ID

1273

Descrizione

NSABP PROTOCOL R-04: TREATMENT FORM Radiation Therapy and Either Capecitabine or Fluorouracil With or Without Oxaliplatin Before Surgery in Treating Patients With Resectable Rectal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B7822823-8FBF-24ED-E034-0003BA12F5E7

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B7822823-8FBF-24ED-E034-0003BA12F5E7

Keywords

versioni (3)
  1. 27/08/12 27/08/12 -
  2. 09/01/15 09/01/15 - Martin Dugas
  3. 24/09/15 24/09/15 - Martin Dugas
Caricato su

27 agosto 2012

DOI

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Licenza

Creative Commons BY-NC 3.0 Legacy
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Colorectal Cancer NCT00058474 Treatment - NSABP PROTOCOL R-04: TREATMENT FORM - 2082638v3.0

Inglese

No Instruction available.

1 moduli  
  1. StudyEvent: NSABP PROTOCOL R-04: TREATMENT FORM
    1. No Instruction available.
Ccrr Module For Nsabp Protocol R-04: Treatment Form
Descrizione

Ccrr Module For Nsabp Protocol R-04: Treatment Form

First Three Letters of Patients Last Name
Descrizione

FirstThreeLettersofPatient'sLastName

Tipo di dati

text

Patient Study ID
Descrizione

PatientNationalSurgicalAdjuvantBreastProjectIdentifierNumber

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C15818
UMLS 2011AA Property
C1513905
Institution Name / Affiliate Name
Descrizione

AffiliatedInstitutionName

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus ObjectClass
C25413
UMLS 2011AA ObjectClass
C1510826
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
Person Completing Form, Last Name
Descrizione

ResponsiblePersonLastName

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25551
UMLS 2011AA Property
C1517741
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
Person Completing Form, First Name
Descrizione

ResponsiblePersonFirstName

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
Person Completing Form, Phone
Descrizione

ResponsiblePersonPhoneNumber

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25395
UMLS 2011AA Property
C0039457
Are Data Amended?
Descrizione

DataAmendedInd-3

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
First day of infusion
Descrizione

Firstdayofinfusion

Tipo di dati

text

Last day of infusion
Descrizione

Lastdayofinfusion

Tipo di dati

text

Number of days any capecitabine taken
Descrizione

AgentDuration

Tipo di dati

double

Number of days any capecitabine taken
Descrizione

AgentDuration

Tipo di dati

double

First day pills taken
Descrizione

AgentBeginDate

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Last day pills taken
Descrizione

AgentEndDate

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Total cumulative dose
Descrizione

AgentTotalCumulativeDose

Tipo di dati

double

Total cumulative dose
Descrizione

AgentTotalCumulativeDose

Tipo di dati

double

Total cumulative dose
Descrizione

AgentTotalCumulativeDose

Tipo di dati

double

CEA Date
Descrizione

CarcinoembryonicAntigenSpecimenCollectionDate

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25159
UMLS 2011AA ObjectClass
C0007082
NCI Thesaurus Property
C25453
UMLS 2011AA Property
C1516698
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
CEA Value
Descrizione

LaboratoryProcedureCarcinoembryonicAntigenOutcomeValue

Tipo di dati

text

Alias
NCI Thesaurus Property
C25159
UMLS 2011AA Property
C0007082
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Reason 5-FU or Capecitabine was discontinued or never started
Descrizione

Off-treatmentReason

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Other complicating disease, specify
Descrizione

OffTreatmentReason,ComplicatingDisease

Tipo di dati

text

other, specify
Descrizione

OffTreatmentReason,Other

Tipo di dati

text

Were any treatments delayed or skipped?
Descrizione

DoseModificationInd

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C25256
UMLS 2011AA ObjectClass
C1265611
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain
C25572
Were any treatments delayed or skipped?
Descrizione

DoseModificationInd

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C25256
UMLS 2011AA ObjectClass
C1265611
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain
C25572
What was the reason for the treatment modification?
Descrizione

Whatwasthereasonforthetreatmentmodification?

