Information:
Fel:
ID
44162
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
Nyckelord
Versioner (7)
- 2014-03-19 2014-03-19 - Martin Dugas
- 2014-08-09 2014-08-09 - Martin Dugas
- 2015-06-02 2015-06-02 -
- 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
20 september 2021
DOI
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Licens
Creative Commons BY-NC 3.0 Legacy
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ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D
study documentation
- StudyEvent: study documentation
Similar models
study documentation
- StudyEvent: study documentation
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Pre-Registration Eligibility Checklist - Cover Sheet/Demographics (N063D)
NCCTG Study No
Item
Studie Nr.
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
Labor Nr
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
Institutions-Nr.
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
Patienteninitialien
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
Gruppen-Protokoll Nr.
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
Gruppen-Code
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 Titel
string
Study Protocol (Code-1)
C2348563 (UMLS CUI-1)
C2348563 (UMLS CUI-1)
Patient Medical Record Number
Item
Nr. Krankenakte
string
Participating Group Code
Item
Gruppen-Code Teilnehmer
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
veränderte Daten
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
Registrierungs-Typ
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
erste Einreichung (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
zweite Einrichung (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
erste Einreichung
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
(1)
CL Item
(2)
Last Name
Item
Nachname
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
Vorname
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
Telefon
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
(1)
CL Item
(2)
CL Item
(3)
Date of Birth
Item
Patienten-Geburtsdatum
date
C0421451 (UMLS CUI-1)
184099003 (SNOMED CT-1)
184099003 (SNOMED CT-1)
ZIP Code
Item
Postleitzahl Patient
integer
C0421454 (UMLS CUI-1)
184102003 (SNOMED CT-1)
Patient address (Code-2)
C0421449 (UMLS CUI-2)
184097001 (SNOMED CT-2)
184102003 (SNOMED CT-1)
Patient address (Code-2)
C0421449 (UMLS CUI-2)
184097001 (SNOMED CT-2)
Country of Residence
Item
Wohnort
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
Rasse
integer
CL Item
Kaukasier (White)
Caucasoid Race (Code-1)
C0007457 (UMLS CUI-1)
413773004 (SNOMED CT-1)
C0007457 (UMLS CUI-1)
413773004 (SNOMED CT-1)
CL Item
Afroamerikaner (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
Pazifikinsulaner (Native Hawaiian or other Pacific Islander)
Pacific Island Americans (Code-1)
C0242191 (UMLS CUI-1)
C0242191 (UMLS CUI-1)
CL Item
Asiate (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
amerikaner Ureinwohner (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
Nicht berichtet (Not Reported)
Not Stated (Code-1)
C1706613 (UMLS CUI-1)
C1706613 (UMLS CUI-1)
CL Item
Unbekannt (Unknown)
Unknown (Code-1)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-1)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-1)
Item
Ethnische Gruppe
integer
Ethnic group (Code-1)
C0015031 (UMLS CUI-1)
364699009 (SNOMED CT-1)
C0015031 (UMLS CUI-1)
364699009 (SNOMED CT-1)
CL Item
keine Hispanoamerikanische Herkunft (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
Hispanoamerikanische Herkunft (HISPANIC OR LATINO)
CL Item
Nicht berichtet (Not reported)
Not Stated (Code-1)
C1706613 (UMLS CUI-1)
C1706613 (UMLS CUI-1)
CL Item
Unbekannt (Unknown)
Unknown (Code-1)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-1)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-1)
Item
Einschlusskriterien
integer
Inclusion Criteria (Code-1)
C1512693 (UMLS CUI-1)
C1512693 (UMLS CUI-1)
CL Item
Alter >= 18 (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)
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)
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
Hormon Rezeptor Status (Östrogen/Progesteron oder Östrogen alleine) (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)
CL Item
nicht metastasiertes operables Mamma-Karzinom (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
Her2Neu positives Mamma-Karzinom (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
Einverständniserklärung unterschrieben (Signed written informed consent)
Informed consent obtained (Code-1)
C0514044 (UMLS CUI-1)
C0514044 (UMLS CUI-1)
Item
Ausschlusskriterien
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)
CL Item
klinisches T4 Stadium (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 (see list in instructions))
CL Item
(Any prior mediastinal irradiation except internal mammary node irradiation for the present)
CL Item
beidseitige Tumoren (Bilateral tumors)
Bilateral Breast Carcinoma (Code-1)
C0281267 (UMLS CUI-1)
C0281267 (UMLS CUI-1)
CL Item
(Concomitant use of CYP3A4 inhibitors or inducers)
CL Item
(Concurrent anti-cancer treatment in another investigational trial with hormone therapy or immunotherapy)
CL Item
gleichzeitige Tumor-Therapie, außer Hormontherapie (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
Mammakarzinom in der Vorgeschichte (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)
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)
CL Item
multifokaler Tumor (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)
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)
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)
CL Item
Schwanger oder stillende Frau (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)
CL Item
(Serious cardiac illness or medical conditions (including...))
CL Item
(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)
Date of Randomization
Item
date
CL Item
(Trastuzumab alone)
CL Item
(Lapatinib alone)
CL Item
(Trastuzumab followed by Lapatinib)
CL Item
(Lapatinib in combination with Trastuzumab)
Date Informed consent signed
Item
Datum Einverstädniserklärung
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
Datum Einverstädniserklärung für Pharmakogenetische Tests
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
Datum Einverstädniserklärung für Blutproben
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
Datum Einverstädniserklärung für Tumorgewebe
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
Datum Einverstädniserklärung für zusätzliche Blutproben
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
Datum Einverstädniserklärung für gefrorene Proben
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
Menopausenstatus
integer
Menopause finding (finding) (Code-1)
C0455962 (UMLS CUI-1)
276477006 (SNOMED CT-1)
C0455962 (UMLS CUI-1)
276477006 (SNOMED CT-1)
CL Item
Prämenopause (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
Postmenopause (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
Kategorien nicht anwendbar, Alter unter 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
Kategorien nicht anwendbar, älter als 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
Datum letzte Menstruation
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
Datum Schwangerschaftstest
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
Schwangerschaftstest
integer
Pregnancy Tests (Code-1)
C0032976 (UMLS CUI-1)
74036000 (SNOMED CT-1)
10036572 (MedDRA-1)
C0032976 (UMLS CUI-1)
74036000 (SNOMED CT-1)
10036572 (MedDRA-1)
CL Item
positiv (positive)
Positive Finding (Code-1)
C1446409 (UMLS CUI-1)
10828004 (SNOMED CT-1)
C1446409 (UMLS CUI-1)
10828004 (SNOMED CT-1)
CL Item
negativ (negative)
Negative Finding (Code-1)
C0205160 (UMLS CUI-1)
260385009 (SNOMED CT-1)
C0205160 (UMLS CUI-1)
260385009 (SNOMED CT-1)
CL Item
nicht anwendbar (not applicable, not female of child-bearing potential)
None or Not Applicable (Code-1)
CL413952 (UMLS CUI-1)
CL413952 (UMLS CUI-1)
Has the patient had a hysterectomy?
