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5706

Beskrivning

NCIC MA.32 Baseline Report 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=81E21D11-128C-1198-E040-BB89AD434372

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=81E21D11-128C-1198-E040-BB89AD434372

Nyckelord

Pre-Study Form

Breast Neoplasms

Uppladdad den

11 augusti 2014

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT01101438 Pre-Study - NCIC MA.32 Baseline Report - 3027459v1.0

model
Detaljer

Aim - The aim of the Baseline Folder is to collect information about patient status at the time of randomization. Completion - The Baseline Report Folder must be completed within 6 weeks after randomization Timing of Investigations - The timing of protocol-required pre-treatment investigations covered by the Baseline Report is as follows: (Please note: Some protocol required pre-treatment investigations are collected on the Eligibility Checklist, so they are not repeated on this Report. Please refer to the protocol (section 6.0) for a complete list of required pre-treatment investigations.) ¿ Adverse Events (AEs) ¿ within 14 days before first treatment Note: Correlative Studies details will be reported in the separate correlative studies folder.

1 Formulär

StudyEvent: NCIC MA.32 Baseline Report
1. Aim - The aim of the Baseline Folder is to collect information about patient status at the time of randomization. Completion - The Baseline Report Folder must be completed within 6 weeks after randomization Timing of Investigations - The timing of protocol-required pre-treatment investigations covered by the Baseline Report is as follows: (Please note: Some protocol required pre-treatment investigations are collected on the Eligibility Checklist, so they are not repeated on this Report. Please refer to the protocol (section 6.0) for a complete list of required pre-treatment investigations.) ¿ Adverse Events (AEs) ¿ within 14 days before first treatment Note: Correlative Studies details will be reported in the separate correlative studies folder.

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

TOBACCO SMOKING HISTORY - BASELINE

Item Group

Tobacco Smoking History - Baseline

Smoking use

Item

Has the patient previously been a smoker?

text

C38148 (NCI Thesaurus ValueDomain)
C3241966 (UMLS CUI-1)
C17934 (NCI Thesaurus ObjectClass)
C25340 (NCI Thesaurus Property)

CL.1

Code List

Has the patient previously been a smoker?

CL Item

Yes (yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (no)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Unknown (unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Current Smoker

Item

Does the patient currently smoke

text

C38148 (NCI Thesaurus ValueDomain)
C3241966 (UMLS CUI-1)
C25471 (NCI Thesaurus Property)
C17934 (NCI Thesaurus ObjectClass)
C0449865 (NCI Metathesaurus Property)

CL.2

Code List

Does the patient currently smoke

CL Item

Yes (yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (no)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

Smoker amount smoked

Item

Average number of cigarettes smoked per day

double

C25337 (NCI Thesaurus ValueDomain)
C1608325 (UMLS CUI-1)
C17934 (NCI Thesaurus ObjectClass)
C25340 (NCI Thesaurus Property)

SmokingDiscontinuedDate

Item

Date of quitting smoking

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
C17934 (NCI Thesaurus ObjectClass)
C0453996 (UMLS 2011AA ObjectClass)

CurrentSmokingHistoryType

Item

Smoking history

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25471 (NCI Thesaurus ObjectClass)
C0521116 (UMLS 2011AA ObjectClass)
C17934 (NCI Thesaurus ObjectClass)
C0453996 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)

CL.3

Code List

Smoking history

CL Item

Pipe Or Cigar Smoker Only (Pipe or cigar smoker only)

CL Item

100 Or Fewer Cigarettes During Lifetime (100 or fewer cigarettes during lifetime)

CL Item

Greater Than 100 Cigarettes During Lifetime (greater than 100 cigarettes during lifetime)

SmokingUseBeginDate

Item

Date started smoking

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C17934 (NCI Thesaurus ObjectClass)
C0453996 (UMLS 2011AA ObjectClass)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)

CigarettesSmokingYearNumber

Item

Number of years smoked cigarettes

double

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C1802 (NCI Thesaurus ObjectClass)
C0677453 (UMLS 2011AA ObjectClass)
C29848 (NCI Thesaurus ValueDomain)
C0439234 (UMLS 2011AA ValueDomain)
C17934 (NCI Thesaurus Property)
C0453996 (UMLS 2011AA Property)

