ID

6993

Descrição

NCIC MA.32 Treatment Report Form A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=80FC65BF-C111-5459-E040-BB89AD430BEC

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=80FC65BF-C111-5459-E040-BB89AD430BEC

Palavras-chave

D001943

Transferido a

8 de janeiro de 2015

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT01101438 Treatment - NCIC MA.32 Treatment Report Form - 3018892v1.0

model
Detalhes

The purpose of the "Treatment Report" is to document drug administration, adverse events and response for one reporting period. For this study a reporting period is defined as one cycle (i.e. 1 cycle = 3 weeks or 21 days). Cycle length will be increased in cases where the start of the next cycle of treatment is delayed and will be decreased if the patient goes off protocol treatment before the end of the cycle. The "Treatment Report" should be completed within 2 weeks of the end of each reporting period.

1 Formulários

StudyEvent: NCIC MA.32 Treatment Report Form
1. The purpose of the "Treatment Report" is to document drug administration, adverse events and response for one reporting period. For this study a reporting period is defined as one cycle (i.e. 1 cycle = 3 weeks or 21 days). Cycle length will be increased in cases where the start of the next cycle of treatment is delayed and will be decreased if the patient goes off protocol treatment before the end of the cycle. The "Treatment Report" should be completed within 2 weeks of the end of each reporting period.

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

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

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)

Cycle number

Item

On Treatment Reporting Period

text

C25284 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25616 (NCI Thesaurus Property-2)
C15368 (NCI Thesaurus ObjectClass)

CL.1

Code List

On Treatment Reporting Period

CL Item

6 Months (6 months)

CL Item

12 Months (12 months)

CL Item

24 Months (24 months)

CL Item

36 Months (36 months)

CL Item

48 Months (48 months)

PHYSICAL EXAM - ON TREATMENT

Item Group

Physical Exam

PatientPhysicalExaminationDate

Item

Date of Physical Exam (yyyy-mmm-dd)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)

Patient Weight

Item

Weight (kg)

float

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

PersonBodyMassIndexValue

Item

BMI

float

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C16358 (NCI Thesaurus Property)
C1305855 (UMLS 2011AA Property)
C16358 (NCI Thesaurus ValueDomain-2)
C1305855 (UMLS 2011AA ValueDomain-2)

WaistCircumferenceMeasurementNumber3CharactersNoDecimal

Item

Waist Circumference

float

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25209 (NCI Thesaurus Property)
C0242485 (UMLS 2011AA Property)
C0332520 (NCI Metathesaurus ObjectClass)
C64192 (NCI Thesaurus ObjectClass)
C0230097 (UMLS 2011AA ObjectClass)

HipCircumferenceMeasurementNumbers3NoDecimal

Item

Hip Circumference

float

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25209 (NCI Thesaurus Property)
C0242485 (UMLS 2011AA Property)
C0019552 (NCI Metathesaurus ObjectClass)
C0332520 (NCI Metathesaurus ObjectClass-2)

Systolic blood pressure

Item

Blood Pressure, Systolic

float

C25209 (NCI Thesaurus ValueDomain)
C0871470 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25298 (NCI Thesaurus ObjectClass)

Diastolic blood pressure

Item

Blood pressure, Diastolic

float

C25209 (NCI Thesaurus ValueDomain)
C0428883 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25299 (NCI Thesaurus ObjectClass)

DISEASE STATUS

Item Group

Disease Status

CancerFollow-UpMostRecentStatus

Item

Status of Most Recent Clinical Assessment

text

C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25577 (NCI Thesaurus ValueDomain-2)
C1513491 (UMLS 2011AA ValueDomain-2)

CL.2

Code List

Status of Most Recent Clinical Assessment

CL Item

No Evidence Of Disease (No evidence of disease)

CL Item

Cancer Present (Cancer present)

IN SITU DISEASE FOLLOW-UP

Item Group

In Situ Disease Follow-up

DuctalBreastCarcinomainSituHistologicallyConfirmedInd-2

Item

Since the last report has there been a biopsy proven diagnosis of DCIS

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C2924 (NCI Thesaurus ObjectClass)
C0007124 (UMLS 2011AA ObjectClass)
C25527 (NCI Thesaurus Property-2)
C0205462 (UMLS 2011AA Property-2)

PrimaryTumorLateralityType

Item

Tumor Laterality (If yes,)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C25185 (NCI Thesaurus Property)
C0332304 (UMLS 2011AA Property)

DuctalBreastCarcinomainSituHistologicallyRadiologicFindingConfirmedDate

Item

Date of radiologic detection of DCIS (If yes,)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C2924 (NCI Thesaurus ObjectClass)
C0007124 (UMLS 2011AA ObjectClass)
C35869 (NCI Thesaurus Property-2)
C1290916 (UMLS 2011AA Property-2)

DuctalBreastCarcinomainSituHistologicallyConfirmedDate

Item

Date of histologic DCIS diagnosis (If yes,)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C2924 (NCI Thesaurus ObjectClass)
C0007124 (UMLS 2011AA ObjectClass)
C25527 (NCI Thesaurus Property-2)
C0205462 (UMLS 2011AA Property-2)

KIT RETURN - QUESTION

Item Group

Kit Return - Question

TreatmentKitReturnInd-2

Item

Have any treatment kits been returned this reporting period

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C42793 (NCI Thesaurus ObjectClass-2)
C0812225 (UMLS 2011AA ObjectClass)
C71900 (NCI Thesaurus Property)
C0332156 (UMLS 2011AA Property)

KIT RETURN

Item Group

Kit Return

BlindedProtocolAgentIdentifierNumber

Item

Kit number

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C41161 (NCI Thesaurus ObjectClass)
C1521826 (UMLS 2011AA ObjectClass)
C49068 (NCI Thesaurus ObjectClass-2)
C0150108 (UMLS 2011AA ObjectClass-2)

PillsRemainingCount

Item

Number of pills returned

float

C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25394 (NCI Thesaurus ObjectClass)
C0994475 (UMLS 2011AA ObjectClass)
C25649 (NCI Thesaurus Property)
C1527428 (UMLS 2011AA Property)

KIT DISPENSION - QUESTION

Item Group

Kit Dispension - Question

TreatmentKitDispenseInd-2

Item

Have any treatment kits been dispensed this reporting period

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C42793 (NCI Thesaurus ObjectClass-2)
C0812225 (UMLS 2011AA ObjectClass)
C64658 (NCI Thesaurus Property)
C1880359 (UMLS 2011AA Property)

KIT DISPENSATION

Item Group

Kit Dispensation

BlindedProtocolAgentIdentifierNumber

Item

Kit number

text

TreatmentKitDispenseDate

Item

Date dispensed

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C42793 (NCI Thesaurus ObjectClass-2)
C0812225 (UMLS 2011AA ObjectClass)
C64658 (NCI Thesaurus Property)
C1880359 (UMLS 2011AA Property)

METFORMIN/PLACEBO ADMINISTRATION - RAMP-UP

Item Group

Metformin/placebo Administration - Ramp-up

Treatment Start Date

Item

Date of Initial Dose

date

C15368 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus Property)
C3173309 (UMLS CUI-1)
C25256 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)

TherapyFullDoseScheduleDate

Item

Date subject scheduled to begin full dose

date

C15368 (NCI Thesaurus ObjectClass)
C25488 (NCI Thesaurus Property)
C0178602 (UMLS 2011AA Property)
C25211 (NCI Thesaurus Property-2)
C0086960 (UMLS 2011AA Property-2)
C25517 (NCI Thesaurus Property-3)
C0443225 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

TherapyFullDoseAdministrationDate

Item

Date subject reports full dose begun

date

C15368 (NCI Thesaurus ObjectClass)
C25488 (NCI Thesaurus Property)
C0178602 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property-2)
C1533734 (UMLS 2011AA Property-2)
C25517 (NCI Thesaurus Property-3)
C0443225 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

METFORMIN/PLACEBO ADMINISTRATION

Item Group

Metformin/placebo Administration

ClinicalStudyProtocolMedicationDailySelf-AdministeredInd-2

Item

Has subject taken protocol medication every day

boolean

C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C459 (NCI Thesaurus ObjectClass-2)
C0013227 (UMLS 2011AA ObjectClass-2)
C25473 (NCI Thesaurus Property)
C0332173 (UMLS 2011AA Property)
C25670 (NCI Thesaurus Property-2)
C1519231 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PillsNegationTakenCount

Item

How many pills does the subject report having missed (If no,)

float

C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25394 (NCI Thesaurus ObjectClass)
C0994475 (UMLS 2011AA ObjectClass)
C25701 (NCI Thesaurus Property-2)
C1883727 (UMLS 2011AA Property-2)

Dose Modification Reason

Item

Dose Modification Reason (If no, please enter the reasons for dose modifications in the table below:)

text

C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C0392360 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)

CL.7

Code List

Dose Modification Reason (If no, please enter the reasons for dose modifications in the table below:)

CL Item

Hold For Procedure (Hold for procedure)

CL Item

Dosing Error (Dosing error)

CL Item

Intercurrent Illness (Intercurrent illness)

CL Item

Patient Forgot (Patient forgot)

CL Item

Patient Request (Patient request)

CL Item

Adverse Event (Adverse event)

C41331 (NCI Thesaurus)
C0877248 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

Dose Modification Reason, other

Item

Specify

text

C25685 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C3840932 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)

Dose Increased

Item

Was this dose modification or addition/omission as per protocol guidelines

boolean

C38147 (NCI Thesaurus ValueDomain)
C1707810 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)

RADIOLOGY INVESTIGATIONS - QUESTION

Item Group

Radiology Investigations - Question

MammogramPerformedInd-3b

Item

Was a mammogram performed

text

C20178 (NCI Thesaurus ObjectClass)
C0024671 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)

CL.9

Code List

Was a mammogram performed

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

MammogramPerformedAnatomicSite

Item

Mammogram laterality

text

C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C20178 (NCI Thesaurus ObjectClass)
C0024671 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)

CL.10

Code List

Mammogram laterality

CL Item

Bilateral (Bilateral)

C13332 (NCI Thesaurus)
C0238767 (UMLS 2011AA)

CL Item

Unilateral (unilateral)

C28012 (NCI Thesaurus)
C0205092 (UMLS 2011AA)

MammogramUnilateralPerformedAnatomicSite

Item

Specify side

text

C20178 (NCI Thesaurus ObjectClass)
C0024671 (UMLS 2011AA ObjectClass)
C28012 (NCI Thesaurus Property)
C0205092 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25306 (NCI Thesaurus ValueDomain-2)
C0441987 (UMLS 2011AA ValueDomain-2)

CL.11

Code List

Specify side

CL Item

Right (Right)

C25228 (NCI Thesaurus)
C0205090 (UMLS 2011AA)

CL Item

Left (Left)

C25229 (NCI Thesaurus)
C0205091 (UMLS 2011AA)

DiagnosticImagingRecurrentDiseasePerformedInd-3

Item

Was imaging done to assess for recurrence (other than mammogram)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C38155 (NCI Thesaurus Property-2)
C0277556 (UMLS 2011AA Property-2)

RADIOLOGY INVESTIGATIONS

Item Group

Radiology Investigations

ImagingMethodType

Item

Type of imaging

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)

CL.13

Code List

Type of imaging

CL Item

Mammography (Mammography)

C16818 (NCI Thesaurus)
C0024671 (UMLS 2011AA)

CL Item

Magnetic Resonance Imaging (MRI)

C16809 (NCI Thesaurus)
C0024485 (UMLS 2011AA)

CL Item

Scan - Bone (Scan - bone)

CL Item

Scan - Ct Abdomen (Scan - CT abdomen)

CL Item

Scan - Ct Brain (Scan - CT brain)

CL Item

Scan - Ct Chest (Scan - CT chest)

