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Information:
Fel:
ID
42042
Beskrivning
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
Nyckelord
Versioner (9)
- 2012-09-19 2012-09-19 -
- 2014-03-19 2014-03-19 - Martin Dugas
- 2014-08-09 2014-08-09 - Martin Dugas
- 2015-06-26 2015-06-26 - Martin Dugas
- 2015-07-28 2015-07-28 - Julian Varghese
- 2015-09-29 2015-09-29 - Martin Dugas
- 2021-03-15 2021-03-15 - Dr. rer. medic Philipp Neuhaus
- 2021-04-13 2021-04-13 - Dr. rer. medic Philipp Neuhaus
- 2021-09-20 2021-09-20 -
Uppladdad den
15 mars 2021
DOI
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Licens
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
- StudyEvent: study documentation
Similar models
Outcome of Pregnancy Breast Cancer NCT00490139
- StudyEvent: study documentation
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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)
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)
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)
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)
C2986440 (UMLS CUI-1)
Patients (Code-2)
C0030705 (UMLS CUI-2)
116154003 (SNOMED CT-2)
Institution
Item
Institution
string
C0021622 (UMLS CUI-1)
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)
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)
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)
C2348563 (UMLS CUI-1)
Patient Medical Record Number
Item
Patient Medical Record Number
string
Participating Group Code
Item
Participating Group Code
string
Study Protocol Version Participating Organization Type Code (Code-1)
C2986314 (UMLS CUI-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)
C1691222 (UMLS CUI-1)
Data (Code-2)
C1511726 (UMLS CUI-2)
Item
Registration Type
integer
Type of registration (attribute) (Code-1)
C0449520 (UMLS CUI-1)
246243005 (SNOMED CT-1)
C0449520 (UMLS CUI-1)
246243005 (SNOMED CT-1)
CL Item
First Submission (First Submission)
Submission (Code-1)
C1515023 (UMLS CUI-1)
First (Code-2)
C0205435 (UMLS CUI-2)
255216001 (SNOMED CT-2)
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)
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)
C1515023 (UMLS CUI-1)
First (Code-2)
C0205435 (UMLS CUI-2)
255216001 (SNOMED CT-2)
CL Item
Pre-Registration Eligibility Checklist Cover Sheet/Demographics (1)
CL Item
Eligibility Checklist (2)
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)
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)
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)
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)
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)
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)
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)
184099003 (SNOMED CT-1)
ZIP Code
Item
Patient postal code
integer
C0421454 (UMLS CUI-1)
184102003 (SNOMED CT-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)
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
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)
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)
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)
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)
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)
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)
C1706613 (UMLS CUI-1)
CL Item
Could Not Be Determined Or Unsure (Unknown)
Unknown (Code-1)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-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)
C0015031 (UMLS CUI-1)
364699009 (SNOMED CT-1)
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)
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)
CL Item
Not Provided Or Available (Not reported)
Not Stated (Code-1)
C1706613 (UMLS CUI-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)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-1)
Item
Inclusion Criteria
integer
Inclusion Criteria (Code-1)
C1512693 (UMLS CUI-1)
C1512693 (UMLS CUI-1)
CL Item
>= 18 Years Of Age (Age >= 18 years)
patient age (Code-1)
CL386174 (UMLS CUI-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)
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)
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)
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)
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)
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)
C0514044 (UMLS CUI-1)
Item
Exclusion criteria
integer
Exclusion Criteria (Code-1)
C0680251 (UMLS CUI-1)
C0680251 (UMLS CUI-1)
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)
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)
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)
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)
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)
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)
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)
Date of Randomization
Item
Date of Randomization
date
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)
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)
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)
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)
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)
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)
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)
C1548793 (UMLS CUI-1)
Informed consent obtained (Code-2)
C0514044 (UMLS CUI-2)
MTHU008888 (MedDRA-2)
Item
Menopausal Status
integer
Menopause finding (finding) (Code-1)
C0455962 (UMLS CUI-1)
276477006 (SNOMED CT-1)
C0455962 (UMLS CUI-1)
276477006 (SNOMED CT-1)
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)
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)
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)
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)
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)
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)
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)
74036000 (SNOMED CT-1)
10036572 (MedDRA-1)
C0032976 (UMLS CUI)
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)
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)
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)
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)
182353008 (SNOMED CT-1)
Unilateral Oophorectomy (Code-2)
C0041687 (UMLS CUI-2)
33159007 (SNOMED CT-2)
10030344 (MedDRA-2)
CL Item
Right (Right)
C0205090 (UMLS CUI-1)
24028007 (SNOMED CT-1)
24028007 (SNOMED CT-1)
CL Item
Left (Left)
C0205091 (UMLS CUI-1)
7771000 (SNOMED CT-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)
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)
Date of Physical exam
Item
Date of Physical exam
date
Physical Examination Date (Code-1)
C2826643 (UMLS CUI-1)
C2826643 (UMLS CUI-1)
Item
Physical Examination
integer
CL Item
Normal (Normal)
Normal (Code-1)
C0205307 (UMLS CUI-1)
17621005 (SNOMED CT-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)
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)
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)
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)
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)
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)
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)
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)
heart rate (Code-1)
364075005 (SNOMED CT-1)
10019299 (MedDRA-1)
MTHU003114 (LOINC-1)
C0018810 (UMLS CUI-1)
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)
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)
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)
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)
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)
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)
C1827926 (UMLS CUI-1)
423409001 (SNOMED CT-1)
date of ECG
Item
date
CL Item
Normal (Normal)
CL Item
Abnormal - Clinically significant (Abnormal - Clinically significant)
CL Item
Abnormal - Not clinically significant (Abnormal - Not clinically significant)
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)
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)
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)
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)
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)
C1274040 (UMLS CUI-1)
394617004 (SNOMED CT-1)
Left Ventricular Ejection Fraction (Code-2)
CL433348 (UMLS CUI-2)
CL Item
Normal (Normal)
Normal (Code-1)
C0205307 (UMLS CUI-1)
17621005 (SNOMED CT-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)
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)
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
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)
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
CL Item
Positive (Positive )
HER2-positive carcinoma of breast (disorder) (Code-1)
C1960398 (UMLS CUI-1)
427685000 (SNOMED CT-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)
C0459423 (UMLS CUI-1)
280414007 (SNOMED CT-1)
CL Item
Negative (Negative )
HER2-negative breast cancer (Code-1)
CL412283 (UMLS CUI-1)
CL412283 (UMLS CUI-1)
CL Item
Non-interpretable (Non-interpretable )
Unevaluable (Code-1)
C1883425 (UMLS CUI-1)
C1883425 (UMLS CUI-1)
Percentage of invasive tumor cells with complete membrane staining
Item
integer
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)
C0162789 (UMLS CUI-1)
426329006 (SNOMED CT-1)
10066931 (MedDRA-1)
CL Item
Positive Finding (Amplified )
Positive Finding (Code-1)
C1446409 (UMLS CUI-1)
10828004 (SNOMED CT-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)
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)
