Outcome of Pregnancy Breast Cancer NCT00490139

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

Header Module

Studie Nr.
Description

NCCTG Study No

Data type

string

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

Central Lab ID Number

Data type

string

Alias
Code-1
Laboratory
UMLS CUI-1
C0022877
SNOMED CT-1
261904005
LOINC-1
MTHU029808
Code-2
Numbers
UMLS CUI-2
C0237753
SNOMED CT-2
260299005
LOINC-2
MTHU024869
Institutions-Nr.
Description

Institution Number

Data type

string

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

Patient Initials

Data type

string

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

Institution

Data type

string

Alias
UMLS CUI-1
C0021622
Registration Header
Description

Registration Header

Gruppen-Protokoll Nr.
Description

Coordinating Group Protocol Number (N063D)

Data type

string

Alias
Code-1
Group
UMLS CUI-1
C0441833
SNOMED CT-1
246261001
Code-2
Protocols documentation
UMLS CUI-2
C0442711
SNOMED CT-2
258049002
Gruppen-Code
Description

Coordinating Group Code (NCCTG)

Data type

string

Alias
Code-1
Group
UMLS CUI-1
C0441833
SNOMED CT-1
246261001
Code-2
Code
UMLS CUI-2
C0805701
Protocol Titel
Description

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

Data type

string

Alias
Code-1
Study Protocol
UMLS CUI-1
C2348563
Nr. Krankenakte
Description

Patient Medical Record Number

Data type

string

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

Participating Group Code

Data type

string

Alias
Code-1
Study Protocol Version Participating Organization Type Code
UMLS CUI-1
C2986314
veränderte Daten
Description

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

Data type

boolean

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

Unnamed 1

Registrierungs-Typ
Description

Pre-Registration Type

Data type

integer

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

First Submission

Data type

integer

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

Contact Person For Pathology Results

Nachname
Description

Last Name

Data type

string

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

First Name

Data type

string

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

Phone

Data type

string

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

Fax

Data type

string

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

E-Mail

Data type

string

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

Patient Demographics

Patienten-Geschlecht
Description

Gender

Data type

integer

Alias
SNOMED CT-1
184100006
UMLS CUI
C0079399
Patienten-Geburtsdatum
Description

Date of Birth

Data type

date

Alias
UMLS CUI-1
C0421451
SNOMED CT-1
184099003
Postleitzahl Patient
Description

ZIP Code

Data type

integer

Alias
UMLS CUI-1
C0421454
SNOMED CT-1
184102003
Wohnort
Description

Country of Residence

Data type

string

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

Method of Payment

Data type

integer

Rasse
Description

Race

Data type

integer

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

Ethnicity

Data type

integer

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

Eligibility Screening Form

Einschlusskriterien
Description

Inclusion Criteria

Data type

integer

Alias
Code-1
Inclusion Criteria
UMLS CUI-1
C1512693
Ausschlusskriterien
Description

Exclusion criteria

Data type

integer

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

Randomization

Date of Randomization
Description

Date of Randomization

Data type

date

Assigned Treatment Arm
Description

Assigned Treatment Arm

Data type

integer

Informed consent
Description

Informed consent

Datum Einverstädniserklärung
Description

Date Informed consent signed

Data type

date

Alias
Code-1
Informed consent obtained
UMLS CUI-1
C0514044
Code-2
Date in time
UMLS CUI-2
C0011008
SNOMED CT-2
410671006
LOINC-2
MTHU021546
Datum Einverstädniserklärung für Pharmakogenetische Tests
Description

Date of consent [for] pharmacogenetic research

Data type

date

Alias
Code-1
Informed consent obtained
UMLS CUI-1
C0514044
Code-2
Pharmacogenetic Test
UMLS CUI-2
C2347500
Code-3
Date in time
UMLS CUI-3
C0011008
SNOMED CT-3
410671006
LOINC-3
MTHU021546
Datum Einverstädniserklärung für Blutproben
Description

Did the patient consent to donate blood sample

Data type

boolean

Alias
Code-1
Blood Sample
UMLS CUI-1
C0178913
SNOMED CT-1
119297000
Code-2
Informed consent obtained
UMLS CUI-2
C0514044
MedDRA-2
MTHU008888
Datum Einverstädniserklärung für Tumorgewebe
Description

Did the patient consent to tumor tissue

Data type

boolean

Alias
Code-1
Tissue Collection
UMLS CUI-1
C0040278
Code-2
Informed consent obtained
UMLS CUI-2
C0514044
MedDRA-2
MTHU008888
Datum Einverstädniserklärung für zusätzliche Blutproben
Description

Did the patient consent to donate additional blood sample

Data type

boolean

Alias
Code-1
Additional
UMLS CUI-1
C1524062
Code-2
Blood Sample
UMLS CUI-2
C0178913
SNOMED CT-2
119297000
Code-3
Informed consent obtained
UMLS CUI-3
C0514044
MedDRA-3
MTHU008888
Datum Einverstädniserklärung für gefrorene Proben
Description

Did the patient consent to donate fresh/frozen tissue

Data type

boolean

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

Unnamed 1

Menopausenstatus
Description

Menopausal Status

Data type

integer

Alias
Code-1
Menopause finding (finding)
UMLS CUI-1
C0455962
SNOMED CT-1
276477006
Datum letzte Menstruation
Description

Date of last menstrual cycle

Data type

date

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

Date of pregnancy test

Data type

date

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

Pregnancy test

Data type

integer

Alias
Code-1
Pregnancy Tests
SNOMED CT-1
74036000
MedDRA-1
10036572
UMLS CUI
C0032976
Hatte die Patientin eine Hysterektomie?
Description

Has the patient had a hysterectomy?

Data type

boolean

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

Hysterectomy

Data type

date

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

Unilateral ovariectomy/oophorectomy

Data type

boolean

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

Specify side

Data type

integer

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

Unilateral oophorectomy Date

Data type

date

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

Patient Status

Datum körperliche Untersuchung
Description

Date of Physical exam

Data type

date

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

Physical exam

Data type

integer

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

Height

Data type

float

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

Weight

Data type

float

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

BSA

Data type

float

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

Systolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
Code-1
Systolic Blood Pressure
SNOMED CT-1
271649006
UMLS CUI-1
C0871470
mmHg
Diastolischer Blutdruck
Description

Diastolic blood pressure

Data type

integer

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

Heart rate

Data type

integer

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

ECOG

Data type

integer

Alias
UMLS CUI-1
C1632812
ECG
Description

ECG

Alias
UMLS CUI-1
C1623258
date of ECG
Description

date of ECG

Data type

date

Result
Description

Result

Data type

integer

Cardiac Monitoring
Description

Cardiac Monitoring

Alias
UMLS CUI-1
C0150496
Datum Linksventrikuläre Ejektionsfraktion
Description

LVEF date

Data type

date

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

LVEF

Data type

float

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

Echocardiogramm

Data type

boolean

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

Muga Scan

Data type

boolean

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

Result

Data type

integer

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

Symptomatic CHF

Data type

boolean

NYHA Classification
Description

NYHA Classification

Data type

text

Alias
UMLS CUI-1
C1275491
Local Her2 Results
Description

Local Her2 Results

Staining Antibody
Description

Staining Antibody

Data type

integer

nicht_sinnvoll_für_Untersuchung
Description

other

Data type

string

Her2/Neu Status
Description

ICH Result

Data type

integer

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

Percentage of invasive tumor cells with complete membrane staining

Data type

integer

FISH Kit or Test Type
Description

FISH Kit or Test Type

Data type

integer

nicht_sinnvoll_für_Untersuchung
Description

other

Data type

string

FisH-Test
Description

FISH Result

Data type

integer

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

FISH HER2/neu chromosome 17 Ratio

Data type

integer

Chromosome 17 copy number
Description

Chromosome 17 copy number

Data type

integer

Test Datum
Description

Sample test date

Data type

date

Alias
Code-1
Test Date
UMLS CUI-1
C2826247
nicht durchgeführt
Description

Not done

Data type

string

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

CISH Kit or Test Type

Data type

integer

nicht_sinnvoll_für_Untersuchung
Description

Other

Data type

string

CISH
Description

CISH Result

Data type

integer

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

Chromosome 17 copy number

Data type

integer

Hormonal Receptor Status
Description

Hormonal Receptor Status

Östrogenrezeptor-positive Zellen %
Description

ER % cells stained positive

Data type

integer

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

PgR % cells stained positive

Data type

integer

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

History Of Primary Breast Cancer

Diagnosedatum
Description

Date of initial Pathologic Diagnosis

Data type

date

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

Tumor Laterality

Data type

integer

Alias
UMLS CUI-1
C0441987
SNOMED CT-1
182353008
LOINC-1
MTHU014973
Code-2
Tumor site
UMLS CUI-2
C0475445
SNOMED CT-2
263591006
LOINC-2
MTHU015562
klinische Tumorgröße
Description

Clinical Size of Tumor

Data type

integer

Alias
Code-1
Tumor size (observable entity)
UMLS CUI-1
C0475440
SNOMED CT-1
263605001
Code-2
Clinical
UMLS CUI-2
C0205210
SNOMED CT-2
58147004
N - Stadium der regionalen Lymphknoten
Description

Clinical N Stage

Data type

integer

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

Pathologic Primary Tumor Size

Data type

integer

Alias
Code-1
Tumor size (observable entity)
UMLS CUI-1
C0475440
SNOMED CT-1
263605001
Schnittrand infiltiert durch Tumor
Description

Margin involvement

Data type

boolean

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

Histologic Type

Data type

integer

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

other

Data type

string

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

Is carcinoma in situ present

Data type

boolean

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

Histologic Type

Data type

integer

Alias
Code-1
Histologic Type
UMLS CUI-1
C0449574
SNOMED CT-1
263541007
LOINC-1
MTHU020048
Morbus Paget der Mamille
Description

Is Paget's disease of the nipple present?