CL Item

Scan - Ct Pelvis (Scan - CT pelvis)

CL Item

Ultrasound - Abdomen (Ultrasound - abdomen)

CL Item

Ultrasound - Pelvis (Ultrasound - pelvis)

CL Item

Xray - Chest (Xray - chest)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

ImagingMethodSpecify

Item

Specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)

DiagnosticImagingProcedureDate

Item

Date of test

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C25218 (NCI Thesaurus Property)
C1948041 (UMLS 2011AA Property)

AssessmentImageReportingType

Item

Result

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C25651 (NCI Thesaurus ValueDomain-2)
C0700287 (UMLS 2011AA ValueDomain-2)
C19477 (NCI Thesaurus Property)
C1704254 (UMLS 2011AA Property)

CL.14

Code List

Result

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)

CL Item

Abnormal, Malignant (Abnormal, malignant)

CL Item

Abnormal, Non-malignant (Abnormal, non-malignant)

HEMATOLOGY

Item Group

Hematology

HematologySpecimenCollectedDate

Item

Lab, Hematology, Sample Collection Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C25452 (NCI Thesaurus Property)

LaboratoryProcedureEvaluationPerformedDate

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

BloodSpecimenCollectedInd-3

Item

Was sample obtained

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C25452 (NCI Thesaurus Property)

LaboratoryProcedureHemoglobinResultUnspecifiedValue

Item

Hemoglobin

float

C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureHemoglobinResultSpecifiedLowerLimitofNormalValue

Item

Hemoglobin (Hgb) (g/dl), LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C0205369 (UMLS 2011AA ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
C1518030 (UMLS 2011AA ValueDomain-3)

LaboratoryProcedureHemoglobinResultUpperLimitofNormalValue

Item

Hemoglobin, ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedurePlateletResultUnspecifiedValue

Item

Platelet count

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property-2)
C0005821 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedurePlateletResultLowerLimitofNormalValue

Item

Platelets LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property-2)
C0005821 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedurePlateletResultUpperLimitofNormalValue

Item

Platelets ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property-2)
C0005821 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureLeukocyteResultUnspecifiedValue

Item

WBC

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12529 (NCI Thesaurus Property)
C0023516 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureLeukocyteResultLowerLimitofNormalValue

Item

WBC count (x1000), LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12529 (NCI Thesaurus Property)
C0023516 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureLeukocyteResultUpperLimitofNormalValue

Item

Peripheral WBC count, ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C12529 (NCI Thesaurus Property)
C0023516 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureGranulocyteResultCount

Item

Peripheral Granulocytes Count

float

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12530 (NCI Thesaurus Property-2)
C0018183 (UMLS 2011AA Property-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

LaboratoryProcedureGranulocyteResultLowerLimitofNormalCount

Item

Peripheral Granulocytes Count LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12530 (NCI Thesaurus Property-2)
C0018183 (UMLS 2011AA Property-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureGranulocyteResultUpperLimitofNormalCount

Item

Granulocytes, ULN

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12530 (NCI Thesaurus Property-2)
C0018183 (UMLS 2011AA Property-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

HematologyErythrocyteMeanCorpuscularVolumeLaboratoryUnspecifiedValue

Item

Mean Corpuscular Volume

text

C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C64799 (NCI Thesaurus Property-2)
C1948043 (UMLS 2011AA Property-2)

AssessmentLabUOM

Item

Units

text

C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)

AssessmentLabUOM

Item

Units

text

AssessmentLabUOM

Item

Units

text

AssessmentLabUOM

Item

Units

text

AssessmentLabUOM

Item

Units

text

LaboratoryProcedureErythrocyteMeanCorpuscularVolumeOutcomeLowerLimitofNormalValue

Item

Mean Corpuscular Volume, LLN

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C64799 (NCI Thesaurus Property-2)
C1948043 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureErythrocyteMeanCorpuscularVolumeOutcomeUpperLimitofNormalValue

Item

Mean Corpuscular Volume, ULN

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C64799 (NCI Thesaurus Property-2)
C1948043 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

BIOCHEMISTRY

Item Group

Biochemistry

SpecimenCollectedDate

Item

Date Specimen collected (biochemical investigations)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA 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)

SpecimenObtainInd-2

Item

Was sample obtained

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C52349 (NCI Thesaurus Property)
C1301820 (UMLS 2011AA Property)

LaboratoryProcedureAlkalinePhosphataseResultValue

Item

Alkaline Phosphatase

float

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C16276 (NCI Thesaurus Property-2)
C0002059 (UMLS 2011AA Property-2)

LaboratoryProcedureAlkalinePhosphataseResultLowerLimitNormalValue

Item

Alkaline Phosphatase LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C16276 (NCI Thesaurus Property-2)
C0002059 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureAlkalinePhosphataseResultUpperLimitNormalValue

Item

Alkaline Phosphatase ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C16276 (NCI Thesaurus Property-2)
C0002059 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUnspecifiedValue

Item

SGPT (ALT)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultLowerLimitofNormalValue

Item

SGPT (ALT) LLN

float

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

Item

SGPT (ALT) ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedValue

Item

SGOT (AST)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultLowerLimitofNormalValue

Item

SGOT (AST) LLN

float

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Item

SGOT (AST) ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureTotalBilirubinResultUnspecifiedValue

Item

Total Bilirubin

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureTotalBilirubinResultLowerLimitofNormalValue

Item

Total bilirubin LLN

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS 2011AA Property-2)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
C49100 (NCI Thesaurus ValueDomain-2)
C1704610 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureTotalBilirubinResultUpperLimitNormalValue

Item

Total Bilirubin ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureCreatinineResultUnspecifiedValue

Item

Serum Creatinine

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property-2)
C0010294 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

AssessmentLabUOM

Item

Units

text

AssessmentLabUOM

Item

Units

text

AssessmentLabUOM

Item

Units

text

AssessmentLabUOM

Item

Units

text

AssessmentLabUOM

Item

Units

text

LaboratoryProcedureCreatinineResultLowerLimitofNormalValue

Item

Serum Creatinine LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property-2)
C0010294 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureCreatinineResultUpperLimitofNormalValue

Item

Serum Creatinine ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property-2)
C0010294 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureVitaminB12OutcomeValue

Item

Serum Vitamin B12

text

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C939 (NCI Thesaurus Property-2)
C0042845 (UMLS 2011AA Property-2)

LaboratoryProcedureVitaminB12OutcomeLowerLimitofNormalValue

Item

Serum Vitamin B12, LLN

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C939 (NCI Thesaurus Property-2)
C0042845 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureVitaminB12OutcomeUpperLimitofNormalValue

Item

Serum Vitamin B12, ULN

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C939 (NCI Thesaurus Property-2)
C0042845 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureFastingPlasmaGlucoseMeasurementOutcomeValue

Item

Fasting glucose

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C41376 (NCI Thesaurus Property-2)
C0202042 (UMLS 2011AA Property-2)
C63663 (NCI Thesaurus Property-3)
C0015663 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureFastingPlasmaGlucoseMeasurementOutcomeLowerLimitofNormalValue

Item

Fasting glucose, LLN

float

LaboratoryProcedureFastingPlasmaGlucoseMeasurementOutcomeLabUpperLimitNormalValue

Item

Fasting glucose, ULN

float

SERIOUS ADVERSE EVENT - QUESTION

Item Group

Serious Adverse Event - Question

SeriousAdverseEventReportInd-2

Item

Did the patient experience a Serious Adverse Event, as defined in protocol section 11, during this reporting period

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C54035 (NCI Thesaurus ObjectClass-2)
C0205404 (UMLS 2011AA ObjectClass-2)

ADVERSE EVENTS ON TREATMENT - QUESTION

Item Group

Adverse Events On Treatment - Question

OtherAdverseEventPresentIndicator

Item

Were any additional adverse events experienced by the patient

text

C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ObjectClass-2)
C0877248 (UMLS 2011AA ObjectClass-2)

CL.18

Code List

Were any additional adverse events experienced by the patient

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Not Assessed (Not assessed)

NewCancerDiagnosisInd-3

Item

Has a new primary cancer or MDS been diagnosed that has not been previously reported?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

DiabetesMellitusNewInd-3

Item

Has there been a new diagnosis of diabetes since the last report

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C2985 (NCI Thesaurus ObjectClass)
C0011849 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)

ADVERSE EVENTS

Item Group

Adverse Events

AdverseEventContinueReportInd-2

Item

Would you like to carry forward the adverse events (indicated as continuing) from the previous reporting period

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C53279 (NCI Thesaurus Property)
C0549178 (UMLS 2011AA Property)
C25375 (NCI Thesaurus Property-2)
C0684224 (UMLS 2011AA Property-2)

AdverseEventCommonTerminologyforAdverseEventsVersion4TermName

Item

CTCAE Term

text

C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C49704 (NCI Thesaurus Property)
C1516728 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property-2)
C1705313 (UMLS 2011AA Property-2)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain-2)
C1516728 (UMLS 2011AA ValueDomain-2)
C42614 (NCI Thesaurus ValueDomain-3)
C0027365 (UMLS 2011AA ValueDomain-3)
C45559 (NCI Thesaurus ValueDomain-4)
C1705313 (UMLS 2011AA ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C0333052 (UMLS 2011AA ValueDomain-5)

CL.22

Code List

CTCAE Term

CL Item

Abdominal Distention (Abdominal distension)

C78161 (NCI Thesaurus)
C0000731 (UMLS 2011AA)

CL Item

Abdominal Infection (Abdominal infection)

C35669 (NCI Thesaurus)
C1112209 (UMLS 2011AA)

CL Item

Abdominal Pain (Abdominal pain)

C26682 (NCI Thesaurus)
C0000737 (UMLS 2011AA)

CL Item

Abdominal Soft Tissue Necrotic Lesion (Abdominal soft tissue necrosis)

CL Item

Abducens Nerve Disorder (Abducens nerve disorder)

CL Item

Accessory Nerve Disorder (Accessory nerve disorder)

CL Item

Acidosis (Acidosis)

C28228 (NCI Thesaurus)
C0220981 (UMLS 2011AA)

CL Item

Vestibulocochlear Nerve Disorder (Acoustic nerve disorder NOS)

CL Item

Prolonged Partial Thromboplastin Time (Activated partial thromboplastin time prolonged)

CL Item

Acute Coronary Syndrome (Acute coronary syndrome)

CL Item

Acute Renal Failure (Acute kidney injury)

CL Item

Adrenal Gland Insufficiency (Adrenal insufficiency)

C26691 (NCI Thesaurus)
C0001623 (UMLS 2011AA)

CL Item

Adult Respiratory Distress Syndrome (Adult respiratory distress syndrome)

CL Item

Agitation (Agitation)

CL Item

Akathisia (Akathisia)

CL Item

Alanine Aminotransferase Increased (Alanine aminotransferase increased)

CL Item

Alcohol Intolerance (Alcohol intolerance)

C78167 (NCI Thesaurus)
C0151474 (UMLS 2011AA)

CL Item

Blood Alkaline Phosphatase Increased (Alkaline phosphatase increased)

C35607 (NCI Thesaurus)
C0852911 (UMLS 2011AA)

CL Item

Alkalosis (Alkalosis)

C37909 (NCI Thesaurus)
C0002063 (UMLS 2011AA)

CL Item

Hypersensitivity (Allergic reaction)

C3114 (NCI Thesaurus)
C0020517 (UMLS 2011AA)

CL Item

Allergic Rhinitis (Allergic rhinitis)

CL Item

Alopecia (Alopecia)

CL Item

Amnesia (Amnesia)

C2867 (NCI Thesaurus)
C0002622 (UMLS 2011AA)

CL Item

Anorectal Fistula (Anal fistula)