Item
Hatte die Patientin eine Hysterektomie?
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
Datum Hysterektomie
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
Einseitige Ovarektomie
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
Seite Ovarektomie
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
rechts (Right)
C0205090 (UMLS CUI-1)
24028007 (SNOMED CT-1)
24028007 (SNOMED CT-1)
CL Item
links (Left)
C0205091 (UMLS CUI-1)
7771000 (SNOMED CT-1)
7771000 (SNOMED CT-1)
Unilateral oophorectomy Date
Item
Datum Einseitige Ovarektomie
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
Datum körperliche Untersuchung
date
Physical Examination Date (Code-1)
C2826643 (UMLS CUI-1)
C2826643 (UMLS CUI-1)
Item
körperliche Untersuchung
integer
CL Item
unauffällig (Normal)
Normal (Code-1)
C0205307 (UMLS CUI-1)
17621005 (SNOMED CT-1)
C0205307 (UMLS CUI-1)
17621005 (SNOMED CT-1)
CL Item
auffällig, klinisch signifikant (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
auffällig, klinisch nicht signifikant (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
Größe
integer
cm (Item-Info)
Length of body (observable entity) (Code-1)
C0005890 (UMLS CUI-1)
248334005 (SNOMED CT-1)
Length of body (observable entity) (Code-1)
C0005890 (UMLS CUI-1)
248334005 (SNOMED CT-1)
Weight
Item
Körpergewicht
integer
kg (Item-Info)
Body Weight (Code-1)
C0005910 (UMLS CUI-1)
27113001 (SNOMED CT-1)
MTHU001885 (LOINC-1)
Body Weight (Code-1)
C0005910 (UMLS CUI-1)
27113001 (SNOMED CT-1)
MTHU001885 (LOINC-1)
BSA
Item
Körperoberfläche
integer
m^2 (Item-Info)
Body Surface Area (Code-1)
C0005902 (UMLS CUI-1)
301898006 (SNOMED CT-1)
10050311 (MedDRA-1)
Body Surface Area (Code-1)
C0005902 (UMLS CUI-1)
301898006 (SNOMED CT-1)
10050311 (MedDRA-1)
Blood Pressure, systolic
Item
Systolischer Blutdruck
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
Diastolischer Blutdruck
integer
Diastolic Blood Pressure (Code-1)
C0428883 (UMLS CUI-1)
271650006 (SNOMED CT-1)
C0428883 (UMLS CUI-1)
271650006 (SNOMED CT-1)
Heart Rate
Item
Herzfrequenz
integer
beats/min (Item-Info)
heart rate (Code-1)
C0018810 (UMLS CUI-1)
364075005 (SNOMED CT-1)
10019299 (MedDRA-1)
MTHU003114 (LOINC-1)
heart rate (Code-1)
C0018810 (UMLS CUI-1)
364075005 (SNOMED CT-1)
10019299 (MedDRA-1)
MTHU003114 (LOINC-1)
CL Item
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
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
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
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
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
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
(1)
CL Item
(2)
CL Item
(3)
Date of LVEF
Item
Datum Linksventrikuläre Ejektionsfraktion
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
Linksventrikuläre Ejektionsfraktion
string
Left Ventricular Ejection Fraction (Code-1)
CL433348 (UMLS CUI-1)
CL433348 (UMLS CUI-1)
Echocardiogramm
Item
Echokardiographie
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
Radionuklidventrikulographie
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
Ergebnis
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
unauffällig (Normal)
Normal (Code-1)
C0205307 (UMLS CUI-1)
17621005 (SNOMED CT-1)
C0205307 (UMLS CUI-1)
17621005 (SNOMED CT-1)
CL Item
auffällig, klinisch signifikant (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
auffällig, klinisch nicht signifikant (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
(Class I)
CL Item
(Class II)
CL Item
(Class III)
CL Item
(Class IV)
CL Item
nicht_sinnvoll_für_Untersuchung (Dako Herceptest [tm] )
CL Item
nicht_sinnvoll_für_Untersuchung (Dako A0485 )
CL Item
nicht_sinnvoll_für_Untersuchung (Cb-11/ventana Kit )
CL Item
nicht_sinnvoll_für_Untersuchung (Tab-250 )
CL Item
nicht_sinnvoll_für_Untersuchung (Ncl-c-erbb2-316 )
CL Item
nicht_sinnvoll_für_Untersuchung (other)
other
Item
nicht_sinnvoll_für_Untersuchung
string
CL Item
positiv (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
fraglich (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
negativ (Negative )
HER2-negative breast cancer (Code-1)
CL412283 (UMLS CUI-1)
CL412283 (UMLS CUI-1)
CL Item
Nicht auswertbar (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
nicht_sinnvoll_für_Untersuchung (Vysis/path Vysion[tm] )
CL Item
nicht_sinnvoll_für_Untersuchung (Other)
other
Item
nicht_sinnvoll_für_Untersuchung
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
positiv (Amplified )
Positive Finding (Code-1)
C1446409 (UMLS CUI-1)
10828004 (SNOMED CT-1)
C1446409 (UMLS CUI-1)
10828004 (SNOMED CT-1)
CL Item
fraglich (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
negativ (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 )
CL Item
(Monosomy )
CL Item
(Normal )
Sample test date
Item
Test Datum
date
Test Date (Code-1)
C2826247 (UMLS CUI-1)
C2826247 (UMLS CUI-1)
Not done
Item
nicht durchgeführt
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
nicht_sinnvoll_für_Untersuchung (Ventana Inform)
CL Item
nicht_sinnvoll_für_Untersuchung (Other)
Other
Item
nicht_sinnvoll_für_Untersuchung
string
Item
CISH
integer
Cytokine-Inducible SH2-Containing Protein (Code-1)
C0299250 (UMLS CUI-1)
C0299250 (UMLS CUI-1)
CL Item
positiv (Amplified )
Positive Finding (Code-1)
C1446409 (UMLS CUI-1)
10828004 (SNOMED CT-1)
C1446409 (UMLS CUI-1)
10828004 (SNOMED CT-1)
CL Item
fraglich (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
negativ (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 )
CL Item
(Monosomy )
CL Item
(Normal )
ER % cells stained positive
Item
Östrogenrezeptor-positive Zellen %
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
Progesteronrezeptor-positive Zellen %