Tipo di dati

text

dose reduction or interruption due to other medical reason, specify
Descrizione

dosereductionorinterruptionduetoothermedicalreason,specify

Tipo di dati

text

dose reduction or interruption due to non-medical reason, specify
Descrizione

dosereductionorinterruptionduetonon-medicalreason,specify

Tipo di dati

text

other, specify
Descrizione

DoseModificationReason

Tipo di dati

text

Specify type of toxicity
Descrizione

Specifytypeoftoxicity

Tipo di dati

text

date of first injection
Descrizione

dateoffirstinjection

Tipo di dati

text

date of last injection
Descrizione

dateoflastinjection

Tipo di dati

text

Was epoetin alfa discontinued while the patient was still receiving chemotherapy or radiation?
Descrizione

Wasepoetinalfadiscontinuedwhilethepatientwasstillreceivingchemotherapyorradiation?

Tipo di dati

text

If yes, mark reason
Descrizione

Ifyes,markreason

Tipo di dati

text

Date of chemistries
Descrizione

Dateofchemistries

Tipo di dati

text

Total bilirubin
Descrizione

Lab,Hepatic,Bilirubin

Tipo di dati

double

Total bilirubin, Upper limit of lab normal
Descrizione

HepaticBilirubinLabUpperLimitNormalValue

Tipo di dati

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C305
UMLS 2011AA Property
C0005437
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Alkaline phosphatase
Descrizione

Lab,Hepatic,AlkalinePhosphatase

Tipo di dati

double

Alkaline phosphatase, Upper limit of lab normal
Descrizione

LaboratoryProcedureAlkalinePhosphataseResultUpperLimitNormalValue

Tipo di dati

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C16276
UMLS 2011AA Property
C0002059
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
AST (SGOT)
Descrizione

HepaticSGOT(AST)LabUnspecifiedValue

Tipo di dati

double

Alias
NCI Thesaurus ObjectClass
C13308
UMLS 2011AA ObjectClass
C0205054
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus ValueDomain
C38046
UMLS 2011AA ValueDomain
C0205370
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
AST (SGOT), Upper limit of lab normal
Descrizione

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Tipo di dati

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25202
UMLS 2011AA Property
C0242192
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Serum Creatinine
Descrizione

RenalCreatinineLabSpecifiedValue

Tipo di dati

double

Unità di misura
  • mg/dL
Alias
NCI Thesaurus ObjectClass
C25225
UMLS 2011AA ObjectClass
C0022646
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
mg/dL
Serum Creatinine, Upper limit of lab normal
Descrizione

LaboratoryProcedureCreatinineResultUpperLimitNormalValue

Tipo di dati

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C399
UMLS 2011AA Property
C0010294
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
BUN
Descrizione

Lab,Renal,BUN

Tipo di dati

double

BUN, Upper limit of lab normal
Descrizione

LaboratoryProcedureBloodUreaNitrogenResultUpperLimitNormalValue

Tipo di dati

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C61019
UMLS 2011AA Property
C0005845
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
WBC
Descrizione

Lab,Hematology,WBC

Tipo di dati

double

WBC, Lower limit of lab normal
Descrizione

WBCcount(x1000),LLN

Tipo di dati

text

AGC/ANC
Descrizione

AGC/ANC

Tipo di dati

text

AGC/ANC, Lower limit of lab normal
Descrizione

AGC/ANC,Lowerlimitoflabnormal

Tipo di dati

text

Platelets
Descrizione

HematologyPlateletLabUnspecifiedValue

Tipo di dati

double

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Platelets, Lower limit of lab normal
Descrizione

Plateletscount(x1000),LLN

Tipo di dati

double

Alias
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25555
UMLS 2011AA ValueDomain
C1518030
HGB
Descrizione

LaboratoryProcedureHemoglobinResultSpecifiedValue

Tipo di dati

double

Unità di misura
  • g/dL
Alias
NCI Thesaurus Property
C16676
UMLS 2011AA Property
C0019046
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
g/dL
HGB, Lower limit of lab normal
Descrizione

Hemoglobin(g/dl),LLN

Tipo di dati

text

Date of hematologies
Descrizione

SpecimenLaboratoryProcedureCollectionDate

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25453
UMLS 2011AA Property
C1516698
NCI Thesaurus Property
C25294
UMLS 2011AA Property
C0022885
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
other, specify (reason)
Descrizione

other,specify(reason)

Tipo di dati

text

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Similar models

No Instruction available.