CL Item

Anal Hemorrhage (Anal hemorrhage)

CL Item

Anal Mucositis (Anal mucositis)

CL Item

Anal Necrotic Lesion (Anal necrosis)

C78171 (NCI Thesaurus)
C1697981 (UMLS 2011AA)

CL Item

Anal Pain (Anal pain)

CL Item

Anal Stenosis (Anal stenosis)

CL Item

Anal Ulcer (Anal ulcer)

CL Item

Anaphylactic Shock (Anaphylaxis)

CL Item

Anemia (Anemia)

CL Item

Ankle Fracture (Ankle fracture)

CL Item

Anorectal Infection (Anorectal infection)

CL Item

Anorexia (Anorexia)

C2875 (NCI Thesaurus)
C0003123 (UMLS 2011AA)

CL Item

Anorgasmia (Anorgasmia)

CL Item

Anxiety (Anxiety)

CL Item

Aortic Injury (Aortic injury)

CL Item

Aortic Valve Disorder (Aortic valve disease)

CL Item

Aphonia (Aphonia)

CL Item

Apnea (Apnea)

C26698 (NCI Thesaurus)
C0003578 (UMLS 2011AA)

CL Item

Acute Appendicitis (Appendicitis)

CL Item

Acute Perforated Appendicitis (Appendicitis perforated)

CL Item

Arachnoiditis (Arachnoiditis)

CL Item

Arterial Injury (Arterial injury)

CL Item

Arteritis (Arteritis infective)

C34399 (NCI Thesaurus)
C0003860 (UMLS 2011AA)

CL Item

Arthralgia (Arthralgia)

C50464 (NCI Thesaurus)
C0003862 (UMLS 2011AA)

CL Item

Arthritis (Arthritis)

CL Item

Ascites (Ascites)

C2885 (NCI Thesaurus)
C0003962 (UMLS 2011AA)

CL Item

Aspartate Aminotransferase Increased (Aspartate aminotransferase increased)

CL Item

Aspiration (Aspiration)

C15631 (NCI Thesaurus)
C0349707 (UMLS 2011AA)

CL Item

Cardiac Arrest (Asystole)

CL Item

Ataxia (Ataxia)

CL Item

Atelectasis (Atelectasis)

CL Item

Atrial Fibrillation (Atrial fibrillation)

CL Item

Atrial Flutter (Atrial flutter)

CL Item

Av Block Third Degree (Atrioventricular block complete)

C50501 (NCI Thesaurus)
C0151517 (UMLS 2011AA)

CL Item

Av Block First Degree (Atrioventricular block first degree)

C62015 (NCI Thesaurus)
C0085614 (UMLS 2011AA)

CL Item

Autoimmune Disease (Autoimmune disorder)

CL Item

Bone Necrosis (Avascular necrosis)

CL Item

Azoospermia (Azoospermia)

CL Item

Back Pain (Back pain)

CL Item

Bile Duct Stenosis (Bile duct stenosis)

CL Item

Biliary Anastomotic Leakage (Biliary anastomotic leak)

CL Item

Biliary Fistula (Biliary fistula)

CL Item

Cholangitis (Biliary tract infection)

CL Item

Bladder Anastomotic Leakage (Bladder anastomotic leak)

CL Item

Cystitis (Bladder infection)

C26738 (NCI Thesaurus)
C0010692 (UMLS 2011AA)

CL Item

Bladder Perforation (Bladder perforation)

CL Item

Bladder Spasm (Bladder spasm)

CL Item

Bloating (Bloating)

CL Item

Hematopoietic And Lymphoid System Disorder Other Specify (Blood and lymphatic system disorders - Other, specify)

CL Item

Abnormal Blood Antidiuretic Hormone (Blood antidiuretic hormone abnormal)

C78214 (NCI Thesaurus)
C0853592 (UMLS 2011AA)

CL Item

Elevated Bilirubin (Blood bilirubin increased)

C27088 (NCI Thesaurus)
C0311468 (UMLS 2011AA)

CL Item

Blood Corticotrophin Decreased (Blood corticotrophin decreased)

CL Item

Abnormal Blood Gonadotrophin (Blood gonadotrophin abnormal)

C78216 (NCI Thesaurus)
C0853603 (UMLS 2011AA)

CL Item

Abnormal Blood Prolactin (Blood prolactin abnormal)

C78217 (NCI Thesaurus)
C0853620 (UMLS 2011AA)

CL Item

Blurred Vision (Blurred vision)

CL Item

Body Odor (Body odor)

CL Item

Bone Infection (Bone infection)

CL Item

Hypocellular Bone Marrow (Bone marrow hypocellular)

C35167 (NCI Thesaurus)
C0151773 (UMLS 2011AA)

CL Item

Bone Pain (Bone pain)

CL Item

Brachial Plexopathy (Brachial plexopathy)

CL Item

Breast Atrophy (Breast atrophy)

CL Item

Mastitis (Breast infection)

C53662 (NCI Thesaurus)
C0024894 (UMLS 2011AA)

CL Item

Breast Pain (Breast pain)

CL Item

Bronchial Fistula (Bronchial fistula)

CL Item

Bronchitis (Bronchial infection)

C2911 (NCI Thesaurus)
C0006277 (UMLS 2011AA)

CL Item

Bronchial Obstruction (Bronchial obstruction)

CL Item

Bronchial Stricture (Bronchial stricture)

CL Item

Bronchopleural Fistula (Bronchopleural fistula)

CL Item

Bronchial Hemorrhage (Bronchopulmonary hemorrhage)

CL Item

Bronchospasm (Bronchospasm)

CL Item

Bruise (Bruising)

CL Item

Bullous Dermatitis (Bullous dermatitis)

CL Item

Burn (Burn)

C34441 (NCI Thesaurus)
C0006434 (UMLS 2011AA)

CL Item

Buttock Pain (Buttock pain)

CL Item

Capillary Leak Syndrome Capillary Leak Syndrome (Capillary leak syndrome)

CL Item

Decreased Carbon Monoxide Diffusing Capacity (Carbon monoxide diffusing capacity decreased)

C78229 (NCI Thesaurus)
C1697788 (UMLS 2011AA)

CL Item

Cardiac Arrest (Cardiac arrest)

CL Item

Heart Disorder Other Specify (Cardiac disorders - Other, specify)

CL Item

Blood Cardiac Troponin I Increased (Cardiac troponin I increased)

C78230 (NCI Thesaurus)
C0852692 (UMLS 2011AA)

CL Item

Blood Cardiac Troponin T Increased (Cardiac troponin T increased)

C78231 (NCI Thesaurus)
C0852680 (UMLS 2011AA)

CL Item

Cataract (Cataract)

CL Item

Catheter-related Infection (Catheter related infection)

CL Item

Cd4 Lymphocytes Decreased (CD4 lymphocytes decreased)

CL Item

Cecal Hemorrhage (Cecal hemorrhage)

CL Item

Cecal Infection (Cecal infection)

CL Item

Central Nervous System Necrotic Lesion (Central nervous system necrosis)

CL Item

Cerebrospinal Fluid Leakage (Cerebrospinal fluid leakage)

CL Item

Infectious Cervicitis (Cervicitis infection)

CL Item

Cheilitis (Cheilitis)

C79545 (NCI Thesaurus)
C0007971 (UMLS 2011AA)

CL Item

Angina (Chest pain - cardiac)

CL Item

Chest Wall Pain (Chest wall pain)

CL Item

Chills (Chills)

CL Item

Cholecystitis (Cholecystitis)

CL Item

Hypercholesterolemia (Cholesterol high)

CL Item

Chronic Kidney Disease (Chronic kidney disease)

CL Item

Chylothorax (Chylothorax)

CL Item

Cognitive Disturbance (Cognitive disturbance)

CL Item

Colitis (Colitis)

CL Item

Colonic Fistula (Colonic fistula)

CL Item

Colonic Hemorrhage (Colonic hemorrhage)

CL Item

Colonic Obstruction (Colonic obstruction)

CL Item

Colonic Perforation (Colonic perforation)

CL Item

Colonic Stenosis (Colonic stenosis)

CL Item

Colonic Ulcer (Colonic ulcer)

CL Item

Concentration Impairment (Concentration impairment)

CL Item

Heart Conduction Disorder (Conduction disorder)

CL Item

Confusion (Confusion)

CL Item

Congenital, Familial And Genetic Disorder Class Other Specify (Congenital, familial and genetic disorders - Other, specify)

CL Item

Conjunctivitis (Conjunctivitis)

CL Item

Acute Contagious Conjunctivitis (Conjunctivitis infective)

CL Item

Constipation (Constipation)

CL Item

Constrictive Pericarditis (Constrictive pericarditis)

CL Item

Keratitis (Corneal infection)

CL Item

Corneal Ulcer (Corneal ulcer)

CL Item

Cough (Cough)

CL Item

Creatine Phosphokinase Increased (CPK increased)

C78247 (NCI Thesaurus)
C0151576 (UMLS 2011AA)

CL Item

Cranial Nerve Infection (Cranial nerve infection)

CL Item

Increased Creatinine (Creatinine increased)

C78249 (NCI Thesaurus)
C0151578 (UMLS 2011AA)

CL Item

Cushingoid (Cushingoid)

CL Item

Non-infectious Cystitis (Cystitis noninfective)

C78250 (NCI Thesaurus)
C0403632 (UMLS 2011AA)

CL Item

Cytokine Release Syndrome (Cytokine release syndrome)

CL Item

Neonatal Death (Death neonatal)

CL Item

Death (Death NOS)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

CL Item

Dehydration (Dehydration)

CL Item

Delayed Orgasm (Delayed orgasm)

CL Item

Delayed Puberty (Delayed puberty)

CL Item

Delirium (Delirium)

CL Item

Delusion (Delusions)

CL Item

Caries (Dental caries)

CL Item

Depressed Level Of Consciousness (Depressed level of consciousness)

CL Item

Depression (Depression)

CL Item

Radiation-induced Dermatitis (Dermatitis radiation)

CL Item

Prosthesis-related Infection (Device related infection)

CL Item

Diarrhea (Diarrhea)

CL Item

Disseminated Intravascular Coagulation (Disseminated intravascular coagulation)

C2992 (NCI Thesaurus)
C0012739 (UMLS 2011AA)

CL Item

Dizziness (Dizziness)

CL Item

Dry Eye Syndrome (Dry eye)

C34553 (NCI Thesaurus)
C0013238 (UMLS 2011AA)

CL Item

Xerostomia (Dry mouth)

C26917 (NCI Thesaurus)
C0043352 (UMLS 2011AA)

CL Item

Dry Skin (Dry Skin)

CL Item

Duodenal Fistula (Duodenal fistula)

CL Item

Duodenal Hemorrhage (Duodenal hemorrhage)

CL Item

Duodenal Infection (Duodenal infection)

CL Item

Duodenal Obstruction (Duodenal obstruction)

CL Item

Duodenal Perforation (Duodenal perforation)

CL Item

Duodenal Stenosis (Duodenal stenosis)

CL Item

Duodenal Ulcer (Duodenal ulcer)

C26755 (NCI Thesaurus)
C0013295 (UMLS 2011AA)

CL Item

Dysarthria (Dysarthria)

CL Item

Dysesthesia (Dysesthesia)

C28246 (NCI Thesaurus)
C0392699 (UMLS 2011AA)

CL Item

Dysgeusia (Dysgeusia)

C28145 (NCI Thesaurus)
C0013378 (UMLS 2011AA)

CL Item

Dysmenorrhea (Dysmenorrhea)

C34559 (NCI Thesaurus)
C0013390 (UMLS 2011AA)

CL Item

Dyspareunia (Dyspareunia)

C2997 (NCI Thesaurus)
C1384606 (UMLS 2011AA)

CL Item

Dyspepsia (Dyspepsia)