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
Diagnosedatum
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
Körperseite Tumor
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
links (Left)
C0205091 (UMLS CUI-1)
7771000 (SNOMED CT-1)
7771000 (SNOMED CT-1)
CL Item
rechts (Right)
C0205090 (UMLS CUI-1)
24028007 (SNOMED CT-1)
24028007 (SNOMED CT-1)
Clinical Size of Tumor
Item
klinische Tumorgröße
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 - Stadium der regionalen Lymphknoten
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
N0 Stadium (N0)
N0 Stage Finding (Code-1)
C0441959 (UMLS CUI-1)
62455006 (SNOMED CT-1)
C0441959 (UMLS CUI-1)
62455006 (SNOMED CT-1)
CL Item
N1 Stadium (N1)
N1 Stage Finding (Code-1)
C0441962 (UMLS CUI-1)
53623008 (SNOMED CT-1)
C0441962 (UMLS CUI-1)
53623008 (SNOMED CT-1)
CL Item
N2 Stadium (N2)
N2 Stage Finding (Code-1)
C0441960 (UMLS CUI-1)
46059003 (SNOMED CT-1)
C0441960 (UMLS CUI-1)
46059003 (SNOMED CT-1)
CL Item
N3 Stadium (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
Tumorgröße
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
Schnittrand infiltiert durch Tumor
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
histologischer Typ
integer
CL Item
Duktales Karzinom (Ductal NOS)
Ductal Breast Carcinoma (Code-1)
C1527349 (UMLS CUI-1)
C1527349 (UMLS CUI-1)
CL Item
invasives lobuläre Karzinom (Lobular )
Invasive Lobular Breast Carcinoma (Code-1)
CL029510 (UMLS CUI-1)
CL029510 (UMLS CUI-1)
CL Item
Gemischt, duktal und lobulär (Mixed ductal and lobular)
Mixed Lobular and Ductal Breast Carcinoma (Code-1)
CL007210 (UMLS CUI-1)
CL007210 (UMLS CUI-1)
CL Item
tubulär (Tubular (pure > or =90%))
Tubular Breast Carcinoma (Code-1)
C0279561 (UMLS CUI-1)
C0279561 (UMLS CUI-1)
CL Item
apokrin (Apocrine )
Apocrine Breast Carcinoma (Code-1)
C1332316 (UMLS CUI-1)
10066206 (MedDRA-1)
C1332316 (UMLS CUI-1)
10066206 (MedDRA-1)
CL Item
Tubulolobulär (Tubulolobular )
Invasive Lobular Breast Carcinoma, Tubulolobular Variant (Code-1)
CL429657 (UMLS CUI-1)
CL429657 (UMLS CUI-1)
CL Item
Mikropapillär (Micropapillary )
Invasive Micropapillary Breast Carcinoma (Code-1)
C3838947 (UMLS CUI-1)
C3838947 (UMLS CUI-1)
CL Item
Cribriform (Cribriform )
Invasive Cribriform Breast Carcinoma (Code-1)
C1334275 (UMLS CUI-1)
C1334275 (UMLS CUI-1)
CL Item
Muzinöses Adenokarzinom (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
invasives Karzinom (Invasive NOS)
Invasive Breast Carcinoma (Code-1)
C0853879 (UMLS CUI-1)
10006190 (MedDRA-1)
C0853879 (UMLS CUI-1)
10006190 (MedDRA-1)
CL Item
Medulläres Karzinom (Medullary)
Medullary Breast Carcinoma (Code-1)
C0860580 (UMLS CUI-1)
C0860580 (UMLS CUI-1)
CL Item
andere (other)
Other (Code-1)
C0205394 (UMLS CUI-1)
74964007 (SNOMED CT-1)
C0205394 (UMLS CUI-1)
74964007 (SNOMED CT-1)
other
Item
andere
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
histologischer Typ
integer
CL Item
DCIS (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
lobuläres Carcinoma in situ (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
Gemischt, duktales und lobuläres 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
Morbus Paget der Mamille
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)
Item
Histopathologisches Grading
integer
C0919553 (UMLS CUI-1)
371469007 (SNOMED CT-1)
371469007 (SNOMED CT-1)
CL Item
nicht bestimmbar (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 gut differenziert (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 mäßig differenziert (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 schlecht differenziert (G3)
G3 grade (finding) (Code-1)
C0475271 (UMLS CUI-1)
61026006 (SNOMED CT-1)
C0475271 (UMLS CUI-1)
61026006 (SNOMED CT-1)
Item
Lymphknotenbefall
integer
CL Item
nicht anwendbar (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)
CL Item
(1-3 positive nodes, no neoadjuvant chemotherapy)
CL Item
(>= 4 positive nodes, no neoadjuvant chemotherapy)
CL Item
(Sequentially)
CL Item
(Concurrently with targeted therapy)
Hematology And Biochemistry
Item
integer
Date of blood specimen collection
Item
date
CL Item
(1)
CL Item
(2)
CL Item
(3)
Laboratory Name
Item
Name Labor
string
Laboratory (Code-1)
C0022877 (UMLS CUI-1)
261904005 (SNOMED CT-1)
C0022877 (UMLS CUI-1)
261904005 (SNOMED CT-1)
Item
Östrogen-Rezeptor
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
positiv (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
negativ (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
unbekannt (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
Stauts Östrogenrezeptor im Tumor
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
Wert Östrogenrezeptor
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
Progesteron-Rezeptor
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
positiv (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
negativ (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
unbekannt (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
Stauts Progesteronrezeptor im Tumor
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
Wert Progesteronrezeptor
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
Durchführung Sentinellymphknotenbiopsie
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
Datum Sentinellymphknotenbiopsie
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
Körperseite
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
rechts (Left)
C0205090 (UMLS CUI-1)
24028007 (SNOMED CT-1)
24028007 (SNOMED CT-1)
CL Item
links (Right)
C0205091 (UMLS CUI-1)
7771000 (SNOMED CT-1)
7771000 (SNOMED CT-1)
Item
Sentinellymphknoten Biospie Axilla
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
