ID

44090

Beschrijving

Bogen 1 Einschluss Randomisierung TIGER Studie Version 22052012 Condition NCT01657604

Trefwoorden

  1. 04-01-14 04-01-14 -
  2. 04-01-14 04-01-14 -
  3. 07-01-14 07-01-14 -
  4. 06-06-15 06-06-15 - Martin Dugas
  5. 11-06-15 11-06-15 - Martin Dugas
  6. 15-03-21 15-03-21 - Dr. rer. medic Philipp Neuhaus
  7. 20-09-21 20-09-21 -
Geüploaded op

20 september 2021

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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CML TIGER inclusion DRKS00005243 NCT01657604

Bogen 1 Einschluss Randomisierung CML NCT01657604

  1. StudyEvent: Bogen 1 Einschluss Randomisierung
    1. Bogen 1 Einschluss Randomisierung CML NCT01657604
Administrative Items
Beschrijving

Administrative Items

Hospital Identifier
Beschrijving

Klinik-Nr.

Datatype

integer

Alias
Code-1
Identifier
UMLS CUI 2011AB
C0600091
SNOMEDCT_2012_01_31
118522005
Code-2
Hospitals
UMLS CUI 2011AB
C0019994
LOINC Version 232
MTHU002722
Patient identifier
Beschrijving

Patienten-Nr.

Datatype

integer

Alias
Code-1
Identifier
UMLS CUI 2011AB
C0600091
SNOMEDCT_2012_01_31
118522005
Code-2
Patients
UMLS CUI 2011AB
C0030705
SNOMEDCT_2012_01_31
116154003
Date of birth
Beschrijving

Date of birth

Month of birth
Beschrijving

Geburtsmonat

Datatype

integer

Alias
Code-1
month
UMLS CUI 2011AB
C0439231
SNOMEDCT_2012_01_31
258706009
HL7 V3 2006_05
MO
Day of birth
Beschrijving

Geburtstag

Datatype

integer

Alias
Code-1
day
UMLS CUI 2011AB
C0439228
SNOMEDCT_2012_01_31
258703001
LOINC Version 232
MTHU039849
HL7 V3 2006_05
D
Administrative Items
Beschrijving

Administrative Items

Date of Evaluation
Beschrijving

Beurteilungsdatum

Datatype

date

Alias
Code-1
Evaluation
UMLS CUI 2011AB
C0220825
Code-2
Date in time
UMLS CUI 2011AB
C0011008
SNOMEDCT_2012_01_31
410671006
LOINC Version 232
MTHU021546
Date of diagnosis
Beschrijving

Diagnosedatum

Datatype

date

Alias
Code-1
Date of diagnosis
UMLS CUI 2011AB
C2316983
SNOMEDCT_2012_01_31
432213005
LOINC Version 232
MTHU038128
Sex
Beschrijving

Geschlecht

Datatype

integer

Alias
Code-1
Patient sex
UMLS CUI 2011AB
C0150831
SNOMEDCT_2012_01_31
184100006
Randomization
Beschrijving

Randomization

Medication
Beschrijving

Medikation

Datatype

integer

Alias
Code-1
Protocol Treatment Arm
UMLS CUI 2011AB
C1522541
Date of Randomization
Beschrijving

Datum der Randomisierung

Datatype

date

Alias
Code-1
Randomization
UMLS CUI 2011AB
C0034656
Code-2
Date in time
UMLS CUI 2011AB
C0011008
SNOMEDCT_2012_01_31
410671006
LOINC Version 232
MTHU021546
Randomization not possible
Beschrijving

nicht randomisierbar

Datatype

boolean

Alias
Code-1
Randomization
UMLS CUI 2011AB
C0034656
Code-2
Facility
UMLS CUI 2011AB
C1547538
LOINC Version 232
MTHU020558
Code-3
Negation
UMLS CUI 2011AB
C1518422
Reason of not possible Randomization
Beschrijving

Grund für nicht mögliche Randomisierung

Datatype

string

Alias
Code-1
Indication of (contextual qualifier)
UMLS CUI 2011AB
C0392360
SNOMEDCT_2012_01_31
410666004
LOINC Version 232
MTHU008319
Code-2
Randomization
UMLS CUI 2011AB
C0034656
Code-3
Facility
UMLS CUI 2011AB
C1547538
LOINC Version 232
MTHU020558
Code-4
Negation
UMLS CUI 2011AB
C1518422
Laboratory values
Beschrijving

Laboratory values

Date laboratory
Beschrijving

Datum der Laborwerte

Datatype

date

Alias
Code-1
Date in time
UMLS CUI 2011AB
C0011008
SNOMEDCT_2012_01_31
410671006
LOINC Version 232
MTHU021546
Code-2
Laboratory Procedures
UMLS CUI 2011AB
C0022885
SNOMEDCT_2012_01_31
15220000
MedDRA 14.1
10059938
Code-3
Result
UMLS CUI 2011AB
C1274040
SNOMEDCT_2012_01_31
394617004
Leukocytes (10^9/l)
Beschrijving

Leukozyten (10^9/l)

Datatype

integer

Alias
Code-1
Leukocytes:NCnc:Pt:Bld:Qn
UMLS CUI 2011AB
C0945357
LOINC Version 232
26464-8
Code-2
Billion Cells per Liter
UMLS CUI 2011AB
C0456524
SNOMEDCT_2012_01_31
277199001
Blasts (%)
Beschrijving

Blasten (%)

Datatype

integer

Alias
Code-1
Blasts/100 leukocytes:NFr:Pt:Bld:Qn
UMLS CUI 2011AB
C0942416
LOINC Version 232
26446-5 
Promyelocytes (%)
Beschrijving

Promyelozyten (%)

Datatype

integer

Alias
Code-1
Promyelocytes/100 leukocytes
UMLS CUI 2011AB
C0369884
LOINC Version 232
MTHU002430
Myelocytes, Metamyelocytes (%)
Beschrijving

Myelozyten, Metamyelozyten (%)

Datatype

integer

Alias
Code-1
Myelocytes/100 leukocytes
UMLS CUI 2011AB
C0369716
LOINC Version 232
MTHU007801
Code-2
Metamyelocytes/100 leukocytes:NFr:Pt:Bld:Qn
UMLS CUI 2011AB
C0944135
LOINC Version 232
28541-1 
Neutrophils - band form (%)
Beschrijving

Stabkernige (%)

Datatype

integer

Alias
Code-1
Neutrophils.band form/100 leukocytes:NFr:Pt:Bld:Qn
UMLS CUI 2011AB
C0942468
LOINC Version 232
26508-2
Neutrophils - segmented (%)
Beschrijving

Segmentkernige (%)

Datatype

integer

Alias
Code-1
Neutrophils.segmented/100 leukocytes:NFr:Pt:Bld:Qn
UMLS CUI 2011AB
C0942466
LOINC Version 232
26505-8
Eosinophils (%)
Beschrijving

Eosinophile (%)

Datatype

integer

Alias
Code-1
Eosinophils/100 leukocytes:NFr:Pt:Bld:Qn
UMLS CUI 2011AB
C0945354
LOINC Version 232
26450-7 
Basophils (%)
Beschrijving

Basophile (%)

Datatype

integer

Alias
Code-1
Basophils/100 leukocytes:NFr:Pt:Bld:Qn
UMLS CUI 2011AB
C1114065
LOINC Version 232
30180-4 
Monocytes (%)
Beschrijving

Monozyten (%)

Datatype

integer

Alias
Code-1
Monocytes/100 leukocytes:NFr:Pt:Bld:Qn
UMLS CUI 2011AB
C0942447
LOINC Version 232
26485-3
Lymphocytes (%)
Beschrijving

Lymphozyten (%)

Datatype

integer

Alias
Code-1
Lymphocytes/100 leukocytes:NFr:Pt:Bld:Qn
UMLS CUI 2011AB
C0942440
LOINC Version 232
26478-8
Normoblasts (%)
Beschrijving

Normoblasten (%)

Datatype

integer

Alias
Code-1
Normoblasts/100 blasts:NFr:Pt:Bld:Qn
UMLS CUI 2011AB
C1316420
LOINC Version 232
33957-2
Platelets (10^9/L)
Beschrijving

