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. Do not leave any entries blank. Enter -1 to indicate that an answer in unknown, unobtainable, not applicable, or not done. Retain a copy for your records and submit ORIGINAL to the CALGB Data Management Center.

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
CALGB clinical trial administrative data
CALGBForm
Item
CALGB Form
text
C1516238 (UMLS CUI-1)
C0348078 (UMLS CUI-2)
CALGBStudyNo
Item
CALGB Study No
text
C1516238 (UMLS CUI-1)
C2826693 (UMLS CUI-2)
CALGBPatientID
Item
CALGB Patient ID
text
C1516238 (UMLS CUI-1)
C1549734 (UMLS CUI-2)
Item
Amended data?
text
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
C1511726 (UMLS CUI-1)
C1691222 (UMLS CUI-2)
Code List
Amended data?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
IntervalReportFromDate
Item
From
date
C0580096 (UMLS CUI-1)
IntervalReportToDate
Item
To
date
C0806020 (UMLS CUI-1)
Item Group
Patient demographics
C1955348 (UMLS CUI-1)
Patient'sName
Item
Patient Name
text
C1299487 (UMLS CUI-1)
ParticipatingGroup
Item
Participating Group
float
C17005 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C1257890 (UMLS CUI-1)
C0600091 (UMLS CUI-2)
PatientHospitalNumber
Item
Patient Hospital Number
text
C0421459 (UMLS CUI-1)
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
C2826263 (UMLS CUI-1)
AffiliateName
Item
Main Member Institution/Adjunct
float
C2698041 (UMLS CUI-1)
ParticipatingGroupPatientID
Item
Participating Group Patient No.
text
C0441833 (UMLS CUI-1)
C1830427 (UMLS CUI-2)
Item Group
Target Lesion(s) Follow-up Evaluation
Lesion,ReferenceNumber
Item
Lesion Number
integer
C0449791 (UMLS CUI-1)
Lesion,AnatomicSite,New
Item
Site
float
C0449685 (UMLS CUI-1)
AssessmentDate
Item
Date of Evaluation
date
C2985720 (UMLS CUI-1)
Item
Method of Evaluation
text
C2911685 (UMLS CUI-1)
Code List
Method of Evaluation
CL Item
Clinical Examination (clinical examination)
C1456356 (UMLS CUI-1)
CL Item
Chest X-ray (chest x-ray)
C0039985 (UMLS CUI-1)
CL Item
Ct Scan (CT scan)
C0040405 (UMLS CUI-1)
CL Item
Spiral Ct Scan (Spiral CT scan)
C0860888 (UMLS CUI-1)
CL Item
Mri (MRI (NMR))
C0024485 (UMLS CUI-1)
CL Item
Ultrasound (Ultrasound)
C64384 (NCI Thesaurus)
C1456803 (UMLS CUI-1)
CL Item
Bone Scan (Bone scan)
C17646 (NCI Thesaurus)
C0203668 (UMLS CUI-1)
CL Item
Not Evaluated (not evaluated)
C3846720 (UMLS CUI-1)
CL Item
Other (other)
C17649 (NCI Thesaurus)
C0205394 (UMLS CUI-1)
Item
If other, specify (method of evaluation)
text
C0846619 (UMLS CUI-1)
C3845569 (UMLS CUI-2)
Code List
If other, specify (method of evaluation)
CL Item
complete response (CR) (complete response (CR))
C0677874 (UMLS CUI-1)
CL Item
partial response (PR) (partial response (PR))
C1521726 (UMLS CUI-1)
CL Item
stable disease (SD) (stable disease (SD))
C0677946 (UMLS CUI-1)
CL Item
progressive disease (PD) (progressive disease (PD))
C1335499 (UMLS CUI-1)
CL Item
insufficient evaluation to determine response status (insufficient evaluation to determine response status)
C0205412 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Lesion,TumorDiameter
Item
Longest Diameter (cm)
integer
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS CUI-1)
C1301886 (UMLS CUI-2)
Lesion,Diameter,LongestSum
Item
Sum of Longest Diameteres of All Target lesions (cm)
integer
C3272915 (UMLS CUI-1)
C2986546 (UMLS CUI-2)
Item
Response Status at this assessment (Target Lesion)
text
C1704632 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Code List
Response Status at this assessment (Target Lesion)
CL Item
Complete Response (complete response (CR))
C0677874 (UMLS CUI-1)
CL Item
Partial Response (partial response (PR))
C18212 (NCI Thesaurus)
C1521726 (UMLS CUI-1)
CL Item
Incomplete Response Or Stable Disesase (stable disease (SD))
C0205257 (UMLS CUI-1)
C1704632 (UMLS CUI-2)
C0677946 (UMLS CUI-3)
CL Item
Partial Response; At Least A 30% Decrease In The Sum Of Ld Of Target Lesions Taking As Reference The Baseline Sum Ld (progressive disease (PD))
C1521726 (UMLS CUI-1)
C0547047 (UMLS CUI-2)
C3828606 (UMLS CUI-3)
CL Item
Insufficient Evaluation (insufficient evaluation to determine response status)
C0231180 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Item Group
Non-target Lesion(s) Follow-up Evaluation
NontargetLesionInd
Item
Are there any non-target lesions?
boolean
C2986547 (UMLS CUI-1)
Lesion,AnatomicSite,Nontarget
Item
Site
text
C0449685 (UMLS CUI-1)
Item Group
New Lesion(s) At Follow-up Evaluation
NewLesionInd
Item
Was the appearance of any new lesions documented since the baseline evaluation?
boolean
C2986548 (UMLS CUI-1)
PersonCompletingForm,FirstName
Item
Completed by
text
C25190 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C3258039 (UMLS CUI-1)
FormCompletionDate,Original
Item
Date completed
date
C1115437 (UMLS CUI-1)
Item Group
Ccrr Module For Calgb: Follow-up Solid Tumor Evaluation Form

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