negativ (Negative)
Negative Finding (Code-1)
C0205160 (UMLS CUI-1)
260385009 (SNOMED CT-1)
C0205160 (UMLS CUI-1)
260385009 (SNOMED CT-1)
CL Item
positiv (Positive )
Positive Finding (Code-1)
C1446409 (UMLS CUI-1)
10828004 (SNOMED CT-1)
C1446409 (UMLS CUI-1)
10828004 (SNOMED CT-1)
Item
Sentinel Biopsie der internen Brustlymphknoten
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
negativ (Negative)
Negative Finding (Code-1)
C0205160 (UMLS CUI-1)
260385009 (SNOMED CT-1)
C0205160 (UMLS CUI-1)
260385009 (SNOMED CT-1)
CL Item
positiv (Positive )
Positive Finding (Code-1)
C1446409 (UMLS CUI-1)
10828004 (SNOMED CT-1)
C1446409 (UMLS CUI-1)
10828004 (SNOMED CT-1)
Not done
Item
nicht durchgeführt
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
Operation
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
Lumpektomie (Lumpectomy )
Lumpectomy of breast (Code-1)
C0851238 (UMLS CUI-1)
C0851238 (UMLS CUI-1)
CL Item
Segmentale Mastektomie (Quandrantectomy / Segmentectomy)
Segmental Mastectomy (Code-1)
C0024885 (UMLS CUI-1)
367502008 (SNOMED CT-1)
C0024885 (UMLS CUI-1)
367502008 (SNOMED CT-1)
CL Item
Paritielle Mastektomie (Partial Mastectomy )
Segmental Mastectomy (Code-1)
C0024885 (UMLS CUI-1)
64368001 (SNOMED CT-1)
C0024885 (UMLS CUI-1)
64368001 (SNOMED CT-1)
CL Item
nicht_kodiert (Modified Radical Mastectomy )
CL Item
nicht_kodiert (Radical Mastectomy )
CL Item
andere (Other )
Other (Code-1)
C0205394 (UMLS CUI-1)
74964007 (SNOMED CT-1)
C0205394 (UMLS CUI-1)
74964007 (SNOMED CT-1)
Specify
Item
genauere Bezeichnung
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
Seite
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
rechts (Right)
C0205090 (UMLS CUI-1)
24028007 (SNOMED CT-1)
24028007 (SNOMED CT-1)
CL Item
links (Left)
C0205091 (UMLS CUI-1)
7771000 (SNOMED CT-1)
7771000 (SNOMED CT-1)
Primary surgery Date
Item
Datum der OP
date
Date of Axillary Dissection
Item
Datum Axilladissektion
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
Seite
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
rechts (Right)
C0205090 (UMLS CUI-1)
24028007 (SNOMED CT-1)
24028007 (SNOMED CT-1)
CL Item
links (Left)
C0205091 (UMLS CUI-1)
7771000 (SNOMED CT-1)
7771000 (SNOMED CT-1)
Number of Lymph Nodes examinded
Item
Anzahl der untersuchten Lymphknoten
integer
C2733494 (UMLS CUI-1)
444025001 (SNOMED CT-1)
444025001 (SNOMED CT-1)
Number positive Lymph nodes
Item
Anzahl der beteiligten Lymphknoten
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 )
CL Item
(Isolated Tumor Cells Alone)
CL Item
(Micrometastases)
CL Item
(Macrometastases)
CL Item
(Not Measured )
Not done
Item
nicht durchgeführt
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
Chemotherapie Substanz
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
kumulative Dosis
integer
C2986497 (UMLS CUI-1)
initial dose
Item
erste Dosis
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
Zyklen geplant
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
Intention - letzte Chemotherapie
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
Neoadjuvant (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 (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
Datum Beginn
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
Datum Ende
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
nicht_sinnvoll_für_Untersuchung
boolean
Medical condition
Item
nicht_sinnvoll_für_Untersuchung
string
CL Item
nicht_sinnvoll_für_Untersuchung (Resolved)
CL Item
nicht_sinnvoll_für_Untersuchung (Current)
Treatment Required
Item
nicht_sinnvoll_für_Untersuchung
boolean
Has the patient been assessed for systemic disease
Item
nicht_sinnvoll_für_Untersuchung
boolean
CL Item
nicht_sinnvoll_für_Untersuchung (Abdominal CT-scan)
CL Item
nicht_sinnvoll_für_Untersuchung (Bilateral mammogram)
CL Item
nicht_sinnvoll_für_Untersuchung (Bone scan (scintigraphy))
CL Item
nicht_sinnvoll_für_Untersuchung (Bone X-ray)
CL Item
nicht_sinnvoll_für_Untersuchung (Chest CT-scan)
CL Item
nicht_sinnvoll_für_Untersuchung (Chest X-Ray)
CL Item
nicht_sinnvoll_für_Untersuchung (Left mammogram, only)
CL Item
nicht_sinnvoll_für_Untersuchung (Right mammogram, only)
CL Item
nicht_sinnvoll_für_Untersuchung (CT Scan)
CL Item
nicht_sinnvoll_für_Untersuchung (Endoscopy )
CL Item
nicht_sinnvoll_für_Untersuchung (Lymphangiogram )
CL Item
nicht_sinnvoll_für_Untersuchung (Mammography )
CL Item
nicht_sinnvoll_für_Untersuchung (MRI)
CL Item
nicht_sinnvoll_für_Untersuchung (Nuclear Scan )
CL Item
nicht_sinnvoll_für_Untersuchung (PET Scan)
CL Item
nicht_sinnvoll_für_Untersuchung (PET/CT scan)
CL Item
nicht_sinnvoll_für_Untersuchung (Transvaginal Ultrasound)
CL Item
nicht_sinnvoll_für_Untersuchung (Ultrasound )
CL Item
nicht_sinnvoll_für_Untersuchung (X-ray)
CL Item
nicht_sinnvoll_für_Untersuchung (Other )
Specify
Item
nicht_sinnvoll_für_Untersuchung
string
CL Item
nicht_sinnvoll_für_Untersuchung (Abdomen/abdominal Wall )
CL Item
nicht_sinnvoll_für_Untersuchung (Abdomen )
CL Item
nicht_sinnvoll_für_Untersuchung (Bone )
CL Item
nicht_sinnvoll_für_Untersuchung (Bladder )
CL Item
nicht_sinnvoll_für_Untersuchung (Breast )
CL Item
nicht_sinnvoll_für_Untersuchung (Colon )
CL Item
nicht_sinnvoll_für_Untersuchung (Colorectal )
CL Item
nicht_sinnvoll_für_Untersuchung (Central Nervous System (CNS))
CL Item
nicht_sinnvoll_für_Untersuchung (Chest )
CL Item
nicht_sinnvoll_für_Untersuchung (Cervix Uteri )
CL Item
nicht_sinnvoll_für_Untersuchung (Esophagus )
CL Item
nicht_sinnvoll_für_Untersuchung (Head And Neck )
CL Item
nicht_sinnvoll_für_Untersuchung (Heart )
CL Item
nicht_sinnvoll_für_Untersuchung (Kidney )
CL Item
nicht_sinnvoll_für_Untersuchung (Lung )
CL Item
