ID

42619

Description

NCIC MA.32 Short Follow-Up Report Form A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=81DD7330-A8C4-A3E4-E040-BB89AD43612E

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=81DD7330-A8C4-A3E4-E040-BB89AD43612E

Keywords

Clinical Trial

Breast Neoplasms

Follow-Up Studies

Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT01101438 Follow-Up - NCIC MA.32 Short Follow-Up Report Form - 3026031v1.0

model
Details

Aim - The purpose of the Short Follow-Up Report is to collect follow-up information on all patients who have permanently discontinued protocol treatment. Follow-Up visits after end of protocol treatment must occur annually. Each Short Follow-Up Report Folder must contain information for the time interval between the most recent protocol-mandated clinic visit and the current protocol-mandated clinic visit. Completion A Short Follow-Up Report Folder must be completed within 6 weeks after each Follow-Up visit Timing of Investigations - The timing of protocol-required investigations for the interval covered by the Short Follow-Up Report is as follows: ¿ Physical exam - at each clinic visit ¿ Radiology - mammogram (annually from baseline mammogram) of any remaining breast tissue is required until the time of distant recurrence / progression or an incurable non-breast primary malignancy ¿ Adverse Events (AEs) - patients must be evaluated ONLY for adverse events that are related to protocol therapy at each clinic visit (except for cardiovascular adverse events associated with hospitalizations ¿ these need to be reported regardless of attribution).

1 forms

StudyEvent: NCIC MA.32 Short Follow-Up Report Form
1. Aim - The purpose of the Short Follow-Up Report is to collect follow-up information on all patients who have permanently discontinued protocol treatment. Follow-Up visits after end of protocol treatment must occur annually. Each Short Follow-Up Report Folder must contain information for the time interval between the most recent protocol-mandated clinic visit and the current protocol-mandated clinic visit. Completion A Short Follow-Up Report Folder must be completed within 6 weeks after each Follow-Up visit Timing of Investigations - The timing of protocol-required investigations for the interval covered by the Short Follow-Up Report is as follows: ¿ Physical exam - at each clinic visit ¿ Radiology - mammogram (annually from baseline mammogram) of any remaining breast tissue is required until the time of distant recurrence / progression or an incurable non-breast primary malignancy ¿ Adverse Events (AEs) - patients must be evaluated ONLY for adverse events that are related to protocol therapy at each clinic visit (except for cardiovascular adverse events associated with hospitalizations ¿ these need to be reported regardless of attribution).

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

TIMING OF REPORT - FOLLOW-UP

Item Group

Physical Exam

Follow-Up visit date

Item

Post-treatment follow-up visit date

date

C25164 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C16033 (NCI Thesaurus Property)
C3694716 (UMLS CUI-1)

Off Treatment Report Period

Item

Off Treatment Report Period

text

C25190 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25601 (NCI Thesaurus Property-2)
C25207 (NCI Thesaurus Property-3)
C25284 (NCI Thesaurus ValueDomain)

CL.1

Code List

Off Treatment Report Period

CL Item

12 Months (12 months)

CL Item

24 Months (24 months)

CL Item

36 Months (36 months)

CL Item

48 Months (48 months)

CL Item

60 Months (60 months)

CL Item

72 Months (72 months)

CL Item

Other (Other)

Assessment Period

Item

Assessment Period, Specify

text

C25685 (NCI Thesaurus ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)

PatientVisitType

Item

Visit Type

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25716 (NCI Thesaurus Property)
C0545082 (UMLS 2011AA Property)

CL.2

Code List

Visit Type

CL Item

Prior To The Appearance Of Any Invasive Cancer (Prior to the appearance of any invasive cancer)

CL Item

After Local Breast Cancer Recurrence But No Distant Recurrence (After local breast cancer recurrence but no distant recurrence)

CL Item

After Distant Recurrence/progression (After distant recurrence/progression)

CL Item

After Contralateral Breast Carcinoma Only (After contralateral breast carcinoma only)

CL Item

After New Non-breast Primary Malignancy, Treated With Curative Intent (After new non-breast primary malignancy, treated with curative intent)

CL Item

After New Non-breast Primary Malignancy, Incurable (After new non-breast primary malignancy, incurable)

Patient Weight

Item

Weight (kg)

float

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

PersonBodyMassIndexValue

Item

BMI

float

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

DISEASE STATUS

Item Group

Disease Status

CancerFollow-UpMostRecentStatus

Item

Status of Most Recent Clinical Assessment

text

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

CL.3

Code List

Status of Most Recent Clinical Assessment

CL Item

No Evidence Of Disease (No evidence of disease)

CL Item

Cancer Present (Cancer present)

IN SITU DISEASE FOLLOW-UP

Item Group

In Situ Disease Follow-up

DuctalBreastCarcinomainSituHistologicallyConfirmedInd-2

Item

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

boolean

C38147 (NCI Thesaurus ValueDomain)
C25458 (NCI Thesaurus Property)
C2924 (NCI Thesaurus ObjectClass)
C25527 (NCI Thesaurus Property-2)
C1512698 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
C0007124 (UMLS CUI-3)
C0205462 (UMLS CUI-4)

PrimaryTumorLateralityType

Item

Tumor Laterality (If yes,)

text

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

DuctalBreastCarcinomainSituHistologicallyRadiologicFindingConfirmedDate

Item

Date of radiologic detection of DCIS (If yes,)

date

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

DuctalBreastCarcinomainSituHistologicallyConfirmedDate

Item

Date of histologic DCIS diagnosis (If yes,)