C0205160 (UMLS CUI-1)
260385009 (SNOMED CT-1)
FISH HER2/neu chromosome 17 Ratio
Item
integer
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)
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)
C1272696 (UMLS CUI-1)
385660001 (SNOMED CT-1)
Her2/Neu Status (Code-2)
C1512413 (UMLS CUI-2)
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)
C0299250 (UMLS CUI-1)
CL Item
Positive Finding (Amplified )
Positive Finding (Code-1)
C1446409 (UMLS CUI-1)
10828004 (SNOMED CT-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)
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)
C0205160 (UMLS CUI-1)
260385009 (SNOMED CT-1)
CL Item
Polysomy (Polysomy )
CL Item
Monosomy (Monosomy )
CL Item
Normal (Normal )
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)
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)
C1532336 (UMLS CUI-1)
415067009 (SNOMED CT-1)
Progesterone receptor positive tumor (disorder) (Code-2)
C1562928 (UMLS CUI-2)
416561008 (SNOMED CT-2)
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)
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)
182353008 (SNOMED CT-1)
MTHU014973 (LOINC-1)
Tumor site (Code-2)
C0475445 (UMLS CUI-2)
263591006 (SNOMED CT-2)
MTHU015562 (LOINC-2)
CL Item
Left (Left)
C0205091 (UMLS CUI-1)
7771000 (SNOMED CT-1)
7771000 (SNOMED CT-1)
CL Item
Right (Right)
C0205090 (UMLS CUI-1)
24028007 (SNOMED CT-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)
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)
C1275865 (UMLS CUI-1)
399534004 (SNOMED CT-1)
CL Item
No Regional Lymph Node Metastasis (N0) (N0)
N0 Stage Finding (Code-1)
C0441959 (UMLS CUI-1)
62455006 (SNOMED CT-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)
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)
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)
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)
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)
C1273678 (UMLS CUI-1)
384689007 (SNOMED CT-1)
Item
Histologic Type
integer
CL Item
Ductal Nos (Ductal NOS)
Ductal Breast Carcinoma (Code-1)
C1527349 (UMLS CUI-1)
C1527349 (UMLS CUI-1)
CL Item
Lobular (Lobular )
Invasive Lobular Breast Carcinoma (Code-1)
CL029510 (UMLS CUI-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)
CL007210 (UMLS CUI-1)
CL Item
Tubular (Tubular (pure > or =90%))
Tubular Breast Carcinoma (Code-1)
C0279561 (UMLS CUI-1)
C0279561 (UMLS CUI-1)
CL Item
Apocrine (Apocrine )
Apocrine Breast Carcinoma (Code-1)
C1332316 (UMLS CUI-1)
10066206 (MedDRA-1)
C1332316 (UMLS CUI-1)
10066206 (MedDRA-1)
CL Item
Tubulolobular (Tubulolobular )
Invasive Lobular Breast Carcinoma, Tubulolobular Variant (Code-1)
CL429657 (UMLS CUI-1)
CL429657 (UMLS CUI-1)
CL Item
Micropapillary (Micropapillary )
Invasive Micropapillary Breast Carcinoma (Code-1)
C1334279 (UMLS CUI-1)
C1334279 (UMLS CUI-1)
CL Item
Cribriform (Cribriform )
Invasive Cribriform Breast Carcinoma (Code-1)
C1334275 (UMLS CUI-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)
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)
C0853879 (UMLS CUI-1)
10006190 (MedDRA-1)
CL Item
Medullary Carcinoma (Medullary)
Medullary Breast Carcinoma (Code-1)
C0860580 (UMLS CUI-1)
C0860580 (UMLS CUI-1)
CL Item
Other Specify (other)
Other (Code-1)
C0205394 (UMLS CUI-1)
74964007 (SNOMED CT-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)
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)
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
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)
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)
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)
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)
C1704323 (UMLS CUI-1)
403946000 (SNOMED CT-1)
10033364 (MedDRA-1)
CL Item
Gx Grade Cannot Be Assessed (GX) (GX)
Grade cannot be determined (finding) (Code-1)
C1273714 (UMLS CUI-1)
384741006 (SNOMED CT-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)
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)
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)
C0475271 (UMLS CUI-1)
61026006 (SNOMED CT-1)
Item
Lymphnode involvement
integer
CL Item
Not Applicable (Not Applicable)
Not Applicable (Code-1)
C1546968 (UMLS CUI-1)
385432009 (SNOMED CT-1)
NA (HL7 V3-1)
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)
CL Item
Sequential (Sequentially)
CL Item
Concurrent (Concurrently with targeted therapy)
Hematology And Biochemistry
Item
integer
Date of blood specimen collection
Item
date
CL Item
Normal (Normal)
CL Item
Abnormal - Clinically significant (Abnormal - Clinically significant)
CL Item
Abnormal - Not clinically significant (Abnormal - Not clinically significant)
Laboratory Name
Item
Laboratory Name
string
Laboratory (Code-1)
C0022877 (UMLS CUI-1)
261904005 (SNOMED CT-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)
C2919271 (UMLS CUI-1)
445028008 (SNOMED CT-1)
CL Item
positive (Positive )
Estrogen receptor positive tumor (disorder) (Code-1)
C1562312 (UMLS CUI-1)
416053008 (SNOMED CT-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)
C2584629 (UMLS CUI-1)
441117001 (SNOMED CT-1)
CL Item
unknown (Unknown)
Unknown (Code-1)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-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)
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)
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)
C2919590 (UMLS CUI-1)
445029000 (SNOMED CT-1)
CL Item
positive (Positive )
Progesterone receptor positive tumor (disorder) (Code-1)
C1562928 (UMLS CUI-1)
416561008 (SNOMED CT-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)
C2584628 (UMLS CUI-1)
441118006 (SNOMED CT-1)
CL Item
unknown (Unknown)
Unknown (Code-1)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-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)
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)
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
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)
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)
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)
182353008 (SNOMED CT-1)
MTHU014973 (LOINC-1)
Sentinel Lymph Node Biopsy (Code-2)
C0796693 (UMLS CUI-2)
396487001 (SNOMED CT-2)
CL Item
Right (Left)
C0205090 (UMLS CUI-1)
24028007 (SNOMED CT-1)
24028007 (SNOMED CT-1)
CL Item
Left (Right)
C0205091 (UMLS CUI-1)
7771000 (SNOMED CT-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)
C0796693 (UMLS CUI-1)
396487001 (SNOMED CT-1)
Axilla (Code-2)
C0004454 (UMLS CUI-2)
91470000 (SNOMED CT-2)
MTHU024430 (LOINC-2)
CL Item
Negative Finding (Negative)
Negative Finding (Code-1)
C0205160 (UMLS CUI-1)
260385009 (SNOMED CT-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)
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)
C0447180 (UMLS CUI-1)
245340002 (SNOMED CT-1)
Sentinel Lymph Node Biopsy (Code-2)
C0796693 (UMLS CUI-2)
396487001 (SNOMED CT-2)
CL Item
Negative Finding (Negative)
Negative Finding (Code-1)
C0205160 (UMLS CUI-1)
260385009 (SNOMED CT-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)
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)
C1272696 (UMLS CUI-1)
385660001 (SNOMED CT-1)
Sentinel Lymph Node Biopsy (Code-2)
C0796693 (UMLS CUI-2)
396487001 (SNOMED CT-2)
Item
Operative Surgical Procedures
integer
Operative Surgical Procedures (Code-1)
C0543467 (UMLS CUI-1)
387713003 (SNOMED CT-1)
10042609 (MedDRA-1)
MTHU007597 (LOINC-1)
C0543467 (UMLS CUI-1)
387713003 (SNOMED CT-1)
10042609 (MedDRA-1)
MTHU007597 (LOINC-1)
CL Item
Lumpectomy (Lumpectomy )
Lumpectomy of breast (Code-1)
C0851238 (UMLS CUI-1)
C0851238 (UMLS CUI-1)
CL Item
Quandrantectomy / Segmentectomy (Quandrantectomy / Segmentectomy)
Segmental Mastectomy (Code-1)
C0024885 (UMLS CUI-1)
367502008 (SNOMED CT-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)
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)
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)
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)
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)
CL Item
Right (Right)
C0205090 (UMLS CUI-1)
24028007 (SNOMED CT-1)
24028007 (SNOMED CT-1)
CL Item
Left (Left)
C0205091 (UMLS CUI-1)
7771000 (SNOMED CT-1)
7771000 (SNOMED CT-1)
Primary surgery Date
Item
Date of surgery
date
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)
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)
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)
CL Item
Right (Right)
C0205090 (UMLS CUI-1)
24028007 (SNOMED CT-1)
24028007 (SNOMED CT-1)
CL Item
Left (Left)
C0205091 (UMLS CUI-1)
7771000 (SNOMED CT-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)
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)
C2732750 (UMLS CUI-1)
443527007 (SNOMED CT-1)
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)
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)
Agent Name
Item
Chemotherapeutic agent
string
Chemotherapeutic agent (product) (Code-1)
C0729502 (UMLS CUI-1)
312059006 (SNOMED CT-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)
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)
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)
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)
CL Item
Neo-adjuvant - intent (Neoadjuvant)
Neo-adjuvant - intent (qualifier value) (Code-1)
C1298676 (UMLS CUI-1)
373847000 (SNOMED CT-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)
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)
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)
C1531784 (UMLS CUI-1)
413947000 (SNOMED CT-1)
Chemotherapy Regimen (Code-2)
C0392920 (UMLS CUI-2)
69960004 (SNOMED CT-2)
10061758 (MedDRA-2)
Has the patient suffered cardiovascular disease?