nicht_sinnvoll_für_Untersuchung (Lymph Node )
CL Item
nicht_sinnvoll_für_Untersuchung (Liver )
CL Item
nicht_sinnvoll_für_Untersuchung (Mouth (Oral Cavity))
CL Item
nicht_sinnvoll_für_Untersuchung (Other )
CL Item
nicht_sinnvoll_für_Untersuchung (Ovary )
CL Item
nicht_sinnvoll_für_Untersuchung (Pleura )
CL Item
nicht_sinnvoll_für_Untersuchung (Peritoneum )
CL Item
nicht_sinnvoll_für_Untersuchung (Prostate Gland )
CL Item
nicht_sinnvoll_für_Untersuchung (Pancreas )
CL Item
nicht_sinnvoll_für_Untersuchung (Pelvis )
CL Item
nicht_sinnvoll_für_Untersuchung (Rectum )
CL Item
nicht_sinnvoll_für_Untersuchung (Stomach )
CL Item
nicht_sinnvoll_für_Untersuchung (Small Intestine)
CL Item
nicht_sinnvoll_für_Untersuchung (Skin )
CL Item
nicht_sinnvoll_für_Untersuchung (Spleen )
CL Item
nicht_sinnvoll_für_Untersuchung (Thyroid Gland (Thyroid))
CL Item
nicht_sinnvoll_für_Untersuchung (Testis (Testicle))
Date of test
Item
nicht_sinnvoll_für_Untersuchung
date
Are there any clinically significant abnormalites
Item
nicht_sinnvoll_für_Untersuchung
boolean
Specify
Item
nicht_sinnvoll_für_Untersuchung
string
Not done
Item
nicht_sinnvoll_für_Untersuchung
string
CL Item
nicht_sinnvoll_für_Untersuchung (FFPE tumor block)
CL Item
nicht_sinnvoll_für_Untersuchung (Blood Sample For Pgx)
CL Item
nicht_sinnvoll_für_Untersuchung (Tumor Tissue For Pgx)
CL Item
nicht_sinnvoll_für_Untersuchung (Additional Blood Sample For Ctc (circulating Tumor Cells) (Additional blood sample for CTC (circulating tumor cells)))
CL Item
nicht_sinnvoll_für_Untersuchung (Additional Blood Sample For Proteomics (Additional blood sample for Proteomics))
CL Item
nicht_sinnvoll_für_Untersuchung (Additional Fresh Frozen Tumor Samples (Additional fresh frozen tumor samples))
Date of blood specimen collection
Item
nicht_sinnvoll_für_Untersuchung
date
Was sample obtained
Item
nicht_sinnvoll_für_Untersuchung
boolean
Percentage greater than or equal to 3 Chromosome 17 signals
Item
string
NACA (No apparent Chromosome 17 anomaly)
Item
boolean
CL Item
nicht_sinnvoll_für_Untersuchung (Interductal Only )
CL Item
nicht_sinnvoll_für_Untersuchung (Hybridization Failure)
CL Item
nicht_sinnvoll_für_Untersuchung (Insufficient Tissue )
CL Item
nicht_sinnvoll_für_Untersuchung (No Cancer Tissue )
CL Item
nicht_sinnvoll_für_Untersuchung (Other)
Specify
Item
string
CL Item
nicht_sinnvoll_für_Untersuchung (Duplication Of Her2 )
CL Item
nicht_sinnvoll_für_Untersuchung (Most Cells With No Centromere 17 )
CL Item
nicht_sinnvoll_für_Untersuchung (Negative Her2 )
CL Item
nicht_sinnvoll_für_Untersuchung (Normal Her2 )
CL Item
nicht_sinnvoll_für_Untersuchung (Not A Small Clone )
CL Item
nicht_sinnvoll_für_Untersuchung (Other )
CL Item
nicht_sinnvoll_für_Untersuchung (Small Clone Of Amplification )
Percentage of invasive tumor cells with complete membrane staining
Item
nicht_sinnvoll_für_Untersuchung
integer
CL Item
(Present)
CL Item
(Absent)
CL Item
(Present)
CL Item
(Absent)
CL Item
negativ (Negative - 0)
HER2-negative breast cancer (Code-1)
CL412283 (UMLS CUI-1)
CL412283 (UMLS CUI-1)
CL Item
negativ (Negative - 1+)
HER2-negative breast cancer (Code-1)
CL412283 (UMLS CUI-1)
CL412283 (UMLS CUI-1)
CL Item
borderline (Equivocal - 2+)
Borderline (Code-1)
C0205189 (UMLS CUI-1)
C0205189 (UMLS CUI-1)
CL Item
positiv (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
positiv (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
nicht ausreichend Gewebe (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
Gefäßinvasion
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
Strahlentherapie durchgeführt
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
Ort der Bestrahlung
string
Organ target(s) (Code-1)
C0807185 (UMLS CUI-1)
C0807185 (UMLS CUI-1)
Item
Körperseite
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
links (Left)
C0205091 (UMLS CUI-1)
7771000 (SNOMED CT-1)
7771000 (SNOMED CT-1)
CL Item
rechts (Right)
C0205090 (UMLS CUI-1)
24028007 (SNOMED CT-1)
24028007 (SNOMED CT-1)
RT Total Dose
Item
Gesamtdosis
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
Rad (Rad)
Radiation Therapy Start Date
Item
Beginn Strahlentherapie
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
Ende Strahlentherapie
date
Radiotherapy completed (situation) (Code-1)
C0436385 (UMLS CUI-1)
168534004 (SNOMED CT-1)
C0436385 (UMLS CUI-1)
168534004 (SNOMED CT-1)
Has the patient received hormone therapy before or during the trial
Item
Hormon- / endokrine Therapie
boolean
C0279025 (UMLS CUI-1)
169413002 (SNOMED CT-1)
10065646 (MedDRA-1)
169413002 (SNOMED CT-1)
10065646 (MedDRA-1)
Name of treatment or surgical procedure
Item
Therapieart
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
Einzeldosis
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
Milligramm (mg)
C0439210 (UMLS CUI-1)
258684004 (SNOMED CT-1)
258684004 (SNOMED CT-1)
CL Item
nicht anwendbar (N/A)
None or Not Applicable (Code-1)
CL413952 (UMLS CUI-1)
CL413952 (UMLS CUI-1)
Begin date
Item
Datum Therapiebeginn - endokrine Therapie
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
Datum Therapieende - endokrine Therapie
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
fortlaufend am Studienende
integer
Continue (Code-1)
C0549178 (UMLS CUI-1)
Study End Date (Code-2)
C2983670 (UMLS CUI-2)
Endocrine Therapy (Code-3)
C0279025 (UMLS CUI-3)
169413002 (SNOMED CT-3)
C0549178 (UMLS CUI-1)
Study End Date (Code-2)
C2983670 (UMLS CUI-2)
Endocrine Therapy (Code-3)
C0279025 (UMLS CUI-3)
169413002 (SNOMED CT-3)
CL Item
Ja (Yes)
C1298907 (UMLS CUI-1)
373066001 (SNOMED CT-1)
373066001 (SNOMED CT-1)
Name of treatment
Item
Name Nebentherapie
string
Concomitant Therapy (Code-1)
C1707479 (UMLS CUI-1)