Data type

boolean

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

Histologic Grade

Data type

integer

Alias
UMLS CUI-1
C0919553
SNOMED CT-1
371469007
Lymphknotenbefall
Description

Lymphnode involvement

Data type

integer

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

Timing of chemotherapy

Data type

integer

Hematology And Biochemistry
Description

Hematology And Biochemistry

Data type

integer

Date of blood specimen collection
Description

Date of blood specimen collection

Data type

date

Result
Description

Result

Data type

integer

History Of Primary Cancer (continued)
Description

History Of Primary Cancer (continued)

Name Labor
Description

Laboratory Name

Data type

string

Alias
Code-1
Laboratory
UMLS CUI-1
C0022877
SNOMED CT-1
261904005
Östrogen-Rezeptor
Description

ER status

Data type

integer

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

Is estrogen receptor analysis result available

Data type

boolean

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

Estrogen receptor value

Data type

integer

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

H-Score

Data type

integer

Allred-Score
Description

Allred-Score

Data type

integer

Remmle score
Description

Remmle score

Data type

integer

other
Description

other

Data type

string

Method
Description

Method

Data type

string

Range
Description

Range

Data type

string

Progesteron-Rezeptor
Description

PgR Status

Data type

integer

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

Is progesterone receptor analysis result available

Data type

boolean

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

Progesterone receptor value

Data type

integer

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

H-Score

Data type

integer

Allred-Score
Description

Allred-Score

Data type

integer

Remmle score
Description

Remmle score

Data type

integer

other
Description

other

Data type

string

Method
Description

Method

Data type

string

Range
Description

Range

Data type

string

Sentinel Node Sampling
Description

Sentinel Node Sampling

Durchführung Sentinellymphknotenbiopsie
Description

Was sentinel node sampling performed

Data type

boolean

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

Sentinel Node Biopsy Date

Data type

date

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

Laterality

Data type

integer

Alias
UMLS CUI-1
C0441987
SNOMED CT-1
182353008
LOINC-1
MTHU014973
Code-2
Sentinel Lymph Node Biopsy
UMLS CUI-2
C0796693
SNOMED CT-2
396487001
Sentinellymphknoten Biospie Axilla
Description

Axillary sentinel node biopsy

Data type

integer

Alias
Code-1
Sentinel Lymph Node Biopsy
UMLS CUI-1
C0796693
SNOMED CT-1
396487001
Code-2
Axilla
UMLS CUI-2
C0004454
SNOMED CT-2
91470000
LOINC-2
MTHU024430
Sentinel Biopsie der internen Brustlymphknoten
Description

Internal sentinel mammary nodes biopsy

Data type

integer

Alias
Code-1
Internal mammary node (body structure)
UMLS CUI-1
C0447180
SNOMED CT-1
245340002
Code-2
Sentinel Lymph Node Biopsy
UMLS CUI-2
C0796693
SNOMED CT-2
396487001
nicht durchgeführt
Description

Not done

Data type

string

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

Most Extensive Primary Surgery

Operation
Description

Primary breast cancer surgery

Data type

integer

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

Specify

Data type

string

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

Laterality

Data type

integer

Alias
Code-1
Operative Surgical Procedures
UMLS CUI-1
C0543467
SNOMED CT-1
387713003
MedDRA-1
10042609
LOINC-1
MTHU007597
Code-2
Side
UMLS CUI-2
C0441987
SNOMED CT-2
182353008
LOINC-2
MTHU014973
Datum der OP
Description

Primary surgery Date

Data type

date

Alias
Code-1
Date surgery
UMLS CUI-1
C1628561
LOINC-1
MTHU019327
Axilladissektion
Description

Axilladissektion

Datum Axilladissektion
Description

Date of Axillary Dissection

Data type

date

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

Laterality

Data type

integer

Alias
Code-1
Axillary Lymph Node Dissection
UMLS CUI-1
C0193867
SNOMED CT-1
234254000
MedDRA-1
10068477
Code-2
Side
UMLS CUI-2
C0441987
SNOMED CT-2
182353008
LOINC-2
MTHU014973
Anzahl der untersuchten Lymphknoten
Description

Number of Lymph Nodes examinded

Data type

integer

Alias
UMLS CUI-1
C2733494
SNOMED CT-1
444025001
Anzahl der beteiligten Lymphknoten
Description

Number positive Lymph nodes

Data type

integer

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

Largest tumor deposit

Data type

integer

nicht durchgeführt
Description

Not done

Data type

string

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

Chemotherapy

Chemotherapie Substanz
Description

Agent Name

Data type

string

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

Total Dose

Data type

integer

Alias
UMLS CUI-1
C2986497
erste Dosis
Description

initial dose

Data type

integer

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

Total No. Cycles

Data type

integer

Alias
Code-1
Plan
UMLS CUI-1
C1301732
SNOMED CT-1
397943006
Code-2
Chemotherapy cycle (procedure)
UMLS CUI-2
C1302181
SNOMED CT-2
399042005
Intention - letzte Chemotherapie
Description

Prior Treatment Regimen Type

Data type

integer

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

Date Started

Data type

date

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

Date Stopped

Data type

date

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

Previous Or Current Cardiovascular Disease

nicht_sinnvoll_für_Untersuchung
Description

Has the patient suffered cardiovascular disease?

Data type

boolean

nicht_sinnvoll_für_Untersuchung
Description

Medical condition

Data type

string

nicht_sinnvoll_für_Untersuchung
Description

Medical condition

Data type

integer

nicht_sinnvoll_für_Untersuchung
Description

Treatment Required

Data type

boolean

nicht_sinnvoll_für_Untersuchung
Description

Has the patient been assessed for systemic disease

Data type

boolean

ECG
Description

ECG

Alias
UMLS CUI-1
C1623258
nicht_sinnvoll_für_Untersuchung
Description

Type of radiological Examination

Data type

integer

nicht_sinnvoll_für_Untersuchung
Description

Specify

Data type

string

nicht_sinnvoll_für_Untersuchung
Description

Anatomical Site

Data type

integer

nicht_sinnvoll_für_Untersuchung
Description

Date of test

Data type

date

nicht_sinnvoll_für_Untersuchung
Description

Are there any clinically significant abnormalites

Data type

boolean

nicht_sinnvoll_für_Untersuchung
Description

Specify

Data type

string

nicht_sinnvoll_für_Untersuchung
Description

Not done

Data type

string

Translational Research
Description

Translational Research

nicht_sinnvoll_für_Untersuchung
Description

Type of tissue

Data type

integer

nicht_sinnvoll_für_Untersuchung
Description

Date of blood specimen collection

Data type

date

nicht_sinnvoll_für_Untersuchung
Description

Was sample obtained

Data type

boolean

Central Her2 Testing Form - FISH
Description

Central Her2 Testing Form - FISH

Percentage greater than or equal to 3 Chromosome 17 signals
Description

Percentage greater than or equal to 3 Chromosome 17 signals

Data type

string

NACA (No apparent Chromosome 17 anomaly)
Description

NACA (No apparent Chromosome 17 anomaly)

Data type

boolean

Why no result
Description

Why no result

Data type

integer

Specify
Description

Specify

Data type

string

Other features
Description

Other features

Data type

integer

Central Her2 Testing Form - IHC
Description

Central Her2 Testing Form - IHC

nicht_sinnvoll_für_Untersuchung
Description

Percentage of invasive tumor cells with complete membrane staining

Data type

integer

Uniformity of staining
Description

Uniformity of staining

Data type

integer

Homogeneous dark circumferential pattern
Description

Homogeneous dark circumferential pattern

Data type

integer

Her-2/neu
Description

IHC Result

Data type

integer

Alias
Code-1
Her2/Neu Status
UMLS CUI-1
C1512413
Gefäßinvasion
Description

Is there vascular invasion

Data type

boolean

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

Suitable for TMA

Data type

boolean

Radiotherapy
Description

Radiotherapy

Strahlentherapie durchgeführt
Description

prior Radiation Therapy

Data type

boolean

Alias
Code-1
Therapeutic radiology procedure
UMLS CUI-1
C1522449
SNOMED CT-1
108290001
MedDRA-1
10037770
Ort der Bestrahlung
Description

RT Site

Data type

string

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

Side

Data type

integer

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

RT Total Dose

Data type

integer

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

Dose UOM

Data type

integer

Beginn Strahlentherapie
Description

Radiation Therapy Start Date

Data type

date

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

Radiation Therapy End Date

Data type

date

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

Hormonetherapy

Alias
UMLS CUI-1
C0279025
Hormon- / endokrine Therapie
Description

Endocrine Therapy

Data type

boolean

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

Name of treatment or surgical procedure

Data type

string

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

Dose

Data type

integer

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

Unit

Data type

integer

Alias
UMLS CUI-1
C0565912
SNOMED CT-1
288462000
Datum Therapiebeginn - endokrine Therapie
Description

