ID

43309

Description

A randomized, multi-center phase II trial to assess the efficacy of 5-azacytidine added to standard primary therapy in elderly patients with newly diagnosed AML NCT00915252

Keywords

Versions (7)
  1. 10/24/13 10/24/13 -
  2. 10/24/13 10/24/13 -
  3. 12/21/14 12/21/14 - Martin Dugas
  4. 5/22/15 5/22/15 - Martin Dugas
  5. 5/22/15 5/22/15 - Martin Dugas
  6. 8/28/15 8/28/15 - Martin Dugas
  7. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0
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Initial assessment Leukemia AML-AZA in elderly patients NCT00915252

German English

Initial assessment Leukemia AML-AZA in elderly patients NCT00915252

1 forms  
  1. StudyEvent: Akute myeloische Leukämie(AML) AML alle außer FAB M3
    1. Initial assessment Leukemia AML-AZA in elderly patients NCT00915252
Patient data
Description

Patient data

Alias
LOINC Version 232
MTHU031990
UMLS CUI-1
C2707520
Pat. No.: -
Description

Pat. No.: -

Data type

integer

Alias
LOINC Version 232
MTHU021361
UMLS CUI-1
C1830427
Birth date:
Description

Geburtsdatum

Data type

date

Alias
SNOMEDCT_2012_01_31
184099003
LOINC Version 232
MTHU009540
UMLS CUI [1]
C0421451
Gender:
Description

Geschlecht

Data type

integer

Alias
SNOMEDCT_2012_01_31
263495000
LOINC Version 232
MTHU002975
UMLS CUI [1]
C0079399
Medical History
Description

Anamnesestatus

Data type

integer

Alias
Code-1
Medical History
SNOMEDCT_2012_01_31
417662000
LOINC Version 232
MTHU027722
UMLS CUI-1
C0262926
Date of diagnosis MDS
Description

Diagnosedatum MDS

Data type

date

Alias
Code-1
Date of diagnosis
UMLS CUI 2011AB
C2316983
SNOMEDCT_2012_01_31
432213005
Code-2
Dysmyelopoietic Syndromes
UMLS CUI 2011AB
C3463824
SNOMEDCT_2012_01_31
128623006
MedDRA 14.1
10028533
ICD-10-CM Version 2010
D46
ICD-9-CM Version 2011
238.75
CTCAE 1105E
E12552
Date of diagnosis MPS
Description

Diagnosedatum MPS

Data type

date

Alias
Code-1
Date of diagnosis
UMLS CUI 2011AB
C2316983
SNOMEDCT_2012_01_31
432213005
Code-2
Myeloproliferative disease
UMLS CUI 2011AB
C0027022
SNOMEDCT_2012_01_31
128925001
MedDRA 14.1
10028576
ICD-10-CM Version 2010
D47.1
Year chemotherapy
Description

Jahr Chemotherapie

Data type

integer

Alias
Code-1
year
UMLS CUI 2011AB
C0439234
SNOMEDCT_2012_01_31
258707000
HL7 V3 2006_05
Y
Code-2
Chemotherapy Regimen
UMLS CUI 2011AB
C0392920
SNOMEDCT_2012_01_31
367336001
Regimen
Description

Schema

Data type

string

Alias
Code-1
Chemotherapy Protocols, Antineoplastic
UMLS CUI 2011AB
C0949219
Year radiotherapy
Description

Jahr Strahlentherapie

Data type

integer

Alias
Code-1
year
UMLS CUI 2011AB
C0439234
SNOMEDCT_2012_01_31
258707000
HL7 V3 2006_05
Y
Code-2
Therapeutic radiology procedure
UMLS CUI 2011AB
C1522449
SNOMEDCT_2012_01_31
108290001
MedDRA 14.1
10037770
Clinical findings
Description

Clinical findings

Alias
SNOMEDCT_2012_01_31
404684003
UMLS CUI-1
C0037088
Physical Examination Date
Description

Untersuchungsdatum

Data type

date

Alias
UMLS CUI 2011AB
C2826643
ECOG status at study inclusion:
Description

ECOG-Status bei Studieneinschluss

Data type

integer

Alias
Code-1
ECOG performance status finding
UMLS CUI 2011AB
C1828127
SNOMEDCT_2012_01_31
424122007
Code-2
Clinical Trial
UMLS CUI 2011AB
C0008976
SNOMEDCT_2012_01_31
110465008
Code-3
Beginning
UMLS CUI 2011AB
C0439659
SNOMEDCT_2012_01_31
255395001
LOINC Version 232
MTHU026300
Size
Description

Height

Data type

integer

Measurement units
  • cm
Alias
Code-1
Size
SNOMEDCT_2012_01_31
246115007
LOINC Version 232
MTHU010347
Code-2
cm
SNOMEDCT_2012_01_31
258672001
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
Code-1
Weight
SNOMEDCT_2012_01_31
272102008
LOINC Version 232
MTHU021563
Code-2
kg
SNOMEDCT_2012_01_31
258683005
UMLS CUI [1]
C0005910
kg
Body surface area
Description

BSA

Data type

float

Measurement units
  • m²
Alias
Code-1
Body Surface Area
SNOMEDCT_2012_01_31
301898006
MedDRA 14.1
10050311
Code-2
m2
SNOMEDCT_2012_01_31
278077005
UMLS CUI [1]
C0005902
m²
Extramedullary AML manifestation
Description