C26756 (NCI Thesaurus)
C0013395 (UMLS 2011AA)

CL Item

Dysphagia (Dysphagia)

C2980 (NCI Thesaurus)
C0011168 (UMLS 2011AA)

CL Item

Dysphasia (Dysphasia)

C35546 (NCI Thesaurus)
C0973461 (UMLS 2011AA)

CL Item

Dyspnea (Dyspnea)

CL Item

Ear And Labyrinth Disorder Class Other Specify (Ear and labyrinth disorders - Other, specify)

CL Item

Earache (Ear pain)

CL Item

Cerebral Edema (Edema cerebral)

C4909 (NCI Thesaurus)
C0006114 (UMLS 2011AA)

CL Item

Face Edema (Edema face)

C78289 (NCI Thesaurus)
C0542571 (UMLS 2011AA)

CL Item

Edema Limbs (Edema limbs)

C78262 (NCI Thesaurus)
C0085649 (UMLS 2011AA)

CL Item

Edema Trunk (Edema trunk)

C78263 (NCI Thesaurus)
C0578541 (UMLS 2011AA)

CL Item

Ejaculation Disorder (Ejaculation disorder)

C78264 (NCI Thesaurus)
C0235969 (UMLS 2011AA)

CL Item

Ejection Fraction Decreased (Ejection fraction decreased)

C83492 (NCI Thesaurus)
C0743400 (UMLS 2011AA)

CL Item

Prolonged Qt Interval (Electrocardiogram QT corrected interval prolonged)

C71034 (NCI Thesaurus)
C0151878 (UMLS 2011AA)

CL Item

Infectious Encephalitis (Encephalitis infection)

C79550 (NCI Thesaurus)
C0596773 (UMLS 2011AA)

CL Item

Infectious Encephalomyelitis (Encephalomyelitis infection)

C79551 (NCI Thesaurus)
C0856705 (UMLS 2011AA)

CL Item

Encephalopathy (Encephalopathy)

CL Item

Infective Endocarditis (Endocarditis infective)

CL Item

Endocrine Disorder Other Specify (Endocrine disorders - Other, specify)

CL Item

Endophthalmitis (Endophthalmitis)

CL Item

Enterocolitis (Enterocolitis)

CL Item

Infectious Enterocolitis (Enterocolitis infectious)

CL Item

Enterovesical Fistula (Enterovesical fistula)

CL Item

Epistaxis (Epistaxis)

CL Item

Impotence (Erectile dysfunction)

CL Item

Erythema Multiforme (Erythema multiforme)

CL Item

Erythroderma (Erythroderma)

CL Item

Esophageal Anastomotic Leakage (Esophageal anastomotic leak)

CL Item

Esophageal Fistula (Esophageal fistula)

CL Item

Esophageal Hemorrhage (Esophageal hemorrhage)

CL Item

Esophageal Infection (Esophageal infection)

CL Item

Esophageal Necrotic Lesion (Esophageal necrosis)

CL Item

Esophageal Obstruction (Esophageal obstruction)

CL Item

Esophageal Pain (Esophageal pain)

CL Item

Perforation Of Esophagus (Esophageal perforation)

CL Item

Esophageal Stricture (Esophageal stenosis)

CL Item

Esophageal Ulcer (Esophageal ulcer)

CL Item

Esophageal Varices Hemorrhage (Esophageal varices hemorrhage)

CL Item

Esophagitis (Esophagitis)

CL Item

Euphoria (Euphoria)

C34598 (NCI Thesaurus)
C0235146 (UMLS 2011AA)

CL Item

Exostosis (Exostosis)

CL Item

External Ear Inflammation (External ear inflammation)

C79601 (NCI Thesaurus)
C0029878 (UMLS 2011AA)

CL Item

External Ear Pain (External ear pain)

CL Item

Extraocular Muscle Paresis (Extraocular muscle paresis)

C78286 (NCI Thesaurus)
C0262918 (UMLS 2011AA)

CL Item

Extrapyramidal Disorder (Extrapyramidal disorder)

C79593 (NCI Thesaurus)
C0015371 (UMLS 2011AA)

CL Item

Eye Disorder Other Specify (Eye disorders - Other, specify)

CL Item

Eye Infection (Eye infection)

C45372 (NCI Thesaurus)
C0015403 (UMLS 2011AA)

CL Item

Eye Pain (Eye pain)

C78287 (NCI Thesaurus)
C0151827 (UMLS 2011AA)

CL Item

Eyelid Function Disorder (Eyelid function disorder)

C78288 (NCI Thesaurus)
C0854286 (UMLS 2011AA)

CL Item

Facial Muscle Weakness (Facial muscle weakness)

C78290 (NCI Thesaurus)
C0427055 (UMLS 2011AA)

CL Item

Facial Nerve Disorder (Facial nerve disorder)

C27594 (NCI Thesaurus)
C0015464 (UMLS 2011AA)

CL Item

Facial Pain (Facial pain)

C79594 (NCI Thesaurus)
C0015468 (UMLS 2011AA)

CL Item

Fall (Fall)

C50558 (NCI Thesaurus)
C0085639 (UMLS 2011AA)

CL Item

Fallopian Tube Anastomotic Leakage (Fallopian tube anastomotic leak)

C78292 (NCI Thesaurus)
C1698039 (UMLS 2011AA)

CL Item

Fallopian Tube Obstruction (Fallopian tube obstruction)

C78293 (NCI Thesaurus)
C0041274 (UMLS 2011AA)

CL Item

Fallopian Tube Perforation (Fallopian tube perforation)

C78294 (NCI Thesaurus)
C1557983 (UMLS 2011AA)

CL Item

Fallopian Tube Stenosis (Fallopian tube stenosis)

C78295 (NCI Thesaurus)
C0459524 (UMLS 2011AA)

CL Item

Adipose Tissue Atrophy (Fat atrophy)

C78297 (NCI Thesaurus)
C0333650 (UMLS 2011AA)

CL Item

Fatigue (Fatigue)

CL Item

Neutropenic Fever (Febrile neutropenia)

CL Item

Fecal Incontinence (Fecal incontinence)

CL Item

Female Genital Tract Fistula (Female genital tract fistula)

C78298 (NCI Thesaurus)
C0269131 (UMLS 2011AA)

CL Item

Acquired Feminization (Feminization acquired)

C78299 (NCI Thesaurus)
C0877195 (UMLS 2011AA)

CL Item

Intrauterine Fetal Death (Fetal death)

C50620 (NCI Thesaurus)
C0015927 (UMLS 2011AA)

CL Item

Fetal Growth Retardation (Fetal growth retardation)

CL Item

Fever (Fever)

CL Item

Fibrinogen Decreased (Fibrinogen decreased)

CL Item

Deep Connective Tissue Fibrosis (Fibrosis deep connective tissue)

CL Item

Flank Pain (Flank pain)

CL Item

Flasher (Flashing lights)

CL Item

Flatulence (Flatulence)

CL Item

Floaters (Floaters)

CL Item

Flu-like Symptoms (Flu like symptoms)

CL Item

Flushing (Flushing)

CL Item

Decreased Forced Expiratory Volume (Forced expiratory volume decreased)

CL Item

Fracture (Fracture)

CL Item

Gait Disturbance (Gait disturbance)

CL Item

Gallbladder Fistula (Gallbladder fistula)

CL Item

Gallbladder Infection (Gallbladder infection)

CL Item

Gallbladder Necrotic Lesion (Gallbladder necrosis)

CL Item

Gallbladder Obstruction (Gallbladder obstruction)

CL Item

Gallbladder Pain (Gallbladder pain)

CL Item

Gallbladder Perforation (Gallbladder perforation)

CL Item

Gastric Anastomotic Leakage (Gastric anastomotic leak)

CL Item

Gastric Fistula (Gastric fistula)

CL Item

Gastric Hemorrhage (Gastric hemorrhage)

CL Item

Gastric Necrotic Lesion (Gastric necrosis)

CL Item

Gastric Perforation (Gastric perforation)

CL Item

Gastric Stenosis (Gastric stenosis)

CL Item

Gastric Ulcer (Gastric ulcer)

CL Item

Gastritis (Gastritis)

CL Item

Gastroesophageal Reflux Disease (Gastroesophageal reflux disease)

CL Item

Gastrointestinal System Anastomotic Leakage (Gastrointestinal anastomotic leak)

CL Item

Gastrointestinal Disorder Other Specify (Gastrointestinal disorders - Other, specify)

CL Item

Gastrointestinal Fistula (Gastrointestinal fistula)

CL Item

Gastrointestinal Pain (Gastrointestinal pain)

CL Item

Gastrointestinal Stoma Necrotic Lesion (Gastrointestinal stoma necrosis)

CL Item

Gastroparesis (Gastroparesis)

CL Item

General Disorders And Administration Site Conditions Class Other Specify (General disorders and administration site conditions - Other, specify)

CL Item

Generalized Muscle Weakness (Generalized muscle weakness)

CL Item

Genital Edema (Genital edema)

CL Item

Gamma-glutamyltransferase Increased (GGT increased)

CL Item

Gingival Pain (Gingival pain)

CL Item

Glaucoma (Glaucoma)

CL Item

Glossopharyngeal Nerve Disorder (Glossopharyngeal nerve disorder)

CL Item

Glucose Intolerance (Glucose intolerance)

C34646 (NCI Thesaurus)
C0271650 (UMLS 2011AA)

CL Item

Accelerated Growth (Growth accelerated)

CL Item

Abnormal Growth Hormone (Growth hormone abnormal)

CL Item

Growth Retardation (Growth suppression)

CL Item

Gum Infection (Gum infection)

CL Item

Gynecomastia (Gynecomastia)

CL Item

Hallucination (Hallucinations)

CL Item

Haptoglobin Decreased (Haptoglobin decreased)

CL Item

Head Soft Tissue Necrotic Lesion (Head soft tissue necrosis)

CL Item

Headache (Headache)

CL Item

Hearing Impairment (Hearing impaired)

CL Item

Heart Failure (Heart failure)

CL Item

Hematoma (Hematoma)

C50579 (NCI Thesaurus)
C0018944 (UMLS 2011AA)

CL Item

Hematosalpinx (Hematosalpinx)

CL Item

Hematuria (Hematuria)

CL Item

Hemoglobin Increased (Hemoglobin increased)

CL Item

Hemoglobinuria (Hemoglobinuria)

CL Item

Hemolysis (Hemolysis)

CL Item

Hemolytic Uremic Syndrome (Hemolytic uremic syndrome)

CL Item

Hemorrhoidal Hemorrhage (Hemorrhoidal hemorrhage)

CL Item

Hemorrhoid (Hemorrhoids)

CL Item

Hepatic Failure (Hepatic failure)

CL Item

Hepatic Hemorrhage (Hepatic hemorrhage)

CL Item

Hepatic Infection (Hepatic infection)

CL Item

Hepatic Necrotic Lesion (Hepatic necrosis)

CL Item

Hepatic Pain (Hepatic pain)

CL Item

Viral Hepatitis (Hepatitis viral)

CL Item

Liver And Biliary Tract Disorder Other Specify (Hepatobiliary disorders - Other, specify)

CL Item

Hiccough (Hiccups)

CL Item

Hip Fracture (Hip fracture)

CL Item

Hirsutism (Hirsutism)

CL Item

Hoarseness (Hoarseness)

CL Item

Hot Flashes (Hot flashes)

CL Item

Hydrocephalus (Hydrocephalus)

CL Item

Hypercalcemia (Hypercalcemia)

CL Item

Hyperglycemia (Hyperglycemia)

CL Item

Hyperhidrosis (Hyperhidrosis)

C78345 (NCI Thesaurus)
C0020458 (UMLS 2011AA)

CL Item

Hyperkalemia (Hyperkalemia)

