ID

8301

Beschrijving

RTOG 1115 F1: Phase III RT + Standard ADT vs RT + Enhanced ADT + TAK-700 Follow-Up Form Hormone Therapy, Radiation Therapy, and Steroid 17alpha-monooxygenase TAK-700 in Treating Patients With High-Risk Prostate Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AE931EC8-EB71-0470-E040-BB89AD430843

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AE931EC8-EB71-0470-E040-BB89AD430843

Trefwoorden

D016430

C61

Follow-Up Studies

18-12-14 18-12-14 - Martin Dugas
09-01-15 09-01-15 - Martin Dugas

Geüploaded op

9 januari 2015

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0 Legacy

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Prostate Cancer NCT01546987 Follow-Up - RTOG 1115 F1: Phase III RT + Standard ADT vs RT + Enhanced ADT + TAK-700 Follow-Up Form - 3289581v1.0

model
Details

INSTRUCTIONS: Submit this form at the appropriate follow-up interval. All dates to be reported mm-dd-yyyy unless otherwise indicated

1 Formulieren

StudyEvent: RTOG 1115 F1: Phase III RT + Standard ADT vs RT + Enhanced ADT + TAK-700 Follow-Up Form
1. INSTRUCTIONS: Submit this form at the appropriate follow-up interval. All dates to be reported mm-dd-yyyy unless otherwise indicated

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Header Module

Item Group

Unnamed2

Protocol ID RTOG

Item

RTOG Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1514695 (UMLS CUI-2)
C19778 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

RadiationTherapyOncologyGroupPatientCaseIdentifierNumber

Item

Case #

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19778 (NCI Thesaurus ObjectClass-2)
C1514695 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C49152 (NCI Thesaurus Property-2)
C1706256 (UMLS 2011AA Property-2)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

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)

Institution Number

Item

Institution No.

text

C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)

Patient Initials

Item

Patient Initials

text

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

Trial subject ID RTOG

Item

RTOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1514695 (UMLS CUI-2)
C19778 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Amended Data

Item Group

Header

Data amended

Item

Amended Data

boolean

C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)

Patient Information

Item Group

Unnamed 3

Patient Status

Item

Patient's Vital Status

text

C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25717 (NCI Thesaurus Property)

CL.2

Code List

Patient's Vital Status

CL Item

Alive (Alive)

CL Item

Dead (Dead)

Date last contact

Item

Date of Last Contact or Death

date

C16960 (NCI Thesaurus ObjectClass)
C0805839 (UMLS CUI-1)
C25461 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

Primary Cause of Death

Item

Primary Cause of Death

text

C25638 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C28554 (NCI Thesaurus Property)
C25251 (NCI Thesaurus ValueDomain-2)

CL.3

Code List

Primary Cause of Death

CL Item

Not Applicable (Not applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

CL Item

Due To This Disease (Due to this disease)

CL Item

Due To Protocol Treatment (Due to protocol treatment)

CL Item

Due To Other Cause (Due to other cause)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Primary Cause of Death, specify

Item

Due to other cause, specify

text

C16960 (NCI Thesaurus ObjectClass)
C0007465 (UMLS CUI-1)
C25251 (NCI Thesaurus ObjectClass-2)
C0007465 (NCI Metathesaurus ObjectClass)
C17649 (NCI Thesaurus Property)
C25365 (NCI Thesaurus Property-2)
C25685 (NCI Thesaurus ValueDomain)

Documented clinical assessment for this cancer

Item

Has the patient had a documented clinical assessment for this cancer (SINCE SUBMISSION OF THE PREVIOUS FOLLOW-UP FORM)

text

C38148 (NCI Thesaurus ValueDomain)
C1522577 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C0006826 (UMLS CUI-2)
C9305 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property-2)

CL.4

Code List

Has the patient had a documented clinical assessment for this cancer (SINCE SUBMISSION OF THE PREVIOUS FOLLOW-UP FORM)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

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)

ECOG Performance Status

Item

Performance Status (ZUBROD 0-5, 9-UNKNOWN)

text

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

CL.5

Code List

Performance Status (ZUBROD 0-5, 9-UNKNOWN)

CL Item

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

CL Item

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

CL Item

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

CL Item

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

CL Item

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

CL Item

Dead (5)

DataUnknownText

Item

Mark an 'X' if unknown

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C17998 (NCI Thesaurus Property)
C0439673 (UMLS 2011AA Property)

Disease Information

Item Group

Unnamed Module 6

Prostate Biopsy

Item

Has the patient had a prostate biopsy (SINCE SUBMISSION OF THE LAST FOLLOW-UP FORM)

text

C15189 (NCI Thesaurus ObjectClass)
C0194804 (UMLS CUI-1)
C12410 (NCI Thesaurus ObjectClass-2)
C38000 (NCI Thesaurus Property)
C25688 (NCI Thesaurus ValueDomain)

CL.6

Code List

Has the patient had a prostate biopsy (SINCE SUBMISSION OF THE LAST FOLLOW-UP FORM)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes, Negative (Yes, negative)

CL Item

Yes, Positive (Yes, positive)

CL Item

Yes, Results Unknown (Yes, results unknown)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Biopsy Date

Item

Biopsy Date

date

C25164 (NCI Thesaurus ValueDomain)
C0005558 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C15189 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)

Palpable Tumor

Item

Is the tumor palpable

text

C25180 (NCI Thesaurus ValueDomain)
C0746412 (UMLS CUI-1)
C3262 (NCI Thesaurus ObjectClass)
C25626 (NCI Thesaurus Property)
C25606 (NCI Thesaurus ObjectClass-2)

CL.7

Code List

Is the tumor palpable

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Equivocal (Equivocal)

C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)

CL Item

Not Evaluated (Not evaluated)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Recurrence Information

Item Group

Unnamed Module 5

PSA Failure

Item

Has the patient been diagnosed with biochemical recurrence since submission of the last follow-up form

text

C38148 (NCI Thesaurus ValueDomain)
C2985506 (UMLS CUI-1)
C25626 (NCI Thesaurus Property)
C25331 (NCI Thesaurus ObjectClass)
C25434 (NCI Thesaurus ObjectClass-2)

CL.8

Code List

Has the patient been diagnosed with biochemical recurrence since submission of the last follow-up form

CL Item

No (NO)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus-3)
C1298908 (UMLS 2011AA-4)

CL Item

Yes (YES)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus-3)
C1705108 (UMLS 2011AA-4)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Neoplasm recurrence, Local

Item

Has the patient been diagnosed with a first local recurrence (SINCE SUBMISSION OF LAST FOLLOW-UP FORM See Protocol Section 11)

text

C19987 (NCI Thesaurus ObjectClass)
C0027643 (UMLS CUI-1)
C67263 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C15220 (NCI Thesaurus Property-3)
C38148 (NCI Thesaurus ValueDomain)

CL.9

Code List

Has the patient been diagnosed with a first local recurrence (SINCE SUBMISSION OF LAST FOLLOW-UP FORM See Protocol Section 11)

CL Item

No (NO)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus-3)
C1298908 (UMLS 2011AA-4)

CL Item

Yes (YES)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus-3)
C1705108 (UMLS 2011AA-4)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Date of Neoplasm local recurrence

Item

Date

date

C3352 (NCI Thesaurus ObjectClass)
C0027643 (UMLS CUI-1)
C25388 (NCI Thesaurus ObjectClass-2)
C0011008 (UMLS CUI-2)
C25509 (NCI Thesaurus Property)
C15220 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)

Evaluation method

Item

Method of Evaluation (DISTANT PROGRESSION)

text

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

CL.12

Code List

Method of Evaluation (DISTANT PROGRESSION)

CL Item

Not Applicable (Not applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

CL Item

Physical Exam (Physical exam)

CL Item

Pathologic (Pathologic)

C25610 (NCI Thesaurus)
C1521733 (UMLS 2011AA)

CL Item

Radiographic (Radiographic)

CL Item

Mri (MRI (NMR))

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

Evaluation method

Item

Method of Evaluation (DISTANT PROGRESSION)

text

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

CL.12

Code List

Method of Evaluation (DISTANT PROGRESSION)

CL Item

Not Applicable (Not applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

CL Item

Physical Exam (Physical exam)

CL Item

Pathologic (Pathologic)

C25610 (NCI Thesaurus)
C1521733 (UMLS 2011AA)

CL Item

Radiographic (Radiographic)

CL Item

Mri (MRI (NMR))

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

Neoplasm recurrence, Distal

Item

Has the patient been diagnosed with first distant progression (SINCE SUBMISSION OF THE LAST FOLLOW-UP FORM)

text

C19987 (NCI Thesaurus ObjectClass)
C0027627 (UMLS CUI-1)
C25321 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C15220 (NCI Thesaurus Property-3)
C25180 (NCI Thesaurus ValueDomain)

CL.11

Code List

Has the patient been diagnosed with first distant progression (SINCE SUBMISSION OF THE LAST FOLLOW-UP FORM)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Date of Neoplasm distal recurrence

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0027627 (UMLS CUI-1)
C25331 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus ValueDomain-2)
C0011008 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)

Progression Sites

Item

Sites of Progression (First distant)

text

C25704 (NCI Thesaurus ValueDomain)
C0280457 (UMLS CUI-1)
C25341 (NCI Thesaurus Property)
C25331 (NCI Thesaurus ObjectClass)

Evaluation method, specify

Item

Other Specify

text

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

Evaluation method, specify

Item

Other Specify

text

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

Fasting Glucose (mg/dL)

Item Group

Baseline Lab Values (hematologic)

LaboratoryProcedureGlucoseElectrolytesOutcomeInd-3

Item

Fasting glucose

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C2831 (NCI Thesaurus Property-2)
C0017725 (UMLS 2011AA Property-2)
C464 (NCI Thesaurus Property-3)
C0013832 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.13

Code List

Fasting glucose

CL Item

No (no)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Laboratory Procedure Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)

LaboratoryProcedureFastingPlasmaGlucoseMeasurementOutcomeValue

Item

Fasting glucose (mg/dL)

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

Fasting Lipids

Item Group

Fasting Lipid Panel

LaboratoryProcedureLipidResultInd-3

Item

Fasting lipids

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C616 (NCI Thesaurus Property-2)
C0023779 (UMLS 2011AA Property-2)

CL.14

Code List

Fasting lipids

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Laboratory Procedure Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)

LaboratoryProcedureFastingSerumTotalCholesterolMeasurementOutcomeValue

Item

Cholesterol (mg/dL)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C63663 (NCI Thesaurus Property-2)
C0015663 (UMLS 2011AA Property-2)
C61032 (NCI Thesaurus Property-3)
C1445957 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureFastingSerumTotalCholesterolMeasurementOutcomeLowerLimitofNormalValue

Item

Cholesterol LLN

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C63663 (NCI Thesaurus Property-2)
C0015663 (UMLS 2011AA Property-2)
C61032 (NCI Thesaurus Property-3)
C1445957 (UMLS 2011AA Property-3)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
C49100 (NCI Thesaurus ValueDomain-2)
C1704610 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureFastingSerumTotalCholesterolMeasurementOutcomeUpperLimitNormalValue

Item

Cholesterol ULN

float

HematologySerumHighDensityLipoprotein(HDL)CholesterolLaboratoryResultValueinmg/dL

Item

HDL (mg/dL)

float

C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C13325 (NCI Thesaurus Property)
C0229671 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25186 (NCI Thesaurus Property-3)
C0023821 (UMLS 2011AA Property-3)
C369 (NCI Thesaurus Property-4)
C0008377 (UMLS 2011AA Property-4)
C28253 (NCI Thesaurus ValueDomain)
C0439210 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus ValueDomain-2)
C1274040 (UMLS 2011AA ValueDomain-2)
C37984 (NCI Thesaurus ValueDomain-3)
C0022877 (UMLS 2011AA ValueDomain-3)
C25712 (NCI Thesaurus ValueDomain-4)
C1522609 (UMLS 2011AA ValueDomain-4)

HematologySerumHighDensityLipoprotein(HDL)CholesterolLaboratoryProcedureLowerLimitofNormalValue

Item

HDL LLN

text

C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C13325 (NCI Thesaurus Property)
C0229671 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25186 (NCI Thesaurus Property-3)
C0023821 (UMLS 2011AA Property-3)
C369 (NCI Thesaurus Property-4)
C0008377 (UMLS 2011AA Property-4)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
C49100 (NCI Thesaurus ValueDomain-2)
C1704610 (UMLS 2011AA ValueDomain-2)

HematologySerumHighDensityLipoprotein(HDL)CholesterolLaboratoryProcedureUpperLimitofNormalValue

Item

HDL ULN

float

C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C13325 (NCI Thesaurus Property)
C0229671 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25186 (NCI Thesaurus Property-3)
C0023821 (UMLS 2011AA Property-3)
C369 (NCI Thesaurus Property-4)
C0008377 (UMLS 2011AA Property-4)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