Extramedulläre AML-Manifestation

Data type

integer

Alias
Code-1
Leukaemic infiltration extramedullary
UMLS CUI 2011AB
C1868812
MedDRA 14.1
10067117
if yes, localization:
Description

Lokalisation

Data type

integer

Alias
Code-1
Localization
UMLS CUI 2011AB
C0475264
SNOMEDCT_2012_01_31
257880008
Code-2
Leukaemic infiltration extramedullary
UMLS CUI 2011AB
C1868812
MedDRA 14.1
10067117
Other:
Description

andere

Data type

string

Alias
UMLS CUI 2011AB
C0205394
SNOMEDCT_2012_01_31
74964007
Clinically relevant pre-existing conditions and comorbidities
Description

Clinically relevant pre-existing conditions and comorbidities

Alias
Code-1
clinical
SNOMEDCT_2012_01_31
58147004
Code-2
relevant
Code-3
Pre-existing conditions
SNOMEDCT_2012_01_31
102478008
Code-4
Comorbidities
UMLS CUI-1
C0009488
Clinically relevant pre-existing conditions and comorbidities
Description

Clinically relevant pre-existing conditions and comorbidities

Data type

integer

Alias
Code-1
clinical
SNOMEDCT_2012_01_31
58147004
Code-2
relevant
Code-3
Pre-existing conditions
SNOMEDCT_2012_01_31
102478008
Code-4
Comorbidities
UMLS CUI-1
C0205210
UMLS CUI-2
C2347946
UMLS CUI-3
C0521987
UMLS CUI-4
C0009488
Disease
Description

Disease

Data type

text

Alias
SNOMEDCT_2012_01_31
64572001
UMLS CUI-1
C0012634
Onset (Month)
Description

Beginn (Monat)

Data type

integer

Alias
Code-1
Onset
UMLS CUI 2011AB
C0332162
SNOMEDCT_2012_01_31
77374008
Code-2
Month
UMLS CUI 2011AB
C0439231
SNOMEDCT_2012_01_31
258706009
HL7 V3 2006_05
MO
Onset (Year)
Description

Beginn (Jahr)

Data type

integer

Alias
Code-1
Onset
UMLS CUI 2011AB
C0332162
SNOMEDCT_2012_01_31
77374008
Code-2
Year
UMLS CUI 2011AB
C0439234
SNOMEDCT_2012_01_31
258707000
HL7 V3 2006_05
Y
ongoing
Description

ongoing

Data type

boolean

Alias
Code-2
Disease
SNOMEDCT_2012_01_31
64572001
UMLS CUI-1
C0549178
Differential blood count
Description

Differential blood count

Alias
Code-1
Differential Leukocyte Count
SNOMEDCT_2012_01_31
165511009
MedDRA 14.1
10012784
UMLS CUI-1
C0162401
Date:
Description

Datum

Data type

date

Alias
UMLS CUI 2011AB
C0011008
SNOMEDCT_2012_01_31
410671006
LOINC Version 232
MTHU021546
Code-2
Differential Leukocyte Count
UMLS CUI 2011AB
C0162401
SNOMEDCT_2012_01_31
165511009
MedDRA 14.1
10012784
Hemoglobin
Description

Hemoglobin

Data type

float

Measurement units
  • g/dL
Alias
Code-1
Hemoglobin
MedDRA 14.1
10018876
UMLS CUI [1]
C0019046
g/dL
Leukocytes
Description

Leukocytes

Data type

float

Measurement units
  • /ul
Alias
Code-1
Leukocytes:NCnc:Pt:Bld:Qn
LOINC Version 232
26464-8
UMLS CUI [1]
C0023516
/ul
Neutrophil percentage
Description

Prozentanteil Neutrophile

Data type

integer

Alias
Code-1
Neutrophils/100 leukocytes:NFr:Pt:Bld:Qn
UMLS CUI 2011AB
C0942471
LOINC Version 232
26511-6
Band neutrophil percentage
Description

Prozentanteil Stabkernige

Data type

integer

Alias
Code-1
Neutrophils.band form/100 leukocytes:NFr:Pt:Bld:Qn
UMLS CUI 2011AB
C0942468
LOINC Version 232
26508-2
[or] Segmented neutrophil percentage
Description

[oder] Prozentanteil Segmentkernige

Data type

integer

Alias
Code-1
Neutrophils.segmented/100 leukocytes:NFr:Pt:Bld:Qn
UMLS CUI 2011AB
C0942466
LOINC Version 232
26505-8
Lymphocyte percentage
Description

Prozentanteil Lymphozyten

Data type

integer

Alias
Code-1
Lymphocytes/100 leukocytes:NFr:Pt:Bld:Qn
UMLS CUI 2011AB
C0942440
LOINC Version 232
26478-8
Monocyte percentage
Description

Prozentanteil Monozyten

Data type

integer

Alias
Code-1
Monocytes/100 leukocytes:NFr:Pt:Bld:Qn
UMLS CUI 2011AB
C0942447
LOINC Version 232
26485-3
Eosinophil percentage
Description

Prozentanteil Eosinophile

Data type

integer

Alias
Code-1
Eosinophils/100 leukocytes:NFr:Pt:Bld:Qn
UMLS CUI 2011AB
C0945354
LOINC Version 232
26450-7 
Basophil percentage
Description

Prozentanteil Basophile

Data type

integer

Alias
Code-1
Basophils/100 leukocytes:NFr:Pt:Bld:Qn
UMLS CUI 2011AB
C1114065
LOINC Version 232
30180-4 
Blast cell percentage
Description