Thrombozyten (10^9/L)

Datatype

integer

Alias
Code-1
Platelets:NCnc:Pt:Bld:Qn
UMLS CUI 2011AB
C0942474
LOINC Version 232
26515-7
Code-2
Billion Cells per Liter
UMLS CUI 2011AB
C0456524
SNOMEDCT_2012_01_31
277199001
Hemoglobin (mmol/L)
Beschrijving

Hemoglobin

Datatype

float

Maateenheden
  • mmol/L
Alias
Code-1
Hemoglobin:SCnc:Pt:Bld:Qn
LOINC Version 232
59260-0
UMLS CUI-1
C0019046
mmol/L
Hemoglobin (g/dL)
Beschrijving

Hämoglobin

Datatype

float

Maateenheden
  • g/dL
Alias
Code-1
Hemoglobin:MCnc:Pt:Bld:Qn
LOINC Version 232
718-7
UMLS CUI-1
C0019046
g/dL
Hematocrit (%)
Beschrijving

Hämatokrit (%)

Datatype

integer

Alias
Code-1
Hematocrit - finding
UMLS CUI 2011AB
C0518014
SNOMEDCT_2012_01_31
365616005
Urea (mg/dL)
Beschrijving

Harnstoff (mg/dL)

Datatype

integer

Alias
Code-1
Urea:MCnc:Pt:Bld:Qn
UMLS CUI 2011AB
C0803775
LOINC Version 232
20977-5 
Creatinine (mg/dL)
Beschrijving

Kreatinin (mg/dL)

Datatype

integer

Alias
Code-1
Creatinine:MCnc:Pt:Bld:Qn
UMLS CUI 2011AB
C1526484
LOINC Version 232
38483-4 
Urate (mg/dL)
Beschrijving

Harnsäure (mg/dL)

Datatype

integer

Alias
Code-1
Urate [Mass/volume] in Serum or Plasma
UMLS CUI 2011AB
C0365228
LOINC Version 232
3084-1
Code-2
mg/dl
UMLS CUI 2011AB
C0439269
SNOMEDCT_2012_01_31
258797006
Albumin (g/dL)
Beschrijving

Albumin (g/dL)

Datatype

integer

Alias
Code-1
Albumin:MCnc:Pt:Ser/Plas:Qn
UMLS CUI 2011AB
C0363885
LOINC Version 232
1751-7
Protein (g/dL)
Beschrijving

Protein (g/dL)

Datatype

integer

Alias
Code-1
Total Protein Measurement
UMLS CUI 2011AB
C0555903
SNOMEDCT_2012_01_31
304383000
MedDRA 14.1
10050537
Code-2
g/dL
UMLS CUI 2011AB
C0439267
SNOMEDCT_2012_01_31
258795003
Bilirubin - total (μmol/L)
Beschrijving

Bilirubin - total (μmol/L)

Datatype

float

Maateenheden
  • μmol/L
Alias
Code-1
Bilirubin.total [Moles/​volume] in Blood
LOINC Version 232
54363-7 
UMLS CUI-1
C0201913
μmol/L
Bilirubin - total (mg/dL)
Beschrijving

Bilirubin - total (mg/dL)

Datatype

float

Maateenheden
  • mg/dL
Alias
Code-1
Bilirubin:MCnc:Pt:Bld:Qn
LOINC Version 232
42719-5 
UMLS CUI-1
C0201913
mg/dL
Bilirubin - direct (μmol/L)
Beschrijving

Bilirubin direkt (μmol/L)

Datatype

integer

Alias
Code-1
Bilirubin.glucuronidated+Bilirubin.albumin bound:SCnc:Pt:Ser/Plas:Qn
UMLS CUI 2011AB
C0797804
LOINC Version 232
14629-0
Bilirubin - direkt (mg/dL)
Beschrijving

Bilirubin direkt (mg/dL)

Datatype

integer

Alias
Code-1
Bilirubin.glucuronidated+Bilirubin.albumin bound:MCnc:Pt:Ser/Plas:Qn
UMLS CUI 2011AB
C0364101
LOINC Version 232
1968-7
Bilirubin - indirect (μmol/L)
Beschrijving

Bilirubin indirekt (μmol/L)

Datatype

integer

Alias
Code-1
Bilirubin.non-glucuronidated:SCnc:Pt:Ser/Plas:Qn
UMLS CUI 2011AB
C0797805
LOINC Version 232
14630-8
Bilirubin - indirect (mg/dL)
Beschrijving

Bilirubin indirekt (mg/dL)

Datatype

integer

Alias
Code-1
Bilirubin.non-glucuronidated:MCnc:Pt:Ser/Plas:Qn
UMLS CUI 2011AB
C0364104
LOINC Version 232
1971-1
Alanine aminotransferase (U/L)
Beschrijving

ALAT (SGPT) (U/L)

Datatype

integer

Alias
Code-1
Alanine aminotransferase:CCnc:Pt:Ser/Plas:Qn
UMLS CUI 2011AB
C0363876
LOINC Version 232
1742-6 
Aspartate aminotransferase (U/L)
Beschrijving

ASAT (SGOT) (U/L)

Datatype

integer

Alias
Code-1
Aspartate aminotransferase:CCnc:Pt:Ser/Plas:Qn
UMLS CUI 2011AB
C0364055
LOINC Version 232
1920-8 
Lactate Dehydrogenase (U/L)
Beschrijving

LDH (U/L)

Datatype

integer

Alias
Code-1
Lactate Dehydrogenase
UMLS CUI 2011AB
C0022917
SNOMEDCT_2012_01_31
259319003
LOINC Version 232
MTHU002348
Code-2
Unit per Liter
UMLS CUI 2011AB
C0439339
SNOMEDCT_2012_01_31
258947003
Sodium (mmol/L)
Beschrijving

Natrium (mmol/L)

Datatype

integer

Alias
Code-1
Sodium:SCnc:Pt:Ser/Plas:Qn
UMLS CUI 2011AB
C0365095
LOINC Version 232
2951-2
Calcium (mmol/L)
Beschrijving

Kalzium (mmol/L)

Datatype

integer

Alias
Code-1
Calcium.ionized:SCnc:Pt:Ser/Plas:Qn
UMLS CUI 2011AB
C0364128
LOINC Version 232
1995-0
Phosphate (mmol/L)
Beschrijving

Phosphat (mmol/L)

Datatype

integer

Alias
Code-1
Phosphate:Mass Concentration:Point in time:Serum/Plasma:Quantitative
UMLS CUI 2011AB
C1370010
LOINC Version 232
2777-1
Triacylglycerol lipase (U/L)
Beschrijving

Lipase (U/L)

Datatype

integer

Alias
Code-1
Triacylglycerol lipase:CCnc:Pt:Ser/Plas:Qn
UMLS CUI 2011AB
C0365184
LOINC Version 232
3040-3
Amylase (U/L)
Beschrijving

Amylase (U/L)

Datatype

integer

Alias
Code-1
Amylase:CCnc:Pt:Ser/Plas:Qn
UMLS CUI 2011AB
C0484652
LOINC Version 232
1798-8
Potassium (mmol/L)
Beschrijving

Kalium (mmol/L)

Datatype

integer

Alias
Code-1
Potassium:SCnc:Pt:Ser/Plas:Qn
UMLS CUI 2011AB
C0364968
LOINC Version 232
2823-3
Magnesium (mmol/L)
Beschrijving

Magnesium (mmol/L)

Datatype

integer

Alias
Code-1
Magnesium:Substance Concentration:Point in time:Serum/Plasma:Quantitative
UMLS CUI 2011AB
C0364745
LOINC Version 232
2601-3 
Thyrotropin (mU/L)
Beschrijving

TSH (mU/L)

Datatype

integer

Alias
Code-1
Thyrotropin:ACnc:Pt:Bld:Qn
UMLS CUI 2011AB
C0365159
LOINC Version 232
3015-5
Glucose: (mg/dL)
Beschrijving

Glukose (mg/dL)

Datatype

integer

Alias
Code-1
Glucose:MCnc:Pt:Bld:Qn
UMLS CUI 2011AB
C0364479
LOINC Version 232
2339-0
Glucose (mmol/L)
Beschrijving