C37968 (NCI Thesaurus)
C0020461 (UMLS 2011AA)

CL Item

Hypermagnesemia (Hypermagnesemia)

C37969 (NCI Thesaurus)
C1522135 (UMLS 2011AA)

CL Item

Hypernatremia (Hypernatremia)

C37970 (NCI Thesaurus)
C1522136 (UMLS 2011AA)

CL Item

Hyperparathyroidism (Hyperparathyroidism)

CL Item

Hypersomnia (Hypersomnia)

C78346 (NCI Thesaurus)
C0917799 (UMLS 2011AA)

CL Item

Hypertension (Hypertension)

CL Item

Hyperthyroidism (Hyperthyroidism)

CL Item

Hypertrichosis (Hypertrichosis)

C79597 (NCI Thesaurus)
C0020555 (UMLS 2011AA)

CL Item

Hypertriglyceridemia (Hypertriglyceridemia)

C37971 (NCI Thesaurus)
C1522137 (UMLS 2011AA)

CL Item

Hyperuricemia (Hyperuricemia)

C3961 (NCI Thesaurus)
C0740394 (UMLS 2011AA)

CL Item

Hypoalbuminemia (Hypoalbuminemia)

C37972 (NCI Thesaurus)
C0239981 (UMLS 2011AA)

CL Item

Hypocalcemia (Hypocalcemia)

C37973 (NCI Thesaurus)
C0020598 (UMLS 2011AA)

CL Item

Hypoglossal Nerve Disorder (Hypoglossal nerve disorder)

C26954 (NCI Thesaurus)
C0152181 (UMLS 2011AA)

CL Item

Hypoglycemia (Hypoglycemia)

CL Item

Hypohidrosis (Hypohidrosis)

C34718 (NCI Thesaurus)
C0020620 (UMLS 2011AA)

CL Item

Hypokalemia (Hypokalemia)

C37974 (NCI Thesaurus)
C0020621 (UMLS 2011AA)

CL Item

Hypomagnesemia (Hypomagnesemia)

C37975 (NCI Thesaurus)
C0151723 (UMLS 2011AA)

CL Item

Hyponatremia (Hyponatremia)

C37976 (NCI Thesaurus)
C0020625 (UMLS 2011AA)

CL Item

Hypoparathyroidism (Hypoparathyroidism)

C78350 (NCI Thesaurus)
C0020626 (UMLS 2011AA)

CL Item

Hypophosphatemia (Hypophosphatemia)

C37977 (NCI Thesaurus)
C0085682 (UMLS 2011AA)

CL Item

Hypotension (Hypotension)

CL Item

Hypothermia (Hypothermia)

C78351 (NCI Thesaurus)
C2364050 (UMLS 2011AA)

CL Item

Hypothyroidism (Hypothyroidism)

C26800 (NCI Thesaurus)
C0020676 (UMLS 2011AA)

CL Item

Hypoxia (Hypoxia)

CL Item

Ileal Fistula (Ileal fistula)

CL Item

Ileal Hemorrhage (Ileal hemorrhage)

CL Item

Ileal Obstruction (Ileal obstruction)

CL Item

Ileal Perforation (Ileal perforation)

CL Item

Ileal Stenosis (Ileal stenosis)

CL Item

Ileal Ulcer (Ileal ulcer)

CL Item

Ileus (Ileus)

CL Item

Immune System Disorder Other Specify (Immune system disorders - Other, specify)

CL Item

Infection Other Specify (Infections and infestations - Other, specify)

CL Item

Infectious Myositis (Infective myositis)

CL Item

Infusion-related Reaction (Infusion related reaction)

CL Item

Infusion Site Extravasation (Infusion site extravasation)

CL Item

Injection Site Reaction (Injection site reaction)

CL Item

Injury To Carotid Artery (Injury to carotid artery)

CL Item

Injury To Inferior Vena Cava (Injury to inferior vena cava)

CL Item

Injury To Jugular Vein (Injury to jugular vein)

CL Item

Injury To Superior Vena Cava (Injury to superior vena cava)

CL Item

Injury, Poisoning And Procedural Complication Class Other Specify (Injury, poisoning and procedural complications - Other, specify)

CL Item

Inr Increased (INR increased)

CL Item

Insomnia (Insomnia)

CL Item

Intestinal Stoma Leakage (Intestinal stoma leak)

CL Item

Intestinal Stoma Obstruction (Intestinal stoma obstruction)

CL Item

Intestinal Stoma Site Hemorrhage (Intestinal stoma site bleeding)

CL Item

Intra-abdominal Hemorrhage (Intra-abdominal hemorrhage)

CL Item

Intracranial Hemorrhage (Intracranial hemorrhage)

CL Item

Intraoperative Arterial Injury (Intraoperative arterial injury)

CL Item

Intraoperative Breast Injury (Intraoperative breast injury)

CL Item

Intraoperative Cardiac Injury (Intraoperative cardiac injury)

CL Item

Intraoperative Ear Injury (Intraoperative ear injury)

CL Item

Intraoperative Endocrine Injury (Intraoperative endocrine injury)

CL Item

Intraoperative Gastrointestinal Injury (Intraoperative gastrointestinal injury)

CL Item

Intraoperative Head And Neck Injury (Intraoperative head and neck injury)

CL Item

Intraoperative Hemorrhage (Intraoperative hemorrhage)

CL Item

Intraoperative Hepatobiliary Injury (Intraoperative hepatobiliary injury)

CL Item

Intraoperative Musculoskeletal Injury (Intraoperative musculoskeletal injury)

CL Item

Intraoperative Neurological Injury (Intraoperative neurological injury)

CL Item

Intraoperative Ocular Injury (Intraoperative ocular injury)

CL Item

Intraoperative Renal Injury (Intraoperative renal injury)

CL Item

Intraoperative Reproductive System Injury (Intraoperative reproductive tract injury)

CL Item

Intraoperative Respiratory Injury (Intraoperative respiratory injury)

CL Item

Intraoperative Skin Injury (Intraoperative skin injury)

CL Item

Intraoperative Splenic Injury (Intraoperative splenic injury)

CL Item

Intraoperative Urinary System Injury (Intraoperative urinary injury)

CL Item

Intraoperative Venous Injury (Intraoperative venous injury)

CL Item

Investigation Other Specify (Investigations - Other, specify)

CL Item

Iron Overload (Iron overload)

CL Item

Irregular Menstruation (Irregular menstruation)

CL Item

Irritability (Irritability)

CL Item

Cerebrovascular Ischemia (Ischemia cerebrovascular)

CL Item

Trochlear Nerve Disorder (IVth nerve disorder)

CL Item

Jejunal Fistula (Jejunal fistula)

CL Item

Jejunal Hemorrhage (Jejunal hemorrhage)

CL Item

Jejunal Obstruction (Jejunal obstruction)

CL Item

Jejunal Perforation (Jejunal perforation)

CL Item

Jejunal Stenosis (Jejunal stenosis)

CL Item

Jejunal Ulcer (Jejunal ulcer)

CL Item

Joint Effusion (Joint effusion)

CL Item

Joint Infection (Joint infection)

CL Item

Joint Range Of Motion Decreased (Joint range of motion decreased)

CL Item

Cervical Spine Joint Range Of Motion Decreased (Joint range of motion decreased cervical spine)

CL Item

Lumbar Spine Joint Range Of Motion Decreased (Joint range of motion decreased lumbar spine)

CL Item

Keratitis (Keratitis)

CL Item

Kidney Anastomotic Leakage (Kidney anastomotic leak)

CL Item

Pyelonephritis (Kidney infection)

CL Item

Kyphosis (Kyphosis)

CL Item

Lactation Disorder (Lactation disorder)

CL Item

Large Intestinal Anastomotic Leakage (Large intestinal anastomotic leak)

CL Item

Laryngeal Edema (Laryngeal edema)

CL Item

Laryngeal Fistula (Laryngeal fistula)

CL Item

Laryngeal Hemorrhage (Laryngeal hemorrhage)

CL Item

Laryngitis (Laryngeal inflammation)

CL Item

Laryngeal Mucositis (Laryngeal mucositis)

CL Item

Laryngeal Obstruction (Laryngeal obstruction)

CL Item

Laryngeal Stenosis (Laryngeal stenosis)

CL Item

Laryngitis (Laryngitis)

CL Item

Laryngopharyngeal Dysesthesia (Laryngopharyngeal dysesthesia)

CL Item

Laryngospasm (Laryngospasm)

CL Item

Left Ventricular Systolic Dysfunction (Left ventricular systolic dysfunction)

CL Item

Lethargy (Lethargy)

CL Item

Chemotherapy-related Leukemia (Leukemia secondary to oncology chemotherapy)

CL Item

Leukocytosis (Leukocytosis)

CL Item

Leukoencephalopathy (Leukoencephalopathy)

CL Item

Decreased Libido (Libido decreased)

CL Item

Increased Libido (Libido increased)

CL Item

Lip Infection (Lip infection)

CL Item

Lip Pain (Lip pain)

CL Item

Lipase Increased (Lipase increased)

CL Item

Lipohypertrophy (Lipohypertrophy)

CL Item

Localized Edema (Localized edema)

CL Item

Lordosis (Lordosis)

CL Item

Lower Gastrointestinal Hemorrhage (Lower gastrointestinal hemorrhage)

CL Item

Infectious Lung Disorder (Lung infection)

CL Item

Lymphadenitis (Lymph gland infection)

CL Item

Lymph Leakage (Lymph leakage)

CL Item

Lymph Node Pain (Lymph node pain)

CL Item

Lymphedema (Lymphedema)

CL Item

Lymphocele (Lymphocele)

CL Item

Lymphopenia (Lymphocyte count decreased)

CL Item

Lymphocytosis (Lymphocyte count increased)

CL Item

Malabsorption Syndrome (Malabsorption)

CL Item

Malaise (Malaise)

CL Item

Mania (Mania)

CL Item

Mediastinal Hemorrhage (Mediastinal hemorrhage)

CL Item

Mediastinitis (Mediastinal infection)

CL Item

Memory Impairment (Memory impairment)

C78444 (NCI Thesaurus)
C0233794 (UMLS 2011AA)

CL Item

Meningismus (Meningismus)

CL Item

Meningitis (Meningitis)

CL Item

Menopause (Menopause)

CL Item

Menorrhagia (Menorrhagia)

CL Item

Metabolism And Nutrition Disorder Class Other Specify (Metabolism and nutrition disorders - Other, specify)

CL Item

Otitis Media (Middle ear inflammation)

CL Item

Mitral Valve Disorder (Mitral valve disease)

CL Item

Av Block Second Degree Mobitz Type Ii (Mobitz (type) II atrioventricular block)

CL Item

Av Block Second Degree Mobitz Type I (Mobitz type I)

CL Item

Involuntary Movements (Movements involuntary)

CL Item

Mucosal Infection (Mucosal infection)

CL Item

Stomatitis (Mucositis oral)

CL Item

Multiple Organ Failure (Multi-organ failure)

CL Item

Muscle Weakness Left-sided (Muscle weakness left-sided)

CL Item

Muscle Weakness Lower Limb (Muscle weakness lower limb)

CL Item

Muscle Weakness Right-sided (Muscle weakness right-sided)

CL Item

Muscle Weakness Trunk (Muscle weakness trunk)

CL Item

Muscle Weakness Upper Limb (Muscle weakness upper limb)

CL Item

Connective And Soft Tissue Disorder Other Specify (Musculoskeletal and connective tissue disorder - Other, specify)

CL Item

Musculoskeletal Deformity (Musculoskeletal deformity)

CL Item

Myalgia (Myalgia)

C27009 (NCI Thesaurus)
C0231528 (UMLS 2011AA)

CL Item

Myelitis (Myelitis)

CL Item

Mds (Myelodysplastic syndrome)

