To be completed on all patients every 3 months for 2 years, every 6 months for 2 additional years and then annually until progression or death (after first progression submit Short Follow-up report annually until death). To be submitted electronically within 8 weeks of the date the patient was seen at the clinic.

1 moduli

StudyEvent: NCIC OV 21 Follow-Up Report Form
1. To be completed on all patients every 3 months for 2 years, every 6 months for 2 additional years and then annually until progression or death (after first progression submit Short Follow-up report annually until death). To be submitted electronically within 8 weeks of the date the patient was seen at the clinic.

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

Patient Information

Item Group

Patient Information

PatientNationalCancerInstituteofCanadaIdentifierNumber

Item

NCIC Patient ID (NCIC CTG Patient Serial Number issued at the time of randomization)

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)
C25582 (NCI Thesaurus Property-2)
C1513884 (UMLS 2011AA Property-2)

Patient Initials

Item

Patient Initials (first-middle-last)

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)

Medical Record Number

Item

Patient Hospital No. (if permitted by REB)

text

C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)

PhysicianInvestigatorIdentifierNumber

Item

Investigator No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C17089 (NCI Thesaurus ObjectClass-2)
C0035173 (UMLS 2011AA ObjectClass-2)

InvestigatorFirstName

Item

Investigator First Name

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)

TreatingPhysicianMiddleName

Item

Investigator Middle Name

text

C25741 (NCI Thesaurus ObjectClass)
C0031831 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25569 (NCI Thesaurus Property-2)
C0444598 (UMLS 2011AA Property-2)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)

InvestigatorLastName

Item

Investigator Last Name

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
C25551 (NCI Thesaurus Property-2)
C1517741 (UMLS 2011AA Property-2)

TIMING OF REPORT

Item Group

Timing Of Report

VisitReportMonthCount

Item

Month of report (Off-treatment)

text

C29846 (NCI Thesaurus Property)
C0439231 (UMLS 2011AA Property)
C25375 (NCI Thesaurus ObjectClass)
C0684224 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25716 (NCI Thesaurus ObjectClass-2)
C0545082 (UMLS 2011AA ObjectClass-2)

CL.1

Code List

Month of report (Off-treatment)

CL Item

3 (3)

CL Item

6 (6)

CL Item

9 (9)

CL Item

12 (12)

CL Item

15 (15)

CL Item

18 (18)

CL Item

21 (21)

CL Item

24 (24)

CL Item

30 (30)

CL Item

36 (36)

CL Item

42 (42)

CL Item

48 (48)

CL Item

60 (60)

CL Item

72 (72)

CL Item

Other Month (OTHER)

AssessmentPeriodSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)

PHYSICAL EXAM

Item Group

Physical Exam

Patient Weight

Item

Weight (kg)

float

C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)

ECOG Performance Status

Item

Performance Status (ECOG)

text

C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)

CL.2

Code List

Performance Status (ECOG)

CL Item

Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)

CL Item

Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)

CL Item

Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)

CL Item

Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)

CL Item

Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)

Assessment Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

RESPONSE ASSESSMENT - QUESTION 2

Item Group

Response Assessment - Question 2

DiseaseAssessmentResultInd-2

Item

Were disease assessment results obtained this report period?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)

EvaluationNotDoneReasonType

Item

Reason evaluation not done

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus ObjectClass)
C0220825 (UMLS 2011AA ObjectClass)
C49484 (NCI Thesaurus Property)
C1272696 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)

CL.4

Code List

Reason evaluation not done

CL Item

Not Required Per Protocol (Not required per protocol)

CL Item

Institution Error (Institution error)

CL Item

Patient Noncompliance (Patient noncompliance)

C0376405 (NCI Metathesaurus)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

EvaluationNotDoneReasonSpecify

Item

Specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus ObjectClass)
C0220825 (UMLS 2011AA ObjectClass)
C49484 (NCI Thesaurus Property)
C1272696 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)

TARGET LESIONS

Item Group

Target Lesions

DiseasePost-OperativeStatusType

Item

Did the patient have any target lesions by imaging or clinical exam on post-op baseline report

boolean

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25623 (NCI Thesaurus Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property)

LesionTargetSite

Item

Target Lesion Site (e.g. pelvis)

text

C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25702 (NCI Thesaurus Property-2)
C1521840 (UMLS 2011AA Property-2)
C37901 (NCI Thesaurus ValueDomain)
C0205145 (UMLS 2011AA ValueDomain)

Evaluation method

Item

Method of Evaluation

text

C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)

Evaluation method, specify

Item

Other Specify

text

C25685 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C16847 (NCI Thesaurus Property)

Assessment Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

TumorLargestDimensionMeasurement

Item

Dimension 1 (End of Reporting Period Measurements)

float

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25550 (NCI Thesaurus Property)
C0443228 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property-2)
C0439534 (UMLS 2011AA Property-2)

