ID

2763

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CALGB: ARTERIAL THROMBOEMBOLIC EVENT REPORT Docetaxel and Prednisone With or Without Bevacizumab in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=EF4BCCC7-ECC6-11A8-E034-0003BA3F9857

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https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=EF4BCCC7-ECC6-11A8-E034-0003BA3F9857

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19 september 2012

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Prostate Cancer NCT00110214 Toxicity - CALGB: ARTERIAL THROMBOEMBOLIC EVENT REPORT - 2301817v3.0

model
Detaljer

For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. If data are amended, circle amended items and check the "Yes" box.

1 Formulär

StudyEvent: CALGB: ARTERIAL THROMBOEMBOLIC EVENT REPORT
1. For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. If data are amended, circle amended items and check the "Yes" box.

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

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)

PrimaryAdverseEventBeginDate

Item

Start date of primary AE (^2)

date

C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)

PrimaryAdverseEventEndDate

Item

Endt date of primary AE (^2)

date

C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25496 (NCI Thesaurus Property)
C2746065 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

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

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)

HospitalPatientIdentifierNumber

Item

Patient Hospital No

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus Property)
C0030705 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C16696 (NCI Thesaurus ObjectClass)
C0019994 (UMLS 2011AA ObjectClass)

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)

Unnamed 4

Item Group

Unnamed 4

TreatmentCycleAdverseEventOccurrenceNumber

Item

Course number on which event occurred (s)

text

C25472 (NCI Thesaurus ObjectClass)
C1511572 (UMLS 2011AA ObjectClass)
C0087111 (NCI Metathesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C0683157 (NCI Metathesaurus Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

AgentCourseCount

Item

Total number of courses to date

double

C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)

AdverseEventDescriptiveText

Item

Description of event (s Record if not submitting AdEERS report.)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)

MedDRACode

Item

MedDRA code

double

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)

CommonToxicityCriteriaAdverseEventTermType

Item

Adverse event

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)

CL.2

Code List

Adverse event

CL Item

Myocardial Ischaemia (Cardiac ischemia/infarction)

C0151744 (NCI Metathesaurus)

CL Item

Cerebral Ischaemia (CNS cerebrovascular ischemia)

C0917798 (NCI Metathesaurus)

CL Item

Peripheral Ischaemia Nos (Peripheral arterial ischemia)

CommonToxicityCriteriaAdverseEventInfarctionGrade

Item

Cardiac-ischemia/infarction Grade (Mark one with an X.)

double

C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25738 (NCI Thesaurus Property)
C0021308 (UMLS 2011AA Property)

CL.3

Code List

Cardiac-ischemia/infarction Grade (Mark one with an X.)

CL Item

Asymptomatic And Testing Suggesting Ischemia; Stable Angina (2)

CL Item

Symptomatic And Testing Consistent With Ischemia; Unstable Angina; Intervention Indicated (3)

CL Item

Acute Myocardial Infarction (4)

C35204 (NCI Thesaurus)
C0155626 (UMLS 2011AA)

CL Item

Death (5)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

CommonToxicityCriteriaAdverseEventCTCAdverseEventsCentralNervousSystemCerebrovascularAccidentIschemiaGrade

Item

CNS cerebrovascular ischemia Grade

double

C12438 (NCI Thesaurus Property)
C0927232 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C0038454 (NCI Metathesaurus Property)

CL.4

Code List

CNS cerebrovascular ischemia Grade

CL Item

Transient Ischemic Event Or Attack (tia) <=24 Hrs Duration (3)

CL Item

Cerebral Vascular Accident (cva, Stroke), Neurologic Deficit >24 Hrs (4)

CL Item

Death (5)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

CommonToxicityCriteriaAdverseEventPeripheralArterialIschemiaGrade

Item

Peripheral arterial ischemia Grade

double

C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25233 (NCI Thesaurus Property)
C0205100 (UMLS 2011AA Property)
CL163817 (NCI Metathesaurus Property)

CL.5

Code List

Peripheral arterial ischemia Grade

CL Item

Recurring Or Prolonged (>=24 Hrs) And/or Invasive Intervention Indicated (3)

CL Item

Life-threatening, Disabling And/or Associated With End Organ Damage (e.g., Limb Loss) (4)

CL Item

Death (5)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

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.8

Code List

CTC AE attribution code

CL Item

Unrelated (unrelated)

C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)

CL Item

Unlikely (unlikely)

CL Item

Possible (possible)

C0332149 (NCI Metathesaurus)

CL Item

Probable (probable)

C0332148 (NCI Metathesaurus)

CL Item

Definite (definite)

CL209464 (NCI Metathesaurus)

PrimaryAdverseEventOccurrenceInd-2

Item

Is primary AE (^2)

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

Unnamed 8

Item Group

Unnamed 8

CommonToxicityCriteriaAdverseEventGrade

Item

CTC AE grade

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.7

Code List

CTC AE grade

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)

AdverseEventTreatmentAdministeredType

Item

Treatment of event (s Mark all that apply with an X.)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C25382 (NCI Thesaurus ValueDomain)
C1521801 (UMLS 2011AA ValueDomain)

CL.9

Code List

Treatment of event (s Mark all that apply with an X.)

CL Item

Hospitalization (Hospitalization)

CL Item

Surgery (Surgery)

C17173 (NCI Thesaurus)
C0038894 (UMLS 2011AA)

HospitalAdmissionDate

Item

Hospital admission date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16696 (NCI Thesaurus ObjectClass)
C0019994 (UMLS 2011AA ObjectClass)
C25385 (NCI Thesaurus Property)
C0809949 (UMLS 2011AA Property)

HospitalDischargeDate

Item

Hospital discharge date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16696 (NCI Thesaurus ObjectClass)
C0019994 (UMLS 2011AA ObjectClass)
C0012621 (NCI Metathesaurus Property)

AdverseEventTreatmentSurgicalProcedureSpecify

Item

Surgery, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)

CTCAdverseEventAttributionScale

Item

CTC AE attribution code

text

CL.8

Code List

CTC AE attribution code

CL Item

Unrelated (unrelated)

C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)

CL Item

Unlikely (unlikely)

CL Item

Possible (possible)

C0332149 (NCI Metathesaurus)

CL Item

Probable (probable)

C0332148 (NCI Metathesaurus)

CL Item

Definite (definite)

CL209464 (NCI Metathesaurus)

CALGBAdverseEventPresentStatus

Item

Present status (Mark all that apply with an X.)

text

C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25442 (NCI Thesaurus ObjectClass)
C1516238 (UMLS 2011AA ObjectClass)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.10

Code List

Present status (Mark all that apply with an X.)

CL Item

Removed From Protocol Treatment (Removed from protocol treatment)

CL Item

Resumed Protocol Treatment (Resumed protocol treatment)

OffTreatmentDate

Item

Removed from protocol treatment, specify date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

ResponsiblePersonName

Item

Completed by

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

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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Prostate Cancer NCT00110214 Toxicity - CALGB: ARTERIAL THROMBOEMBOLIC EVENT REPORT - 2301817v3.0

For optimal accuracy use black ink. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. If data are amended, circle amended items and check the "Yes" box.

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