Item
not_useful_for_research
boolean
Medical condition
Item
not_useful_for_research
string
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
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
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
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
Percentage greater than or equal to 3 Chromosome 17 signals
Item
string
NACA (No apparent Chromosome 17 anomaly)
Item
boolean
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
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 )
Percentage of invasive tumor cells with complete membrane staining
Item
not_useful_for_research
integer
CL Item
Present (Present)
CL Item
Absent (Absent)
CL Item
Present (Present)
CL Item
Absent (Absent)
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)
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)
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)
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)
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)
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)
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)
C1318569 (UMLS CUI-1)
372287009 (SNOMED CT-1)
Suitable for TMA
Item
boolean
prior Radiation Therapy
Item
prior Radiation Therapy
boolean
Therapeutic radiology procedure (Code-1)
C1522449 (UMLS CUI-1)
108290001 (SNOMED CT-1)
10037770 (MedDRA-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)
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)
182353008 (SNOMED CT-1)
MTHU014973 (LOINC-1)
Tumor site (Code-2)
C0475445 (UMLS CUI-2)
263591006 (SNOMED CT-2)
MTHU015562 (LOINC-2)
CL Item
Left (Left)
C0205091 (UMLS CUI-1)
7771000 (SNOMED CT-1)
7771000 (SNOMED CT-1)
CL Item
Right (Right)
C0205090 (UMLS CUI-1)
24028007 (SNOMED CT-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)
C2919490 (UMLS CUI-1)
445461008 (SNOMED CT-1)
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)
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)
C0436385 (UMLS CUI-1)
168534004 (SNOMED CT-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)
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)
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)
C1960417 (UMLS CUI-1)
426146003 (SNOMED CT-1)
CL Item
Milligram (mg)
C0439210 (UMLS CUI-1)
258684004 (SNOMED CT-1)
258684004 (SNOMED CT-1)
CL Item
Not Applicable (N/A)
None or Not Applicable (Code-1)
CL413952 (UMLS CUI-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)
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)
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)
C0750536 (UMLS CUI-1)
Study End Date (Code-2)
C2983670 (UMLS CUI-2)
Endocrine Therapy (Code-3)
C0279025 (UMLS CUI-3)
169413002 (SNOMED CT-3)
C0750536 (UMLS CUI-1)
Study End Date (Code-2)
C2983670 (UMLS CUI-2)
Endocrine Therapy (Code-3)
C0279025 (UMLS CUI-3)
169413002 (SNOMED CT-3)
CL Item
Yes (Yes)
C1298907 (UMLS CUI-1)
373066001 (SNOMED CT-1)
373066001 (SNOMED CT-1)
Name of treatment
Item
Name of concomitant treatment
string
Concomitant Therapy (Code-1)
C1707479 (UMLS CUI-1)
C1707479 (UMLS CUI-1)
Item
Intent
integer
C1283828 (UMLS CUI-1)
367565008 (SNOMED CT-1)
Concomitant Therapy (Code-2)
C1707479 (UMLS CUI-2)
367565008 (SNOMED CT-1)
Concomitant Therapy (Code-2)
C1707479 (UMLS CUI-2)
CL Item
Prevention (Prophylaxis)
Prophylactic treatment (Code-1)
C0199176 (UMLS CUI-1)
129429009 (SNOMED CT-1)
10036898 (MedDRA-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)
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)
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)
C1531784 (UMLS CUI-1)
413947000 (SNOMED CT-1)
Concomitant Therapy (Code-2)
C1707479 (UMLS CUI-2)
Item
Ongoing
integer
Continue (Code-1)
C0750536 (UMLS CUI-1)
Study End Date (Code-2)
C2983670 (UMLS CUI-2)
Concomitant Therapy (Code-3)
C1707479 (UMLS CUI-3)
C0750536 (UMLS CUI-1)
Study End Date (Code-2)
C2983670 (UMLS CUI-2)
Concomitant Therapy (Code-3)
C1707479 (UMLS CUI-3)
CL Item
Yes (Yes)
C1298907 (UMLS CUI-1)
373066001 (SNOMED CT-1)
373066001 (SNOMED CT-1)
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)
C1960417 (UMLS CUI-1)
426146003 (SNOMED CT-1)
Total Dose
Item
Cumulative Dose
integer
C2986497 (UMLS CUI-1)
Was treatment delayed
Item
boolean
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)
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
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)
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
CL Item
Miligram per Meter squared (mg/m2)
Date started
Item
date
Date stopped
Item
date
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
CL Item
Miligram per Meter squared (mg/m2)
Date started
Item
date
Date stopped
Item
date
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)
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
CL Item
Miligram per Meter squared (mg/m2)
CL Item
Not Applicable (N/A)
Date started
Item
date
Date stopped
Item
date
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)
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
CL Item
Left (Left)
CL Item
Right (Right)
Total Dose
Item
integer
CL Item
Miligram per Meter squared (mg/m2)
Radiation Therapy Start Date
Item
date
Radiation Therapy End Date
Item
date
Did the patient receive surgery after recurrence of breast cancer or second primary malignancy of contralateral breast cancer
Item
relapse treatment - Operative Surgical Procedures
boolean
