ID

44163

Description

A Randomised, Multi-centre, Open-label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients With HER2/ErbB2 Positive Primary Breast Cancer Outcome of Pregnancy - 2764926v1.0 NCT00490139

Keywords

  1. 9/19/12 9/19/12 -
  2. 3/19/14 3/19/14 - Martin Dugas
  3. 8/9/14 8/9/14 - Martin Dugas
  4. 6/26/15 6/26/15 - Martin Dugas
  5. 7/28/15 7/28/15 - Julian Varghese
  6. 9/29/15 9/29/15 - Martin Dugas
  7. 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
  8. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
  9. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer ALTTO Study BIG 2-06/N063D NCT00490139

Outcome of Pregnancy Breast Cancer NCT00490139

  1. StudyEvent: study documentation
    1. Outcome of Pregnancy Breast Cancer NCT00490139
Header Module
Description

Header Module

NCCTG Study No
Description

NCCTG Study No

Data type

string

Alias
UMLS CUI-1
C0008976
SNOMED CT-1
110465008
Code-2
Numbers
UMLS CUI-2
C0237753
SNOMED CT-2
260299005
LOINC-2
MTHU024869
Code-3
North Central Cancer Treatment Group
UMLS CUI-3
C1518419
Central Lab ID Number
Description

Central Lab ID Number

Data type

string

Alias
Code-1
Laboratory
UMLS CUI-1
C0022877
SNOMED CT-1
261904005
LOINC-1
MTHU029808
Code-2
Numbers
UMLS CUI-2
C0237753
SNOMED CT-2
260299005
LOINC-2
MTHU024869
Institution Number
Description

Institution Number

Data type

string

Alias
UMLS CUI-1
C0021622
Code-2
Numbers
UMLS CUI-2
C0237753
SNOMED CT-2
260299005
LOINC-2
MTHU024869
Patient Initials
Description

Patient Initials

Data type

string

Alias
Code-1
Person Initials
UMLS CUI-1
C2986440
Code-2
Patients
UMLS CUI-2
C0030705
SNOMED CT-2
116154003
Institution
Description

Institution

Data type

string

Alias
UMLS CUI-1
C0021622
Registration Header
Description

Registration Header

Coordinating Group Protocol Number (N063D)
Description

Coordinating Group Protocol Number (N063D)

Data type

string

Alias
Code-1
Group
UMLS CUI-1
C0441833
SNOMED CT-1
246261001
Code-2
Protocols documentation
UMLS CUI-2
C0442711
SNOMED CT-2
258049002
Coordinating Group Code (NCCTG)
Description

Coordinating Group Code (NCCTG)

Data type

string

Alias
Code-1
Group
UMLS CUI-1
C0441833
SNOMED CT-1
246261001
Code-2
Code
UMLS CUI-2
C0805701
Protocol Title (ALTTO: Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation Trial)
Description

Protocol Title (ALTTO: Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation Trial)

Data type

string

Alias
Code-1
Study Protocol
UMLS CUI-1
C2348563
Patient Medical Record Number
Description

Patient Medical Record Number

Data type

string

Alias
Code-1
Medical record number
UMLS CUI-1
C1301894
SNOMED CT-1
398225001
LOINC-1
MTHU021237
Participating Group Code
Description

Participating Group Code

Data type

string

Alias
Code-1
Study Protocol Version Participating Organization Type Code
UMLS CUI-1
C2986314
amended data
Description

Are data amended (check one if data are amended, please circle in red when using paper form)

Data type

boolean

Alias
Code-1
Amended
UMLS CUI-1
C1691222
Code-2
Data
UMLS CUI-2
C1511726
Submission Details
Description

Submission Details

Registration Type
Description

Pre-Registration Type

Data type

integer

Alias
Code-1
Type of registration (attribute)
UMLS CUI-1
C0449520
SNOMED CT-1
246243005
First Submission
Description

First Submission

Data type

integer

Alias
Code-1
Submission
UMLS CUI-1
C1515023
Code-2
First
UMLS CUI-2
C0205435
SNOMED CT-2
255216001
Contact Person For Pathology Results
Description

Contact Person For Pathology Results

Last Name
Description

Last Name

Data type

string

Alias
Code-1
Last Name
UMLS CUI-1
C1301584
SNOMED CT-1
397678008
LOINC-1
MTHU020554
Code-2
contact person
UMLS CUI-2
C0337611
SNOMED CT-2
70862002
HL7 V3-2
CON
Code-3
Pathology
UMLS CUI-3
C0030664
SNOMED CT-3
394595002
Forename
Description

First Name

Data type

string

Alias
Item-Info
First Name
UMLS CUI-1
C1443235
SNOMED CT-1
408677003
LOINC-1
MTHU020551
Code-2
contact person
UMLS CUI-2
C0337611
SNOMED CT-2
70862002
HL7 V3-2
CON
Code-3
Pathology
UMLS CUI-3
C0030664
SNOMED CT-3
394595002
Phone
Description

Phone

Data type

string

Alias
Code-1
Telephone Number
UMLS CUI-1
C1515258
LOINC-1
MTHU039653
Code-2
contact person
UMLS CUI-2
C0337611
SNOMED CT-2
70862002
HL7 V3-2
CON
Code-3
Pathology
UMLS CUI-3
C0030664
SNOMED CT-3
394595002
Fax
Description

Fax

Data type

string

Alias
Code-1
Fax Number
UMLS CUI-1
C1549619
Code-2
contact person
UMLS CUI-2
C0337611
SNOMED CT-2
70862002
HL7 V3-2
CON
Code-3
Pathology
UMLS CUI-3
C0030664
SNOMED CT-3
394595002
E-Mail
Description

E-Mail

Data type

string

Alias
Code-1
E-mail Address
UMLS CUI-1
C1705961
Code-2
contact person
UMLS CUI-2
C0337611
SNOMED CT-2
70862002
HL7 V3-2
CON
Code-3
Pathology
UMLS CUI-3
C0030664
SNOMED CT-3
394595002
Patient Demographics
Description

Patient Demographics

Patient sex
Description

Gender

Data type

integer

Alias
SNOMED CT-1
184100006
UMLS CUI
C0079399
Patient date of birth
Description

Date of Birth

Data type

date

Alias
UMLS CUI-1
C0421451
SNOMED CT-1
184099003
Patient postal code
Description

ZIP Code

Data type

integer

Alias
UMLS CUI-1
C0421454
SNOMED CT-1
184102003
Country of Residence
Description

Country of Residence

Data type

string

Alias
Code-1
Country of residence (observable entity)
UMLS CUI-1
C1562954
SNOMED CT-1
416647007
Code-2
Patient address
UMLS CUI-2
C0421449
SNOMED CT-2
184097001
Method of Payment
Description

Method of Payment

Data type

integer

Race
Description

Race

Data type

integer

Alias
Code-1
Racial group
UMLS CUI-1
C0034510
SNOMED CT-1
103579009
LOINC-1
MTHU009923
Ethnic group
Description

Ethnicity

Data type

integer

Alias
Code-1
Ethnic group
UMLS CUI-1
C0015031
SNOMED CT-1
364699009
Eligibility Screening Form
Description

Eligibility Screening Form

Inclusion Criteria
Description

Inclusion Criteria

Data type

integer

Alias
Code-1
Inclusion Criteria
UMLS CUI-1
C1512693
Exclusion criteria
Description

Exclusion criteria

Data type

integer

Alias
Code-1
Exclusion Criteria
UMLS CUI-1
C0680251
Randomization
Description

Randomization

Date of Randomization
Description

Date of Randomization

Data type

date

Assigned Treatment Arm
Description

Assigned Treatment Arm

Data type

integer

Informed consent
Description

Informed consent

Date Informed consent signed
Description

Date Informed consent signed

Data type

date

Alias
Code-1
Informed consent obtained
UMLS CUI-1
C0514044
Code-2
Date in time
UMLS CUI-2
C0011008
SNOMED CT-2
410671006
LOINC-2
MTHU021546
Date of consent [for] pharmacogenetic research
Description

Date of consent [for] pharmacogenetic research

Data type

date

Alias
Code-1
Informed consent obtained
UMLS CUI-1
C0514044
Code-2
Pharmacogenetic Test
UMLS CUI-2
C2347500
Code-3
Date in time
UMLS CUI-3
C0011008
SNOMED CT-3
410671006
LOINC-3
MTHU021546
Did the patient consent to donate blood sample
Description

Did the patient consent to donate blood sample

Data type

boolean

Alias
Code-1
Blood Sample
UMLS CUI-1
C0178913
SNOMED CT-1
119297000
Code-2
Informed consent obtained
UMLS CUI-2
C0514044
MedDRA-2
MTHU008888
Did the patient consent to tumor tissue
Description

Did the patient consent to tumor tissue

Data type

boolean

Alias
Code-1
Tissue Collection
UMLS CUI-1
C0040278
Code-2
Informed consent obtained
UMLS CUI-2
C0514044
MedDRA-2
MTHU008888
Did the patient consent to donate additional blood sample
Description

Did the patient consent to donate additional blood sample

Data type

boolean

Alias
Code-1
Additional
UMLS CUI-1
C1524062
Code-2
Blood Sample
UMLS CUI-2
C0178913
SNOMED CT-2
119297000
Code-3
Informed consent obtained
UMLS CUI-3
C0514044
MedDRA-3
MTHU008888
Did the patient consent to donate fresh/frozen tissue
Description

Did the patient consent to donate fresh/frozen tissue

Data type

boolean

Alias
Code-1
Frozen Specimen
UMLS CUI-1
C1548793
Code-2
Informed consent obtained
UMLS CUI-2
C0514044
MedDRA-2
MTHU008888
Gynecological status
Description

Gynecological status

Menopausal Status
Description

Menopausal Status

Data type

integer

Alias
Code-1
Menopause finding (finding)
UMLS CUI-1
C0455962
SNOMED CT-1
276477006
Date last menstrual cycle
Description

Date of last menstrual cycle

Data type

date

Alias
Code-1
Menstrual cycle
UMLS CUI-1
C0025329
SNOMED CT-1
78456001
Code-2
Last
UMLS CUI-2
C1517741
Code-3
Date in time
UMLS CUI-3
C0011008
SNOMED CT-3
410671006
LOINC-3
MTHU021546
Date of pregnancy test
Description

Date of pregnancy test

Data type

date

Alias
Code-1
Pregnancy Tests
UMLS CUI-1
C0032976
SNOMED CT-1
74036000
MedDRA-1
10036572
Code-2
Date in time
UMLS CUI-2
C0011008
SNOMED CT-2
410671006
LOINC-2
MTHU021546
Pregnancy test
Description

Pregnancy test

Data type

integer

Alias
Code-1
Pregnancy Tests
SNOMED CT-1
74036000
MedDRA-1
10036572
UMLS CUI
C0032976
Has the patient had a hysterectomy?
Description

Has the patient had a hysterectomy?

Data type

boolean

Alias
Code-1
Hysterectomy
UMLS CUI-1
C0020699
SNOMED CT-1
236886002
MedDRA-1
10021151
Date Hysterectomy
Description

Hysterectomy

Data type

date

Alias
Code-1
Hysterectomy
UMLS CUI-1
C0020699
SNOMED CT-1
236886002
MedDRA-1
10021151
Code-2
Date in time
UMLS CUI-2
C0011008
SNOMED CT-2
410671006
LOINC-2
MTHU021546
Unilateral Oophorectomy
Description

Unilateral ovariectomy/oophorectomy

Data type

boolean

Alias
Code-1
Unilateral Oophorectomy
UMLS CUI-1
C0041687
SNOMED CT-1
33159007
MedDRA-1
10030344
ICD-9-CM-1
65.3
Side Ovariectomy
Description

Specify side

Data type

integer

Alias
UMLS CUI-1
C0441987
SNOMED CT-1
182353008
Code-2
Unilateral Oophorectomy
UMLS CUI-2
C0041687
SNOMED CT-2
33159007
MedDRA-2
10030344
Date Unilateral Oophorectomy
Description

Unilateral oophorectomy Date

Data type

date

Alias
Code-1
Unilateral Oophorectomy
UMLS CUI-1
C0041687
SNOMED CT-1
33159007
MedDRA-1
10030344
Code-2
Date in time
UMLS CUI-2
C0011008
SNOMED CT-2
410671006
LOINC-2
MTHU021546
Patient Status
Description

Patient Status

Date of Physical exam
Description

Date of Physical exam

Data type

date

Alias
Code-1
Physical Examination Date
UMLS CUI-1
C2826643
Physical Examination
Description

Physical exam

Data type

integer

Alias
UMLS CUI-1
C0031809
SNOMED CT-1
5880005
MedDRA-1
10034986
LOINC-1
MTHU028014
Height
Description

Length of body

Data type

float

Measurement units
  • cm
Alias
Item-Info
cm
Code-1
Length of body (observable entity)
SNOMED CT-1
248334005
UMLS CUI-1
C0005890
cm
Body weight
Description

Body weight

Data type

float

Measurement units
  • kg
Alias
Item-Info
kg
Code-1
Body Weight
SNOMED CT-1
27113001
LOINC-1
MTHU001885
UMLS CUI-1
C0005910
kg
Body surface area
Description

Body surface area

Data type

float

Measurement units
Alias
Item-Info
m^2
Code-1
Body Surface Area
SNOMED CT-1
301898006
MedDRA-1
10050311
UMLS CUI-1
C0005902
Systolic blood pressure
Description

Systolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
Code-1
Systolic Blood Pressure
SNOMED CT-1
271649006
UMLS CUI-1
C0871470
mmHg
Diastolic blood pressure
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
Code-1
Diastolic Blood Pressure
SNOMED CT-1
271650006
UMLS CUI-1
C0428883
mmHg
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
Item-Info
beats/min
Code-1
heart rate
SNOMED CT-1
364075005
MedDRA-1
10019299
LOINC-1
MTHU003114
UMLS CUI-1
C0018810
bpm
ECOG performance status grade
Description

ECOG

Data type

integer

Alias
UMLS CUI-1
C1632812
ECG
Description

ECG

Alias
UMLS CUI-1
C1623258
date of ECG
Description

date of ECG

Data type

date

Result
Description

Result

Data type

integer

Cardiac Monitoring
Description

Cardiac Monitoring

Alias
UMLS CUI-1
C0150496
Date Left Ventricular Ejection Fraction
Description

Date Left Ventricular Ejection Fraction

Data type

date

Alias
Code-1
Left Ventricular Ejection Fraction
Code-2
Date in time
SNOMED CT-2
410671006
LOINC-2
MTHU021546
UMLS CUI-1
C0428772
UMLS CUI-2
C0011008
Left Ventricular Ejection Fraction
Description

Left Ventricular Ejection Fraction

Data type

float

Measurement units
  • %
Alias
Code-1
Left Ventricular Ejection Fraction
UMLS CUI-1
C0428772
%
Echocardiography
Description

Echocardiogramm

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Echocardiography
UMLS CUI-1
C0013516
SNOMED CT-1
40701008
MedDRA-1
10014113
ICD-9-CM-1
88.72
Radionuclide Ventriculogram Scan
Description

Muga Scan

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Radionuclide Ventriculogram Scan
UMLS CUI-1
C0521317
SNOMED CT-1
404221001
MedDRA-1
10028211
Result
Description

Result

Data type

integer

Alias
Code-1
Result
UMLS CUI-1
C1274040
SNOMED CT-1
394617004
Code-2
Left Ventricular Ejection Fraction
UMLS CUI-2
CL433348
Symptomatic CHF
Description

Symptomatic CHF

Data type

boolean

NYHA Classification
Description

NYHA Classification

Data type

text

Alias
UMLS CUI-1
C1275491
Local Her2 Results
Description

Local Her2 Results

Description

Staining Antibody

Data type

integer

not_useful_for_research
Description

other

Data type

string

Her2/Neu Status
Description

ICH Result

Data type

integer

Alias
Code-1
Her2/Neu Status
UMLS CUI-1
C1512413
Percentage of invasive tumor cells with complete membrane staining
Description

Percentage of invasive tumor cells with complete membrane staining

Data type

integer

FISH Kit or Test Type
Description

FISH Kit or Test Type

Data type

integer

not_useful_for_research
Description

other

Data type

string

FisH-Test
Description

FISH Result

Data type

integer

Alias
Code-1
Fluorescent in Situ Hybridization
UMLS CUI-1
C0162789
SNOMED CT-1
426329006
MedDRA-1
10066931
FISH HER2/neu chromosome 17 Ratio
Description

FISH HER2/neu chromosome 17 Ratio

Data type

integer

Chromosome 17 copy number
Description

Chromosome 17 copy number

Data type

integer

Test Date
Description

Sample test date

Data type

date

Alias
Code-1
Test Date
UMLS CUI-1
C2826247
Not done
Description

Not done

Data type

string

Alias
Code-1
Not Done
UMLS CUI-1
C1272696
SNOMED CT-1
385660001
Code-2
Her2/Neu Status
UMLS CUI-2
C1512413
CISH Kit or Test Type
Description