CL Item

Myocardial Infarction (Myocardial infarction)

C27996 (NCI Thesaurus)
C0027051 (UMLS 2011AA)

CL Item

Myocarditis (Myocarditis)

C34831 (NCI Thesaurus)
C0027059 (UMLS 2011AA)

CL Item

Myositis (Myositis)

CL Item

Nail Discoloration (Nail discoloration)

CL Item

Nail Infection (Nail infection)

CL Item

Nail Loss (Nail loss)

CL Item

Nail Ridging (Nail ridging)

CL Item

Nasal Congestion (Nasal congestion)

CL Item

Nausea (Nausea)

CL Item

Neck Edema (Neck edema)

CL Item

Neck Pain (Neck pain)

CL Item

Neck Soft Tissue Necrotic Lesion (Neck soft tissue necrosis)

CL Item

Neoplasm Other Specify (Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify)

CL Item

Nervous System Disorder Other Specify (Nervous system disorders - Other, specify)

CL Item

Neuralgia (Neuralgia)

CL Item

Neutrophil Count Decreased (Neutrophil count decreased)

CL Item

Night Blindness (Night blindness)

CL Item

Nipple Deformity (Nipple deformity)

CL Item

Non-cardiac Chest Pain (Non-cardiac chest pain)

CL Item

Nystagmus (Nystagmus)

C3282 (NCI Thesaurus)
C0028738 (UMLS 2011AA)

CL Item

Obesity (Obesity)

CL Item

Gastric Obstruction (Obstruction gastric)

CL Item

Oculomotor Nerve Disorder (Oculomotor nerve disorder)

CL Item

Olfactory Nerve Disorder (Olfactory nerve disorder)

CL Item

Oligospermia (Oligospermia)

CL Item

Optic Nerve Disorder (Optic nerve disorder)

CL Item

Oral Cavity Fistula (Oral cavity fistula)

CL Item

Burning Mouth Syndrome (Oral dysesthesia)

CL Item

Oral Hemorrhage (Oral hemorrhage)

CL Item

Oral Pain (Oral pain)

CL Item

Osteonecrosis Of Jaw (Osteonecrosis of jaw)

CL Item

Osteoporosis (Osteoporosis)

CL Item

External Ear Infection (Otitis externa)

C3299 (NCI Thesaurus)
C0021355 (UMLS 2011AA)

CL Item

Otitis Media (Otitis media)

CL Item

Ovarian Hemorrhage (Ovarian hemorrhage)

CL Item

Ovarian Infection (Ovarian infection)

CL Item

Ovarian Rupture (Ovarian rupture)

CL Item

Ovulatory Pain (Ovulation pain)

CL Item

Pain (Pain)

C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)

CL Item

Pain In Extremity (Pain in extremity)

CL Item

Skin Pain (Pain of skin)

CL Item

Palmar-plantar Erythodysthesia (Palmar-plantar erythrodysesthesia syndrome)

CL Item

Palpitation (Palpitations)

CL Item

Pancreatic Infection (Pancreas infection)

CL Item

Pancreatic Anastomotic Leakage (Pancreatic anastomotic leak)

CL Item

Pancreatic Duct Stenosis (Pancreatic duct stenosis)

CL Item

Pancreatic Enzymes Decreased (Pancreatic enzymes decreased)

CL Item

Pancreatic Fistula (Pancreatic fistula)

CL Item

Pancreatic Hemorrhage (Pancreatic hemorrhage)

CL Item

Pancreatic Necrotic Lesion (Pancreatic necrosis)

CL Item

Pancreatitis (Pancreatitis)

C3306 (NCI Thesaurus)
C0030305 (UMLS 2011AA)

CL Item

Papilledema (Papilledema)

C3307 (NCI Thesaurus)
C0030353 (UMLS 2011AA)

CL Item

Papulopustular Rash (Papulopustular rash)

CL Item

Paresthesia (Paresthesia)

CL Item

Paronychia (Paronychia)

CL Item

Paroxysmal Atrial Tachycardia (Paroxysmal atrial tachycardia)

CL Item

Pelvic Floor Muscle Weakness (Pelvic floor muscle weakness)

CL Item

Pelvic Inflammatory Disease (Pelvic infection)

CL Item

Pelvic Pain (Pelvic pain)

CL Item

Pelvic Soft Tissue Necrotic Lesion (Pelvic soft tissue necrosis)

CL Item

Penile Infection (Penile infection)

CL Item

Penile Pain (Penile pain)

CL Item

Bile Duct Perforation (Perforation bile duct)

CL Item

Pericardial Effusion (Pericardial effusion)

CL Item

Cardiac Tamponade (Pericardial tamponade)

CL Item

Pericarditis (Pericarditis)

CL Item

Perineal Pain (Perineal pain)

CL Item

Periodontal Disorder (Periodontal disease)

CL Item

Periorbital Edema (Periorbital edema)

CL Item

Periorbital Infection (Periorbital infection)

C78531 (NCI Thesaurus)
C0948065 (UMLS 2011AA)

CL Item

Peripheral Ischemia (Peripheral ischemia)

C78535 (NCI Thesaurus)
C0235490 (UMLS 2011AA)

CL Item

Peripheral Motor Neuropathy (Peripheral motor neuropathy)

C3500 (NCI Thesaurus)
C0018995 (UMLS 2011AA)

CL Item

Peripheral Nervous System Infectious Disorder (Peripheral nerve infection)

C27589 (NCI Thesaurus)
C1278821 (UMLS 2011AA)

CL Item

Peripheral Sensory Neuropathy (Peripheral sensory neuropathy)

C3501 (NCI Thesaurus)
C0151313 (UMLS 2011AA)

CL Item

Peritoneal Infection (Peritoneal infection)

C78540 (NCI Thesaurus)
C0851980 (UMLS 2011AA)

CL Item

Peritoneal Necrotic Lesion (Peritoneal necrosis)

C78543 (NCI Thesaurus)
C1696082 (UMLS 2011AA)

CL Item

Personality Change (Personality change)

C78548 (NCI Thesaurus)
C0240735 (UMLS 2011AA)

CL Item

Phantom Pain (Phantom pain)

C79703 (NCI Thesaurus)
C0031315 (UMLS 2011AA)

CL Item

Pharyngeal Anastomotic Leakage (Pharyngeal anastomotic leak)

C78550 (NCI Thesaurus)
C1696702 (UMLS 2011AA)

CL Item

Pharyngeal Fistula (Pharyngeal fistula)

C78551 (NCI Thesaurus)
C1536454 (UMLS 2011AA)

CL Item

Pharyngeal Hemorrhage (Pharyngeal hemorrhage)

C26986 (NCI Thesaurus)
C0576995 (UMLS 2011AA)

CL Item

Pharyngeal Mucositis (Pharyngeal mucositis)

C78553 (NCI Thesaurus)
C1699324 (UMLS 2011AA)

CL Item

Pharyngeal Necrotic Lesion (Pharyngeal necrosis)

C78554 (NCI Thesaurus)
C1696156 (UMLS 2011AA)

CL Item

Pharyngeal Stenosis (Pharyngeal stenosis)

C78555 (NCI Thesaurus)
C0396006 (UMLS 2011AA)

CL Item

Pharyngitis (Pharyngitis)

C26851 (NCI Thesaurus)
C0031350 (UMLS 2011AA)

CL Item

Pharyngolaryngeal Pain (Pharyngolaryngeal pain)

C78556 (NCI Thesaurus)
C0858635 (UMLS 2011AA)

CL Item

Phlebitis (Phlebitis)

C38003 (NCI Thesaurus)
C0031542 (UMLS 2011AA)

CL Item

Infective Phlebitis (Phlebitis infective)

C78558 (NCI Thesaurus)
C1112243 (UMLS 2011AA)

CL Item

Photophobia (Photophobia)

CL Item

Photosensitivity (Photosensitivity)

C38004 (NCI Thesaurus)
C0349506 (UMLS 2011AA)

CL Item

Thrombocytopenia (Platelet count decreased)

C3408 (NCI Thesaurus)
C0040034 (UMLS 2011AA)

CL Item

Pleural Effusion (Pleural effusion)

C3331 (NCI Thesaurus)
C0021071 (UMLS 2011AA)

CL Item

Hemothorax (Pleural hemorrhage)

C50582 (NCI Thesaurus)
C0019123 (UMLS 2011AA)

CL Item

Pleural Infection (Pleural infection)

CL Item

Pleuritic Pain (Pleuritic pain)

C78564 (NCI Thesaurus)
C0008033 (UMLS 2011AA)

CL Item

Pneumonia (Pneumonitis)

CL Item

Pneumothorax (Pneumothorax)

C38006 (NCI Thesaurus)
C0032326 (UMLS 2011AA)

CL Item

Portal Hypertension (Portal Hypertension)

CL Item

Portal Vein Thrombosis (Portal vein thrombosis)

C78565 (NCI Thesaurus)
C0155773 (UMLS 2011AA)

CL Item

Post-nasal Drip (Postnasal drip)

C78566 (NCI Thesaurus)
C0032781 (UMLS 2011AA)

CL Item

Postoperative Bleeding (Postoperative hemorrhage)

C34938 (NCI Thesaurus)
C0032788 (UMLS 2011AA)

CL Item

Thoracic Procedure Postoperative Complication (Postoperative thoracic procedure complication)

CL Item

Precocious Puberty (Precocious puberty)

CL Item

Pregnancy, Puerperium And Perinatal Condition Class Other Specify (Pregnancy, puerperium and perinatal conditions - Other, specify)

CL Item

Premature Labor (Premature delivery)

CL Item

Premature Menopause (Premature menopause)

CL Item

Presyncope (Presyncope)

CL Item

Proctitis (Proctitis)

CL Item

Productive Cough (Productive cough)

CL Item

Intestinal Stoma Prolapse (Prolapse of intestinal stoma)

CL Item

Urostomy Prolapse (Prolapse of urostomy)

CL Item

Prostatic Infection (Prostate infection)

CL Item

Prostatic Hemorrhage (Prostatic hemorrhage)

CL Item

Prostatic Obstruction (Prostatic obstruction)

CL Item

Prostatic Pain (Prostatic pain)

CL Item

Proteinuria (Proteinuria)

CL Item

Pruritus (Pruritus)

CL Item

Psychiatric Disorder Other Specify (Psychiatric disorders - Other, specify)

CL Item

Psychosis (Psychosis)

CL Item

Pulmonary Edema (Pulmonary edema)

CL Item

Pulmonary Fibrosis (Pulmonary fibrosis)

CL Item

Pulmonary Fistula (Pulmonary fistula)

CL Item

Pulmonary Hypertension (Pulmonary hypertension)

CL Item

Pulmonary Valve Disorder (Pulmonary valve disease)

CL Item

Purpura (Purpura)

CL Item

Pyramidal Tract Dysfunction (Pyramidal tract syndrome)

CL Item

Radiation-recall Dermatitis (Radiation recall reaction (dermatologic))

CL Item

Radiculitis (Radiculitis)

CL Item

Acneiform Dermatitis (Rash acneiform)

CL Item

Maculopapular Lesion (Rash maculo-papular)

CL Item

Papulopustular Rash (Rash pustular)

CL Item

Rectal Anastomotic Leakage (Rectal anastomotic leak)

CL Item

Rectal Fistula (Rectal fistula)

CL Item

Rectal Hemorrhage (Rectal hemorrhage)

CL Item

Rectal Mucositis (Rectal mucositis)

CL Item

Rectal Necrotic Lesion (Rectal necrosis)

CL Item

Rectal Obstruction (Rectal obstruction)

CL Item

Rectal Pain (Rectal pain)

CL Item

Rectal Perforation (Rectal perforation)

CL Item

Rectal Stenosis (Rectal stenosis)