Begin date

Data type

date

Alias
Code-1
Date treatment started (observable entity)
UMLS CUI-1
C3173309
SNOMED CT-1
413946009
Code-2
Endocrine Therapy
UMLS CUI-2
C0279025
SNOMED CT-2
169413002
Datum Therapieende - endokrine Therapie
Description

End date

Data type

date

Alias
Code-1
Date treatment stopped (observable entity)
UMLS CUI-1
C1531784
SNOMED CT-1
413947000
Code-2
Endocrine Therapy
UMLS CUI-2
C0279025
SNOMED CT-2
169413002
fortlaufend am Studienende
Description

ongoing at time of study completion

Data type

integer

Alias
Code-1
Continue
UMLS CUI-1
C0750536
Code-2
Study End Date
UMLS CUI-2
C2983670
Code-3
Endocrine Therapy
UMLS CUI-3
C0279025
SNOMED CT-3
169413002
Concomitant Treatment
Description

Concomitant Treatment

Name Nebentherapie
Description

Name of treatment

Data type

string

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

Indication for use

Data type

integer

Alias
UMLS CUI-1
C1283828
SNOMED CT-1
367565008
Code-2
Concomitant Therapy
UMLS CUI-2
C1707479
Datum Therapiebeginn
Description

Date started

Data type

date

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

Date stopped

Data type

date

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

Ongoing

Data type

integer

Alias
Code-1
Continue
UMLS CUI-1
C0750536
Code-2
Study End Date
UMLS CUI-2
C2983670
Code-3
Concomitant Therapy
UMLS CUI-3
C1707479
Administration of Study Drug
Description

Administration of Study Drug

Date Agent Administered
Description

Date Agent Administered

Data type

date

Einzeldosis
Description

Dose

Data type

integer

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

Total Dose

Data type

integer

Alias
UMLS CUI-1
C2986497
Was treatment delayed
Description

Was treatment delayed

Data type

boolean

Specify code
Description

Specify code

Data type

integer

specify
Description

specify

Data type

string

Dosislevel der Chemotherapie reduziert
Description

Was dose reduced

Data type

boolean

Alias
UMLS CUI-1
C0861114
Specify code
Description

Specify code

Data type

integer

specify
Description

specify

Data type

string

Chemotherapy
Description

Chemotherapy

Rezidivtherapie - Chemotherapie
Description

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

Data type

boolean

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

Agent Name

Data type

string

Total No. Cycles
Description

Total No. Cycles

Data type

integer

initial dose
Description

initial dose

Data type

integer

Dose UOM
Description

Dose UOM

Data type

integer

Date started
Description

Date started

Data type

date

Date stopped
Description

Date stopped

Data type

date

Targeted Therapy
Description

Targeted Therapy

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

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

Data type

boolean

Agent Name
Description

Agent Name

Data type

string

Total No. Cycles
Description

Total No. Cycles

Data type

integer

initial dose
Description

initial dose

Data type

integer

Dose UOM
Description

Dose UOM

Data type

integer

Date started
Description

Date started

Data type

date

Date stopped
Description

Date stopped

Data type

date

Hormonetherapy
Description

Hormonetherapy

Rezidivtherapie - Hormontherapie
Description

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

Data type

boolean

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

Agent Name

Data type

string

Total No. Cycles
Description

Total No. Cycles

Data type

integer

initial dose
Description

initial dose

Data type

integer

Dose UOM
Description

Dose UOM

Data type

integer

Date started
Description

Date started

Data type

date

Date stopped
Description

Date stopped

Data type

date

Radiotherapy
Description

Radiotherapy

Rezidivtherapie - Bestrahlung
Description

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

Data type

boolean

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

Radiation Therapy Site

Data type

string

Side
Description

Side

Data type

integer

Total Dose
Description

Total Dose

Data type

integer

Dose UOM
Description

Dose UOM

Data type

integer

Radiation Therapy Start Date
Description

Radiation Therapy Start Date

Data type

date

Radiation Therapy End Date
Description

Radiation Therapy End Date

Data type

date

Surgery
Description

Surgery

Rezidivtherapie - Operation
Description

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

Data type

boolean

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

Surgical site

Data type

string

Surgery Date
Description

Surgery Date

Data type

date

Adverse Event (AE)
Description

Adverse Event (AE)

Name Adverse Event
Description

AE Name

Data type

integer

Alias
UMLS CUI-1
C0877248
MedDRA-1
10060933
LOINC-1
MTHU014542
Laborwerte
Description

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

Data type

boolean

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

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

Data type

boolean

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

Niere/Blase

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

Infection Nos (Infection-Other (Specify))

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

Endocrine Other (Endocrine-Other (Specify))

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Adverse Event Associated with the Endocrine System
UMLS CUI-1
C1559198
CTCAE-1
MTHU112145
Herz, allgemein
Description

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

Data type

boolean

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

Haemoglobin Decreased (Hemoglobin)

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

Blood Creatinine Increased (Creatinine)

Data type

boolean

Alias
Code-Info
changed_datatype
Code-1
Creatinine Adverse Event
UMLS CUI-1
C1561535
CTCAE-1
MTHU116842
Peripherer Nerv
Description

Neuralgia Nos (Pain - Neuralgia/peripheral nerve)

Data type

boolean

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

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

Data type

boolean

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

Blood Bilirubin Increased (Bilirubin (hyperbilirubinemia))

Data type

boolean

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

Leucopenia Nos (Leukocytes (total WBC))

Data type

boolean

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

Blood Alkaline Phosphatase Nos Increased (Alkaline phosphatase)

Data type

boolean

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

Proteinuria Present (Proteinuria)

Data type

boolean

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

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

Data type

boolean

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

Constipation (Constipation)

Data type

boolean

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

Diarrhoea Nos (Diarrhea)

Data type

boolean

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

Haematuria Present (Hemorrhage, GU - Urinary NOS)

Data type

boolean

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

Pain Other (Pain-Other (Specify))

Data type

boolean

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

Platelet Count Decreased (Platelets)

Data type

boolean

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

Nausea (Nausea)

Data type

boolean

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

Arrhythmia Nos (Cardiac Arrhythmia-Other (Specify))

Data type

boolean

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

Pericarditis (Pericarditis)

Data type

boolean

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

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

Data type

boolean

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

Dyspnoea Nos (Dyspnea (shortness of breath))

Data type

boolean

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

Cystitis (Cystitis)

Data type

boolean

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

Vomiting Nos (Vomiting)

Data type

boolean

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

1024 more adverse events

Data type

integer

SAE reported
Description

SAE reported

Data type

boolean

CTCAE Begin Date
Description

CTCAE Begin Date

Data type

date

CTCAE End Date
Description

CTCAE End Date

Data type

date

Grad der Nebenwirkung
Description

CTC Adverse Event Grade

Data type

integer

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

CTC Adverse Event Outcomme

Data type

integer

Action Taken at Time of Adverse Event
Description

Action Taken at Time of Adverse Event

Data type

integer

relation to study drug
Description

relation to study drug

Data type

boolean

Second Primary Malignancy and Contralateral Breast Cancer
Description

Second Primary Malignancy and Contralateral Breast Cancer

Rezdivtumor
Description

Type of recurrence

Data type

string

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

Date of First Recurrence or Progression

Data type

date

Medizinische Untersuchung
Description

Method of Evaluation

Data type

integer

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

Biopsy

Data type

boolean

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

Biopsy Date

Data type

date

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

Specify other Histologic Type

Data type

string

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

Patient Status

Alias
UMLS CUI-1
C0449437
körperliche Untersuchung
Description

Date of Physical Exam

Data type

date

Alias
UMLS CUI-1
C0031809
SNOMED CT-1
5880005
MedDRA-1
10034986
LOINC-1
MTHU028014
Code-2
Date in time
UMLS CUI-2
C0011008
SNOMED CT-2
410671006
LOINC-2
MTHU021546
nicht durchgeführt
Description

Not done

Data type

string

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

Are there any changes since the previous assessment

Data type

boolean

Are there any changes since the previous assessment
Description

Are there any changes since the previous assessment

Data type

integer

Datum des letzten Kontaktes
Description

Date of last contact

Data type

date

Alias
Code-1
Date last contact
UMLS CUI-1
C0805839
LOINC-1
MTHU010432
ECOG Leistungszustand
Description

ECOG Performance Status

Data type

integer

Alias
UMLS CUI-1
C1632812
Systolischer Blutdruck
Description

Blood Pressure, systolic

Data type

integer

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

Blood Pressure, diastolic

Data type

integer

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

Cardiac Monitoring

Datum Linksventrikuläre Ejektionsfraktion
Description

Date of LVEF

Data type

date

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

LVEF

Data type

string

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

Echocardiogram

Data type

boolean

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

MUGA Scan

Data type

boolean

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

Result

Data type

integer

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

Symptomatic CHF

Data type

boolean

New York Heart Association
Description

New York Heart Association

Data type

integer

Mammogram
Description

Mammogram

Mammogramm
Description

Mammogram

Data type

integer

Alias
Code-1
Mammography
UMLS CUI-1
C0024671
SNOMED CT-1
71651007
MedDRA-1
10026735
Untersuchungsdatum
Description