Prozentanteil Blasten

Data type

integer

Alias
Code-1
Blasts/100 leukocytes:NFr:Pt:Bld:Qn
UMLS CUI 2011AB
C0942416
LOINC Version 232
26446-5 
Promyelocyte percentage
Description

Prozentanteil Promyelozyten

Data type

integer

Alias
Code-1
Promyelocytes/100 leukocytes:Number Fraction:Point in time:Whole blood:Quantitative
UMLS CUI 2011AB
C1114906
LOINC Version 232
26524-9 
Myelocyte percentage
Description

Prozentanteil Myelozyten

Data type

integer

Alias
Code-1
Myelocytes/100 leukocytes:NFr:Pt:Bld:Qn
UMLS CUI 2011AB
C0942460
LOINC Version 232
26498-6 
Metamyelocyte percentage
Description

Prozentanteil Metamyelozyten

Data type

integer

Alias
Code-1
Metamyelocytes/100 leukocytes:NFr:Pt:Bld:Qn
UMLS CUI 2011AB
C0944135
LOINC Version 232
28541-1 
Percentage of other cells
Description

Prozentanteil sonstige Zellen

Data type

integer

Alias
Code-1
Other cells/100 leukocytes
UMLS CUI 2011AB
C1978275
LOINC Version 232
MTHU026796
Peripheral Platelet Count
Description

Platelets

Data type

float

Measurement units
  • 1000/uL
Alias
Code-1
Platelets:NCnc:Pt:Bld:Qn
LOINC Version 232
26515-7
UMLS CUI [1]
C0005821
1000/uL
Clinical Chemistry
Description

Clinical Chemistry

Alias
UMLS CUI-1
C0008000
Sodium
Description

Sodium

Data type

float

Measurement units
  • mmol/L
Alias
Code-1
Sodium:SCnc:Pt:Bld:Qn
LOINC Version 232
2947-0
UMLS CUI [1]
C0337443
mmol/L
Potassium
Description

Potassium

Data type

float

Measurement units
  • mmol/l
Alias
Code-1
Potassium:SCnc:Pt:Bld:Qn
LOINC Version 232
6298-4
UMLS CUI [1]
C0202194
mmol/l
Total Protein
Description

Total Protein

Data type

float

Measurement units
  • mg/dL
Alias
Code-1
Total Protein Measurement
SNOMEDCT_2012_01_31
304383000
MedDRA 14.1
10050537
UMLS CUI [1]
C0036836
mg/dL
Uric acid
Description

Uric acid

Data type

float

Measurement units
  • md/dl
Alias
Code-1
Urate [Mass/volume] in Serum or Plasma
LOINC Version 232
3084-1
UMLS CUI [1]
C0041980
md/dl
BUN
Description

BUN

Data type

float

Measurement units
  • mg/dL
Alias
Code-1
Blood urea nitrogen measurement
SNOMEDCT_2012_01_31
250623007
MedDRA 14.1
10005845
UMLS CUI [1]
C0005845
mg/dL
Urea
Description

Urea

Data type

integer

Measurement units
  • mg/dL
Alias
Code-1
Urea Measurement
SNOMEDCT_2012_01_31
105010007
MedDRA 14.1
10046346
UMLS CUI [1]
C0523961
mg/dL
Creatinine
Description

Creatinine, Serum

Data type

float

Measurement units
  • mg/dL
Alias
Code-1
Creatinine Measurement
SNOMEDCT_2012_01_31
70901006
MedDRA 14.1
10005480
UMLS CUI [1]
C0201976
mg/dL
Bilirubin, total
Description

Bilirubin, total

Data type

float

Measurement units
  • mg/dL
Alias
Code-1
Total Bilirubin Measurement
SNOMEDCT_2012_01_31
359986008
MedDRA 14.1
10004696
UMLS CUI [1]
C0201913
mg/dL
AST (SGOT)
Description

AST

Data type

float

Measurement units
  • U/L
Alias
Code-1
Aspartate transaminase level
SNOMEDCT_2012_01_31
373679006
UMLS CUI [1]
C0201899
U/L
ALT (SGPT)
Description

ALT

Data type

float

Measurement units
  • U/L
Alias
Code-1
Alanine Transaminase
SNOMEDCT_2012_01_31
56935002
LOINC Version 232
MTHU006766
UMLS CUI [1]
C0201836
U/L
Alkaline Phosphatase
Description

Alkaline Phosphatase

Data type

float

Measurement units
  • U/L
Alias
Code-1
Alkaline phosphatase level - finding
SNOMEDCT_2012_01_31
365771003
UMLS CUI [1]
C0201850
U/L
Lactate Dehydrogenase
Description

LDH

Data type

float

Measurement units
  • U/L
Alias
Code-1
Lactate Dehydrogenase
SNOMEDCT_2012_01_31
259319003
LOINC Version 232
MTHU002348
UMLS CUI [1]
C0202113
U/L
CRP
Description

CRP

Data type

float

Measurement units
  • md/dl
Alias
Code-1
C-reactive protein
SNOMEDCT_2012_01_31
61425002
LOINC Version 232
MTHU002335
UMLS CUI [1]
C0201657
md/dl
Quick
Description

Quick

Data type

float

Measurement units
  • %
Alias
Code-1
Prothrombin time ratio
MedDRA 14.1
10037064
UMLS CUI [1]
C0483455
%
INR
Description

INR

Data type

float

Alias
Code-1
International Normalized Ratio
UMLS CUI [1]
C0525032
PTT
Description