CISH Kit or Test Type

Data type

integer

not_useful_for_research
Description

Other

Data type

string

CISH
Description

CISH Result

Data type

integer

Alias
Code-1
Cytokine-Inducible SH2-Containing Protein
UMLS CUI-1
C0299250
Chromosome 17 copy number
Description

Chromosome 17 copy number

Data type

integer

Hormonal Receptor Status
Description

Hormonal Receptor Status

ER % cells stained positive
Description

ER % cells stained positive

Data type

integer

Alias
Code-1
Percentage unit (qualifier value)
UMLS CUI-1
C1532336
SNOMED CT-1
415067009
Code-2
Estrogen receptor positive tumor (disorder)
UMLS CUI-2
C1562312
SNOMED CT-2
416053008
PgR % cells stained positive
Description

PgR % cells stained positive

Data type

integer

Alias
Code-1
Percentage unit (qualifier value)
UMLS CUI-1
C1532336
SNOMED CT-1
415067009
Code-2
Progesterone receptor positive tumor (disorder)
UMLS CUI-2
C1562928
SNOMED CT-2
416561008
History Of Primary Breast Cancer
Description

History Of Primary Breast Cancer

Date of diagnosis
Description

Date of initial Pathologic Diagnosis

Data type

date

Alias
Code-1
Date of diagnosis
UMLS CUI-1
C2316983
SNOMED CT-1
432213005
Code-2
Tumor finding (finding)
UMLS CUI-2
C1274082
SNOMED CT-2
395557000
LOINC-2
MTHU021546
Tumor Laterality
Description

Tumor Laterality

Data type

integer

Alias
UMLS CUI-1
C0441987
SNOMED CT-1
182353008
LOINC-1
MTHU014973
Code-2
Tumor site
UMLS CUI-2
C0475445
SNOMED CT-2
263591006
LOINC-2
MTHU015562
Clinical Size of Tumor
Description

Clinical Size of Tumor

Data type

integer

Alias
Code-1
Tumor size (observable entity)
UMLS CUI-1
C0475440
SNOMED CT-1
263605001
Code-2
Clinical
UMLS CUI-2
C0205210
SNOMED CT-2
58147004
N - Regional lymph node stage
Description

Clinical N Stage

Data type

integer

Alias
Code-1
cN category (observable entity)
UMLS CUI-1
C1275865
SNOMED CT-1
399534004
Tumor size
Description

Pathologic Primary Tumor Size

Data type

integer

Alias
Code-1
Tumor size (observable entity)
UMLS CUI-1
C0475440
SNOMED CT-1
263605001
Surgical margin involved by malignant neoplasm
Description

Margin involvement

Data type

boolean

Alias
Code-1
Surgical margin involved by malignant neoplasm (finding)
UMLS CUI-1
C1273678
SNOMED CT-1
384689007
Histologic Type
Description

Histologic Type

Data type

integer

Alias
Code-1
Histologic Type
UMLS CUI-1
C0449574
SNOMED CT-1
263541007
LOINC-1
MTHU020048
other
Description

other

Data type

string

Alias
Code-1
Other
UMLS CUI-1
C0205394
SNOMED CT-1
74964007
Code-2
Free Text Format
UMLS CUI-2
C2348713
Carcinoma in Situ
Description

Is carcinoma in situ present

Data type

boolean

Alias
Code-1
Carcinoma in Situ
UMLS CUI-1
C0007099
SNOMED CT-1
109355002
MedDRA-1
10061450
ICD-10-CM-1
D09.9
ICD-9-CM-1
234.9
Histologic Type
Description

Histologic Type

Data type

integer

Alias
Code-1
Histologic Type
UMLS CUI-1
C0449574
SNOMED CT-1
263541007
LOINC-1
MTHU020048
Paget's Disease of the Nipple
Description

Is Paget's disease of the nipple present?

Data type

boolean

Alias
Code-1
Paget's Disease of the Nipple
UMLS CUI-1
C1704323
SNOMED CT-1
403946000
MedDRA-1
10033364
Histologic Grade
Description

Histologic Grade

Data type

integer

Alias
UMLS CUI-1
C0919553
SNOMED CT-1
371469007
Lymphnode involvement
Description

Lymphnode involvement

Data type

integer

Alias
Code-1
Lymph Node Involvement
UMLS CUI-1
C0806692
LOINC-1
MTHU010351
Timing of chemotherapy
Description

Timing of chemotherapy

Data type

integer

Hematology And Biochemistry
Description

Hematology And Biochemistry

Data type

integer

Date of blood specimen collection
Description

Date of blood specimen collection

Data type

date

Result
Description

Result

Data type

integer

History Of Primary Cancer (continued)
Description

History Of Primary Cancer (continued)

Laboratory Name
Description

Laboratory Name

Data type

string

Alias
Code-1
Laboratory
UMLS CUI-1
C0022877
SNOMED CT-1
261904005
Estrogen Receptor
Description

ER status

Data type

integer

Alias
Code-1
Status of estrogen receptors of neoplasm (observable entity)
UMLS CUI-1
C2919271
SNOMED CT-1
445028008
Status of estrogen receptors of neoplasm
Description

Is estrogen receptor analysis result available

Data type

boolean

Alias
Code-1
Status of estrogen receptors of neoplasm (observable entity)
UMLS CUI-1
C2919271
SNOMED CT-1
445028008
Code-2
Availability
UMLS CUI-2
C0470187
SNOMED CT-2
103328004
Estrogen receptor value
Description

Estrogen receptor value

Data type

integer

Alias
Code-1
Estrogen Receptors
UMLS CUI-1
C0034804
SNOMED CT-1
23307004
LOINC-1
MTHU004667
Code-2
Value
UMLS CUI-2
C1522609
H-Score
Description

H-Score

Data type

integer

Allred-Score
Description

Allred-Score

Data type

integer

Remmle score
Description

Remmle score

Data type

integer

other
Description

other

Data type

string

Method
Description

Method

Data type

string

Range
Description

Range

Data type

string

progesterone receptor
Description

PgR Status

Data type

integer

Alias
Code-1
Status of progesterone receptors of neoplasm (observable entity)
UMLS CUI-1
C2919590
SNOMED CT-1
445029000
Status of progesterone receptors of neoplasm
Description

Is progesterone receptor analysis result available

Data type

boolean

Alias
Code-1
Status of progesterone receptors of neoplasm (observable entity)
UMLS CUI-1
C2919590
SNOMED CT-1
445029000
Code-2
Availability
UMLS CUI-2
C0470187
SNOMED CT-2
103328004
Progesterone receptor value
Description

Progesterone receptor value

Data type

integer

Alias
Code-1
Receptors, Progesterone
UMLS CUI-1
C0034833
SNOMED CT-1
61078009
LOINC-1
MTHU002145
Code-2
Value
UMLS CUI-2
C1522609
H-Score
Description

H-Score

Data type

integer

Allred-Score
Description

Allred-Score

Data type

integer

Remmle score
Description

Remmle score

Data type

integer

other
Description

other

Data type

string

Method
Description

Method

Data type

string

Range
Description

Range

Data type

string

Sentinel Node Sampling
Description

Sentinel Node Sampling

Was sentinel node sampling performed
Description

Was sentinel node sampling performed

Data type

boolean

Alias
Code-1
Sentinel Lymph Node Biopsy
UMLS CUI-1
C0796693
SNOMED CT-1
396487001
Sentinel Node Biopsy Date
Description

Sentinel Node Biopsy Date

Data type

date

Alias
Code-1
Sentinel Lymph Node Biopsy
UMLS CUI-1
C0796693
SNOMED CT-1
396487001
Code-2
Date in time
UMLS CUI-2
C0011008
SNOMED CT-2
410671006
LOINC-2
MTHU021546
Side
Description

Laterality

Data type

integer

Alias
UMLS CUI-1
C0441987
SNOMED CT-1
182353008
LOINC-1
MTHU014973
Code-2
Sentinel Lymph Node Biopsy
UMLS CUI-2
C0796693
SNOMED CT-2
396487001
Axillary sentinel node biopsy
Description

Axillary sentinel node biopsy

Data type

integer

Alias
Code-1
Sentinel Lymph Node Biopsy
UMLS CUI-1
C0796693
SNOMED CT-1
396487001
Code-2
Axilla
UMLS CUI-2
C0004454
SNOMED CT-2
91470000
LOINC-2
MTHU024430
Internal sentinel mammary nodes biopsy
Description

Internal sentinel mammary nodes biopsy

Data type

integer

Alias
Code-1
Internal mammary node (body structure)
UMLS CUI-1
C0447180
SNOMED CT-1
245340002
Code-2
Sentinel Lymph Node Biopsy
UMLS CUI-2
C0796693
SNOMED CT-2
396487001
Not done
Description

Not done

Data type

string

Alias
Code-1
Not Done
UMLS CUI-1
C1272696
SNOMED CT-1
385660001
Code-2
Sentinel Lymph Node Biopsy
UMLS CUI-2
C0796693
SNOMED CT-2
396487001
Most Extensive Primary Surgery
Description

Most Extensive Primary Surgery

Operative Surgical Procedures
Description

Primary breast cancer surgery

Data type

integer

Alias
Code-1
Operative Surgical Procedures
UMLS CUI-1
C0543467
SNOMED CT-1
387713003
MedDRA-1
10042609
LOINC-1
MTHU007597
Specify
Description

Specify

Data type

string

Alias
Code-1
Operative Surgical Procedures
UMLS CUI-1
C0543467
SNOMED CT-1
387713003
MedDRA-1
10042609
LOINC-1
MTHU007597
Code-2
Free Text Format
UMLS CUI-2
C2348713
Laterality
Description

Laterality

Data type

integer

Alias
Code-1
Operative Surgical Procedures
UMLS CUI-1
C0543467
SNOMED CT-1
387713003
MedDRA-1
10042609
LOINC-1
MTHU007597
Code-2
Side
UMLS CUI-2
C0441987
SNOMED CT-2
182353008
LOINC-2
MTHU014973
Date of surgery
Description

Primary surgery Date

Data type

date

Alias
Code-1
Date surgery
UMLS CUI-1
C1628561
LOINC-1
MTHU019327
Axillary Lymph Node Dissection
Description

Axillary Lymph Node Dissection

Date of Axillary Dissection
Description

Date of Axillary Dissection

Data type

date

Alias
Code-1
Axillary Lymph Node Dissection
UMLS CUI-1
C0193867
SNOMED CT-1
234254000
MedDRA-1
10068477
ICD-9-CM-1
40.23
Code-2
Date in time
UMLS CUI-2
C0011008
SNOMED CT-2
410671006
LOINC-2
MTHU021546
Laterality
Description

Laterality

Data type

integer

Alias
Code-1
Axillary Lymph Node Dissection
UMLS CUI-1
C0193867
SNOMED CT-1
234254000
MedDRA-1
10068477
Code-2
Side
UMLS CUI-2
C0441987
SNOMED CT-2
182353008
LOINC-2
MTHU014973
Number of lymph nodes examined
Description

Number of Lymph Nodes examinded

Data type

integer

Alias
UMLS CUI-1
C2733494
SNOMED CT-1
444025001
Number of lymph nodes involved by malignant neoplasm
Description

Number positive Lymph nodes

Data type

integer

Alias
Code-1
Number of lymph nodes involved by malignant neoplasm (observable entity)
UMLS CUI-1
C2732750
SNOMED CT-1
443527007
Largest tumor deposit
Description

Largest tumor deposit

Data type

integer

Not done
Description

Not done

Data type

string

Alias
Code-1
Not Done
UMLS CUI-1
C1272696
SNOMED CT-1
385660001
Code-2
Operative Surgical Procedures
UMLS CUI-2
C0543467
SNOMED CT-2
387713003
MedDRA-2
10042609
LOINC-2
MTHU007597
Chemotherapy
Description

Chemotherapy

Chemotherapeutic agent
Description

Agent Name

Data type

string

Alias
Code-1
Chemotherapeutic agent (product)
UMLS CUI-1
C0729502
SNOMED CT-1
312059006
Cumulative Dose
Description

Total Dose

Data type

integer

Alias
UMLS CUI-1
C2986497
initial dose
Description

initial dose

Data type

integer

Alias
Code-1
Initial (qualifier value)
UMLS CUI-1
C0205265
SNOMED CT-1
884001
Code-2
Dosage
UMLS CUI-2
C0178602
SNOMED CT-2
277406006
planned cycles
Description

Total No. Cycles

Data type

integer

Alias
Code-1
Plan
UMLS CUI-1
C1301732
SNOMED CT-1
397943006
Code-2
Chemotherapy cycle (procedure)
UMLS CUI-2
C1302181
SNOMED CT-2
399042005
Intent - prior chemotherapy
Description

Prior Treatment Regimen Type

Data type

integer

Alias
UMLS CUI-1
C1283828
SNOMED CT-1
367565008
Code-2
Chemotherapy Regimen
UMLS CUI-2
C0392920
SNOMED CT-2
69960004
MedDRA-2
10061758
Code-3
Prior
UMLS CUI-3
C0332152
SNOMED CT-3
288556008
Date treatment started
Description

Date Started

Data type

date

Alias
Code-1
Date treatment started (observable entity)
UMLS CUI-1
C3173309
SNOMED CT-1
413946009
Code-2
Chemotherapy Regimen
UMLS CUI-2
C0392920
SNOMED CT-2
69960004
MedDRA-2
10061758
Date treatment stopped
Description

Date Stopped

Data type

date

Alias
Code-1
Date treatment stopped (observable entity)
UMLS CUI-1
C1531784
SNOMED CT-1
413947000
Code-2
Chemotherapy Regimen
UMLS CUI-2
C0392920
SNOMED CT-2
69960004
MedDRA-2
10061758
Previous Or Current Cardiovascular Disease
Description

Previous Or Current Cardiovascular Disease

not_useful_for_research
Description

Has the patient suffered cardiovascular disease?

Data type

boolean

not_useful_for_research
Description

Medical condition

Data type

string

not_useful_for_research
Description

Medical condition

Data type

integer

not_useful_for_research
Description

Treatment Required

Data type

boolean

not_useful_for_research
Description

Has the patient been assessed for systemic disease

Data type

boolean

ECG
Description

ECG

Alias
UMLS CUI-1
C1623258
not_useful_for_research
Description

Type of radiological Examination

Data type

integer

not_useful_for_research
Description

Specify

Data type

string

not_useful_for_research
Description

Anatomical Site

Data type

integer

not_useful_for_research
Description

Date of test

Data type

date

not_useful_for_research
Description

Are there any clinically significant abnormalites

Data type

boolean

not_useful_for_research
Description

Specify

Data type

string

not_useful_for_research
Description

Not done

Data type

string

Translational Research
Description

Translational Research

not_useful_for_research
Description

Type of tissue

Data type

integer

not_useful_for_research
Description

Date of blood specimen collection

Data type

date

not_useful_for_research
Description

Was sample obtained

Data type

boolean

Central Her2 Testing Form - FISH
Description

Central Her2 Testing Form - FISH

Percentage greater than or equal to 3 Chromosome 17 signals
Description

Percentage greater than or equal to 3 Chromosome 17 signals

Data type

string

NACA (No apparent Chromosome 17 anomaly)
Description

NACA (No apparent Chromosome 17 anomaly)

Data type

boolean

Why no result
Description

Why no result

Data type

integer

Specify
Description

Specify

Data type

string

Other features
Description

Other features

Data type

integer

Central Her2 Testing Form - IHC
Description

Central Her2 Testing Form - IHC

not_useful_for_research
Description

Percentage of invasive tumor cells with complete membrane staining

Data type

integer

Uniformity of staining
Description

Uniformity of staining

Data type

integer

Homogeneous dark circumferential pattern
Description

Homogeneous dark circumferential pattern

Data type

integer

Her-2/neu
Description

IHC Result

Data type

integer

Alias
Code-1
Her2/Neu Status
UMLS CUI-1
C1512413
Is there vascular invasion
Description

Is there vascular invasion

Data type

boolean

Alias
Code-1
Vascular invasion of tumor present (finding)
UMLS CUI-1
C1318569
SNOMED CT-1
372287009
Suitable for TMA
Description

Suitable for TMA

Data type

boolean

Radiotherapy
Description

Radiotherapy

prior Radiation Therapy
Description

prior Radiation Therapy

Data type

boolean

Alias
Code-1
Therapeutic radiology procedure
UMLS CUI-1
C1522449
SNOMED CT-1
108290001
MedDRA-1
10037770
RT Site
Description

RT Site

Data type

string

Alias
Code-1
Organ target(s)
UMLS CUI-1
C0807185
Side
Description

Side

Data type

integer

Alias
UMLS CUI-1
C0441987
SNOMED CT-1
182353008
LOINC-1
MTHU014973
Code-2
Tumor site
UMLS CUI-2
C0475445
SNOMED CT-2
263591006
LOINC-2
MTHU015562
Total radiation dose
Description