HematologySerumLowDensityLipoprotein(LDL)CholesterolLaboratoryResultValueinmg/dL

Item

LDL (mg/dL)

float

C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C13325 (NCI Thesaurus Property)
C0229671 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25187 (NCI Thesaurus Property-3)
C0023823 (UMLS 2011AA Property-3)
C369 (NCI Thesaurus Property-4)
C0008377 (UMLS 2011AA Property-4)
C28253 (NCI Thesaurus ValueDomain)
C0439210 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus ValueDomain-2)
C1274040 (UMLS 2011AA ValueDomain-2)
C37984 (NCI Thesaurus ValueDomain-3)
C0022877 (UMLS 2011AA ValueDomain-3)
C25712 (NCI Thesaurus ValueDomain-4)
C1522609 (UMLS 2011AA ValueDomain-4)

HematologySerumLowDensityLipoprotein(LDL)CholesterolLaboratoryProcedureLowerLimitofNormalValue

Item

LDL LLN

text

C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C13325 (NCI Thesaurus Property)
C0229671 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25187 (NCI Thesaurus Property-3)
C0023823 (UMLS 2011AA Property-3)
C369 (NCI Thesaurus Property-4)
C0008377 (UMLS 2011AA Property-4)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
C49100 (NCI Thesaurus ValueDomain-2)
C1704610 (UMLS 2011AA ValueDomain-2)

HematologySerumLowDensityLipoprotein(LDL)CholesterolLaboratoryProcedureUpperLimitofNormalValue

Item

LDL ULN

float

C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C13325 (NCI Thesaurus Property)
C0229671 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property-2)
C0022885 (UMLS 2011AA Property-2)
C25187 (NCI Thesaurus Property-3)
C0023823 (UMLS 2011AA Property-3)
C369 (NCI Thesaurus Property-4)
C0008377 (UMLS 2011AA Property-4)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureFastingTriglycerideMeasurementOutcomeValue

Item

Triglycerides (mg/dL)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C63663 (NCI Thesaurus Property-2)
C0015663 (UMLS 2011AA Property-2)
C64812 (NCI Thesaurus Property-3)
C0202236 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureFastingTriglycerideMeasurementOutcomeLowerLimitofNormalValue

Item

Triglycerides LLN

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C63663 (NCI Thesaurus Property-2)
C0015663 (UMLS 2011AA Property-2)
C64812 (NCI Thesaurus Property-3)
C0202236 (UMLS 2011AA Property-3)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
C49100 (NCI Thesaurus ValueDomain-2)
C1704610 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureFastingTriglycerideMeasurementOutcomeUpperLimitNormalValue

Item

Triglycerides ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C63663 (NCI Thesaurus Property-2)
C0015663 (UMLS 2011AA Property-2)
C64812 (NCI Thesaurus Property-3)
C0202236 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

Hemoglobin A1C (%)

Item Group

Hemoglobin A1 C (%)

LaboratoryProcedureGlycosylatedHemoglobinMeasurementOutcomeInd-3

Item

Hemoglobin A1C (%)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C64849 (NCI Thesaurus Property-2)
C0202054 (UMLS 2011AA Property-2)

CL.15

Code List

Hemoglobin A1C (%)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

HematologyGlycosylatedHemoglobinMeasurementLabPercentageValue

Item

Hemogloblin A1C

float

C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C64849 (NCI Thesaurus Property)
C0202054 (UMLS 2011AA Property)

LaboratoryProcedureGlycosylatedHemoglobinMeasurementOutcomeLowerLimitofNormalValue

Item

Hemoglobin A1C LLN

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C64849 (NCI Thesaurus Property-2)
C0202054 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureGlycosylatedHemoglobinMeasurementOutcomeUpperLimitofNormalValue

Item

Hemoglobin A1C ULN

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C64849 (NCI Thesaurus Property-2)
C0202054 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

Serum Testosterone

Item Group

Serum Testosterone

LaboratoryProcedureTestosteroneResultInd-3

Item

Serum testosterone

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C2299 (NCI Thesaurus Property-2)
C0039601 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

CL.16

Code List

Serum testosterone

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Laboratory Procedure Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)

LaboratoryProcedureTestosteroneResultSpecifiedValue

Item

Testosterone

float

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C2299 (NCI Thesaurus Property-2)
C0039601 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureTestosteroneResultLowerLimitofNormalValue

Item

Testosterone LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C2299 (NCI Thesaurus Property-2)
C0039601 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureTestosteroneResultUpperLimitofNormalValue

Item

Testosterone ULN

text

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C2299 (NCI Thesaurus Property-2)
C0039601 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-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)

CL.18

Code List

Units

CL Item

N/milligram (n/mg)

CL Item

Nanograms Per Milliliter (ng/mL)

CL Item

Units Per Liter (U/L)

CL Item

Nanograms Per Deciliter (ng/dL)

CL Item

Micrograms Per Liter (mcg/L)

CL Item

Not Otherwise Specified (NOS)

CL006269 (NCI Metathesaurus)

PROSTATE: PSA MEASUREMENTS

Item Group

Unnamed Module 4a

PSA date

Item

PSA Date (s)

date

C25294 (NCI Thesaurus ObjectClass)
C0138741 (UMLS CUI-1)
C17525 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C20200 (NCI Thesaurus Property-2)
C17220 (NCI Thesaurus Property-3)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

PSA

Item

PSA Value (s)

float

C25294 (NCI Thesaurus ObjectClass)
C0138741 (UMLS CUI-1)
C17525 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C17220 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)

PSAManufacturerAssayType

Item

Method of Assay

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17525 (NCI Thesaurus ObjectClass)
C0138741 (UMLS 2011AA ObjectClass)
C16341 (NCI Thesaurus Property)
C0005507 (UMLS 2011AA Property)
C25392 (NCI Thesaurus Property-2)
C0947322 (UMLS 2011AA Property-2)

CL.19

Code List

Method of Assay

CL Item

Abbott Labs (Abbott)

CL Item

Bayer (Bayer)

CL Item

Dpc (DPC)

CL Item

Hybritech (Hybritech)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Unknown (Unknown)

AssessmentLabUOM

Item

Units

text

CL.18

Code List

Units

CL Item

N/milligram (n/mg)

CL Item

Nanograms Per Milliliter (ng/mL)

CL Item

Units Per Liter (U/L)

CL Item

Nanograms Per Deciliter (ng/dL)

CL Item

Micrograms Per Liter (mcg/L)

CL Item

Not Otherwise Specified (NOS)

CL006269 (NCI Metathesaurus)

Non-protocol Cancer Therapy

Item Group

Non-protocol Therapy

Non-protocolTherapyAdministeredInd-3

Item

Is the patient receiving any non-protocol cancer therapy not previously reported (PROSTATE If yes, enter therapy type and date for each therapy delivered during the follow-up period.)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (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.20

Code List

Is the patient receiving any non-protocol cancer therapy not previously reported (PROSTATE If yes, enter therapy type and date for each therapy delivered during the follow-up period.)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

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.21

Code List

Non-Protocol Therapy Type

CL Item

Radiation To Pelvis (Radiation to pelvis)

CL Item

Radiation To Other Sites, Specify (Radiation to other sites)

CL Item

Surgery (Surgery)

C17173 (NCI Thesaurus)
C0038894 (UMLS 2011AA)

CL Item

Chemotherapy (Chemotherapy)

C15632 (NCI Thesaurus)
C0392920 (UMLS 2011AA)

CL Item

Hormones (Hormones)

CL Item

Other Specify (Other)

Non-ProtocolTherapyFirstAdministeredDate

Item

Date of First Non-Protocol Therapy

date

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

Non-ProtocolTreatmentFirstAdministeredSpecify

Item

Specify

text

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

New Primary Cancer

Item Group

Unnamed Module 7

NewCancerDiagnosisInd-3

Item

Has a new primary cancer or MDS been diagnosed that has not been previously reported? (MYELODYSPLASTIC SYNDROME)

text

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)

CL.22

Code List

Has a new primary cancer or MDS been diagnosed that has not been previously reported? (MYELODYSPLASTIC SYNDROME)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Second Primary Tumor Site

Item

Second Primary Tumor Site

text

C13717 (NCI Thesaurus ValueDomain)
C0751623 (UMLS CUI-1)
C3262 (NCI Thesaurus ObjectClass)
C1515974 (UMLS CUI-2)
C25341 (NCI Thesaurus Property)
C25666 (NCI Thesaurus ObjectClass-2)

CL.23

Code List

Second Primary Tumor Site

CL Item

Aml/mds (AML/MDS)

C9441 (NCI Thesaurus)

CL Item

Bcc (BCC)

CL Item

Bladder Is The Site Of Second Primary Or Recurrent Tumor (bladder)

CL Item

Brain Is The Site Of Second Primary Or Recurrent Tumor (brain)

CL Item

Colorectal (Colorectal)

C13363 (NCI Thesaurus)
C0555952 (UMLS 2011AA)

CL Item

Esophageal (Esophageal)

C37950 (NCI Thesaurus)
C1522619 (UMLS 2011AA)

CL Item

Gastric (Gastric)

C13307 (NCI Thesaurus)
C1704242 (UMLS 2011AA)

CL Item

Liver Is The Site Of Second Primary Or Recurrent Tumor (liver)

CL Item

Lung Is The Site Of Second Primary Or Recurrent Tumor (lung)

CL Item

Melanoma (Melanoma)

C3224 (NCI Thesaurus)
C0025202 (UMLS 2011AA)

CL Item

Nhl (NHL)

CL Item

Pancreatic (Pancreatic)

C25726 (NCI Thesaurus)
C0030274 (UMLS 2011AA)

CL Item

Renal (Renal)

C25225 (NCI Thesaurus)
C0022646 (UMLS 2011AA)

CL Item

Squamous-skin (Squamous-skin)

CL Item

Other Hematologic (Other hematologic)

CL Item

Other Solid (Other solid)

CL Item

Unknown Primary (Unknown primary)

Second Primary Tumor Date

Item

Second Primary Cancer Date

date

C3262 (NCI Thesaurus ObjectClass)
C0751623 (UMLS CUI-1)
C25251 (NCI Thesaurus ObjectClass-2)
C0011008 (UMLS CUI-2)
C25666 (NCI Thesaurus ObjectClass-3)
C15220 (NCI Thesaurus Property)
C25164 (NCI Thesaurus ValueDomain)

Primary Disease Site

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C0449695 (UMLS CUI-1)
C25341 (NCI Thesaurus Property)
C25251 (NCI Thesaurus ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)

Patient Evaluations

Item Group

Patient Evaluations

Patient Weight

Item

Weight (kg)

float

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

Laboratory Procedure Date

Item

Date

date

C25164 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)

Survivorship

Item Group

Survivorship

DiabetesMellitusHistoryInd-3

Item

Diabetes Mellitus

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2985 (NCI Thesaurus ObjectClass)
C0011849 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)

CL.24

Code List

Diabetes Mellitus

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

ChronicDiseaseCoronaryArteryInd-3

Item

Coronary Artery Disease

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C14141 (NCI Thesaurus ObjectClass-2)
C0205191 (UMLS 2011AA ObjectClass-2)
C0205042 (NCI Metathesaurus Property)

CL.25

Code List

Coronary Artery Disease

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PatientPriorMyocardialInfarctionInd-3

Item

Myocardial infarction

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C27996 (NCI Thesaurus Property)
C0027051 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)

CL.26

Code List

Myocardial infarction

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PatientCerebrovascularAccidentHistoryInd-3

Item

Stroke

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3390 (NCI Thesaurus Property)
C0038454 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)

CL.27

Code List

Stroke

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PersonPulmonaryEmbolismInd-3

Item

Pulmonary embolism

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C50713 (NCI Thesaurus Property)
C0034065 (UMLS 2011AA Property)

CL.28

Code List

Pulmonary embolism

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PersonDeepVeinThrombosisPersonalMedicalHistoryInd-3

Item

Deep vein thrombosis

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C49343 (NCI Thesaurus Property)
C0149871 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)

CL.29

Code List

Deep vein thrombosis

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PersonOsteoporosisFracturePersonalMedicalHistoryInd-3

Item

Osteoporotic fracture

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C3298 (NCI Thesaurus Property)
C0029456 (UMLS 2011AA Property)
C3046 (NCI Thesaurus Property-2)
C0016658 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.30

Code List

Osteoporotic fracture

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Concomitant Medications

Item Group

Concomitant Medications

ConcomitantMedicationModificationInd-3

Item

Any changes in medication

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C25572 (NCI Thesaurus Property)

CL.31

Code List

Any changes in medication

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Concomitant Medication

Item

Medication

text

C25704 (NCI Thesaurus ValueDomain)
C2347852 (UMLS CUI-1)
C459 (NCI Thesaurus ObjectClass)
C25639 (NCI Thesaurus Property)
C25730 (NCI Thesaurus ObjectClass-2)

ConcomitantMedicationAdministeredDose

Item

Dose

float

C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

ConcomitantMedicationModificationType

Item

Change in medication

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C25572 (NCI Thesaurus Property)

