noncompliance (Patient refusal/noncompliance)
CL Item
Scheduling (Scheduling (e.g., physician schedule, patient schedule, holiday, vacation, etc.))
CL Item
Dosing Error (Dosing error)
Item
Were there any unscheduled interruptions in radiation therapy?
text
Code List
Were there any unscheduled interruptions in radiation therapy?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, planned per protocol (Yes, planned per protocol)
CL Item
Yes, unplanned (Yes, unplanned)
Item
RT interruptions reason
text
Code List
RT interruptions reason
CL Item
Adverse event or toxicity (including death) (Adverse event or toxicity (including death))
CL Item
Patient refusal/noncompliance (Patient refusal/noncompliance)
CL Item
Scheduling (e.g., physician schedule, patient schedule, holiday, vacation, etc.) (Scheduling (e.g., physician schedule, patient schedule, holiday, vacation, etc.))
CL Item
Dosing error (Dosing error)
Item
Reason treatment ended
text
Code List
Reason treatment ended
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 treatment (Patient withdrawal or refusal after beginning protocol treatment)
CL Item
Patient withdrawal or refusal prior to beginning protocol treatment (Patient withdrawal or refusal prior to beginning protocol treatment)
CL Item
Alternative therapy (Alternative therapy)
CL Item
Patient off-treatment for other complicating disease (Patient off-treatment for other complicating disease)
CL Item
Disease progression, relapse prior to beginning protocol therapy (Disease progression, relapse prior to beginning protocol therapy)
CL Item
Death prior to beginning protocol therapy (Death prior to beginning protocol therapy)
CL Item
Other, specify (Other, specify)
CytogeneticAnalysis,OtherReason,NoSuccess
Item
Other, specify
text
PersonCompletingForm,FirstName
Item
Completed by
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
FormCompletionDate,Original
Item
Date completed
date

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