RT Total Dose

Data type

integer

Alias
Code-1
Total radiation dose delivered (observable entity)
UMLS CUI-1
C2919490
SNOMED CT-1
445461008
Dose UOM
Description

Dose UOM

Data type

integer

Start Radiotherapy
Description

Radiation Therapy Start Date

Data type

date

Alias
Code-1
Radiotherapy started (situation)
UMLS CUI-1
C0436382
SNOMED CT-1
168531007
End Radiotherapy
Description

Radiation Therapy End Date

Data type

date

Alias
Code-1
Radiotherapy completed (situation)
UMLS CUI-1
C0436385
SNOMED CT-1
168534004
Hormone therapy
Description

Hormone therapy

Alias
UMLS CUI-1
C0279025
Has the patient received hormone therapy before or during the trial
Description

Has the patient received hormone therapy before or during the trial

Data type

boolean

Alias
SNOMED CT-1
169413002
MedDRA-1
10065646
UMLS CUI-1
C0279025
Therapeutic procedure
Description

Name of treatment or surgical procedure

Data type

string

Alias
UMLS CUI-1
C0087111
SNOMED CT-1
277132007
MedDRA-1
10053757
LOINC-1
MTHU008880
Code-2
Free Text Format
UMLS CUI-2
C2348713
Single dose characteristic
Description

Dose

Data type

integer

Alias
Code-1
Single dose characteristic (observable entity)
UMLS CUI-1
C1960417
SNOMED CT-1
426146003
Unit type (qualifier value)
Description

Unit

Data type

integer

Alias
UMLS CUI-1
C0565912
SNOMED CT-1
288462000
Date treatment started - endocrine therapy
Description

Begin date

Data type

date

Alias
Code-1
Date treatment started (observable entity)
UMLS CUI-1
C3173309
SNOMED CT-1
413946009
Code-2
Endocrine Therapy
UMLS CUI-2
C0279025
SNOMED CT-2
169413002
Date treatment stopped - endocrine therapy
Description

End date

Data type

date

Alias
Code-1
Date treatment stopped (observable entity)
UMLS CUI-1
C1531784
SNOMED CT-1
413947000
Code-2
Endocrine Therapy
UMLS CUI-2
C0279025
SNOMED CT-2
169413002
ongoing at time of study completion
Description

ongoing at time of study completion

Data type

integer

Alias
Code-1
Continue
UMLS CUI-1
C0549178
Code-2
Study End Date
UMLS CUI-2
C2983670
Code-3
Endocrine Therapy
UMLS CUI-3
C0279025
SNOMED CT-3
169413002
Concomitant Treatment
Description

Concomitant Treatment

Name of concomitant treatment
Description

Name of treatment

Data type

string

Alias
Code-1
Concomitant Therapy
UMLS CUI-1
C1707479
Intent
Description

Indication for use

Data type

integer

Alias
UMLS CUI-1
C1283828
SNOMED CT-1
367565008
Code-2
Concomitant Therapy
UMLS CUI-2
C1707479
Date treatment started
Description

Date started

Data type

date

Alias
Code-1
Date treatment started (observable entity)
UMLS CUI-1
C3173309
SNOMED CT-1
413946009
Code-2
Concomitant Therapy
UMLS CUI-2
C1707479
Date stopped
Description

Date stopped

Data type

date

Alias
Code-1
Date treatment stopped (observable entity)
UMLS CUI-1
C1531784
SNOMED CT-1
413947000
Code-2
Concomitant Therapy
UMLS CUI-2
C1707479
Ongoing
Description

Ongoing

Data type

integer

Alias
Code-1
Continue
UMLS CUI-1
C0549178
Code-2
Study End Date
UMLS CUI-2
C2983670
Code-3
Concomitant Therapy
UMLS CUI-3
C1707479
Administration of Study Drug
Description

Administration of Study Drug

Date Agent Administered
Description

Date Agent Administered

Data type

date

Single dose characteristic
Description

Dose

Data type

integer

Alias
Code-1
Single dose characteristic (observable entity)
UMLS CUI-1
C1960417
SNOMED CT-1
426146003
Cumulative Dose
Description

Total Dose

Data type

integer

Alias
UMLS CUI-1
C2986497
Was treatment delayed
Description

Was treatment delayed

Data type

boolean

Specify code
Description

Specify code

Data type

integer

specify
Description

specify

Data type

string

Chemotherapeutic drug level decreased
Description

Was dose reduced

Data type

boolean

Alias
UMLS CUI-1
C0861114
Specify code
Description

Specify code

Data type

integer

specify
Description

specify

Data type

string

Chemotherapy
Description

Chemotherapy

relapse treatment - chemotherapy
Description

Did the patient receive additional chemotherapy after recurrence of breast cancer or second primary malignancy of contralateral breast cancer

Data type

boolean

Alias
Code-1
relapse treatment
UMLS CUI-1
C0679868
Code-2
Chemotherapy Regimen
UMLS CUI-2
C0392920
SNOMED CT-2
69960004
MedDRA-2
10061758
Agent Name
Description

Agent Name

Data type

string

Total No. Cycles
Description

Total No. Cycles

Data type

integer

initial dose
Description

initial dose

Data type

integer

Dose UOM
Description

Dose UOM

Data type

integer

Date started
Description

Date started

Data type

date

Date stopped
Description

Date stopped

Data type

date

Targeted Therapy
Description

Targeted Therapy

Did the patient receive additional target therapy after recurrence of breast cancer or second primary malignancy of contralateral breast cancer
Description

Did the patient receive additional target therapy after recurrence of breast cancer or second primary malignancy of contralateral breast cancer

Data type

boolean

Agent Name
Description

Agent Name

Data type

string

Total No. Cycles
Description

Total No. Cycles

Data type

integer

initial dose
Description

initial dose

Data type

integer

Dose UOM
Description

Dose UOM

Data type

integer

Date started
Description

Date started

Data type

date

Date stopped
Description

Date stopped

Data type

date

Hormonetherapy
Description

Hormonetherapy

relapse treatment - endocrine therapy
Description

Did the patient receive hormone therapy after recurrence of breast cancer or second primary malignancy of contralateral breast cancer

Data type

boolean

Alias
Code-1
relapse treatment
UMLS CUI-1
C0679868
Code-2
Endocrine Therapy
UMLS CUI-2
C0279025
SNOMED CT-2
169413002
MedDRA-2
10065646
Agent Name
Description

Agent Name

Data type

string

Total No. Cycles
Description

Total No. Cycles

Data type

integer

initial dose
Description

initial dose

Data type

integer

Dose UOM
Description

Dose UOM

Data type

integer

Date started
Description

Date started

Data type

date

Date stopped
Description

Date stopped

Data type

date

Radiotherapy
Description

Radiotherapy

relapse treatment - radiotherapy
Description

Did the patient receive radiotherapy after recurrence of breast cancer or second primary malignancy of contralateral breast cancer

Data type

boolean

Alias
Code-1
relapse treatment
UMLS CUI-1
C0679868
Code-2
Therapeutic radiology procedure
UMLS CUI-2
C1522449
SNOMED CT-2
108290001
MedDRA-2
10037794
Radiation Therapy Site
Description

Radiation Therapy Site

Data type

string

Side
Description

Side

Data type

integer

Total Dose
Description

Total Dose

Data type

integer

Dose UOM
Description

Dose UOM

Data type

integer

Radiation Therapy Start Date
Description

Radiation Therapy Start Date

Data type

date

Radiation Therapy End Date
Description

Radiation Therapy End Date

Data type

date

Surgery
Description

Surgery

relapse treatment - Operative Surgical Procedures
Description

Did the patient receive surgery after recurrence of breast cancer or second primary malignancy of contralateral breast cancer

Data type

boolean

Alias
Code-1
relapse treatment
UMLS CUI-1
C0679868
Code-2
Operative Surgical Procedures
UMLS CUI-2
C0543467
SNOMED CT-2
387713003
MedDRA-2
10042609
LOINC-2
MTHU007597
Surgical site
Description

Surgical site

Data type

string

Surgery Date
Description

Surgery Date

Data type

date

Adverse Event (AE)
Description

Adverse Event (AE)

AE Name
Description

AE Name

Data type

integer

Alias
UMLS CUI-1
C0877248
MedDRA-1
10060933
LOINC-1
MTHU014542
Laboratory Values
Description

Metabolic/laboratory Other (Metabolic/Laboratory-Other (Specify))

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Other Metabolic and Laboratory Adverse Event
UMLS CUI-1
C1559945
CTCAE-1
MTHU117254
Gastrointestinal system
Description

Renal/genitourinary Other (Renal/Genitourinary-Other (Specify))

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Adverse Event Associated with the Gastrointestinal System
UMLS CUI-1
C1559265
CTCAE-1
MTHU112146
Genitourinary system
Description

Niere/Blase

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Renal or Genitourinary Other Adverse Event
UMLS CUI-1
C1558061
CTCAE-1
MTHU117419
Skin
Description

Dermatology/skin Other (Dermatology/Skin-Other (Specify))

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Other Dermatology or Skin Adverse Event
UMLS CUI-1
C1559104
CTCAE-1
MTHU117246
Allergic Reaction
Description

Allergy/immunology Other (Allergy/Immunology-Other (Specify))

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Adverse Event Associated with Allergy and Immunology
UMLS CUI-1
C1560126
CTCAE-1
MTHU112125
Fever
Description

Pyrexia (Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L))

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Fever Without Neutropenia Adverse Event
UMLS CUI-1
C1556366
CTCAE-1
MTHU116933
Infection
Description

Infection Nos (Infection-Other (Specify))

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Adverse Event Associated with Infection
UMLS CUI-1
C1556682
CTCAE-1
MTHU112135
Entire sensory organ
Description

Auditory/ear Other (Auditory/Ear-Other (Specify))

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Adverse Event Associated with the Ear and Auditory System
UMLS CUI-1
C1560154
CTCAE-1
MTHU112144
General symptom
Description

Constitutional Symptoms Other (Constitutional Symptoms-Other (Specify))

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Adverse Event Associated with Constitutional Symptoms
UMLS CUI-1
C1556354
CTCAE-1
MTHU112129
Lung/Larynx
Description

Pulmonary/upper Respiratory Other (Pulmonary/Upper Respiratory-Other (Specify))

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Adverse Event Associated with Pulmonary and Upper Respiratory Systems
UMLS CUI-1
C1557628
CTCAE-1
MTHU112139
Endocrine system
Description

Endocrine Other (Endocrine-Other (Specify))

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Adverse Event Associated with the Endocrine System
UMLS CUI-1
C1559198
CTCAE-1
MTHU112145
Cardiac General Other
Description

Cardiac General Other (Cardiac General-Other (Specify))

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Adverse Event Associated with the Heart in General
UMLS CUI-1
C1556247
CTCAE-1
MTHU112147
Hemoglobin
Description

Haemoglobin Decreased (Hemoglobin)

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Hemoglobin Adverse Event
UMLS CUI-1
C2239101
CTCAE-1
MTHU116997
Aspartate Transaminase
Description

Aspartate Aminotransferase Increased (AST, SGOT (serum glutamic oxaloacetic transaminase))

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Serum Glutamic Oxaloacetic Transaminase Adverse Event
UMLS CUI-1
C1557198
CTCAE-1
MTHU117449
Alanine Transaminase
Description

Alanine Aminotransferase Increased (ALT, SGPT (serum glutamic pyruvic transaminase))

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Serum Glutamic Pyruvic Transaminase Adverse Event
UMLS CUI-1
C1557189
CTCAE-1
MTHU117450
Creatinine
Description

Blood Creatinine Increased (Creatinine)

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Creatinine Adverse Event
UMLS CUI-1
C1561535
CTCAE-1
MTHU116842
Peripheral Nerves
Description

Neuralgia Nos (Pain - Neuralgia/peripheral nerve)

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Neuralgia and Peripheral Nerve Pain Adverse Event
UMLS CUI-1
C1557517
CTCAE-1
MTHU117196
Hemorrhage
Description

Hemorrhage/bleeding Other (Hemorrhage/Bleeding-Other (Specify))

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Other Hemorrhage and Bleeding Adverse Event
UMLS CUI-1
C1556642
CTCAE-1
MTHU117250
Bilirubin
Description

Blood Bilirubin Increased (Bilirubin (hyperbilirubinemia))

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Hyperbilirubinemia Adverse Event
UMLS CUI-1
C1557209
CTCAE-1
MTHU117008
Leukocytes
Description

Leucopenia Nos (Leukocytes (total WBC))

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Leukocytes Adverse Event
UMLS CUI-1
C1560219
CTCAE-1
MTHU117099
Alkaline Phosphatase
Description

Blood Alkaline Phosphatase Nos Increased (Alkaline phosphatase)

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Alkaline Phosphatase Adverse Event
UMLS CUI-1
C1561546
CTCAE-1
MTHU112158
Proteinuria
Description

Proteinuria Present (Proteinuria)

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Proteinuria Adverse Event
UMLS CUI-1
C1962972
CTCAE-1
MTHU117382
Hair
Description

Alopecia (Hair loss/Alopecia (scalp or body))

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Alopecia Adverse Event
UMLS CUI-1
C1559115
CTCAE-1
MTHU112161
Obstipation
Description

Constipation (Constipation)

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Constipation Adverse Event
UMLS CUI-1
C1963087
CTCAE-1
MTHU116803
Diarrhea
Description

Diarrhoea Nos (Diarrhea)

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Diarrhea Adverse Event
UMLS CUI-1
C0232708
CTCAE-1
MTHU116856
Hematuria
Description

Haematuria Present (Hemorrhage, GU - Urinary NOS)

Data type

boolean

Alias
Code-Info
changed_datatype
UMLS CUI-1
C0018965
SNOMED CT-1
34436003
MedDRA-1
10018867
ICD-10-CM-1
R31.9
ICD-9-CM-1
599.7
CTCAE-1
E13000
Pain
Description

Pain Other (Pain-Other (Specify))

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Other Pain Adverse Event
UMLS CUI-1
C1557623
CTCAE-1
MTHU117260
Blood Platelets
Description

Platelet Count Decreased (Platelets)

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Platelets Adverse Event
UMLS CUI-1
C1963076
CTCAE-1
MTHU117353
Nausea
Description

Nausea (Nausea)

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Nausea Adverse Event
UMLS CUI-1
C1963179
CTCAE-1
MTHU117189
Heart Rhythm
Description

Arrhythmia Nos (Cardiac Arrhythmia-Other (Specify))

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Adverse Event Associated with Cardiac Arrhythmia
UMLS CUI-1
C1560249
CTCAE-1
MTHU112127
Pericarditis
Description

Pericarditis (Pericarditis)

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Pericarditis Adverse Event
UMLS CUI-1
C1963211
CTCAE-1
MTHU117310
Conscious
Description

Depressed Level Of Consciousness (Somnolence/depressed level of consciousness)

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Somnolence and Depressed Level of Consciousness Adverse Event
UMLS CUI-1
C1557290
CTCAE-1
MTHU117503
Dyspnea
Description

Dyspnoea Nos (Dyspnea (shortness of breath))

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Dyspnea Adverse Event
UMLS CUI-1
C1963100
CTCAE-1
MTHU116873
Cystitis
Description

Cystitis (Cystitis)

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Cystitis Adverse Event
UMLS CUI-1
C1963088
CTCAE-1
MTHU116844
Erbrechen
Description

Vomiting Nos (Vomiting)

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Vomiting Adverse Event
UMLS CUI-1
C1963281
CTCAE-1
MTHU117700
1024 more adverse events
Description

1024 more adverse events

Data type

integer

SAE reported
Description

SAE reported

Data type

boolean

CTCAE Begin Date
Description

CTCAE Begin Date

Data type

date

CTCAE End Date
Description

CTCAE End Date

Data type

date

CTC Adverse Event Grade
Description

CTC Adverse Event Grade

Data type

integer

Alias
Code-1
Adverse Event Grade Code
UMLS CUI-1
C2985911
CTC Adverse Event Outcomme
Description

CTC Adverse Event Outcomme

Data type

integer

Action Taken at Time of Adverse Event
Description

Action Taken at Time of Adverse Event

Data type

integer

relation to study drug
Description

relation to study drug

Data type

boolean

Second Primary Malignancy and Contralateral Breast Cancer
Description

Second Primary Malignancy and Contralateral Breast Cancer

Recurrence Tumor
Description

Type of recurrence

Data type

string

Alias
Code-1
Recurrent Malignant Neoplasm
UMLS CUI-1
C0549379
SNOMED CT-1
10038111
Date of First Recurrence or Progression
Description

Date of First Recurrence or Progression

Data type

date

Medical Examination
Description

Method of Evaluation

Data type

integer

Alias
UMLS CUI-1
C0582103
SNOMED CT-1
225886003
Code-2
Recurrent Malignant Neoplasm
UMLS CUI-2
C0549379
SNOMED CT-2
10038111
Biopsy
Description