relapse treatment (Code-1)
C0679868 (UMLS CUI-1)
Operative Surgical Procedures (Code-2)
C0543467 (UMLS CUI-2)
387713003 (SNOMED CT-2)
10042609 (MedDRA-2)
MTHU007597 (LOINC-2)
C0679868 (UMLS CUI-1)
Operative Surgical Procedures (Code-2)
C0543467 (UMLS CUI-2)
387713003 (SNOMED CT-2)
10042609 (MedDRA-2)
MTHU007597 (LOINC-2)
Surgical site
Item
string
Surgery Date
Item
date
Metabolic/laboratory Other (Metabolic/Laboratory-Other (Specify))
Item
Laboratory Values
boolean
changed_datatype (Code-Info)
Other Metabolic and Laboratory Adverse Event (Code-1)
C1559945 (UMLS CUI-1)
MTHU117254 (CTCAE-1)
Other Metabolic and Laboratory Adverse Event (Code-1)
C1559945 (UMLS CUI-1)
MTHU117254 (CTCAE-1)
Renal/genitourinary Other (Renal/Genitourinary-Other (Specify))
Item
Gastrointestinal system
boolean
changed_datatype (Code-Info)
Adverse Event Associated with the Gastrointestinal System (Code-1)
C1559265 (UMLS CUI-1)
MTHU112146 (CTCAE-1)
Adverse Event Associated with the Gastrointestinal System (Code-1)
C1559265 (UMLS CUI-1)
MTHU112146 (CTCAE-1)
Niere/Blase
Item
Genitourinary system
boolean
changed_datatype (Code-Info)
Renal or Genitourinary Other Adverse Event (Code-1)
C1558061 (UMLS CUI-1)
MTHU117419 (CTCAE-1)
Renal or Genitourinary Other Adverse Event (Code-1)
C1558061 (UMLS CUI-1)
MTHU117419 (CTCAE-1)
Dermatology/skin Other (Dermatology/Skin-Other (Specify))
Item
Skin
boolean
changed_datatype (Code-Info)
Other Dermatology or Skin Adverse Event (Code-1)
C1559104 (UMLS CUI-1)
MTHU117246 (CTCAE-1)
Other Dermatology or Skin Adverse Event (Code-1)
C1559104 (UMLS CUI-1)
MTHU117246 (CTCAE-1)
Allergy/immunology Other (Allergy/Immunology-Other (Specify))
Item
Allergic Reaction
boolean
changed_datatype (Code-Info)
Adverse Event Associated with Allergy and Immunology (Code-1)
C1560126 (UMLS CUI-1)
MTHU112125 (CTCAE-1)
Adverse Event Associated with Allergy and Immunology (Code-1)
C1560126 (UMLS CUI-1)
MTHU112125 (CTCAE-1)
Pyrexia (Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L))
Item
Fever
boolean
changed_datatype (Code-Info)
Fever Without Neutropenia Adverse Event (Code-1)
C1556366 (UMLS CUI-1)
MTHU116933 (CTCAE-1)
Fever Without Neutropenia Adverse Event (Code-1)
C1556366 (UMLS CUI-1)
MTHU116933 (CTCAE-1)
Infection Nos (Infection-Other (Specify))
Item
Infection
boolean
changed_datatype (Code-Info)
Adverse Event Associated with Infection (Code-1)
C1556682 (UMLS CUI-1)
MTHU112135 (CTCAE-1)
Adverse Event Associated with Infection (Code-1)
C1556682 (UMLS CUI-1)
MTHU112135 (CTCAE-1)
Auditory/ear Other (Auditory/Ear-Other (Specify))
Item
Entire sensory organ
boolean
changed_datatype (Code-Info)
Adverse Event Associated with the Ear and Auditory System (Code-1)
C1560154 (UMLS CUI-1)
MTHU112144 (CTCAE-1)
Adverse Event Associated with the Ear and Auditory System (Code-1)
C1560154 (UMLS CUI-1)
MTHU112144 (CTCAE-1)
Constitutional Symptoms Other (Constitutional Symptoms-Other (Specify))
Item
General symptom
boolean
changed_datatype (Code-Info)
Adverse Event Associated with Constitutional Symptoms (Code-1)
C1556354 (UMLS CUI-1)
MTHU112129 (CTCAE-1)
Adverse Event Associated with Constitutional Symptoms (Code-1)
C1556354 (UMLS CUI-1)
MTHU112129 (CTCAE-1)
Pulmonary/upper Respiratory Other (Pulmonary/Upper Respiratory-Other (Specify))
Item
Lung/Larynx
boolean
changed_datatype (Code-Info)
Adverse Event Associated with Pulmonary and Upper Respiratory Systems (Code-1)
C1557628 (UMLS CUI-1)
MTHU112139 (CTCAE-1)
Adverse Event Associated with Pulmonary and Upper Respiratory Systems (Code-1)
C1557628 (UMLS CUI-1)
MTHU112139 (CTCAE-1)
Endocrine Other (Endocrine-Other (Specify))
Item
Endocrine system
boolean
changed_datatype (Code-Info)
Adverse Event Associated with the Endocrine System (Code-1)
C1559198 (UMLS CUI-1)
MTHU112145 (CTCAE-1)
Adverse Event Associated with the Endocrine System (Code-1)
C1559198 (UMLS CUI-1)
MTHU112145 (CTCAE-1)
Cardiac General Other (Cardiac General-Other (Specify))
Item
Cardiac General Other
boolean
changed_datatype (Code-Info)
Adverse Event Associated with the Heart in General (Code-1)
C1556247 (UMLS CUI-1)
MTHU112147 (CTCAE-1)
Adverse Event Associated with the Heart in General (Code-1)
C1556247 (UMLS CUI-1)
MTHU112147 (CTCAE-1)
Haemoglobin Decreased (Hemoglobin)
Item
Hemoglobin
boolean
changed_datatype (Code-Info)
Hemoglobin Adverse Event (Code-1)
C2239101 (UMLS CUI-1)
MTHU116997 (CTCAE-1)
Hemoglobin Adverse Event (Code-1)
C2239101 (UMLS CUI-1)
MTHU116997 (CTCAE-1)
Aspartate Aminotransferase Increased (AST, SGOT (serum glutamic oxaloacetic transaminase))
Item
Aspartate Transaminase
boolean
changed_datatype (Code-Info)
Serum Glutamic Oxaloacetic Transaminase Adverse Event (Code-1)
C1557198 (UMLS CUI-1)
MTHU117449 (CTCAE-1)
Serum Glutamic Oxaloacetic Transaminase Adverse Event (Code-1)
C1557198 (UMLS CUI-1)
MTHU117449 (CTCAE-1)
Alanine Aminotransferase Increased (ALT, SGPT (serum glutamic pyruvic transaminase))
Item
Alanine Transaminase
boolean
changed_datatype (Code-Info)
Serum Glutamic Pyruvic Transaminase Adverse Event (Code-1)
C1557189 (UMLS CUI-1)
MTHU117450 (CTCAE-1)
Serum Glutamic Pyruvic Transaminase Adverse Event (Code-1)
C1557189 (UMLS CUI-1)
MTHU117450 (CTCAE-1)
Blood Creatinine Increased (Creatinine)
Item
Creatinine
boolean
changed_datatype (Code-Info)
Creatinine Adverse Event (Code-1)
C1561535 (UMLS CUI-1)
MTHU116842 (CTCAE-1)
Creatinine Adverse Event (Code-1)
C1561535 (UMLS CUI-1)