Date of Test

Data type

date

Alias
Code-1
Mammography
UMLS CUI-1
C0024671
SNOMED CT-1
71651007
MedDRA-1
10026735
Code-2
Date in time
UMLS CUI-2
C0011008
SNOMED CT-2
410671006
LOINC-2
MTHU021546
nicht durchgeführt
Description

Not done

Data type

string

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

Are there any clinically significant abnormalites

Data type

boolean

specify
Description

specify

Data type

string

Hematoly and Biochemistry
Description

Hematoly and Biochemistry

Date of blood specimen collection
Description

Date of blood specimen collection

Data type

date

Result
Description

Result

Data type

integer

Survival Follow-Up
Description

Survival Follow-Up

Vitalstatus
Description

Vital Status

Data type

integer

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

Dead

Data type

date

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

Date of last contact

Data type

date

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

Investigator Signature

Data type

string

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

Date

Data type

date

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

Treatment Completion

nicht_sinnvoll_für_Untersuchung
Description

Did the patient complete Lapatinib as per protocol

Data type

integer

nicht_sinnvoll_für_Untersuchung
Description

Did the patient complete Trastuzumab as per protocol

Data type

integer

nicht_sinnvoll_für_Untersuchung
Description

Did the patient complete Paclitaxel as per protocol

Data type

integer

Grund für Therapeabbruch
Description

Reasons for treatment discontinuation

Data type

integer

Alias
Code-1
Discontinue
UMLS CUI-1
C1444662
SNOMED CT-1
410546004
Code-2
Indication of (contextual qualifier)
UMLS CUI-2
C0392360
SNOMED CT-2
410666004
LOINC-2
MTHU008319
Code-3
Therapeutic procedure
UMLS CUI-3
C0087111
SNOMED CT-3
277132007
MedDRA-3
10053757
LOINC-3
MTHU008880
Datum letzter Kontakt während Behandlungsperiode
Description

Date of last contact within treatment period

Data type

date

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

Additional Comments

CRF Page Number
Description

CRF Page Number

Data type

integer

Kommentar
Description

Comments

Data type

string

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

Investigator Signature

Data type

string

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

Date

Data type

date

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

Death Form

Todesdatum
Description

Date of Death

Data type

date

Alias
UMLS CUI-1
C1148348
SNOMED CT-1
399753006
LOINC-1
MTHU014693
Todesursache
Description

Primary Cause of death

Data type

integer

Alias
Code-1
Cause of Death
UMLS CUI-1
C0007465
SNOMED CT-1
184305005
andere Todesursache
Description