CigaretteSmokingLifetimeUseAverageNumber

Item

Average per day over lifetime of smoking

double

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C18270 (NCI Thesaurus ObjectClass)
C0700219 (UMLS 2011AA ObjectClass)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
C19662 (NCI Thesaurus Property)
C1517878 (UMLS 2011AA Property)

CigaretteSmokingHistoryPackYearAmount

Item

Number pack years smoked

text

C17934 (NCI Thesaurus ObjectClass)
C0453996 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C25417 (NCI Thesaurus ValueDomain)

ALCOHOL CONSUMPTION - QUESTION

Item Group

Alcohol Consumption - Question

AlcoholConsumptionPastYearIndicator

Item

Alcohol Use in the Past Year

text

C2190 (NCI Thesaurus ObjectClass)
C0001962 (UMLS 2011AA ObjectClass)
C29848 (NCI Thesaurus Property)
C0439234 (UMLS 2011AA Property)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
C25609 (NCI Thesaurus Property)
C1444637 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.4

Code List

Alcohol Use in the Past Year

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

AlcoholCurrentUseRangeType

Item

Average Alcohol Consumption

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C2190 (NCI Thesaurus ObjectClass)
C0001962 (UMLS 2011AA ObjectClass)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)

CL.5

Code List

Average Alcohol Consumption

CL Item

Less Than 1 Drink Per Month (Less than 1 drink per month)

CL Item

1 To 5 Drinks Per Month (1 to 5 drinks per month)

CL Item

1 To 10 Drinks Per Week (1 to 10 drinks per week)

CL Item

11 To 30 Drinks Per Week (11 to 30 drinks per week)

CL Item

More Than 30 Drinks Per Week (More than 30 drinks per week)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

BILATERAL BREAST CARCINOMA - QUESTION

Item Group

Bilateral Breast Carcinoma - Question

BilateralBreastCarcinomaPatientClinicalTrialEnrollmentInd-2

Item

Was this subject enrolled as having bilateral breast carcinoma

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C13332 (NCI Thesaurus ObjectClass)
C0238767 (UMLS 2011AA ObjectClass)
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C71104 (NCI Thesaurus Property)
C0008976 (UMLS 2011AA Property)
C37948 (NCI Thesaurus Property)
C1516879 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.6

Code List

Was this subject enrolled as having bilateral breast carcinoma

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

BILATERAL BREAST CARCINOMA

Item Group

Bilateral Breast Carcinoma

BreastTumorPathologicTStage

Item

Pathologic T Stage

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property)
C0475455 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.7

Code List

Pathologic T Stage

CL Item

No Evidence Of Primary Tumor (T0)

CL Item

Tumor 2 Cm Or Less In Greatest Dimension (T1)

CL Item

Tumor More Than 0.1 Cm But Not More Than 0.5 Cm In Greatest Dimension (T1a)

CL Item

Tumor More Than 0.5 Cm But Not More Than 1 Cm In Greatest Dimension (T1b)

CL Item

Tumor More Than 1 Cm But Not More Than 2 Cm In Greatest Dimension (T1c)

CL Item

Microinvasion 0.1 Cm Or Less In Greatest Dimension (T1mic)

CL Item

Tumor More Than 2 Cm But Not More Than 5 Cm In Greatest Dimension (T2)

CL Item

Tumor More Than 5 Cm In Greatest Dimension (T3)

CL Item

Tumor Of Any Size With Direct (T4)

CL Item

Extension To Chest Wall (T4a)

CL Item

Edema (including Peau D'orange) Or Ulceration Of The Skin Of The Breast Or Satellite Skin Nodules Confined To The Same Breast (T4b)

CL Item

Both T4a And T4b (T4c)

CL Item

Inflammatory Carcinoma (T4d)

C0334385 (NCI Metathesaurus)

CL Item

Carcinoma In Situ: Intraductal Carcinoma, Lobular Carcinoma In Situ, Or Paget's Disease Of The Nipple With No Tumor (Tis)

CL Item

Ductal Carcinoma In Situ (Tis (DCIS))

CL Item

Lobular Carcinoma In Situ (Tis (LCIS))

CL Item

Paget's Disease Of The Nipple With No Tumor. [note: Paget's Disease Associated With A Tumor Is Classified According To The Size Of The Tumor.] (Tis (Paget's))

CL Item

Primary Tumor Cannot Be Assessed (TX)

BreastTumorPathologicNStage

Item

Pathologic N Stage

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property)
C0456532 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.8