Glukose (mmol/L)

Datatype

integer

Alias
Code-1
Glucose:SCnc:Pt:Bld:Qn
UMLS CUI 2011AB
C0798246
LOINC Version 232
15074-8
Hemoglobin A1c
Beschrijving

Hemoglobin A1c

Datatype

float

Maateenheden
  • mmol/L
Alias
Code-1
Hemoglobin A1c measurement
SNOMEDCT_2012_01_31
43396009
Code-2
Millimole
SNOMEDCT_2012_01_31
258718000
Code-3
Per
Code-4
Mole, unit of measurement
SNOMEDCT_2012_01_31
258717005
HL7 V3 2006_05
MOL
UMLS CUI-1
C0474680
mmol/L
Cholesterol (mg/dL)
Beschrijving

Cholesterin (mg/dL)

Datatype

integer

Alias
Code-1
Cholesterol:Mass Concentration:Point in time:Serum/Plasma:Quantitative
UMLS CUI 2011AB
C0364708
LOINC Version 232
2093-3
Cholesterol (mmol/L)
Beschrijving

Cholesterin (mmol/L)

Datatype

integer

Alias
Code-1
Cholesterol:SCnc:Pt:Ser/Plas:Qn
UMLS CUI 2011AB
C0797822
LOINC Version 232
14647-2
Molecular Biology
Beschrijving

Molecular Biology

not performed
Beschrijving

nicht durchgeführt

Datatype

boolean

Alias
Code-1
Molecular biology method
UMLS CUI 2011AB
C0200924
SNOMEDCT_2012_01_31
108262000
Code-2
Negation
UMLS CUI 2011AB
C1518422
Code-3
Performed
UMLS CUI 2011AB
C0884358
SNOMEDCT_2012_01_31
398166005
Date of Performance
Beschrijving

Datum der Durchführung

Datatype

date

Alias
Code-1
Date in time
UMLS CUI 2011AB
C0011008
SNOMEDCT_2012_01_31
410671006
LOINC Version 232
MTHU021546
Code-2
Molecular biology method
UMLS CUI 2011AB
C0200924
SNOMEDCT_2012_01_31
108262000
BCR-ABL1 Fusion Protein Expression
Beschrijving

BCR-ABL1 Fusion Protein Expression

b2a2
Beschrijving

b2a2

Datatype

boolean

Alias
Code-1
BCR-ABL1 b2a2 fusion protein (CUI C1955180)
LOINC Version 232
MTHU026437
b3a2
Beschrijving

b3a2

Datatype

boolean

Alias
Code-1
BCR-ABL1 b3a2 fusion protein (CUI C1955181)
LOINC Version 232
MTHU026438
b2a3
Beschrijving

b2a3

Datatype

boolean

Alias
Code-1
t(BCR.e.13;ABL1.e.4)
UMLS CUI 2011AB
CL342155
b3a3
Beschrijving

b3a3

Datatype

boolean

Alias
Code-1
t(BCR.e.14;ABL1.e.4)
UMLS CUI 2011AB
CL340724
e1a2
Beschrijving

e1a2

Datatype

boolean

Alias
Code-1
BCR-ABL1 e1a2 fusion protein
UMLS CUI 2011AB
C2963376
LOINC Version 232
MTHU036003
e6a2
Beschrijving

e6a2

Datatype

boolean

Alias
Code-1
BCR/ABL1 Fusion Protein p190
UMLS CUI 2011AB
C0029006
e19a2
Beschrijving

e19a2

Datatype

boolean

Alias
Code-1
BCR/ABL1 Fusion Protein p230
UMLS CUI 2011AB
C2936177
other
Beschrijving

sonstige

Datatype

boolean

Alias
Code-1
Other
UMLS CUI 2011AB
C0205394
SNOMEDCT_2012_01_31
74964007
Code-2
BCR-ABL1 Fusion Protein Expression
UMLS CUI 2011AB
C1516132
other
Beschrijving

sonstige

Datatype

string

Alias
Code-1
Other
UMLS CUI 2011AB
C0205394
SNOMEDCT_2012_01_31
74964007
Code-2
BCR-ABL1 Fusion Protein Expression
UMLS CUI 2011AB
C1516132
Code-3
Free Text Format
UMLS CUI 2011AB
C2348713
no BCR-ABL Transcript
Beschrijving

kein BCR-ABL-Transkript

Datatype

boolean

Alias
Code-1
Negation
UMLS CUI 2011AB
C1518422
Code-2
BCR-ABL1 Fusion Protein Expression
UMLS CUI 2011AB
C1516132
Investigator/Place
Beschrijving

Untersucher/Ort

Datatype

string

Alias
Code-1
Investigator Name
UMLS CUI 2011AB
C2826892
Code-2
Place
UMLS CUI 2011AB
C0442504
SNOMEDCT_2012_01_31
257557008
HL7 V3 2006_05
PLC
Code-3
Molecular Biology
UMLS CUI 2011AB
C0026376
Laboratory Number
Beschrijving

Labor-Nr.

Datatype

integer

Alias
Code-1
Laboratory Identifier
UMLS CUI 2011AB
C2986056
Code-2
Molecular Biology
UMLS CUI 2011AB
C0026376
Quality of Life
Beschrijving

Quality of Life

Questionaire completed
Beschrijving

Fragebogen ausgefüllt

Datatype

boolean

Alias
Code-1
Quality of life assessment completed
UMLS CUI 2011AB
C1271978
SNOMEDCT_2012_01_31
391167008
Physical Examination
Beschrijving

Physical Examination

Date of Physical Examination
Beschrijving

Datum klinischer Befund

Datatype

date

Alias
Code-1
Date in time
UMLS CUI 2011AB
C0011008
SNOMEDCT_2012_01_31
410671006
LOINC Version 232
MTHU021546
Code-2
Physical Examination
UMLS CUI 2011AB
C0031809
SNOMEDCT_2012_01_31
5880005
MedDRA 14.1
10034986
LOINC Version 232
MTHU028014
ICD-9-CM Version 2011
89.7
Length of body
Beschrijving

Körpergröße (cm)

Datatype

integer

Alias
Code-1
Length of body (observable entity)
UMLS CUI 2011AB
C0221097
SNOMEDCT_2012_01_31
248334005
Body Weight
Beschrijving

Gewicht (kg)

Datatype

integer

Alias
Code-1
Body Weight
UMLS CUI 2011AB
C0005910
SNOMEDCT_2012_01_31
27113001
LOINC Version 232
MTHU001885
Size of Spleen with Palpation
Beschrijving

Milzgröße (palpiert unter dem Rippenbogen)

Datatype

integer

Alias
Code-1
Palpation of spleen
UMLS CUI 2011AB
C0030250
SNOMEDCT_2012_01_31
47241002
Code-2
size
UMLS CUI 2011AB
C0456389
SNOMEDCT_2012_01_31
246115007
LOINC Version 232
MTHU010347
Size of Spleen with Ultrasound, greatest diameter
Beschrijving

Milz in US, größter Durchmesser

Datatype

integer

Alias
Code-1
US scan of spleen
UMLS CUI 2011AB
C0412541
SNOMEDCT_2012_01_31
241476005
Code-2
Longest Diameter
UMLS CUI 2011AB
C0552406
LOINC Version 232
MTHU002939
Blood Pressure
Beschrijving

Blood Pressure

Systolic Blood Pressure
Beschrijving

Blutdruck systolisch

Datatype

integer

Alias
Code-1
Systolic Blood Pressure
UMLS CUI 2011AB
C0871470
SNOMEDCT_2012_01_31
271649006
Diastolic Blood Pressure
Beschrijving

Blutdruck diastolisch

Datatype

integer

Alias
Code-1
Diastolic Blood Pressure
UMLS CUI 2011AB
C0428883
SNOMEDCT_2012_01_31
271650006
Physical Examination
Beschrijving

Physical Examination

heart rate (/min)
Beschrijving

Herzfrequenz (/min)

Datatype

integer

Alias
Code-1
heart rate
UMLS CUI 2011AB
C0018810
SNOMEDCT_2012_01_31
364075005
MedDRA 14.1
10019299
LOINC Version 232
MTHU003114
Leukaemic infiltration extramedullary
Beschrijving

Extramedulläre Manifestationen

Datatype

boolean

Alias
Code-1
Leukaemic infiltration extramedullary
UMLS CUI 2011AB
C1868812
MedDRA 14.1
10067117
which (e.g. Lymph node, Skin, etc.)
Beschrijving

welche (z.B. LK, Haut, usw.)