C1707479 (UMLS CUI-1)
Item
Intention
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
Prävention (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
Kurativ (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
Datum Therapiebeginn
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
Datum Ende
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
fortlaufend
integer
Continue (Code-1)
C0549178 (UMLS CUI-1)
Study End Date (Code-2)
C2983670 (UMLS CUI-2)
Concomitant Therapy (Code-3)
C1707479 (UMLS CUI-3)
C0549178 (UMLS CUI-1)
Study End Date (Code-2)
C2983670 (UMLS CUI-2)
Concomitant Therapy (Code-3)
C1707479 (UMLS CUI-3)
CL Item
Ja (Yes)
C1298907 (UMLS CUI-1)
373066001 (SNOMED CT-1)
373066001 (SNOMED CT-1)
Date Agent Administered
Item
date
Dose
Item
Einzeldosis
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
kumulative Dosis
integer
C2986497 (UMLS CUI-1)
Was treatment delayed
Item
boolean
CL Item
(Hematologic Adverse Event )
CL Item
(Cardiac Adverse Event)
CL Item
(Adverse Event Other Than Hematologic Or Cardiac )
CL Item
(Dosing Error )
CL Item
(Subject Non-compliance)
CL Item
(Administrative Reasons )
CL Item
(Other )
specify
Item
string
Was dose reduced
Item
Dosislevel der Chemotherapie reduziert
boolean
C0861114 (UMLS CUI-1)
CL Item
(Hematologic Adverse Event )
CL Item
(Cardiac Adverse Event)
CL Item
(Adverse Event Other Than Hematologic Or Cardiac )
CL Item
(Dosing Error )
CL Item
(Subject Non-compliance)
CL Item
(Administrative Reasons )
CL Item
(Other )
specify
Item
string
Did the patient receive additional chemotherapy after recurrence of breast cancer or second primary malignancy of contralateral breast cancer
Item
Rezidivtherapie - Chemotherapie
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
(mg/m2)
Date started
Item
date
Date stopped
Item
date
AdditionalTargetTherapy
Item
boolean
Agent Name
Item
string
Total No. Cycles
Item
integer
initial dose
Item
integer
CL Item
(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
Rezidivtherapie - Hormontherapie
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
(mg/m2)
CL Item
(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
Rezidivtherapie - Bestrahlung
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)
CL Item
(Right)
Total Dose
Item
integer
CL Item
(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
Rezidivtherapie - Operation
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
Item
Name Adverse Event
integer
CL Item
Laborwerte (Metabolic/laboratory Other (Metabolic/Laboratory-Other (Specify)))
Other Metabolic and Laboratory Adverse Event (Code-1)
C1559945 (UMLS CUI-1)
MTHU117254 (CTCAE-1)
C1559945 (UMLS CUI-1)
MTHU117254 (CTCAE-1)
CL Item
Gastrointestinaltrakt (Renal/genitourinary Other (Renal/Genitourinary-Other (Specify)))
Adverse Event Associated with the Gastrointestinal System (Code-1)
C1559265 (UMLS CUI-1)
MTHU112146 (CTCAE-1)
C1559265 (UMLS CUI-1)
MTHU112146 (CTCAE-1)
CL Item
Urogenital-System (Niere/Blase)
Renal or Genitourinary Other Adverse Event (Code-1)
C1558061 (UMLS CUI-1)
MTHU117419 (CTCAE-1)
C1558061 (UMLS CUI-1)
MTHU117419 (CTCAE-1)
CL Item
Haut (Dermatology/skin Other (Dermatology/Skin-Other (Specify)))
Other Dermatology or Skin Adverse Event (Code-1)
C1559104 (UMLS CUI-1)
MTHU117246 (CTCAE-1)
C1559104 (UMLS CUI-1)
MTHU117246 (CTCAE-1)
CL Item
Allergie (Allergy/immunology Other (Allergy/Immunology-Other (Specify)))
Adverse Event Associated with Allergy and Immunology (Code-1)
C1560126 (UMLS CUI-1)
MTHU112125 (CTCAE-1)
C1560126 (UMLS CUI-1)
MTHU112125 (CTCAE-1)
CL Item
Fieber (Pyrexia (Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L)))
Fever Without Neutropenia Adverse Event (Code-1)
C1556366 (UMLS CUI-1)
MTHU116933 (CTCAE-1)
C1556366 (UMLS CUI-1)
MTHU116933 (CTCAE-1)
CL Item
Infektion (Infection Nos (Infection-Other (Specify)))
Adverse Event Associated with Infection (Code-1)
C1556682 (UMLS CUI-1)
MTHU112135 (CTCAE-1)
C1556682 (UMLS CUI-1)
MTHU112135 (CTCAE-1)
CL Item
Sinnesorgane (Auditory/ear Other (Auditory/Ear-Other (Specify)))
Adverse Event Associated with the Ear and Auditory System (Code-1)
C1560154 (UMLS CUI-1)
MTHU112144 (CTCAE-1)
C1560154 (UMLS CUI-1)
MTHU112144 (CTCAE-1)
CL Item
Allgemeinsymptome (Constitutional Symptoms Other (Constitutional Symptoms-Other (Specify)))
Adverse Event Associated with Constitutional Symptoms (Code-1)
C1556354 (UMLS CUI-1)
MTHU112129 (CTCAE-1)
C1556354 (UMLS CUI-1)
MTHU112129 (CTCAE-1)
CL Item
Lunge/Kehlkopf (Pulmonary/upper Respiratory Other (Pulmonary/Upper Respiratory-Other (Specify)))
Adverse Event Associated with Pulmonary and Upper Respiratory Systems (Code-1)
C1557628 (UMLS CUI-1)
MTHU112139 (CTCAE-1)
C1557628 (UMLS CUI-1)
MTHU112139 (CTCAE-1)
CL Item
Endokrines System (Endocrine Other (Endocrine-Other (Specify)))
Adverse Event Associated with the Endocrine System (Code-1)
C1559198 (UMLS CUI-1)
MTHU112145 (CTCAE-1)
C1559198 (UMLS CUI-1)
MTHU112145 (CTCAE-1)
CL Item
Herz, allgemein (Cardiac General Other (Cardiac General-Other (Specify)))
Adverse Event Associated with the Heart in General (Code-1)
C1556247 (UMLS CUI-1)
MTHU112147 (CTCAE-1)
C1556247 (UMLS CUI-1)
MTHU112147 (CTCAE-1)
CL Item
Hämoglobin (Haemoglobin Decreased (Hemoglobin))
Hemoglobin Adverse Event (Code-1)
C2239101 (UMLS CUI-1)
MTHU116997 (CTCAE-1)
C2239101 (UMLS CUI-1)
MTHU116997 (CTCAE-1)
CL Item
Aspartat-Transaminase (Aspartate Aminotransferase Increased (AST, SGOT (serum glutamic oxaloacetic transaminase)))
Serum Glutamic Oxaloacetic Transaminase Adverse Event (Code-1)
C1557198 (UMLS CUI-1)
MTHU117449 (CTCAE-1)
C1557198 (UMLS CUI-1)
MTHU117449 (CTCAE-1)
CL Item
