ID

2083

Beschreibung

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

Stichworte

Hochgeladen am

19. September 2012

DOI

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Leukemia NCT00513747 Toxicity - CALGB-10501 Infectious Complications Form - 2661567v1.0

Modell
Details

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 Formulare

StudyEvent: CALGB-10501 Infectious Complications Form
1. 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

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Unnamed1

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)

DataAmendedInd-3

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)

Unnamed2

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)

Unnamed3

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)

Causitive Agent/Primary Site

Item Group

Causitive Agent

AdverseEventComplicatingInfectionType

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)

AdverseEventComplicatingInfectionAnatomicSite

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)

Labs at Time of Infection/CTCAE Information

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)

CommonToxicityCriteriaAdverseEventGrade

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)

AdverseEventComplicatingInfectionResultType

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)

CTCAdverseEventAttributionScale

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)

Footer Module

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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Leukemia NCT00513747 Toxicity - CALGB-10501 Infectious Complications Form - 2661567v1.0

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

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