MTHU116842 (CTCAE-1)
Neuralgia Nos (Pain - Neuralgia/peripheral nerve)
Item
Peripheral Nerves
boolean
changed_datatype (Code-Info)
Neuralgia and Peripheral Nerve Pain Adverse Event (Code-1)
C1557517 (UMLS CUI-1)
MTHU117196 (CTCAE-1)
Neuralgia and Peripheral Nerve Pain Adverse Event (Code-1)
C1557517 (UMLS CUI-1)
MTHU117196 (CTCAE-1)
Hemorrhage/bleeding Other (Hemorrhage/Bleeding-Other (Specify))
Item
Hemorrhage
boolean
changed_datatype (Code-Info)
Other Hemorrhage and Bleeding Adverse Event (Code-1)
C1556642 (UMLS CUI-1)
MTHU117250 (CTCAE-1)
Other Hemorrhage and Bleeding Adverse Event (Code-1)
C1556642 (UMLS CUI-1)
MTHU117250 (CTCAE-1)
Blood Bilirubin Increased (Bilirubin (hyperbilirubinemia))
Item
Bilirubin
boolean
changed_datatype (Code-Info)
Hyperbilirubinemia Adverse Event (Code-1)
C1557209 (UMLS CUI-1)
MTHU117008 (CTCAE-1)
Hyperbilirubinemia Adverse Event (Code-1)
C1557209 (UMLS CUI-1)
MTHU117008 (CTCAE-1)
Leucopenia Nos (Leukocytes (total WBC))
Item
Leukocytes
boolean
changed_datatype (Code-Info)
Leukocytes Adverse Event (Code-1)
C1560219 (UMLS CUI-1)
MTHU117099 (CTCAE-1)
Leukocytes Adverse Event (Code-1)
C1560219 (UMLS CUI-1)
MTHU117099 (CTCAE-1)
Blood Alkaline Phosphatase Nos Increased (Alkaline phosphatase)
Item
Alkaline Phosphatase
boolean
changed_datatype (Code-Info)
Alkaline Phosphatase Adverse Event (Code-1)
C1561546 (UMLS CUI-1)
MTHU112158 (CTCAE-1)
Alkaline Phosphatase Adverse Event (Code-1)
C1561546 (UMLS CUI-1)
MTHU112158 (CTCAE-1)
Proteinuria Present (Proteinuria)
Item
Proteinuria
boolean
changed_datatype (Code-Info)
Proteinuria Adverse Event (Code-1)
C1962972 (UMLS CUI-1)
MTHU117382 (CTCAE-1)
Proteinuria Adverse Event (Code-1)
C1962972 (UMLS CUI-1)
MTHU117382 (CTCAE-1)
Alopecia (Hair loss/Alopecia (scalp or body))
Item
Hair
boolean
changed_datatype (Code-Info)
Alopecia Adverse Event (Code-1)
C1559115 (UMLS CUI-1)
MTHU112161 (CTCAE-1)
Alopecia Adverse Event (Code-1)
C1559115 (UMLS CUI-1)
MTHU112161 (CTCAE-1)
Constipation (Constipation)
Item
Obstipation
boolean
changed_datatype (Code-Info)
Constipation Adverse Event (Code-1)
C1963087 (UMLS CUI-1)
MTHU116803 (CTCAE-1)
Constipation Adverse Event (Code-1)
C1963087 (UMLS CUI-1)
MTHU116803 (CTCAE-1)
Diarrhoea Nos (Diarrhea)
Item
Diarrhea
boolean
changed_datatype (Code-Info)
Diarrhea Adverse Event (Code-1)
C0232708 (UMLS CUI-1)
MTHU116856 (CTCAE-1)
Diarrhea Adverse Event (Code-1)
C0232708 (UMLS CUI-1)
MTHU116856 (CTCAE-1)
Haematuria Present (Hemorrhage, GU - Urinary NOS)
Item
Hematuria
boolean
changed_datatype (Code-Info)
C0018965 (UMLS CUI-1)
34436003 (SNOMED CT-1)
10018867 (MedDRA-1)
R31.9 (ICD-10-CM-1)
599.7 (ICD-9-CM-1)
E13000 (CTCAE-1)
C0018965 (UMLS CUI-1)
34436003 (SNOMED CT-1)
10018867 (MedDRA-1)
R31.9 (ICD-10-CM-1)
599.7 (ICD-9-CM-1)
E13000 (CTCAE-1)
Pain Other (Pain-Other (Specify))
Item
Pain
boolean
changed_datatype (Code-Info)
Other Pain Adverse Event (Code-1)
C1557623 (UMLS CUI-1)
MTHU117260 (CTCAE-1)
Other Pain Adverse Event (Code-1)
C1557623 (UMLS CUI-1)
MTHU117260 (CTCAE-1)
Platelet Count Decreased (Platelets)
Item
Blood Platelets
boolean
changed_datatype (Code-Info)
Platelets Adverse Event (Code-1)
C1963076 (UMLS CUI-1)
MTHU117353 (CTCAE-1)
Platelets Adverse Event (Code-1)
C1963076 (UMLS CUI-1)
MTHU117353 (CTCAE-1)
Nausea (Nausea)
Item
Nausea
boolean
changed_datatype (Code-Info)
Nausea Adverse Event (Code-1)
C1963179 (UMLS CUI-1)
MTHU117189 (CTCAE-1)
Nausea Adverse Event (Code-1)
C1963179 (UMLS CUI-1)
MTHU117189 (CTCAE-1)
Arrhythmia Nos (Cardiac Arrhythmia-Other (Specify))
Item
Heart Rhythm
boolean
changed_datatype (Code-Info)
Adverse Event Associated with Cardiac Arrhythmia (Code-1)
C1560249 (UMLS CUI-1)
MTHU112127 (CTCAE-1)
Adverse Event Associated with Cardiac Arrhythmia (Code-1)
C1560249 (UMLS CUI-1)
MTHU112127 (CTCAE-1)
Pericarditis (Pericarditis)
Item
Pericarditis
boolean
changed_datatype (Code-Info)
Pericarditis Adverse Event (Code-1)
C1963211 (UMLS CUI-1)
MTHU117310 (CTCAE-1)
Pericarditis Adverse Event (Code-1)
C1963211 (UMLS CUI-1)
MTHU117310 (CTCAE-1)
Depressed Level Of Consciousness (Somnolence/depressed level of consciousness)
Item
Conscious
boolean
changed_datatype (Code-Info)
Somnolence and Depressed Level of Consciousness Adverse Event (Code-1)
C1557290 (UMLS CUI-1)
MTHU117503 (CTCAE-1)
Somnolence and Depressed Level of Consciousness Adverse Event (Code-1)
C1557290 (UMLS CUI-1)
MTHU117503 (CTCAE-1)
Dyspnoea Nos (Dyspnea (shortness of breath))
Item
Dyspnea
boolean
changed_datatype (Code-Info)
Dyspnea Adverse Event (Code-1)
C1963100 (UMLS CUI-1)
MTHU116873 (CTCAE-1)
Dyspnea Adverse Event (Code-1)
C1963100 (UMLS CUI-1)
MTHU116873 (CTCAE-1)
Cystitis (Cystitis)
Item
Cystitis
boolean
changed_datatype (Code-Info)
Cystitis Adverse Event (Code-1)
C1963088 (UMLS CUI-1)
MTHU116844 (CTCAE-1)
Cystitis Adverse Event (Code-1)
C1963088 (UMLS CUI-1)
MTHU116844 (CTCAE-1)
Vomiting Nos (Vomiting)
Item
Erbrechen
boolean
changed_datatype (Code-Info)
Vomiting Adverse Event (Code-1)
C1963281 (UMLS CUI-1)
MTHU117700 (CTCAE-1)
Vomiting Adverse Event (Code-1)
C1963281 (UMLS CUI-1)
MTHU117700 (CTCAE-1)
1024 more adverse events
Item
1024 more adverse events
integer
SAE reported
Item
boolean
CTCAE Begin Date
Item
date
CTCAE End Date
Item
date
CTC Adverse Event Grade
Item
CTC Adverse Event Grade
integer
Adverse Event Grade Code (Code-1)
C2985911 (UMLS CUI-1)
C2985911 (UMLS CUI-1)
CL Item