PTT

Data type

float

Measurement units
  • seconds
Alias
Code-1
Activated Partial Thromboplastin Time measurement
SNOMEDCT_2012_01_31
42525009
MedDRA 14.1
10000630
UMLS CUI [1]
C0030605
seconds
Fibrinogen
Description

Fibrinogen

Data type

float

Measurement units
  • g/l
Alias
Code-1
Fibrinogen
SNOMEDCT_2012_01_31
23295004
LOINC Version 232
MTHU007030
UMLS CUI [1]
C0016006
g/l
AT III percentage
Description

AT III percentage

Data type

float

Measurement units
  • %
Alias
Code-1
Antithrombin III
SNOMEDCT_2012_01_31
34086003
LOINC Version 232
MTHU008554
Code-2
Percentage
UMLS CUI [1]
C0003438
%
Bone marrow examination
Description

Bone marrow examination

Alias
UMLS CUI 2011AB
C0005957
SNOMEDCT_2012_01_31
167907006
MedDRA 14.1
10005988
Date:
Description

Datum

Data type

date

Alias
UMLS CUI 2011AB
C0011008
SNOMEDCT_2012_01_31
410671006
LOINC Version 232
MTHU021546
Obligatory materials shipping (bone marrow + blood) for determination of methylation status to:
Description

Obligater Materialversand

Data type

integer

Alias
Code-1
Mandatory
UMLS CUI 2011AB
C1514873
Code-2
Materials
UMLS CUI 2011AB
C0520510
SNOMEDCT_2012_01_31
260769002
LOINC Version 232
MTHU013790
HL7 V3 2006_05
MAT
Code-3
Shipping
UMLS CUI 2011AB
C1524049
Code-4
Bone marrow
UMLS CUI 2011AB
C0005953
SNOMEDCT_2012_01_31
14016003
LOINC Version 232
MTHU016536
Code-5
Blood
UMLS CUI 2011AB
C0005767
SNOMEDCT_2012_01_31
87612001
LOINC Version 232
MTHU029981
HL7 V3 2006_05
Determination
Code-6
C1148554
no shipping because
Description

kein Versand weil

Data type

string

Alias
Code-1
Absent
UMLS CUI 2011AB
C0332197
SNOMEDCT_2012_01_31
2667000
Code-2
Shipping
UMLS CUI 2011AB
C1524049
Code-3
Reason
UMLS CUI 2011AB
C0392360
SNOMEDCT_2012_01_31
410666004
LOINC Version 232
MTHU008862
Code-4
Materials
UMLS CUI 2011AB
C0520510
SNOMEDCT_2012_01_31
260769002
LOINC Version 232
MTHU013790
HL7 V3 2006_05
MAT
Code-5
Shipping
UMLS CUI 2011AB
C1524049
Shipping of an iliac crest biopsy to:
Description

Versand einer Beckenkammbiopsie

Data type

integer

Alias
Code-1
Shipping
UMLS CUI 2011AB
C1524049
Code-2
Iliac crest
UMLS CUI 2011AB
C0223651
SNOMEDCT_2012_01_31
29850006
Code-3
Biopsy
UMLS CUI 2011AB
C0005558
SNOMEDCT_2012_01_31
86273004
MedDRA 14.1
10004720
LOINC Version 232
MTHU028106
no shipping because
Description

kein Versand weil

Data type

string

Alias
Code-1
Absent
UMLS CUI 2011AB
C0332197
SNOMEDCT_2012_01_31
2667000
Code-2
Shipping
UMLS CUI 2011AB
C1524049
Code-3
Reason
UMLS CUI 2011AB
C0392360
SNOMEDCT_2012_01_31
410666004
LOINC Version 232
MTHU008862
Code-4
Iliac crest
UMLS CUI 2011AB
C0223651
SNOMEDCT_2012_01_31
29850006
Code-5
Biopsy
UMLS CUI 2011AB
C0005558
SNOMEDCT_2012_01_31
86273004
MedDRA 14.1
10004720
LOINC Version 232
MTHU028106
Cytology
Description

Cytology

Alias
UMLS CUI 2011AB
C1305671
MedDRA 14.1
10061804
LOINC Version 232
MTHU000052
Blast percentage
Description

Blastenanteil

Data type

integer

Alias
Code-1
Blasts
UMLS CUI 2011AB
C0368761
SNOMEDCT_2012_01_31
312256009
LOINC Version 232
MTHU005201
Code-2
Percentage
UMLS CUI 2011AB
CL343029
HL7 V3 2006_05
%
If >=5%, please specify [%]
Description

wenn >=5%, dann bitte angeben [%]

Data type

integer

Alias
Code-1
if
UMLS CUI 2011AB
C0750557
Code-2
Not Less Than
UMLS CUI 2011AB
C0439091
SNOMEDCT_2012_01_31
276138003
HL7 V3 2006_05
GE
Code-3
5
UMLS CUI 2011AB
C0205451
SNOMEDCT_2012_01_31
34001005
Code-4
Percent
UMLS CUI 2011AB
C0439165
SNOMEDCT_2012_01_31
118582008
Code-5
Specify
UMLS CUI 2011AB
C1521902
Dysplasia sign:
Description

Dysplasiezeichen

Data type

integer

Alias
Code-1
Dysplasia
UMLS CUI 2011AB
C0334044
SNOMEDCT_2012_01_31
25723000
MedDRA 14.1
10058314
Code-2
Sign
UMLS CUI 2011AB
C0311392
SNOMEDCT_2012_01_31
72670004
LOINC Version 232
MTHU001426
FAB
Description