TumorSecondDimensionMeasurement

Item

Dimension 2 (End of Reporting Period Measurements)

float

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25666 (NCI Thesaurus Property)
C0205436 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property-2)
C0439534 (UMLS 2011AA Property-2)

LongestLesionSumDiameterMeasurement

Item

Sum of Longest Diameters of All Target Lesions

float

C25558 (NCI Thesaurus ObjectClass)
C1522425 (UMLS 2011AA ObjectClass)
C3824 (NCI Thesaurus ObjectClass-2)
C0221198 (UMLS 2011AA ObjectClass-2)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25697 (NCI Thesaurus Property-2)
C1515051 (UMLS 2011AA Property-2)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)

NON-TARGET LESIONS DURING TREATMENT

Item Group

Non- Target Lesions During Treatment

LesionNontargetBaselineLocationInd-3

Item

Were there any non-target lesions reported at baseline

boolean

C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus Property)
C1518389 (UMLS 2011AA Property)
C25341 (NCI Thesaurus Property-2)
C0450429 (UMLS 2011AA Property-2)
C25213 (NCI Thesaurus Property-3)
C1442488 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ValueDomain-2)
C0006826 (UMLS 2011AA ValueDomain-2)

LesionNontargetSite

Item

Nontarget Lesion Site (e.g. pelvis)

text

Evaluation method

Item

Method of Evaluation

text

C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)

Evaluation method, specify

Item

Other Specify

text

C25685 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C16847 (NCI Thesaurus Property)

Assessment Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

Non-TargetLesionFollow-upStatus

Item

Follow-up status of nontarget lesion (End of Reporting Period )

text

C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus ObjectClass-2)
C1518389 (UMLS 2011AA ObjectClass-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.7

Code List

Follow-up status of nontarget lesion (End of Reporting Period )

CL Item

Absent (Absent)

C48190 (NCI Thesaurus)
C0332197 (UMLS 2011AA)

CL Item

Present-no Change (Present-no change)

CL Item

Increase (Increase)

CL Item

Increased To Pd (Increased to PD)

CL Item

Unevaluable (Unevaluable)

C62222 (NCI Thesaurus)
C1883425 (UMLS 2011AA)

NEW LESIONS

Item Group

New Lesions

NewLesionAppearanceInd-2

Item

Was the appearance of any new lesions documented (since baseline i.e. previously or current reporting periods Note: New Lesions constitute objective disease progression)

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus ObjectClass-2)
C0205314 (UMLS 2011AA ObjectClass-2)
C25377 (NCI Thesaurus Property)
C0700364 (UMLS 2011AA Property)

LesionNewSite

Item

New Lesion Site (e.g. pelvis)

text

C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C25341 (NCI Thesaurus Property-2)
C0450429 (UMLS 2011AA Property-2)
C37901 (NCI Thesaurus ValueDomain)
C0205145 (UMLS 2011AA ValueDomain)

Evaluation method

Item

Method of Evaluation

text

C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)

Evaluation method, specify

Item

Other Specify

text

C25685 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C16847 (NCI Thesaurus Property)

Assessment Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

RADIOLOGY

Item Group

Other Radiology

Assessment Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)

CA 125 - TABLE

Item Group

Ca 125 - Table

LaboratoryProcedureCA-125AntigenTumorMarkerResultDate

Item

Date of CA125

date

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C325 (NCI Thesaurus Property)
C0006610 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C17220 (NCI Thesaurus Property-3)
C0041365 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

LaboratoryProcedureCA-125AntigenTumorMarkerResultValue

Item

CA125

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C325 (NCI Thesaurus Property)
C0006610 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C17220 (NCI Thesaurus Property-3)
C0041365 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

PathologyCoreFacilityLaboratoryIdentifierNumber

Item

Lab ID (Upper Normal Limit)

text

C37984 (NCI Thesaurus ObjectClass)
C0022877 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus ObjectClass-2)
C0030664 (UMLS 2011AA ObjectClass-2)
C15896 (NCI Thesaurus ObjectClass-3)
C1511521 (UMLS 2011AA ObjectClass-3)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

ADVERSE EVENTS / INTERCURRENT ILLNESS

Item Group

Adverse Events / Intercurrent Illness

AdverseEventCancerTreatmentRelatedInd-3

Item

Were there any study-specific adverse events during this report period (ONGOING or NEW relations 3, 4 or 5)

boolean

C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus Property)
C0027651 (UMLS 2011AA Property)
C15368 (NCI Thesaurus Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25648 (NCI Thesaurus ValueDomain-2)
C0439849 (UMLS 2011AA ValueDomain-2)

AdverseEventNoAssessmentText

Item

Not Assessed

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C25217 (NCI Thesaurus Property-2)
C1516048 (UMLS 2011AA Property-2)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)

CommonToxicityCriteriaAdverseEventShortNameType

Item

CTC Adverse Event Short Name

text

C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C0332307 (NCI Metathesaurus ValueDomain)
C25249 (NCI Thesaurus Property-2)
C1806781 (UMLS 2011AA Property-2)