Code List

Pathologic N Stage

CL Item

No Regional Lymph Node Metastasis Histologically, No Additional Examination For Isolated Tumor Cells (itc) (pN0)

CL Item

No Regional Lymph Node Metastasis Histologically, Positive Ihc, No Ihc Cluster >0.2 Mm (pN0(i+))

CL Item

No Regional Lymph Node Metastasis Histologically, Negative Ihc (pN0(i-))

CL Item

No Regionally Lymph Node Metastasis Histologically, Positive Molecular Findings (rt-pcr) (pN0(mol+))

CL Item

No Regional Lymph Node Metastasis Histologically, Negative Molecular Findings (rt-pcr) (pN0(mol-))

CL Item

Metastasis In 1 To 3 Axillary Lymph Nodes, And/or In Internal Mammary Nodes With Microscopic Disease Detected By Sln Dissection But Not Clinically Apparent (pN1)

CL Item

Metastasis In 1 To 3 Axillary Lymph Nodes (pN1a)

CL Item

Metastasis In Internal Mammary Nodes With Microscopic Disease Detected By Sln Dissection But Not Clinically Apparent (pN1b)

CL Item

Metastasis In 1 To 3 Axillary Lymph Nodes And In Internal Mammary Lymph Nodes With Microscopic Disease Detected By Sln Dissection But Not Clinically Apparent. (pN1c)

CL Item

Micrometastasis (>0.2 Mm But <=2.0 Mm) (pN1mi)

CL Item

Metastasis In 4 To 9 Axillary Lymph Nodes, Or In Clinically Apparent ** Internal Mammary Lymph Nodes In The Absence Of Axillary Lymph Node Metastasis To Ipsilateral Axillary Lymph Node(s) Fixed To Each Other Or To Other Structures (pN2)

CL Item

Metastasis In 4 To 9 Axillary Lymph Nodes (at Least 1 Tumor Deposit >2.0 Mm) (pN2a)

CL Item

Metastasis In Clinically Apparent* Internal Mammary Lymph Nodes In The Absence Of Axillary Lymph Node Metastasis (pN2b)

CL Item

Metastasis In >= Axillary Lymph Nodes, Or In Infraclavicular Lymph Nodes, Or In Clinically Apparent* Ipsilateral Internal Mammary Lymph Node(s) In The Presence Of 1 Or More Positive Axillary Lymph Node(s); Or, In >3 Axillary Lymph Nodes With Clinically N (pN3)

CL Item

Metastasis In >=10 Axillary Lymph Nodes (at Least 1 Tumor Deposit >2.0 Mm); Or, Metastasis To The Infraclavicular Lymph Nodes (pN3a)

CL Item

Metastasis In Clinically Apparent* Ipsilateral Internal Mammary Lymph Nodes In The Presence Of >=1 Positive Axillary Lymph Node(s); Or, In >3 Axillary Lymph Nodes And In Internal Mammary Lymph Nodes With Microscopic Disease Detected By Sentinel Lymph Node (pN3b)

CL Item

Metastasis In Ipsilateral Supraclavicular Lymph Nodes (pN3c)

CL Item

Regional Lymph Nodes Cannot Be Assessed (e.g., Not Removed For Pathologic Study Or Previously Removed) (pNX)

BreastTumorPathologicMStage

Item

Pathologic M Stage

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25727 (NCI Thesaurus Property)
C0456533 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.9

Code List

Pathologic M Stage

CL Item

No Distant Metastasis (M0)

CL Item

Distant Metastasis (M1)

C18206 (NCI Thesaurus)
C1269798 (UMLS 2011AA)

CL Item

Distant Metastasis Cannot Be Assessed (MX)

SentinelNodeBiopsyInd-3

Item

Was sentinel node sampling performed

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)

CL.10

Code List

Was sentinel node sampling performed

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

SentinelNodeBiopsyDate

Item

Sentinel Node Biopsy Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)

SentinelNodeExaminedCount

Item

Number of Sentinel Nodes Examined

double

C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)

SentinelNodePositiveAssessmentCount

Item

Number of Positive Sentinel Nodes

double

C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C0205159 (NCI Metathesaurus Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)

AxillaryNodeDissectionInd-3

Item

Was axillary dissection performed?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)

CL.11

Code List

Was axillary dissection performed?