FAB

Alias
Code-1
French-American-British Classification
UMLS CUI 2011AB
C2984084
FAB:
Description

FAB

Data type

integer

Alias
Code-1
French-American-British Classification
UMLS CUI 2011AB
C2984084
Cytogenetics (Please attach copy of findings!)
Description

Zytogenetik

Data type

integer

Alias
Code-1
Cytogenetics
UMLS CUI 2011AB
C0010802
other aberrations:
Description

sonstige Aberrationen

Data type

string

Alias
Code-1
Other
UMLS CUI 2011AB
C0205394
SNOMEDCT_2012_01_31
74964007
Code-2
Aberration, Chromosome
UMLS CUI 2011AB
C0008625
Molecular Genetic Analysis (Please attach copy of findings!)
Description

Molecular Genetic Analysis (Please attach copy of findings!)

Alias
UMLS CUI 2011AB
C1513380
AML1/ETO:
Description

AML1/ETO

Data type

integer

Alias
UMLS CUI 2011AB
C1851466
PML/RARa:
Description

PML/RARa

Data type

integer

Alias
UMLS CUI 2011AB
C1867259
CBFbeta/MYH11:
Description

CBFbeta/MYH11

Data type

integer

Alias
UMLS CUI 2011AB
CL435279
C/EBPalpha:
Description

C/EBPalpha

Data type

integer

Alias
UMLS CUI 2011AB
C1413322
NPM1(mut):
Description

NPM1-Mut

Data type

integer

Alias
UMLS CUI 2011AB
C2826175
IDH mutation:
Description

IDH-Mutation

Data type

integer

Alias
Code-1
Isocitrate Dehydrogenase (NAD+)
UMLS CUI 2011AB
C0022157
SNOMEDCT_2012_01_31
259318006
LOINC Version 232
MTHU012138
Code-2
Mutation
UMLS CUI 2011AB
C0026882
SNOMEDCT_2012_01_31
55446002
FLT3 point mutation:
Description

Flt3-Punktmutation

Data type

integer

Alias
Code-1
FLT3 Tyrosine Kinase Domain Point Mutation
UMLS CUI 2011AB
C2348501
FLT3-ITD:
Description

Flt3-ITD

Data type

integer

Alias
Code-1
FLT3 Internal Tandem Duplication
UMLS CUI 2011AB
C2348499
Flt3-ITD-ratio
Description

Flt3-ITD-ratio

Data type

integer

Alias
Code-1
FLT3 Internal Tandem Duplication
UMLS CUI 2011AB
C2348499
Code-2
Ratio
UMLS CUI 2011AB
C0456603
SNOMEDCT_2012_01_31
118586006
Flt3-ITD Percentage
Description

Flt3-ITD Prozentsatz

Data type

integer

Alias
Code-1
FLT3 Internal Tandem Duplication
UMLS CUI 2011AB
C2348499
Code-2
Percentage
UMLS CUI 2011AB
CL343029
HL7 V3 2006_05
%
Other:
Description

Sonstige

Data type

string

Alias
UMLS CUI 2011AB
C0205394
SNOMEDCT_2012_01_31
74964007
Signature
Description

Signature

Alias
UMLS CUI 2011AB
C1519316
Date:
Description

Datum

Data type

date

Alias
UMLS CUI 2011AB
C0011008
SNOMEDCT_2012_01_31
410671006
LOINC Version 232
MTHU021546
Name/Signature study physician
Description

Name/Unterschrift Prüfarzt

Data type

string

Alias
Code-1
Name
UMLS CUI 2011AB
C0027365
LOINC Version 232
MTHU008539
Code-2
Signature
UMLS CUI 2011AB
C1519316
Code-3
Study
UMLS CUI 2011AB
C0008976
SNOMEDCT_2012_01_31
110465008
Code-4
Physician
UMLS CUI 2011AB
C0031831
SNOMEDCT_2012_01_31
309343006
LOINC Version 232
MTHU010489
HL7 V3 2006_05
PHYS
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Similar models