date

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

KIT RETURN - QUESTION

Item Group

Kit Return - Question

TreatmentKitReturnInd-2

Item

Have any treatment kits been returned this reporting period

boolean

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

KIT RETURN

Item Group

Kit Return

BlindedProtocolAgentIdentifierNumber

Item

Kit number

text

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

PillsRemainingCount

Item

Number of pills returned

float

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

KIT DISPENSION - QUESTION

Item Group

Kit Dispension - Question

TreatmentKitDispenseInd-2

Item

Have any treatment kits been dispensed this reporting period

boolean

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

KIT DISPENSATION

Item Group

Kit Dispensation

BlindedProtocolAgentIdentifierNumber

Item

Kit number

text

TreatmentKitDispenseDate

Item

Date dispensed

date

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

METFORMIN/PLACEBO ADMINISTRATION - RAMP-UP

Item Group

Metformin/placebo Administration - Ramp-up

Treatment Start Date

Item

Date of Initial Dose

date

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

TherapyFullDoseScheduleDate

Item

Date subject scheduled to begin full dose

date

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

TherapyFullDoseAdministrationDate

Item

Date subject reports full dose begun

date

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

METFORMIN/PLACEBO ADMINISTRATION

Item Group

Metformin/placebo Administration

ClinicalStudyProtocolMedicationDailySelf-AdministeredInd-2

Item

Has subject taken protocol medication every day

boolean

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

PillsNegationTakenCount

Item

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

float

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

Dose Modification Reason

Item

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

text

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

CL.8

Code List

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

CL Item

Hold For Procedure (Hold for procedure)

CL Item

Dosing Error (Dosing error)

CL Item

Intercurrent Illness (Intercurrent illness)

CL Item

Patient Forgot (Patient forgot)

CL Item

Patient Request (Patient request)

CL Item

Adverse Event (Adverse event)

C41331 (NCI Thesaurus)
C0877248 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

Dose Modification Reason, other

Item

Specify

text

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

Dose Increased

Item

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

boolean

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

RADIOLOGY INVESTIGATIONS - QUESTION

Item Group

Radiology Investigations - Question

MammogramPerformedInd-3b

Item

Was a mammogram performed

text

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

CL.10

Code List

Was a mammogram performed

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

MammogramPerformedAnatomicSite

Item

Mammogram laterality

text

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

CL.11

Code List

Mammogram laterality

CL Item

Bilateral (Bilateral)

C13332 (NCI Thesaurus)
C0238767 (UMLS 2011AA)

CL Item

Unilateral (unilateral)

C28012 (NCI Thesaurus)
C0205092 (UMLS 2011AA)

MammogramUnilateralPerformedAnatomicSite

Item

Specify side

text

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

CL.12

Code List

Specify side

CL Item

Right (Right)

C25228 (NCI Thesaurus)
C0205090 (UMLS 2011AA)

CL Item

Left (Left)

C25229 (NCI Thesaurus)
C0205091 (UMLS 2011AA)

DiagnosticImagingRecurrentDiseasePerformedInd-3

Item

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

boolean

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

RADIOLOGY INVESTIGATIONS

Item Group

Radiology Investigations

ImagingMethodType

Item

Type of imaging

text

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

CL.14

Code List

Type of imaging

CL Item

Mammography (Mammography)

C16818 (NCI Thesaurus)
C0024671 (UMLS 2011AA)

CL Item

Magnetic Resonance Imaging (MRI)

C16809 (NCI Thesaurus)
C0024485 (UMLS 2011AA)

CL Item

Scan - Bone (Scan - bone)

CL Item

Scan - Ct Abdomen (Scan - CT abdomen)

CL Item

Scan - Ct Brain (Scan - CT brain)

CL Item

Scan - Ct Chest (Scan - CT chest)

CL Item

Scan - Ct Pelvis (Scan - CT pelvis)

CL Item

Ultrasound - Abdomen (Ultrasound - abdomen)

CL Item

Ultrasound - Pelvis (Ultrasound - pelvis)

CL Item

Xray - Chest (Xray - chest)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

ImagingMethodSpecify

Item

Specify

text

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

DiagnosticImagingProcedureDate

Item

Date of test

date

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

AssessmentImageReportingType

Item

Result

text

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

CL.15

Code List

Result

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)

CL Item

Abnormal, Malignant (Abnormal, malignant)

CL Item

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

HEMATOLOGY

Item Group

Hematology

HematologySpecimenCollectedDate

Item

Lab, Hematology, Sample Collection Date

date

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

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)

BloodSpecimenCollectedInd-3

Item

Was sample obtained

boolean

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

Hemoglobin

Item

Hemoglobin

float

C16676 (NCI Thesaurus Property)
C0019046 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)

Hemoglobin LLN

Item

Hemoglobin (Hgb) (g/dl), LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0019046 (UMLS CUI-1)
C16676 (NCI Thesaurus Property)
C1518030 (UMLS CUI-2)
C20200 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)

LaboratoryProcedureHemoglobinResultUpperLimitofNormalValue

Item

Hemoglobin, ULN

float

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

Platelets

Item

Platelet count

float

C25294 (NCI Thesaurus ObjectClass)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C12520 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

Platelets LLN

Item

Platelets LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1518030 (UMLS CUI-2)
C12520 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedurePlateletResultUpperLimitofNormalValue

Item

Platelets ULN

float

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

Leukocytes (WBC)

Item

WBC

float

C25294 (NCI Thesaurus ObjectClass)
C0023508 (UMLS CUI-1)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedureLeukocyteResultLowerLimitofNormalValue

Item

WBC count (x1000), LLN

float

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

LaboratoryProcedureLeukocyteResultUpperLimitofNormalValue

Item

Peripheral WBC count, ULN

float

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

Granulocyte count

Item

Peripheral Granulocytes Count

float

C20200 (NCI Thesaurus Property)
C0857490 (UMLS CUI-1)
C12530 (NCI Thesaurus Property-2)
C25463 (NCI Thesaurus ValueDomain)
C25294 (NCI Thesaurus ObjectClass)

LaboratoryProcedureGranulocyteResultLowerLimitofNormalCount

Item

Peripheral Granulocytes Count LLN

float

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

LaboratoryProcedureGranulocyteResultUpperLimitofNormalCount

Item

Granulocytes, ULN

text

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

HematologyErythrocyteMeanCorpuscularVolumeLaboratoryUnspecifiedValue

Item

Mean Corpuscular Volume

text

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

AssessmentLabUOM

Item

Units

text

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

AssessmentLabUOM

Item

Units

text

AssessmentLabUOM

Item

Units

text

AssessmentLabUOM

Item

Units

text

AssessmentLabUOM

Item

Units

text

LaboratoryProcedureErythrocyteMeanCorpuscularVolumeOutcomeLowerLimitofNormalValue

