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  1. StudyEvent: CALGB: 90104 Treatment and Follow-up Form
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Ccrr Module For Calgb: 90104 Treatment And Follow-up Form
CALGB Form
Item
CALGB Form
text
C3262252 (UMLS CUI-1)
C1516238 (UMLS CUI-2)
Protocol ID CALGB
Item
CALGB Study No
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Trial subject ID CALGB
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Reporting Period Start Date
Item
From
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Reporting Period End Date
Item
To
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
Item
Amended data?
text
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
CL.1
Code List
Amended data?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus-3)
C1705108 (UMLS 2011AA-4)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Participating Group
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Medical Record Number
Item
Patient Medical Record Number
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
Study Number Participating Group
Item
Participating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Institution Name
Item
Institute/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Item
Patient's vital status
text
C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25365 (NCI Thesaurus Property)
CL.2
Code List
Patient's vital status
CL Item
Alive (Alive-NED)
CL Item
Alive (Alive with disease)
CL Item
Dead (Dead)
Item
Primary cause of death
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
C28554 (NCI Thesaurus ValueDomain-2)
C0011065 (UMLS 2011AA ValueDomain-2)
CL.3
Code List
Primary cause of death
CL Item
Due To This Disease (due to this disease)
CL Item
Due To Protocol Treatment (due to protocol treatment)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Due To Other Cause, Specify (due to other cause)
Cause of Death, specify
Item
Due to other cause, specify
text
C25685 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C28554 (NCI Thesaurus Property)
Date last contact
Item
Date of last contact or death
date
C25164 (NCI Thesaurus ValueDomain)
C0805839 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25461 (NCI Thesaurus Property)
RecombinantGranulocyteColonyStimulatingFactorReceivedInd-2
Item
GCSF administered?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C1287 (NCI Thesaurus ObjectClass)
C0376562 (UMLS 2011AA ObjectClass)
Ifyes,specifywhy(GCSFadministered)
Item
If yes, specify why (GCSF administered)
text
Item
Treatment
text
C25337 (NCI Thesaurus ValueDomain)
C1522541 (UMLS CUI-1)
C32141 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
CL.5
Code List
Treatment
CL Item
Arm A (Arm A)
CL Item
Arm B (Arm B)
Item
Reason treatment ended
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
CL.6
Code List
Reason treatment ended
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Disease Progression, Relapse Prior To Beginning Protocol Therapy (Disease progression, relapse prior to beginning protocol therapy)
CL Item
Toxicity/side Effects/complications (Toxicity/side effects/complications)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal or refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal or refusal prior to beginning protocol therapy)
CL Item
disease recurrence (disease recurrence)
CL Item
Death After Beginning Protocol Therapy (death after beginning protocol therapy)
CL Item
Death Prior To Beginning Protocol Therapy (death prior to beginning protocol therapy)
CL Item
Alternative Therapy (alternative therapy)
CL Item
Other (other complicating disease)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Other (Other, specify)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
OffTreatmentReason,Other
Item
Other, specify (off treatment reason)
text
Item
Were there any dose modifications or additions/omissions to protocol treatment?
text
C25180 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25256 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain-2)
CL.7
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 (i.e., The Treatment Was Changed According To Protocol Guidelines) (yes, planned)
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (yes, unplanned)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
DoseModificationText
Item
If yes, specify (modification)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus ObjectClass)
C1265611 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
Lab,Renal,CreatinineClearance
Item
Calculated creatinine clearance
float
Lab,Hematology,WBC
Item
WBC
float
LaboratoryProcedureNeutrophilResultSpecifiedValue
Item
ANC
float
C12533 (NCI Thesaurus Property)
C0027950 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
HepaticSGOT(AST)LabUnspecifiedValue
Item
AST
float
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property-2)
C0022877 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Platelets
Item
Platelet count
float
C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Blood Urea Nitrogen
Item
BUN
float
C20200 (NCI Thesaurus Property)
C0005845 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C61019 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
LaboratoryProcedureBloodUreaNitrogenResultUpperLimitNormalValue
Item
BUN, ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C61019 (NCI Thesaurus Property-2)
C0005845 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
Lab,Hepatic,Bilirubin
Item
Bilirubin
float
HepaticBilirubinLabUpperLimitNormalValue
Item
Bilirubin, ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property-2)
C0005437 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
RenalCreatinineLabSpecifiedValue
Item
Serum creatinine
float
C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Lab,Hepatic,AlkalinePhosphatase
Item
alkaline phosphatase
float
Alkaline Phosphatase ULN
Item