1 moduli
  1. StudyEvent: NSABP PROTOCOL R-04: TREATMENT FORM
    1. No Instruction available.
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Ccrr Module For Nsabp Protocol R-04: Treatment Form
FirstThreeLettersofPatient'sLastName
Item
First Three Letters of Patients Last Name
text
PatientNationalSurgicalAdjuvantBreastProjectIdentifierNumber
Item
Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C15818 (NCI Thesaurus Property)
C1513905 (UMLS 2011AA Property)
AffiliatedInstitutionName
Item
Institution Name / Affiliate Name
text
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25413 (NCI Thesaurus ObjectClass)
C1510826 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
ResponsiblePersonLastName
Item
Person Completing Form, Last Name
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25551 (NCI Thesaurus Property)
C1517741 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
ResponsiblePersonFirstName
Item
Person Completing Form, First Name
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
ResponsiblePersonPhoneNumber
Item
Person Completing Form, Phone
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25395 (NCI Thesaurus Property)
C0039457 (UMLS 2011AA Property)
Item
Are Data Amended?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
CL.1
Code List
Are Data Amended?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Firstdayofinfusion
Item
First day of infusion
text
Lastdayofinfusion
Item
Last day of infusion
text
AgentDuration
Item
Number of days any capecitabine taken
double
AgentDuration
Item
Number of days any capecitabine taken
double
AgentBeginDate
Item
First day pills taken
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
AgentEndDate
Item
Last day pills taken
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
AgentTotalCumulativeDose
Item
Total cumulative dose
double
AgentTotalCumulativeDose
Item
Total cumulative dose
double
AgentTotalCumulativeDose
Item
Total cumulative dose
double
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)
C0370003 (UMLS 2011AA ObjectClass)
LaboratoryProcedureCarcinoembryonicAntigenOutcomeValue
Item
CEA Value
text
C25159 (NCI Thesaurus Property)
C0007082 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
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 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
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
Item
Were any treatments delayed or skipped?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus ObjectClass)
C1265611 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain)
CL.4
Code List
Were any treatments delayed or skipped?
CL Item
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (yes)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Were any treatments delayed or skipped?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus ObjectClass)
C1265611 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain)
CL.4
Code List
Were any treatments delayed or skipped?
CL Item
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (yes)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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
Item
Was epoetin alfa discontinued while the patient was still receiving chemotherapy or radiation?
text
CL.7
Code List
Was epoetin alfa discontinued while the patient was still receiving chemotherapy or radiation?
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
Dateofchemistries
Item
Date of chemistries
text
Lab,Hepatic,Bilirubin
Item
Total bilirubin
double
HepaticBilirubinLabUpperLimitNormalValue
Item
Total bilirubin, Upper limit of lab normal
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property)
C0005437 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Lab,Hepatic,AlkalinePhosphatase
Item
Alkaline phosphatase
double
LaboratoryProcedureAlkalinePhosphataseResultUpperLimitNormalValue
Item
Alkaline phosphatase, Upper limit of lab normal
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C16276 (NCI Thesaurus Property)
C0002059 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
HepaticSGOT(AST)LabUnspecifiedValue
Item
AST (SGOT)
double
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
Item
AST (SGOT), Upper limit of lab normal
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
RenalCreatinineLabSpecifiedValue
Item
Serum Creatinine
double
C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureCreatinineResultUpperLimitNormalValue
Item
Serum Creatinine, Upper limit of lab normal
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Lab,Renal,BUN
Item
BUN
double
LaboratoryProcedureBloodUreaNitrogenResultUpperLimitNormalValue
Item
BUN, Upper limit of lab normal
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C61019 (NCI Thesaurus Property)
C0005845 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Lab,Hematology,WBC
Item
WBC
double
WBCcount(x1000),LLN
Item
WBC, Lower limit of lab normal
text
AGC/ANC
Item
AGC/ANC
text
AGC/ANC,Lowerlimitoflabnormal
Item
AGC/ANC, Lower limit of lab normal
text
HematologyPlateletLabUnspecifiedValue
Item
Platelets
double
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
Plateletscount(x1000),LLN
Item
Platelets, Lower limit of lab normal
double
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
LaboratoryProcedureHemoglobinResultSpecifiedValue
Item
HGB
double
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Hemoglobin(g/dl),LLN
Item
HGB, Lower limit of lab normal
text
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)
C0022885 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
other,specify(reason)
Item
other, specify (reason)
text
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