Item

Mean Corpuscular Volume, LLN

text

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

LaboratoryProcedureErythrocyteMeanCorpuscularVolumeOutcomeUpperLimitofNormalValue

Item

Mean Corpuscular Volume, ULN

text

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

BIOCHEMISTRY

Item Group

Biochemistry

SpecimenCollectedDate

Item

Date Specimen collected (biochemical investigations)

date

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

Assessment Date

Item

Date

date

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

SpecimenObtainInd-2

Item

Was sample obtained

boolean

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

Alkaline Phosphatase

Item

Alkaline Phosphatase

float

C20200 (NCI Thesaurus Property)
C0201850 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C16276 (NCI Thesaurus Property-2)

LaboratoryProcedureAlkalinePhosphataseResultLowerLimitNormalValue

Item

Alkaline Phosphatase LLN

float

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

Alkaline Phosphatase ULN

Item

Alkaline Phosphatase ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0151420 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C16276 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)

SGPT (ALT)

Item

SGPT (ALT)

float

C25294 (NCI Thesaurus ObjectClass)
C0201836 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C25293 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultLowerLimitofNormalValue

Item

SGPT (ALT) LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property-2)
C0376147 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
C1518030 (UMLS 2011AA ValueDomain-3)

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

Item

SGPT (ALT) ULN

float

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

SGOT (AST)

Item

SGOT (AST)

float

C25294 (NCI Thesaurus ObjectClass)
C0201899 (UMLS CUI-1)
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultLowerLimitofNormalValue

Item

SGOT (AST) LLN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
C1518030 (UMLS 2011AA ValueDomain-3)

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Item

SGOT (AST) ULN

float

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

Bilirubin, Total

Item

Total Bilirubin

float

C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C38037 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedureTotalBilirubinResultLowerLimitofNormalValue

Item

Total bilirubin LLN

text

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

Bilirubin, Total ULN

Item

Total Bilirubin ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0201913 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C38037 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)

Creatinine, Serum

Item

Serum Creatinine

float

C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)

AssessmentLabUOM

Item

Units

text

AssessmentLabUOM

Item

Units

text

AssessmentLabUOM

Item

Units

text

AssessmentLabUOM

Item

Units

text

AssessmentLabUOM

Item

Units

text

LaboratoryProcedureCreatinineResultLowerLimitofNormalValue

Item

Serum Creatinine LLN

float

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

Creatinine, serum ULN

Item

Serum Creatinine ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)

LaboratoryProcedureVitaminB12OutcomeValue

Item

Serum Vitamin B12

text

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

LaboratoryProcedureVitaminB12OutcomeLowerLimitofNormalValue

Item

Serum Vitamin B12, LLN

text

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

LaboratoryProcedureVitaminB12OutcomeUpperLimitofNormalValue

Item

Serum Vitamin B12, ULN

text

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

LaboratoryProcedureFastingPlasmaGlucoseMeasurementOutcomeValue

Item

Fasting glucose

float

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

LaboratoryProcedureFastingPlasmaGlucoseMeasurementOutcomeLowerLimitofNormalValue

Item

Fasting glucose, LLN

float

LaboratoryProcedureFastingPlasmaGlucoseMeasurementOutcomeLabUpperLimitNormalValue

Item

Fasting glucose, ULN

float

SERIOUS ADVERSE EVENT - QUESTION

Item Group

Serious Adverse Event - Question

SeriousAdverseEventReportInd-2

Item

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

boolean

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

ADVERSE EVENTS ON TREATMENT - QUESTION

Item Group

Adverse Events On Treatment - Question

OtherAdverseEventPresentIndicator

Item

Were any additional adverse events experienced by the patient

text

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

CL.19

Code List

Were any additional adverse events experienced by the patient

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Not Assessed (Not assessed)

NewCancerDiagnosisInd-3

Item

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

boolean

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

DiabetesMellitusNewInd-3

Item

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

boolean

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

ADVERSE EVENTS

Item Group

Adverse Events

AdverseEventContinueReportInd-2

Item

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

boolean

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

AdverseEventCommonTerminologyforAdverseEventsVersion4TermName

Item

CTCAE Term

text

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

CL.23

Code List

CTCAE Term

CL Item

Abdominal Distention (Abdominal distension)

C78161 (NCI Thesaurus)
C0000731 (UMLS 2011AA)

CL Item

Abdominal Infection (Abdominal infection)

C35669 (NCI Thesaurus)
C1112209 (UMLS 2011AA)

CL Item

Abdominal Pain (Abdominal pain)

C26682 (NCI Thesaurus)
C0000737 (UMLS 2011AA)

CL Item

Abdominal Soft Tissue Necrotic Lesion (Abdominal soft tissue necrosis)

CL Item

Abducens Nerve Disorder (Abducens nerve disorder)

CL Item

Accessory Nerve Disorder (Accessory nerve disorder)

CL Item

Acidosis (Acidosis)

C28228 (NCI Thesaurus)
C0220981 (UMLS 2011AA)

CL Item

Vestibulocochlear Nerve Disorder (Acoustic nerve disorder NOS)

CL Item

Prolonged Partial Thromboplastin Time (Activated partial thromboplastin time prolonged)

CL Item

Acute Coronary Syndrome (Acute coronary syndrome)

CL Item

Acute Renal Failure (Acute kidney injury)

CL Item

Adrenal Gland Insufficiency (Adrenal insufficiency)

C26691 (NCI Thesaurus)
C0001623 (UMLS 2011AA)

CL Item

Adult Respiratory Distress Syndrome (Adult respiratory distress syndrome)

CL Item

Agitation (Agitation)

CL Item

Akathisia (Akathisia)

CL Item

Alanine Aminotransferase Increased (Alanine aminotransferase increased)

CL Item

Alcohol Intolerance (Alcohol intolerance)

C78167 (NCI Thesaurus)
C0151474 (UMLS 2011AA)

CL Item

Blood Alkaline Phosphatase Increased (Alkaline phosphatase increased)