Alkaline phlosphatase, ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0151420 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C16276 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
CancerFollow-upStatusInd-3
Item
Has the patient had a documented clinical assessment for this cancer?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CancerFollow-UpStatusDate
Item
Date of last clinical assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
ChestX-RayAssessmentDate
Item
chest x-ray assessment date
date
Item
Chest x-ray result
text
CL.9
Code List
Chest x-ray result
CL Item
Negative (negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Equivocal (equivocal)
C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)
Abdominal/PelvicCTAssessmentDate
Item
abdominal/pelvic CT assessment date
text
Item
Abdominal/pelvic CT result
text
CL.10
Code List
Abdominal/pelvic CT result
CL Item
Not Done (not done)
CL281691 (NCI Metathesaurus)
CL Item
Normal (normal)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
CL Item
Equivocal (equivocal)
C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)
CL Item
Abnormal-disease Related (abnormal-disease related)
CL Item
Abnormal-not Disease Related (abnormal-not disease related)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
DiseaseAdvancedProgressionInd-3
Item
Has the patient been diagnosed with a local recurrence that has not been previously reported?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C25411 (NCI Thesaurus Property-2)
C0205179 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
ProgressionDate,FirstLocal
Item
Date of first local progression
date
Item
Site(s) of first local progression
text
CL.12
Code List
Site(s) of first local progression
CL Item
Local Progression To The Abdominal Wall (abdominal wall)
CL Item
Local Progression To The Pelvic Wall (pelvic wall)
CL Item
Local Spread To Peritoneal Tissue (peritoneum)
CL Item
Spread Of Cancer To Skin Or Subcutaneous Tissue Near To The Bladder (skin)
CL Item
Local Spread To The Vagina (vagina)
CL Item
Local Spread To The Urethra (urethra)
CL Item
Progression To Another Site, Specify Site (other, specify)
CL Item
Progression To Another Site, Specify Site (Other, specify)
LocalLymphNodeProgressionInd-3
Item
Has the patient been diagnosed with a local-regional lymph node recurrence that has not been previously reported?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25388 (NCI Thesaurus ObjectClass-2)
C1947913 (UMLS 2011AA ObjectClass-2)
ProgressionDate,FirstLocalNode
Item
Date of first local-regional lymph node progression
date
Item
Site(s) of first local-regional lymph node progression
text
CL.14
Code List
Site(s) of first local-regional lymph node progression
CL Item
Disease Is Present In The Internal Iliac Lymph Nodes (internal iliac)
CL Item
Disease Is Present In The External Iliac Lymph Nodes (external iliac)
CL Item
Disease Is Present In The Common Iliac Lymph Nodes (common iliac)
CL Item
Disease Is Present In The Hypogastric Lymph Nodes (hypogastric)
CL Item
Disease Is Present In The Para-aortic Lymph Nodes (para-aortic)
CL Item
Disease Is Present In Another Local-regional Lymph Nodes, Specify (other, specify)
CL Item
Disease Is Present In Another Local-regional Lymph Nodes, Specify (Other, specify)
DistantMetastasisProgressionInd-3
Item
Has the patient been diagnosed with a distant metastatic progression that has not been previously reported?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C25321 (NCI Thesaurus ObjectClass)
C0443203 (UMLS 2011AA ObjectClass)
C19151 (NCI Thesaurus ObjectClass-2)
C0027627 (UMLS 2011AA ObjectClass-2)
ProgressionDate,FirstDistant
Item
Date of first distant progression
date
Item
Site(s) of first local (distant) progression
text
CL.16
Code List
Site(s) of first local (distant) progression
CL Item
Bone (bone)
C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)
CL Item
Liver (liver)
C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)
CL Item
Lung (lung)
C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)
CL Item
Peritoneum (peritoneum)
C12770 (NCI Thesaurus)
C0031153 (UMLS 2011AA)
CL Item
Pleura (pleura)
C12469 (NCI Thesaurus)
C0032225 (UMLS 2011AA)
CL Item
Skin (skin)
C12470 (NCI Thesaurus)
C1123023 (UMLS 2011AA)
CL Item
Central Nervous System Or Brain (central nervous system/brain)
CL Item
Distant Lymph Nodes (distant nodes)
CL Item
Other, Specify (other)
LymphNodes,DistantLocation
Item
distant nodes, specify
text
MetastaticSite,Other
Item
other, specify
text
NewCancerDiagnosisInd-3
Item
Has a new primary cancer or myelodysplatsic syndrome been diagnosed that has not been previously reported?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
NewCancerDiagnosisDate
Item
Date of first local progression (new primary)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
NewCancerSiteText
Item
Site(s) of new primary
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
LateAdverseEventInd
Item
Has the patient experienced any severe, long-term toxicity that has not been previously reported?
boolean
RTOGAdverseEventTermText
Item
late adverse event term
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C19778 (NCI Thesaurus ObjectClass)
C1514695 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass-2)
C0877248 (UMLS 2011AA ObjectClass-2)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
RTOGAdverseEventGrade
Item
late adverse event grade
float
C19778 (NCI Thesaurus ObjectClass)
C1514695 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass-2)
C0877248 (UMLS 2011AA ObjectClass-2)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
LateAdverseEventOnsetDate
Item
date of onset of long-term toxicity
date
Research Comments
Item
comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Person Completing Form
Item
completed by
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
date form completed
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
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