Initial assessment Leukemia AML-AZA in elderly patients NCT00915252

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  1. StudyEvent: Akute myeloische Leukämie(AML) AML alle außer FAB M3
    1. Initial assessment Leukemia AML-AZA in elderly patients NCT00915252
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient data
MTHU031990 (LOINC Version 232)
C2707520 (UMLS CUI-1)
Patient number
Item
Pat. No.: -
integer
MTHU021361 (LOINC Version 232)
C1830427 (UMLS CUI-1)
Geburtsdatum
Item
Birth date:
date
184099003 (SNOMEDCT_2012_01_31)
MTHU009540 (LOINC Version 232)
C0421451 (UMLS CUI [1])
Item
Gender:
integer
263495000 (SNOMEDCT_2012_01_31)
MTHU002975 (LOINC Version 232)
C0079399 (UMLS CUI [1])
Geschlecht
Code List
Gender:
CL Item
male (1)
C0086582 (UMLS CUI 2011AB)
248153007 (SNOMEDCT_2012_01_31)
CL Item
female (2)
C0086287 (UMLS CUI 2011AB)
248152002 (SNOMEDCT_2012_01_31)
Item
Medical History
integer
Medical History (Code-1)
417662000 (SNOMEDCT_2012_01_31)
MTHU027722 (LOINC Version 232)
C0262926 (UMLS CUI-1)
Anamnesestatus
Code List
Medical History
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
CL Item
 (5)
Diagnosedatum MDS
Item
Date of diagnosis MDS
date
Date of diagnosis (Code-1)
C2316983 (UMLS CUI 2011AB)
432213005 (SNOMEDCT_2012_01_31)
Dysmyelopoietic Syndromes (Code-2)
C3463824 (UMLS CUI 2011AB)
128623006 (SNOMEDCT_2012_01_31)
10028533 (MedDRA 14.1)
D46 (ICD-10-CM Version 2010)
238.75 (ICD-9-CM Version 2011)
E12552 (CTCAE 1105E)
Diagnosedatum MPS
Item
Date of diagnosis MPS
date
Date of diagnosis (Code-1)
C2316983 (UMLS CUI 2011AB)
432213005 (SNOMEDCT_2012_01_31)
Myeloproliferative disease (Code-2)
C0027022 (UMLS CUI 2011AB)
128925001 (SNOMEDCT_2012_01_31)
10028576 (MedDRA 14.1)
D47.1 (ICD-10-CM Version 2010)
Jahr Chemotherapie
Item
Year chemotherapy
integer
year (Code-1)
C0439234 (UMLS CUI 2011AB)
258707000 (SNOMEDCT_2012_01_31)
Y (HL7 V3 2006_05)
Chemotherapy Regimen (Code-2)
C0392920 (UMLS CUI 2011AB)
367336001 (SNOMEDCT_2012_01_31)
Schema
Item
Regimen
string
Chemotherapy Protocols, Antineoplastic (Code-1)
C0949219 (UMLS CUI 2011AB)
Jahr Strahlentherapie
Item
Year radiotherapy
integer
year (Code-1)
C0439234 (UMLS CUI 2011AB)
258707000 (SNOMEDCT_2012_01_31)
Y (HL7 V3 2006_05)
Therapeutic radiology procedure (Code-2)
C1522449 (UMLS CUI 2011AB)
108290001 (SNOMEDCT_2012_01_31)
10037770 (MedDRA 14.1)
Item Group
Clinical findings
404684003 (SNOMEDCT_2012_01_31)
C0037088 (UMLS CUI-1)
Untersuchungsdatum
Item
Physical Examination Date
date
C2826643 (UMLS CUI 2011AB)
Item
ECOG status at study inclusion:
integer
ECOG performance status finding (Code-1)
C1828127 (UMLS CUI 2011AB)
424122007 (SNOMEDCT_2012_01_31)
Clinical Trial (Code-2)
C0008976 (UMLS CUI 2011AB)
110465008 (SNOMEDCT_2012_01_31)
Beginning (Code-3)
C0439659 (UMLS CUI 2011AB)
255395001 (SNOMEDCT_2012_01_31)
MTHU026300 (LOINC Version 232)
ECOG-Status bei Studieneinschluss
Code List
ECOG status at study inclusion:
CL Item
ECOG performance status - grade 0 (Normal physical fitness) (0)
C1828078 (UMLS CUI 2011AB)
425389002 (SNOMEDCT_2012_01_31)
CL Item
ECOG performance status - grade 1 (Outpatient care, easy work possible) (1)
C1827388 (UMLS CUI 2011AB)
422512005 (SNOMEDCT_2012_01_31)
CL Item
ECOG performance status - grade 2 (Less than half day bed-ridden, self-sufficiency possible, but not able to work) (2)
C1828242 (UMLS CUI 2011AB)
422894000 (SNOMEDCT_2012_01_31)
CL Item
ECOG performance status - grade 3 (More than half day bed-ridden, limited self-sufficiency possible) (3)
C1827126 (UMLS CUI 2011AB)
423053003 (SNOMEDCT_2012_01_31)
CL Item
ECOG performance status - grade 4 (Permanent bed-ridden) (4)
C1827528 (UMLS CUI 2011AB)
423237006 (SNOMEDCT_2012_01_31)
Height
Item
Size
integer
Size (Code-1)
246115007 (SNOMEDCT_2012_01_31)
MTHU010347 (LOINC Version 232)
cm (Code-2)
258672001 (SNOMEDCT_2012_01_31)
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
Weight (Code-1)
272102008 (SNOMEDCT_2012_01_31)
MTHU021563 (LOINC Version 232)
kg (Code-2)
258683005 (SNOMEDCT_2012_01_31)
C0005910 (UMLS CUI [1])
BSA
Item
Body surface area
float
Body Surface Area (Code-1)
301898006 (SNOMEDCT_2012_01_31)
10050311 (MedDRA 14.1)
m2 (Code-2)
278077005 (SNOMEDCT_2012_01_31)
C0005902 (UMLS CUI [1])
Item
Extramedullary AML manifestation
integer
Leukaemic infiltration extramedullary (Code-1)
C1868812 (UMLS CUI 2011AB)
10067117 (MedDRA 14.1)