Datatype

string

Alias
Code-1
Leukaemic infiltration extramedullary
UMLS CUI 2011AB
C1868812
MedDRA 14.1
10067117
Code-2
Free Text Format
UMLS CUI 2011AB
C2348713
Pre-existing Condition and concomitant disease
Beschrijving

Pre-existing Condition and concomitant disease

Pre-existing Condition and concomitant disease
Beschrijving

Vor- und Begleiterkrankung

Datatype

string

Alias
Code-1
Pre-existing Condition
UMLS CUI 2011AB
C0521987
SNOMEDCT_2012_01_31
102478008
Code-2
concomitant disease
UMLS CUI 2011AB
C0243087
Drugs
Beschrijving

Drugs

Drug
Beschrijving

Medikament

Datatype

string

Alias
Code-1
Pharmaceutical Preparations
UMLS CUI 2011AB
C0013227
SNOMEDCT_2012_01_31
410942007
Dosage
Beschrijving

Dosis

Datatype

integer

Alias
Code-1
Dosage
UMLS CUI 2011AB
C0178602
SNOMEDCT_2012_01_31
277406006
Code-2
Pharmaceutical Preparations
UMLS CUI 2011AB
C0013227
SNOMEDCT_2012_01_31
410942007
Dosage Form Unit
Beschrijving

Einheit der Dosis

Datatype

string

Alias
Code-1
Dosage Form Unit
UMLS CUI 2011AB
C2348328
Code-2
Pharmaceutical Preparations
UMLS CUI 2011AB
C0013227
SNOMEDCT_2012_01_31
410942007
Start Drug
Beschrijving

Beginn Medikament

Datatype

date

Alias
Code-1
Pharmaceutical Preparations
UMLS CUI 2011AB
C0013227
SNOMEDCT_2012_01_31
410942007
Code-2
Date treatment started (observable entity)
UMLS CUI 2011AB
C3173309
SNOMEDCT_2012_01_31
413946009
End Drug
Beschrijving

Ende Medikament

Datatype

date

Alias
Code-1
Pharmaceutical Preparations
UMLS CUI 2011AB
C0013227
SNOMEDCT_2012_01_31
410942007
Code-2
Date treatment stopped (observable entity)
UMLS CUI 2011AB
C1531784
SNOMEDCT_2012_01_31
413947000
continuing Medication
Beschrijving

andauernde Medikation

Datatype

boolean

Alias
Code-1
Continue
UMLS CUI 2011AB
C0549178
Code-2
Pharmaceutical Preparations
UMLS CUI 2011AB
C0013227
SNOMEDCT_2012_01_31
410942007
Bone Marrow Examination
Beschrijving

Bone Marrow Examination

Not performed
Beschrijving

nich durchgeführt

Datatype

boolean

Alias
Code-1
Not performed
UMLS CUI 2011AB
C0445106
SNOMEDCT_2012_01_31
262008008
Code-2
Bone Marrow Examination
UMLS CUI 2011AB
C0005957
SNOMEDCT_2012_01_31
167907006
MedDRA 14.1
10005988
No Information Available
Beschrijving

nicht vorliegend

Datatype

boolean

Alias
Code-1
No Information Available
UMLS CUI 2011AB
C1546437
Code-2
Bone Marrow Examination
UMLS CUI 2011AB
C0005957
SNOMEDCT_2012_01_31
167907006
MedDRA 14.1
10005988
Date of Performance
Beschrijving

Datum der Durchführung

Datatype

date

Alias
Code-1
Date in time
UMLS CUI 2011AB
C0011008
SNOMEDCT_2012_01_31
410671006
LOINC Version 232
MTHU021546
Code-2
Bone Marrow Examination
UMLS CUI 2011AB
C0005957
SNOMEDCT_2012_01_31
167907006
MedDRA 14.1
10005988
Cellularity
Beschrijving

Zellularität

Datatype

integer

Alias
Code-1
Cellularity
UMLS CUI 2011AB
C1516377
Blasts (%)
Beschrijving

Blasten (%)

Datatype

integer

Alias
Code-1
Blasts/100 cells:NFr:Pt:Bone mar:Qn
UMLS CUI 2011AB
C0549792
LOINC Version 232
11150-0
Promyelocytes (%)
Beschrijving

Promyelozyten (%)

Datatype

integer

Alias
Code-1
Promyelocytes/100 cells:NFr:Pt:Bone mar:Qn:Microscopy
UMLS CUI 2011AB
C0549848
LOINC Version 232
11120-3
Basophils (%)
Beschrijving

Basophile (%)

Datatype

integer

Alias
Code-1
Basophils/100 cells:NFr:Pt:Bone mar:Qn:Microscopy
UMLS CUI 2011AB
C0549791
LOINC Version 232
11105-4
Cytogenetics
Beschrijving

Cytogenetics

evaluted mitosis
Beschrijving

ausgewertete Mitosen

Datatype

integer

Alias
Code-1
Number
UMLS CUI 2011AB
C0449788
SNOMEDCT_2012_01_31
410681005
Code-2
Evaluation
UMLS CUI 2011AB
C0220825
Code-3
Mitosis
UMLS CUI 2011AB
C0026255
SNOMEDCT_2012_01_31
7041004
Normal karyotype
Beschrijving

Normaler Karyotyp

Datatype

integer

Alias
Code-1
Normal karyotype
UMLS CUI 2011AB
C0333684
SNOMEDCT_2012_01_31
2232008
Normal karyotype with addtional aberrations
Beschrijving

Normal, aber mit Zusatzaberrationen

Datatype

integer

Alias
Code-1
Normal karyotype
UMLS CUI 2011AB
C0333684
SNOMEDCT_2012_01_31
2232008
Code-2
Additional
UMLS CUI 2011AB
C1524062
LOINC Version 232
MTHU013802
Code-3
Chromosome Aberrations
UMLS CUI 2011AB
C0008625
Philadelphia Chromosome
Beschrijving

Philadelphia-Chromosom t(9;22)

Datatype

integer

Alias
Code-1
Philadelphia Chromosome
UMLS CUI 2011AB
C0031526
Philadelphia Chromosome with additional aberrations
Beschrijving

Philadelphia-Chromosom mit Zusatzaberrationen

Datatype

integer

Alias
Code-1
Philadelphia Chromosome
UMLS CUI 2011AB
C0031526
Code-2
Additional
UMLS CUI 2011AB
C1524062
LOINC Version 232
MTHU013802
Code-3
Chromosome Aberrations
UMLS CUI 2011AB
C0008625
Chromosome analysis result in ISCN expression
Beschrijving

Befunde nach ISCN:

Datatype

string

Alias
Code-1
Chromosome analysis result in ISCN expression
UMLS CUI 2011AB
C2963412
LOINC Version 232
MTHU036703
unevaluable mitosis
Beschrijving

Nicht auswertbare Mitosen

Datatype

integer

Alias
Code-1
Unevaluable
UMLS CUI 2011AB
C1883425
Code-2
Mitosis
UMLS CUI 2011AB
C0026255
SNOMEDCT_2012_01_31
7041004
Code-3
Number
UMLS CUI 2011AB
C0449788
SNOMEDCT_2012_01_31
410681005
Investigator/Place
Beschrijving

Untersucher/Ort

Datatype

string

Alias
Code-1
Investigator Name
UMLS CUI 2011AB
C2826892
Code-2
Place
UMLS CUI 2011AB
C0442504
SNOMEDCT_2012_01_31
257557008
HL7 V3 2006_05
PLC
Code-3
Bone Marrow Examination
UMLS CUI 2011AB
C0005957
SNOMEDCT_2012_01_31
167907006
MedDRA 14.1
10005988
Laboratory Number
Beschrijving

Labor-Nr.

