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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Tobacco Smoking History - Baseline
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-3)
C1705108 (UMLS 2011AA-4)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus-3)
C1298908 (UMLS 2011AA-4)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
C17998 (NCI Thesaurus-3)
C0439673 (UMLS 2011AA-4)
Current Smoker
Item
Does the patient currently smoke
boolean
C38148 (NCI Thesaurus ValueDomain)
C3241966 (UMLS CUI-1)
C25471 (NCI Thesaurus Property)
C17934 (NCI Thesaurus ObjectClass)
C0449865 (NCI Metathesaurus Property)
Smoker amount smoked
Item
Average number of cigarettes smoked per day
float
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)
Item
Smoking history
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25471 (NCI Thesaurus ObjectClass)
C0521116 (UMLS 2011AA ObjectClass)
C17934 (NCI Thesaurus ObjectClass-2)
C0453996 (UMLS 2011AA ObjectClass-2)
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-2)
C0439659 (UMLS 2011AA ValueDomain-2)
C17934 (NCI Thesaurus ObjectClass)
C0453996 (UMLS 2011AA ObjectClass)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
CigarettesSmokingYearNumber
Item
Number of years smoked cigarettes
float
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C1802 (NCI Thesaurus ObjectClass)
C0677453 (UMLS 2011AA ObjectClass)
C29848 (NCI Thesaurus ValueDomain-2)
C0439234 (UMLS 2011AA ValueDomain-2)
C17934 (NCI Thesaurus Property)
C0453996 (UMLS 2011AA Property)
CigaretteSmokingLifetimeUseAverageNumber
Item
Average per day over lifetime of smoking
float
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-2)
C1517878 (UMLS 2011AA Property-2)
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)
Item Group
Alcohol Consumption - Question
AlcoholConsumptionPastYearIndicator
Item
Alcohol Use in the Past Year
boolean
C2190 (NCI Thesaurus ObjectClass)
C0001962 (UMLS 2011AA ObjectClass)
C29848 (NCI Thesaurus Property)
C0439234 (UMLS 2011AA Property)
C25340 (NCI Thesaurus Property-2)
C0457083 (UMLS 2011AA Property-2)
C25609 (NCI Thesaurus Property-3)
C1444637 (UMLS 2011AA Property-3)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
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-2)
C0457083 (UMLS 2011AA Property-2)
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)
Item Group
Bilateral Breast Carcinoma - Question
BilateralBreastCarcinomaPatientClinicalTrialEnrollmentInd-2
Item
Was this subject enrolled as having bilateral breast carcinoma
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C13332 (NCI Thesaurus ObjectClass-2)
C0238767 (UMLS 2011AA ObjectClass-2)
C4872 (NCI Thesaurus ObjectClass-3)
C0678222 (UMLS 2011AA ObjectClass-3)
C71104 (NCI Thesaurus Property)
C0008976 (UMLS 2011AA Property)
C37948 (NCI Thesaurus Property-2)
C1516879 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Bilateral Breast Carcinoma
Item
Pathologic T Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property-2)
C0475455 (UMLS 2011AA Property-2)
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)
Item
Pathologic N Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property-2)
C0456532 (UMLS 2011AA Property-2)
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)
Item
Pathologic M Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25727 (NCI Thesaurus Property-2)
C0456533 (UMLS 2011AA Property-2)
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
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
SentinelNodeBiopsyDate
Item
Sentinel Node Biopsy Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
SentinelNodeExaminedCount
Item
Number of Sentinel Nodes Examined
float
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
float
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?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)
AxillaryLymphNodeCoreBiopsyFine-NeedleAspirationLymphNodeBiopsyPriorClinicalStudyPerformedDate
Item
Date of Axillary Node Biopsy
date
C15680 (NCI Thesaurus ObjectClass)
C1318309 (UMLS 2011AA ObjectClass)
C15361 (NCI Thesaurus ObjectClass-2)
C1510483 (UMLS 2011AA ObjectClass-2)
C51900 (NCI Thesaurus ObjectClass-3)
C0193842 (UMLS 2011AA ObjectClass-3)
C12904 (NCI Thesaurus ObjectClass-4)
C0729594 (UMLS 2011AA ObjectClass-4)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C15206 (NCI Thesaurus Property-3)
C0008972 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
AxillaryNodeExaminedTotalCount
Item
Number of axillary nodes examined
float
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)
PositiveAxillaryNodeExaminedTotalCount
Item
Number of positive axillary nodes
float
C25246 (NCI Thesaurus ObjectClass)
C1446409 (UMLS 2011AA ObjectClass)
C12904 (NCI Thesaurus ObjectClass-2)
C0729594 (UMLS 2011AA ObjectClass-2)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C0750480 (UMLS 2011AA ValueDomain-2)
LymphNodeExaminedCount
Item
Number of Lymph Nodes Examined
float
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
float
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
Item Group
Baseline Adverse Events - Question
SymptomorAdverseEventOccurrenceInd
Item
Did the participant report any symptoms or adverse events?
