ID

2083

Description

CALGB-10501 Infectious Complications Form Early or Delayed Fludarabine and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3410554E-9E86-2D64-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3410554E-9E86-2D64-E044-0003BA3F9857

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 6/18/15 6/18/15 -
Uploaded on

September 19, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Leukemia NCT00513747 Toxicity - CALGB-10501 Infectious Complications Form - 2661567v1.0

English

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. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice

1 forms  
Unnamed1
Description

Unnamed1

CALGB Form
Description

CALGBFormIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C19464
UMLS 2011AA ObjectClass
C0376315
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C25442
UMLS 2011AA ObjectClass
C1516238
CALGB Study No
Description

ProtocolCALGBIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25442
UMLS 2011AA Property
C1516238
CALGB Patient ID
Description

PatientCALGBIdentifierNumber

Data type

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
C25442
UMLS 2011AA Property
C1516238
Date of Onset of Infection (MM DD YYYY)
Description

AdverseEventInfectionBeginDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C26726
UMLS 2011AA Property
C0009450
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
Infection form number
Description

InfectionCaseReportFormSubmissionPageNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C40988
UMLS 2011AA ObjectClass
C1516308
NCI Thesaurus ObjectClass
C26726
UMLS 2011AA ObjectClass
C0009450
NCI Thesaurus Property
C25694
UMLS 2011AA Property
C1515022
Are data amended
Description

DataAmendedInd-3

Data type

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
Unnamed2
Description

Unnamed2

Patient Initials (Last, First Middle)
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Patient Hospital No.
Description

PatientMedicalRecordNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25261
UMLS 2011AA Property
C0205476
NCI Thesaurus Property
C25198
UMLS 2011AA Property
C0034869
Institution/Affiliate
Description

CombinedInstitutionName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS 2011AA ObjectClass
C0205195
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
Participating Group
Description

ParticipatingGroupName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25608
UMLS 2011AA ObjectClass
C0679823
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Participating Group Study No
Description

ProtocolParticipatingIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Participating Group Patient ID
Description

PatientParticipatingIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Unnamed3
Description

Unnamed3

Cycle number during which infection was diagnosed
Description

TreatmentCycleInfectionDiagnosisNumber

Data type

double

Alias
NCI Thesaurus ObjectClass
C25472
UMLS 2011AA ObjectClass
C1511572
NCI Metathesaurus ObjectClass
C0087111
NCI Thesaurus Property
C26726
UMLS 2011AA Property
C0009450
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
Causitive Agent
Description

Causitive Agent

Causative Infectious Agent (Mark one with an X.)
Description

AdverseEventComplicatingInfectionType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C26726
UMLS 2011AA Property
C0009450
NCI Thesaurus Property
C25455
UMLS 2011AA Property
C1522701
Other, specify
Description

AdverseEventComplicatingBacteriaInfectionSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C14187
UMLS 2011AA Property
C0004611
NCI Thesaurus Property
C26726
UMLS 2011AA Property
C0009450
NCI Thesaurus Property
C25455
UMLS 2011AA Property
C1522701
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Other, specify
Description

AdverseEventComplicatingFungalInfectionSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C26726
UMLS 2011AA Property
C0009450
NCI Thesaurus Property
C14209
UMLS 2011AA Property
C0016832
NCI Thesaurus Property
C25455
UMLS 2011AA Property
C1522701
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Other, specify
Description

AdverseEventComplicatingViralInfectionSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C26726
UMLS 2011AA Property
C0009450
NCI Thesaurus Property
C27985
UMLS 2011AA Property
C0521026
NCI Thesaurus Property
C25455
UMLS 2011AA Property
C1522701
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Other, Specify
Description

AdverseEventInfectionSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C26726
UMLS 2011AA Property
C0009450
Primary Site of Infection (Mark one with an X.)
Description

AdverseEventComplicatingInfectionAnatomicSite

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property
C26726
UMLS 2011AA Property
C0009450
NCI Thesaurus Property
C25421
UMLS 2011AA Property
C0002808
NCI Thesaurus Property
C25455
UMLS 2011AA Property
C1522701
NCI Thesaurus ValueDomain
C37901
UMLS 2011AA ValueDomain
C0205145
Other, specify
Description