CTC Adverse Event Term

Item

CTC Select AE

text

C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C38024 (NCI Thesaurus Property)
C45559 (NCI Thesaurus Property-2)

CTC Adverse Event Attribution Category

Item

CTC AE Attribution Code

text

C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)

CL.10

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)

AdverseEventSeriousnessAttributionScale

Item

Seriousness Attributed to Adverse Event

text

C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)

CL.11

Code List

Seriousness Attributed to Adverse Event

CL Item

Not Serious (Not serious)

CL Item

Death (Death)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

CL Item

Life Threatening (Life threatening)

CL Item

Hospitalized (Hospitalization, initial or prolonged)

CL Item

Disability (Disability/incapacity)

C21007 (NCI Thesaurus)
C0231170 (UMLS 2011AA)

CL Item

Congenital Anomaly (Congenital anomaly)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

ANTI-CANCER TREATMENT

Item Group

Anti-cancer Treatment

Non-ProtocolTherapyAdministeredType

Item

Non-Protocol Therapy Type

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.12

Code List

Non-Protocol Therapy Type

CL Item

Chemotherapy (Chemotherapy)

C15632 (NCI Thesaurus)
C0392920 (UMLS 2011AA)

CL Item

Radiation Therapy (Radiation therapy)

C15313 (NCI Thesaurus)
C1522449 (UMLS 2011AA)

CL Item

Hormonal Therapy (Hormonal Therapy)

CL025695 (NCI Metathesaurus)

CL Item

Immunotherapy (Immunotherapy)

C15262 (NCI Thesaurus)
C0021083 (UMLS 2011AA)

CL Item

Other Specify (Other)

Non-ProtocolTherapyAdministeredSpecify

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

Non-protocolTherapyAdministeredText

Item

Name of non-protocol cancer therapy (eg. 2nd look surgery, tamoxifen)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

PriorAdverseEventContinuedInd-2

Item

Ongoing from previous reporting period

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C0750536 (NCI Metathesaurus Property)

Non-protocolTherapyBeginDate

Item

Treatment Start Date (yyyy-mmm-dd)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

Medication continued

Item

Continuing at end of this reporting period

boolean

C38147 (NCI Thesaurus ValueDomain)
C0013227 (UMLS CUI-1)
C459 (NCI Thesaurus ObjectClass)
C0549178 (UMLS CUI-2)
C25409 (NCI Thesaurus Property)
C0750536 (NCI Metathesaurus Property)

Non-protocolTherapyAdministeredEndDate

Item

Treatment Stop Date (yyyy-mmm-dd)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

QUALITY OF LIFE QUESTIONNAIRE

Item Group

Quality Of Life Questionnaire

QualityofLifeCompleteAssessmentInd-2

Item

Was QoL Questionnaire completed?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus Property-2)

QualityofLifeCompleteAssessmentDate

Item

Date Questionnaire Completed

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus Property-2)

QOLNotAdministeredReason

Item

Specify the reason the questionnaire was not completed

text

C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus ObjectClass)
C0518214 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)

CL.16

Code List

Specify the reason the questionnaire was not completed

CL Item

Patient Kept Appointment For Examination, But Could Not Complete Questionnaire Due To Illness (Patient kept appointment for examination, but could not complete questionnaire due to illness)

CL Item

Patient Kept Appointment For Examination, But Refused To Complete Questionnaire For Reasons Other Than Illness (Patient kept appointment for examination, but refused to complete questionnaire for reasons other)

CL Item

Patient Did Not Keep Appointment (Patient did not keep appointment)

CL Item

Patient Could Not Be Contacted (Patient could not be contacted)

CL Item

Test Omitted Due To Institution/investigator Error (Questionnaire not administered due to institutional error)

CL Item

Other Reason (Other reason)

Quality-of-LifeAssessmentOtherIncompleteSpecify

Item

Specify other reason

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C49160 (NCI Thesaurus Property-2)
C0205257 (UMLS 2011AA Property-2)
C15584 (NCI Thesaurus ObjectClass)
C0281588 (UMLS 2011AA ObjectClass)

Comments

Item Group

Comments

Research Comments

Item

Comments

text

C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)

Contact Information

Item Group

Contact Information

CRAName

Item

CRA Name

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25465 (NCI Thesaurus ObjectClass)
C1516627 (UMLS 2011AA ObjectClass)

ClinicalResearchAssociatePersonTelephoneNumber

Item

Phone number

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25395 (NCI Thesaurus Property)
C0039457 (UMLS 2011AA Property)
C25465 (NCI Thesaurus ObjectClass-2)
C1516627 (UMLS 2011AA ObjectClass-2)

ClinicalResearchAssociatePersonFaxNumber

Item

Fax Number

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25465 (NCI Thesaurus ObjectClass-2)
C1516627 (UMLS 2011AA ObjectClass-2)
C25210 (NCI Thesaurus Property)
C0085205 (UMLS 2011AA Property)

Institution Name

Item

Institution Name

text

C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)

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