Adverse Event Is Resolved (resolved)
CL Item
Adverse Event Has Improved (improved)
CL Item
Adverse Event Is Ongoing (ongoing)
CL Item
Adverse Event Is Resolved With Sequelae (resolved with sequelae)
CL Item
Adverse Event Was Fatal (fatal)
CL Item
Protocol Treatment Was Discontinued As A Result Of The Adverse Event (protocol treatment discontinued)
CL Item
Study Dose Was Reduced As A Result Of The Adverse Event (study dose reduced)
CL Item
There Was No Action Taken Based On The Adverse Event (none)
CL Item
Protocol Treatment Was Delayed As A Result Of The Adverse Event (protocol treatment delayed)
CL Item
Other Treatment Was Required As A Result Of The Adverse Event (other treatment required)
relation to study drug
Item
boolean
Item Group
Second Primary Malignancy and Contralateral Breast Cancer
Type of recurrence
Item
Recurrence Tumor
string
Recurrent Malignant Neoplasm (Code-1)
C0549379 (UMLS CUI-1)
10038111 (SNOMED CT-1)
C0549379 (UMLS CUI-1)
10038111 (SNOMED CT-1)
Date of First Recurrence or Progression
Item
date
Item
Medical Examination
integer
C0582103 (UMLS CUI-1)
225886003 (SNOMED CT-1)
Recurrent Malignant Neoplasm (Code-2)
C0549379 (UMLS CUI-2)
10038111 (SNOMED CT-2)
225886003 (SNOMED CT-1)
Recurrent Malignant Neoplasm (Code-2)
C0549379 (UMLS CUI-2)
10038111 (SNOMED CT-2)
CL Item
Physical Examination (Clinical)
CL Item
Radiology (Radiological)
Diagnostic radiologic examination (Code-1)
C0043299 (UMLS CUI-1)
363680008 (SNOMED CT-1)
C0043299 (UMLS CUI-1)
363680008 (SNOMED CT-1)
Biopsy
Item
Biopsy
boolean
Biopsy (Code-1)
C0005558 (UMLS CUI-1)
86273004 (SNOMED CT-1)
10004720 (MedDRA-1)
MTHU028106 (LOINC-1)
Recurrent Malignant Neoplasm (Code-2)
C0549379 (UMLS CUI-2)
10038111 (SNOMED CT-2)
C0005558 (UMLS CUI-1)
86273004 (SNOMED CT-1)
10004720 (MedDRA-1)
MTHU028106 (LOINC-1)
Recurrent Malignant Neoplasm (Code-2)
C0549379 (UMLS CUI-2)
10038111 (SNOMED CT-2)
Biopsy Date
Item
Biopsy Date
date
Biopsy (Code-1)
C0005558 (UMLS CUI-1)
86273004 (SNOMED CT-1)
10004720 (MedDRA-1)
MTHU028106 (LOINC-1)
Date in time (Code-2)
C0011008 (UMLS CUI-2)
410671006 (SNOMED CT-2)
MTHU021546 (LOINC-2)
Recurrent Malignant Neoplasm (Code-3)
C0549379 (UMLS CUI-3)
10038111 (SNOMED CT-3)
C0005558 (UMLS CUI-1)
86273004 (SNOMED CT-1)
10004720 (MedDRA-1)
MTHU028106 (LOINC-1)
Date in time (Code-2)
C0011008 (UMLS CUI-2)
410671006 (SNOMED CT-2)
MTHU021546 (LOINC-2)
Recurrent Malignant Neoplasm (Code-3)
C0549379 (UMLS CUI-3)
10038111 (SNOMED CT-3)
Specify other Histologic Type
Item
histologic type
string
Histologic Type (Code-1)
C0449574 (UMLS CUI-1)
263541007 (SNOMED CT-1)
MTHU020048 (LOINC-1)
Recurrent Malignant Neoplasm (Code-2)
C0549379 (UMLS CUI-2)
10038111 (SNOMED CT-2)
C0449574 (UMLS CUI-1)
263541007 (SNOMED CT-1)
MTHU020048 (LOINC-1)
Recurrent Malignant Neoplasm (Code-2)
C0549379 (UMLS CUI-2)
10038111 (SNOMED CT-2)
Date of Physical Exam
Item
Physical Examination
date
C0031809 (UMLS CUI-1)
5880005 (SNOMED CT-1)
10034986 (MedDRA-1)
MTHU028014 (LOINC-1)
Date in time (Code-2)
C0011008 (UMLS CUI-2)
410671006 (SNOMED CT-2)
MTHU021546 (LOINC-2)
5880005 (SNOMED CT-1)
10034986 (MedDRA-1)
MTHU028014 (LOINC-1)
Date in time (Code-2)
C0011008 (UMLS CUI-2)
410671006 (SNOMED CT-2)
MTHU021546 (LOINC-2)
Not done
Item
Not done
string
Not Done (Code-1)
C1272696 (UMLS CUI-1)
385660001 (SNOMED CT-1)
C1272696 (UMLS CUI-1)
385660001 (SNOMED CT-1)
Are there any changes since the previous assessment
Item
boolean
Code List
Are there any changes since the previous assessment
CL Item
Recurrence Of Disease (Recurrence of disease)
Recurrent Malignant Neoplasm (Code-1)
C0549379 (UMLS CUI-1)
10038111 (MedDRA-1)
C0549379 (UMLS CUI-1)
10038111 (MedDRA-1)
CL Item
Second Primary Malignancy Or Contralateral Breast Cancer (Second primary malignancy or contralateral breast cancer)
Secondary Malignant Neoplasm (Code-1)
C0751623 (UMLS CUI-1)
10039801 (MedDRA-1)
C0751623 (UMLS CUI-1)
10039801 (MedDRA-1)
CL Item
Significant Cardiac Disease (Significant cardiac disease)
Heart Diseases (Code-1)
C0018799 (UMLS CUI-1)
56265001 (SNOMED CT-1)
10061024 (MedDRA-1)
I51.9 (ICD-10-CM-1)
429.9 (ICD-9-CM-1)
C0018799 (UMLS CUI-1)
56265001 (SNOMED CT-1)
10061024 (MedDRA-1)
I51.9 (ICD-10-CM-1)
429.9 (ICD-9-CM-1)
CL Item
Adverse Event (Adverse Event)
CL Item
Patient died (Death )
Patient died (finding) (Code-1)
C1306577 (UMLS CUI-1)
397709008 (SNOMED CT-1)
10011906 (MedDRA-1)
C1306577 (UMLS CUI-1)
397709008 (SNOMED CT-1)
10011906 (MedDRA-1)
CL Item
Lost to follow up (Lost To Follow-up)
Lost To Follow-up (Code-1)
C1302313 (UMLS CUI-1)
399307001 (SNOMED CT-1)
C1302313 (UMLS CUI-1)
399307001 (SNOMED CT-1)
CL Item
Patient Withdrew Study Consent (Patient withdrew study consent)
Consent Withdrawn (Code-1)
C1707492 (UMLS CUI-1)
C1707492 (UMLS CUI-1)
Date of last contact
Item
Date last contact
date
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)
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)
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)
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)
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)
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)
C1827926 (UMLS CUI-1)
423409001 (SNOMED CT-1)
Blood Pressure, systolic
Item
Systolic Blood Pressure
integer
Systolic Blood Pressure (Code-1)
C0871470 (UMLS CUI-1)
271649006 (SNOMED CT-1)
C0871470 (UMLS CUI-1)
271649006 (SNOMED CT-1)
Blood Pressure, diastolic