Extramedulläre AML-Manifestation
Code List
Extramedullary AML manifestation
CL Item
yes (1)
C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)
CL Item
no (2)
C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)
CL Item
unknown (3)
C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)
Item
if yes, localization:
integer
Localization (Code-1)
C0475264 (UMLS CUI 2011AB)
257880008 (SNOMEDCT_2012_01_31)
Leukaemic infiltration extramedullary (Code-2)
C1868812 (UMLS CUI 2011AB)
10067117 (MedDRA 14.1)
Lokalisation
Code List
if yes, localization:
CL Item
CNS (1)
C1269563 (UMLS CUI 2011AB)
278199004 (SNOMEDCT_2012_01_31)
CL Item
Other: (2)
C0205394 (UMLS CUI 2011AB)
74964007 (SNOMEDCT_2012_01_31)
andere
Item
Other:
string
C0205394 (UMLS CUI 2011AB)
74964007 (SNOMEDCT_2012_01_31)
Item Group
Clinically relevant pre-existing conditions and comorbidities
clinical (Code-1)
58147004 (SNOMEDCT_2012_01_31)
relevant (Code-2)
Pre-existing conditions (Code-3)
102478008 (SNOMEDCT_2012_01_31)
Comorbidities (Code-4)
C0009488 (UMLS CUI-1)
Item
Clinically relevant pre-existing conditions and comorbidities
integer
clinical (Code-1)
58147004 (SNOMEDCT_2012_01_31)
relevant (Code-2)
Pre-existing conditions (Code-3)
102478008 (SNOMEDCT_2012_01_31)
Comorbidities (Code-4)
C0205210 (UMLS CUI-1)
C2347946 (UMLS CUI-2)
C0521987 (UMLS CUI-3)
C0009488 (UMLS CUI-4)
Klinisch relevante Vor- und Begleiterkrankungen
Code List
Clinically relevant pre-existing conditions and comorbidities
CL Item
Present (1)
C0150312 (UMLS CUI 2011AB)
52101004 (SNOMEDCT_2012_01_31)
CL Item
Absent (2)
C0332197 (UMLS CUI 2011AB)
2667000 (SNOMEDCT_2012_01_31)
Disease
Item
Disease
text
64572001 (SNOMEDCT_2012_01_31)
C0012634 (UMLS CUI-1)
Beginn (Monat)
Item
Onset (Month)
integer
Onset (Code-1)
C0332162 (UMLS CUI 2011AB)
77374008 (SNOMEDCT_2012_01_31)
Month (Code-2)
C0439231 (UMLS CUI 2011AB)
258706009 (SNOMEDCT_2012_01_31)
MO (HL7 V3 2006_05)
Beginn (Jahr)
Item
Onset (Year)
integer
Onset (Code-1)
C0332162 (UMLS CUI 2011AB)
77374008 (SNOMEDCT_2012_01_31)
Year (Code-2)
C0439234 (UMLS CUI 2011AB)
258707000 (SNOMEDCT_2012_01_31)
Y (HL7 V3 2006_05)
ongoing
Item
ongoing
boolean
Disease (Code-2)
64572001 (SNOMEDCT_2012_01_31)
C0549178 (UMLS CUI-1)
Item Group
Differential blood count
Differential Leukocyte Count (Code-1)
165511009 (SNOMEDCT_2012_01_31)
10012784 (MedDRA 14.1)
C0162401 (UMLS CUI-1)
Datum
Item
Date:
date
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Differential Leukocyte Count (Code-2)
C0162401 (UMLS CUI 2011AB)
165511009 (SNOMEDCT_2012_01_31)
10012784 (MedDRA 14.1)
Hemoglobin
Item
Hemoglobin
float
Hemoglobin (Code-1)
10018876 (MedDRA 14.1)
C0019046 (UMLS CUI [1])
Leukocytes
Item
Leukocytes
float
Leukocytes:NCnc:Pt:Bld:Qn (Code-1)
26464-8 (LOINC Version 232)
C0023516 (UMLS CUI [1])
Prozentanteil Neutrophile
Item
Neutrophil percentage
integer
Neutrophils/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0942471 (UMLS CUI 2011AB)
26511-6 (LOINC Version 232)
Prozentanteil Stabkernige
Item
Band neutrophil percentage
integer
Neutrophils.band form/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0942468 (UMLS CUI 2011AB)
26508-2 (LOINC Version 232)
[oder] Prozentanteil Segmentkernige
Item
[or] Segmented neutrophil percentage
integer
Neutrophils.segmented/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0942466 (UMLS CUI 2011AB)
26505-8 (LOINC Version 232)
Prozentanteil Lymphozyten
Item
Lymphocyte percentage
integer
Lymphocytes/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0942440 (UMLS CUI 2011AB)
26478-8 (LOINC Version 232)
Prozentanteil Monozyten
Item
Monocyte percentage
integer
Monocytes/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0942447 (UMLS CUI 2011AB)
26485-3 (LOINC Version 232)
Prozentanteil Eosinophile
Item
Eosinophil percentage
integer
Eosinophils/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0945354 (UMLS CUI 2011AB)
26450-7  (LOINC Version 232)
Prozentanteil Basophile
Item
Basophil percentage
integer
Basophils/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C1114065 (UMLS CUI 2011AB)
30180-4  (LOINC Version 232)
Prozentanteil Blasten
Item
Blast cell percentage
integer
Blasts/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0942416 (UMLS CUI 2011AB)
26446-5  (LOINC Version 232)
Prozentanteil Promyelozyten
Item
Promyelocyte percentage
integer