CL.32

Code List

Change in medication

CL Item

Addition (Addition)

CL Item

Discontinued (Discontinued)

C25484 (NCI Thesaurus)
C1444662 (UMLS 2011AA)

CL Item

Dose Increased (Dose increase)

C49503 (NCI Thesaurus)
C1707810 (UMLS 2011AA)

CL Item

Lower Dose (Dose decrease)

C25488 (NCI Thesaurus)
C0178602 (UMLS 2011AA)
C86568 (NCI Thesaurus-3)
C2003888 (UMLS 2011AA-4)

CL Item

Other (Other change)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

ConcomitantMedicationModificationSpecify

Item

Specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C25572 (NCI Thesaurus Property)

Adverse Events

Item Group

Protocol Specific Adverse Event Evaluation

Adverse Event

Item

Any Treatment Related Adverse Events

text

C25648 (NCI Thesaurus ObjectClass)
C0877248 (UMLS CUI-1)
C41331 (NCI Thesaurus ObjectClass-2)
C15368 (NCI Thesaurus ObjectClass-3)
C0684224 (NCI Metathesaurus Property)
C38148 (NCI Thesaurus ValueDomain)

CL.33

Code List

Any Treatment Related Adverse Events

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Primary Site MedDRA Code

Item

MedDRA Disease Code

text

C41331 (NCI Thesaurus ObjectClass)
C0449695 (UMLS CUI-1)
C71886 (NCI Thesaurus ObjectClass-2)
C1552878 (UMLS CUI-2)
C25162 (NCI Thesaurus Property)
C43820 (NCI Thesaurus Property-2)
C25162 (NCI Thesaurus ValueDomain)
C41331 (NCI Thesaurus ValueDomain-2)
C45255 (NCI Thesaurus ValueDomain-3)
C43820 (NCI Thesaurus ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)

CommonTerminologyCriteriaforAdverseEventsVersion4.0LowLevelTermName

Item

CTC Adverse Event 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.34

Code List

CTC Adverse Event Term

CL Item

Abdominal Distension (Abdominal distension)

E10456 (CTCAE)

CL Item

Abdominal Infection (Abdominal infection)

E11282 (CTCAE)

CL Item

Abdominal Pain (Abdominal pain)

E10460 (CTCAE)

CL Item

Abdominal Soft Tissue Necrosis (Abdominal soft tissue necrosis)

E12369 (CTCAE)

CL Item

Abducens Nerve Disorder (Abducens nerve disorder)

E12569 (CTCAE)

CL Item

Accessory Nerve Disorder (Accessory nerve disorder)

E12573 (CTCAE)

CL Item

Acidosis (Acidosis)

E12237 (CTCAE)

CL Item

Acoustic Nerve Disorder Nos (Acoustic nerve disorder NOS)

E12577 (CTCAE)

CL Item

Activated Partial Thromboplastin Time Prolonged (Activated partial thromboplastin time prolonged)

E12073 (CTCAE)

CL Item

Acute Coronary Syndrome (Acute coronary syndrome)

E10066 (CTCAE)

CL Item

Acute Kidney Injury (Acute kidney injury)

E12973 (CTCAE)

CL Item

Adrenal Insufficiency (Adrenal insufficiency)

E10298 (CTCAE)

CL Item

Adult Respiratory Distress Syndrome (Adult respiratory distress syndrome)

E13299 (CTCAE)

CL Item

Agitation (Agitation)

E12874 (CTCAE)

CL Item

Akathisia (Akathisia)

E12581 (CTCAE)

CL Item

Alanine Aminotransferase Increased (Alanine aminotransferase increased)

E12077 (CTCAE)

CL Item

Alcohol Intolerance (Alcohol intolerance)

E12242 (CTCAE)

CL Item

Alkaline Phosphatase Increased (Alkaline phosphatase increased)

E12082 (CTCAE)

CL Item

Alkalosis (Alkalosis)

E12247 (CTCAE)

CL Item

Allergic Reaction (Allergic reaction)

E11248 (CTCAE)

CL Item

Allergic Rhinitis (Allergic rhinitis)

E13303 (CTCAE)

CL Item

Alopecia (Alopecia)

E13611 (CTCAE)

CL Item

Amnesia (Amnesia)

E12585 (CTCAE)

CL Item

Anal Fistula (Anal fistula)

E10464 (CTCAE)

CL Item

Anal Hemorrhage (Anal hemorrhage)

E10470 (CTCAE)

CL Item

Anal Mucositis (Anal mucositis)

E10476 (CTCAE)

CL Item

Anal Necrosis (Anal necrosis)

E10482 (CTCAE)

CL Item

Anal Pain (Anal pain)

E10486 (CTCAE)

CL Item

Anal Stenosis (Anal stenosis)

E10490 (CTCAE)

CL Item

Anal Ulcer (Anal ulcer)

E10496 (CTCAE)

CL Item

Anaphylaxis (Anaphylaxis)

E11254 (CTCAE)

CL Item

Anemia (Anemia)

E10010 (CTCAE)

CL Item

Ankle Fracture (Ankle fracture)

E11640 (CTCAE)

CL Item

Anorectal Infection (Anorectal infection)

E11286 (CTCAE)

CL Item

Anorexia (Anorexia)

E12252 (CTCAE)

CL Item

Anorgasmia (Anorgasmia)

E12880 (CTCAE)

CL Item

Anxiety (Anxiety)

E12883 (CTCAE)

CL Item

Aortic Injury (Aortic injury)

E11644 (CTCAE)

CL Item

Aortic Valve Disease (Aortic valve disease)

E10071 (CTCAE)

CL Item

Aphonia (Aphonia)

E12589 (CTCAE)

CL Item

Apnea (Apnea)

E13306 (CTCAE)

CL Item

Appendicitis (Appendicitis)

E11292 (CTCAE)

CL Item

Appendicitis Perforated (Appendicitis perforated)

E11296 (CTCAE)

CL Item

Arachnoiditis (Arachnoiditis)

E12591 (CTCAE)

CL Item

Arterial Injury (Arterial injury)

E11648 (CTCAE)

CL Item

Arteritis Infective (Arteritis infective)

E11301 (CTCAE)

CL Item

Arthralgia (Arthralgia)

E12374 (CTCAE)

CL Item

Arthritis (Arthritis)

E12378 (CTCAE)

CL Item

Ascites (Ascites)

E10502 (CTCAE)

CL Item

Aspartate Aminotransferase Increased (Aspartate aminotransferase increased)

E12087 (CTCAE)

CL Item

Aspiration (Aspiration)

E13310 (CTCAE)

CL Item

Asystole (Asystole)

E10077 (CTCAE)

CL Item

Ataxia (Ataxia)

E12597 (CTCAE)

CL Item

Atelectasis (Atelectasis)

E13316 (CTCAE)

CL Item

Atrial Fibrillation (Atrial fibrillation)

E10081 (CTCAE)

CL Item

Atrial Flutter (Atrial flutter)

E10087 (CTCAE)

CL Item

Atrioventricular Block Complete (Atrioventricular block complete)

E10093 (CTCAE)

CL Item

Atrioventricular Block First Degree (Atrioventricular block first degree)

E10098 (CTCAE)

CL Item

Autoimmune Disorder (Autoimmune disorder)

E11258 (CTCAE)

CL Item

Avascular Necrosis (Avascular necrosis)

E12382 (CTCAE)

CL Item

Azoospermia (Azoospermia)

E13067 (CTCAE)

CL Item

Back Pain (Back pain)

E12388 (CTCAE)

CL Item

Bile Duct Stenosis (Bile duct stenosis)

E11173 (CTCAE)

CL Item

Biliary Anastomotic Leak (Biliary anastomotic leak)

E11654 (CTCAE)

CL Item

Biliary Fistula (Biliary fistula)

E11179 (CTCAE)

CL Item

Biliary Tract Infection (Biliary tract infection)

E11305 (CTCAE)

CL Item

Bladder Anastomotic Leak (Bladder anastomotic leak)

E11660 (CTCAE)

CL Item

Bladder Infection (Bladder infection)

E11309 (CTCAE)

CL Item

Bladder Perforation (Bladder perforation)

E12979 (CTCAE)

CL Item

Bladder Spasm (Bladder spasm)

E12984 (CTCAE)

CL Item

Bloating (Bloating)

E10508 (CTCAE)

CL Item

Blood And Lymphatic System Disorders - Other, Specify (Blood and lymphatic system disorders - Other, Specify)

E10016 (CTCAE)

CL Item

Blood Antidiuretic Hormone Abnormal (Blood antidiuretic hormone abnormal)

E12092 (CTCAE)

CL Item

Blood Bilirubin Increased (Blood bilirubin increased)

E12096 (CTCAE)

CL Item

Blood Corticotrophin Decreased (Blood corticotrophin decreased)

E12101 (CTCAE)

CL Item

Blood Gonadotrophin Abnormal (Blood gonadotrophin abnormal)

E12105 (CTCAE)

CL Item

Blood Prolactin Abnormal (Blood prolactin abnormal)

E12109 (CTCAE)

CL Item

Blurred Vision (Blurred vision)

E10346 (CTCAE)

CL Item

Body Odor (Body odor)

E13614 (CTCAE)

CL Item

Bone Infection (Bone infection)

E11314 (CTCAE)

CL Item

Bone Marrow Hypocellular (Bone marrow hypocellular)

E10022 (CTCAE)

CL Item

Bone Pain (Bone pain)

E12392 (CTCAE)

CL Item

Brachial Plexopathy (Brachial plexopathy)

E12601 (CTCAE)

CL Item

Breast Atrophy (Breast atrophy)

E13069 (CTCAE)

CL Item

Breast Infection (Breast infection)

E11318 (CTCAE)

CL Item

Breast Pain (Breast pain)

E13073 (CTCAE)

CL Item

Bronchial Fistula (Bronchial fistula)

E13322 (CTCAE)

CL Item

Bronchial Infection (Bronchial infection)

E11323 (CTCAE)

CL Item

Bronchial Obstruction (Bronchial obstruction)

E13328 (CTCAE)

CL Item

Bronchial Stricture (Bronchial stricture)

E13334 (CTCAE)

CL Item

Bronchopleural Fistula (Bronchopleural fistula)

E13340 (CTCAE)

CL Item

Bronchopulmonary Hemorrhage (Bronchopulmonary hemorrhage)

E13346 (CTCAE)

CL Item

Bronchospasm (Bronchospasm)

E13352 (CTCAE)

CL Item

Bruising (Bruising)

E11666 (CTCAE)

CL Item

Bullous Dermatitis (Bullous dermatitis)

E13617 (CTCAE)

CL Item

Burn (Burn)

E11669 (CTCAE)

CL Item

Buttock Pain (Buttock pain)

E12396 (CTCAE)

CL Item

Capillary Leak Syndrome (Capillary leak syndrome)

E13766 (CTCAE)

CL Item

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

E12112 (CTCAE)

CL Item

Cardiac Arrest (Cardiac arrest)

E10101 (CTCAE)

CL Item

Cardiac Disorders - Other, Specify (Cardiac disorders - Other, Specify)

E10104 (CTCAE)

CL Item

Cardiac Troponin I Increased (Cardiac troponin I increased)

E12116 (CTCAE)

CL Item

Cardiac Troponin T Increased (Cardiac troponin T increased)

E12119 (CTCAE)

CL Item

Cataract (Cataract)

E10350 (CTCAE)

CL Item

Catheter Related Infection (Catheter related infection)

E11328 (CTCAE)

CL Item

Cd4 Lymphocytes Decreased (CD4 lymphocytes decreased)

E12122 (CTCAE)

CL Item

Cecal Hemorrhage (Cecal hemorrhage)

E10511 (CTCAE)

CL Item

Cecal Infection (Cecal infection)

E11333 (CTCAE)

CL Item

Central Nervous System Necrosis (Central nervous system necrosis)

E12605 (CTCAE)

CL Item

Cerebrospinal Fluid Leakage (Cerebrospinal fluid leakage)

E12611 (CTCAE)

CL Item

Cervicitis Infection (Cervicitis infection)

E11337 (CTCAE)

CL Item

Cheilitis (Cheilitis)

E10517 (CTCAE)

CL Item

Chest Pain - Cardiac (Chest pain - cardiac)

E10110 (CTCAE)

CL Item

Chest Wall Pain (Chest wall pain)

E12400 (CTCAE)

CL Item

Chills (Chills)

E11074 (CTCAE)

CL Item

Cholecystitis (Cholecystitis)

E11184 (CTCAE)

CL Item

Cholesterol High (Cholesterol high)

E12127 (CTCAE)

CL Item

Chronic Kidney Disease (Chronic kidney disease)

E12988 (CTCAE)

CL Item

Chylothorax (Chylothorax)

E13358 (CTCAE)

CL Item

Cognitive Disturbance (Cognitive disturbance)

E12617 (CTCAE)

CL Item

Colitis (Colitis)

E10521 (CTCAE)

CL Item

Colonic Fistula (Colonic fistula)

E10527 (CTCAE)