specify

Data type

string

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

Autopsy

Data type

integer

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

Please summarize findings

Data type

string

Similar models

Outcome of Pregnancy Breast Cancer NCT00490139

  1. StudyEvent: study documentation
    1. Outcome of Pregnancy Breast Cancer NCT00490139
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
NCCTG Study No
Item
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)
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)
Institution Number
Item
Institutions-Nr.
string
C0021622 (UMLS CUI-1)
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)
Institution
Item
Institution
string
C0021622 (UMLS CUI-1)
Item Group
Registration Header
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)
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)
Protocol Title (ALTTO: Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation Trial)
Item
Protocol Titel
string
Study Protocol (Code-1)
C2348563 (UMLS CUI-1)
Patient Medical Record Number
Item
Nr. Krankenakte
string
Medical record number (Code-1)
C1301894 (UMLS CUI-1)
398225001 (SNOMED CT-1)
MTHU021237 (LOINC-1)
Participating Group Code
Item
Gruppen-Code Teilnehmer
string
Study Protocol Version Participating Organization Type Code (Code-1)
C2986314 (UMLS CUI-1)
Are data amended (check one if data are amended, please circle in red when using paper form)
Item
veränderte Daten
boolean
Amended (Code-1)
C1691222 (UMLS CUI-1)
Data (Code-2)
C1511726 (UMLS CUI-2)
Item Group
Unnamed 1
Item
Registrierungs-Typ
integer
Type of registration (attribute) (Code-1)
C0449520 (UMLS CUI-1)
246243005 (SNOMED CT-1)
Code List
Registrierungs-Typ
CL Item
erste Einreichung (First Submission)
Submission (Code-1)
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)
Item
erste Einreichung
integer
Submission (Code-1)
C1515023 (UMLS CUI-1)
First (Code-2)
C0205435 (UMLS CUI-2)
255216001 (SNOMED CT-2)
Code List
erste Einreichung
CL Item
 (1)
CL Item
 (2)
Item Group
Contact Person For Pathology Results
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)
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)
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)
Fax
Item
Fax
string
Fax Number (Code-1)
C1549619 (UMLS CUI-1)
contact person (Code-2)
C0337611 (UMLS CUI-2)
70862002 (SNOMED CT-2)
CON (HL7 V3-2)
Pathology (Code-3)
C0030664 (UMLS CUI-3)
394595002 (SNOMED CT-3)
E-Mail
Item
E-Mail
string
E-mail Address (Code-1)
C1705961 (UMLS CUI-1)
contact person (Code-2)
C0337611 (UMLS CUI-2)
70862002 (SNOMED CT-2)
CON (HL7 V3-2)
Pathology (Code-3)
C0030664 (UMLS CUI-3)
394595002 (SNOMED CT-3)
Item Group
Patient Demographics
Item
Patienten-Geschlecht
integer
184100006 (SNOMED CT-1)
C0079399 (UMLS CUI)
Code List
Patienten-Geschlecht
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
Date of Birth
Item
Patienten-Geburtsdatum
date
C0421451 (UMLS CUI-1)
184099003 (SNOMED CT-1)
ZIP Code
Item
Postleitzahl Patient
integer
C0421454 (UMLS CUI-1)
184102003 (SNOMED CT-1)
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)
Method of Payment
Item
integer
Item
Rasse
integer
Racial group (Code-1)
C0034510 (UMLS CUI-1)
103579009 (SNOMED CT-1)
MTHU009923 (LOINC-1)
Code List
Rasse
CL Item
Kaukasier (White)
Caucasoid Race (Code-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)
CL Item
Pazifikinsulaner (Native Hawaiian or other Pacific Islander)
Pacific Island Americans (Code-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)
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)
CL Item
Nicht berichtet (Not Reported)
Not Stated (Code-1)
C1706613 (UMLS CUI-1)
CL Item
Unbekannt (Unknown)
Unknown (Code-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)
Code List
Ethnische Gruppe
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)
CL Item
Hispanoamerikanische Herkunft (HISPANIC OR LATINO)
Hispanics (Code-1)
C0086409 (UMLS CUI-1)
MTHU010274 (LOINC-1)
CL Item
Nicht berichtet (Not reported)
Not Stated (Code-1)
C1706613 (UMLS CUI-1)
CL Item
Unbekannt (Unknown)
Unknown (Code-1)
C0439673 (UMLS CUI-1)
261665006 (SNOMED CT-1)
Item Group
Eligibility Screening Form
Item
Einschlusskriterien
integer
Inclusion Criteria (Code-1)
C1512693 (UMLS CUI-1)
Code List
Einschlusskriterien
CL Item
Alter >= 18  (Age >= 18 years)
patient age (Code-1)
CL386174 (UMLS CUI-1)
CL Item
 (Baseline LVEF > 50% measured by echocardiography or MUGA scan after completion of all anthracycline-based (neo-) adjuvant chemotherapy and prior to the targeted therapy(ies)
zu_spezielles_item (Item-Info)
Left Ventricular Ejection Fraction (Code-1)
CL433348 (UMLS CUI-1)
Complete (Code-2)
C0205197 (UMLS CUI-2)
255594003 (SNOMED CT-2)
CL Item
 (Completion of all necessary baseline laboratory and radiological investigations)
CL Item
Eastern Cooperative Oncology Group (ecog) Performance Status < 1  (Eastern Cooperative Oncology Group (ECOG) performance status < 1)
Eastern Cooperative Oncology Group performance status - grade 0 (finding) (Code-1)
C1828078 (UMLS CUI-1)
425389002 (SNOMED CT-1)
CL Item
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)
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)
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)
CL Item
Einverständniserklärung unterschrieben (Signed written informed consent)
Informed consent obtained (Code-1)
C0514044 (UMLS CUI-1)
Item
Ausschlusskriterien
integer
Exclusion Criteria (Code-1)
C0680251 (UMLS CUI-1)
Code List
Ausschlusskriterien
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)
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)
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)
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)
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)
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)
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)
Item Group
Randomization
Date of Randomization
Item
date
Code List
Assigned Treatment Arm
CL Item
 (Trastuzumab alone)
CL Item
 (Lapatinib alone)
CL Item
 (Trastuzumab followed by Lapatinib)
CL Item
 (Lapatinib in combination with Trastuzumab)
Item Group
Informed consent
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)
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)
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)
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)
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)
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)
Item Group
Unnamed 1
Item
Menopausenstatus
integer
Menopause finding (finding) (Code-1)
C0455962 (UMLS CUI-1)
276477006 (SNOMED CT-1)
Code List
Menopausenstatus
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)
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)
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)
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)
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)
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)
Item
Schwangerschaftstest
integer
Pregnancy Tests (Code-1)
74036000 (SNOMED CT-1)
10036572 (MedDRA-1)
C0032976 (UMLS CUI)
Code List
Schwangerschaftstest
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
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)
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)
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)
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)
Code List
Seite Ovarektomie
CL Item
rechts (Right)
C0205090 (UMLS CUI-1)
24028007 (SNOMED CT-1)
CL Item
links (Left)
C0205091 (UMLS CUI-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)
Item Group
Patient Status
Date of Physical exam
Item
Datum körperliche Untersuchung
date
Physical Examination Date (Code-1)
C2826643 (UMLS CUI-1)
Item
körperliche Untersuchung
integer
C0031809 (UMLS CUI-1)
5880005 (SNOMED CT-1)
10034986 (MedDRA-1)
MTHU028014 (LOINC-1)
Code List
körperliche Untersuchung
CL Item
unauffällig (Normal)
Normal (Code-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)
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)
Height
Item
Größe
float
cm (Item-Info)
Length of body (observable entity) (Code-1)
248334005 (SNOMED CT-1)
C0005890 (UMLS CUI-1)
Weight
Item
Körpergewicht
float
kg (Item-Info)
Body Weight (Code-1)
27113001 (SNOMED CT-1)
MTHU001885 (LOINC-1)
C0005910 (UMLS CUI-1)
BSA
Item
Körperoberfläche
float
m^2 (Item-Info)
Body Surface Area (Code-1)
301898006 (SNOMED CT-1)
10050311 (MedDRA-1)
C0005902 (UMLS CUI-1)
Systolic blood pressure
Item
Systolischer Blutdruck
integer
Systolic Blood Pressure (Code-1)
271649006 (SNOMED CT-1)
C0871470 (UMLS CUI-1)
Diastolic blood pressure
Item
Diastolischer Blutdruck
integer
Diastolic Blood Pressure (Code-1)
271650006 (SNOMED CT-1)
C0428883 (UMLS CUI-1)
Heart rate
Item
Herzfrequenz
integer
beats/min (Item-Info)
heart rate (Code-1)
364075005 (SNOMED CT-1)
10019299 (MedDRA-1)
MTHU003114 (LOINC-1)
C0018810 (UMLS CUI-1)
Item
ECOG Leistungszustand
integer
C1632812 (UMLS CUI-1)
Code List
ECOG Leistungszustand
CL Item
0 (0)
Eastern Cooperative Oncology Group performance status - grade 0 (finding) (Code-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)
CL Item
2 (2)
Eastern Cooperative Oncology Group performance status - grade 2 (finding) (Code-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)
CL Item
4 (4)
Eastern Cooperative Oncology Group performance status - grade 4 (finding) (Code-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)
Item Group
ECG
C1623258 (UMLS CUI-1)
date of ECG
Item
date
Item
integer
Code List
Result
CL Item
 (Normal)
CL Item
 (Abnormal - Clinically significant)
CL Item
 (Abnormal - Not clinically significant)
Item Group
Cardiac Monitoring
C0150496 (UMLS CUI-1)
LVEF date
Item
Datum Linksventrikuläre Ejektionsfraktion
date
Left Ventricular Ejection Fraction (Code-1)
Date in time (Code-2)
410671006 (SNOMED CT-2)
MTHU021546 (LOINC-2)
C0428772 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
LVEF
Item
Linksventrikuläre Ejektionsfraktion
float
Left Ventricular Ejection Fraction (Code-1)
C0428772 (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)
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)