AdverseEventComplicatingInfectionAnatomicSiteSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property
C26726
UMLS 2011AA Property
C0009450
NCI Thesaurus Property
C25421
UMLS 2011AA Property
C0002808
NCI Thesaurus Property
C25455
UMLS 2011AA Property
C1522701
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Labs At Time Of Infection
Description

Labs At Time Of Infection

Peripheral WBC Count (X 10^3/uL)
Description

LaboratoryProcedureLeukocyteResultSpecifiedValue

Data type

double

Measurement units
  • 1000/uL
Alias
NCI Thesaurus Property
C12529
UMLS 2011AA Property
C0023516
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C38024
UMLS 2011AA ValueDomain
C0205369
1000/uL
Peripheral Neutrophils (%) (segs + bands)
Description

LaboratoryProcedureNeutrophilResultPercentageValue

Data type

double

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C12533
UMLS 2011AA Property
C0027950
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
%
CTC Adverse Event Grade (Mark one with an X.)
Description

CommonToxicityCriteriaAdverseEventGrade

Data type

double

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Outcome of infection (Mark one with an X.)
Description

AdverseEventComplicatingInfectionResultType

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C26726
UMLS 2011AA Property
C0009450
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C25455
UMLS 2011AA Property
C1522701
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other, specify
Description

AdverseEventComplicatingInfectionResultSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C26726
UMLS 2011AA Property
C0009450
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C25455
UMLS 2011AA Property
C1522701
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
CTC AE Attribution Code
Description

CTCAdverseEventAttributionScale

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
Overall Response
Description

Overall Response

Completed by (print or type name)
Description

ResponsiblePersonName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25657
UMLS 2011AA ObjectClass
C1273518
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Date Form Completed (MM DD YYYY)
Description

FormCompleteDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C40988
UMLS 2011AA ObjectClass
C1516308
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ValueDomain
C25367
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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. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unnamed1
CALGBFormIdentifierNumber
Item
CALGB Form
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus ObjectClass)
C1516238 (UMLS 2011AA ObjectClass)
ProtocolCALGBIdentifierNumber
Item
CALGB Study No
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)
PatientCALGBIdentifierNumber
Item
CALGB Patient 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)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)
AdverseEventInfectionBeginDate
Item
Date of Onset of Infection (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
InfectionCaseReportFormSubmissionPageNumber
Item
Infection form number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus ObjectClass)
C0009450 (UMLS 2011AA ObjectClass)
C25694 (NCI Thesaurus Property)
C1515022 (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)
Item Group
Unnamed2
PatientInitialsName
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
PatientMedicalRecordNumber
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25198 (NCI Thesaurus Property)
C0034869 (UMLS 2011AA Property)
CombinedInstitutionName
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (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)
ParticipatingGroupName
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
ProtocolParticipatingIdentifierNumber
Item
Participating Group Study No
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientParticipatingIdentifierNumber
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Item Group
Unnamed3
TreatmentCycleInfectionDiagnosisNumber
Item
Cycle number during which infection was diagnosed
double
C25472 (NCI Thesaurus ObjectClass)
C1511572 (UMLS 2011AA ObjectClass)
C0087111 (NCI Metathesaurus ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
Item Group
Causitive Agent
Item
Causative Infectious Agent (Mark one with an X.)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C25455 (NCI Thesaurus Property)
C1522701 (UMLS 2011AA Property)
CL.2
Code List
Causative Infectious Agent (Mark one with an X.)
CL Item
Gram Negative Bacillus (Bacterial - Gram negative)
CL Item
Gram Positive Bacillus (Bacterial - Gram positive)
CL Item
Bacterial - Other (Bacterial - other)
CL Item
Fungal - Aspergillus (Fungal - Aspergillus)
CL Item
Fungal - Candida (Fungal - Candida)
CL Item
Fungal - Other (Fungal - other)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Parasitic Infection (Parasitic)
CL Item
Pneumocystis Carinii (Pneumocystis (PCP))
C0032276 (NCI Metathesaurus)
CL Item
Specific Infectious Causative Agent Not Determined (Specific infectious causative agent not determined)
CL Item
Viral - Cytomegalovirus (cmv) (Viral - Cytomegalovirus (CMV))
CL Item
Viral - Herpes Simplex (hsv) (Viral - Herpes Simplex (HSV))
CL Item
Viral - Other (Viral - other)
CL Item
Viral - Varicella Zoster (vzv) (Viral - Varicella Zoster (VZV))
AdverseEventComplicatingBacteriaInfectionSpecify
Item
Other, specify
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C14187 (NCI Thesaurus Property)
C0004611 (UMLS 2011AA Property)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C25455 (NCI Thesaurus Property)
C1522701 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
AdverseEventComplicatingFungalInfectionSpecify
Item
Other, specify
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C14209 (NCI Thesaurus Property)
C0016832 (UMLS 2011AA Property)
C25455 (NCI Thesaurus Property)
C1522701 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
AdverseEventComplicatingViralInfectionSpecify
Item
Other, specify
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C27985 (NCI Thesaurus Property)
C0521026 (UMLS 2011AA Property)
C25455 (NCI Thesaurus Property)
C1522701 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
AdverseEventInfectionSpecify
Item
Other, Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
Item
Primary Site of Infection (Mark one with an X.)
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C25421 (NCI Thesaurus Property)
C0002808 (UMLS 2011AA Property)
C25455 (NCI Thesaurus Property)
C1522701 (UMLS 2011AA Property)
C37901 (NCI Thesaurus ValueDomain)
C0205145 (UMLS 2011AA ValueDomain)
CL.3
Code List
Primary Site of Infection (Mark one with an X.)
CL Item
Blood (Blood)
C12434 (NCI Thesaurus)
C0229664 (UMLS 2011AA)
CL Item
Bone/joint (Bone/Joint)
CL Item
Cns (CNS)
CL Item
Disseminated (multiple Sites) (Disseminated (multiple sites))
CL Item
Ear (Ear)
C12394 (NCI Thesaurus)
C0013443 (UMLS 2011AA)
CL Item
Eye (Eye)
C12401 (NCI Thesaurus)
C0015392 (UMLS 2011AA)
CL Item
Gastrointestinal Tract (GI)
C34082 (NCI Thesaurus)
C0017189 (UMLS 2011AA)
CL Item
Liver/spleen (Liver/Spleen)
CL Item
Lower Respiratory Tract (lrt) (Lower Respiratory Tract (LRT))
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Reproductive System (Reproductive system)
CL Item
Skin And Soft Tissue (Skin/Soft Tissue)
CL Item
Upper Respiratory Tract (urt) (Upper Respiratory Tract (URT))
CL Item
Urinary Tract (Urinary tract)
AdverseEventComplicatingInfectionAnatomicSiteSpecify
Item
Other, specify
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C25421 (NCI Thesaurus Property)
C0002808 (UMLS 2011AA Property)
C25455 (NCI Thesaurus Property)
C1522701 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item Group
Labs At Time Of Infection
LaboratoryProcedureLeukocyteResultSpecifiedValue
Item
Peripheral WBC Count (X 10^3/uL)
double
C12529 (NCI Thesaurus Property)
C0023516 (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)
C38024 (NCI Thesaurus ValueDomain)
C0205369 (UMLS 2011AA ValueDomain)
LaboratoryProcedureNeutrophilResultPercentageValue
Item
Peripheral Neutrophils (%) (segs + bands)
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12533 (NCI Thesaurus Property)
C0027950 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
Item
CTC Adverse Event Grade (Mark one with an X.)
double
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.4
Code List
CTC Adverse Event Grade (Mark one with an X.)
CL Item
No Adverse Event Or Within Normal Limits (0)
CL Item
Mild Adverse Event (1)
C41338 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C41339 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (3)
C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)
CL Item
Life-threatening Or Disabling Adverse Event (4)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
Item
Outcome of infection (Mark one with an X.)
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25455 (NCI Thesaurus Property)
C1522701 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.5
Code List
Outcome of infection (Mark one with an X.)
CL Item
Death Due To Infection (Death due to infection)
CL Item
Death Due To Other Causes (Death due to other causes)
CL Item
Not Resolved (Not resolved)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Adverse Event Is Resolved (Resolved)
AdverseEventComplicatingInfectionResultSpecify
Item
Other, specify
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C26726 (NCI Thesaurus Property)
C0009450 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25455 (NCI Thesaurus Property)
C1522701 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
CTC AE Attribution Code
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
CL.6
Code List
CTC AE Attribution Code
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
Item Group
Overall Response
ResponsiblePersonName
Item
Completed by (print or type name)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
FormCompleteDate
Item
Date Form Completed (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
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