CL Item

Colonic Hemorrhage (Colonic hemorrhage)

E10533 (CTCAE)

CL Item

Colonic Obstruction (Colonic obstruction)

E10539 (CTCAE)

CL Item

Colonic Perforation (Colonic perforation)

E10545 (CTCAE)

CL Item

Colonic Stenosis (Colonic stenosis)

E10550 (CTCAE)

CL Item

Colonic Ulcer (Colonic ulcer)

E10556 (CTCAE)

CL Item

Concentration Impairment (Concentration impairment)

E12621 (CTCAE)

CL Item

Conduction Disorder (Conduction disorder)

E10114 (CTCAE)

CL Item

Confusion (Confusion)

E12889 (CTCAE)

CL Item

Congenital, Familial And Genetic Disorders - Other, Specify (Congenital, familial and genetic disorders - Other, Specify)

E10250 (CTCAE)

CL Item

Conjunctivitis (Conjunctivitis)

E10355 (CTCAE)

CL Item

Conjunctivitis Infective (Conjunctivitis infective)

E11342 (CTCAE)

CL Item

Constipation (Constipation)

E10562 (CTCAE)

CL Item

Constrictive Pericarditis (Constrictive pericarditis)

E10120 (CTCAE)

CL Item

Corneal Infection (Corneal infection)

E11347 (CTCAE)

CL Item

Corneal Ulcer (Corneal ulcer)

E10359 (CTCAE)

CL Item

Cough (Cough)

E13364 (CTCAE)

CL Item

Cpk Increased (CPK increased)

E12132 (CTCAE)

CL Item

Cranial Nerve Infection (Cranial nerve infection)

E11352 (CTCAE)

CL Item

Creatinine Increased (Creatinine increased)

E12137 (CTCAE)

CL Item

Cushingoid (Cushingoid)

E10304 (CTCAE)

CL Item

Cystitis Noninfective (Cystitis noninfective)

E12994 (CTCAE)

CL Item

Cytokine Release Syndrome (Cytokine release syndrome)

E11264 (CTCAE)

CL Item

Death Neonatal (Death neonatal)

E11078 (CTCAE)

CL Item

Death Nos (Death NOS)

E11080 (CTCAE)

CL Item

Dehydration (Dehydration)

E12258 (CTCAE)

CL Item

Delayed Orgasm (Delayed orgasm)

E12895 (CTCAE)

CL Item

Delayed Puberty (Delayed puberty)

E10308 (CTCAE)

CL Item

Delirium (Delirium)

E12898 (CTCAE)

CL Item

Delusions (Delusions)

E12904 (CTCAE)

CL Item

Dental Caries (Dental caries)

E10568 (CTCAE)

CL Item

Depressed Level Of Consciousness (Depressed level of consciousness)

E12625 (CTCAE)

CL Item

Depression (Depression)

E12909 (CTCAE)

CL Item

Dermatitis Radiation (Dermatitis radiation)

E11675 (CTCAE)

CL Item

Device Related Infection (Device related infection)

E11356 (CTCAE)

CL Item

Diarrhea (Diarrhea)

E10572 (CTCAE)

CL Item

Disseminated Intravascular Coagulation (Disseminated intravascular coagulation)

E10028 (CTCAE)

CL Item

Dizziness (Dizziness)

E12631 (CTCAE)

CL Item

Dry Eye (Dry eye)

E10363 (CTCAE)

CL Item

Dry Mouth (Dry mouth)

E10578 (CTCAE)

CL Item

Dry Skin (Dry skin)

E13623 (CTCAE)

CL Item

Duodenal Fistula (Duodenal fistula)

E10582 (CTCAE)

CL Item

Duodenal Hemorrhage (Duodenal hemorrhage)

E10588 (CTCAE)

CL Item

Duodenal Infection (Duodenal infection)

E11360 (CTCAE)

CL Item

Duodenal Obstruction (Duodenal obstruction)

E10594 (CTCAE)

CL Item

Duodenal Perforation (Duodenal perforation)

E10600 (CTCAE)

CL Item

Duodenal Stenosis (Duodenal stenosis)

E10605 (CTCAE)

CL Item

Duodenal Ulcer (Duodenal ulcer)

E10611 (CTCAE)

CL Item

Dysarthria (Dysarthria)

E12635 (CTCAE)

CL Item

Dysesthesia (Dysesthesia)

E12639 (CTCAE)

CL Item

Dysgeusia (Dysgeusia)

E12643 (CTCAE)

CL Item

Dysmenorrhea (Dysmenorrhea)

E13077 (CTCAE)

CL Item

Dyspareunia (Dyspareunia)

E13081 (CTCAE)

CL Item

Dyspepsia (Dyspepsia)

E10617 (CTCAE)

CL Item

Dysphagia (Dysphagia)

E10621 (CTCAE)

CL Item

Dysphasia (Dysphasia)

E12646 (CTCAE)

CL Item

Dyspnea (Dyspnea)

E13368 (CTCAE)

CL Item

Ear And Labyrinth Disorders - Other, Specify (Ear and labyrinth disorders - Other, Specify)

E10256 (CTCAE)

CL Item

Ear Pain (Ear pain)

E10262 (CTCAE)

CL Item

Edema Cerebral (Edema cerebral)

E12650 (CTCAE)

CL Item

Edema Face (Edema face)

E11082 (CTCAE)

CL Item

Edema Limbs (Edema limbs)

E11086 (CTCAE)

CL Item

Edema Trunk (Edema trunk)

E11090 (CTCAE)

CL Item

Ejaculation Disorder (Ejaculation disorder)

E13085 (CTCAE)

CL Item

Ejection Fraction Decreased (Ejection fraction decreased)

E12142 (CTCAE)

CL Item

Electrocardiogram Qt Corrected Interval Prolonged (Electrocardiogram QT corrected interval prolonged)

E12146 (CTCAE)

CL Item

Encephalitis Infection (Encephalitis infection)

E11365 (CTCAE)

CL Item

Encephalomyelitis Infection (Encephalomyelitis infection)

E11369 (CTCAE)

CL Item

Encephalopathy (Encephalopathy)

E12652 (CTCAE)

CL Item

Endocarditis Infective (Endocarditis infective)

E11373 (CTCAE)

CL Item

Endocrine Disorders - Other, Specify (Endocrine disorders - Other, Specify)

E10311 (CTCAE)

CL Item

Endophthalmitis (Endophthalmitis)

E11377 (CTCAE)

CL Item

Enterocolitis (Enterocolitis)

E10627 (CTCAE)

CL Item

Enterocolitis Infectious (Enterocolitis infectious)

E11381 (CTCAE)

CL Item

Enterovesical Fistula (Enterovesical fistula)

E10633 (CTCAE)

CL Item

Epistaxis (Epistaxis)

E13374 (CTCAE)

CL Item

Erectile Dysfunction (Erectile dysfunction)

E13088 (CTCAE)

CL Item

Erythema Multiforme (Erythema multiforme)

E13627 (CTCAE)

CL Item

Erythroderma (Erythroderma)

E13633 (CTCAE)

CL Item

Esophageal Anastomotic Leak (Esophageal anastomotic leak)

E11681 (CTCAE)

CL Item

Esophageal Fistula (Esophageal fistula)

E10639 (CTCAE)

CL Item

Esophageal Hemorrhage (Esophageal hemorrhage)

E10645 (CTCAE)

CL Item

Esophageal Infection (Esophageal infection)

E11386 (CTCAE)

CL Item

Esophageal Necrosis (Esophageal necrosis)

E10651 (CTCAE)

CL Item

Esophageal Obstruction (Esophageal obstruction)

E10655 (CTCAE)

CL Item

Esophageal Pain (Esophageal pain)

E10661 (CTCAE)

CL Item

Esophageal Perforation (Esophageal perforation)

E10665 (CTCAE)

CL Item

Esophageal Stenosis (Esophageal stenosis)

E10670 (CTCAE)

CL Item

Esophageal Ulcer (Esophageal ulcer)

E10676 (CTCAE)

CL Item

Esophageal Varices Hemorrhage (Esophageal varices hemorrhage)

E10682 (CTCAE)

CL Item

Esophagitis (Esophagitis)

E10687 (CTCAE)

CL Item

Euphoria (Euphoria)

E12915 (CTCAE)

CL Item

Exostosis (Exostosis)

E12404 (CTCAE)

CL Item

External Ear Inflammation (External ear inflammation)

E10266 (CTCAE)

CL Item

External Ear Pain (External ear pain)

E10272 (CTCAE)

CL Item

Extraocular Muscle Paresis (Extraocular muscle paresis)

E10367 (CTCAE)

CL Item

Extrapyramidal Disorder (Extrapyramidal disorder)

E12658 (CTCAE)

CL Item

Eye Disorders - Other, Specify (Eye disorders - Other, Specify)

E10371 (CTCAE)

CL Item

Eye Infection (Eye infection)

E11391 (CTCAE)

CL Item

Eye Pain (Eye pain)

E10376 (CTCAE)

CL Item

Eyelid Function Disorder (Eyelid function disorder)

E10380 (CTCAE)

CL Item

Facial Muscle Weakness (Facial muscle weakness)

E12664 (CTCAE)

CL Item

Facial Nerve Disorder (Facial nerve disorder)

E12668 (CTCAE)

CL Item

Facial Pain (Facial pain)

E11094 (CTCAE)

CL Item

Fall (Fall)

E11687 (CTCAE)

CL Item

Fallopian Tube Anastomotic Leak (Fallopian tube anastomotic leak)

E11691 (CTCAE)

CL Item

Fallopian Tube Obstruction (Fallopian tube obstruction)

E13092 (CTCAE)

CL Item

Fallopian Tube Perforation (Fallopian tube perforation)

E11697 (CTCAE)

CL Item

Fallopian Tube Stenosis (Fallopian tube stenosis)

E13096 (CTCAE)

CL Item

Fat Atrophy (Fat atrophy)

E13638 (CTCAE)

CL Item

Fatigue (Fatigue)

E11098 (CTCAE)

CL Item

Febrile Neutropenia (Febrile neutropenia)

E10033 (CTCAE)

CL Item

Fecal Incontinence (Fecal incontinence)

E10693 (CTCAE)

CL Item

Female Genital Tract Fistula (Female genital tract fistula)

E13102 (CTCAE)

CL Item

Feminization Acquired (Feminization acquired)

E13108 (CTCAE)

CL Item

Fetal Death (Fetal death)

E12855 (CTCAE)

CL Item

Fetal Growth Retardation (Fetal growth retardation)

E12857 (CTCAE)

CL Item

Fever (Fever)

E11102 (CTCAE)

CL Item

Fibrinogen Decreased (Fibrinogen decreased)

E12151 (CTCAE)

CL Item

Fibrosis Deep Connective Tissue (Fibrosis deep connective tissue)

E12408 (CTCAE)

CL Item

Flank Pain (Flank pain)

E12414 (CTCAE)

CL Item

Flashing Lights (Flashing lights)

E10384 (CTCAE)

CL Item

Flatulence (Flatulence)

E10697 (CTCAE)

CL Item

Floaters (Floaters)

E10388 (CTCAE)

CL Item

Flu Like Symptoms (Flu like symptoms)

E11108 (CTCAE)

CL Item

Flushing (Flushing)

E13771 (CTCAE)

CL Item

Forced Expiratory Volume Decreased (Forced expiratory volume decreased)

E12156 (CTCAE)

CL Item

Fracture (Fracture)

E11703 (CTCAE)

CL Item

Gait Disturbance (Gait disturbance)

E11112 (CTCAE)

CL Item

Gallbladder Fistula (Gallbladder fistula)

E11189 (CTCAE)

CL Item

Gallbladder Infection (Gallbladder infection)

E11396 (CTCAE)

CL Item

Gallbladder Necrosis (Gallbladder necrosis)

E11195 (CTCAE)

CL Item

Gallbladder Obstruction (Gallbladder obstruction)

E11198 (CTCAE)

CL Item

Gallbladder Pain (Gallbladder pain)

E11204 (CTCAE)

CL Item

Gallbladder Perforation (Gallbladder perforation)

E11208 (CTCAE)

CL Item

Gastric Anastomotic Leak (Gastric anastomotic leak)

E11709 (CTCAE)

CL Item

Gastric Fistula (Gastric fistula)

E10700 (CTCAE)

CL Item

Gastric Hemorrhage (Gastric hemorrhage)

E10706 (CTCAE)

CL Item

Gastric Necrosis (Gastric necrosis)

E10712 (CTCAE)

CL Item

Gastric Perforation (Gastric perforation)

E10716 (CTCAE)

CL Item

Gastric Stenosis (Gastric stenosis)

E10721 (CTCAE)

CL Item

Gastric Ulcer (Gastric ulcer)

E10727 (CTCAE)

CL Item

Gastritis (Gastritis)

E10733 (CTCAE)

CL Item

Gastroesophageal Reflux Disease (Gastroesophageal reflux disease)

E10739 (CTCAE)