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

AxillaryLymphNodeCoreBiopsyFine-NeedleAspirationLymphNodeBiopsyPriorClinicalStudyPerformedDate

Item

Date of Axillary Node Biopsy

date

C15680 (NCI Thesaurus ObjectClass)
C1318309 (UMLS 2011AA ObjectClass)
C15361 (NCI Thesaurus ObjectClass)
C1510483 (UMLS 2011AA ObjectClass)
C51900 (NCI Thesaurus ObjectClass)
C0193842 (UMLS 2011AA ObjectClass)
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15206 (NCI Thesaurus Property)
C0008972 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

AxillaryNodeExaminedTotalCount

Item

Number of axillary nodes examined

double

C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)

PositiveAxillaryNodeExaminedTotalCount

Item

Number of positive axillary nodes

double

C25246 (NCI Thesaurus ObjectClass)
C1446409 (UMLS 2011AA ObjectClass)
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

LymphNodeExaminedCount

Item

Number of Lymph Nodes Examined

double

C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

LymphNodePositiveCount

Item

Number of Positive Lymph Nodes

double

C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

BASELINE ADVERSE EVENTS - QUESTION

Item Group

Baseline Adverse Events - Question

SymptomorAdverseEventOccurrenceInd

Item

Did the participant report any symptoms or adverse events?

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
CL209504 (NCI Metathesaurus Property)

CL.12

Code List

Did the participant report any symptoms or adverse events?

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

BASELINE ADVERSE EVENTS

Item Group

Baseline Advers Events

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)
C1705313 (UMLS 2011AA Property)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain)
C1516728 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
C45559 (NCI Thesaurus ValueDomain)
C1705313 (UMLS 2011AA ValueDomain)
C25714 (NCI Thesaurus ValueDomain)
C0333052 (UMLS 2011AA ValueDomain)

CommonToxicityCriteriaAdverseEventReportingGrade

Item

Grade

double

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

CL.13

Code List

Grade

CL Item

No Adverse Event Or Within Normal Limits (0)

CL Item

Mild Adverse Event (1)

C41338 (NCI Thesaurus)
C1513302 (UMLS 2011AA)

CL Item

Moderate Adverse Event (2)

C41339 (NCI Thesaurus)
C1513374 (UMLS 2011AA)

CL Item

Severe Adverse Event (3)

C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)

CL Item

Life-threatening Or Disabling Adverse Event (4)

CL Item

Death Related To Adverse Event (5)

C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)

AdverseEventContinueIndicator

Item

AE Ongoing

text

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

CL.14

Code List

AE Ongoing

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CARDIOVASCULAR HISTORY - QUESTION

Item Group

Cardiovascular History - Question

CardiovascularDiseasePresentInd-2

Item

Has the patient suffered cardiovascular disease?

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25292 (NCI Thesaurus ObjectClass)
C0007226 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

CL.15

Code List

Has the patient suffered cardiovascular disease?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CARDIOVASCULAR HISTORY

Item Group

Cardiovascular History

CardiacDiseaseAssessmentType

Item

Problem, cardiovascular

text

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

CL.16

Code List

Problem, cardiovascular

CL Item

Myocardial Infarction (Myocardial Infarction)

C27996 (NCI Thesaurus)
C0027051 (UMLS 2011AA)

CL Item

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

C50781 (NCI Thesaurus)
C0007787 (UMLS 2011AA)
C3390 (NCI Thesaurus)
C0038454 (UMLS 2011AA)

CL Item

New Or Worsening Angina (New or worsening angina)

CL Item

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

CL Item

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

CL Item

Thromboembolism (Thromboembolic Event)

C28195 (NCI Thesaurus)
C0040038 (UMLS 2011AA)

CL Item

Other (Other)

CardiacDiseaseAssessmentSpecify

Item

Specify

text

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

BASELINE CONCOMITANT MEDICATIONS

Item Group

Baseline Concomitant Medications

ConcomitantMedicationUseInd-3

Item

Did the participant report taking any concomitant medication

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass)
C0521115 (UMLS 2011AA ObjectClass)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)

CL.17

Code List

Did the participant report taking any concomitant medication

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

ConcomitantMedicationReceivedText

Item

Concomitant Medication

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25730 (NCI Thesaurus ObjectClass)
C0521115 (UMLS 2011AA ObjectClass)

ConcomitantMedicationAdministeredReasonText

Item

Reason for Administration

text

C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass)
C0521115 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)

MedicationContinuedAdministrationInd-2

Item

Is this medication continuing?