C35607 (NCI Thesaurus)
C0852911 (UMLS 2011AA)

CL Item

Alkalosis (Alkalosis)

C37909 (NCI Thesaurus)
C0002063 (UMLS 2011AA)

CL Item

Hypersensitivity (Allergic reaction)

C3114 (NCI Thesaurus)
C0020517 (UMLS 2011AA)

CL Item

Allergic Rhinitis (Allergic rhinitis)

CL Item

Alopecia (Alopecia)

CL Item

Amnesia (Amnesia)

C2867 (NCI Thesaurus)
C0002622 (UMLS 2011AA)

CL Item

Anorectal Fistula (Anal fistula)

CL Item

Anal Hemorrhage (Anal hemorrhage)

CL Item

Anal Mucositis (Anal mucositis)

CL Item

Anal Necrotic Lesion (Anal necrosis)

C78171 (NCI Thesaurus)
C1697981 (UMLS 2011AA)

CL Item

Anal Pain (Anal pain)

CL Item

Anal Stenosis (Anal stenosis)

CL Item

Anal Ulcer (Anal ulcer)

CL Item

Anaphylactic Shock (Anaphylaxis)

CL Item

Anemia (Anemia)

CL Item

Ankle Fracture (Ankle fracture)

CL Item

Anorectal Infection (Anorectal infection)

CL Item

Anorexia (Anorexia)

C2875 (NCI Thesaurus)
C0003123 (UMLS 2011AA)

CL Item

Anorgasmia (Anorgasmia)

CL Item

Anxiety (Anxiety)

CL Item

Aortic Injury (Aortic injury)

CL Item

Aortic Valve Disorder (Aortic valve disease)

CL Item

Aphonia (Aphonia)

CL Item

Apnea (Apnea)

C26698 (NCI Thesaurus)
C0003578 (UMLS 2011AA)

CL Item

Acute Appendicitis (Appendicitis)

CL Item

Acute Perforated Appendicitis (Appendicitis perforated)

CL Item

Arachnoiditis (Arachnoiditis)

CL Item

Arterial Injury (Arterial injury)

CL Item

Arteritis (Arteritis infective)

C34399 (NCI Thesaurus)
C0003860 (UMLS 2011AA)

CL Item

Arthralgia (Arthralgia)

C50464 (NCI Thesaurus)
C0003862 (UMLS 2011AA)

CL Item

Arthritis (Arthritis)

CL Item

Ascites (Ascites)

C2885 (NCI Thesaurus)
C0003962 (UMLS 2011AA)

CL Item

Aspartate Aminotransferase Increased (Aspartate aminotransferase increased)

CL Item

Aspiration (Aspiration)

C15631 (NCI Thesaurus)
C0349707 (UMLS 2011AA)

CL Item

Cardiac Arrest (Asystole)

CL Item

Ataxia (Ataxia)

CL Item

Atelectasis (Atelectasis)

CL Item

Atrial Fibrillation (Atrial fibrillation)

CL Item

Atrial Flutter (Atrial flutter)

CL Item

Av Block Third Degree (Atrioventricular block complete)

C50501 (NCI Thesaurus)
C0151517 (UMLS 2011AA)

CL Item

Av Block First Degree (Atrioventricular block first degree)

C62015 (NCI Thesaurus)
C0085614 (UMLS 2011AA)

CL Item

Autoimmune Disease (Autoimmune disorder)

CL Item

Bone Necrosis (Avascular necrosis)

CL Item

Azoospermia (Azoospermia)

CL Item

Back Pain (Back pain)

CL Item

Bile Duct Stenosis (Bile duct stenosis)

CL Item

Biliary Anastomotic Leakage (Biliary anastomotic leak)

CL Item

Biliary Fistula (Biliary fistula)

CL Item

Cholangitis (Biliary tract infection)

CL Item

Bladder Anastomotic Leakage (Bladder anastomotic leak)

CL Item

Cystitis (Bladder infection)

C26738 (NCI Thesaurus)
C0010692 (UMLS 2011AA)

CL Item

Bladder Perforation (Bladder perforation)

CL Item

Bladder Spasm (Bladder spasm)

CL Item

Bloating (Bloating)

CL Item

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

CL Item

Abnormal Blood Antidiuretic Hormone (Blood antidiuretic hormone abnormal)

C78214 (NCI Thesaurus)
C0853592 (UMLS 2011AA)

CL Item

Elevated Bilirubin (Blood bilirubin increased)

C27088 (NCI Thesaurus)
C0311468 (UMLS 2011AA)

CL Item

Blood Corticotrophin Decreased (Blood corticotrophin decreased)

CL Item

Abnormal Blood Gonadotrophin (Blood gonadotrophin abnormal)

C78216 (NCI Thesaurus)
C0853603 (UMLS 2011AA)

CL Item

Abnormal Blood Prolactin (Blood prolactin abnormal)

C78217 (NCI Thesaurus)
C0853620 (UMLS 2011AA)

CL Item

Blurred Vision (Blurred vision)

CL Item

Body Odor (Body odor)

CL Item

Bone Infection (Bone infection)

CL Item

Hypocellular Bone Marrow (Bone marrow hypocellular)

C35167 (NCI Thesaurus)
C0151773 (UMLS 2011AA)

CL Item

Bone Pain (Bone pain)

CL Item

Brachial Plexopathy (Brachial plexopathy)

CL Item

Breast Atrophy (Breast atrophy)

CL Item

Mastitis (Breast infection)

C53662 (NCI Thesaurus)
C0024894 (UMLS 2011AA)

CL Item

Breast Pain (Breast pain)

CL Item

Bronchial Fistula (Bronchial fistula)

CL Item

Bronchitis (Bronchial infection)

C2911 (NCI Thesaurus)
C0006277 (UMLS 2011AA)

CL Item

Bronchial Obstruction (Bronchial obstruction)

CL Item

Bronchial Stricture (Bronchial stricture)

CL Item

Bronchopleural Fistula (Bronchopleural fistula)

CL Item

Bronchial Hemorrhage (Bronchopulmonary hemorrhage)

CL Item

Bronchospasm (Bronchospasm)