CL Item

Gastrointestinal Anastomotic Leak (Gastrointestinal anastomotic leak)

E11715 (CTCAE)

CL Item

Gastrointestinal Disorders - Other, Specify (Gastrointestinal disorders - Other, Specify)

E10743 (CTCAE)

CL Item

Gastrointestinal Fistula (Gastrointestinal fistula)

E10749 (CTCAE)

CL Item

Gastrointestinal Pain (Gastrointestinal pain)

E10755 (CTCAE)

CL Item

Gastrointestinal Stoma Necrosis (Gastrointestinal stoma necrosis)

E11721 (CTCAE)

CL Item

Gastroparesis (Gastroparesis)

E10759 (CTCAE)

CL Item

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

E11116 (CTCAE)

CL Item

Generalized Muscle Weakness (Generalized muscle weakness)

E12418 (CTCAE)

CL Item

Genital Edema (Genital edema)

E13111 (CTCAE)

CL Item

Ggt Increased (GGT increased)

E12161 (CTCAE)

CL Item

Gingival Pain (Gingival pain)

E10763 (CTCAE)

CL Item

Glaucoma (Glaucoma)

E10392 (CTCAE)

CL Item

Glossopharyngeal Nerve Disorder (Glossopharyngeal nerve disorder)

E12672 (CTCAE)

CL Item

Glucose Intolerance (Glucose intolerance)

E12264 (CTCAE)

CL Item

Growth Accelerated (Growth accelerated)

E10317 (CTCAE)

CL Item

Growth Hormone Abnormal (Growth hormone abnormal)

E12166 (CTCAE)

CL Item

Growth Suppression (Growth suppression)

E12422 (CTCAE)

CL Item

Gum Infection (Gum infection)

E11400 (CTCAE)

CL Item

Gynecomastia (Gynecomastia)

E13115 (CTCAE)

CL Item

Hallucinations (Hallucinations)

E12919 (CTCAE)

CL Item

Haptoglobin Decreased (Haptoglobin decreased)

E12169 (CTCAE)

CL Item

Head Soft Tissue Necrosis (Head soft tissue necrosis)

E12426 (CTCAE)

CL Item

Headache (Headache)

E12678 (CTCAE)

CL Item

Hearing Impaired (Hearing impaired)

E10276 (CTCAE)

CL Item

Heart Failure (Heart failure)

E10124 (CTCAE)

CL Item

Hematoma (Hematoma)

E13775 (CTCAE)

CL Item

Hematosalpinx (Hematosalpinx)

E13119 (CTCAE)

CL Item

Hematuria (Hematuria)

E13000 (CTCAE)

CL Item

Hemoglobin Increased (Hemoglobin increased)

E12171 (CTCAE)

CL Item

Hemoglobinuria (Hemoglobinuria)

E13006 (CTCAE)

CL Item

Hemolysis (Hemolysis)

E10037 (CTCAE)

CL Item

Hemolytic Uremic Syndrome (Hemolytic uremic syndrome)

E10043 (CTCAE)

CL Item

Hemorrhoidal Hemorrhage (Hemorrhoidal hemorrhage)

E10767 (CTCAE)

CL Item

Hemorrhoids (Hemorrhoids)

E10773 (CTCAE)

CL Item

Hepatic Failure (Hepatic failure)

E11211 (CTCAE)

CL Item

Hepatic Hemorrhage (Hepatic hemorrhage)

E11215 (CTCAE)

CL Item

Hepatic Infection (Hepatic infection)

E11406 (CTCAE)

CL Item

Hepatic Necrosis (Hepatic necrosis)

E11221 (CTCAE)

CL Item

Hepatic Pain (Hepatic pain)

E11224 (CTCAE)

CL Item

Hepatitis Viral (Hepatitis viral)

E11410 (CTCAE)

CL Item

Hepatobiliary Disorders - Other, Specify (Hepatobiliary disorders - Other, Specify)

E11228 (CTCAE)

CL Item

Hiccups (Hiccups)

E13380 (CTCAE)

CL Item

Hip Fracture (Hip fracture)

E11726 (CTCAE)

CL Item

Hirsutism (Hirsutism)

E13642 (CTCAE)

CL Item

Hoarseness (Hoarseness)

E13384 (CTCAE)

CL Item

Hot Flashes (Hot flashes)

E13781 (CTCAE)

CL Item

Hydrocephalus (Hydrocephalus)

E12682 (CTCAE)

CL Item

Hypercalcemia (Hypercalcemia)

E12270 (CTCAE)

CL Item

Hyperglycemia (Hyperglycemia)

E12276 (CTCAE)

CL Item

Hyperhidrosis (Hyperhidrosis)

E13645 (CTCAE)

CL Item

Hyperkalemia (Hyperkalemia)

E12282 (CTCAE)

CL Item

Hypermagnesemia (Hypermagnesemia)

E12288 (CTCAE)

CL Item

Hypernatremia (Hypernatremia)

E12293 (CTCAE)

CL Item

Hyperparathyroidism (Hyperparathyroidism)

E10319 (CTCAE)

CL Item

Hypersomnia (Hypersomnia)

E12688 (CTCAE)

CL Item

Hypertension (Hypertension)

E13785 (CTCAE)

CL Item

Hyperthyroidism (Hyperthyroidism)

E10322 (CTCAE)

CL Item

Hypertrichosis (Hypertrichosis)

E13649 (CTCAE)

CL Item

Hypertriglyceridemia (Hypertriglyceridemia)

E12299 (CTCAE)

CL Item

Hyperuricemia (Hyperuricemia)

E12305 (CTCAE)

CL Item

Hypoalbuminemia (Hypoalbuminemia)

E12310 (CTCAE)

CL Item

Hypocalcemia (Hypocalcemia)

E12316 (CTCAE)

CL Item

Hypoglossal Nerve Disorder (Hypoglossal nerve disorder)

E12692 (CTCAE)

CL Item

Hypoglycemia (Hypoglycemia)

E12322 (CTCAE)

CL Item

Hypohidrosis (Hypohidrosis)

E13652 (CTCAE)

CL Item

Hypokalemia (Hypokalemia)

E12327 (CTCAE)

CL Item

Hypomagnesemia (Hypomagnesemia)

E12333 (CTCAE)

CL Item

Hyponatremia (Hyponatremia)

E12339 (CTCAE)

CL Item

Hypoparathyroidism (Hypoparathyroidism)

E10328 (CTCAE)

CL Item

Hypophosphatemia (Hypophosphatemia)

E12344 (CTCAE)

CL Item

Hypotension (Hypotension)

E13791 (CTCAE)

CL Item

Hypothermia (Hypothermia)

E11122 (CTCAE)

CL Item

Hypothyroidism (Hypothyroidism)

E10334 (CTCAE)

CL Item

Hypoxia (Hypoxia)

E13388 (CTCAE)

CL Item

Ileal Fistula (Ileal fistula)

E10777 (CTCAE)

CL Item

Ileal Hemorrhage (Ileal hemorrhage)

E10783 (CTCAE)

CL Item

Ileal Obstruction (Ileal obstruction)

E10789 (CTCAE)

CL Item

Ileal Perforation (Ileal perforation)

E10795 (CTCAE)

CL Item

Ileal Stenosis (Ileal stenosis)

E10800 (CTCAE)

CL Item

Ileal Ulcer (Ileal ulcer)

E10806 (CTCAE)

CL Item

Ileus (Ileus)

E10812 (CTCAE)

CL Item

Immune System Disorders - Other, Specify (Immune system disorders - Other, Specify)

E11270 (CTCAE)

CL Item

Infections And Infestations - Other, Specify (Infections and infestations - Other, Specify)

E11415 (CTCAE)

CL Item

Infective Myositis (Infective myositis)

E11421 (CTCAE)

CL Item

Infusion Related Reaction (Infusion related reaction)

E11127 (CTCAE)

CL Item

Infusion Site Extravasation (Infusion site extravasation)

E11133 (CTCAE)

CL Item

Injection Site Reaction (Injection site reaction)

E11138 (CTCAE)

CL Item

Injury To Carotid Artery (Injury to carotid artery)

E11730 (CTCAE)

CL Item

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

E11734 (CTCAE)

CL Item

Injury To Jugular Vein (Injury to jugular vein)

E11737 (CTCAE)

CL Item

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

E11741 (CTCAE)

CL Item

Injury, Poisoning And Procedural Complications - Other, Specify (Injury, poisoning and procedural complications - Other, Specify)

E11747 (CTCAE)

CL Item

Inr Increased (INR increased)

E12175 (CTCAE)

CL Item

Insomnia (Insomnia)

E12925 (CTCAE)

CL Item

Intestinal Stoma Leak (Intestinal stoma leak)

E11753 (CTCAE)

CL Item

Intestinal Stoma Obstruction (Intestinal stoma obstruction)

E11759 (CTCAE)

CL Item

Intestinal Stoma Site Bleeding (Intestinal stoma site bleeding)

E11764 (CTCAE)

CL Item

Intra-abdominal Hemorrhage (Intra-abdominal hemorrhage)

E10817 (CTCAE)

CL Item

Intracranial Hemorrhage (Intracranial hemorrhage)

E12696 (CTCAE)

CL Item

Intraoperative Arterial Injury (Intraoperative arterial injury)

E11770 (CTCAE)

CL Item

Intraoperative Breast Injury (Intraoperative breast injury)

E11776 (CTCAE)

CL Item

Intraoperative Cardiac Injury (Intraoperative cardiac injury)

E11782 (CTCAE)

CL Item

Intraoperative Ear Injury (Intraoperative ear injury)

E11786 (CTCAE)

CL Item

Intraoperative Endocrine Injury (Intraoperative endocrine injury)

E11792 (CTCAE)

CL Item

Intraoperative Gastrointestinal Injury (Intraoperative gastrointestinal injury)

E11798 (CTCAE)

CL Item

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

E11804 (CTCAE)

CL Item

Intraoperative Hemorrhage (Intraoperative hemorrhage)

E11810 (CTCAE)

CL Item

Intraoperative Hepatobiliary Injury (Intraoperative hepatobiliary injury)

E11814 (CTCAE)

CL Item

Intraoperative Musculoskeletal Injury (Intraoperative musculoskeletal injury)

E11820 (CTCAE)

CL Item

Intraoperative Neurological Injury (Intraoperative neurological injury)

E11826 (CTCAE)

CL Item

Intraoperative Ocular Injury (Intraoperative ocular injury)

E11832 (CTCAE)

CL Item

Intraoperative Renal Injury (Intraoperative renal injury)

E11838 (CTCAE)

CL Item

Intraoperative Reproductive Tract Injury (Intraoperative reproductive tract injury)

E11844 (CTCAE)

CL Item

Intraoperative Respiratory Injury (Intraoperative respiratory injury)

E11850 (CTCAE)

CL Item

Intraoperative Skin Injury (Intraoperative skin injury)

E11856 (CTCAE)

CL Item

Intraoperative Splenic Injury (Intraoperative splenic injury)

E11862 (CTCAE)

CL Item

Intraoperative Urinary Injury (Intraoperative urinary injury)

E11867 (CTCAE)

CL Item

Intraoperative Venous Injury (Intraoperative venous injury)

E11873 (CTCAE)

CL Item

Investigations - Other, Specify (Investigations - Other, Specify)

E12179 (CTCAE)

CL Item

Iron Overload (Iron overload)

E12350 (CTCAE)

CL Item

Irregular Menstruation (Irregular menstruation)

E13125 (CTCAE)

CL Item

Irritability (Irritability)

E11144 (CTCAE)

CL Item

Ischemia Cerebrovascular (Ischemia cerebrovascular)

E12702 (CTCAE)

CL Item

Ivth Nerve Disorder (IVth nerve disorder)

E12705 (CTCAE)

CL Item

Jejunal Fistula (Jejunal fistula)

E10822 (CTCAE)

CL Item

Jejunal Hemorrhage (Jejunal hemorrhage)

E10828 (CTCAE)

CL Item

Jejunal Obstruction (Jejunal obstruction)

E10834 (CTCAE)

CL Item

Jejunal Perforation (Jejunal perforation)

E10840 (CTCAE)

CL Item

Jejunal Stenosis (Jejunal stenosis)

E10845 (CTCAE)

CL Item

Jejunal Ulcer (Jejunal ulcer)

E10851 (CTCAE)

CL Item

Joint Effusion (Joint effusion)

E12431 (CTCAE)

CL Item

Joint Infection (Joint infection)

E11426 (CTCAE)

CL Item

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

E12435 (CTCAE)

CL Item

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

E12439 (CTCAE)

CL Item

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

E12443 (CTCAE)

CL Item

Keratitis (Keratitis)

E10397 (CTCAE)

CL Item

Kidney Anastomotic Leak (Kidney anastomotic leak)

E11879 (CTCAE)

CL Item

Kidney Infection (Kidney infection)

E11431 (CTCAE)

CL Item

Kyphosis (Kyphosis)

E12447 (CTCAE)

CL Item

Lactation Disorder (Lactation disorder)

E13129 (CTCAE)