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C0750536 (NCI Metathesaurus Property)

CL.18

Code List

Is this medication continuing?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

ADJUVANT RADIATION THERAPY

Item Group

Adjuvant Radiation Therapy

AdjuvantRadiationTherapyAdministeredInd-3

Item

Has the patient received adjuvant RT

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass)
C0001552 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.19

Code List

Has the patient received adjuvant RT

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

AdjuvantRadiationTherapyBeginDate

Item

Date Adjuvant Radiation Therapy Started

date

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass)
C0001552 (UMLS 2011AA ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)

AdjuvantRadiationTherapyEndDate

Item

Date Adjuvant Radiation Therapy Ended

date

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass)
C0001552 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25496 (NCI Thesaurus Property)
C2746065 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

RTAdministeredTotalDose

Item

Total Dose of Radiation Therapy (cGy)

double

C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

SYSTEMIC THERAPY

Item Group

Systemic Therapy

SystemicTherapyAdministeredInd-3

Item

Has the patient received systemic therapy?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15698 (NCI Thesaurus ObjectClass)
C1515119 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.20

Code List

Has the patient received systemic therapy?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

AgentName

Item

Agent Name

text

C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)

Non-protocolTherapyAdministeredBeginDate

Item

Non-protocol Therapy Start Date

date

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

Non-ProtocolTherapyContinueInd-2

Item

Continuing

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS 2011AA ObjectClass)
C54064 (NCI Thesaurus Property)

CL.21

Code List

Continuing

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Non-protocolTherapyAdministeredEndDate

Item

Non-protocol Therapy End Date

date

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

TreatmentRegimenType

Item

Therapy Intent

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)

CL.22

Code List

Therapy Intent

CL Item

Adjuvant (Adjuvant)

C25722 (NCI Thesaurus)
C1522673 (UMLS 2011AA)

CL Item

Neoadjuvant Therapy (Neoadjuvant)

C15665 (NCI Thesaurus)
C0600558 (UMLS 2011AA)

CL Item

Advanced/recurrent/metastatic Disease (Advanced/recurrent/metastatic disease)

CL Item

Other Specify (Other)

TherapyRegimenSpecify

Item

Specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)

MAJOR MEDICAL PROBLEMS AT BASELINE

Item Group

Major Medical Problems At Baseline

PatientHistoryText

Item

Concomitant Diseases and/or Relevant Medical Conditions

text

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

PatientMedicalHistoryBaselineProblemInd-2

Item

Ongoing

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus ObjectClass)
C0262926 (UMLS 2011AA ObjectClass)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C28020 (NCI Thesaurus Property)
C0033213 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.24

Code List

Ongoing

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

PatientMedicalHistoryBaselineProblemInd-2

Item

Ongoing

text

CL.24

Code List

Ongoing

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

OTHER CLINICAL TRIAL PARTICIPATION

Item Group

Other Clinical Trial Participation

PatientBreastMalignantNeoplasmOtherClinicalTrialParticipantInd-2

Item

Is the subject participating in another clinical trial of Breast Cancer treatment

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C12971 (NCI Thesaurus Property)
C0006141 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C29867 (NCI Thesaurus Property)
C0679646 (UMLS 2011AA Property)
C71104 (NCI Thesaurus Property)
C0008976 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.25

Code List

Is the subject participating in another clinical trial of Breast Cancer treatment

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

ClinicalTrialProtocolIdentifier64CharacterText

Item

Clinical Trial Protocol ID

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C45253 (NCI Thesaurus ValueDomain)
C1547402 (UMLS 2011AA ValueDomain)

ClinicalTrialSponsorName64CharacterText

Item

Clinical Trial Sponsor Name

text

C48355 (NCI Thesaurus ObjectClass)
C1711305 (UMLS 2011AA ObjectClass)
C71104 (NCI Thesaurus ObjectClass)
C0008976 (UMLS 2011AA ObjectClass)
C42614 (NCI Thesaurus Property)
C0027365 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C45253 (NCI Thesaurus ValueDomain)
C1547402 (UMLS 2011AA ValueDomain)

PatientEnrollmentDate

Item

Patient Entry Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)

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Breast Cancer NCT01101438 Pre-Study - NCIC MA.32 Baseline Report - 3027459v1.0

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