CL Item

Bruise (Bruising)

CL Item

Bullous Dermatitis (Bullous dermatitis)

CL Item

Burn (Burn)

C34441 (NCI Thesaurus)
C0006434 (UMLS 2011AA)

CL Item

Buttock Pain (Buttock pain)

CL Item

Capillary Leak Syndrome Capillary Leak Syndrome (Capillary leak syndrome)

CL Item

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

C78229 (NCI Thesaurus)
C1697788 (UMLS 2011AA)

CL Item

Cardiac Arrest (Cardiac arrest)

CL Item

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

CL Item

Blood Cardiac Troponin I Increased (Cardiac troponin I increased)

C78230 (NCI Thesaurus)
C0852692 (UMLS 2011AA)

CL Item

Blood Cardiac Troponin T Increased (Cardiac troponin T increased)

C78231 (NCI Thesaurus)
C0852680 (UMLS 2011AA)

CL Item

Cataract (Cataract)

CL Item

Catheter-related Infection (Catheter related infection)

CL Item

Cd4 Lymphocytes Decreased (CD4 lymphocytes decreased)

CL Item

Cecal Hemorrhage (Cecal hemorrhage)

CL Item

Cecal Infection (Cecal infection)

CL Item

Central Nervous System Necrotic Lesion (Central nervous system necrosis)

CL Item

Cerebrospinal Fluid Leakage (Cerebrospinal fluid leakage)

CL Item

Infectious Cervicitis (Cervicitis infection)

CL Item

Cheilitis (Cheilitis)

C79545 (NCI Thesaurus)
C0007971 (UMLS 2011AA)

CL Item

Angina (Chest pain - cardiac)

CL Item

Chest Wall Pain (Chest wall pain)

CL Item

Chills (Chills)

CL Item

Cholecystitis (Cholecystitis)

CL Item

Hypercholesterolemia (Cholesterol high)

CL Item

Chronic Kidney Disease (Chronic kidney disease)

CL Item

Chylothorax (Chylothorax)

CL Item

Cognitive Disturbance (Cognitive disturbance)

CL Item

Colitis (Colitis)

CL Item

Colonic Fistula (Colonic fistula)

CL Item

Colonic Hemorrhage (Colonic hemorrhage)

CL Item

Colonic Obstruction (Colonic obstruction)

CL Item

Colonic Perforation (Colonic perforation)

CL Item

Colonic Stenosis (Colonic stenosis)

CL Item

Colonic Ulcer (Colonic ulcer)

CL Item

Concentration Impairment (Concentration impairment)

CL Item

Heart Conduction Disorder (Conduction disorder)

CL Item

Confusion (Confusion)

CL Item

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

CL Item

Conjunctivitis (Conjunctivitis)

CL Item

Acute Contagious Conjunctivitis (Conjunctivitis infective)

CL Item

Constipation (Constipation)

CL Item

Constrictive Pericarditis (Constrictive pericarditis)

CL Item

Keratitis (Corneal infection)

CL Item

Corneal Ulcer (Corneal ulcer)

CL Item

Cough (Cough)

CL Item

Creatine Phosphokinase Increased (CPK increased)

C78247 (NCI Thesaurus)
C0151576 (UMLS 2011AA)

CL Item

Cranial Nerve Infection (Cranial nerve infection)

CL Item

Increased Creatinine (Creatinine increased)

C78249 (NCI Thesaurus)
C0151578 (UMLS 2011AA)

CL Item

Cushingoid (Cushingoid)

CL Item

Non-infectious Cystitis (Cystitis noninfective)

C78250 (NCI Thesaurus)
C0403632 (UMLS 2011AA)

CL Item

Cytokine Release Syndrome (Cytokine release syndrome)

CL Item

Neonatal Death (Death neonatal)

CL Item

Death (Death NOS)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

CL Item

Dehydration (Dehydration)

CL Item

Delayed Orgasm (Delayed orgasm)

CL Item

Delayed Puberty (Delayed puberty)

CL Item

Delirium (Delirium)

CL Item

Delusion (Delusions)

CL Item

Caries (Dental caries)

CL Item

Depressed Level Of Consciousness (Depressed level of consciousness)

CL Item

Depression (Depression)

CL Item

Radiation-induced Dermatitis (Dermatitis radiation)

CL Item

Prosthesis-related Infection (Device related infection)

CL Item

Diarrhea (Diarrhea)

CL Item

Disseminated Intravascular Coagulation (Disseminated intravascular coagulation)

C2992 (NCI Thesaurus)
C0012739 (UMLS 2011AA)

CL Item

Dizziness (Dizziness)

CL Item

Dry Eye Syndrome (Dry eye)

C34553 (NCI Thesaurus)
C0013238 (UMLS 2011AA)

CL Item

Xerostomia (Dry mouth)

C26917 (NCI Thesaurus)
C0043352 (UMLS 2011AA)

CL Item

Dry Skin (Dry Skin)

CL Item

Duodenal Fistula (Duodenal fistula)

CL Item

Duodenal Hemorrhage (Duodenal hemorrhage)

CL Item

Duodenal Infection (Duodenal infection)

CL Item

Duodenal Obstruction (Duodenal obstruction)

CL Item

Duodenal Perforation (Duodenal perforation)

CL Item

Duodenal Stenosis (Duodenal stenosis)

CL Item

Duodenal Ulcer (Duodenal ulcer)

C26755 (NCI Thesaurus)
C0013295 (UMLS 2011AA)

CL Item

Dysarthria (Dysarthria)

CL Item

Dysesthesia (Dysesthesia)

C28246 (NCI Thesaurus)
C0392699 (UMLS 2011AA)

CL Item

Dysgeusia (Dysgeusia)

C28145 (NCI Thesaurus)
C0013378 (UMLS 2011AA)

CL Item

Dysmenorrhea (Dysmenorrhea)

C34559 (NCI Thesaurus)
C0013390 (UMLS 2011AA)

CL Item

Dyspareunia (Dyspareunia)

C2997 (NCI Thesaurus)
C1384606 (UMLS 2011AA)

CL Item

Dyspepsia (Dyspepsia)