Item
Ergebnis
integer
Result (Code-1)
C1274040 (UMLS CUI-1)
394617004 (SNOMED CT-1)
Left Ventricular Ejection Fraction (Code-2)
CL433348 (UMLS CUI-2)
Code List
Ergebnis
CL Item
unauffällig (Normal)
Normal (Code-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)
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)
Symptomatic CHF
Item
boolean
Item
text
C1275491 (UMLS CUI-1)
Code List
NYHA Classification
CL Item
 (Class I)
CL Item
 (Class II)
CL Item
 (Class III)
CL Item
 (Class IV)
Item Group
Local Her2 Results
Item
integer
Code List
Staining Antibody
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
Item
Her2/Neu Status
integer
Her2/Neu Status (Code-1)
C1512413 (UMLS CUI-1)
Code List
Her2/Neu Status
CL Item
positiv (Positive )
HER2-positive carcinoma of breast (disorder) (Code-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)
CL Item
negativ (Negative )
HER2-negative breast cancer (Code-1)
CL412283 (UMLS CUI-1)
CL Item
Nicht auswertbar (Non-interpretable )
Unevaluable (Code-1)
C1883425 (UMLS CUI-1)
Percentage of invasive tumor cells with complete membrane staining
Item
integer
Code List
FISH Kit or Test Type
CL Item
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)
Code List
FisH-Test
CL Item
positiv (Amplified )
Positive Finding (Code-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)
CL Item
negativ (Not Amplified )
Negative Finding (Code-1)
C0205160 (UMLS CUI-1)
260385009 (SNOMED CT-1)
FISH HER2/neu chromosome 17 Ratio
Item
integer
Code List
Chromosome 17 copy number
CL Item
 (Polysomy )
CL Item
 (Monosomy )
CL Item
 (Normal )
Sample test date
Item
Test Datum
date
Test Date (Code-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)
Code List
CISH Kit or Test Type
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)
Code List
CISH
CL Item
positiv (Amplified )
Positive Finding (Code-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)
CL Item
negativ (Not Amplified )
Negative Finding (Code-1)
C0205160 (UMLS CUI-1)
260385009 (SNOMED CT-1)
Code List
Chromosome 17 copy number
CL Item
 (Polysomy )
CL Item
 (Monosomy )
CL Item
 (Normal )
Item Group
Hormonal Receptor Status
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)
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)
Item Group
History Of Primary Breast Cancer
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)
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)
Code List
Körperseite Tumor
CL Item
links (Left)
C0205091 (UMLS CUI-1)
7771000 (SNOMED CT-1)
CL Item
rechts (Right)
C0205090 (UMLS CUI-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)
Item
N - Stadium der regionalen Lymphknoten
integer
cN category (observable entity) (Code-1)
C1275865 (UMLS CUI-1)
399534004 (SNOMED CT-1)
Code List
N - Stadium der regionalen Lymphknoten
CL Item
N0 Stadium  (N0)
N0 Stage Finding (Code-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)
CL Item
N2 Stadium (N2)
N2 Stage Finding (Code-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)
Pathologic Primary Tumor Size
Item
Tumorgröße
integer
Tumor size (observable entity) (Code-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)
Item
histologischer Typ
integer
Histologic Type (Code-1)
C0449574 (UMLS CUI-1)
263541007 (SNOMED CT-1)
MTHU020048 (LOINC-1)
Code List
histologischer Typ
CL Item
Duktales Karzinom (Ductal NOS)
Ductal Breast Carcinoma (Code-1)
C1527349 (UMLS CUI-1)
CL Item
invasives lobuläre Karzinom (Lobular )
Invasive Lobular Breast Carcinoma (Code-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)
CL Item
tubulär (Tubular (pure > or =90%))
Tubular Breast Carcinoma (Code-1)
C0279561 (UMLS CUI-1)
CL Item
apokrin (Apocrine )
Apocrine Breast Carcinoma (Code-1)
C1332316 (UMLS CUI-1)
10066206 (MedDRA-1)
CL Item
Tubulolobulär  (Tubulolobular )
Invasive Lobular Breast Carcinoma, Tubulolobular Variant (Code-1)
CL429657 (UMLS CUI-1)
CL Item
Mikropapillär (Micropapillary )
Invasive Micropapillary Breast Carcinoma (Code-1)
C1334279 (UMLS CUI-1)
CL Item
Cribriform  (Cribriform )
Invasive Cribriform Breast Carcinoma (Code-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)
CL Item
invasives Karzinom (Invasive NOS)
Invasive Breast Carcinoma (Code-1)
C0853879 (UMLS CUI-1)
10006190 (MedDRA-1)
CL Item
Medulläres Karzinom (Medullary)
Medullary Breast Carcinoma (Code-1)
C0860580 (UMLS CUI-1)
CL Item
andere (other)
Other (Code-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)
Is carcinoma in situ present
Item
Carcinoma in Situ
boolean
Carcinoma in Situ (Code-1)
C0007099 (UMLS CUI-1)
109355002 (SNOMED CT-1)
10061450 (MedDRA-1)
D09.9 (ICD-10-CM-1)
234.9 (ICD-9-CM-1)
Item
histologischer Typ
integer
Histologic Type (Code-1)
C0449574 (UMLS CUI-1)
263541007 (SNOMED CT-1)
MTHU020048 (LOINC-1)
Code List
histologischer Typ
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)
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)
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)
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)
Item
Histopathologisches Grading
integer
C0919553 (UMLS CUI-1)
371469007 (SNOMED CT-1)
Code List
Histopathologisches Grading
CL Item
nicht bestimmbar (GX)
Grade cannot be determined (finding) (Code-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)
CL Item
G2 mäßig differenziert (G2)
G2 grade (finding) (Code-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)
Item
Lymphknotenbefall
integer
Lymph Node Involvement (Code-1)
C0806692 (UMLS CUI-1)
MTHU010351 (LOINC-1)
Code List
Lymphknotenbefall
CL Item
nicht anwendbar (Not Applicable)
Not Applicable (Code-1)
C1546968 (UMLS CUI-1)
385432009 (SNOMED CT-1)
NA (HL7 V3-1)
CL Item
 (Node negative, no neoadjuvant chemotherapy)
CL Item
 (1-3 positive nodes, no neoadjuvant chemotherapy)
CL Item
 (>= 4 positive nodes, no neoadjuvant chemotherapy)
Code List
Timing of chemotherapy
CL Item
 (Sequentially)
CL Item
 (Concurrently with targeted therapy)
Hematology And Biochemistry
Item
integer
Date of blood specimen collection
Item
date
Item
integer
Code List
Result
CL Item
 (Normal)
CL Item
 (Abnormal - Clinically significant)
CL Item
 (Abnormal - Not clinically significant)
Item Group
History Of Primary Cancer (continued)
Laboratory Name
Item
Name Labor
string
Laboratory (Code-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)
Code List
Östrogen-Rezeptor
CL Item
positiv (Positive )
Estrogen receptor positive tumor (disorder) (Code-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)
CL Item
unbekannt (Unknown)
Unknown (Code-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)
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)
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)
Code List
Progesteron-Rezeptor
CL Item
positiv (Positive )
Progesterone receptor positive tumor (disorder) (Code-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)
CL Item
unbekannt (Unknown)
Unknown (Code-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)
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)
H-Score
Item
integer
Allred-Score
Item
integer
Remmle score
Item
integer
other
Item
string
Method
Item
string
Range
Item
string
Item Group
Sentinel Node Sampling
Was sentinel node sampling performed
Item
Durchführung Sentinellymphknotenbiopsie
boolean
Sentinel Lymph Node Biopsy (Code-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)
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)
Code List
Körperseite
CL Item
rechts (Left)
C0205090 (UMLS CUI-1)
24028007 (SNOMED CT-1)
CL Item
links (Right)
C0205091 (UMLS CUI-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)
Code List
Sentinellymphknoten Biospie Axilla
CL Item
negativ (Negative)
Negative Finding (Code-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)
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)
Code List
Sentinel Biopsie der internen Brustlymphknoten
CL Item
negativ (Negative)
Negative Finding (Code-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)
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)
Item Group
Most Extensive Primary Surgery
Item
Operation
integer
Operative Surgical Procedures (Code-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)
CL Item
Segmentale Mastektomie (Quandrantectomy / Segmentectomy)
Segmental Mastectomy (Code-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)
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)
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)
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)
Code List
Seite
CL Item
rechts (Right)
C0205090 (UMLS CUI-1)
24028007 (SNOMED CT-1)
CL Item
links (Left)
C0205091 (UMLS CUI-1)
7771000 (SNOMED CT-1)
Primary surgery Date
Item
Datum der OP
date
Date surgery (Code-1)
C1628561 (UMLS CUI-1)
MTHU019327 (LOINC-1)
Item Group
Axilladissektion
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)
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)
Code List
Seite
CL Item
rechts (Right)
C0205090 (UMLS CUI-1)
24028007 (SNOMED CT-1)
CL Item
links (Left)
C0205091 (UMLS CUI-1)
7771000 (SNOMED CT-1)
Number of Lymph Nodes examinded
Item
Anzahl der untersuchten Lymphknoten
integer
C2733494 (UMLS CUI-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)
Code List
Largest tumor deposit
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)
Item Group
Chemotherapy
Agent Name
Item
Chemotherapie Substanz
string
Chemotherapeutic agent (product) (Code-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)
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)
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)
Code List
Intention - letzte Chemotherapie
CL Item
Neoadjuvant (Neoadjuvant)
Neo-adjuvant - intent (qualifier value) (Code-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)
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)
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)
Item Group
Previous Or Current Cardiovascular Disease
Has the patient suffered cardiovascular disease?
Item
nicht_sinnvoll_für_Untersuchung
boolean
Medical condition
Item
nicht_sinnvoll_für_Untersuchung
string
Item
nicht_sinnvoll_für_Untersuchung
integer
Code List
nicht_sinnvoll_für_Untersuchung
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