CL Item

Rectal Ulcer (Rectal ulcer)

CL Item

Recurrent Laryngeal Nerve Paralysis (Recurrent laryngeal nerve palsy)

CL Item

Urinary Tract Disorder Other Specify (Renal and urinary disorders - Other, specify)

CL Item

Renal Stone (Renal calculi)

CL Item

Renal Colic (Renal colic)

CL Item

Renal Hemorrhage (Renal hemorrhage)

CL Item

Reproductive System And Breast Disorder Class Other Specify (Reproductive system and breast disorders - Other, specify)

CL Item

Respiratory Failure (Respiratory failure)

CL Item

Respiratory And Thoracic Disorder Other Specify (Respiratory, thoracic and mediastinal disorders - Other, specify)

CL Item

Restlessness (Restlessness)

CL Item

Restrictive Cardiomyopathy (Restrictive cardiomyopathy)

CL Item

Retinal Detachment (Retinal detachment)

CL Item

Retinal Tear (Retinal tear)

CL Item

Retinal Vascular Disorder (Retinal vascular disorder)

CL Item

Retinoic Acid Syndrome (Retinoic acid syndrome)

CL Item

Retinopathy (Retinopathy)

CL Item

Retroperitoneal Hemorrhage (Retroperitoneal hemorrhage)

CL Item

Reversible Posterior Leukoencephalopathy Syndrome (Reversible posterior leukoencephalopathy syndrome)

CL Item

Infectious Rhinitis (Rhinitis infective)

CL Item

Right Ventricular Dysfunction (Right ventricular dysfunction)

CL Item

Salivary Duct Inflammation (Salivary duct inflammation)

CL Item

Salivary Gland Fistula (Salivary gland fistula)

CL Item

Salivary Gland Infection (Salivary gland infection)

CL Item

Scalp Pain (Scalp pain)

CL Item

Sclera Disorder (Scleral disorder)

CL Item

Scoliosis (Scoliosis)

C78603 (NCI Thesaurus)
C0036439 (UMLS 2011AA)

CL Item

Scrotal Infection (Scrotal infection)

C78606 (NCI Thesaurus)
C1299539 (UMLS 2011AA)

CL Item

Scrotal Pain (Scrotal pain)

C78607 (NCI Thesaurus)
C0236078 (UMLS 2011AA)

CL Item

Seizure (Seizure)

CL Item

Septicemia (Sepsis)

CL Item

Seroma (Seroma)

C50739 (NCI Thesaurus)
C0262627 (UMLS 2011AA)

CL Item

Serum Amylase Increased (Serum amylase increased)

C78608 (NCI Thesaurus)
C0476327 (UMLS 2011AA)

CL Item

Serum Sickness (Serum sickness)

C79718 (NCI Thesaurus)
C0036830 (UMLS 2011AA)

CL Item

Sick Sinus Syndrome (Sick sinus syndrome)

C62244 (NCI Thesaurus)
C0037052 (UMLS 2011AA)

CL Item

Sinus Bradycardia (Sinus bradycardia)

CL Item

Paranasal Sinus Disorder (Sinus disorder)

C26843 (NCI Thesaurus)
C0030469 (UMLS 2011AA)

CL Item

Sinus Pain (Sinus pain)

C78609 (NCI Thesaurus)
C0522251 (UMLS 2011AA)

CL Item

Sinus Tachycardia (Sinus tachycardia)

CL Item

Sinusitis (Sinusitis)

CL Item

Skin Disorder Other Specify (Skin and subcutaneous tissue disorders - Other, specify)

CL Item

Skin Atrophy (Skin atrophy)

CL Item

Skin Hyperpigmentation (Skin hyperpigmentation)

C79731 (NCI Thesaurus)
C0162834 (UMLS 2011AA)

CL Item

Skin Hypopigmentation (Skin hypopigmentation)

C78610 (NCI Thesaurus)
C0162835 (UMLS 2011AA)

CL Item

Skin Induration (Skin induration)

C78611 (NCI Thesaurus)
C0241075 (UMLS 2011AA)

CL Item

Skin Infection (Skin infection)

C35025 (NCI Thesaurus)
C0037278 (UMLS 2011AA)

CL Item

Skin Ulcer (Skin ulceration)

C54247 (NCI Thesaurus)
C0037299 (UMLS 2011AA)

CL Item

Sleep Apnea (Sleep apnea)

CL Item

Small Intestinal Anastomotic Leakage (Small intestinal anastomotic leak)

C78612 (NCI Thesaurus)
C1698195 (UMLS 2011AA)

CL Item

Small Intestinal Mucositis (Small intestinal mucositis)

C78613 (NCI Thesaurus)
C1698626 (UMLS 2011AA)

CL Item

Small Intestinal Obstruction (Small intestinal obstruction)

C78615 (NCI Thesaurus)
C0235329 (UMLS 2011AA)

CL Item

Small Intestinal Perforation (Small intestinal perforation)

C78616 (NCI Thesaurus)
C0151739 (UMLS 2011AA)

CL Item

Small Intestinal Stenosis (Small intestinal stenosis)

C78617 (NCI Thesaurus)
C0151924 (UMLS 2011AA)

CL Item

Small Intestinal Infection (Small intestine infection)

C78618 (NCI Thesaurus)
C1698036 (UMLS 2011AA)

CL Item

Small Intestinal Ulcer (Small intestine ulcer)

CL Item

Sneezing (Sneezing)

CL Item

Social Circumstances Other Specify (Social circumstances - Other, specify)

CL Item

Soft Tissue Infection (Soft tissue infection)

CL Item

Lower Limb Soft Tissue Necrotic Lesion (Soft tissue necrosis lower limb)

CL Item

Upper Limb Soft Tissue Necrotic Lesion (Soft tissue necrosis upper limb)

CL Item

Somnolence (Somnolence)

CL Item

Sore Throat (Sore throat)

CL Item

Spasticity (Spasticity)

CL Item

Spermatic Cord Anastomotic Leakage (Spermatic cord anastomotic leak)

C78622 (NCI Thesaurus)
C1699328 (UMLS 2011AA)

CL Item

Spermatic Cord Hemorrhage (Spermatic cord hemorrhage)

CL Item

Spermatic Cord Obstruction (Spermatic cord obstruction)

CL Item

Vertebral Fracture (Spinal fracture)

CL Item

Splenic Disorder (Spleen disorder)

CL Item

Splenic Infection (Splenic infection)

CL Item

Gastrointestinal Stoma Stenosis (Stenosis of gastrointestinal stoma)

C78628 (NCI Thesaurus)
C1699177 (UMLS 2011AA)

CL Item

Stevens-johnson Syndrome (Stevens-Johnson syndrome)

CL Item

Stoma Site Infection (Stoma site infection)

CL Item

Stomach Pain (Stomach pain)

CL Item

Stomal Ulcer (Stomal ulcer)

CL Item

Stridor (Stridor)

CL Item

Cerebrovascular Accident (Stroke)

CL Item

Sudden Cardiac Death (Sudden death NOS)

CL Item

Suicidal Ideation (Suicidal ideation)

CL Item

Suicide Attempt (Suicide attempt)

CL Item

Superficial Soft Tissue Fibrosis (Superficial soft tissue fibrosis)

CL Item

Superficial Thrombophlebitis (Superficial thrombophlebitis)

CL Item

Superior Vena Cava Syndrome (Superior vena cava syndrome)

CL Item

Supraventricular Tachycardia (Supraventricular tachycardia)

CL Item

Intervention Or Procedure Other Specify (Surgical and medical procedures - Other, specify)

CL Item

Syncope (Syncope)

CL Item

Telangiectasia (Telangiectasia)

CL Item

Testicular Disorder (Testicular disorder)

CL Item

Testicular Hemorrhage (Testicular hemorrhage)

CL Item

Testicular Pain (Testicular pain)

CL Item

Thromboembolism (Thromboembolic event)

CL Item

Thrombotic Thrombocytopenic Purpura (Thrombotic thrombocytopenic purpura)

CL Item

Tinnitus (Tinnitus)

CL Item

Dental Developmental Disorder (Tooth development disorder)

CL Item

Tooth Discoloration (Tooth discoloration)

CL Item

Tooth Infection (Tooth infection)

CL Item

Toothache (Toothache)

C78640 (NCI Thesaurus)
C0040460 (UMLS 2011AA)

CL Item

Toxic Epidermal Necrolysis (Toxic epidermal necrolysis)

C79777 (NCI Thesaurus)
C0014518 (UMLS 2011AA)

CL Item

Tracheal Fistula (Tracheal fistula)

C78641 (NCI Thesaurus)
C0340214 (UMLS 2011AA)

CL Item

Tracheal Hemorrhage (Tracheal hemorrhage)

C78642 (NCI Thesaurus)
C0340220 (UMLS 2011AA)

CL Item

Tracheal Mucositis (Tracheal mucositis)

C78644 (NCI Thesaurus)
C1699329 (UMLS 2011AA)

CL Item

Tracheal Obstruction (Tracheal obstruction)

C78645 (NCI Thesaurus)
C0340221 (UMLS 2011AA)

CL Item

Tracheal Stenosis (Tracheal stenosis)

C78646 (NCI Thesaurus)
C0040583 (UMLS 2011AA)

CL Item

Tracheitis (Tracheitis)

C78647 (NCI Thesaurus)
C1868703 (UMLS 2011AA)

CL Item

Tracheostomy Site Bleeding (Tracheostomy site bleeding)

C78648 (NCI Thesaurus)
C1699657 (UMLS 2011AA)

CL Item

Transient Ischemic Attack (Transient ischemic attacks)

C50781 (NCI Thesaurus)
C0007787 (UMLS 2011AA)

CL Item

Therapy-related Malignant Neoplasm (Treatment related secondary malignancy)

CL Item

Tremor (Tremor)

CL Item

Tricuspid Valve Disorder (Tricuspid valve disease)

CL Item

Trigeminal Nerve Disorder (Trigeminal nerve disorder)

CL Item

Trismus (Trismus)

CL Item

Tumor Lysis Syndrome (Tumor lysis syndrome)

CL Item

Tumor Pain (Tumor pain)

CL Item

Typhlitis (Typhlitis)

CL Item

Unequal Limb Length (Unequal limb length)

CL Item

Unintended Pregnancy (Unintended pregnancy)

CL Item

Upper Gastrointestinal Hemorrhage (Upper gastrointestinal hemorrhage)

CL Item

Upper Respiratory Tract Infection (Upper respiratory infection)

CL Item

Ureteric Anastomotic Leakage (Ureteric anastomotic leak)

CL Item

Urethral Anastomotic Leakage (Urethral anastomotic leak)

CL Item

Urethral Infection (Urethral infection)

CL Item

Urinary Tract Fistula (Urinary fistula)

CL Item

Urinary Frequency (Urinary frequency)

CL Item

Urinary Incontinence (Urinary incontinence)

CL Item

Urinary Retention (Urinary retention)

CL Item

Urinary Tract Infection (Urinary tract infection)

CL Item

Urinary Tract Obstruction (Urinary tract obstruction)

CL Item

Urinary Tract Pain (Urinary tract pain)

CL Item

Urinary Urgency (Urinary urgency)

CL Item

Urine Discoloration (Urine discoloration)

CL Item

Urine Output Decreased (Urine output decreased)

CL Item

Urostomy Leakage (Urostomy leak)

C78679 (NCI Thesaurus)
C1698193 (UMLS 2011AA)

CL Item

Urostomy Obstruction (Urostomy obstruction)

CL Item

Urostomy Site Bleeding (Urostomy site bleeding)

CL Item

Urostomy Stenosis (Urostomy stenosis)

CL Item

Urticaria (Urticaria)

C3432 (NCI Thesaurus)
C0042109 (UMLS 2011AA)