C26756 (NCI Thesaurus)
C0013395 (UMLS 2011AA)

CL Item

Dysphagia (Dysphagia)

C2980 (NCI Thesaurus)
C0011168 (UMLS 2011AA)

CL Item

Dysphasia (Dysphasia)

C35546 (NCI Thesaurus)
C0973461 (UMLS 2011AA)

CL Item

Dyspnea (Dyspnea)

CL Item

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

CL Item

Earache (Ear pain)

CL Item

Cerebral Edema (Edema cerebral)

C4909 (NCI Thesaurus)
C0006114 (UMLS 2011AA)

CL Item

Face Edema (Edema face)

C78289 (NCI Thesaurus)
C0542571 (UMLS 2011AA)

CL Item

Edema Limbs (Edema limbs)

C78262 (NCI Thesaurus)
C0085649 (UMLS 2011AA)

CL Item

Edema Trunk (Edema trunk)

C78263 (NCI Thesaurus)
C0578541 (UMLS 2011AA)

CL Item

Ejaculation Disorder (Ejaculation disorder)

C78264 (NCI Thesaurus)
C0235969 (UMLS 2011AA)

CL Item

Ejection Fraction Decreased (Ejection fraction decreased)

C83492 (NCI Thesaurus)
C0743400 (UMLS 2011AA)

CL Item

Prolonged Qt Interval (Electrocardiogram QT corrected interval prolonged)

C71034 (NCI Thesaurus)
C0151878 (UMLS 2011AA)

CL Item

Infectious Encephalitis (Encephalitis infection)

C79550 (NCI Thesaurus)
C0596773 (UMLS 2011AA)

CL Item

Infectious Encephalomyelitis (Encephalomyelitis infection)

C79551 (NCI Thesaurus)
C0856705 (UMLS 2011AA)

CL Item

Encephalopathy (Encephalopathy)

CL Item

Infective Endocarditis (Endocarditis infective)

CL Item

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

CL Item

Endophthalmitis (Endophthalmitis)

CL Item

Enterocolitis (Enterocolitis)

CL Item

Infectious Enterocolitis (Enterocolitis infectious)

CL Item

Enterovesical Fistula (Enterovesical fistula)

CL Item

Epistaxis (Epistaxis)

CL Item

Impotence (Erectile dysfunction)

CL Item

Erythema Multiforme (Erythema multiforme)

CL Item

Erythroderma (Erythroderma)

CL Item

Esophageal Anastomotic Leakage (Esophageal anastomotic leak)

CL Item

Esophageal Fistula (Esophageal fistula)

CL Item

Esophageal Hemorrhage (Esophageal hemorrhage)

CL Item

Esophageal Infection (Esophageal infection)

CL Item

Esophageal Necrotic Lesion (Esophageal necrosis)

CL Item

Esophageal Obstruction (Esophageal obstruction)

CL Item

Esophageal Pain (Esophageal pain)

CL Item

Perforation Of Esophagus (Esophageal perforation)

CL Item

Esophageal Stricture (Esophageal stenosis)

CL Item

Esophageal Ulcer (Esophageal ulcer)

CL Item

Esophageal Varices Hemorrhage (Esophageal varices hemorrhage)

CL Item

Esophagitis (Esophagitis)

CL Item

Euphoria (Euphoria)

C34598 (NCI Thesaurus)
C0235146 (UMLS 2011AA)

CL Item

Exostosis (Exostosis)

CL Item

External Ear Inflammation (External ear inflammation)

C79601 (NCI Thesaurus)
C0029878 (UMLS 2011AA)

CL Item

External Ear Pain (External ear pain)

CL Item

Extraocular Muscle Paresis (Extraocular muscle paresis)

C78286 (NCI Thesaurus)
C0262918 (UMLS 2011AA)

CL Item

Extrapyramidal Disorder (Extrapyramidal disorder)

C79593 (NCI Thesaurus)
C0015371 (UMLS 2011AA)

CL Item

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

CL Item

Eye Infection (Eye infection)

C45372 (NCI Thesaurus)
C0015403 (UMLS 2011AA)

CL Item

Eye Pain (Eye pain)

C78287 (NCI Thesaurus)
C0151827 (UMLS 2011AA)

CL Item

Eyelid Function Disorder (Eyelid function disorder)

C78288 (NCI Thesaurus)
C0854286 (UMLS 2011AA)

CL Item

Facial Muscle Weakness (Facial muscle weakness)

C78290 (NCI Thesaurus)
C0427055 (UMLS 2011AA)

CL Item

Facial Nerve Disorder (Facial nerve disorder)

C27594 (NCI Thesaurus)
C0015464 (UMLS 2011AA)

CL Item

Facial Pain (Facial pain)

C79594 (NCI Thesaurus)
C0015468 (UMLS 2011AA)

CL Item

Fall (Fall)

C50558 (NCI Thesaurus)
C0085639 (UMLS 2011AA)

CL Item

Fallopian Tube Anastomotic Leakage (Fallopian tube anastomotic leak)

C78292 (NCI Thesaurus)
C1698039 (UMLS 2011AA)

CL Item

Fallopian Tube Obstruction (Fallopian tube obstruction)

C78293 (NCI Thesaurus)
C0041274 (UMLS 2011AA)

CL Item

Fallopian Tube Perforation (Fallopian tube perforation)

C78294 (NCI Thesaurus)
C1557983 (UMLS 2011AA)

CL Item

Fallopian Tube Stenosis (Fallopian tube stenosis)

C78295 (NCI Thesaurus)
C0459524 (UMLS 2011AA)

CL Item

Adipose Tissue Atrophy (Fat atrophy)

C78297 (NCI Thesaurus)
C0333650 (UMLS 2011AA)

CL Item

Fatigue (Fatigue)

CL Item

Neutropenic Fever (Febrile neutropenia)

CL Item

Fecal Incontinence (Fecal incontinence)

CL Item

Female Genital Tract Fistula (Female genital tract fistula)

C78298 (NCI Thesaurus)
C0269131 (UMLS 2011AA)

CL Item

Acquired Feminization (Feminization acquired)