Alanin-Transaminase (Alanine Aminotransferase Increased (ALT, SGPT (serum glutamic pyruvic transaminase)))
Serum Glutamic Pyruvic Transaminase Adverse Event (Code-1)
C1557189 (UMLS CUI-1)
MTHU117450 (CTCAE-1)
C1557189 (UMLS CUI-1)
MTHU117450 (CTCAE-1)
CL Item
Kreatinin (Blood Creatinine Increased (Creatinine))
Creatinine Adverse Event (Code-1)
C1561535 (UMLS CUI-1)
MTHU116842 (CTCAE-1)
C1561535 (UMLS CUI-1)
MTHU116842 (CTCAE-1)
CL Item
Peripherer Nerv (Neuralgia Nos (Pain - Neuralgia/peripheral nerve))
Neuralgia and Peripheral Nerve Pain Adverse Event (Code-1)
C1557517 (UMLS CUI-1)
MTHU117196 (CTCAE-1)
C1557517 (UMLS CUI-1)
MTHU117196 (CTCAE-1)
CL Item
Blutungen (Hemorrhage/bleeding Other (Hemorrhage/Bleeding-Other (Specify)))
Other Hemorrhage and Bleeding Adverse Event (Code-1)
C1556642 (UMLS CUI-1)
MTHU117250 (CTCAE-1)
C1556642 (UMLS CUI-1)
MTHU117250 (CTCAE-1)
CL Item
Bilirubin (Blood Bilirubin Increased (Bilirubin (hyperbilirubinemia)))
Hyperbilirubinemia Adverse Event (Code-1)
C1557209 (UMLS CUI-1)
MTHU117008 (CTCAE-1)
C1557209 (UMLS CUI-1)
MTHU117008 (CTCAE-1)
CL Item
Leukozyten (Leucopenia Nos (Leukocytes (total WBC)))
Leukocytes Adverse Event (Code-1)
C1560219 (UMLS CUI-1)
MTHU117099 (CTCAE-1)
C1560219 (UMLS CUI-1)
MTHU117099 (CTCAE-1)
CL Item
Alkalische Phosphatase (Blood Alkaline Phosphatase Nos Increased (Alkaline phosphatase))
Alkaline Phosphatase Adverse Event (Code-1)
C1561546 (UMLS CUI-1)
MTHU112158 (CTCAE-1)
C1561546 (UMLS CUI-1)
MTHU112158 (CTCAE-1)
CL Item
Proteinurie (Proteinuria Present (Proteinuria))
Proteinuria Adverse Event (Code-1)
C1962972 (UMLS CUI-1)
MTHU117382 (CTCAE-1)
C1962972 (UMLS CUI-1)
MTHU117382 (CTCAE-1)
CL Item
Haar (Alopecia (Hair loss/Alopecia (scalp or body)))
Alopecia Adverse Event (Code-1)
C1559115 (UMLS CUI-1)
MTHU112161 (CTCAE-1)
C1559115 (UMLS CUI-1)
MTHU112161 (CTCAE-1)
CL Item
Obstipation (Constipation (Constipation))
Constipation Adverse Event (Code-1)
C1963087 (UMLS CUI-1)
MTHU116803 (CTCAE-1)
C1963087 (UMLS CUI-1)
MTHU116803 (CTCAE-1)
CL Item
Diarrhoe (Diarrhoea Nos (Diarrhea))
Diarrhea Adverse Event (Code-1)
C0232708 (UMLS CUI-1)
MTHU116856 (CTCAE-1)
C0232708 (UMLS CUI-1)
MTHU116856 (CTCAE-1)
CL Item
Hämaturie (Haematuria Present (Hemorrhage, GU - Urinary NOS))
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)
34436003 (SNOMED CT-1)
10018867 (MedDRA-1)
R31.9 (ICD-10-CM-1)
599.7 (ICD-9-CM-1)
E13000 (CTCAE-1)
CL Item
Schmerzen (Pain Other (Pain-Other (Specify)))
Other Pain Adverse Event (CUI C1557623) (Code-1)
MTHU117260 (CTCAE-1)
MTHU117260 (CTCAE-1)
CL Item
Thrombozyten (Platelet Count Decreased (Platelets))
Platelets Adverse Event (Code-1)
C1963076 (UMLS CUI-1)
MTHU117353 (CTCAE-1)
C1963076 (UMLS CUI-1)
MTHU117353 (CTCAE-1)
CL Item
Übelkeit (Nausea (Nausea))
Nausea Adverse Event (Code-1)
C1963179 (UMLS CUI-1)
MTHU117189 (CTCAE-1)
C1963179 (UMLS CUI-1)
MTHU117189 (CTCAE-1)
CL Item
Herzrhythmus (Arrhythmia Nos (Cardiac Arrhythmia-Other (Specify)))
Adverse Event Associated with Cardiac Arrhythmia (Code-1)
C1560249 (UMLS CUI-1)
MTHU112127 (CTCAE-1)
C1560249 (UMLS CUI-1)
MTHU112127 (CTCAE-1)
CL Item
Perikarditis (Pericarditis (Pericarditis))
Pericarditis Adverse Event (Code-1)
C1963211 (UMLS CUI-1)
MTHU117310 (CTCAE-1)
C1963211 (UMLS CUI-1)
MTHU117310 (CTCAE-1)
CL Item
Bewusstsein (Depressed Level Of Consciousness (Somnolence/depressed level of consciousness))
Somnolence and Depressed Level of Consciousness Adverse Event (Code-1)
C1557290 (UMLS CUI-1)
MTHU117503 (CTCAE-1)
C1557290 (UMLS CUI-1)
MTHU117503 (CTCAE-1)
CL Item
Dyspnoe (Dyspnoea Nos (Dyspnea (shortness of breath)))
Dyspnea Adverse Event (Code-1)
C1963100 (UMLS CUI-1)
MTHU116873 (CTCAE-1)
C1963100 (UMLS CUI-1)
MTHU116873 (CTCAE-1)
CL Item
Zystitis (Cystitis (Cystitis))
Cystitis Adverse Event (Code-1)
C1963088 (UMLS CUI-1)
MTHU116844 (CTCAE-1)
C1963088 (UMLS CUI-1)
MTHU116844 (CTCAE-1)
CL Item
Vomiting (Vomiting Nos (Vomiting))
Vomiting Adverse Event (Code-1)
C1963281 (UMLS CUI-1)
MTHU117700 (CTCAE-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
Grad der Nebenwirkung
integer
Adverse Event Grade Code (Code-1)
C2985911 (UMLS CUI-1)
C2985911 (UMLS CUI-1)
CL Item
(resolved)
CL Item
(improved)
CL Item
(ongoing)
CL Item
(resolved with sequelae)
CL Item
(fatal)
CL Item
(protocol treatment discontinued)
CL Item
(study dose reduced)
CL Item
(none)
CL Item
(protocol treatment delayed)
CL Item
(other treatment required)
relation to study drug
Item
boolean
Item Group
Second Primary Malignancy and Contralateral Breast Cancer
Type of recurrence
Item
Rezdivtumor
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
Medizinische Untersuchung
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
körperliche Untersuchung (Clinical)
CL Item
radiologisch (Radiological)
Diagnostic radiologic examination (Code-1)
C0043299 (UMLS CUI-1)
363680008 (SNOMED CT-1)
C0043299 (UMLS CUI-1)
363680008 (SNOMED CT-1)
Biopsy
Item
Biopsie
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
Datum Biopsie
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
histologischer Typ
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
körperliche Untersuchung
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
nicht durchgeführt
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
Rezdivtumor (Recurrence of disease)
Recurrent Malignant Neoplasm (Code-1)
C0549379 (UMLS CUI-1)
10038111 (MedDRA-1)
C0549379 (UMLS CUI-1)
10038111 (MedDRA-1)
CL Item
Zweittumor (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
Herzerkrankung (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)
CL Item
Patient verstorben (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
keine Nachuntersuchung erfolgt (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)