Datatype

integer

Alias
Code-1
Laboratory Identifier
UMLS CUI 2011AB
C2986056
Code-2
Bone Marrow Examination
UMLS CUI 2011AB
C0005957
SNOMEDCT_2012_01_31
167907006
MedDRA 14.1
10005988
Signature
Beschrijving

Signature

Comment
Beschrijving

Kommentar

Datatype

string

Alias
Code-1
Comment
UMLS CUI 2011AB
C0947611
LOINC Version 232
MTHU013736
Hospital
Beschrijving

Klinik

Datatype

string

Alias
Code-1
Hospitals
UMLS CUI 2011AB
C0019994
LOINC Version 232
MTHU002722
Date
Beschrijving

Datum

Datatype

date

Alias
Code-1
Signature date
UMLS CUI 2011AB
C0807937
LOINC Version 232
MTHU008294
Signature
Beschrijving

Unterschrift

Datatype

string

Alias
Code-1
Investigator Signature
UMLS CUI 2011AB
C2346576

Similar models

Bogen 1 Einschluss Randomisierung CML NCT01657604

  1. StudyEvent: Bogen 1 Einschluss Randomisierung
    1. Bogen 1 Einschluss Randomisierung CML NCT01657604
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Items
Klinik-Nr.
Item
Hospital Identifier
integer
Identifier (Code-1)
C0600091 (UMLS CUI 2011AB)
118522005 (SNOMEDCT_2012_01_31)
Hospitals (Code-2)
C0019994 (UMLS CUI 2011AB)
MTHU002722 (LOINC Version 232)
Patienten-Nr.
Item
Patient identifier
integer
Identifier (Code-1)
C0600091 (UMLS CUI 2011AB)
118522005 (SNOMEDCT_2012_01_31)
Patients (Code-2)
C0030705 (UMLS CUI 2011AB)
116154003 (SNOMEDCT_2012_01_31)
Item Group
Date of birth
Geburtsmonat
Item
Month of birth
integer
month (Code-1)
C0439231 (UMLS CUI 2011AB)
258706009 (SNOMEDCT_2012_01_31)
MO (HL7 V3 2006_05)
Geburtstag
Item
Day of birth
integer
day (Code-1)
C0439228 (UMLS CUI 2011AB)
258703001 (SNOMEDCT_2012_01_31)
MTHU039849 (LOINC Version 232)
D (HL7 V3 2006_05)
Item Group
Administrative Items
Beurteilungsdatum
Item
Date of Evaluation
date
Evaluation (Code-1)
C0220825 (UMLS CUI 2011AB)
Date in time (Code-2)
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Diagnosedatum
Item
Date of diagnosis
date
Date of diagnosis (Code-1)
C2316983 (UMLS CUI 2011AB)
432213005 (SNOMEDCT_2012_01_31)
MTHU038128 (LOINC Version 232)
Item
Sex
integer
Patient sex (Code-1)
C0150831 (UMLS CUI 2011AB)
184100006 (SNOMEDCT_2012_01_31)
Code List
Sex
CL Item
Male (männlich)
Male gender (Code-1)
C0086582 (UMLS CUI 2011AB)
10052007 (SNOMEDCT_2012_01_31)
CL Item
Female (weiblich)
C0086287 (UMLS CUI 2011AB)
1086007 (SNOMEDCT_2012_01_31)
Item Group
Randomization
Item
Medication
integer
Protocol Treatment Arm (Code-1)
C1522541 (UMLS CUI 2011AB)
Code List
Medication
CL Item
Nilotinib 2*300mg (Nilotinib 2*300mg)
Nilotinib (Code-1)
C1721377 (UMLS CUI 2011AB)
427941004 (SNOMEDCT_2012_01_31)
Twice (Code-2)
C1948050 (UMLS CUI 2011AB)
Three (Code-3)
C0205449 (UMLS CUI 2011AB)
421291004 (SNOMEDCT_2012_01_31)
One Hundred (Code-4)
CL447292 (UMLS CUI 2011AB)
Milligram (Code-5)
C0439210 (UMLS CUI 2011AB)
258684004 (SNOMEDCT_2012_01_31)
CL Item
Nilotinib + PEG-IFN (Nilotinib + PEG-IFN)
Nilotinib (Code-1)
C1721377 (UMLS CUI 2011AB)
427941004 (SNOMEDCT_2012_01_31)
Pegylated Interferon Alfa (Code-2)
C0907160 (UMLS CUI 2011AB)
Datum der Randomisierung
Item
Date of Randomization
date
Randomization (Code-1)
C0034656 (UMLS CUI 2011AB)
Date in time (Code-2)
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
nicht randomisierbar
Item
Randomization not possible
boolean
Randomization (Code-1)
C0034656 (UMLS CUI 2011AB)
Facility (Code-2)
C1547538 (UMLS CUI 2011AB)
MTHU020558 (LOINC Version 232)
Negation (Code-3)
C1518422 (UMLS CUI 2011AB)
Grund für nicht mögliche Randomisierung
Item
Reason of not possible Randomization
string
Indication of (contextual qualifier) (Code-1)
C0392360 (UMLS CUI 2011AB)
410666004 (SNOMEDCT_2012_01_31)
MTHU008319 (LOINC Version 232)
Randomization (Code-2)
C0034656 (UMLS CUI 2011AB)
Facility (Code-3)
C1547538 (UMLS CUI 2011AB)
MTHU020558 (LOINC Version 232)
Negation (Code-4)
C1518422 (UMLS CUI 2011AB)
Item Group
Laboratory values
Datum der Laborwerte
Item
Date laboratory
date
Date in time (Code-1)
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Laboratory Procedures (Code-2)
C0022885 (UMLS CUI 2011AB)
15220000 (SNOMEDCT_2012_01_31)
10059938 (MedDRA 14.1)
Result (Code-3)
C1274040 (UMLS CUI 2011AB)
394617004 (SNOMEDCT_2012_01_31)
Leukozyten (10^9/l)
Item
Leukocytes (10^9/l)
integer
Leukocytes:NCnc:Pt:Bld:Qn (Code-1)
C0945357 (UMLS CUI 2011AB)
26464-8 (LOINC Version 232)
Billion Cells per Liter (Code-2)
C0456524 (UMLS CUI 2011AB)
277199001 (SNOMEDCT_2012_01_31)
Blasten (%)
Item
Blasts (%)
integer
Blasts/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0942416 (UMLS CUI 2011AB)
26446-5  (LOINC Version 232)
Promyelozyten (%)
Item
Promyelocytes (%)
integer
Promyelocytes/100 leukocytes (Code-1)
C0369884 (UMLS CUI 2011AB)
MTHU002430 (LOINC Version 232)
Myelozyten, Metamyelozyten (%)
Item
Myelocytes, Metamyelocytes (%)
integer
Myelocytes/100 leukocytes (Code-1)
C0369716 (UMLS CUI 2011AB)
MTHU007801 (LOINC Version 232)
Metamyelocytes/100 leukocytes:NFr:Pt:Bld:Qn (Code-2)
C0944135 (UMLS CUI 2011AB)
28541-1  (LOINC Version 232)
Stabkernige (%)
Item
Neutrophils - band form (%)
integer
Neutrophils.band form/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0942468 (UMLS CUI 2011AB)
26508-2 (LOINC Version 232)
Segmentkernige (%)
Item
Neutrophils - segmented (%)
integer
Neutrophils.segmented/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0942466 (UMLS CUI 2011AB)
26505-8 (LOINC Version 232)
Eosinophile (%)
Item
Eosinophils (%)
integer
Eosinophils/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0945354 (UMLS CUI 2011AB)
26450-7  (LOINC Version 232)
