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  1. StudyEvent: NSABP PROTOCOL R-04: TREATMENT FORM
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Treatment
C0087111 (UMLS CUI-1)
FirstThreeLettersofPatient'sLastName
Item
First Three Letters of Patients Last Name
text
Patient ID NSABP
Item
Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1513905 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C15818 (NCI Thesaurus Property-2)
Affiliate Name
Item
Institution Name / Affiliate Name
text
C21541 (NCI Thesaurus ObjectClass)
C1510825 (UMLS CUI-1)
C25413 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Person Completing Form Last Name
Item
Person Completing Form, Last Name
text
C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1301584 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)
Person Completing Form First Name
Item
Person Completing Form, First Name
text
C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1443235 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)
Person Completing Form Phone
Item
Person Completing Form, Phone
text
C25337 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C1515258 (UMLS CUI-2)
C25657 (NCI Thesaurus ObjectClass-2)
C25395 (NCI Thesaurus Property)
Data amended
Item
Are Data Amended?
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
AgentDuration
Item
Number of days any capecitabine taken
float
Firstdayofinfusion
Item
First day of infusion
text
Lastdayofinfusion
Item
Last day of infusion
text
AgentTotalCumulativeDose
Item
Total cumulative dose
float
Agent Start Date
Item
First day pills taken
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C25431 (NCI Thesaurus ValueDomain-2)
C0808070 (UMLS CUI-2)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
Agent End Date
Item
Last day pills taken
date
C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
CarcinoembryonicAntigenSpecimenCollectionDate
Item
CEA Date
text
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25159 (NCI Thesaurus ObjectClass)
C0007082 (UMLS 2011AA ObjectClass)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
LaboratoryProcedureCarcinoembryonicAntigenOutcomeValue
Item
CEA Value
text
C25159 (NCI Thesaurus Property)
C0007082 (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)
Item
Reason 5-FU or Capecitabine was discontinued or never started
text
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS CUI-1)
C25365 (NCI Thesaurus Property)
C0566251 (UMLS CUI-2)
CL.2
Code List
Reason 5-FU or Capecitabine was discontinued or never started
CL Item
Treatment Completed Per Protocol Criteria (treatment completed per protocol)
CL Item
Disease Progression, Relapse During Active Treatment (disease progression/treatment failure)
CL Item
second primary (second primary)
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)
CL Item
Alternative Therapy (alternative therapy)
CL Item
Adverse Event/side Effects/complications (complications of radiation 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,ComplicatingDisease
Item
Other complicating disease, specify
text
OffTreatmentReason,Other
Item
other, specify
text
Dose Modification
Item
Were any treatments delayed or skipped?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25256 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain-2)
Item
What was the reason for the treatment modification?
text
CL.5
Code List
What was the reason for the treatment modification?
CL Item
Dose Reduction (dose reduction)
CL Item
Interruption In Treatment Due To Toxicity (interruption in treatment due to toxicity)
CL Item
Dose Reduction Or Interruption Due To Other Medical Reason (dose reduction or interruption due to other medical reason)
CL Item
Dose Reduction Or Interruption Due To Non-medical Reason (dose reduction or interruption due to non-medical reason)
CL Item
Other, Specify (other, specify)
dosereductionorinterruptionduetoothermedicalreason,specify
Item
dose reduction or interruption due to other medical reason, specify
text
dosereductionorinterruptionduetonon-medicalreason,specify
Item
dose reduction or interruption due to non-medical reason, specify
text
DoseModificationReason
Item
other, specify
text
Item
Specify type of toxicity
text
CL.6
Code List
Specify type of toxicity
CL Item
Chemotherapy-associated (chemotherapy-associated)
CL Item
Radiation-associated (radiation-associated)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
dateoffirstinjection
Item
date of first injection
text
dateoflastinjection
Item
date of last injection
text
Epoetin alfa discontinued during chemotherapy or radiation
Item
Was epoetin alfa discontinued while the patient was still receiving chemotherapy or radiation?
boolean
Item
If yes, mark reason
text
CL.8
Code List
If yes, mark reason
CL Item
Patient Refused Epoetin Alfa (patient refused epoetin alfa)
CL Item
Excessively High Hemoglobin (excessively high hemoglobin)
CL Item
Other, Specify (other, specify)
other,specify(reason)
Item
other, specify (reason)
text
Dateofchemistries
Item
Date of chemistries
text
Bilirubin, total
Item
Total Bilirubin
float
C0201913 (UMLS CUI [1])
Bilirubin, total ULN
Item
Total bilirubin ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C305 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0201913 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C0201850 (UMLS CUI [1])
Alkaline Phosphatase ULN
Item
Alkaline Phosphatase ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C16276 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0151420 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
AST
Item
AST (SGOT)
float
C13308 (NCI Thesaurus ObjectClass)
C25202 (NCI Thesaurus Property)
C37984 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0201899 (UMLS CUI [1])
AST ULN
Item
AST (SGOT) ULN
float
C25294 (NCI Thesaurus ObjectClass)
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0242192 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Creatinine, Serum
Item
Creatinine
float
C25225 (NCI Thesaurus ObjectClass)
C399 (NCI Thesaurus Property)
C25294 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C0201976 (UMLS CUI [1])
Creatinine, serum ULN
Item
Serum Creatinine, Upper limit of lab normal
float
C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
BUN
Item
BUN
float
C0005845 (UMLS CUI [1])
BUN ULN
Item
BUN ULN
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C61019 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0005845 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Leukocytes (WBC)
Item
WBC
float
C0023508 (UMLS CUI [1])
WBC LLN
Item
WBC LLN
float
C0023508 (UMLS CUI [1,1])
C1518030 (UMLS CUI [1,2])
AGC/ANC
Item
AGC/ANC
text
AGC/ANC,Lowerlimitoflabnormal
Item
AGC/ANC, Lower limit of lab normal
text
Platelets
Item
Peripheral Platelet Count
float
C20200 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C0005821 (UMLS CUI [1])
Platelets LLN
Item
Platelets LLN
float
C25712 (NCI Thesaurus ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C0005821 (UMLS CUI [1,1])
C1518030 (UMLS CUI [1,2])
Hemoglobin
Item
HGB
float
C16676 (NCI Thesaurus Property)
C0019046 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Hemoglobin LLN
Item
Hemoglobin, LLN
float
C0019046 (UMLS CUI [1,1])
C1518030 (UMLS CUI [1,2])
SpecimenLaboratoryProcedureCollectionDate
Item
Date of hematologies
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
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