Item Group
ECG
C1623258 (UMLS CUI-1)
Item
nicht_sinnvoll_für_Untersuchung
integer
Code List
nicht_sinnvoll_für_Untersuchung
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
Item
nicht_sinnvoll_für_Untersuchung
integer
Code List
nicht_sinnvoll_für_Untersuchung
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
Item Group
Translational Research
Item
nicht_sinnvoll_für_Untersuchung
integer
Code List
nicht_sinnvoll_für_Untersuchung
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
Item Group
Central Her2 Testing Form - FISH
Percentage greater than or equal to 3 Chromosome 17 signals
Item
string
NACA (No apparent Chromosome 17 anomaly)
Item
boolean
Item
integer
Code List
Why no result
CL Item
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
Item
integer
Code List
Other features
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 )
Item Group
Central Her2 Testing Form - IHC
Percentage of invasive tumor cells with complete membrane staining
Item
nicht_sinnvoll_für_Untersuchung
integer
Code List
Uniformity of staining
CL Item
 (Present)
CL Item
 (Absent)
Code List
Homogeneous dark circumferential pattern
CL Item
 (Present)
CL Item
 (Absent)
Item
Her-2/neu
integer
Her2/Neu Status (Code-1)
C1512413 (UMLS CUI-1)
Code List
Her-2/neu
CL Item
negativ (Negative - 0)
HER2-negative breast cancer (Code-1)
CL412283 (UMLS CUI-1)
CL Item
negativ (Negative - 1+)
HER2-negative breast cancer (Code-1)
CL412283 (UMLS CUI-1)
CL Item
borderline (Equivocal - 2+)
Borderline (Code-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)
CL Item
positiv (Positive - 3+)
HER2-positive carcinoma of breast (disorder) (Code-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)
Is there vascular invasion
Item
Gefäßinvasion
boolean
Vascular invasion of tumor present (finding) (Code-1)
C1318569 (UMLS CUI-1)
372287009 (SNOMED CT-1)
Suitable for TMA
Item
boolean
Item Group
Radiotherapy
prior Radiation Therapy
Item
Strahlentherapie durchgeführt
boolean
Therapeutic radiology procedure (Code-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)
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)
Code List
Körperseite
CL Item
links (Left)
C0205091 (UMLS CUI-1)
7771000 (SNOMED CT-1)
CL Item
rechts (Right)
C0205090 (UMLS CUI-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)
Item
Dosis - Einheit
integer
Code List
Dosis - Einheit
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)
Radiation Therapy End Date
Item
Ende Strahlentherapie
date
Radiotherapy completed (situation) (Code-1)
C0436385 (UMLS CUI-1)
168534004 (SNOMED CT-1)
Item Group
Hormonetherapy
C0279025 (UMLS CUI-1)
Endocrine Therapy
Item
Hormon- / endokrine Therapie
boolean
169413002 (SNOMED CT-1)
10065646 (MedDRA-1)
C0279025 (UMLS CUI-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)
Dose
Item
Einzeldosis
integer
Single dose characteristic (observable entity) (Code-1)
C1960417 (UMLS CUI-1)
426146003 (SNOMED CT-1)
Item
Einheit
integer
C0565912 (UMLS CUI-1)
288462000 (SNOMED CT-1)
Code List
Einheit
CL Item
Milligramm (mg)
C0439210 (UMLS CUI-1)
258684004 (SNOMED CT-1)
CL Item
nicht anwendbar (N/A)
None or Not Applicable (Code-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)
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)
Item
fortlaufend am Studienende
integer
Continue (Code-1)
C0750536 (UMLS CUI-1)
Study End Date (Code-2)
C2983670 (UMLS CUI-2)
Endocrine Therapy (Code-3)
C0279025 (UMLS CUI-3)
169413002 (SNOMED CT-3)
Code List
fortlaufend am Studienende
CL Item
Ja (Yes)
C1298907 (UMLS CUI-1)
373066001 (SNOMED CT-1)
Item Group
Concomitant Treatment
Name of treatment
Item
Name Nebentherapie
string
Concomitant Therapy (Code-1)
C1707479 (UMLS CUI-1)
Item
Intention
integer
C1283828 (UMLS CUI-1)
367565008 (SNOMED CT-1)
Concomitant Therapy (Code-2)
C1707479 (UMLS CUI-2)
Code List
Intention
CL Item
Prävention (Prophylaxis)
Prophylactic treatment (Code-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)
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)
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)
Item
fortlaufend
integer
Continue (Code-1)
C0750536 (UMLS CUI-1)
Study End Date (Code-2)
C2983670 (UMLS CUI-2)
Concomitant Therapy (Code-3)
C1707479 (UMLS CUI-3)
Code List
fortlaufend
CL Item
Ja (Yes)
C1298907 (UMLS CUI-1)
373066001 (SNOMED CT-1)
Item Group
Administration of Study Drug
Date Agent Administered
Item
date
Dose
Item
Einzeldosis
integer
Single dose characteristic (observable entity) (Code-1)
C1960417 (UMLS CUI-1)
426146003 (SNOMED CT-1)
Total Dose
Item
kumulative Dosis
integer
C2986497 (UMLS CUI-1)
Was treatment delayed
Item
boolean
Item
integer
Code List
Specify code
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)
Item
integer
Code List
Specify code
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
Item Group
Chemotherapy
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)
Agent Name
Item
string
Total No. Cycles
Item
integer
initial dose
Item
integer
Item
integer
Code List
Dose UOM
CL Item
 (mg/m2)
Date started
Item
date
Date stopped
Item
date
Did the patient receive additional target therapy after recurrence of breast cancer or second primary malignancy of contralateral breast cancer
Item
boolean
Agent Name
Item
string
Total No. Cycles
Item
integer
initial dose
Item
integer
Item
integer
Code List
Dose UOM
CL Item
 (mg/m2)
Date started
Item
date
Date stopped
Item
date
Item Group
Hormonetherapy
Did the patient receive hormone therapy after recurrence of breast cancer or second primary malignancy of contralateral breast cancer
Item
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)
Agent Name
Item
string
Total No. Cycles
Item
integer
initial dose
Item
integer
Item
integer
Code List
Dose UOM
CL Item
 (mg/m2)
CL Item
 (N/A)
Date started
Item
date
Date stopped
Item
date
Item Group
Radiotherapy
Did the patient receive radiotherapy after recurrence of breast cancer or second primary malignancy of contralateral breast cancer
Item
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)
Radiation Therapy Site
Item
string
Item
integer
Code List
Side
CL Item
 (Left)
CL Item
 (Right)
Total Dose
Item
integer
Item
integer
Code List
Dose UOM
CL Item
 (mg/m2)
Radiation Therapy Start Date
Item
date
Radiation Therapy End Date
Item
date
Item Group
Surgery
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)
Surgical site
Item
string
Surgery Date
Item
date
Item Group
Adverse Event (AE)
AE Name
Item
Name Adverse Event
integer
C0877248 (UMLS CUI-1)
10060933 (MedDRA-1)
MTHU014542 (LOINC-1)
Metabolic/laboratory Other (Metabolic/Laboratory-Other (Specify))
Item
Laborwerte
boolean
changed_datatype (Code-Info)
Other Metabolic and Laboratory Adverse Event (Code-1)
C1559945 (UMLS CUI-1)
MTHU117254 (CTCAE-1)
Renal/genitourinary Other (Renal/Genitourinary-Other (Specify))
Item
Gastrointestinaltrakt
boolean
changed_datatype (Code-Info)
Adverse Event Associated with the Gastrointestinal System (Code-1)
C1559265 (UMLS CUI-1)
MTHU112146 (CTCAE-1)
Niere/Blase
Item
Urogenital-System
boolean
changed_datatype (Code-Info)
Renal or Genitourinary Other Adverse Event (Code-1)
C1558061 (UMLS CUI-1)
MTHU117419 (CTCAE-1)
Dermatology/skin Other (Dermatology/Skin-Other (Specify))
Item
Haut
boolean
changed_datatype (Code-Info)
Other Dermatology or Skin Adverse Event (Code-1)
C1559104 (UMLS CUI-1)
MTHU117246 (CTCAE-1)
Allergy/immunology Other (Allergy/Immunology-Other (Specify))
Item
Allergie
boolean
changed_datatype (Code-Info)
Adverse Event Associated with Allergy and Immunology (Code-1)
C1560126 (UMLS CUI-1)
MTHU112125 (CTCAE-1)
Pyrexia (Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L))
Item
Fieber
boolean
changed_datatype (Code-Info)
Fever Without Neutropenia Adverse Event (Code-1)
C1556366 (UMLS CUI-1)
MTHU116933 (CTCAE-1)
Infection Nos (Infection-Other (Specify))
Item
Infektion
boolean
changed_datatype (Code-Info)
Adverse Event Associated with Infection (Code-1)
C1556682 (UMLS CUI-1)
MTHU112135 (CTCAE-1)
Auditory/ear Other (Auditory/Ear-Other (Specify))
Item
Sinnesorgane
boolean
changed_datatype (Code-Info)
Adverse Event Associated with the Ear and Auditory System (Code-1)
C1560154 (UMLS CUI-1)
MTHU112144 (CTCAE-1)
Constitutional Symptoms Other (Constitutional Symptoms-Other (Specify))
Item
Allgemeinsymptome
boolean
changed_datatype (Code-Info)
Adverse Event Associated with Constitutional Symptoms (Code-1)
C1556354 (UMLS CUI-1)
MTHU112129 (CTCAE-1)
Pulmonary/upper Respiratory Other (Pulmonary/Upper Respiratory-Other (Specify))
Item
Lunge/Kehlkopf
boolean
changed_datatype (Code-Info)
Adverse Event Associated with Pulmonary and Upper Respiratory Systems (Code-1)
C1557628 (UMLS CUI-1)
MTHU112139 (CTCAE-1)
Endocrine Other (Endocrine-Other (Specify))
Item
Endokrines System
boolean
changed_datatype (Code-Info)
Adverse Event Associated with the Endocrine System (Code-1)
C1559198 (UMLS CUI-1)
MTHU112145 (CTCAE-1)
Cardiac General Other (Cardiac General-Other (Specify))
Item
Herz, allgemein
boolean
changed_datatype (Code-Info)
Adverse Event Associated with the Heart in General (Code-1)
C1556247 (UMLS CUI-1)
MTHU112147 (CTCAE-1)
Haemoglobin Decreased (Hemoglobin)
Item
Hämoglobin
boolean
changed_datatype (Code-Info)
Hemoglobin Adverse Event (Code-1)
C2239101 (UMLS CUI-1)
MTHU116997 (CTCAE-1)
Aspartate Aminotransferase Increased (AST, SGOT (serum glutamic oxaloacetic transaminase))
Item
Aspartat-Transaminase
boolean
changed_datatype (Code-Info)
Serum Glutamic Oxaloacetic Transaminase Adverse Event (Code-1)
C1557198 (UMLS CUI-1)
MTHU117449 (CTCAE-1)
Alanine Aminotransferase Increased (ALT, SGPT (serum glutamic pyruvic transaminase))
Item
Alanin-Transaminase
boolean
changed_datatype (Code-Info)
Serum Glutamic Pyruvic Transaminase Adverse Event (Code-1)
C1557189 (UMLS CUI-1)
MTHU117450 (CTCAE-1)
Blood Creatinine Increased (Creatinine)
Item
Kreatinin
boolean
changed_datatype (Code-Info)
Creatinine Adverse Event (Code-1)
C1561535 (UMLS CUI-1)
MTHU116842 (CTCAE-1)
Neuralgia Nos (Pain - Neuralgia/peripheral nerve)
Item
Peripherer Nerv
boolean
changed_datatype (Code-Info)
Neuralgia and Peripheral Nerve Pain Adverse Event (Code-1)
C1557517 (UMLS CUI-1)
MTHU117196 (CTCAE-1)