Basophile (%)
Item
Basophils (%)
integer
Basophils/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C1114065 (UMLS CUI 2011AB)
30180-4  (LOINC Version 232)
Monozyten (%)
Item
Monocytes (%)
integer
Monocytes/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0942447 (UMLS CUI 2011AB)
26485-3 (LOINC Version 232)
Lymphozyten (%)
Item
Lymphocytes (%)
integer
Lymphocytes/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0942440 (UMLS CUI 2011AB)
26478-8 (LOINC Version 232)
Normoblasten (%)
Item
Normoblasts (%)
integer
Normoblasts/100 blasts:NFr:Pt:Bld:Qn (Code-1)
C1316420 (UMLS CUI 2011AB)
33957-2 (LOINC Version 232)
Thrombozyten (10^9/L)
Item
Platelets (10^9/L)
integer
Platelets:NCnc:Pt:Bld:Qn (Code-1)
C0942474 (UMLS CUI 2011AB)
26515-7 (LOINC Version 232)
Billion Cells per Liter (Code-2)
C0456524 (UMLS CUI 2011AB)
277199001 (SNOMEDCT_2012_01_31)
Hemoglobin
Item
Hemoglobin (mmol/L)
float
Hemoglobin:SCnc:Pt:Bld:Qn (Code-1)
59260-0 (LOINC Version 232)
C0019046 (UMLS CUI-1)
Hemoglobin
Item
Hemoglobin (g/dL)
float
Hemoglobin:MCnc:Pt:Bld:Qn (Code-1)
718-7 (LOINC Version 232)
C0019046 (UMLS CUI-1)
Hämatokrit (%)
Item
Hematocrit (%)
integer
Hematocrit - finding (Code-1)
C0518014 (UMLS CUI 2011AB)
365616005 (SNOMEDCT_2012_01_31)
Harnstoff (mg/dL)
Item
Urea (mg/dL)
integer
Urea:MCnc:Pt:Bld:Qn (Code-1)
C0803775 (UMLS CUI 2011AB)
20977-5  (LOINC Version 232)
Kreatinin (mg/dL)
Item
Creatinine (mg/dL)
integer
Creatinine:MCnc:Pt:Bld:Qn (Code-1)
C1526484 (UMLS CUI 2011AB)
38483-4  (LOINC Version 232)
Harnsäure (mg/dL)
Item
Urate (mg/dL)
integer
Urate [Mass/volume] in Serum or Plasma (Code-1)
C0365228 (UMLS CUI 2011AB)
3084-1 (LOINC Version 232)
mg/dl (Code-2)
C0439269 (UMLS CUI 2011AB)
258797006 (SNOMEDCT_2012_01_31)
Albumin (g/dL)
Item
Albumin (g/dL)
integer
Albumin:MCnc:Pt:Ser/Plas:Qn (Code-1)
C0363885 (UMLS CUI 2011AB)
1751-7 (LOINC Version 232)
Protein (g/dL)
Item
Protein (g/dL)
integer
Total Protein Measurement (Code-1)
C0555903 (UMLS CUI 2011AB)
304383000 (SNOMEDCT_2012_01_31)
10050537 (MedDRA 14.1)
g/dL (Code-2)
C0439267 (UMLS CUI 2011AB)
258795003 (SNOMEDCT_2012_01_31)
Bilirubin total
Item
Bilirubin - total (μmol/L)
float
Bilirubin.total [Moles/​volume] in Blood (Code-1)
54363-7  (LOINC Version 232)
C0201913 (UMLS CUI-1)
Bilirubin total
Item
Bilirubin - total (mg/dL)
float
Bilirubin:MCnc:Pt:Bld:Qn (Code-1)
42719-5  (LOINC Version 232)
C0201913 (UMLS CUI-1)
Bilirubin direkt (μmol/L)
Item
Bilirubin - direct (μmol/L)
integer
Bilirubin.glucuronidated+Bilirubin.albumin bound:SCnc:Pt:Ser/Plas:Qn (Code-1)
C0797804 (UMLS CUI 2011AB)
14629-0 (LOINC Version 232)
Bilirubin direkt (mg/dL)
Item
Bilirubin - direkt (mg/dL)
integer
Bilirubin.glucuronidated+Bilirubin.albumin bound:MCnc:Pt:Ser/Plas:Qn (Code-1)
C0364101 (UMLS CUI 2011AB)
1968-7 (LOINC Version 232)
Bilirubin indirekt (μmol/L)
Item
Bilirubin - indirect (μmol/L)
integer
Bilirubin.non-glucuronidated:SCnc:Pt:Ser/Plas:Qn (Code-1)
C0797805 (UMLS CUI 2011AB)
14630-8 (LOINC Version 232)
Bilirubin indirekt (mg/dL)
Item
Bilirubin - indirect (mg/dL)
integer
Bilirubin.non-glucuronidated:MCnc:Pt:Ser/Plas:Qn (Code-1)
C0364104 (UMLS CUI 2011AB)
1971-1 (LOINC Version 232)
ALAT (SGPT) (U/L)
Item
Alanine aminotransferase (U/L)
integer
Alanine aminotransferase:CCnc:Pt:Ser/Plas:Qn (Code-1)
C0363876 (UMLS CUI 2011AB)
1742-6  (LOINC Version 232)
ASAT (SGOT) (U/L)
Item
Aspartate aminotransferase (U/L)
integer
Aspartate aminotransferase:CCnc:Pt:Ser/Plas:Qn (Code-1)
C0364055 (UMLS CUI 2011AB)
1920-8  (LOINC Version 232)
LDH (U/L)
Item
Lactate Dehydrogenase (U/L)
integer
Lactate Dehydrogenase (Code-1)
C0022917 (UMLS CUI 2011AB)
259319003 (SNOMEDCT_2012_01_31)
MTHU002348 (LOINC Version 232)
Unit per Liter (Code-2)
C0439339 (UMLS CUI 2011AB)
258947003 (SNOMEDCT_2012_01_31)
Natrium (mmol/L)
Item
Sodium (mmol/L)
integer
Sodium:SCnc:Pt:Ser/Plas:Qn (Code-1)
C0365095 (UMLS CUI 2011AB)
2951-2 (LOINC Version 232)
Kalzium (mmol/L)
Item
Calcium (mmol/L)
integer
Calcium.ionized:SCnc:Pt:Ser/Plas:Qn (Code-1)
C0364128 (UMLS CUI 2011AB)
1995-0 (LOINC Version 232)
Phosphat (mmol/L)
Item
Phosphate (mmol/L)
integer
Phosphate:Mass Concentration:Point in time:Serum/Plasma:Quantitative (Code-1)
C1370010 (UMLS CUI 2011AB)
2777-1 (LOINC Version 232)
Lipase (U/L)
Item
Triacylglycerol lipase (U/L)
integer
Triacylglycerol lipase:CCnc:Pt:Ser/Plas:Qn (Code-1)
C0365184 (UMLS CUI 2011AB)
3040-3 (LOINC Version 232)
Amylase (U/L)
Item
Amylase (U/L)
integer
Amylase:CCnc:Pt:Ser/Plas:Qn (Code-1)
C0484652 (UMLS CUI 2011AB)
1798-8 (LOINC Version 232)
Kalium (mmol/L)
Item
Potassium (mmol/L)
integer
Potassium:SCnc:Pt:Ser/Plas:Qn (Code-1)
C0364968 (UMLS CUI 2011AB)
2823-3 (LOINC Version 232)
Magnesium (mmol/L)
Item
Magnesium (mmol/L)
integer
Magnesium:Substance Concentration:Point in time:Serum/Plasma:Quantitative (Code-1)
C0364745 (UMLS CUI 2011AB)
2601-3  (LOINC Version 232)
TSH (mU/L)
Item
Thyrotropin (mU/L)
integer
Thyrotropin:ACnc:Pt:Bld:Qn (Code-1)
C0365159 (UMLS CUI 2011AB)
3015-5 (LOINC Version 232)
Glukose (mg/dL)
Item
Glucose: (mg/dL)
integer
Glucose:MCnc:Pt:Bld:Qn (Code-1)
C0364479 (UMLS CUI 2011AB)
2339-0 (LOINC Version 232)
Glukose (mmol/L)
Item
Glucose (mmol/L)
integer
Glucose:SCnc:Pt:Bld:Qn (Code-1)
C0798246 (UMLS CUI 2011AB)
15074-8 (LOINC Version 232)
Hemoglobin A1c
Item
Hemoglobin A1c
float
Hemoglobin A1c measurement (Code-1)
43396009 (SNOMEDCT_2012_01_31)
Millimole (Code-2)
258718000 (SNOMEDCT_2012_01_31)
Per (Code-3)
Mole, unit of measurement (Code-4)
258717005 (SNOMEDCT_2012_01_31)
MOL (HL7 V3 2006_05)