C78299 (NCI Thesaurus)
C0877195 (UMLS 2011AA)

CL Item

Intrauterine Fetal Death (Fetal death)

C50620 (NCI Thesaurus)
C0015927 (UMLS 2011AA)

CL Item

Fetal Growth Retardation (Fetal growth retardation)

CL Item

Fever (Fever)

CL Item

Fibrinogen Decreased (Fibrinogen decreased)

CL Item

Deep Connective Tissue Fibrosis (Fibrosis deep connective tissue)

CL Item

Flank Pain (Flank pain)

CL Item

Flasher (Flashing lights)

CL Item

Flatulence (Flatulence)

CL Item

Floaters (Floaters)

CL Item

Flu-like Symptoms (Flu like symptoms)

CL Item

Flushing (Flushing)

CL Item

Decreased Forced Expiratory Volume (Forced expiratory volume decreased)

CL Item

Fracture (Fracture)

CL Item

Gait Disturbance (Gait disturbance)

CL Item

Gallbladder Fistula (Gallbladder fistula)

CL Item

Gallbladder Infection (Gallbladder infection)

CL Item

Gallbladder Necrotic Lesion (Gallbladder necrosis)

CL Item

Gallbladder Obstruction (Gallbladder obstruction)

CL Item

Gallbladder Pain (Gallbladder pain)

CL Item

Gallbladder Perforation (Gallbladder perforation)

CL Item

Gastric Anastomotic Leakage (Gastric anastomotic leak)

CL Item

Gastric Fistula (Gastric fistula)

CL Item

Gastric Hemorrhage (Gastric hemorrhage)

CL Item

Gastric Necrotic Lesion (Gastric necrosis)

CL Item

Gastric Perforation (Gastric perforation)

CL Item

Gastric Stenosis (Gastric stenosis)

CL Item

Gastric Ulcer (Gastric ulcer)

CL Item

Gastritis (Gastritis)

CL Item

Gastroesophageal Reflux Disease (Gastroesophageal reflux disease)

CL Item

Gastrointestinal System Anastomotic Leakage (Gastrointestinal anastomotic leak)

CL Item

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

CL Item

Gastrointestinal Fistula (Gastrointestinal fistula)

CL Item

Gastrointestinal Pain (Gastrointestinal pain)

CL Item

Gastrointestinal Stoma Necrotic Lesion (Gastrointestinal stoma necrosis)

CL Item

Gastroparesis (Gastroparesis)

CL Item

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

CL Item

Generalized Muscle Weakness (Generalized muscle weakness)

CL Item

Genital Edema (Genital edema)

CL Item

Gamma-glutamyltransferase Increased (GGT increased)

CL Item

Gingival Pain (Gingival pain)

CL Item

Glaucoma (Glaucoma)

CL Item

Glossopharyngeal Nerve Disorder (Glossopharyngeal nerve disorder)

CL Item

Glucose Intolerance (Glucose intolerance)

C34646 (NCI Thesaurus)
C0271650 (UMLS 2011AA)

CL Item

Accelerated Growth (Growth accelerated)

CL Item

Abnormal Growth Hormone (Growth hormone abnormal)

CL Item

Growth Retardation (Growth suppression)

CL Item

Gum Infection (Gum infection)

CL Item

Gynecomastia (Gynecomastia)

CL Item

Hallucination (Hallucinations)

CL Item

Haptoglobin Decreased (Haptoglobin decreased)

CL Item

Head Soft Tissue Necrotic Lesion (Head soft tissue necrosis)

CL Item

Headache (Headache)

CL Item

Hearing Impairment (Hearing impaired)

CL Item

Heart Failure (Heart failure)

CL Item

Hematoma (Hematoma)

C50579 (NCI Thesaurus)
C0018944 (UMLS 2011AA)

CL Item

Hematosalpinx (Hematosalpinx)

CL Item

Hematuria (Hematuria)

CL Item

Hemoglobin Increased (Hemoglobin increased)

CL Item

Hemoglobinuria (Hemoglobinuria)

CL Item

Hemolysis (Hemolysis)

CL Item

Hemolytic Uremic Syndrome (Hemolytic uremic syndrome)

CL Item

Hemorrhoidal Hemorrhage (Hemorrhoidal hemorrhage)

CL Item

Hemorrhoid (Hemorrhoids)

CL Item

Hepatic Failure (Hepatic failure)

CL Item

Hepatic Hemorrhage (Hepatic hemorrhage)

CL Item

Hepatic Infection (Hepatic infection)

CL Item

Hepatic Necrotic Lesion (Hepatic necrosis)

CL Item

Hepatic Pain (Hepatic pain)

CL Item

Viral Hepatitis (Hepatitis viral)

CL Item

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

CL Item

Hiccough (Hiccups)

CL Item

Hip Fracture (Hip fracture)

CL Item

Hirsutism (Hirsutism)

CL Item

Hoarseness (Hoarseness)

CL Item

Hot Flashes (Hot flashes)

CL Item

Hydrocephalus (Hydrocephalus)

CL Item

Hypercalcemia (Hypercalcemia)

CL Item

Hyperglycemia (Hyperglycemia)

CL Item

Hyperhidrosis (Hyperhidrosis)

C78345 (NCI Thesaurus)
C0020458 (UMLS 2011AA)

CL Item

Hyperkalemia (Hyperkalemia)

C37968 (NCI Thesaurus)
C0020461 (UMLS 2011AA)

CL Item

Hypermagnesemia (Hypermagnesemia)

C37969 (NCI Thesaurus)
C1522135 (UMLS 2011AA)

CL Item

Hypernatremia (Hypernatremia)

C37970 (NCI Thesaurus)
C1522136 (UMLS 2011AA)

CL Item

Hyperparathyroidism (Hyperparathyroidism)

CL Item

Hypersomnia (Hypersomnia)

C78346 (NCI Thesaurus)
C0917799 (UMLS 2011AA)

CL Item

Hypertension (Hypertension)

CL Item

Hyperthyroidism (Hyperthyroidism)

CL Item

Hypertrichosis (Hypertrichosis)