Biopsy

Data type

boolean

Alias
Code-1
Biopsy
UMLS CUI-1
C0005558
SNOMED CT-1
86273004
MedDRA-1
10004720
LOINC-1
MTHU028106
Code-2
Recurrent Malignant Neoplasm
UMLS CUI-2
C0549379
SNOMED CT-2
10038111
Biopsy Date
Description

Biopsy Date

Data type

date

Alias
Code-1
Biopsy
UMLS CUI-1
C0005558
SNOMED CT-1
86273004
MedDRA-1
10004720
LOINC-1
MTHU028106
Code-2
Date in time
UMLS CUI-2
C0011008
SNOMED CT-2
410671006
LOINC-2
MTHU021546
Code-3
Recurrent Malignant Neoplasm
UMLS CUI-3
C0549379
SNOMED CT-3
10038111
histologic type
Description

Specify other Histologic Type

Data type

string

Alias
Code-1
Histologic Type
UMLS CUI-1
C0449574
SNOMED CT-1
263541007
LOINC-1
MTHU020048
Code-2
Recurrent Malignant Neoplasm
UMLS CUI-2
C0549379
SNOMED CT-2
10038111
Patient Status
Description

Patient Status

Alias
UMLS CUI-1
C0449437
Physical Examination
Description

Date of Physical Exam

Data type

date

Alias
UMLS CUI-1
C0031809
SNOMED CT-1
5880005
MedDRA-1
10034986
LOINC-1
MTHU028014
Code-2
Date in time
UMLS CUI-2
C0011008
SNOMED CT-2
410671006
LOINC-2
MTHU021546
Not done
Description

Not done

Data type

string

Alias
Code-1
Not Done
UMLS CUI-1
C1272696
SNOMED CT-1
385660001
Are there any changes since the previous assessment
Description

Are there any changes since the previous assessment

Data type

boolean

Are there any changes since the previous assessment
Description

Are there any changes since the previous assessment

Data type

integer

Date last contact
Description

Date of last contact

Data type

date

Alias
Code-1
Date last contact
UMLS CUI-1
C0805839
LOINC-1
MTHU010432
ECOG performance status grade
Description

ECOG Performance Status

Data type

integer

Alias
UMLS CUI-1
C1632812
Systolic Blood Pressure
Description

Blood Pressure, systolic

Data type

integer

Alias
Code-1
Systolic Blood Pressure
UMLS CUI-1
C0871470
SNOMED CT-1
271649006
Diastolic Blood Pressure
Description

Blood Pressure, diastolic

Data type

integer

Alias
Code-1
Diastolic Blood Pressure
UMLS CUI-1
C0428883
SNOMED CT-1
271650006
Cardiac Monitoring
Description

Cardiac Monitoring

Date Left Ventricular Ejection Fraction
Description

Date of LVEF

Data type

date

Alias
Code-1
Left Ventricular Ejection Fraction
UMLS CUI-1
CL433348
Code-2
Date in time
UMLS CUI-2
C0011008
SNOMED CT-2
410671006
LOINC-2
MTHU021546
Left Ventricular Ejection Fraction
Description

LVEF

Data type

string

Alias
Code-1
Left Ventricular Ejection Fraction
UMLS CUI-1
CL433348
Echocardiography
Description

Echocardiogram

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Echocardiography
UMLS CUI-1
C0013516
SNOMED CT-1
40701008
MedDRA-1
10014113
ICD-9-CM-1
88.72
Radionuclide Ventriculogram Scan
Description

MUGA Scan

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Radionuclide Ventriculogram Scan
UMLS CUI-1
C0521317
SNOMED CT-1
404221001
MedDRA-1
10028211
Result
Description

Result

Data type

integer

Alias
Code-1
Result
UMLS CUI-1
C1274040
SNOMED CT-1
394617004
Code-2
Left Ventricular Ejection Fraction
UMLS CUI-2
CL433348
Symptomatic CHF
Description

Symptomatic CHF

Data type

boolean

New York Heart Association
Description

New York Heart Association

Data type

integer

Mammogram
Description

Mammogram

Mammogram
Description

Mammogram

Data type

integer

Alias
Code-1
Mammography
UMLS CUI-1
C0024671
SNOMED CT-1
71651007
MedDRA-1
10026735
Date of Test
Description

Date of Test

Data type

date

Alias
Code-1
Mammography
UMLS CUI-1
C0024671
SNOMED CT-1
71651007
MedDRA-1
10026735
Code-2
Date in time
UMLS CUI-2
C0011008
SNOMED CT-2
410671006
LOINC-2
MTHU021546
Not done
Description

Not done

Data type

string

Alias
Code-1
Not Done
UMLS CUI-1
C1272696
SNOMED CT-1
385660001
Are there any clinically significant abnormalites
Description

Are there any clinically significant abnormalites

Data type

boolean

specify
Description

specify

Data type

string

Hematoly and Biochemistry
Description

Hematoly and Biochemistry

Date of blood specimen collection
Description

Date of blood specimen collection

Data type

date

Result
Description

Result

Data type

integer

Survival Follow-Up
Description

Survival Follow-Up

Vital status
Description

Vital Status

Data type

integer

Alias
Code-1
Vital status:Type:Point in time:^Patient:Nominal
UMLS CUI-1
C1146895
LOINC-1
31210-8
Dead
Description

Dead

Data type

date

Alias
Code-1
Date of death
UMLS CUI-1
C1148348
SNOMED CT-1
399753006
LOINC-1
MTHU014693
Code-2
Date last contact
UMLS CUI-2
C0805839
LOINC-2
MTHU010432
Date of last contact
Description

Date of last contact

Data type

date

Alias
Code-Info
extended_coding
Code-1
Date last contact
UMLS CUI-1
C0805839
LOINC-1
MTHU010432
Code-2
Date last contact
UMLS CUI-2
C0805839
LOINC-2
MTHU010432
Investigator Signature
Description

Investigator Signature

Data type

string

Alias
Code-1
Investigator Signature
UMLS CUI-1
C2346576
Date
Description

Date

Data type

date

Alias
Code-1
Date in time
UMLS CUI-1
C0011008
SNOMED CT-1
410671006
LOINC-1
MTHU021546
Code-2
Investigator Signature
UMLS CUI-2
C2346576
Treatment Completion
Description

Treatment Completion

not_useful_for_research
Description

Did the patient complete Lapatinib as per protocol

Data type

integer

not_useful_for_research
Description

Did the patient complete Trastuzumab as per protocol

Data type

integer

not_useful_for_research
Description

Did the patient complete Paclitaxel as per protocol

Data type

integer

Reasons for treatment discontinuation
Description

Reasons for treatment discontinuation

Data type

integer

Alias
Code-1
Discontinue
UMLS CUI-1
C1444662
SNOMED CT-1
410546004
Code-2
Indication of (contextual qualifier)
UMLS CUI-2
C0392360
SNOMED CT-2
410666004
LOINC-2
MTHU008319
Code-3
Therapeutic procedure
UMLS CUI-3
C0087111
SNOMED CT-3
277132007
MedDRA-3
10053757
LOINC-3
MTHU008880
Date of last contact within treatment period
Description

Date of last contact within treatment period

Data type

date

Alias
Code-1
Date last contact
UMLS CUI-1
C0805839
LOINC-1
MTHU010432
Code-2
Therapeutic procedure
UMLS CUI-2
C0087111
SNOMED CT-2
277132007
MedDRA-2
10053757
LOINC-2
MTHU008880
Code-3
Period
UMLS CUI-3
C1948053
Additional Comments
Description

Additional Comments

CRF Page Number
Description

CRF Page Number

Data type

integer

Comments
Description

Comments

Data type

string

Alias
Code-1
Comment
UMLS CUI-1
C0947611
Code-2
Therapeutic procedure
UMLS CUI-2
C0087111
SNOMED CT-2
277132007
MedDRA-2
10053757
LOINC-2
MTHU008880
Investigator Signature
Description

Investigator Signature

Data type

string

Alias
Code-1
Investigator Signature
UMLS CUI-1
C2346576
Date
Description

Date

Data type

date

Alias
Code-1
Investigator Signature
UMLS CUI-1
C2346576
Code-2
Date in time
UMLS CUI-2
C0011008
SNOMED CT-2
410671006
LOINC-2
MTHU021546
Death Form
Description

Death Form

Date of death
Description

Date of Death

Data type

date

Alias
UMLS CUI-1
C1148348
SNOMED CT-1
399753006
LOINC-1
MTHU014693
Cause of death
Description

Primary Cause of death

Data type

integer

Alias
Code-1
Cause of Death
UMLS CUI-1
C0007465
SNOMED CT-1
184305005
other cause of death
Description

specify

Data type

string

Alias
Code-1
Other
UMLS CUI-1
C0205394
SNOMED CT-1
74964007
Code-2
Cause of Death
UMLS CUI-2
C0007465
SNOMED CT-2
184305005
Was autopsy performed
Description

Autopsy

Data type

integer

Alias
Code-1
Autopsy
SNOMED CT-1
29240004
MedDRA-1
10050117
ICD-10-CM-1
89.8
UMLS CUI
C0004398
Please summarize findings
Description