C0474680 (UMLS CUI-1)
Cholesterin (mg/dL)
Item
Cholesterol (mg/dL)
integer
Cholesterol:Mass Concentration:Point in time:Serum/Plasma:Quantitative (Code-1)
C0364708 (UMLS CUI 2011AB)
2093-3 (LOINC Version 232)
Cholesterin (mmol/L)
Item
Cholesterol (mmol/L)
integer
Cholesterol:SCnc:Pt:Ser/Plas:Qn (Code-1)
C0797822 (UMLS CUI 2011AB)
14647-2 (LOINC Version 232)
Item Group
Molecular Biology
nicht durchgeführt
Item
not performed
boolean
Molecular biology method (Code-1)
C0200924 (UMLS CUI 2011AB)
108262000 (SNOMEDCT_2012_01_31)
Negation (Code-2)
C1518422 (UMLS CUI 2011AB)
Performed (Code-3)
C0884358 (UMLS CUI 2011AB)
398166005 (SNOMEDCT_2012_01_31)
Datum der Durchführung
Item
Date of Performance
date
Date in time (Code-1)
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Molecular biology method (Code-2)
C0200924 (UMLS CUI 2011AB)
108262000 (SNOMEDCT_2012_01_31)
Item Group
BCR-ABL1 Fusion Protein Expression
b2a2
Item
b2a2
boolean
BCR-ABL1 b2a2 fusion protein (CUI C1955180) (Code-1)
MTHU026437 (LOINC Version 232)
b3a2
Item
b3a2
boolean
BCR-ABL1 b3a2 fusion protein (CUI C1955181) (Code-1)
MTHU026438 (LOINC Version 232)
b2a3
Item
b2a3
boolean
t(BCR.e.13;ABL1.e.4) (Code-1)
CL342155 (UMLS CUI 2011AB)
b3a3
Item
b3a3
boolean
t(BCR.e.14;ABL1.e.4) (Code-1)
CL340724 (UMLS CUI 2011AB)
e1a2
Item
e1a2
boolean
BCR-ABL1 e1a2 fusion protein (Code-1)
C2963376 (UMLS CUI 2011AB)
MTHU036003 (LOINC Version 232)
e6a2
Item
e6a2
boolean
BCR/ABL1 Fusion Protein p190 (Code-1)
C0029006 (UMLS CUI 2011AB)
e19a2
Item
e19a2
boolean
BCR/ABL1 Fusion Protein p230 (Code-1)
C2936177 (UMLS CUI 2011AB)
sonstige
Item
other
boolean
Other (Code-1)
C0205394 (UMLS CUI 2011AB)
74964007 (SNOMEDCT_2012_01_31)
BCR-ABL1 Fusion Protein Expression (Code-2)
C1516132 (UMLS CUI 2011AB)
sonstige
Item
other
string
Other (Code-1)
C0205394 (UMLS CUI 2011AB)
74964007 (SNOMEDCT_2012_01_31)
BCR-ABL1 Fusion Protein Expression (Code-2)
C1516132 (UMLS CUI 2011AB)
Free Text Format (Code-3)
C2348713 (UMLS CUI 2011AB)
kein BCR-ABL-Transkript
Item
no BCR-ABL Transcript
boolean
Negation (Code-1)
C1518422 (UMLS CUI 2011AB)
BCR-ABL1 Fusion Protein Expression (Code-2)
C1516132 (UMLS CUI 2011AB)
Untersucher/Ort
Item
Investigator/Place
string
Investigator Name (Code-1)
C2826892 (UMLS CUI 2011AB)
Place (Code-2)
C0442504 (UMLS CUI 2011AB)
257557008 (SNOMEDCT_2012_01_31)
PLC (HL7 V3 2006_05)
Molecular Biology (Code-3)
C0026376 (UMLS CUI 2011AB)
Labor-Nr.
Item
Laboratory Number
integer
Laboratory Identifier (Code-1)
C2986056 (UMLS CUI 2011AB)
Molecular Biology (Code-2)
C0026376 (UMLS CUI 2011AB)
Item Group
Quality of Life
Fragebogen ausgefüllt
Item
Questionaire completed
boolean
Quality of life assessment completed (Code-1)
C1271978 (UMLS CUI 2011AB)
391167008 (SNOMEDCT_2012_01_31)
Item Group
Physical Examination
Datum klinischer Befund
Item
Date of Physical Examination
date
Date in time (Code-1)
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Physical Examination (Code-2)
C0031809 (UMLS CUI 2011AB)
5880005 (SNOMEDCT_2012_01_31)
10034986 (MedDRA 14.1)
MTHU028014 (LOINC Version 232)
89.7 (ICD-9-CM Version 2011)
Körpergröße (cm)
Item
Length of body
integer
Length of body (observable entity) (Code-1)
C0221097 (UMLS CUI 2011AB)
248334005 (SNOMEDCT_2012_01_31)
Gewicht (kg)
Item
Body Weight
integer
Body Weight (Code-1)
C0005910 (UMLS CUI 2011AB)
27113001 (SNOMEDCT_2012_01_31)
MTHU001885 (LOINC Version 232)
Milzgröße (palpiert unter dem Rippenbogen)
Item
Size of Spleen with Palpation
integer
Palpation of spleen (Code-1)
C0030250 (UMLS CUI 2011AB)
47241002 (SNOMEDCT_2012_01_31)
size (Code-2)
C0456389 (UMLS CUI 2011AB)
246115007 (SNOMEDCT_2012_01_31)
MTHU010347 (LOINC Version 232)
Milz in US, größter Durchmesser
Item
Size of Spleen with Ultrasound, greatest diameter
integer
US scan of spleen (Code-1)
C0412541 (UMLS CUI 2011AB)
241476005 (SNOMEDCT_2012_01_31)
Longest Diameter (Code-2)
C0552406 (UMLS CUI 2011AB)
MTHU002939 (LOINC Version 232)
Item Group
Blood Pressure
Blutdruck systolisch
Item
Systolic Blood Pressure
integer
Systolic Blood Pressure (Code-1)
C0871470 (UMLS CUI 2011AB)
271649006 (SNOMEDCT_2012_01_31)
Blutdruck diastolisch
Item
Diastolic Blood Pressure
integer
Diastolic Blood Pressure (Code-1)
C0428883 (UMLS CUI 2011AB)
271650006 (SNOMEDCT_2012_01_31)
Item Group
Physical Examination
Herzfrequenz (/min)
Item
heart rate (/min)
integer
heart rate (Code-1)
C0018810 (UMLS CUI 2011AB)
364075005 (SNOMEDCT_2012_01_31)
10019299 (MedDRA 14.1)
MTHU003114 (LOINC Version 232)
Extramedulläre Manifestationen
Item
Leukaemic infiltration extramedullary
boolean
Leukaemic infiltration extramedullary (Code-1)
C1868812 (UMLS CUI 2011AB)
10067117 (MedDRA 14.1)
welche (z.B. LK, Haut, usw.)
Item
which (e.g. Lymph node, Skin, etc.)
string
Leukaemic infiltration extramedullary (Code-1)
C1868812 (UMLS CUI 2011AB)
10067117 (MedDRA 14.1)
Free Text Format (Code-2)
C2348713 (UMLS CUI 2011AB)
Item Group
Pre-existing Condition and concomitant disease
Vor- und Begleiterkrankung
Item
Pre-existing Condition and concomitant disease
string
Pre-existing Condition (Code-1)
C0521987 (UMLS CUI 2011AB)
102478008 (SNOMEDCT_2012_01_31)
concomitant disease (Code-2)
C0243087 (UMLS CUI 2011AB)
Item Group
Drugs
Medikament
Item
Drug
string
Pharmaceutical Preparations (Code-1)
C0013227 (UMLS CUI 2011AB)
410942007 (SNOMEDCT_2012_01_31)
Dosis
Item
Dosage
integer
Dosage (Code-1)
C0178602 (UMLS CUI 2011AB)
277406006 (SNOMEDCT_2012_01_31)
Pharmaceutical Preparations (Code-2)
C0013227 (UMLS CUI 2011AB)
410942007 (SNOMEDCT_2012_01_31)