CL Item

Large Intestinal Anastomotic Leak (Large intestinal anastomotic leak)

E11885 (CTCAE)

CL Item

Laryngeal Edema (Laryngeal edema)

E13393 (CTCAE)

CL Item

Laryngeal Fistula (Laryngeal fistula)

E13399 (CTCAE)

CL Item

Laryngeal Hemorrhage (Laryngeal hemorrhage)

E13405 (CTCAE)

CL Item

Laryngeal Inflammation (Laryngeal inflammation)

E13411 (CTCAE)

CL Item

Laryngeal Mucositis (Laryngeal mucositis)

E13415 (CTCAE)

CL Item

Laryngeal Obstruction (Laryngeal obstruction)

E13421 (CTCAE)

CL Item

Laryngeal Stenosis (Laryngeal stenosis)

E13427 (CTCAE)

CL Item

Laryngitis (Laryngitis)

E11435 (CTCAE)

CL Item

Laryngopharyngeal Dysesthesia (Laryngopharyngeal dysesthesia)

E13433 (CTCAE)

CL Item

Laryngospasm (Laryngospasm)

E13439 (CTCAE)

CL Item

Left Ventricular Systolic Dysfunction (Left ventricular systolic dysfunction)

E10130 (CTCAE)

CL Item

Lethargy (Lethargy)

E12709 (CTCAE)

CL Item

Leukemia Secondary To Oncology Chemotherapy (Leukemia secondary to oncology chemotherapy)

E12549 (CTCAE)

CL Item

Leukocytosis (Leukocytosis)

E10048 (CTCAE)

CL Item

Leukoencephalopathy (Leukoencephalopathy)

E12712 (CTCAE)

CL Item

Libido Decreased (Libido decreased)

E12929 (CTCAE)

CL Item

Libido Increased (Libido increased)

E12932 (CTCAE)

CL Item

Lip Infection (Lip infection)

E11440 (CTCAE)

CL Item

Lip Pain (Lip pain)

E10857 (CTCAE)

CL Item

Lipase Increased (Lipase increased)

E12185 (CTCAE)

CL Item

Lipohypertrophy (Lipohypertrophy)

E13657 (CTCAE)

CL Item

Localized Edema (Localized edema)

E11148 (CTCAE)

CL Item

Lordosis (Lordosis)

E12451 (CTCAE)

CL Item

Lower Gastrointestinal Hemorrhage (Lower gastrointestinal hemorrhage)

E10861 (CTCAE)

CL Item

Lung Infection (Lung infection)

E11444 (CTCAE)

CL Item

Lymph Gland Infection (Lymph gland infection)

E11449 (CTCAE)

CL Item

Lymph Leakage (Lymph leakage)

E13797 (CTCAE)

CL Item

Lymph Node Pain (Lymph node pain)

E10052 (CTCAE)

CL Item

Lymphedema (Lymphedema)

E13802 (CTCAE)

CL Item

Lymphocele (Lymphocele)

E13806 (CTCAE)

CL Item

Lymphocyte Count Decreased (Lymphocyte count decreased)

E12190 (CTCAE)

CL Item

Lymphocyte Count Increased (Lymphocyte count increased)

E12195 (CTCAE)

CL Item

Malabsorption (Malabsorption)

E10867 (CTCAE)

CL Item

Malaise (Malaise)

E11152 (CTCAE)

CL Item

Mania (Mania)

E12936 (CTCAE)

CL Item

Mediastinal Hemorrhage (Mediastinal hemorrhage)

E13444 (CTCAE)

CL Item

Mediastinal Infection (Mediastinal infection)

E11454 (CTCAE)

CL Item

Memory Impairment (Memory impairment)

E12718 (CTCAE)

CL Item

Meningismus (Meningismus)

E12722 (CTCAE)

CL Item

Meningitis (Meningitis)

E11458 (CTCAE)

CL Item

Menopause (Menopause)

E13750 (CTCAE)

CL Item

Menorrhagia (Menorrhagia)

E13132 (CTCAE)

CL Item

Metabolism And Nutrition Disorders - Other, Specify (Metabolism and nutrition disorders - Other, Specify)

E12355 (CTCAE)

CL Item

Middle Ear Inflammation (Middle ear inflammation)

E10281 (CTCAE)

CL Item

Mitral Valve Disease (Mitral valve disease)

E10134 (CTCAE)

CL Item

Mobitz (type) Ii Atrioventricular Block (Mobitz (type) II atrioventricular block)

E10140 (CTCAE)

CL Item

Mobitz Type I (Mobitz type I)

E10146 (CTCAE)

CL Item

Movements Involuntary (Movements involuntary)

E12728 (CTCAE)

CL Item

Mucosal Infection (Mucosal infection)

E11462 (CTCAE)

CL Item

Mucositis Oral (Mucositis oral)

E10872 (CTCAE)

CL Item

Multi-organ Failure (Multi-organ failure)

E11155 (CTCAE)

CL Item

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

E12455 (CTCAE)

CL Item

Muscle Weakness Lower Limb (Muscle weakness lower limb)

E12459 (CTCAE)

CL Item

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

E12463 (CTCAE)

CL Item

Muscle Weakness Trunk (Muscle weakness trunk)

E12467 (CTCAE)

CL Item

Muscle Weakness Upper Limb (Muscle weakness upper limb)

E12471 (CTCAE)

CL Item

Musculoskeletal And Connective Tissue Disorder - Other, Specify (Musculoskeletal and connective tissue disorders - Other, Specify)

E12475 (CTCAE)

CL Item

Musculoskeletal Deformity (Musculoskeletal deformity)

E12481 (CTCAE)

CL Item

Myalgia (Myalgia)

E12485 (CTCAE)

CL Item

Myelitis (Myelitis)

E12732 (CTCAE)

CL Item

Myelodysplastic Syndrome (Myelodysplastic syndrome)

E12552 (CTCAE)

CL Item

Myocardial Infarction (Myocardial infarction)

E10152 (CTCAE)

CL Item

Myocarditis (Myocarditis)

E10157 (CTCAE)

CL Item

Myositis (Myositis)

E12489 (CTCAE)

CL Item

Nail Discoloration (Nail discoloration)

E13661 (CTCAE)

CL Item

Nail Infection (Nail infection)

E11468 (CTCAE)

CL Item

Nail Loss (Nail loss)

E13663 (CTCAE)

CL Item

Nail Ridging (Nail ridging)

E13666 (CTCAE)

CL Item

Nasal Congestion (Nasal congestion)

E13450 (CTCAE)

CL Item

Nausea (Nausea)

E10878 (CTCAE)

CL Item

Neck Edema (Neck edema)

E11159 (CTCAE)

CL Item

Neck Pain (Neck pain)

E12493 (CTCAE)

CL Item

Neck Soft Tissue Necrosis (Neck soft tissue necrosis)

E12497 (CTCAE)

CL Item

Neoplasms Benign, Malignant And Unspecified (incl Cysts And Polyps) - Other, Specify (Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Specify)

E12555 (CTCAE)

CL Item

Nervous System Disorders - Other, Specify (Nervous system disorders - Other, Specify)

E12738 (CTCAE)

CL Item

Neuralgia (Neuralgia)

E12744 (CTCAE)

CL Item

Neutrophil Count Decreased (Neutrophil count decreased)

E12198 (CTCAE)

CL Item

Night Blindness (Night blindness)

E10401 (CTCAE)

CL Item

Nipple Deformity (Nipple deformity)

E13138 (CTCAE)

CL Item

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

E11163 (CTCAE)

CL Item

Nystagmus (Nystagmus)

E12748 (CTCAE)

CL Item

Obesity (Obesity)

E12361 (CTCAE)

CL Item

Obstruction Gastric (Obstruction gastric)

E10882 (CTCAE)

CL Item

Oculomotor Nerve Disorder (Oculomotor nerve disorder)

E12751 (CTCAE)

CL Item

Olfactory Nerve Disorder (Olfactory nerve disorder)

E12755 (CTCAE)

CL Item

Oligospermia (Oligospermia)

E13141 (CTCAE)

CL Item

Optic Nerve Disorder (Optic nerve disorder)

E10406 (CTCAE)

CL Item

Oral Cavity Fistula (Oral cavity fistula)

E10888 (CTCAE)

CL Item

Oral Dysesthesia (Oral dysesthesia)

E10894 (CTCAE)

CL Item

Oral Hemorrhage (Oral hemorrhage)

E10898 (CTCAE)

CL Item

Oral Pain (Oral pain)

E10904 (CTCAE)

CL Item

Osteonecrosis Of Jaw (Osteonecrosis of jaw)

E12502 (CTCAE)

CL Item

Osteoporosis (Osteoporosis)

E12508 (CTCAE)

CL Item

Otitis Externa (Otitis externa)

E11472 (CTCAE)

CL Item

Otitis Media (Otitis media)

E11477 (CTCAE)

CL Item

Ovarian Hemorrhage (Ovarian hemorrhage)

E13145 (CTCAE)

CL Item

Ovarian Infection (Ovarian infection)

E11482 (CTCAE)

CL Item

Ovarian Rupture (Ovarian rupture)

E13151 (CTCAE)

CL Item

Ovulation Pain (Ovulation pain)

E13157 (CTCAE)

CL Item

Pain (Pain)

E11167 (CTCAE)

CL Item

Pain In Extremity (Pain in extremity)

E12512 (CTCAE)

CL Item

Pain Of Skin (Pain of skin)

E13668 (CTCAE)

CL Item

Palmar-plantar Erythrodysesthesia Syndrome (Palmar-plantar erythrodysesthesia syndrome)

E13672 (CTCAE)

CL Item

Palpitations (Palpitations)

E10163 (CTCAE)

CL Item

Pancreas Infection (Pancreas infection)

E11487 (CTCAE)

CL Item

Pancreatic Anastomotic Leak (Pancreatic anastomotic leak)

E11891 (CTCAE)

CL Item

Pancreatic Duct Stenosis (Pancreatic duct stenosis)

E10908 (CTCAE)

CL Item

Pancreatic Enzymes Decreased (Pancreatic enzymes decreased)

E12203 (CTCAE)

CL Item

Pancreatic Fistula (Pancreatic fistula)

E10914 (CTCAE)

CL Item

Pancreatic Hemorrhage (Pancreatic hemorrhage)

E10920 (CTCAE)

CL Item

Pancreatic Necrosis (Pancreatic necrosis)

E10926 (CTCAE)

CL Item

Pancreatitis (Pancreatitis)

E10930 (CTCAE)

CL Item

Papilledema (Papilledema)

E10411 (CTCAE)

CL Item

Papulopustular Rash (Papulopustular rash)

E11491 (CTCAE)

CL Item

Paresthesia (Paresthesia)

E12758 (CTCAE)

CL Item

Paronychia (Paronychia)

E11497 (CTCAE)

CL Item

Paroxysmal Atrial Tachycardia (Paroxysmal atrial tachycardia)

E10166 (CTCAE)

CL Item

Pelvic Floor Muscle Weakness (Pelvic floor muscle weakness)

E13161 (CTCAE)

CL Item

Pelvic Infection (Pelvic infection)

E11501 (CTCAE)

CL Item

Pelvic Pain (Pelvic pain)

E13167 (CTCAE)

CL Item

Pelvic Soft Tissue Necrosis (Pelvic soft tissue necrosis)

E12516 (CTCAE)

CL Item

Penile Infection (Penile infection)

E11506 (CTCAE)

CL Item

Penile Pain (Penile pain)

E13171 (CTCAE)

CL Item

Perforation Bile Duct (Perforation bile duct)

E11234 (CTCAE)

CL Item

Pericardial Effusion (Pericardial effusion)

E10172 (CTCAE)

CL Item

Pericardial Tamponade (Pericardial tamponade)

E10177 (CTCAE)

CL Item

Pericarditis (Pericarditis)

E10180 (CTCAE)

CL Item

Perineal Pain (Perineal pain)

E13175 (CTCAE)

CL Item

Periodontal Disease (Periodontal disease)

E10935 (CTCAE)

CL Item

Periorbital Edema (Periorbital edema)

E13676 (CTCAE)

CL Item

Periorbital Infection (Periorbital infection)

E11511 (CTCAE)

CL Item

Peripheral Ischemia (Peripheral ischemia)

E13810 (CTCAE)

CL Item

Peripheral Motor Neuropathy (Peripheral motor neuropathy)

E12762 (CTCAE)

CL Item

Peripheral Nerve Infection (Peripheral nerve infection)

E11516 (CTCAE)

CL Item

Peripheral Sensory Neuropathy (Peripheral sensory neuropathy)

E12768 (CTCAE)

CL Item

Peritoneal Infection (Peritoneal infection)

E11521 (CTCAE)

CL Item

Peritoneal Necrosis (Peritoneal necrosis)

E10939 (CTCAE)

CL Item

Personality Change (Personality change)

E12942 (CTCAE)

CL Item

Phantom Pain (Phantom pain)

E12774 (CTCAE)