Consent Withdrawn (Code-1)
C1707492 (UMLS CUI-1)
C1707492 (UMLS CUI-1)
Date of last contact
Item
Datum des letzten Kontaktes
date
CL Item
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
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
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
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
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
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
Systolischer Blutdruck
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
Diastolischer Blutdruck
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
Datum Linksventrikuläre Ejektionsfraktion
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
Linksventrikuläre Ejektionsfraktion
string
Left Ventricular Ejection Fraction (Code-1)
CL433348 (UMLS CUI-1)
CL433348 (UMLS CUI-1)
Echocardiogram
Item
Echokardiographie
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
Radionuklidventrikulographie
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
Ergebnis
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
unauffällig (Normal)
Normal (Code-1)
C0205307 (UMLS CUI-1)
17621005 (SNOMED CT-1)
C0205307 (UMLS CUI-1)
17621005 (SNOMED CT-1)
CL Item
auffällig, klinisch signifikant (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
auffällig, klinisch nicht signifikant (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
(Class I)
CL Item
(Class II)
CL Item
(Class III)
CL Item
(Class IV)
Item
Mammogramm
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
rechts (Right)
C0205090 (UMLS CUI-1)
24028007 (SNOMED CT-1)
24028007 (SNOMED CT-1)
CL Item
links (Left)
C0205091 (UMLS CUI-1)
7771000 (SNOMED CT-1)
7771000 (SNOMED CT-1)
CL Item
beidseits (Bilateral)
C0238767 (UMLS CUI-1)
51440002 (SNOMED CT-1)
51440002 (SNOMED CT-1)
Date of Test
Item
Untersuchungsdatum
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
nicht durchgeführt
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
unauffällig (Normal)
Normal (Code-1)
C0205307 (UMLS CUI-1)
17621005 (SNOMED CT-1)
C0205307 (UMLS CUI-1)
17621005 (SNOMED CT-1)
CL Item
auffällig, klinisch signifikant (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
auffällig, klinisch nicht signifikant (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)
Item
Vitalstatus
integer
CL Item
lebend (Alive)
Alive (finding) (Code-1)
C2584946 (UMLS CUI-1)
438949009 (SNOMED CT-1)
C2584946 (UMLS CUI-1)
438949009 (SNOMED CT-1)
CL Item
tot (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
keine Nachuntersuchung erfolgt (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
Todesdatum
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
Datum letzter Kontakt
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
Unterschrift Untersuchuer
string
Investigator Signature (Code-1)
C2346576 (UMLS CUI-1)
C2346576 (UMLS CUI-1)
Date
Item
Datum
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
nicht_sinnvoll_für_Untersuchung (Yes)
CL Item
nicht_sinnvoll_für_Untersuchung (No)
CL Item
nicht_sinnvoll_für_Untersuchung (Not Applicable)
CL Item
nicht_sinnvoll_für_Untersuchung (Yes)
CL Item
nicht_sinnvoll_für_Untersuchung (No)
CL Item
nicht_sinnvoll_für_Untersuchung (Not Applicable)
CL Item
nicht_sinnvoll_für_Untersuchung (Yes)
CL Item
nicht_sinnvoll_für_Untersuchung (No)
CL Item
nicht_sinnvoll_für_Untersuchung (Not Applicable)
Item
Grund für Therapeabbruch
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
Verletzung des Protokolls (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)
CL Item
(Subject decided to withdraw from the study)
CL Item
Rediziverkrankung (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
Zweittumor (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
kontrallaterales Mammakarzinom (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
Patient verstorben (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
keine Nachuntersuchung erfolgt (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
Datum letzter Kontakt während Behandlungsperiode
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
Kommentar
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
Unterschrift Untersuchuer
string
Investigator Signature (Code-1)
C2346576 (UMLS CUI-1)
C2346576 (UMLS CUI-1)
Date
Item
Datum
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
Todesdatum
date
Item
Todesursache
integer
Cause of Death (Code-1)
C0007465 (UMLS CUI-1)
184305005 (SNOMED CT-1)
C0007465 (UMLS CUI-1)
184305005 (SNOMED CT-1)
CL Item
Tumor 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 während Studie (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 während Therapie des Rezidiv (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
Todesursache tumorbedingt (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
andere Todesursache (Other)
Other (Code-1)
C0205394 (UMLS CUI-1)
74964007 (SNOMED CT-1)
C0205394 (UMLS CUI-1)
74964007 (SNOMED CT-1)
specify
Item
andere Todesursache
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
Autopsie
integer
Autopsy (Code-1)
C0004398 (UMLS CUI-1)
29240004 (SNOMED CT-1)
10050117 (MedDRA-1)
89.8 (ICD-10-CM-1)
C0004398 (UMLS CUI-1)
29240004 (SNOMED CT-1)
10050117 (MedDRA-1)
89.8 (ICD-10-CM-1)
CL Item
unbekannt (unknown)
Unknown (Code-1)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-1)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-1)
CL Item
Nein (No)
C1298908 (UMLS CUI-1)
373067005 (SNOMED CT-1)
373067005 (SNOMED CT-1)
CL Item
Ja (Yes)
C1298907 (UMLS CUI-1)
373066001 (SNOMED CT-1)
373066001 (SNOMED CT-1)
Please summarize findings
Item
string
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