Item
Diastolic Blood Pressure
integer
Diastolic Blood Pressure (Code-1)
C0428883 (UMLS CUI-1)
271650006 (SNOMED CT-1)
C0428883 (UMLS CUI-1)
271650006 (SNOMED CT-1)
Date of LVEF
Item
Date Left Ventricular Ejection Fraction
date
Left Ventricular Ejection Fraction (Code-1)
CL433348 (UMLS CUI-1)
Date in time (Code-2)
C0011008 (UMLS CUI-2)
410671006 (SNOMED CT-2)
MTHU021546 (LOINC-2)
CL433348 (UMLS CUI-1)
Date in time (Code-2)
C0011008 (UMLS CUI-2)
410671006 (SNOMED CT-2)
MTHU021546 (LOINC-2)
LVEF
Item
Left Ventricular Ejection Fraction
string
Left Ventricular Ejection Fraction (Code-1)
CL433348 (UMLS CUI-1)
CL433348 (UMLS CUI-1)
Echocardiogram
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)
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)
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)
C1274040 (UMLS CUI-1)
394617004 (SNOMED CT-1)
Left Ventricular Ejection Fraction (Code-2)
CL433348 (UMLS CUI-2)
CL Item
Normal (Normal)
Normal (Code-1)
C0205307 (UMLS CUI-1)
17621005 (SNOMED CT-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)
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)
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
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
Mammogram
integer
Mammography (Code-1)
C0024671 (UMLS CUI-1)
71651007 (SNOMED CT-1)
10026735 (MedDRA-1)
C0024671 (UMLS CUI-1)
71651007 (SNOMED CT-1)
10026735 (MedDRA-1)
CL Item
Right (Right)
C0205090 (UMLS CUI-1)
24028007 (SNOMED CT-1)
24028007 (SNOMED CT-1)
CL Item
Left (Left)
C0205091 (UMLS CUI-1)
7771000 (SNOMED CT-1)
7771000 (SNOMED CT-1)
CL Item
Bilateral (Bilateral)
C0238767 (UMLS CUI-1)
51440002 (SNOMED CT-1)
51440002 (SNOMED CT-1)
Date of Test
Item
Date of Test
date
Mammography (Code-1)
C0024671 (UMLS CUI-1)
71651007 (SNOMED CT-1)
10026735 (MedDRA-1)
Date in time (Code-2)
C0011008 (UMLS CUI-2)
410671006 (SNOMED CT-2)
MTHU021546 (LOINC-2)
C0024671 (UMLS CUI-1)
71651007 (SNOMED CT-1)
10026735 (MedDRA-1)
Date in time (Code-2)
C0011008 (UMLS CUI-2)
410671006 (SNOMED CT-2)
MTHU021546 (LOINC-2)
Not done
Item
Not done
string
Not Done (Code-1)
C1272696 (UMLS CUI-1)
385660001 (SNOMED CT-1)
C1272696 (UMLS CUI-1)
385660001 (SNOMED CT-1)
Are there any clinically significant abnormalites
Item
boolean
specify
Item
string
Date of blood specimen collection
Item
date
CL Item
Normal (Normal)
CL Item
Abnormal - Clinically significant (Abnormal - Clinically significant)
CL Item
Abnormal - Not clinically significant (Abnormal - Not clinically significant)
Item
Vital status
integer
CL Item
Alive (Alive)
Alive (finding) (Code-1)
C2584946 (UMLS CUI-1)
438949009 (SNOMED CT-1)
C2584946 (UMLS CUI-1)
438949009 (SNOMED CT-1)
CL Item
Dead (Dead)
Patient died (finding) (Code-1)
C1306577 (UMLS CUI-1)
397709008 (SNOMED CT-1)
10011906 (MedDRA-1)
C1306577 (UMLS CUI-1)
397709008 (SNOMED CT-1)
10011906 (MedDRA-1)
CL Item
Lost to follow up (Lost To Follow-up)
Lost To Follow-up (Code-1)
C1302313 (UMLS CUI-1)
399307001 (SNOMED CT-1)
C1302313 (UMLS CUI-1)
399307001 (SNOMED CT-1)
Dead
Item
Dead
date
Date of death (Code-1)
C1148348 (UMLS CUI-1)
399753006 (SNOMED CT-1)
MTHU014693 (LOINC-1)
Date last contact (Code-2)
C0805839 (UMLS CUI-2)
MTHU010432 (LOINC-2)
C1148348 (UMLS CUI-1)
399753006 (SNOMED CT-1)
MTHU014693 (LOINC-1)
Date last contact (Code-2)
C0805839 (UMLS CUI-2)
MTHU010432 (LOINC-2)
Date of last contact
Item
Date of last contact
date
extended_coding (Code-Info)
Date last contact (Code-1)
C0805839 (UMLS CUI-1)
MTHU010432 (LOINC-1)
Date last contact (Code-2)
C0805839 (UMLS CUI-2)
MTHU010432 (LOINC-2)
Date last contact (Code-1)
C0805839 (UMLS CUI-1)
MTHU010432 (LOINC-1)
Date last contact (Code-2)
C0805839 (UMLS CUI-2)
MTHU010432 (LOINC-2)
Investigator Signature
Item
Investigator Signature
string
Investigator Signature (Code-1)
C2346576 (UMLS CUI-1)
C2346576 (UMLS CUI-1)
Date
Item
Date
date
Date in time (Code-1)
C0011008 (UMLS CUI-1)
410671006 (SNOMED CT-1)
MTHU021546 (LOINC-1)
Investigator Signature (Code-2)
C2346576 (UMLS CUI-2)
C0011008 (UMLS CUI-1)
410671006 (SNOMED CT-1)
MTHU021546 (LOINC-1)
Investigator Signature (Code-2)
C2346576 (UMLS CUI-2)
CL Item
not_useful_for_research (Yes)
CL Item
not_useful_for_research (No)
CL Item
not_useful_for_research (Not Applicable)
CL Item
not_useful_for_research (Yes)
CL Item
not_useful_for_research (No)
CL Item
not_useful_for_research (Not Applicable)
CL Item
not_useful_for_research (Yes)
CL Item
not_useful_for_research (No)
CL Item
not_useful_for_research (Not Applicable)
Item
Reasons for treatment discontinuation
integer
Discontinue (Code-1)
C1444662 (UMLS CUI-1)
410546004 (SNOMED CT-1)
Indication of (contextual qualifier) (Code-2)
C0392360 (UMLS CUI-2)
410666004 (SNOMED CT-2)
MTHU008319 (LOINC-2)
Therapeutic procedure (Code-3)
C0087111 (UMLS CUI-3)
277132007 (SNOMED CT-3)
10053757 (MedDRA-3)
MTHU008880 (LOINC-3)
C1444662 (UMLS CUI-1)
410546004 (SNOMED CT-1)
Indication of (contextual qualifier) (Code-2)
C0392360 (UMLS CUI-2)
410666004 (SNOMED CT-2)
MTHU008319 (LOINC-2)
Therapeutic procedure (Code-3)
C0087111 (UMLS CUI-3)
277132007 (SNOMED CT-3)
10053757 (MedDRA-3)
MTHU008880 (LOINC-3)
CL Item
Adverse Event (Adverse Event)
CL Item
Protocol Violation (Protocol violation)
Protocol Violation (Code-1)
C1709750 (UMLS CUI-1)
C1709750 (UMLS CUI-1)
CL Item
Subject Decided To Withdraw From Investigational Product But Is Continuing To Be Followed Per Protocol (Subject decided to withdraw from investigational product but is continuing to be followed per protocol)