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
CL209504 (NCI Metathesaurus Property)
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-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)
CommonToxicityCriteriaAdverseEventReportingGrade
Item
Grade
float
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
AdverseEventContinueIndicator
Item
AE Ongoing
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C53279 (NCI Thesaurus Property)
C0549178 (UMLS 2011AA Property)
Item Group
Cardiovascular History - Question
CardiovascularDiseasePresentInd-2
Item
Has the patient suffered cardiovascular disease?
boolean
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-2)
C0012634 (UMLS 2011AA ObjectClass-2)
Item Group
Cardiovascular History
Item
Problem, cardiovascular
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C13306 (NCI Thesaurus ObjectClass)
C1522601 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
CL.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-3)
C0038454 (UMLS 2011AA-4)
CL Item
New Or Worsening Angina (New or worsening angina)
CL Item
Angina Requiring Transluminal Coronary Angioplasty (Angina requiring transluminal coronary angioplasty)
CL Item
Angina Requiring Coronary Artery Bypass Graft (Angina requiring coronary artery bypass graft)
CL Item
Thromboembolism (Thromboembolic Event)
C28195 (NCI Thesaurus)
C0040038 (UMLS 2011AA)
CL Item
Other (Other)
CardiacDiseaseAssessmentSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C13306 (NCI Thesaurus ObjectClass)
C1522601 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
Item Group
Baseline Concomitant Medications
ConcomitantMedicationUseInd-3
Item
Did the participant report taking any concomitant medication
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
Concomitant Medication
Item
Concomitant Medication
text
C25704 (NCI Thesaurus ValueDomain)
C2347852 (UMLS CUI-1)
C459 (NCI Thesaurus ObjectClass)
C25639 (NCI Thesaurus Property)
C25730 (NCI Thesaurus ObjectClass-2)
Concomitant Medication Use Indication
Item
Reason for Administration
text
C459 (NCI Thesaurus ObjectClass)
C2826696 (UMLS CUI-1)
C25730 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C25704 (NCI Thesaurus ValueDomain)
C25638 (NCI Thesaurus ValueDomain-2)
Medication continued
Item
Is this medication continuing?
boolean
C38147 (NCI Thesaurus ValueDomain)
C0013227 (UMLS CUI-1)
C459 (NCI Thesaurus ObjectClass)
C0549178 (UMLS CUI-2)
C25409 (NCI Thesaurus Property)
C0750536 (NCI Metathesaurus Property)
Item Group
Adjuvant Radiation Therapy
AdjuvantRadiationTherapyAdministeredInd-3
Item
Has the patient received adjuvant RT
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
AdjuvantRadiationTherapyBeginDate
Item
Date Adjuvant Radiation Therapy Started
date
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
AdjuvantRadiationTherapyEndDate
Item
Date Adjuvant Radiation Therapy Ended
date
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25496 (NCI Thesaurus Property-2)
C2746065 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Radiation Therapy Total Dose
Item
Total Dose of Radiation Therapy (cGy)
float
C25304 (NCI Thesaurus ValueDomain)
C2169193 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C25488 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)
Item Group
Systemic Therapy
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)
Agent
Item
Agent Name
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Non-protocolTherapyAdministeredBeginDate
Item
Non-protocol Therapy Start Date
date
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
Non-ProtocolTherapyContinueInd-2
Item
Continuing
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C54064 (NCI Thesaurus Property)
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-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
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)
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
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus ObjectClass-2)
C0262926 (UMLS 2011AA ObjectClass-2)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C28020 (NCI Thesaurus Property-2)
C0033213 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientMedicalHistoryBaselineProblemInd-2
Item
Ongoing
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus ObjectClass-2)
C0262926 (UMLS 2011AA ObjectClass-2)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C28020 (NCI Thesaurus Property-2)
C0033213 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Other Clinical Trial Participation
PatientBreastMalignantNeoplasmOtherClinicalTrialParticipantInd-2
Item
Is the subject participating in another clinical trial of Breast Cancer treatment
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C12971 (NCI Thesaurus Property-2)
C0006141 (UMLS 2011AA Property-2)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-3)
C29867 (NCI Thesaurus Property-4)
C0679646 (UMLS 2011AA Property-4)
C71104 (NCI Thesaurus Property-5)
C0008976 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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-2)
C1547402 (UMLS 2011AA ValueDomain-2)
ClinicalTrialSponsorName64CharacterText
Item
Clinical Trial Sponsor Name
text
C48355 (NCI Thesaurus ObjectClass)
C1711305 (UMLS 2011AA ObjectClass)
C71104 (NCI Thesaurus ObjectClass-2)
C0008976 (UMLS 2011AA ObjectClass-2)
C42614 (NCI Thesaurus Property)
C0027365 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C45253 (NCI Thesaurus ValueDomain-2)
C1547402 (UMLS 2011AA ValueDomain-2)
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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