Please summarize findings

Data type

string

Similar models

Outcome of Pregnancy Breast Cancer NCT00490139

  1. StudyEvent: study documentation
    1. Outcome of Pregnancy Breast Cancer NCT00490139
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
NCCTG Study No
Item
NCCTG Study No
string
C0008976 (UMLS CUI-1)
110465008 (SNOMED CT-1)
Numbers (Code-2)
C0237753 (UMLS CUI-2)
260299005 (SNOMED CT-2)
MTHU024869 (LOINC-2)
North Central Cancer Treatment Group (Code-3)
C1518419 (UMLS CUI-3)
Central Lab ID Number
Item
Central Lab ID Number
string
Laboratory (Code-1)
C0022877 (UMLS CUI-1)
261904005 (SNOMED CT-1)
MTHU029808 (LOINC-1)
Numbers (Code-2)
C0237753 (UMLS CUI-2)
260299005 (SNOMED CT-2)
MTHU024869 (LOINC-2)
Institution Number
Item
Institution Number
string
C0021622 (UMLS CUI-1)
Numbers (Code-2)
C0237753 (UMLS CUI-2)
260299005 (SNOMED CT-2)
MTHU024869 (LOINC-2)
Patient Initials
Item
Patient Initials
string
Person Initials (Code-1)
C2986440 (UMLS CUI-1)
Patients (Code-2)
C0030705 (UMLS CUI-2)
116154003 (SNOMED CT-2)
Institution
Item
Institution
string
C0021622 (UMLS CUI-1)
Item Group
Registration Header
Coordinating Group Protocol Number (N063D)
Item
Coordinating Group Protocol Number (N063D)
string
Group (Code-1)
C0441833 (UMLS CUI-1)
246261001 (SNOMED CT-1)
Protocols documentation (Code-2)
C0442711 (UMLS CUI-2)
258049002 (SNOMED CT-2)
Coordinating Group Code (NCCTG)
Item
Coordinating Group Code (NCCTG)
string
Group (Code-1)
C0441833 (UMLS CUI-1)
246261001 (SNOMED CT-1)
Code (Code-2)
C0805701 (UMLS CUI-2)
Protocol Title (ALTTO: Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation Trial)
Item
Protocol Title (ALTTO: Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation Trial)
string
Study Protocol (Code-1)
C2348563 (UMLS CUI-1)
Patient Medical Record Number
Item
Patient Medical Record Number
string
Medical record number (Code-1)
C1301894 (UMLS CUI-1)
398225001 (SNOMED CT-1)
MTHU021237 (LOINC-1)
Participating Group Code
Item
Participating Group Code
string
Study Protocol Version Participating Organization Type Code (Code-1)
C2986314 (UMLS CUI-1)
Are data amended (check one if data are amended, please circle in red when using paper form)
Item
amended data
boolean
Amended (Code-1)
C1691222 (UMLS CUI-1)
Data (Code-2)
C1511726 (UMLS CUI-2)
Item Group
Submission Details
Item
Registration Type
integer
Type of registration (attribute) (Code-1)
C0449520 (UMLS CUI-1)
246243005 (SNOMED CT-1)
Code List
Registration Type
CL Item
First Submission (First Submission)
Submission (Code-1)
C1515023 (UMLS CUI-1)
First (Code-2)
C0205435 (UMLS CUI-2)
255216001 (SNOMED CT-2)
CL Item
Second Submission  (Second Submission )
Submission (Code-1)
C1515023 (UMLS CUI-1)
Second (Code-2)
C0205436 (UMLS CUI-2)
81170007 (SNOMED CT-2)
Item
First Submission
integer
Submission (Code-1)
C1515023 (UMLS CUI-1)
First (Code-2)
C0205435 (UMLS CUI-2)
255216001 (SNOMED CT-2)
Code List
First Submission
CL Item
Pre-Registration Eligibility Checklist Cover Sheet/Demographics (1)
CL Item
Eligibility Checklist (2)
Item Group
Contact Person For Pathology Results
Last Name
Item
Last Name
string
Last Name (Code-1)
C1301584 (UMLS CUI-1)
397678008 (SNOMED CT-1)
MTHU020554 (LOINC-1)
contact person (Code-2)
C0337611 (UMLS CUI-2)
70862002 (SNOMED CT-2)
CON (HL7 V3-2)
Pathology (Code-3)
C0030664 (UMLS CUI-3)
394595002 (SNOMED CT-3)
First Name
Item
Forename
string
First Name (Item-Info)
C1443235 (UMLS CUI-1)
408677003 (SNOMED CT-1)
MTHU020551 (LOINC-1)
contact person (Code-2)
C0337611 (UMLS CUI-2)
70862002 (SNOMED CT-2)
CON (HL7 V3-2)
Pathology (Code-3)
C0030664 (UMLS CUI-3)
394595002 (SNOMED CT-3)
Phone
Item
Phone
string
Telephone Number (Code-1)
C1515258 (UMLS CUI-1)
MTHU039653 (LOINC-1)
contact person (Code-2)
C0337611 (UMLS CUI-2)
70862002 (SNOMED CT-2)
CON (HL7 V3-2)
Pathology (Code-3)
C0030664 (UMLS CUI-3)
394595002 (SNOMED CT-3)
Fax
Item
Fax
string
Fax Number (Code-1)
C1549619 (UMLS CUI-1)
contact person (Code-2)
C0337611 (UMLS CUI-2)
70862002 (SNOMED CT-2)
CON (HL7 V3-2)
Pathology (Code-3)
C0030664 (UMLS CUI-3)
394595002 (SNOMED CT-3)
E-Mail
Item
E-Mail
string
E-mail Address (Code-1)
C1705961 (UMLS CUI-1)
contact person (Code-2)
C0337611 (UMLS CUI-2)
70862002 (SNOMED CT-2)
CON (HL7 V3-2)
Pathology (Code-3)
C0030664 (UMLS CUI-3)
394595002 (SNOMED CT-3)
Item Group
Patient Demographics
Item
Patient sex
integer
184100006 (SNOMED CT-1)
C0079399 (UMLS CUI)
Code List
Patient sex
CL Item
Female (1)
CL Item
Male (2)
CL Item
Unknown (3)
Date of Birth
Item
Patient date of birth
date
C0421451 (UMLS CUI-1)
184099003 (SNOMED CT-1)
ZIP Code
Item
Patient postal code
integer
C0421454 (UMLS CUI-1)
184102003 (SNOMED CT-1)
Country of Residence
Item
Country of Residence
string
Country of residence (observable entity) (Code-1)
C1562954 (UMLS CUI-1)
416647007 (SNOMED CT-1)
Patient address (Code-2)
C0421449 (UMLS CUI-2)
184097001 (SNOMED CT-2)
Method of Payment
Item
integer
Item
Race
integer
Racial group (Code-1)
C0034510 (UMLS CUI-1)
103579009 (SNOMED CT-1)
MTHU009923 (LOINC-1)
Code List
Race
CL Item
A Person Having Origins In Any Of The Original Peoples Of Europe, The Middle East, Or North Africa.  (White)
Caucasoid Race (Code-1)
C0007457 (UMLS CUI-1)
413773004 (SNOMED CT-1)
CL Item
A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American."  (Black or African American)
African American (Code-1)
C0085756 (UMLS CUI-1)
15086000 (SNOMED CT-1)
CL Item
A Person Having Origins In Any Of The Original Peoples Of Hawaii, Guam, Samoa, Or Other Pacific Islands.  (Native Hawaiian or other Pacific Islander)
Pacific Island Americans (Code-1)
C0242191 (UMLS CUI-1)
CL Item
A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam.  (Asian)
Asians (Code-1)
C0078988 (UMLS CUI-1)
413582008 (SNOMED CT-1)
2028-9 (HL7 V3-1)
CL Item
A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment.  (American Indian or Alaska Native)
Native Americans (Code-1)
C0282204 (UMLS CUI-1)
413490006 (SNOMED CT-1)
1002-5 (HL7 V3-1)
CL Item
Not Provided Or Available  (Not Reported)
Not Stated (Code-1)
C1706613 (UMLS CUI-1)
CL Item
Could Not Be Determined Or Unsure  (Unknown)
Unknown (Code-1)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-1)
Item
Ethnic group
integer
Ethnic group (Code-1)
C0015031 (UMLS CUI-1)
364699009 (SNOMED CT-1)
Code List
Ethnic group
CL Item
A Person Not Meeting The Definition For Hispanic Or Latino.  (NOT HISPANIC OR LATINO)
Negation (Code-1)
C1518422 (UMLS CUI-1)
Hispanics (Code-2)
C0086409 (UMLS CUI-2)
MTHU010274 (LOINC-2)
CL Item
A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race.  (HISPANIC OR LATINO)
Hispanics (Code-1)
C0086409 (UMLS CUI-1)
MTHU010274 (LOINC-1)
CL Item
Not Provided Or Available  (Not reported)
Not Stated (Code-1)
C1706613 (UMLS CUI-1)
CL Item
Could Not Be Determined Or Unsure  (Unknown)
Unknown (Code-1)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-1)
Item Group
Eligibility Screening Form
Item
Inclusion Criteria
integer
Inclusion Criteria (Code-1)
C1512693 (UMLS CUI-1)
Code List
Inclusion Criteria
CL Item
>= 18 Years Of Age  (Age >= 18 years)
patient age (Code-1)
CL386174 (UMLS CUI-1)
CL Item
Baseline Lvef > 50% Measured By Echocardiography Or Muga Scan After Completion Of All Anthracycline-based (neo-) Adjuvant Chemotherapy And Prior To The Targeted Therapy(ies) (Baseline LVEF > 50% measured by echocardiography or MUGA scan after completion of all anthracycline-based (neo-) adjuvant chemotherapy and prior to the targeted therapy(ies)
zu_spezielles_item (Item-Info)
Left Ventricular Ejection Fraction (Code-1)
CL433348 (UMLS CUI-1)
Complete (Code-2)
C0205197 (UMLS CUI-2)
255594003 (SNOMED CT-2)
CL Item
Completion Of All Necessary Baseline Laboratory And Radiological Investigations (Completion of all necessary baseline laboratory and radiological investigations)
CL Item
Eastern Cooperative Oncology Group (ecog) Performance Status < 1  (Eastern Cooperative Oncology Group (ECOG) performance status < 1)
Eastern Cooperative Oncology Group performance status - grade 0 (finding) (Code-1)
C1828078 (UMLS CUI-1)
425389002 (SNOMED CT-1)
CL Item
Known Hormone Receptor Status (er/pgr Or Er Alone)  (Known hormone receptor status (ER/PgR or ER alone))
Hormone Receptor (Code-1)
C0019929 (UMLS CUI-1)
CL Item
Must Have Received At Least Four Cycles Of An Approved Anthracycline-based (neo-) Adjuvant Chemotherapy Regimen  (Must have received at least four cycles of an approved anthracycline-based (neo-) adjuvant chemotherapy regimen)
CL Item
Non-metastatic Operable Primary Invasive Adenocarcinoma Of The Breast  (Non-metastatic operable primary invasive adenocarcinoma of the breast)
Breast Adenocarcinoma (Code-1)
C0858252 (UMLS CUI-1)
10006173 (MedDRA-1)
Operable (Code-2)
C0205188 (UMLS CUI-2)
76234009 (SNOMED CT-2)
Negative for metastatic tumor (finding) (Code-3)
C0332655 (UMLS CUI-3)
89474008 (SNOMED CT-3)
CL Item
Overexpression And/or Amplification Of Her2 In The Invasive Component Of The Primary Tumor  (Overexpression and/or amplification of HER2 in the invasive component of the primary tumor)
HER2-positive carcinoma of breast (disorder) (Code-1)
C1960398 (UMLS CUI-1)
427685000 (SNOMED CT-1)
CL Item
Signed Written Informed Consent  (Signed written informed consent)
Informed consent obtained (Code-1)
C0514044 (UMLS CUI-1)
Item
Exclusion criteria
integer
Exclusion Criteria (Code-1)
C0680251 (UMLS CUI-1)
Code List
Exclusion criteria
CL Item
(neo-) Or Adjuvant Chemotherapy Using Peripheral Stem Cell Or Bone Marrow Stem Cell Support  ((Neo-) or adjuvant chemotherapy using peripheral stem cell or bone marrow stem cell support)
CL Item
Any Clinically Staged T4 Tumor, Including Inflammatory Breast Cancer  (Any clinically staged T4 tumor, including inflammatory breast cancer)
T4 Stage Finding (Code-1)
C0475751 (UMLS CUI-1)
65565005 (SNOMED CT-1)
cT category (observable entity) (Code-2)
C1275863 (UMLS CUI-2)
399504009 (SNOMED CT-2)
CL Item
Any Of The Following Abnormal Laboratory Tests Immediately Prior To Randomization  (Any of the following abnormal laboratory tests immediately prior to randomization (see list in instructions))
CL Item
Any Prior Mediastinal Irradiation Except Internal Mammary Node Irradiation For The Present Breast Cancer  (Any prior mediastinal irradiation except internal mammary node irradiation for the present)
CL Item
Bilateral Tumors  (Bilateral tumors)
Bilateral Breast Carcinoma (Code-1)
C0281267 (UMLS CUI-1)
CL Item
Concomitant Use Of Cyp3a4 Inhibitors Or Inducers  (Concomitant use of CYP3A4 inhibitors or inducers)
CL Item
Concurrent Anti-cancer Treatment In Another Investigational Trial With Hormone Therapy Or Immunotherapy  (Concurrent anti-cancer treatment in another investigational trial with hormone therapy or immunotherapy)
CL Item
Concurrent Anti-cancer Treatment, Except Hormonal Therapy  (Concurrent anti-cancer treatment, except hormonal therapy)
Cancer Therapeutic Procedure (Code-1)
C0920425 (UMLS CUI-1)
MTHU038130 (LOINC-1)
Concurrent (Code-2)
C0205420 (UMLS CUI-2)
68405009 (SNOMED CT-2)
Except for (attribute) (Code-3)
C0332300 (UMLS CUI-3)
5185003 (SNOMED CT-3)
Endocrine Therapy (Code-4)
C0279025 (UMLS CUI-4)
169413002 (SNOMED CT-4)
10065646 (MedDRA-4)
CL Item
History Of Any Prior (ipsi- And/or Contralateral) Invasive Breast Carcinoma  (History of any prior (ipsi- and/or contralateral) invasive breast carcinoma)
Pre-existing Condition (Code-1)
C0521987 (UMLS CUI-1)
102478008 (SNOMED CT-1)
Invasive Breast Carcinoma (Code-2)
C0853879 (UMLS CUI-2)
10006190 (MedDRA-2)
CL Item
Malabsorption Syndrome, Disease Significantly Affecting Gastrointestinal Function, Or Resection Of The Stomach Or Small Bowel, Or Person Unable To Swallow Oral Medication  (Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, or person unable to swallow oral medication)
CL Item
Maximum Cumulative Dose Of Doxorubicin >360mg/m2 Or Maximum Cumulative Dose Of Epirubicin >720mg/m2 Or Any Prior Anthracyclines Unrelated To The Present Breast Cancer  (Maximum cumulative dose of doxorubicin >360mg/m2 or maximum cumulative dose of epirubicin >720mg/m2 or any prior anthracyclines unrelated to the present breast cancer)
CL Item
Multifocal Tumors  (Multifocal tumors)
Multifocal tumor (finding) (Code-1)
C1302461 (UMLS CUI-1)
399506006 (SNOMED CT-1)
CL Item
Other Concurrent Serious Diseases That May Interfere With Planned Treatment Including Severe Pulmonary Conditions/illness  (Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions/illness)
CL Item
Past Or Current History Of Malignant Neoplasms, Except For Curatively Treated Basal And Squamous Cell Carcinoma Of The Skin Or Carcinoma In Situ Of The Cervix  (Past or current history of malignant neoplasms, except for curatively treated basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix)
CL Item
Patients With Positive Or Suspicious Internal Mammary Nodes Identified By Sentinel Node Technique Which Have Not Been Irradiated Or Will Not Be Irradiated, Or Patients With Supraclavicular Lymph Node Involvement  (Patients with positive or suspicious internal mammary nodes identified by sentinel node technique which have not been irradiated or will not be irradiated, or patients with supraclavicular lymph node involvement)
CL Item
Pregnant Or Lactating Women  (Pregnant or lactating women)
Patient currently pregnant (finding) (Code-1)
C0549206 (UMLS CUI-1)
77386006 (SNOMED CT-1)
10036586 (MedDRA-1)
On examination - lactating breast (finding) (Code-2)
C0437092 (UMLS CUI-2)
163439005 (SNOMED CT-2)
CL Item
Prior Use Of Anti-her2 Therapy For Any Reason Or Other Prior Biologic Or Immunotherapy For Breast Cancer (Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for breast cancer)
CL Item
Serious Cardiac Illness Or Medical Conditions  (Serious cardiac illness or medical conditions (including...))
CL Item
Unresolved Or Unstable Serious Adverse Event From Prior Adjuvant Chemotherapy Or Radiotherapy  (Unresolved or unstable serious adverse event from prior adjuvant chemotherapy or radiotherapy)
CL Item
Women Of Childbearing Potential Including Women Whose Last Menstrual Period Was <1 Year Ago Who Are Unable Or Unwilling To Use Adequate Contraceptive Measures During Study Treatment  (Women of childbearing potential including women whose last menstrual period was <1 year ago who are unable or unwilling to use adequate contraceptive measures during study treatment)
Item Group
Randomization
Date of Randomization
Item
Date of Randomization
date
Item
Assigned Treatment Arm
integer
Code List