CL Item
Subject Decided To Withdraw From The Study (Subject decided to withdraw from the study)
CL Item
Recurrence of disease (Recurrence of disease)
extended_coding (Code-Info)
Recurrent Malignant Neoplasm (Code-1)
C0549379 (UMLS CUI-1)
10038111 (MedDRA-1)
Recurrent Malignant Neoplasm (Code-1)
C0549379 (UMLS CUI-1)
10038111 (MedDRA-1)
CL Item
second primary malignancy (second primary malignancy)
extended_coding (Code-Info)
Secondary Malignant Neoplasm (Code-1)
C0751623 (UMLS CUI-1)
10039801 (MedDRA-1)
Secondary Malignant Neoplasm (Code-1)
C0751623 (UMLS CUI-1)
10039801 (MedDRA-1)
CL Item
contralateral breast cancer (contralateral breast cancer)
extended_coding (Code-Info)
Contralateral Breast Carcinoma (Code-1)
CL433171 (UMLS CUI-1)
Contralateral Breast Carcinoma (Code-1)
CL433171 (UMLS CUI-1)
CL Item
Death (Death )
Patient died (finding) (Code-1)
C1306577 (UMLS CUI-1)
397709008 (SNOMED CT-1)
10011906 (MedDRA-1)
C1306577 (UMLS CUI-1)
397709008 (SNOMED CT-1)
10011906 (MedDRA-1)
CL Item
Lost To Follow-up: C48227 (Lost to follow-up)
Lost To Follow-up (Code-1)
C1302313 (UMLS CUI-1)
399307001 (SNOMED CT-1)
C1302313 (UMLS CUI-1)
399307001 (SNOMED CT-1)
Date of last contact within treatment period
Item
Date of last contact within treatment period
date
Date last contact (Code-1)
C0805839 (UMLS CUI-1)
MTHU010432 (LOINC-1)
Therapeutic procedure (Code-2)
C0087111 (UMLS CUI-2)
277132007 (SNOMED CT-2)
10053757 (MedDRA-2)
MTHU008880 (LOINC-2)
Period (Code-3)
C1948053 (UMLS CUI-3)
C0805839 (UMLS CUI-1)
MTHU010432 (LOINC-1)
Therapeutic procedure (Code-2)
C0087111 (UMLS CUI-2)
277132007 (SNOMED CT-2)
10053757 (MedDRA-2)
MTHU008880 (LOINC-2)
Period (Code-3)
C1948053 (UMLS CUI-3)
CRF Page Number
Item
integer
Comments
Item
Comments
string
Comment (Code-1)
C0947611 (UMLS CUI-1)
Therapeutic procedure (Code-2)
C0087111 (UMLS CUI-2)
277132007 (SNOMED CT-2)
10053757 (MedDRA-2)
MTHU008880 (LOINC-2)
C0947611 (UMLS CUI-1)
Therapeutic procedure (Code-2)
C0087111 (UMLS CUI-2)
277132007 (SNOMED CT-2)
10053757 (MedDRA-2)
MTHU008880 (LOINC-2)
Investigator Signature
Item
Investigator Signature
string
Investigator Signature (Code-1)
C2346576 (UMLS CUI-1)
C2346576 (UMLS CUI-1)
Date
Item
Date
date
Investigator Signature (Code-1)
C2346576 (UMLS CUI-1)
Date in time (Code-2)
C0011008 (UMLS CUI-2)
410671006 (SNOMED CT-2)
MTHU021546 (LOINC-2)
C2346576 (UMLS CUI-1)
Date in time (Code-2)
C0011008 (UMLS CUI-2)
410671006 (SNOMED CT-2)
MTHU021546 (LOINC-2)
Date of Death
Item
Date of death
date
Item
Cause of death
integer
Cause of Death (Code-1)
C0007465 (UMLS CUI-1)
184305005 (SNOMED CT-1)
C0007465 (UMLS CUI-1)
184305005 (SNOMED CT-1)
CL Item
Breast Cancer Progression (Breast cancer progression)
Tumor Progression (Code-1)
C0178874 (UMLS CUI-1)
419835002 (SNOMED CT-1)
C0178874 (UMLS CUI-1)
419835002 (SNOMED CT-1)
CL Item
Adverse Event During Study (Adverse event during study)
Adverse event (Code-1)
C0877248 (UMLS CUI-1)
10060933 (MedDRA-1)
MTHU014542 (LOINC-1)
Clinical Trials (Code-2)
C0008976 (UMLS CUI-2)
110465008 (SNOMED CT-2)
During (Code-3)
C0347984 (UMLS CUI-3)
371881003 (SNOMED CT-3)
C0877248 (UMLS CUI-1)
10060933 (MedDRA-1)
MTHU014542 (LOINC-1)
Clinical Trials (Code-2)
C0008976 (UMLS CUI-2)
110465008 (SNOMED CT-2)
During (Code-3)
C0347984 (UMLS CUI-3)
371881003 (SNOMED CT-3)
CL Item
Adverse Event During Treatment Given After Recurrence (Adverse event during treatment given after recurrence)
Adverse event (Code-1)
C0877248 (UMLS CUI-1)
10060933 (MedDRA-1)
MTHU014542 (LOINC-1)
Therapeutic procedure (Code-2)
C0087111 (UMLS CUI-2)
277132007 (SNOMED CT-2)
10053757 (MedDRA-2)
MTHU008880 (LOINC-2)
During (Code-3)
C0347984 (UMLS CUI-3)
371881003 (SNOMED CT-3)
Recurrent Malignant Neoplasm (Code-4)
C0549379 (UMLS CUI-4)
10038111 (MedDRA-4)
C0877248 (UMLS CUI-1)
10060933 (MedDRA-1)
MTHU014542 (LOINC-1)
Therapeutic procedure (Code-2)
C0087111 (UMLS CUI-2)
277132007 (SNOMED CT-2)
10053757 (MedDRA-2)
MTHU008880 (LOINC-2)
During (Code-3)
C0347984 (UMLS CUI-3)
371881003 (SNOMED CT-3)
Recurrent Malignant Neoplasm (Code-4)
C0549379 (UMLS CUI-4)
10038111 (MedDRA-4)
CL Item
Malignant Disease Other Than Breast Cancer (Malignant disease other than breast cancer)
Malignant Neoplasms (Code-1)
C0006826 (UMLS CUI-1)
363346000 (SNOMED CT-1)
10028997 (MedDRA-1)
MTHU010328 (LOINC-1)
C00-C96 (ICD-10-CM-1)
Other (Code-2)
C0205394 (UMLS CUI-2)
74964007 (SNOMED CT-2)
C0006826 (UMLS CUI-1)
363346000 (SNOMED CT-1)
10028997 (MedDRA-1)
MTHU010328 (LOINC-1)
C00-C96 (ICD-10-CM-1)
Other (Code-2)
C0205394 (UMLS CUI-2)
74964007 (SNOMED CT-2)
CL Item
other cause of death (Other)
Other (Code-1)
C0205394 (UMLS CUI-1)
74964007 (SNOMED CT-1)
C0205394 (UMLS CUI-1)
74964007 (SNOMED CT-1)
specify
Item
other cause of death
string
Other (Code-1)
C0205394 (UMLS CUI-1)
74964007 (SNOMED CT-1)
Cause of Death (Code-2)
C0007465 (UMLS CUI-2)
184305005 (SNOMED CT-2)
C0205394 (UMLS CUI-1)
74964007 (SNOMED CT-1)
Cause of Death (Code-2)
C0007465 (UMLS CUI-2)
184305005 (SNOMED CT-2)
Item
Was autopsy performed
integer
Autopsy (Code-1)
29240004 (SNOMED CT-1)
10050117 (MedDRA-1)
89.8 (ICD-10-CM-1)
C0004398 (UMLS CUI)
29240004 (SNOMED CT-1)
10050117 (MedDRA-1)
89.8 (ICD-10-CM-1)
C0004398 (UMLS CUI)
CL Item
unknown (0)
CL Item
No (2)
CL Item
Yes (1)
Please summarize findings
Item
string