CL Item

Pharyngeal Anastomotic Leak (Pharyngeal anastomotic leak)

E11897 (CTCAE)

CL Item

Pharyngeal Fistula (Pharyngeal fistula)

E13454 (CTCAE)

CL Item

Pharyngeal Hemorrhage (Pharyngeal hemorrhage)

E13460 (CTCAE)

CL Item

Pharyngeal Mucositis (Pharyngeal mucositis)

E13466 (CTCAE)

CL Item

Pharyngeal Necrosis (Pharyngeal necrosis)

E13472 (CTCAE)

CL Item

Pharyngeal Stenosis (Pharyngeal stenosis)

E13476 (CTCAE)

CL Item

Pharyngitis (Pharyngitis)

E11525 (CTCAE)

CL Item

Pharyngolaryngeal Pain (Pharyngolaryngeal pain)

E13482 (CTCAE)

CL Item

Phlebitis (Phlebitis)

E13815 (CTCAE)

CL Item

Phlebitis Infective (Phlebitis infective)

E11530 (CTCAE)

CL Item

Photophobia (Photophobia)

E10416 (CTCAE)

CL Item

Photosensitivity (Photosensitivity)

E13680 (CTCAE)

CL Item

Platelet Count Decreased (Platelet count decreased)

E12207 (CTCAE)

CL Item

Pleural Effusion (Pleural effusion)

E13486 (CTCAE)

CL Item

Pleural Hemorrhage (Pleural hemorrhage)

E13492 (CTCAE)

CL Item

Pleural Infection (Pleural infection)

E11535 (CTCAE)

CL Item

Pleuritic Pain (Pleuritic pain)

E13498 (CTCAE)

CL Item

Pneumonitis (Pneumonitis)

E13502 (CTCAE)

CL Item

Pneumothorax (Pneumothorax)

E13508 (CTCAE)

CL Item

Portal Hypertension (Portal hypertension)

E11238 (CTCAE)

CL Item

Portal Vein Thrombosis (Portal vein thrombosis)

E11243 (CTCAE)

CL Item

Postnasal Drip (Postnasal drip)

E13514 (CTCAE)

CL Item

Postoperative Hemorrhage (Postoperative hemorrhage)

E11903 (CTCAE)

CL Item

Postoperative Thoracic Procedure Complication (Postoperative thoracic procedure complication)

E11909 (CTCAE)

CL Item

Precocious Puberty (Precocious puberty)

E10340 (CTCAE)

CL Item

Pregnancy, Puerperium And Perinatal Conditions - Other, Specify (Pregnancy, puerperium and perinatal conditions - Other, Specify)

E12861 (CTCAE)

CL Item

Premature Delivery (Premature delivery)

E12867 (CTCAE)

CL Item

Premature Menopause (Premature menopause)

E13179 (CTCAE)

CL Item

Presyncope (Presyncope)

E12778 (CTCAE)

CL Item

Proctitis (Proctitis)

E10943 (CTCAE)

CL Item

Productive Cough (Productive cough)

E13517 (CTCAE)

CL Item

Prolapse Of Intestinal Stoma (Prolapse of intestinal stoma)

E11914 (CTCAE)

CL Item

Prolapse Of Urostomy (Prolapse of urostomy)

E11920 (CTCAE)

CL Item

Prostate Infection (Prostate infection)

E11540 (CTCAE)

CL Item

Prostatic Hemorrhage (Prostatic hemorrhage)

E13181 (CTCAE)

CL Item

Prostatic Obstruction (Prostatic obstruction)

E13187 (CTCAE)

CL Item

Prostatic Pain (Prostatic pain)

E13191 (CTCAE)

CL Item

Proteinuria (Proteinuria)

E13008 (CTCAE)

CL Item

Pruritus (Pruritus)

E13686 (CTCAE)

CL Item

Psychiatric Disorders - Other, Specify (Psychiatric disorders - Other, Specify)

E12948 (CTCAE)

CL Item

Psychosis (Psychosis)

E12954 (CTCAE)

CL Item

Pulmonary Edema (Pulmonary edema)

E13521 (CTCAE)

CL Item

Pulmonary Fibrosis (Pulmonary fibrosis)

E13527 (CTCAE)

CL Item

Pulmonary Fistula (Pulmonary fistula)

E13533 (CTCAE)

CL Item

Pulmonary Hypertension (Pulmonary hypertension)

E13539 (CTCAE)

CL Item

Pulmonary Valve Disease (Pulmonary valve disease)

E10186 (CTCAE)

CL Item

Purpura (Purpura)

E13690 (CTCAE)

CL Item

Pyramidal Tract Syndrome (Pyramidal tract syndrome)

E12780 (CTCAE)

CL Item

Radiation Recall Reaction (dermatologic) (Radiation recall reaction (dermatologic))

E11926 (CTCAE)

CL Item

Radiculitis (Radiculitis)

E12786 (CTCAE)

CL Item

Rash Acneiform (Rash acneiform)

E13694 (CTCAE)

CL Item

Rash Maculo-papular (Rash maculo-papular)

E13700 (CTCAE)

CL Item

Rash Pustular (Rash pustular)

E11545 (CTCAE)

CL Item

Rectal Anastomotic Leak (Rectal anastomotic leak)

E11932 (CTCAE)

CL Item

Rectal Fistula (Rectal fistula)

E10949 (CTCAE)

CL Item

Rectal Hemorrhage (Rectal hemorrhage)

E10955 (CTCAE)

CL Item

Rectal Mucositis (Rectal mucositis)

E10961 (CTCAE)

CL Item

Rectal Necrosis (Rectal necrosis)

E10967 (CTCAE)

CL Item

Rectal Obstruction (Rectal obstruction)

E10971 (CTCAE)

CL Item

Rectal Pain (Rectal pain)

E10977 (CTCAE)

CL Item

Rectal Perforation (Rectal perforation)

E10981 (CTCAE)

CL Item

Rectal Stenosis (Rectal stenosis)

E10986 (CTCAE)

CL Item

Rectal Ulcer (Rectal ulcer)

E10992 (CTCAE)

CL Item

Recurrent Laryngeal Nerve Palsy (Recurrent laryngeal nerve palsy)

E12792 (CTCAE)

CL Item

Renal And Urinary Disorders - Other, Specify (Renal and urinary disorders - Other, Specify)

E13012 (CTCAE)

CL Item

Renal Calculi (Renal calculi)

E13018 (CTCAE)

CL Item

Renal Colic (Renal colic)

E13024 (CTCAE)

CL Item

Renal Hemorrhage (Renal hemorrhage)

E13028 (CTCAE)

CL Item

Reproductive System And Breast Disorders - Other, Specify (Reproductive system and breast disorders - Other, Specify)

E13195 (CTCAE)

CL Item

Respiratory Failure (Respiratory failure)

E13545 (CTCAE)

CL Item

Respiratory, Thoracic And Mediastinal Disorders - Other, Specify (Respiratory, thoracic and mediastinal disorders - Other, Specify)

E13548 (CTCAE)

CL Item

Restlessness (Restlessness)

E12960 (CTCAE)

CL Item

Restrictive Cardiomyopathy (Restrictive cardiomyopathy)

E10192 (CTCAE)

CL Item

Retinal Detachment (Retinal detachment)

E10420 (CTCAE)

CL Item

Retinal Tear (Retinal tear)

E10425 (CTCAE)

CL Item

Retinal Vascular Disorder (Retinal vascular disorder)

E10429 (CTCAE)

CL Item

Retinoic Acid Syndrome (Retinoic acid syndrome)

E13554 (CTCAE)

CL Item

Retinopathy (Retinopathy)

E10432 (CTCAE)

CL Item

Retroperitoneal Hemorrhage (Retroperitoneal hemorrhage)

E10998 (CTCAE)

CL Item

Reversible Posterior Leukoencephalopathy Syndrome (Reversible posterior leukoencephalopathy syndrome)

E12798 (CTCAE)

CL Item

Rhinitis Infective (Rhinitis infective)

E11548 (CTCAE)

CL Item

Right Ventricular Dysfunction (Right ventricular dysfunction)

E10196 (CTCAE)

CL Item

Salivary Duct Inflammation (Salivary duct inflammation)

E11003 (CTCAE)

CL Item

Salivary Gland Fistula (Salivary gland fistula)

E11009 (CTCAE)

CL Item

Salivary Gland Infection (Salivary gland infection)

E11550 (CTCAE)

CL Item

Scalp Pain (Scalp pain)

E13704 (CTCAE)

CL Item

Scleral Disorder (Scleral disorder)

E10437 (CTCAE)

CL Item

Scoliosis (Scoliosis)

E12521 (CTCAE)

CL Item

Scrotal Infection (Scrotal infection)

E11555 (CTCAE)

CL Item

Scrotal Pain (Scrotal pain)

E13201 (CTCAE)

CL Item

Seizure (Seizure)

E12804 (CTCAE)

CL Item

Sepsis (Sepsis)

E11560 (CTCAE)

CL Item

Seroma (Seroma)

E11938 (CTCAE)

CL Item

Serum Amylase Increased (Serum amylase increased)

E12212 (CTCAE)

CL Item

Serum Sickness (Serum sickness)

E11276 (CTCAE)

CL Item

Sick Sinus Syndrome (Sick sinus syndrome)

E10202 (CTCAE)

CL Item

Sinus Bradycardia (Sinus bradycardia)

E10208 (CTCAE)

CL Item

Sinus Disorder (Sinus disorder)

E13560 (CTCAE)

CL Item

Sinus Pain (Sinus pain)

E12810 (CTCAE)

CL Item

Sinus Tachycardia (Sinus tachycardia)

E10214 (CTCAE)

CL Item

Sinusitis (Sinusitis)

E11563 (CTCAE)

CL Item

Skin And Subcutaneous Tissue Disorders - Other, Specify (Skin and subcutaneous tissue disorders - Other, Specify)

E13708 (CTCAE)

CL Item

Skin Atrophy (Skin atrophy)

E13714 (CTCAE)

CL Item

Skin Hyperpigmentation (Skin hyperpigmentation)

E13718 (CTCAE)

CL Item

Skin Hypopigmentation (Skin hypopigmentation)

E13721 (CTCAE)

CL Item

Skin Induration (Skin induration)

E13724 (CTCAE)

CL Item

Skin Infection (Skin infection)

E11568 (CTCAE)

CL Item

Skin Ulceration (Skin ulceration)

E13730 (CTCAE)

CL Item

Sleep Apnea (Sleep apnea)

E13566 (CTCAE)

CL Item

Small Intestinal Anastomotic Leak (Small intestinal anastomotic leak)

E11942 (CTCAE)

CL Item

Small Intestinal Mucositis (Small intestinal mucositis)

E11015 (CTCAE)

CL Item

Small Intestinal Obstruction (Small intestinal obstruction)

E11021 (CTCAE)

CL Item

Small Intestinal Perforation (Small intestinal perforation)

E11027 (CTCAE)

CL Item

Small Intestinal Stenosis (Small intestinal stenosis)

E11032 (CTCAE)

CL Item

Small Intestine Infection (Small intestine infection)

E11574 (CTCAE)

CL Item

Small Intestine Ulcer (Small intestine ulcer)

E11038 (CTCAE)

CL Item

Sneezing (Sneezing)

E13572 (CTCAE)

CL Item

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

E13754 (CTCAE)

CL Item

Soft Tissue Infection (Soft tissue infection)

E11579 (CTCAE)

CL Item

Soft Tissue Necrosis Lower Limb (Soft tissue necrosis lower limb)

E12525 (CTCAE)

CL Item

Soft Tissue Necrosis Upper Limb (Soft tissue necrosis upper limb)

E12530 (CTCAE)

CL Item

Somnolence (Somnolence)

E12814 (CTCAE)

CL Item

Sore Throat (Sore throat)

E13575 (CTCAE)

CL Item

Spasticity (Spasticity)

E12820 (CTCAE)

CL Item

Spermatic Cord Anastomotic Leak (Spermatic cord anastomotic leak)

E11948 (CTCAE)

CL Item

Spermatic Cord Hemorrhage (Spermatic cord hemorrhage)

E13205 (CTCAE)

CL Item

Spermatic Cord Obstruction (Spermatic cord obstruction)

E13211 (CTCAE)

CL Item

Spinal Fracture (Spinal fracture)

E11954 (CTCAE)

CL Item

Spleen Disorder (Spleen disorder)

E10056 (CTCAE)

CL Item

Splenic Infection (Splenic infection)

E11584 (CTCAE)

CL Item

Stenosis Of Gastrointestinal Stoma (Stenosis of gastrointestinal stoma)

E11960 (CTCAE)

CL Item

Stevens-johnson Syndrome (Stevens-Johnson syndrome)

E13736 (CTCAE)

CL Item

Stoma Site Infection (Stoma site infection)

E11588 (CTCAE)

CL Item

Stomach Pain (Stomach pain)

E11044 (CTCAE)

CL Item

Stomal Ulcer (Stomal ulcer)

E11965 (CTCAE)

CL Item

Stridor (Stridor)