Assigned Treatment Arm
CL Item
Trastuzumab  (Trastuzumab alone)
CL Item
Lapatinib  (Lapatinib alone)
CL Item
Trastuzumab Followed By Lapatinib  (Trastuzumab followed by Lapatinib)
CL Item
Lapatinib In Combination With Trastuzumab  (Lapatinib in combination with Trastuzumab)
Item Group
Informed consent
Date Informed consent signed
Item
Date Informed consent signed
date
Informed consent obtained (Code-1)
C0514044 (UMLS CUI-1)
Date in time (Code-2)
C0011008 (UMLS CUI-2)
410671006 (SNOMED CT-2)
MTHU021546 (LOINC-2)
Date of consent [for] pharmacogenetic research
Item
Date of consent [for] pharmacogenetic research
date
Informed consent obtained (Code-1)
C0514044 (UMLS CUI-1)
Pharmacogenetic Test (Code-2)
C2347500 (UMLS CUI-2)
Date in time (Code-3)
C0011008 (UMLS CUI-3)
410671006 (SNOMED CT-3)
MTHU021546 (LOINC-3)
Did the patient consent to donate blood sample
Item
Did the patient consent to donate blood sample
boolean
Blood Sample (Code-1)
C0178913 (UMLS CUI-1)
119297000 (SNOMED CT-1)
Informed consent obtained (Code-2)
C0514044 (UMLS CUI-2)
MTHU008888 (MedDRA-2)
Did the patient consent to tumor tissue
Item
Did the patient consent to tumor tissue
boolean
Tissue Collection (Code-1)
C0040278 (UMLS CUI-1)
Informed consent obtained (Code-2)
C0514044 (UMLS CUI-2)
MTHU008888 (MedDRA-2)
Did the patient consent to donate additional blood sample
Item
Did the patient consent to donate additional blood sample
boolean
Additional (Code-1)
C1524062 (UMLS CUI-1)
Blood Sample (Code-2)
C0178913 (UMLS CUI-2)
119297000 (SNOMED CT-2)
Informed consent obtained (Code-3)
C0514044 (UMLS CUI-3)
MTHU008888 (MedDRA-3)
Did the patient consent to donate fresh/frozen tissue
Item
Did the patient consent to donate fresh/frozen tissue
boolean
Frozen Specimen (Code-1)
C1548793 (UMLS CUI-1)
Informed consent obtained (Code-2)
C0514044 (UMLS CUI-2)
MTHU008888 (MedDRA-2)
Item Group
Gynecological status
Item
Menopausal Status
integer
Menopause finding (finding) (Code-1)
C0455962 (UMLS CUI-1)
276477006 (SNOMED CT-1)
Code List
Menopausal Status
CL Item
Pre (<6 Mo Since Lmp And No Prior Bilateral Ovariectomy And Not On Estrogen Replacement)  (Pre (<6 mo since LMP AND no prior bilateral ovariectomy AND not on estrogen replacement))
Premenopausal state (finding) (Code-1)
C0232969 (UMLS CUI-1)
22636003 (SNOMED CT-1)
CL Item
Post (prior Bilateral Ovariectomy Or >12 Mo Since Lmp With No Prior Hysterectomy)  (Post (prior bilateral ovariectomy OR >12 mo since LMP with no prior hysterectomy))
Postmenopausal (Code-1)
C0232970 (UMLS CUI-1)
76498008 (SNOMED CT-1)
CL Item
Above Categories Not Applicable And Age <50  (Above categories not applicable AND Age < 50)
None or Not Applicable (Code-1)
CL413952 (UMLS CUI-1)
patient age (Code-2)
CL386174 (UMLS CUI-2)
CL Item
Above Categories Not Applicable And Age >= 50  (Above categories not applicable AND Age >= 50)
None or Not Applicable (Code-1)
CL413952 (UMLS CUI-1)
patient age (Code-2)
CL386174 (UMLS CUI-2)
Date of last menstrual cycle
Item
Date last menstrual cycle
date
Menstrual cycle (Code-1)
C0025329 (UMLS CUI-1)
78456001 (SNOMED CT-1)
Last (Code-2)
C1517741 (UMLS CUI-2)
Date in time (Code-3)
C0011008 (UMLS CUI-3)
410671006 (SNOMED CT-3)
MTHU021546 (LOINC-3)
Date of pregnancy test
Item
Date of pregnancy test
date
Pregnancy Tests (Code-1)
C0032976 (UMLS CUI-1)
74036000 (SNOMED CT-1)
10036572 (MedDRA-1)
Date in time (Code-2)
C0011008 (UMLS CUI-2)
410671006 (SNOMED CT-2)
MTHU021546 (LOINC-2)
Item
Pregnancy test
integer
Pregnancy Tests (Code-1)
74036000 (SNOMED CT-1)
10036572 (MedDRA-1)
C0032976 (UMLS CUI)
Code List
Pregnancy test
CL Item
positive (1)
CL Item
negative (2)
CL Item
Not Applicable, Not Female Of Child-bearing Potential (3)
Has the patient had a hysterectomy?
Item
Has the patient had a hysterectomy?
boolean
Hysterectomy (Code-1)
C0020699 (UMLS CUI-1)
236886002 (SNOMED CT-1)
10021151 (MedDRA-1)
Hysterectomy
Item
Date Hysterectomy
date
Hysterectomy (Code-1)
C0020699 (UMLS CUI-1)
236886002 (SNOMED CT-1)
10021151 (MedDRA-1)
Date in time (Code-2)
C0011008 (UMLS CUI-2)
410671006 (SNOMED CT-2)
MTHU021546 (LOINC-2)
Unilateral ovariectomy/oophorectomy
Item
Unilateral Oophorectomy
boolean
Unilateral Oophorectomy (Code-1)
C0041687 (UMLS CUI-1)
33159007 (SNOMED CT-1)
10030344 (MedDRA-1)
65.3 (ICD-9-CM-1)
Item
Side Ovariectomy
integer
C0441987 (UMLS CUI-1)
182353008 (SNOMED CT-1)
Unilateral Oophorectomy (Code-2)
C0041687 (UMLS CUI-2)
33159007 (SNOMED CT-2)
10030344 (MedDRA-2)
Code List
Side Ovariectomy
CL Item
Right (Right)
C0205090 (UMLS CUI-1)
24028007 (SNOMED CT-1)
CL Item
Left (Left)
C0205091 (UMLS CUI-1)
7771000 (SNOMED CT-1)
Unilateral oophorectomy Date
Item
Date Unilateral Oophorectomy
date
Unilateral Oophorectomy (Code-1)
C0041687 (UMLS CUI-1)
33159007 (SNOMED CT-1)
10030344 (MedDRA-1)
Date in time (Code-2)
C0011008 (UMLS CUI-2)
410671006 (SNOMED CT-2)
MTHU021546 (LOINC-2)
Item Group
Patient Status
Date of Physical exam
Item
Date of Physical exam
date
Physical Examination Date (Code-1)
C2826643 (UMLS CUI-1)
Item
Physical Examination
integer
C0031809 (UMLS CUI-1)
5880005 (SNOMED CT-1)
10034986 (MedDRA-1)
MTHU028014 (LOINC-1)
Code List
Physical Examination
CL Item
Normal (Normal)
Normal (Code-1)
C0205307 (UMLS CUI-1)
17621005 (SNOMED CT-1)
CL Item
Abnormal - Clinically Significant (Abnormal - Clinically significant)
Abnormal (Code-1)
C0205161 (UMLS CUI-1)
263654008 (SNOMED CT-1)
Clinically Significant Indicator (Code-2)
C2985739 (UMLS CUI-2)
CL Item
Abnormal - Not Clinically Significant  (Abnormal - Not clinically significant)
Abnormal (Code-1)
C0205161 (UMLS CUI-1)
263654008 (SNOMED CT-1)
Clinically Significant Indicator (Code-2)
C2985739 (UMLS CUI-2)
Negation (Code-3)
C1518422 (UMLS CUI-3)
Height
Item
Height
float
cm (Item-Info)
Length of body (observable entity) (Code-1)
248334005 (SNOMED CT-1)
C0005890 (UMLS CUI-1)
Weight
Item
Body weight
float
kg (Item-Info)
Body Weight (Code-1)
27113001 (SNOMED CT-1)
MTHU001885 (LOINC-1)
C0005910 (UMLS CUI-1)
BSA
Item
Body surface area
float
m^2 (Item-Info)
Body Surface Area (Code-1)
301898006 (SNOMED CT-1)
10050311 (MedDRA-1)
C0005902 (UMLS CUI-1)
Systolic blood pressure
Item
Systolic blood pressure
integer
Systolic Blood Pressure (Code-1)
271649006 (SNOMED CT-1)
C0871470 (UMLS CUI-1)
Diastolic blood pressure
Item
Diastolic blood pressure
integer
Diastolic Blood Pressure (Code-1)
271650006 (SNOMED CT-1)
C0428883 (UMLS CUI-1)
Heart rate
Item
Heart rate
integer
beats/min (Item-Info)
heart rate (Code-1)
364075005 (SNOMED CT-1)
10019299 (MedDRA-1)
MTHU003114 (LOINC-1)
C0018810 (UMLS CUI-1)
Item
ECOG performance status grade
integer
C1632812 (UMLS CUI-1)
Code List
ECOG performance status grade
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0) (0)
Eastern Cooperative Oncology Group performance status - grade 0 (finding) (Code-1)
C1828078 (UMLS CUI-1)
25389002 (SNOMED CT-1)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1) (1)
Eastern Cooperative Oncology Group performance status - grade 1 (finding) (Code-1)
C1827388 (UMLS CUI-1)
422512005 (SNOMED CT-1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2) (2)
Eastern Cooperative Oncology Group performance status - grade 2 (finding) (Code-1)
C1828242 (UMLS CUI-1)
422894000 (SNOMED CT-1)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3) (3)
Eastern Cooperative Oncology Group performance status - grade 3 (finding) (Code-1)
C1827126 (UMLS CUI-1)
423053003 (SNOMED CT-1)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4) (4)
Eastern Cooperative Oncology Group performance status - grade 4 (finding) (Code-1)
C1827528 (UMLS CUI-1)
423237006 (SNOMED CT-1)
CL Item
Dead (5) (5)
Eastern Cooperative Oncology Group performance status - grade 5 (finding) (Code-1)
C1827926 (UMLS CUI-1)
423409001 (SNOMED CT-1)
Item Group
ECG
C1623258 (UMLS CUI-1)
date of ECG
Item
date
Item
integer
Code List
Result
CL Item
Normal (Normal)
CL Item
Abnormal - Clinically significant (Abnormal - Clinically significant)
CL Item
Abnormal - Not clinically significant (Abnormal - Not clinically significant)
Item Group
Cardiac Monitoring
C0150496 (UMLS CUI-1)
LVEF date
Item
Date Left Ventricular Ejection Fraction
date
Left Ventricular Ejection Fraction (Code-1)
Date in time (Code-2)
410671006 (SNOMED CT-2)
MTHU021546 (LOINC-2)
C0428772 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
LVEF
Item
Left Ventricular Ejection Fraction
float
Left Ventricular Ejection Fraction (Code-1)
C0428772 (UMLS CUI-1)
Echocardiogramm
Item
Echocardiography
boolean
changed_datatype (Code-Info)
Echocardiography (Code-1)
C0013516 (UMLS CUI-1)
40701008 (SNOMED CT-1)
10014113 (MedDRA-1)
88.72 (ICD-9-CM-1)
Muga Scan
Item
Radionuclide Ventriculogram Scan
boolean
changed_datatype (Code-Info)
Radionuclide Ventriculogram Scan (Code-1)
C0521317 (UMLS CUI-1)
404221001 (SNOMED CT-1)
10028211 (MedDRA-1)
Item
Result
integer
Result (Code-1)
C1274040 (UMLS CUI-1)
394617004 (SNOMED CT-1)
Left Ventricular Ejection Fraction (Code-2)
CL433348 (UMLS CUI-2)
Code List
Result
CL Item
Normal (Normal)
Normal (Code-1)
C0205307 (UMLS CUI-1)
17621005 (SNOMED CT-1)
CL Item
Abnormal - Clinically Significant (Abnormal - Clinically significant)
Abnormal (Code-1)
C0205161 (UMLS CUI-1)
263654008 (SNOMED CT-1)
Clinically Significant Indicator (Code-2)
C2985739 (UMLS CUI-2)
CL Item
Abnormal - Not Clinically Significant  (Abnormal - Not clinically significant)
Abnormal (Code-1)
C0205161 (UMLS CUI-1)
263654008 (SNOMED CT-1)
Clinically Significant Indicator (Code-2)
C2985739 (UMLS CUI-2)
Negation (Code-3)
C1518422 (UMLS CUI-3)
Symptomatic CHF
Item
boolean
Item
NYHA Classification
text
C1275491 (UMLS CUI-1)
Code List
NYHA Classification
CL Item
Patients With Cardiac Disease But Without Resulting Limitation Of Physical Activity. Ordinary Physical Activity Does Not Cause Undue Fatigue, Palpitation, Dyspnea Or Anginal Pain. (Class I) (Class I)
CL Item
Patients With Cardiac Disease Resulting In Slight Limitation Of Physical Activity. They Are Comfortable At Rest. Ordinary Physical Activity Results In Fatigue, Palpitation, Dyspnea Or Anginal Pain. (Class II) (Class II)
CL Item
Patients With Cardiac Disease Resulting In Marked Limitation Of Physical Activity. They Are Comfortable At Rest. Less Than Ordinary Activity Causes Fatigue, Palpitation, Dyspnea Or Anginal Pain. (Class III) (Class III)
CL Item
Patients With Cardiac Disease Resulting In Inability To Carry On Any Physical Activity Without Discomfort. Symptoms Of Heart Failure Or The Anginal Syndrome May Be Present Even At Rest. If Any Physical Activity Is Undertaken, Discomfort Increases. (Class IV) (Class IV)
Item Group
Local Her2 Results
Item
t
integer
CL Item
not_useful_for_research (Dako Herceptest [tm] )
CL Item
not_useful_for_research (Dako A0485 )
CL Item
not_useful_for_research (Cb-11/ventana Kit )
CL Item
not_useful_for_research (Tab-250 )
CL Item
not_useful_for_research (Ncl-c-erbb2-316 )
CL Item
Other Specify  (other)
other
Item
not_useful_for_research
string
Item
Her2/Neu Status
integer
Her2/Neu Status (Code-1)
C1512413 (UMLS CUI-1)
Code List
Her2/Neu Status
CL Item
Positive  (Positive )
HER2-positive carcinoma of breast (disorder) (Code-1)
C1960398 (UMLS CUI-1)
427685000 (SNOMED CT-1)
CL Item
Equivocal  (Equivocal )
Equivocal result (qualifier value) (Code-1)
C0459423 (UMLS CUI-1)
280414007 (SNOMED CT-1)
CL Item
Negative  (Negative )
HER2-negative breast cancer (Code-1)
CL412283 (UMLS CUI-1)
CL Item
Non-interpretable  (Non-interpretable )
Unevaluable (Code-1)
C1883425 (UMLS CUI-1)
Percentage of invasive tumor cells with complete membrane staining
Item
integer
Code List
FISH Kit or Test Type
CL Item
not_useful_for_research (Vysis/path Vysion[tm] )
CL Item
Other Specify (Other)
other
Item
not_useful_for_research
string
Item
FisH-Test
integer
Fluorescent in Situ Hybridization (Code-1)
C0162789 (UMLS CUI-1)
426329006 (SNOMED CT-1)
10066931 (MedDRA-1)
Code List
FisH-Test
CL Item
Positive Finding  (Amplified )
Positive Finding (Code-1)
C1446409 (UMLS CUI-1)
10828004 (SNOMED CT-1)
CL Item
Equivocal  (Equivocal )
Equivocal result (qualifier value) (Code-1)
C0459423 (UMLS CUI-1)
280414007 (SNOMED CT-1)
CL Item
Negative Finding  (Not Amplified )
Negative Finding (Code-1)
C0205160 (UMLS CUI-1)
260385009 (SNOMED CT-1)
FISH HER2/neu chromosome 17 Ratio
Item
integer
Code List
Chromosome 17 copy number
CL Item
Polysomy  (Polysomy )
CL Item
Monosomy  (Monosomy )
CL Item
Normal  (Normal )
Sample test date
Item
Test Date
date
Test Date (Code-1)
C2826247 (UMLS CUI-1)
Not done
Item
Not done
string
Not Done (Code-1)
C1272696 (UMLS CUI-1)
385660001 (SNOMED CT-1)
Her2/Neu Status (Code-2)
C1512413 (UMLS CUI-2)
Code List
CISH Kit or Test Type
CL Item
not_useful_for_research (Ventana Inform)
CL Item
Other Specify  (Other)
Other
Item
not_useful_for_research
string
Item
CISH
integer
Cytokine-Inducible SH2-Containing Protein (Code-1)
C0299250 (UMLS CUI-1)
Code List
CISH
CL Item
Positive Finding  (Amplified )
Positive Finding (Code-1)
C1446409 (UMLS CUI-1)
10828004 (SNOMED CT-1)
CL Item
Equivocal  (Equivocal )
Equivocal result (qualifier value) (Code-1)
C0459423 (UMLS CUI-1)
280414007 (SNOMED CT-1)
CL Item
Negative Finding  (Not Amplified )
Negative Finding (Code-1)
C0205160 (UMLS CUI-1)
260385009 (SNOMED CT-1)
Code List
Chromosome 17 copy number
CL Item
Polysomy  (Polysomy )
CL Item
Monosomy  (Monosomy )
CL Item
Normal  (Normal )
Item Group
Hormonal Receptor Status
ER % cells stained positive
Item
ER % cells stained positive
integer
Percentage unit (qualifier value) (Code-1)
C1532336 (UMLS CUI-1)
415067009 (SNOMED CT-1)
Estrogen receptor positive tumor (disorder) (Code-2)
C1562312 (UMLS CUI-2)
416053008 (SNOMED CT-2)
PgR % cells stained positive
Item
PgR % cells stained positive
integer
Percentage unit (qualifier value) (Code-1)
C1532336 (UMLS CUI-1)
415067009 (SNOMED CT-1)
Progesterone receptor positive tumor (disorder) (Code-2)
C1562928 (UMLS CUI-2)
416561008 (SNOMED CT-2)
Item Group
History Of Primary Breast Cancer
Date of initial Pathologic Diagnosis
Item
Date of diagnosis
date
Date of diagnosis (Code-1)
C2316983 (UMLS CUI-1)
432213005 (SNOMED CT-1)
Tumor finding (finding) (Code-2)
C1274082 (UMLS CUI-2)
395557000 (SNOMED CT-2)
MTHU021546 (LOINC-2)
Item
Tumor Laterality
integer
C0441987 (UMLS CUI-1)
182353008 (SNOMED CT-1)
MTHU014973 (LOINC-1)
Tumor site (Code-2)
C0475445 (UMLS CUI-2)
263591006 (SNOMED CT-2)
MTHU015562 (LOINC-2)
Code List
Tumor Laterality
CL Item
Left (Left)
C0205091 (UMLS CUI-1)
7771000 (SNOMED CT-1)
CL Item
Right (Right)