CL Item

Uterine Anastomotic Leakage (Uterine anastomotic leak)

C78684 (NCI Thesaurus)
C1699812 (UMLS 2011AA)

CL Item

Uterine Fistula (Uterine fistula)

CL Item

Uterine Hemorrhage (Uterine hemorrhage)

CL Item

Endometritis (Uterine infection)

C26764 (NCI Thesaurus)
C0014179 (UMLS 2011AA)

CL Item

Uterine Obstruction (Uterine obstruction)

CL Item

Uterine Pain (Uterine pain)

CL Item

Uterine Perforation (Uterine perforation)

CL Item

Uveitis (Uveitis)

CL Item

Vaginal Anastomotic Leakage (Vaginal anastomotic leak)

C78698 (NCI Thesaurus)
C1698194 (UMLS 2011AA)

CL Item

Vaginal Discharge (Vaginal discharge)

C50795 (NCI Thesaurus)
C0227791 (UMLS 2011AA)

CL Item

Vaginal Dryness (Vaginal dryness)

CL Item

Vaginal Fistula (Vaginal fistula)

CL Item

Vaginal Hemorrhage (Vaginal hemorrhage)

CL Item

Vaginitis (Vaginal infection)

C26911 (NCI Thesaurus)
C0042267 (UMLS 2011AA)

CL Item

Vaginitis (Vaginal inflammation)

C26911 (NCI Thesaurus)
C0042267 (UMLS 2011AA)

CL Item

Vaginal Obstruction (Vaginal obstruction)

C78700 (NCI Thesaurus)
C1408443 (UMLS 2011AA)

CL Item

Vaginal Pain (Vaginal pain)

C78701 (NCI Thesaurus)
C0236082 (UMLS 2011AA)

CL Item

Vaginal Perforation (Vaginal perforation)

C78702 (NCI Thesaurus)
C1696155 (UMLS 2011AA)

CL Item

Vaginal Stricture (Vaginal stricture)

C36064 (NCI Thesaurus)
C0269208 (UMLS 2011AA)

CL Item

Vaginismus (Vaginismus)

CL Item

Vagus Nerve Disorder (Vagus nerve disorder)

C27591 (NCI Thesaurus)
C0152179 (UMLS 2011AA)

CL Item

Vas Deferens Anastomotic Leakage (Vas deferens anastomotic leak)

C78704 (NCI Thesaurus)
C1699326 (UMLS 2011AA)

CL Item

Vascular Access Complication (Vascular access complication)

C78709 (NCI Thesaurus)
C0920165 (UMLS 2011AA)

CL Item

Vascular Disorder Other Specify (Vascular disorders - Other, specify)

CL Item

Vasculitis (Vasculitis)

CL Item

Vasovagal Reaction (Vasovagal reaction)

C50798 (NCI Thesaurus)
C1710621 (UMLS 2011AA)

CL Item

Venous Injury (Venous injury)

C78711 (NCI Thesaurus)
C0340770 (UMLS 2011AA)

CL Item

Ventricular Arrhythmia (Ventricular arrhythmia)

C26924 (NCI Thesaurus)
C0085612 (UMLS 2011AA)

CL Item

Ventricular Fibrillation (Ventricular fibrillation)

C50799 (NCI Thesaurus)
C0042510 (UMLS 2011AA)

CL Item

Ventricular Tachycardia (Ventricular tachycardia)

C50802 (NCI Thesaurus)
C0042514 (UMLS 2011AA)

CL Item

Vertigo (Vertigo)

C38057 (NCI Thesaurus)
C0042571 (UMLS 2011AA)

CL Item

Internal Ear Disorder (Vestibular disorder)

C27166 (NCI Thesaurus)
C0042594 (UMLS 2011AA)

CL Item

Virilization (Virilization)

C79859 (NCI Thesaurus)
C0042755 (UMLS 2011AA)

CL Item

Visceral Artery Ischemia (Visceral arterial ischemia)

C78712 (NCI Thesaurus)
C0853812 (UMLS 2011AA)

CL Item

Abnormal Vital Capacity (Vital capacity abnormal)

CL Item

Vitreous Hemorrhage (Vitreous hemorrhage)

C50469 (NCI Thesaurus)
C0042909 (UMLS 2011AA)

CL Item

Voice Alternation (Voice alteration)

C61043 (NCI Thesaurus)
C0518179 (UMLS 2011AA)

CL Item

Vomiting (Vomiting)

C3442 (NCI Thesaurus)
C0042963 (UMLS 2011AA)

CL Item

Vulval Infection (Vulval infection)

C78716 (NCI Thesaurus)
C1699561 (UMLS 2011AA)

CL Item

Watering Eyes (Watering eyes)

C78717 (NCI Thesaurus)
C0152227 (UMLS 2011AA)

CL Item

Weight Gain (Weight gain)

C62754 (NCI Thesaurus)
C0043094 (UMLS 2011AA)

CL Item

Weight Loss (Weight loss)

C3445 (NCI Thesaurus)
C0043096 (UMLS 2011AA)

CL Item

Wheezing (Wheezing)

CL Item

Leukopenia (White blood cell decreased)

C26816 (NCI Thesaurus)
C0023530 (UMLS 2011AA)

CL Item

Wolff-parkinson-white Syndrome (Wolff-Parkinson-White Syndrome)

CL Item

Wound Complication (Wound complication)

C78719 (NCI Thesaurus)
C1096106 (UMLS 2011AA)

CL Item

Wound Dehiscence (Wound dehiscence)

C50863 (NCI Thesaurus)
C0259768 (UMLS 2011AA)

CL Item

Wound Infection (Wound infection)

C45234 (NCI Thesaurus)
C0043241 (UMLS 2011AA)

CL Item

Wrist Fracture (Wrist fracture)

C80517 (NCI Thesaurus)
C0435630 (UMLS 2011AA)

AdverseEventContinueIndicator

Item

AE Ongoing

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C53279 (NCI Thesaurus Property)
C0549178 (UMLS 2011AA Property)

CL.23

Code List

AE Ongoing

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Not Assessed (Not assessed)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CommonToxicityCriteriaAdverseEventReportingGrade

Item

Grade

float

C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)

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.25

Code List

Seriousness Attributed to Adverse Event

CL Item

Congenital Anomaly (Congenital anomaly)

CL Item

Death (Death)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

CL Item

Disability (Disability/incapacity)

C21007 (NCI Thesaurus)
C0231170 (UMLS 2011AA)

CL Item

Hospitalized (Hospitalization, initial or prolonged)

CL Item

Life Threatening (Life threatening)

CL Item

Not Serious (Not serious)

CL Item

Intervention Required (Required intervention to prevent permanent impairment/damage)

CTCAdverseEventAttributionScale

Item

Attribution

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.26

Code List

Attribution

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)

CARDIOVASCULAR MORBIDITY - QUESTION

Item Group

Cardiovascular Morbidity - Question

HospitalizationCardiovascularDisorderAttributionInd-2

Item

Has there been a hospitalization for a cardiovascular event since the last report

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25179 (NCI Thesaurus ObjectClass)
C0019993 (UMLS 2011AA ObjectClass)
C2931 (NCI Thesaurus Property)
C0007222 (UMLS 2011AA Property)
C25358 (NCI Thesaurus Property-2)
C0596130 (UMLS 2011AA Property-2)

CARDIOVASCULAR MOBIDITY

Item Group

Cardiovascular Mobidity

CardiacDiseaseAssessmentType

Item

Problem, cardiovascular

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C13306 (NCI Thesaurus ObjectClass)
C1522601 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)

CL.28

Code List

Problem, cardiovascular

CL Item

Myocardial Infarction (Myocardial Infarction)

C27996 (NCI Thesaurus)
C0027051 (UMLS 2011AA)

CL Item

Transient Ischemic Attack Cerebrovascular Accident (Stroke / transient inschemic attack TIA)

C50781 (NCI Thesaurus)
C0007787 (UMLS 2011AA)
C3390 (NCI Thesaurus-3)
C0038454 (UMLS 2011AA-4)

CL Item

New Or Worsening Angina (New or worsening angina)

CL Item

Angina Requiring Transluminal Coronary Angioplasty (Angina requiring transluminal coronary angioplasty)

CL Item

Angina Requiring Coronary Artery Bypass Graft (Angina requiring coronary artery bypass graft)

CL Item

Thromboembolism (Thromboembolic Event)

C28195 (NCI Thesaurus)
C0040038 (UMLS 2011AA)

CL Item

Other (Other)

CardiacDiseaseAssessmentSpecify

Item

Specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C13306 (NCI Thesaurus ObjectClass)
C1522601 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)

HospitalAdmissionDate

Item

Date of hospital admission

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)

CANCER TREATMENT SINCE LAST REPORT ¿ QUESTION

Item Group

Cancer Treatment Since Last Report ¿ Question

BreastCarcinomaTherapyNewAdministeredInd-3

Item

Has patient received any new treatment for breast cancer since the last report

text

C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.29

Code List

Has patient received any new treatment for breast cancer since the last report

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CANCER TREATMENT SINCE LAST REPORT

Item Group

Cancer Treatment Since Last Report

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.30

Code List

Non-Protocol Therapy Type

CL Item

Systemic Therapy (Systemic therapy)

CL Item

Radiation Therapy (Radiation therapy)

C15313 (NCI Thesaurus)
C1522449 (UMLS 2011AA)

CL Item

Surgery (Surgery)

C17173 (NCI Thesaurus)
C0038894 (UMLS 2011AA)

CL Item

Other Specify (Other)

Non-ProtocolTherapyAdministeredSpecify

Item

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-protocolTherapyOtherAdministeredName

Item

Name of Other Non-Protocol Therapy

text

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)

Non-protocolSurgeryPerformedType

Item

Non protocol surgery

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass-2)

Non-protocolTherapyAdministeredBeginDate

Item

Non-protocol Therapy Start Date

date

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)

MAJOR MEDICAL PROBLEMS

Item Group

Major Medical Problems

PatientHistoryText

Item

Concomitant Diseases and/or Relevant Medical Conditions

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)

QUESTIONNAIRES

Item Group

Quality Of Life Questionnaire

PatientQuestionnaireCompleteInd-2

Item

Was this subject one of the sub-set of subjects who completed questionnaires at baseline

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C17048 (NCI Thesaurus Property-2)
C0034394 (UMLS 2011AA Property-2)

QuestionnaireRequestType

Item

Questionnaire

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17048 (NCI Thesaurus ObjectClass)
C0034394 (UMLS 2011AA ObjectClass)
C48312 (NCI Thesaurus Property)
C1272683 (UMLS 2011AA Property)

CL.32

Code List

Questionnaire

CL Item

Quality Of Life (Quality of Life)

CL Item

Nhs Ii - Physical Activity (NHS II - Physical Activity)

CL Item

Block Alive Screener (Block Alive screener)

QuestionnaireRequestInd-2

Item

Done

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C17048 (NCI Thesaurus ObjectClass)
C0034394 (UMLS 2011AA ObjectClass)
C48312 (NCI Thesaurus Property)
C1272683 (UMLS 2011AA Property)

PatientQuestionnaireCompleteDate

Item

Date patient filled out questionnaire

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C17048 (NCI Thesaurus Property-2)
C0034394 (UMLS 2011AA Property-2)

PatientQuestionnaireCompleteDate

Item

Date patient filled out questionnaire

date

PatientQuestionnaireCompleteNotAdministeredReason

Item

Reason questionnaire was not completed

text

C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C17048 (NCI Thesaurus Property-2)
C0034394 (UMLS 2011AA Property-2)

CL.34

Code List

Reason 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

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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Breast Cancer NCT01101438 Treatment - NCIC MA.32 Treatment Report Form - 3018892v1.0

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Unidades de medida

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Unidades de medida

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Unidades de medida

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Unidades de medida

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