Hemorrhage/bleeding Other (Hemorrhage/Bleeding-Other (Specify))
Item
Blutungen
boolean
changed_datatype (Code-Info)
Other Hemorrhage and Bleeding Adverse Event (Code-1)
C1556642 (UMLS CUI-1)
MTHU117250 (CTCAE-1)
Blood Bilirubin Increased (Bilirubin (hyperbilirubinemia))
Item
Bilirubin
boolean
changed_datatype (Code-Info)
Hyperbilirubinemia Adverse Event (Code-1)
C1557209 (UMLS CUI-1)
MTHU117008 (CTCAE-1)
Leucopenia Nos (Leukocytes (total WBC))
Item
Leukozyten
boolean
changed_datatype (Code-Info)
Leukocytes Adverse Event (Code-1)
C1560219 (UMLS CUI-1)
MTHU117099 (CTCAE-1)
Blood Alkaline Phosphatase Nos Increased (Alkaline phosphatase)
Item
Alkalische Phosphatase
boolean
changed_datatype (Code-Info)
Alkaline Phosphatase Adverse Event (Code-1)
C1561546 (UMLS CUI-1)
MTHU112158 (CTCAE-1)
Proteinuria Present (Proteinuria)
Item
Proteinurie
boolean
changed_datatype (Code-Info)
Proteinuria Adverse Event (Code-1)
C1962972 (UMLS CUI-1)
MTHU117382 (CTCAE-1)
Alopecia (Hair loss/Alopecia (scalp or body))
Item
Haar
boolean
changed_datatype (Code-Info)
Alopecia Adverse Event (Code-1)
C1559115 (UMLS CUI-1)
MTHU112161 (CTCAE-1)
Constipation (Constipation)
Item
Obstipation
boolean
changed_datatype (Code-Info)
Constipation Adverse Event (Code-1)
C1963087 (UMLS CUI-1)
MTHU116803 (CTCAE-1)
Diarrhoea Nos (Diarrhea)
Item
Diarrhoe
boolean
changed_datatype (Code-Info)
Diarrhea Adverse Event (Code-1)
C0232708 (UMLS CUI-1)
MTHU116856 (CTCAE-1)
Haematuria Present (Hemorrhage, GU - Urinary NOS)
Item
Hämaturie
boolean
changed_datatype (Code-Info)
C0018965 (UMLS CUI-1)
34436003 (SNOMED CT-1)
10018867 (MedDRA-1)
R31.9 (ICD-10-CM-1)
599.7 (ICD-9-CM-1)
E13000 (CTCAE-1)
Pain Other (Pain-Other (Specify))
Item
Schmerzen
boolean
changed_datatype (Code-Info)
Other Pain Adverse Event (Code-1)
C1557623 (UMLS CUI-1)
MTHU117260 (CTCAE-1)
Platelet Count Decreased (Platelets)
Item
Thrombozyten
boolean
changed_datatype (Code-Info)
Platelets Adverse Event (Code-1)
C1963076 (UMLS CUI-1)
MTHU117353 (CTCAE-1)
Nausea (Nausea)
Item
Übelkeit
boolean
changed_datatype (Code-Info)
Nausea Adverse Event (Code-1)
C1963179 (UMLS CUI-1)
MTHU117189 (CTCAE-1)
Arrhythmia Nos (Cardiac Arrhythmia-Other (Specify))
Item
Herzrhythmus
boolean
changed_datatype (Code-Info)
Adverse Event Associated with Cardiac Arrhythmia (Code-1)
C1560249 (UMLS CUI-1)
MTHU112127 (CTCAE-1)
Pericarditis (Pericarditis)
Item
Perikarditis
boolean
changed_datatype (Code-Info)
Pericarditis Adverse Event (Code-1)
C1963211 (UMLS CUI-1)
MTHU117310 (CTCAE-1)
Depressed Level Of Consciousness (Somnolence/depressed level of consciousness)
Item
Bewusstsein
boolean
changed_datatype (Code-Info)
Somnolence and Depressed Level of Consciousness Adverse Event (Code-1)
C1557290 (UMLS CUI-1)
MTHU117503 (CTCAE-1)
Dyspnoea Nos (Dyspnea (shortness of breath))
Item
Dyspnoe
boolean
changed_datatype (Code-Info)
Dyspnea Adverse Event (Code-1)
C1963100 (UMLS CUI-1)
MTHU116873 (CTCAE-1)
Cystitis (Cystitis)
Item
Zystitis
boolean
changed_datatype (Code-Info)
Cystitis Adverse Event (Code-1)
C1963088 (UMLS CUI-1)
MTHU116844 (CTCAE-1)
Vomiting Nos (Vomiting)
Item
Vomiting
boolean
changed_datatype (Code-Info)
Vomiting Adverse Event (Code-1)
C1963281 (UMLS CUI-1)
MTHU117700 (CTCAE-1)
1024 more adverse events
Item
1024 more adverse events
integer
SAE reported
Item
boolean
CTCAE Begin Date
Item
date
CTCAE End Date
Item
date
CTC Adverse Event Grade
Item
Grad der Nebenwirkung
integer
Adverse Event Grade Code (Code-1)
C2985911 (UMLS CUI-1)
Code List
CTC Adverse Event Outcomme
CL Item
 (resolved)
CL Item
 (improved)
CL Item
 (ongoing)
CL Item
 (resolved with sequelae)
CL Item
 (fatal)
Code List
Action Taken at Time of Adverse Event
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)
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)
Code List
Medizinische Untersuchung
CL Item
körperliche Untersuchung (Clinical)
C0031809 (UMLS CUI-1)
5880005 (SNOMED CT-1)
10034986 (MedDRA-1)
MTHU028014 (LOINC-1)
CL Item
radiologisch (Radiological)
Diagnostic radiologic examination (Code-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)
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)
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)
Item Group
Patient Status
C0449437 (UMLS CUI-1)
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)
Not done
Item
nicht durchgeführt
string
Not Done (Code-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)
CL Item
Zweittumor (Second primary malignancy or contralateral breast cancer)
Secondary Malignant Neoplasm (Code-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)
CL Item
 (Adverse Event)
Adverse event (Code-1)
C0877248 (UMLS CUI-1)
10060933 (MedDRA-1)
MTHU014542 (LOINC-1)
CL Item
Patient verstorben (Death )
Patient died (finding) (Code-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)
CL Item
 (Patient withdrew study consent)
Consent Withdrawn (Code-1)
C1707492 (UMLS CUI-1)
Date of last contact
Item
Datum des letzten Kontaktes
date
Date last contact (Code-1)
C0805839 (UMLS CUI-1)
MTHU010432 (LOINC-1)
Item
ECOG Leistungszustand
integer
C1632812 (UMLS CUI-1)
Code List
ECOG Leistungszustand
CL Item
0 (0)
Eastern Cooperative Oncology Group performance status - grade 0 (finding) (Code-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)
CL Item
2 (2)
Eastern Cooperative Oncology Group performance status - grade 2 (finding) (Code-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)
CL Item
4 (4)
Eastern Cooperative Oncology Group performance status - grade 4 (finding) (Code-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)
Blood Pressure, systolic
Item
Systolischer Blutdruck
integer
Systolic Blood Pressure (Code-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)
Item Group
Cardiac Monitoring
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)
LVEF
Item
Linksventrikuläre Ejektionsfraktion
string
Left Ventricular Ejection Fraction (Code-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)
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)
Item
Ergebnis
integer
Result (Code-1)
C1274040 (UMLS CUI-1)
394617004 (SNOMED CT-1)
Left Ventricular Ejection Fraction (Code-2)
CL433348 (UMLS CUI-2)
Code List
Ergebnis
CL Item
unauffällig (Normal)
Normal (Code-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)
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)
Symptomatic CHF
Item
boolean
Code List
New York Heart Association
CL Item
 (Class I)
CL Item
 (Class II)
CL Item
 (Class III)
CL Item
 (Class IV)
Item Group
Mammogram
Item
Mammogramm
integer
Mammography (Code-1)
C0024671 (UMLS CUI-1)
71651007 (SNOMED CT-1)
10026735 (MedDRA-1)
Code List
Mammogramm
CL Item
rechts (Right)
C0205090 (UMLS CUI-1)
24028007 (SNOMED CT-1)
CL Item
links (Left)
C0205091 (UMLS CUI-1)
7771000 (SNOMED CT-1)
CL Item
beidseits (Bilateral)
C0238767 (UMLS CUI-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)
Not done
Item
nicht durchgeführt
string
Not Done (Code-1)
C1272696 (UMLS CUI-1)
385660001 (SNOMED CT-1)
Are there any clinically significant abnormalites
Item
boolean
specify
Item
string
Item Group
Hematoly and Biochemistry
Date of blood specimen collection
Item
date
Item
integer
Code List
Result
CL Item
 (Normal)
CL Item
 (Abnormal - Clinically significant)
CL Item
 (Abnormal - Not clinically significant)
Item Group
Survival Follow-Up
Item
Vitalstatus
integer
Vital status:Type:Point in time:^Patient:Nominal (Code-1)
C1146895 (UMLS CUI-1)
31210-8 (LOINC-1)
Code List
Vitalstatus
CL Item
lebend (Alive)
Alive (finding) (Code-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)
CL Item
keine Nachuntersuchung erfolgt (Lost To Follow-up)
Lost To Follow-up (Code-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)
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)
Investigator Signature
Item
Unterschrift Untersuchuer
string
Investigator Signature (Code-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)
Item Group
Treatment Completion
Item
nicht_sinnvoll_für_Untersuchung
integer
Code List
nicht_sinnvoll_für_Untersuchung
CL Item
nicht_sinnvoll_für_Untersuchung (Yes)
CL Item
nicht_sinnvoll_für_Untersuchung (No)
CL Item
nicht_sinnvoll_für_Untersuchung (Not Applicable)
Item
nicht_sinnvoll_für_Untersuchung
integer
Code List
nicht_sinnvoll_für_Untersuchung
CL Item
nicht_sinnvoll_für_Untersuchung (Yes)
CL Item
nicht_sinnvoll_für_Untersuchung (No)
CL Item
nicht_sinnvoll_für_Untersuchung (Not Applicable)
Item
nicht_sinnvoll_für_Untersuchung
integer
Code List
nicht_sinnvoll_für_Untersuchung
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)
Code List
Grund für Therapeabbruch
CL Item
Adverse Event  (Adverse Event)
Adverse event (Code-1)
C0877248 (UMLS CUI-1)
10060933 (MedDRA-1)
MTHU014542 (LOINC-1)
CL Item
Verletzung des Protokolls (Protocol violation)
Protocol Violation (Code-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)
CL Item
Zweittumor (second primary malignancy)
extended_coding (Code-Info)
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)
CL Item
Patient verstorben (Death )
Patient died (finding) (Code-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)
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)
Item Group
Additional Comments
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)
Investigator Signature
Item
Unterschrift Untersuchuer
string
Investigator Signature (Code-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)
Item Group
Death Form
Date of Death
Item
Todesdatum
date
C1148348 (UMLS CUI-1)
399753006 (SNOMED CT-1)
MTHU014693 (LOINC-1)
Item
Todesursache
integer
Cause of Death (Code-1)
C0007465 (UMLS CUI-1)
184305005 (SNOMED CT-1)
Code List
Todesursache
CL Item
Tumor Progression (Breast cancer progression)
Tumor Progression (Code-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)
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)
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)
CL Item
andere Todesursache (Other)
Other (Code-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)
Item
Autopsie
integer
Autopsy (Code-1)
29240004 (SNOMED CT-1)
10050117 (MedDRA-1)
89.8 (ICD-10-CM-1)
C0004398 (UMLS CUI)
Code List
Autopsie
CL Item
 (0)
CL Item
 (2)
CL Item
 (1)
Please summarize findings
Item
string