C0205090 (UMLS CUI-1)
24028007 (SNOMED CT-1)
Clinical Size of Tumor
Item
Clinical Size of Tumor
integer
Tumor size (observable entity) (Code-1)
C0475440 (UMLS CUI-1)
263605001 (SNOMED CT-1)
Clinical (Code-2)
C0205210 (UMLS CUI-2)
58147004 (SNOMED CT-2)
Item
N - Regional lymph node stage
integer
cN category (observable entity) (Code-1)
C1275865 (UMLS CUI-1)
399534004 (SNOMED CT-1)
Code List
N - Regional lymph node stage
CL Item
No Regional Lymph Node Metastasis (N0) (N0)
N0 Stage Finding (Code-1)
C0441959 (UMLS CUI-1)
62455006 (SNOMED CT-1)
CL Item
Metastasis To Movable Ipsilateral Axillary Lymph Node(s) (N1) (N1)
N1 Stage Finding (Code-1)
C0441962 (UMLS CUI-1)
53623008 (SNOMED CT-1)
CL Item
Metastasis To Ipsilateral Axillary Lymph Node(s) Fixed Or Matted, Or In Clinically Apparent* Ipsilateral Internal Mammary Nodes In The Absence Of Clinically Evident Lymph Node Metastasis (N2) (N2)
N2 Stage Finding (Code-1)
C0441960 (UMLS CUI-1)
46059003 (SNOMED CT-1)
CL Item
Metastasis In Ipsilateral Infraclavicular Lymph Node(s) With Or Without Axillary Lymph Node Involvement, Or In Clinically Apparent* Ipsilateral Internal Mammary Lymph Node(s) And In The Presence Of Clinically Evident Axillary Lymph Node Metastasis; Or, Me (N3) (N3)
N3 Stage Finding (Code-1)
C0441961 (UMLS CUI-1)
5856006 (SNOMED CT-1)
Pathologic Primary Tumor Size
Item
Tumor size
integer
Tumor size (observable entity) (Code-1)
C0475440 (UMLS CUI-1)
263605001 (SNOMED CT-1)
Margin involvement
Item
Surgical margin involved by malignant neoplasm
boolean
Surgical margin involved by malignant neoplasm (finding) (Code-1)
C1273678 (UMLS CUI-1)
384689007 (SNOMED CT-1)
Item
Histologic Type
integer
Histologic Type (Code-1)
C0449574 (UMLS CUI-1)
263541007 (SNOMED CT-1)
MTHU020048 (LOINC-1)
Code List
Histologic Type
CL Item
Ductal Nos  (Ductal NOS)
Ductal Breast Carcinoma (Code-1)
C1527349 (UMLS CUI-1)
CL Item
Lobular  (Lobular )
Invasive Lobular Breast Carcinoma (Code-1)
CL029510 (UMLS CUI-1)
CL Item
Mixed Ductal And Lobular  (Mixed ductal and lobular)
Mixed Lobular and Ductal Breast Carcinoma (Code-1)
CL007210 (UMLS CUI-1)
CL Item
Tubular (Tubular (pure > or =90%))
Tubular Breast Carcinoma (Code-1)
C0279561 (UMLS CUI-1)
CL Item
Apocrine  (Apocrine )
Apocrine Breast Carcinoma (Code-1)
C1332316 (UMLS CUI-1)
10066206 (MedDRA-1)
CL Item
Tubulolobular  (Tubulolobular )
Invasive Lobular Breast Carcinoma, Tubulolobular Variant (Code-1)
CL429657 (UMLS CUI-1)
CL Item
Micropapillary  (Micropapillary )
Invasive Micropapillary Breast Carcinoma (Code-1)
C3838947 (UMLS CUI-1)
CL Item
Cribriform  (Cribriform )
Invasive Cribriform Breast Carcinoma (Code-1)
C1334275 (UMLS CUI-1)
CL Item
Mucinous Adenocarcinoma  (Mucinous)
Mucinous Adenocarcinoma (Code-1)
C0007130 (UMLS CUI-1)
72495009 (SNOMED CT-1)
10061564 (MedDRA-1)
CL Item
Invasive Nos  (Invasive NOS)
Invasive Breast Carcinoma (Code-1)
C0853879 (UMLS CUI-1)
10006190 (MedDRA-1)
CL Item
Medullary Carcinoma  (Medullary)
Medullary Breast Carcinoma (Code-1)
C0860580 (UMLS CUI-1)
CL Item
Other Specify  (other)
Other (Code-1)
C0205394 (UMLS CUI-1)
74964007 (SNOMED CT-1)
other
Item
other
string
Other (Code-1)
C0205394 (UMLS CUI-1)
74964007 (SNOMED CT-1)
Free Text Format (Code-2)
C2348713 (UMLS CUI-2)
Is carcinoma in situ present
Item
Carcinoma in Situ
boolean
Carcinoma in Situ (Code-1)
C0007099 (UMLS CUI-1)
109355002 (SNOMED CT-1)
10061450 (MedDRA-1)
D09.9 (ICD-10-CM-1)
234.9 (ICD-9-CM-1)
Item
Histologic Type
integer
Histologic Type (Code-1)
C0449574 (UMLS CUI-1)
263541007 (SNOMED CT-1)
MTHU020048 (LOINC-1)
Code List
Histologic Type
CL Item
Ductal Breast Carcinoma In Situ  (DCIS)
Noninfiltrating Intraductal Carcinoma (Code-1)
C0007124 (UMLS CUI-1)
86616005 (SNOMED CT-1)
10013806 (MedDRA-1)
D05.1 (ICD-10-CM-1)
CL Item
Lobular carcinoma in situ of breast  (LCIS)
Lobular carcinoma in situ of breast (Code-1)
C0279563 (UMLS CUI-1)
109888004 (SNOMED CT-1)
10024744 (MedDRA-1)
D05.0 (ICD-10-CM-1)
CL Item
Mixed Ductal And Lobular CIS (Mixed DCIS & LCIS)
Lobular carcinoma in situ of breast (Code-1)
C0279563 (UMLS CUI-1)
109888004 (SNOMED CT-1)
10024744 (MedDRA-1)
D05.0 (ICD-10-CM-1)
Noninfiltrating Intraductal Carcinoma (Code-2)
C0007124 (UMLS CUI-2)
86616005 (SNOMED CT-2)
10013806 (MedDRA-2)
D05.1 (ICD-10-CM-2)
Is Paget's disease of the nipple present?
Item
Paget's Disease of the Nipple
boolean
Paget's Disease of the Nipple (Code-1)
C1704323 (UMLS CUI-1)
403946000 (SNOMED CT-1)
10033364 (MedDRA-1)
Item
Histologic Grade
integer
C0919553 (UMLS CUI-1)
371469007 (SNOMED CT-1)
Code List
Histologic Grade
CL Item
Gx Grade Cannot Be Assessed (GX) (GX)
Grade cannot be determined (finding) (Code-1)
C1273714 (UMLS CUI-1)
384741006 (SNOMED CT-1)
CL Item
G1 Low Combined Histologic Grade (favorable) (G1) (G1)
G1 grade (finding) (Code-1)
C0475269 (UMLS CUI-1)
54102005 (SNOMED CT-1)
CL Item
G2 Intermediate Combined Histologic Grade (moderately Favorable) (G2) (G2)
G2 grade (finding) (Code-1)
C0475270 (UMLS CUI-1)
1663004 (SNOMED CT-1)
CL Item
G3 High Combined Histologic Grade (unfavorable) (G3) (G3)
G3 grade (finding) (Code-1)
C0475271 (UMLS CUI-1)
61026006 (SNOMED CT-1)
Item
Lymphnode involvement
integer
Lymph Node Involvement (Code-1)
C0806692 (UMLS CUI-1)
MTHU010351 (LOINC-1)
Code List
Lymphnode involvement
CL Item
Not Applicable (Not Applicable)
Not Applicable (Code-1)
C1546968 (UMLS CUI-1)
385432009 (SNOMED CT-1)
NA (HL7 V3-1)
CL Item
Node Negative, No Neoadjuvant Chemotherapy  (Node negative, no neoadjuvant chemotherapy)
CL Item
1-3 Positive Nodes, No Neoadjuvant Chemotherapy  (1-3 positive nodes, no neoadjuvant chemotherapy)
CL Item
>= 4 Positive Nodes, No Neoadjuvant Chemotherapy (>= 4 positive nodes, no neoadjuvant chemotherapy)
Code List
Timing of chemotherapy
CL Item
Sequential  (Sequentially)
CL Item
Concurrent  (Concurrently with targeted therapy)
Hematology And Biochemistry
Item
integer
Date of blood specimen collection
Item
date
Item
integer
Code List
Result
CL Item
Normal (Normal)
CL Item
Abnormal - Clinically significant (Abnormal - Clinically significant)
CL Item
Abnormal - Not clinically significant (Abnormal - Not clinically significant)
Item Group
History Of Primary Cancer (continued)
Laboratory Name
Item
Laboratory Name
string
Laboratory (Code-1)
C0022877 (UMLS CUI-1)
261904005 (SNOMED CT-1)
Item
Estrogen Receptor
integer
Status of estrogen receptors of neoplasm (observable entity) (Code-1)
C2919271 (UMLS CUI-1)
445028008 (SNOMED CT-1)
Code List
Estrogen Receptor
CL Item
positive (Positive )
Estrogen receptor positive tumor (disorder) (Code-1)
C1562312 (UMLS CUI-1)
416053008 (SNOMED CT-1)
CL Item
negative (Negative )
Estrogen receptor negative neoplasm (disorder) (Code-1)
C2584629 (UMLS CUI-1)
441117001 (SNOMED CT-1)
CL Item
unknown (Unknown)
Unknown (Code-1)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-1)
Is estrogen receptor analysis result available
Item
Status of estrogen receptors of neoplasm
boolean
Status of estrogen receptors of neoplasm (observable entity) (Code-1)
C2919271 (UMLS CUI-1)
445028008 (SNOMED CT-1)
Availability (Code-2)
C0470187 (UMLS CUI-2)
103328004 (SNOMED CT-2)
Estrogen receptor value
Item
Estrogen receptor value
integer
Estrogen Receptors (Code-1)
C0034804 (UMLS CUI-1)
23307004 (SNOMED CT-1)
MTHU004667 (LOINC-1)
Value (Code-2)
C1522609 (UMLS CUI-2)
H-Score
Item
integer
Allred-Score
Item
integer
Remmle score
Item
integer
other
Item
string
Method
Item
string
Range
Item
string
Item
progesterone receptor
integer
Status of progesterone receptors of neoplasm (observable entity) (Code-1)
C2919590 (UMLS CUI-1)
445029000 (SNOMED CT-1)
Code List
progesterone receptor
CL Item
positive (Positive )
Progesterone receptor positive tumor (disorder) (Code-1)
C1562928 (UMLS CUI-1)
416561008 (SNOMED CT-1)
CL Item
negative (Negative )
Progesterone receptor negative neoplasm (disorder) (Code-1)
C2584628 (UMLS CUI-1)
441118006 (SNOMED CT-1)
CL Item
unknown (Unknown)
Unknown (Code-1)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-1)
Is progesterone receptor analysis result available
Item
Status of progesterone receptors of neoplasm
boolean
Status of progesterone receptors of neoplasm (observable entity) (Code-1)
C2919590 (UMLS CUI-1)
445029000 (SNOMED CT-1)
Availability (Code-2)
C0470187 (UMLS CUI-2)
103328004 (SNOMED CT-2)
Progesterone receptor value
Item
Progesterone receptor value
integer
Receptors, Progesterone (Code-1)
C0034833 (UMLS CUI-1)
61078009 (SNOMED CT-1)
MTHU002145 (LOINC-1)
Value (Code-2)
C1522609 (UMLS CUI-2)
H-Score
Item
integer
Allred-Score
Item
integer
Remmle score
Item
integer
other
Item
string
Method
Item
string
Range
Item
string
Item Group
Sentinel Node Sampling
Was sentinel node sampling performed
Item
Was sentinel node sampling performed
boolean
Sentinel Lymph Node Biopsy (Code-1)
C0796693 (UMLS CUI-1)
396487001 (SNOMED CT-1)
Sentinel Node Biopsy Date
Item
Sentinel Node Biopsy Date
date
Sentinel Lymph Node Biopsy (Code-1)
C0796693 (UMLS CUI-1)
396487001 (SNOMED CT-1)
Date in time (Code-2)
C0011008 (UMLS CUI-2)
410671006 (SNOMED CT-2)
MTHU021546 (LOINC-2)
Item
Side
integer
C0441987 (UMLS CUI-1)
182353008 (SNOMED CT-1)
MTHU014973 (LOINC-1)
Sentinel Lymph Node Biopsy (Code-2)
C0796693 (UMLS CUI-2)
396487001 (SNOMED CT-2)
Code List
Side
CL Item
Right (Left)
C0205090 (UMLS CUI-1)
24028007 (SNOMED CT-1)
CL Item
Left (Right)
C0205091 (UMLS CUI-1)
7771000 (SNOMED CT-1)
Item
Axillary sentinel node biopsy
integer
Sentinel Lymph Node Biopsy (Code-1)
C0796693 (UMLS CUI-1)
396487001 (SNOMED CT-1)
Axilla (Code-2)
C0004454 (UMLS CUI-2)
91470000 (SNOMED CT-2)
MTHU024430 (LOINC-2)
Code List
Axillary sentinel node biopsy
CL Item
Negative Finding  (Negative)
Negative Finding (Code-1)
C0205160 (UMLS CUI-1)
260385009 (SNOMED CT-1)
CL Item
Positive Finding  (Positive )
Positive Finding (Code-1)
C1446409 (UMLS CUI-1)
10828004 (SNOMED CT-1)
Item
Internal sentinel mammary nodes biopsy
integer
Internal mammary node (body structure) (Code-1)
C0447180 (UMLS CUI-1)
245340002 (SNOMED CT-1)
Sentinel Lymph Node Biopsy (Code-2)
C0796693 (UMLS CUI-2)
396487001 (SNOMED CT-2)
Code List
Internal sentinel mammary nodes biopsy
CL Item
Negative Finding  (Negative)
Negative Finding (Code-1)
C0205160 (UMLS CUI-1)
260385009 (SNOMED CT-1)
CL Item
Positive Finding  (Positive )
Positive Finding (Code-1)
C1446409 (UMLS CUI-1)
10828004 (SNOMED CT-1)
Not done
Item
Not done
string
Not Done (Code-1)
C1272696 (UMLS CUI-1)
385660001 (SNOMED CT-1)
Sentinel Lymph Node Biopsy (Code-2)
C0796693 (UMLS CUI-2)
396487001 (SNOMED CT-2)
Item Group
Most Extensive Primary Surgery
Item
Operative Surgical Procedures
integer
Operative Surgical Procedures (Code-1)
C0543467 (UMLS CUI-1)
387713003 (SNOMED CT-1)
10042609 (MedDRA-1)
MTHU007597 (LOINC-1)
Code List
Operative Surgical Procedures
CL Item
Lumpectomy  (Lumpectomy )
Lumpectomy of breast (Code-1)
C0851238 (UMLS CUI-1)
CL Item
Quandrantectomy / Segmentectomy (Quandrantectomy / Segmentectomy)
Segmental Mastectomy (Code-1)
C0024885 (UMLS CUI-1)
367502008 (SNOMED CT-1)
CL Item
Partial Mastectomy  (Partial Mastectomy )
Segmental Mastectomy (Code-1)
C0024885 (UMLS CUI-1)
64368001 (SNOMED CT-1)
CL Item
not_coded (Modified Radical Mastectomy )
CL Item
not_coded (Radical Mastectomy )
CL Item
Other  (Other )
Other (Code-1)
C0205394 (UMLS CUI-1)
74964007 (SNOMED CT-1)
Specify
Item
Specify
string
Operative Surgical Procedures (Code-1)
C0543467 (UMLS CUI-1)
387713003 (SNOMED CT-1)
10042609 (MedDRA-1)
MTHU007597 (LOINC-1)
Free Text Format (Code-2)
C2348713 (UMLS CUI-2)
Item
Laterality
integer
Operative Surgical Procedures (Code-1)
C0543467 (UMLS CUI-1)
387713003 (SNOMED CT-1)
10042609 (MedDRA-1)
MTHU007597 (LOINC-1)
Side (Code-2)
C0441987 (UMLS CUI-2)
182353008 (SNOMED CT-2)
MTHU014973 (LOINC-2)
Code List
Laterality
CL Item
Right (Right)
C0205090 (UMLS CUI-1)
24028007 (SNOMED CT-1)
CL Item
Left (Left)
C0205091 (UMLS CUI-1)
7771000 (SNOMED CT-1)
Primary surgery Date
Item
Date of surgery
date
Date surgery (Code-1)
C1628561 (UMLS CUI-1)
MTHU019327 (LOINC-1)
Item Group
Axillary Lymph Node Dissection
Date of Axillary Dissection
Item
Date of Axillary Dissection
date
Axillary Lymph Node Dissection (Code-1)
C0193867 (UMLS CUI-1)
234254000 (SNOMED CT-1)
10068477 (MedDRA-1)
40.23 (ICD-9-CM-1)
Date in time (Code-2)
C0011008 (UMLS CUI-2)
410671006 (SNOMED CT-2)
MTHU021546 (LOINC-2)
Item
Laterality
integer
Axillary Lymph Node Dissection (Code-1)
C0193867 (UMLS CUI-1)
234254000 (SNOMED CT-1)
10068477 (MedDRA-1)
Side (Code-2)
C0441987 (UMLS CUI-2)
182353008 (SNOMED CT-2)
MTHU014973 (LOINC-2)
Code List
Laterality
CL Item
Right (Right)
C0205090 (UMLS CUI-1)
24028007 (SNOMED CT-1)
CL Item
Left (Left)
C0205091 (UMLS CUI-1)
7771000 (SNOMED CT-1)
Number of Lymph Nodes examinded
Item
Number of lymph nodes examined
integer
C2733494 (UMLS CUI-1)
444025001 (SNOMED CT-1)
Number positive Lymph nodes
Item
Number of lymph nodes involved by malignant neoplasm
integer
Number of lymph nodes involved by malignant neoplasm (observable entity) (Code-1)
C2732750 (UMLS CUI-1)
443527007 (SNOMED CT-1)
Code List
Largest tumor deposit
CL Item
None Detected  (None Detected )
CL Item
Isolated Tumor Cells Alone (Isolated Tumor Cells Alone)
CL Item
Micromets  (Micrometastases)
CL Item
Macrometastases  (Macrometastases)
CL Item
Not Measured  (Not Measured )
Not done
Item
Not done
string
Not Done (Code-1)
C1272696 (UMLS CUI-1)
385660001 (SNOMED CT-1)
Operative Surgical Procedures (Code-2)
C0543467 (UMLS CUI-2)
387713003 (SNOMED CT-2)
10042609 (MedDRA-2)
MTHU007597 (LOINC-2)
Item Group
Chemotherapy
Agent Name
Item
Chemotherapeutic agent
string
Chemotherapeutic agent (product) (Code-1)
C0729502 (UMLS CUI-1)
312059006 (SNOMED CT-1)
Total Dose
Item
Cumulative Dose
integer
C2986497 (UMLS CUI-1)
initial dose
Item
initial dose
integer
Initial (qualifier value) (Code-1)
C0205265 (UMLS CUI-1)
884001 (SNOMED CT-1)
Dosage (Code-2)
C0178602 (UMLS CUI-2)
277406006 (SNOMED CT-2)
Total No. Cycles
Item
planned cycles
integer
Plan (Code-1)
C1301732 (UMLS CUI-1)
397943006 (SNOMED CT-1)
Chemotherapy cycle (procedure) (Code-2)
C1302181 (UMLS CUI-2)
399042005 (SNOMED CT-2)
Item
Intent - prior chemotherapy
integer
C1283828 (UMLS CUI-1)
367565008 (SNOMED CT-1)
Chemotherapy Regimen (Code-2)
C0392920 (UMLS CUI-2)
69960004 (SNOMED CT-2)
10061758 (MedDRA-2)
Prior (Code-3)
C0332152 (UMLS CUI-3)
288556008 (SNOMED CT-3)
Code List
Intent - prior chemotherapy
CL Item
Neo-adjuvant - intent  (Neoadjuvant)
Neo-adjuvant - intent (qualifier value) (Code-1)