C79597 (NCI Thesaurus)
C0020555 (UMLS 2011AA)

CL Item

Hypertriglyceridemia (Hypertriglyceridemia)

C37971 (NCI Thesaurus)
C1522137 (UMLS 2011AA)

CL Item

Hyperuricemia (Hyperuricemia)

C3961 (NCI Thesaurus)
C0740394 (UMLS 2011AA)

CL Item

Hypoalbuminemia (Hypoalbuminemia)

C37972 (NCI Thesaurus)
C0239981 (UMLS 2011AA)

CL Item

Hypocalcemia (Hypocalcemia)

C37973 (NCI Thesaurus)
C0020598 (UMLS 2011AA)

CL Item

Hypoglossal Nerve Disorder (Hypoglossal nerve disorder)

C26954 (NCI Thesaurus)
C0152181 (UMLS 2011AA)

CL Item

Hypoglycemia (Hypoglycemia)

CL Item

Hypohidrosis (Hypohidrosis)

C34718 (NCI Thesaurus)
C0020620 (UMLS 2011AA)

CL Item

Hypokalemia (Hypokalemia)

C37974 (NCI Thesaurus)
C0020621 (UMLS 2011AA)

CL Item

Hypomagnesemia (Hypomagnesemia)

C37975 (NCI Thesaurus)
C0151723 (UMLS 2011AA)

CL Item

Hyponatremia (Hyponatremia)

C37976 (NCI Thesaurus)
C0020625 (UMLS 2011AA)

CL Item

Hypoparathyroidism (Hypoparathyroidism)

C78350 (NCI Thesaurus)
C0020626 (UMLS 2011AA)

CL Item

Hypophosphatemia (Hypophosphatemia)

C37977 (NCI Thesaurus)
C0085682 (UMLS 2011AA)

CL Item

Hypotension (Hypotension)

CL Item

Hypothermia (Hypothermia)

C78351 (NCI Thesaurus)
C0020672 (UMLS 2011AA)

CL Item

Hypothyroidism (Hypothyroidism)

C26800 (NCI Thesaurus)
C0020676 (UMLS 2011AA)

CL Item

Hypoxia (Hypoxia)

CL Item

Ileal Fistula (Ileal fistula)

CL Item

Ileal Hemorrhage (Ileal hemorrhage)

CL Item

Ileal Obstruction (Ileal obstruction)

CL Item

Ileal Perforation (Ileal perforation)

CL Item

Ileal Stenosis (Ileal stenosis)

CL Item

Ileal Ulcer (Ileal ulcer)

CL Item

Ileus (Ileus)

CL Item

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

CL Item

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

CL Item

Infectious Myositis (Infective myositis)

CL Item

Infusion-related Reaction (Infusion related reaction)

CL Item

Infusion Site Extravasation (Infusion site extravasation)

CL Item

Injection Site Reaction (Injection site reaction)

CL Item

Injury To Carotid Artery (Injury to carotid artery)

CL Item

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

CL Item

Injury To Jugular Vein (Injury to jugular vein)

CL Item

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

CL Item

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

CL Item

Inr Increased (INR increased)

CL Item

Insomnia (Insomnia)

CL Item

Intestinal Stoma Leakage (Intestinal stoma leak)

CL Item

Intestinal Stoma Obstruction (Intestinal stoma obstruction)

CL Item

Intestinal Stoma Site Hemorrhage (Intestinal stoma site bleeding)

CL Item

Intra-abdominal Hemorrhage (Intra-abdominal hemorrhage)

CL Item

Intracranial Hemorrhage (Intracranial hemorrhage)

CL Item

Intraoperative Arterial Injury (Intraoperative arterial injury)

CL Item

Intraoperative Breast Injury (Intraoperative breast injury)

CL Item

Intraoperative Cardiac Injury (Intraoperative cardiac injury)

CL Item

Intraoperative Ear Injury (Intraoperative ear injury)

CL Item

Intraoperative Endocrine Injury (Intraoperative endocrine injury)

CL Item

Intraoperative Gastrointestinal Injury (Intraoperative gastrointestinal injury)

CL Item

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

CL Item

Intraoperative Hemorrhage (Intraoperative hemorrhage)

CL Item

Intraoperative Hepatobiliary Injury (Intraoperative hepatobiliary injury)

CL Item

Intraoperative Musculoskeletal Injury (Intraoperative musculoskeletal injury)

CL Item

Intraoperative Neurological Injury (Intraoperative neurological injury)

CL Item

Intraoperative Ocular Injury (Intraoperative ocular injury)

CL Item

Intraoperative Renal Injury (Intraoperative renal injury)

CL Item

Intraoperative Reproductive System Injury (Intraoperative reproductive tract injury)

CL Item

Intraoperative Respiratory Injury (Intraoperative respiratory injury)

CL Item

Intraoperative Skin Injury (Intraoperative skin injury)

CL Item

Intraoperative Splenic Injury (Intraoperative splenic injury)

CL Item

Intraoperative Urinary System Injury (Intraoperative urinary injury)

CL Item

Intraoperative Venous Injury (Intraoperative venous injury)

CL Item

Investigation Other Specify (Investigations - Other, specify)

CL Item

Iron Overload (Iron overload)

CL Item

Irregular Menstruation (Irregular menstruation)

CL Item

Irritability (Irritability)

CL Item

Cerebrovascular Ischemia (Ischemia cerebrovascular)

CL Item

Trochlear Nerve Disorder (IVth nerve disorder)

CL Item

Jejunal Fistula (Jejunal fistula)

CL Item

Jejunal Hemorrhage (Jejunal hemorrhage)

CL Item

Jejunal Obstruction (Jejunal obstruction)

CL Item

Jejunal Perforation (Jejunal perforation)

CL Item

Jejunal Stenosis (Jejunal stenosis)

CL Item

Jejunal Ulcer (Jejunal ulcer)

CL Item

Joint Effusion (Joint effusion)

CL Item

Joint Infection (Joint infection)

CL Item

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

CL Item

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

CL Item</

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Breast Cancer NCT01101438 Follow-Up - NCIC MA.32 Short Follow-Up Report Form - 3026031v1.0

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