E13579 (CTCAE)

CL Item

Stroke (Stroke)

E12826 (CTCAE)

CL Item

Sudden Death Nos (Sudden death NOS)

E11171 (CTCAE)

CL Item

Suicidal Ideation (Suicidal ideation)

E12964 (CTCAE)

CL Item

Suicide Attempt (Suicide attempt)

E12969 (CTCAE)

CL Item

Superficial Soft Tissue Fibrosis (Superficial soft tissue fibrosis)

E12535 (CTCAE)

CL Item

Superficial Thrombophlebitis (Superficial thrombophlebitis)

E13817 (CTCAE)

CL Item

Superior Vena Cava Syndrome (Superior vena cava syndrome)

E13819 (CTCAE)

CL Item

Supraventricular Tachycardia (Supraventricular tachycardia)

E10218 (CTCAE)

CL Item

Surgical And Medical Procedures - Other, Specify (Surgical and medical procedures - Other, Specify)

E13760 (CTCAE)

CL Item

Syncope (Syncope)

E12832 (CTCAE)

CL Item

Telangiectasia (Telangiectasia)

E13740 (CTCAE)

CL Item

Testicular Disorder (Testicular disorder)

E13215 (CTCAE)

CL Item

Testicular Hemorrhage (Testicular hemorrhage)

E13221 (CTCAE)

CL Item

Testicular Pain (Testicular pain)

E13227 (CTCAE)

CL Item

Thromboembolic Event (Thromboembolic event)

E13825 (CTCAE)

CL Item

Thrombotic Thrombocytopenic Purpura (Thrombotic thrombocytopenic purpura)

E10061 (CTCAE)

CL Item

Tinnitus (Tinnitus)

E10287 (CTCAE)

CL Item

Tooth Development Disorder (Tooth development disorder)

E11048 (CTCAE)

CL Item

Tooth Discoloration (Tooth discoloration)

E11052 (CTCAE)

CL Item

Tooth Infection (Tooth infection)

E11594 (CTCAE)

CL Item

Toothache (Toothache)

E11054 (CTCAE)

CL Item

Toxic Epidermal Necrolysis (Toxic epidermal necrolysis)

E13743 (CTCAE)

CL Item

Tracheal Fistula (Tracheal fistula)

E13583 (CTCAE)

CL Item

Tracheal Hemorrhage (Tracheal hemorrhage)

E11969 (CTCAE)

CL Item

Tracheal Mucositis (Tracheal mucositis)

E13589 (CTCAE)

CL Item

Tracheal Obstruction (Tracheal obstruction)

E11975 (CTCAE)

CL Item

Tracheal Stenosis (Tracheal stenosis)

E13595 (CTCAE)

CL Item

Tracheitis (Tracheitis)

E11599 (CTCAE)

CL Item

Tracheostomy Site Bleeding (Tracheostomy site bleeding)

E11981 (CTCAE)

CL Item

Transient Ischemic Attacks (Transient ischemic attacks)

E12834 (CTCAE)

CL Item

Treatment Related Secondary Malignancy (Treatment related secondary malignancy)

E12561 (CTCAE)

CL Item

Tremor (Tremor)

E12837 (CTCAE)

CL Item

Tricuspid Valve Disease (Tricuspid valve disease)

E10224 (CTCAE)

CL Item

Trigeminal Nerve Disorder (Trigeminal nerve disorder)

E12841 (CTCAE)

CL Item

Trismus (Trismus)

E12541 (CTCAE)

CL Item

Tumor Lysis Syndrome (Tumor lysis syndrome)

E12365 (CTCAE)

CL Item

Tumor Pain (Tumor pain)

E12565 (CTCAE)

CL Item

Typhlitis (Typhlitis)

E11058 (CTCAE)

CL Item

Unequal Limb Length (Unequal limb length)

E12545 (CTCAE)

CL Item

Unintended Pregnancy (Unintended pregnancy)

E12872 (CTCAE)

CL Item

Upper Gastrointestinal Hemorrhage (Upper gastrointestinal hemorrhage)

E11062 (CTCAE)

CL Item

Upper Respiratory Infection (Upper respiratory infection)

E11604 (CTCAE)

CL Item

Ureteric Anastomotic Leak (Ureteric anastomotic leak)

E11987 (CTCAE)

CL Item

Urethral Anastomotic Leak (Urethral anastomotic leak)

E11993 (CTCAE)

CL Item

Urethral Infection (Urethral infection)

E11609 (CTCAE)

CL Item

Urinary Fistula (Urinary fistula)

E13034 (CTCAE)

CL Item

Urinary Frequency (Urinary frequency)

E13039 (CTCAE)

CL Item

Urinary Incontinence (Urinary incontinence)

E13042 (CTCAE)

CL Item

Urinary Retention (Urinary retention)

E13046 (CTCAE)

CL Item

Urinary Tract Infection (Urinary tract infection)

E11614 (CTCAE)

CL Item

Urinary Tract Obstruction (Urinary tract obstruction)

E13052 (CTCAE)

CL Item

Urinary Tract Pain (Urinary tract pain)

E13058 (CTCAE)

CL Item

Urinary Urgency (Urinary urgency)

E13062 (CTCAE)

CL Item

Urine Discoloration (Urine discoloration)

E13065 (CTCAE)

CL Item

Urine Output Decreased (Urine output decreased)

E12217 (CTCAE)

CL Item

Urostomy Leak (Urostomy leak)

E11999 (CTCAE)

CL Item

Urostomy Obstruction (Urostomy obstruction)

E12005 (CTCAE)

CL Item

Urostomy Site Bleeding (Urostomy site bleeding)

E12011 (CTCAE)

CL Item

Urostomy Stenosis (Urostomy stenosis)

E12017 (CTCAE)

CL Item

Urticaria (Urticaria)

E13746 (CTCAE)

CL Item

Uterine Anastomotic Leak (Uterine anastomotic leak)

E12022 (CTCAE)

CL Item

Uterine Fistula (Uterine fistula)

E13231 (CTCAE)

CL Item

Uterine Hemorrhage (Uterine hemorrhage)

E13237 (CTCAE)

CL Item

Uterine Infection (Uterine infection)

E11619 (CTCAE)

CL Item

Uterine Obstruction (Uterine obstruction)

E13243 (CTCAE)

CL Item

Uterine Pain (Uterine pain)

E13247 (CTCAE)

CL Item

Uterine Perforation (Uterine perforation)

E12028 (CTCAE)

CL Item

Uveitis (Uveitis)

E10442 (CTCAE)

CL Item

Vaginal Anastomotic Leak (Vaginal anastomotic leak)

E12034 (CTCAE)

CL Item

Vaginal Discharge (Vaginal discharge)

E13251 (CTCAE)

CL Item

Vaginal Dryness (Vaginal dryness)

E13254 (CTCAE)

CL Item

Vaginal Fistula (Vaginal fistula)

E13258 (CTCAE)

CL Item

Vaginal Hemorrhage (Vaginal hemorrhage)

E13264 (CTCAE)

CL Item

Vaginal Infection (Vaginal infection)

E11624 (CTCAE)

CL Item

Vaginal Inflammation (Vaginal inflammation)

E13270 (CTCAE)

CL Item

Vaginal Obstruction (Vaginal obstruction)

E13276 (CTCAE)

CL Item

Vaginal Pain (Vaginal pain)

E13280 (CTCAE)

CL Item

Vaginal Perforation (Vaginal perforation)

E13284 (CTCAE)

CL Item

Vaginal Stricture (Vaginal stricture)

E13290 (CTCAE)

CL Item

Vaginismus (Vaginismus)

E13295 (CTCAE)

CL Item

Vagus Nerve Disorder (Vagus nerve disorder)

E12845 (CTCAE)

CL Item

Vas Deferens Anastomotic Leak (Vas deferens anastomotic leak)

E12040 (CTCAE)

CL Item

Vascular Access Complication (Vascular access complication)

E12046 (CTCAE)

CL Item

Vascular Disorders - Other, Specify (Vascular disorders - Other, Specify)

E13831 (CTCAE)

CL Item

Vasculitis (Vasculitis)

E13837 (CTCAE)

CL Item

Vasovagal Reaction (Vasovagal reaction)

E12851 (CTCAE)

CL Item

Venous Injury (Venous injury)

E12051 (CTCAE)

CL Item

Ventricular Arrhythmia (Ventricular arrhythmia)

E10230 (CTCAE)

CL Item

Ventricular Fibrillation (Ventricular fibrillation)

E10236 (CTCAE)

CL Item

Ventricular Tachycardia (Ventricular tachycardia)

E10239 (CTCAE)

CL Item

Vertigo (Vertigo)

E10291 (CTCAE)

CL Item

Vestibular Disorder (Vestibular disorder)

E10295 (CTCAE)

CL Item

Virilization (Virilization)

E10343 (CTCAE)

CL Item

Visceral Arterial Ischemia (Visceral arterial ischemia)

E13843 (CTCAE)

CL Item

Vital Capacity Abnormal (Vital capacity abnormal)

E12220 (CTCAE)

CL Item

Vitreous Hemorrhage (Vitreous hemorrhage)

E10447 (CTCAE)

CL Item

Voice Alteration (Voice alteration)

E13601 (CTCAE)

CL Item

Vomiting (Vomiting)

E11068 (CTCAE)

CL Item

Vulval Infection (Vulval infection)

E11629 (CTCAE)

CL Item

Watering Eyes (Watering eyes)

E10452 (CTCAE)

CL Item

Weight Gain (Weight gain)

E12224 (CTCAE)

CL Item

Weight Loss (Weight loss)

E12228 (CTCAE)

CL Item

Wheezing (Wheezing)

E13605 (CTCAE)

CL Item

White Blood Cell Decreased (White blood cell decreased)

E12232 (CTCAE)

CL Item

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

E10244 (CTCAE)

CL Item

Wound Complication (Wound complication)

E12057 (CTCAE)

CL Item

Wound Dehiscence (Wound dehiscence)

E12063 (CTCAE)

CL Item

Wound Infection (Wound infection)

E11635 (CTCAE)

CL Item

Wrist Fracture (Wrist fracture)

E12069 (CTCAE)

AdverseEventSeverityGrade

Item

CTC AE Grade

text

C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C49705 (NCI Thesaurus Property-2)
C1710065 (UMLS 2011AA Property-2)
C25676 (NCI Thesaurus Property-3)
C0439793 (UMLS 2011AA Property-3)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain-2)
C0441800 (UMLS 2011AA ValueDomain-2)
C25676 (NCI Thesaurus ValueDomain-3)
C0439793 (UMLS 2011AA ValueDomain-3)

CL.35

Code List

CTC AE Grade

CL Item

Absent Adverse Event (0)

C75533 (NCI Thesaurus)
C2699517 (UMLS 2011AA)

CL Item

Mild Adverse Event (1)

C84263 (NCI Thesaurus)
C1513302 (UMLS 2011AA)

CL Item

Moderate Adverse Event (2)

C84264 (NCI Thesaurus)
C1513374 (UMLS 2011AA)

CL Item

Severe Adverse Event (3)

C84265 (NCI Thesaurus)
C2919019 (UMLS 2011AA)

CL Item

Life Threatening Adverse Event (4)

C84266 (NCI Thesaurus)
C1517874 (UMLS 2011AA)

CL Item

Death Related To Adverse Event (5)

C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)

CTCAdverseEventReportBeginDate

Item

CTCAE Begin Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)

CTC Adverse Event Attribution Category

Item

CTC AE Attribution Code

text

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

CL.36

Code List

CTC AE Attribution Code

CL Item

Unrelated (Unrelated)

C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)

CL Item

Unlikely (Unlikely)

CL Item

Possible (Possible)

C0332149 (NCI Metathesaurus)

CL Item

Probable (Probable)

C0332148 (NCI Metathesaurus)

CL Item

Definite (Definite)

CL209464 (NCI Metathesaurus)

SAE report

Item

SAE report submitted

text

C38148 (NCI Thesaurus ValueDomain)
C1519255 (UMLS CUI-1)
C41331 (NCI Thesaurus ObjectClass)
C0684224 (UMLS CUI-2)
C25375 (NCI Thesaurus Property)
C54035 (NCI Thesaurus ObjectClass-2)

CL.37

Code List

SAE report submitted

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Comments

Item Group

Footer

Research Comments

Item

Comments

text

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

Responsible Person Signature

Item

Signature of Person Completing This Form

text

C25704 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C25657 (NCI Thesaurus ObjectClass-2)
C25678 (NCI Thesaurus Property)

Form Completion Date

Item

Date Form Originally Completed

date

C19464 (NCI Thesaurus ObjectClass)
C1549507 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

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Prostate Cancer NCT01546987 Follow-Up - RTOG 1115 F1: Phase III RT + Standard ADT vs RT + Enhanced ADT + TAK-700 Follow-Up Form - 3289581v1.0

INSTRUCTIONS: Submit this form at the appropriate follow-up interval. All dates to be reported mm-dd-yyyy unless otherwise indicated

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