C1298676 (UMLS CUI-1)
373847000 (SNOMED CT-1)
CL Item
Adjuvant - intent (Adjuvant)
Adjuvant - intent (qualifier value) (Code-1)
C1298675 (UMLS CUI-1)
373846009 (SNOMED CT-1)
Date Started
Item
Date treatment started
date
Date treatment started (observable entity) (Code-1)
C3173309 (UMLS CUI-1)
413946009 (SNOMED CT-1)
Chemotherapy Regimen (Code-2)
C0392920 (UMLS CUI-2)
69960004 (SNOMED CT-2)
10061758 (MedDRA-2)
Date Stopped
Item
Date treatment stopped
date
Date treatment stopped (observable entity) (Code-1)
C1531784 (UMLS CUI-1)
413947000 (SNOMED CT-1)
Chemotherapy Regimen (Code-2)
C0392920 (UMLS CUI-2)
69960004 (SNOMED CT-2)
10061758 (MedDRA-2)
Item Group
Previous Or Current Cardiovascular Disease
Has the patient suffered cardiovascular disease?
Item
not_useful_for_research
boolean
Medical condition
Item
not_useful_for_research
string
Item
not_useful_for_research
integer
Code List
not_useful_for_research
CL Item
not_useful_for_research (Resolved)
CL Item
not_useful_for_research (Current)
Treatment Required
Item
not_useful_for_research
boolean
Has the patient been assessed for systemic disease
Item
not_useful_for_research
boolean
Item Group
ECG
C1623258 (UMLS CUI-1)
Item
not_useful_for_research
integer
Code List
not_useful_for_research
CL Item
Abdominal Ct-scan  (Abdominal CT-scan)
CL Item
Bilateral Mammogram  (Bilateral mammogram)
CL Item
Bone Scan  (Bone scan (scintigraphy))
CL Item
Bone X-ray  (Bone X-ray)
CL Item
Ct Scan Of Chest  (Chest CT-scan)
CL Item
Chest X-ray  (Chest X-Ray)
CL Item
Left Mammogram, Only  (Left mammogram, only)
CL Item
Right Mammogram, Only  (Right mammogram, only)
CL Item
Computed Tomography  (CT Scan)
CL Item
Endoscopy  (Endoscopy )
CL Item
Lymphangiogram  (Lymphangiogram )
CL Item
Mammography  (Mammography )
CL Item
Magnetic Resonance Imaging  (MRI)
CL Item
Nuclear Scan  (Nuclear Scan )
CL Item
Positron Emission Tomography  (PET Scan)
CL Item
Pet/ct Scan  (PET/CT scan)
CL Item
Transvaginal Ultrasound  (Transvaginal Ultrasound)
CL Item
Ultrasound  (Ultrasound )
CL Item
X-ray (X-ray)
CL Item
Other  (Other )
Specify
Item
not_useful_for_research
string
Item
not_useful_for_research
integer
Code List
not_useful_for_research
CL Item
not_useful_for_research (Abdomen/abdominal Wall )
CL Item
not_useful_for_research (Abdomen )
CL Item
not_useful_for_research (Bone )
CL Item
not_useful_for_research (Bladder )
CL Item
not_useful_for_research (Breast )
CL Item
not_useful_for_research (Colon )
CL Item
not_useful_for_research (Colorectal )
CL Item
not_useful_for_research (Central Nervous System (CNS))
CL Item
not_useful_for_research (Chest )
CL Item
not_useful_for_research (Cervix Uteri )
CL Item
not_useful_for_research (Esophagus )
CL Item
not_useful_for_research (Head And Neck )
CL Item
not_useful_for_research (Heart )
CL Item
not_useful_for_research (Kidney )
CL Item
not_useful_for_research (Lung )
CL Item
not_useful_for_research (Lymph Node )
CL Item
not_useful_for_research (Liver )
CL Item
not_useful_for_research (Mouth (Oral Cavity))
CL Item
not_useful_for_research (Other )
CL Item
not_useful_for_research (Ovary )
CL Item
not_useful_for_research (Pleura )
CL Item
not_useful_for_research (Peritoneum )
CL Item
not_useful_for_research (Prostate Gland )
CL Item
not_useful_for_research (Pancreas )
CL Item
not_useful_for_research (Pelvis )
CL Item
not_useful_for_research (Rectum )
CL Item
not_useful_for_research (Stomach )
CL Item
not_useful_for_research (Small Intestine)
CL Item
not_useful_for_research (Skin )
CL Item
not_useful_for_research (Spleen )
CL Item
not_useful_for_research (Thyroid Gland (Thyroid))
CL Item
not_useful_for_research (Testis (Testicle))
Date of test
Item
not_useful_for_research
date
Are there any clinically significant abnormalites
Item
not_useful_for_research
boolean
Specify
Item
not_useful_for_research
string
Not done
Item
not_useful_for_research
string
Item Group
Translational Research
Item
not_useful_for_research
integer
Code List
not_useful_for_research
CL Item
not_useful_for_research (FFPE tumor block)
CL Item
not_useful_for_research (Blood Sample For Pgx)
CL Item
not_useful_for_research (Tumor Tissue For Pgx)
CL Item
not_useful_for_research (Additional Blood Sample For Ctc (circulating Tumor Cells) (Additional blood sample for CTC (circulating tumor cells)))
CL Item
not_useful_for_research (Additional Blood Sample For Proteomics (Additional blood sample for Proteomics))
CL Item
not_useful_for_research (Additional Fresh Frozen Tumor Samples (Additional fresh frozen tumor samples))
Date of blood specimen collection
Item
not_useful_for_research
date
Was sample obtained
Item
not_useful_for_research
boolean
Item Group
Central Her2 Testing Form - FISH
Percentage greater than or equal to 3 Chromosome 17 signals
Item
string
NACA (No apparent Chromosome 17 anomaly)
Item
boolean
Item
integer
Code List
Why no result
CL Item
Interductal Only  (Interductal Only )
CL Item
Hybridization Failure (Hybridization Failure)
CL Item
Insufficient Tissue  (Insufficient Tissue )
CL Item
No Cancer Tissue  (No Cancer Tissue )
CL Item
Other (Other)
Specify
Item
string
Item
integer
Code List
Other features
CL Item
Duplication Of Her2  (Duplication Of Her2 )
CL Item
Most Cells With No Centromere 17  (Most Cells With No Centromere 17 )
CL Item
Negative Her2  (Negative Her2 )
CL Item
Normal Her2  (Normal Her2 )
CL Item
Not A Small Clone  (Not A Small Clone )
CL Item
Other  (Other )
CL Item
Small Clone Of Amplification  (Small Clone Of Amplification )
Item Group
Central Her2 Testing Form - IHC
Percentage of invasive tumor cells with complete membrane staining
Item
not_useful_for_research
integer
Code List
Uniformity of staining
CL Item
Present (Present)
CL Item
Absent (Absent)
Code List
Homogeneous dark circumferential pattern
CL Item
Present (Present)
CL Item
Absent (Absent)
Item
Her-2/neu
integer
Her2/Neu Status (Code-1)
C1512413 (UMLS CUI-1)
Code List
Her-2/neu
CL Item
No Staining Or Membranous Staining <=10% Cells (No staining or membranous staining <=10% cells ) (Negative - 0)
HER2-negative breast cancer (Code-1)
CL412283 (UMLS CUI-1)
CL Item
Faint Membrane Staining, Partial >10% Cells (Faint membrane staining, partial >10% cells ) (Negative - 1+)
HER2-negative breast cancer (Code-1)
CL412283 (UMLS CUI-1)
CL Item
Weak To Moderate Staining, Complete >10% Cells (Weak to moderate staining, complete >10% cells ) (Equivocal - 2+)
Borderline (Code-1)
C0205189 (UMLS CUI-1)
CL Item
Strong Staining, Complete >10% <=30% Cells (Strong staining, complete >10% <=30% cells ) (Equivocal - 3+)
HER2-positive carcinoma of breast (disorder) (Code-1)
C1960398 (UMLS CUI-1)
427685000 (SNOMED CT-1)
CL Item
Strong Staining, Complete >30% Cells (Strong staining, complete >30% cells ) (Positive - 3+)
HER2-positive carcinoma of breast (disorder) (Code-1)
C1960398 (UMLS CUI-1)
427685000 (SNOMED CT-1)
CL Item
Insufficient Tissue/hybridization Failure  (Insufficient tissue/hybridization failure)
Insufficient tissue for diagnosis (finding) (Code-1)
C0332630 (UMLS CUI-1)
77289001 (SNOMED CT-1)
Is there vascular invasion
Item
Is there vascular invasion
boolean
Vascular invasion of tumor present (finding) (Code-1)
C1318569 (UMLS CUI-1)
372287009 (SNOMED CT-1)
Suitable for TMA
Item
boolean
Item Group
Radiotherapy
prior Radiation Therapy
Item
prior Radiation Therapy
boolean
Therapeutic radiology procedure (Code-1)
C1522449 (UMLS CUI-1)
108290001 (SNOMED CT-1)
10037770 (MedDRA-1)
RT Site
Item
RT Site
string
Organ target(s) (Code-1)
C0807185 (UMLS CUI-1)
Item
Side
integer
C0441987 (UMLS CUI-1)
182353008 (SNOMED CT-1)
MTHU014973 (LOINC-1)
Tumor site (Code-2)
C0475445 (UMLS CUI-2)
263591006 (SNOMED CT-2)
MTHU015562 (LOINC-2)
Code List
Side
CL Item
Left (Left)
C0205091 (UMLS CUI-1)
7771000 (SNOMED CT-1)
CL Item
Right (Right)
C0205090 (UMLS CUI-1)
24028007 (SNOMED CT-1)
RT Total Dose
Item
Total radiation dose
integer
Total radiation dose delivered (observable entity) (Code-1)
C2919490 (UMLS CUI-1)
445461008 (SNOMED CT-1)
Item
Dose UOM
integer
Code List
Dose UOM
CL Item
Gray (Gy)
CL Item
Centigray (cGy)
CL Item
Radiation Absorbed Dose (Rad)
Radiation Therapy Start Date
Item
Start Radiotherapy
date
Radiotherapy started (situation) (Code-1)
C0436382 (UMLS CUI-1)
168531007 (SNOMED CT-1)
Radiation Therapy End Date
Item
End Radiotherapy
date
Radiotherapy completed (situation) (Code-1)
C0436385 (UMLS CUI-1)
168534004 (SNOMED CT-1)
Item Group
Hormone therapy
C0279025 (UMLS CUI-1)
Endocrine Therapy
Item
Has the patient received hormone therapy before or during the trial
boolean
169413002 (SNOMED CT-1)
10065646 (MedDRA-1)
C0279025 (UMLS CUI-1)
Name of treatment or surgical procedure
Item
Therapeutic procedure
string
C0087111 (UMLS CUI-1)
277132007 (SNOMED CT-1)
10053757 (MedDRA-1)
MTHU008880 (LOINC-1)
Free Text Format (Code-2)
C2348713 (UMLS CUI-2)
Dose
Item
Single dose characteristic
integer
Single dose characteristic (observable entity) (Code-1)
C1960417 (UMLS CUI-1)
426146003 (SNOMED CT-1)
Item
Unit type (qualifier value)
integer
C0565912 (UMLS CUI-1)
288462000 (SNOMED CT-1)
Code List
Unit type (qualifier value)
CL Item
Milligram (mg)
C0439210 (UMLS CUI-1)
258684004 (SNOMED CT-1)
CL Item
Not Applicable (N/A)
None or Not Applicable (Code-1)
CL413952 (UMLS CUI-1)
Begin date
Item
Date treatment started - endocrine therapy
date
Date treatment started (observable entity) (Code-1)
C3173309 (UMLS CUI-1)
413946009 (SNOMED CT-1)
Endocrine Therapy (Code-2)
C0279025 (UMLS CUI-2)
169413002 (SNOMED CT-2)
End date
Item
Date treatment stopped - endocrine therapy
date
Date treatment stopped (observable entity) (Code-1)
C1531784 (UMLS CUI-1)
413947000 (SNOMED CT-1)
Endocrine Therapy (Code-2)
C0279025 (UMLS CUI-2)
169413002 (SNOMED CT-2)
Item
ongoing at time of study completion
integer
Continue (Code-1)
C0549178 (UMLS CUI-1)
Study End Date (Code-2)
C2983670 (UMLS CUI-2)
Endocrine Therapy (Code-3)
C0279025 (UMLS CUI-3)
169413002 (SNOMED CT-3)
Code List
ongoing at time of study completion
CL Item
Yes (Yes)
C1298907 (UMLS CUI-1)
373066001 (SNOMED CT-1)
Item Group
Concomitant Treatment
Name of treatment
Item
Name of concomitant treatment
string
Concomitant Therapy (Code-1)
C1707479 (UMLS CUI-1)
Item
Intent
integer
C1283828 (UMLS CUI-1)
367565008 (SNOMED CT-1)
Concomitant Therapy (Code-2)
C1707479 (UMLS CUI-2)
Code List
Intent
CL Item
Prevention (Prophylaxis)
Prophylactic treatment (Code-1)
C0199176 (UMLS CUI-1)
129429009 (SNOMED CT-1)
10036898 (MedDRA-1)
CL Item
Curative treatment (Curative)
Curative - procedure intent (qualifier value) (Code-1)
C1276305 (UMLS CUI-1)
373808002 (SNOMED CT-1)
Date started
Item
Date treatment started
date
Date treatment started (observable entity) (Code-1)
C3173309 (UMLS CUI-1)
413946009 (SNOMED CT-1)
Concomitant Therapy (Code-2)
C1707479 (UMLS CUI-2)
Date stopped
Item
Date stopped
date
Date treatment stopped (observable entity) (Code-1)
C1531784 (UMLS CUI-1)
413947000 (SNOMED CT-1)
Concomitant Therapy (Code-2)
C1707479 (UMLS CUI-2)
Item
Ongoing
integer
Continue (Code-1)
C0549178 (UMLS CUI-1)
Study End Date (Code-2)
C2983670 (UMLS CUI-2)
Concomitant Therapy (Code-3)
C1707479 (UMLS CUI-3)
Code List
Ongoing
CL Item
Yes (Yes)
C1298907 (UMLS CUI-1)
373066001 (SNOMED CT-1)
Item Group
Administration of Study Drug
Date Agent Administered
Item
date
Dose
Item
Single dose characteristic
integer
Single dose characteristic (observable entity) (Code-1)
C1960417 (UMLS CUI-1)
426146003 (SNOMED CT-1)
Total Dose
Item
Cumulative Dose
integer
C2986497 (UMLS CUI-1)
Was treatment delayed
Item
boolean
Item
integer
Code List
Specify code
CL Item
Hematologic Adverse Event  (Hematologic Adverse Event )
CL Item
Cardiac Adverse Event (Cardiac Adverse Event)
CL Item
Adverse Event Other Than Hematologic Or Cardiac  (Adverse Event Other Than Hematologic Or Cardiac )
CL Item
Dosing Error  (Dosing Error )
CL Item
Subject Non-compliance (Subject Non-compliance)
CL Item
Administrative Reasons  (Administrative Reasons )
CL Item
Other  (Other )
specify
Item
string
Was dose reduced
Item
Chemotherapeutic drug level decreased
boolean
C0861114 (UMLS CUI-1)
Item
integer
Code List
Specify code
CL Item
Hematologic Adverse Event  (Hematologic Adverse Event )
CL Item
Cardiac Adverse Event (Cardiac Adverse Event)
CL Item
Adverse Event Other Than Hematologic Or Cardiac  (Adverse Event Other Than Hematologic Or Cardiac )
CL Item
Dosing Error  (Dosing Error )
CL Item
Subject Non-compliance (Subject Non-compliance)
CL Item
Administrative Reasons  (Administrative Reasons )
CL Item
Other  (Other )
specify
Item
string
Item Group
Chemotherapy
Did the patient receive additional chemotherapy after recurrence of breast cancer or second primary malignancy of contralateral breast cancer
Item
relapse treatment - chemotherapy
boolean
relapse treatment (Code-1)
C0679868 (UMLS CUI-1)
Chemotherapy Regimen (Code-2)
C0392920 (UMLS CUI-2)
69960004 (SNOMED CT-2)
10061758 (MedDRA-2)
Agent Name
Item
string
Total No. Cycles
Item
integer
initial dose
Item
integer
Item
integer
Code List
Dose UOM
CL Item
Miligram per Meter squared (mg/m2)
Date started
Item
date
Date stopped
Item
date
Item Group
Targeted Therapy
Did the patient receive additional target therapy after recurrence of breast cancer or second primary malignancy of contralateral breast cancer
Item
boolean
Agent Name
Item
string
Total No. Cycles
Item
integer
initial dose
Item
integer
Item
integer
Code List
Dose UOM
CL Item
Miligram per Meter squared (mg/m2)
Date started
Item
date
Date stopped
Item
date
Item Group
Hormonetherapy
Did the patient receive hormone therapy after recurrence of breast cancer or second primary malignancy of contralateral breast cancer
Item
relapse treatment - endocrine therapy
boolean
relapse treatment (Code-1)
C0679868 (UMLS CUI-1)
Endocrine Therapy (Code-2)
C0279025 (UMLS CUI-2)
169413002 (SNOMED CT-2)
10065646 (MedDRA-2)
Agent Name
Item
string
Total No. Cycles
Item
integer
initial dose
Item
integer
Item
integer
Code List
Dose UOM
CL Item
Miligram per Meter squared (mg/m2)
CL Item
Not Applicable (N/A)
Date started
Item
date
Date stopped
Item
date
Item Group
Radiotherapy
Did the patient receive radiotherapy after recurrence of breast cancer or second primary malignancy of contralateral breast cancer
Item
relapse treatment - radiotherapy
boolean
relapse treatment (Code-1)
C0679868 (UMLS CUI-1)
Therapeutic radiology procedure (Code-2)
C1522449 (UMLS CUI-2)
108290001 (SNOMED CT-2)
10037794 (MedDRA-2)
Radiation Therapy Site
Item
string
Item
integer
Code List
Side
CL Item
Left (Left)