Einheit der Dosis
Item
Dosage Form Unit
string
Dosage Form Unit (Code-1)
C2348328 (UMLS CUI 2011AB)
Pharmaceutical Preparations (Code-2)
C0013227 (UMLS CUI 2011AB)
410942007 (SNOMEDCT_2012_01_31)
Beginn Medikament
Item
Start Drug
date
Pharmaceutical Preparations (Code-1)
C0013227 (UMLS CUI 2011AB)
410942007 (SNOMEDCT_2012_01_31)
Date treatment started (observable entity) (Code-2)
C3173309 (UMLS CUI 2011AB)
413946009 (SNOMEDCT_2012_01_31)
Ende Medikament
Item
End Drug
date
Pharmaceutical Preparations (Code-1)
C0013227 (UMLS CUI 2011AB)
410942007 (SNOMEDCT_2012_01_31)
Date treatment stopped (observable entity) (Code-2)
C1531784 (UMLS CUI 2011AB)
413947000 (SNOMEDCT_2012_01_31)
andauernde Medikation
Item
continuing Medication
boolean
Continue (Code-1)
C0549178 (UMLS CUI 2011AB)
Pharmaceutical Preparations (Code-2)
C0013227 (UMLS CUI 2011AB)
410942007 (SNOMEDCT_2012_01_31)
Item Group
Bone Marrow Examination
nich durchgeführt
Item
Not performed
boolean
Not performed (Code-1)
C0445106 (UMLS CUI 2011AB)
262008008 (SNOMEDCT_2012_01_31)
Bone Marrow Examination (Code-2)
C0005957 (UMLS CUI 2011AB)
167907006 (SNOMEDCT_2012_01_31)
10005988 (MedDRA 14.1)
nicht vorliegend
Item
No Information Available
boolean
No Information Available (Code-1)
C1546437 (UMLS CUI 2011AB)
Bone Marrow Examination (Code-2)
C0005957 (UMLS CUI 2011AB)
167907006 (SNOMEDCT_2012_01_31)
10005988 (MedDRA 14.1)
Datum der Durchführung
Item
Date of Performance
date
Date in time (Code-1)
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Bone Marrow Examination (Code-2)
C0005957 (UMLS CUI 2011AB)
167907006 (SNOMEDCT_2012_01_31)
10005988 (MedDRA 14.1)
Item
Cellularity
integer
Cellularity (Code-1)
C1516377 (UMLS CUI 2011AB)
Code List
Cellularity
CL Item
aplastic (aplastisch)
Aplastic bone marrow (Code-1)
C1368107 (UMLS CUI 2011AB)
303266002 (SNOMEDCT_2012_01_31)
10005980 (MedDRA 14.1)
CL Item
hypocellular (hypozellulär)
Hypoplastic bone marrow (Code-1)
C1855710 (UMLS CUI 2011AB)
CL Item
normocellular (normozellulär)
Normocellular bone marrow (Code-1)
C2960424 (UMLS CUI 2011AB)
446409001 (SNOMEDCT_2012_01_31)
CL Item
hypercellular (hyperzellulär)
Hypercellular Bone Marrow (Code-1)
C0542080 (UMLS CUI 2011AB)
10026850 (MedDRA 14.1)
CL Item
intense hypercellular (stark hyperzellulär)
Intensity (Code-1)
C0522510 (UMLS CUI 2011AB)
103370009 (SNOMEDCT_2012_01_31)
Hypercellular Bone Marrow (Code-2)
C0542080 (UMLS CUI 2011AB)
10026850 (MedDRA 14.1)
Blasten (%)
Item
Blasts (%)
integer
Blasts/100 cells:NFr:Pt:Bone mar:Qn (Code-1)
C0549792 (UMLS CUI 2011AB)
11150-0 (LOINC Version 232)
Promyelozyten (%)
Item
Promyelocytes (%)
integer
Promyelocytes/100 cells:NFr:Pt:Bone mar:Qn:Microscopy (Code-1)
C0549848 (UMLS CUI 2011AB)
11120-3 (LOINC Version 232)
Basophile (%)
Item
Basophils (%)
integer
Basophils/100 cells:NFr:Pt:Bone mar:Qn:Microscopy (Code-1)
C0549791 (UMLS CUI 2011AB)
11105-4 (LOINC Version 232)
Item Group
Cytogenetics
ausgewertete Mitosen
Item
evaluted mitosis
integer
Number (Code-1)
C0449788 (UMLS CUI 2011AB)
410681005 (SNOMEDCT_2012_01_31)
Evaluation (Code-2)
C0220825 (UMLS CUI 2011AB)
Mitosis (Code-3)
C0026255 (UMLS CUI 2011AB)
7041004 (SNOMEDCT_2012_01_31)
Normaler Karyotyp
Item
Normal karyotype
integer
Normal karyotype (Code-1)
C0333684 (UMLS CUI 2011AB)
2232008 (SNOMEDCT_2012_01_31)
Normal, aber mit Zusatzaberrationen
Item
Normal karyotype with addtional aberrations
integer
Normal karyotype (Code-1)
C0333684 (UMLS CUI 2011AB)
2232008 (SNOMEDCT_2012_01_31)
Additional (Code-2)
C1524062 (UMLS CUI 2011AB)
MTHU013802 (LOINC Version 232)
Chromosome Aberrations (Code-3)
C0008625 (UMLS CUI 2011AB)
Philadelphia-Chromosom t(9;22)
Item
Philadelphia Chromosome
integer
Philadelphia Chromosome (Code-1)
C0031526 (UMLS CUI 2011AB)
Philadelphia-Chromosom mit Zusatzaberrationen
Item
Philadelphia Chromosome with additional aberrations
integer
Philadelphia Chromosome (Code-1)
C0031526 (UMLS CUI 2011AB)
Additional (Code-2)
C1524062 (UMLS CUI 2011AB)
MTHU013802 (LOINC Version 232)
Chromosome Aberrations (Code-3)
C0008625 (UMLS CUI 2011AB)
Befunde nach ISCN:
Item
Chromosome analysis result in ISCN expression
string
Chromosome analysis result in ISCN expression (Code-1)
C2963412 (UMLS CUI 2011AB)
MTHU036703 (LOINC Version 232)
Nicht auswertbare Mitosen
Item
unevaluable mitosis
integer
Unevaluable (Code-1)
C1883425 (UMLS CUI 2011AB)
Mitosis (Code-2)
C0026255 (UMLS CUI 2011AB)
7041004 (SNOMEDCT_2012_01_31)
Number (Code-3)
C0449788 (UMLS CUI 2011AB)
410681005 (SNOMEDCT_2012_01_31)
Untersucher/Ort
Item
Investigator/Place
string
Investigator Name (Code-1)
C2826892 (UMLS CUI 2011AB)
Place (Code-2)
C0442504 (UMLS CUI 2011AB)
257557008 (SNOMEDCT_2012_01_31)
PLC (HL7 V3 2006_05)
Bone Marrow Examination (Code-3)
C0005957 (UMLS CUI 2011AB)
167907006 (SNOMEDCT_2012_01_31)
10005988 (MedDRA 14.1)
Labor-Nr.
Item
Laboratory Number
integer
Laboratory Identifier (Code-1)
C2986056 (UMLS CUI 2011AB)
Bone Marrow Examination (Code-2)
C0005957 (UMLS CUI 2011AB)
167907006 (SNOMEDCT_2012_01_31)
10005988 (MedDRA 14.1)
Item Group
Signature
Kommentar
Item
Comment
string
Comment (Code-1)
C0947611 (UMLS CUI 2011AB)
MTHU013736 (LOINC Version 232)
Klinik
Item
Hospital
string
Hospitals (Code-1)
C0019994 (UMLS CUI 2011AB)
MTHU002722 (LOINC Version 232)
Datum
Item
Date
date
Signature date (Code-1)
C0807937 (UMLS CUI 2011AB)
MTHU008294 (LOINC Version 232)
Unterschrift
Item
Signature
string
Investigator Signature (Code-1)
C2346576 (UMLS CUI 2011AB)

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