Promyelocytes/100 leukocytes:Number Fraction:Point in time:Whole blood:Quantitative (Code-1)
C1114906 (UMLS CUI 2011AB)
26524-9  (LOINC Version 232)
Prozentanteil Myelozyten
Item
Myelocyte percentage
integer
Myelocytes/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0942460 (UMLS CUI 2011AB)
26498-6  (LOINC Version 232)
Prozentanteil Metamyelozyten
Item
Metamyelocyte percentage
integer
Metamyelocytes/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0944135 (UMLS CUI 2011AB)
28541-1  (LOINC Version 232)
Prozentanteil sonstige Zellen
Item
Percentage of other cells
integer
Other cells/100 leukocytes (Code-1)
C1978275 (UMLS CUI 2011AB)
MTHU026796 (LOINC Version 232)
Platelets
Item
Peripheral Platelet Count
float
Platelets:NCnc:Pt:Bld:Qn (Code-1)
26515-7 (LOINC Version 232)
C0005821 (UMLS CUI [1])
Item Group
Clinical Chemistry
C0008000 (UMLS CUI-1)
Sodium
Item
Sodium
float
Sodium:SCnc:Pt:Bld:Qn (Code-1)
2947-0 (LOINC Version 232)
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
float
Potassium:SCnc:Pt:Bld:Qn (Code-1)
6298-4 (LOINC Version 232)
C0202194 (UMLS CUI [1])
Total Protein
Item
Total Protein
float
Total Protein Measurement (Code-1)
304383000 (SNOMEDCT_2012_01_31)
10050537 (MedDRA 14.1)
C0036836 (UMLS CUI [1])
Uric acid
Item
Uric acid
float
Urate [Mass/volume] in Serum or Plasma (Code-1)
3084-1 (LOINC Version 232)
C0041980 (UMLS CUI [1])
BUN
Item
BUN
float
Blood urea nitrogen measurement (Code-1)
250623007 (SNOMEDCT_2012_01_31)
10005845 (MedDRA 14.1)
C0005845 (UMLS CUI [1])
Urea
Item
Urea
integer
Urea Measurement (Code-1)
105010007 (SNOMEDCT_2012_01_31)
10046346 (MedDRA 14.1)
C0523961 (UMLS CUI [1])
Creatinine, Serum
Item
Creatinine
float
Creatinine Measurement (Code-1)
70901006 (SNOMEDCT_2012_01_31)
10005480 (MedDRA 14.1)
C0201976 (UMLS CUI [1])
Bilirubin, total
Item
Bilirubin, total
float
Total Bilirubin Measurement (Code-1)
359986008 (SNOMEDCT_2012_01_31)
10004696 (MedDRA 14.1)
C0201913 (UMLS CUI [1])
AST
Item
AST (SGOT)
float
Aspartate transaminase level (Code-1)
373679006 (SNOMEDCT_2012_01_31)
C0201899 (UMLS CUI [1])
ALT
Item
ALT (SGPT)
float
Alanine Transaminase (Code-1)
56935002 (SNOMEDCT_2012_01_31)
MTHU006766 (LOINC Version 232)
C0201836 (UMLS CUI [1])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
Alkaline phosphatase level - finding (Code-1)
365771003 (SNOMEDCT_2012_01_31)
C0201850 (UMLS CUI [1])
LDH
Item
Lactate Dehydrogenase
float
Lactate Dehydrogenase (Code-1)
259319003 (SNOMEDCT_2012_01_31)
MTHU002348 (LOINC Version 232)
C0202113 (UMLS CUI [1])
CRP
Item
CRP
float
C-reactive protein (Code-1)
61425002 (SNOMEDCT_2012_01_31)
MTHU002335 (LOINC Version 232)
C0201657 (UMLS CUI [1])
Quick
Item
Quick
float
Prothrombin time ratio (Code-1)
10037064 (MedDRA 14.1)
C0483455 (UMLS CUI [1])
INR
Item
INR
float
International Normalized Ratio (Code-1)
C0525032 (UMLS CUI [1])
PTT
Item
PTT
float
Activated Partial Thromboplastin Time measurement (Code-1)
42525009 (SNOMEDCT_2012_01_31)
10000630 (MedDRA 14.1)
C0030605 (UMLS CUI [1])
Fibrinogen
Item
Fibrinogen
float
Fibrinogen (Code-1)
23295004 (SNOMEDCT_2012_01_31)
MTHU007030 (LOINC Version 232)
C0016006 (UMLS CUI [1])
AT III percentage
Item
AT III percentage
float
Antithrombin III (Code-1)
34086003 (SNOMEDCT_2012_01_31)
MTHU008554 (LOINC Version 232)
Percentage (Code-2)
C0003438 (UMLS CUI [1])
Item Group
Bone marrow examination
C0005957 (UMLS CUI 2011AB)
167907006 (SNOMEDCT_2012_01_31)
10005988 (MedDRA 14.1)
Datum
Item
Date:
date
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Item
Obligatory materials shipping (bone marrow + blood) for determination of methylation status to:
integer
Mandatory (Code-1)
C1514873 (UMLS CUI 2011AB)
Materials (Code-2)
C0520510 (UMLS CUI 2011AB)
260769002 (SNOMEDCT_2012_01_31)
MTHU013790 (LOINC Version 232)
MAT (HL7 V3 2006_05)
Shipping (Code-3)
C1524049 (UMLS CUI 2011AB)
Bone marrow (Code-4)
C0005953 (UMLS CUI 2011AB)
14016003 (SNOMEDCT_2012_01_31)
MTHU016536 (LOINC Version 232)
Blood (Code-5)
C0005767 (UMLS CUI 2011AB)
87612001 (SNOMEDCT_2012_01_31)
MTHU029981 (LOINC Version 232)
Determination (HL7 V3 2006_05)
C1148554 (Code-6)
Obligater Materialversand
Code List
Obligatory materials shipping (bone marrow + blood) for determination of methylation status to:
CL Item
Munster (1)
C0454791 (UMLS CUI 2011AB)
223810004 (SNOMEDCT_2012_01_31)
CL Item
Dresden (2)
no_code (Code-1)
CL Item
Frankfurt (3)
no_code (Code-1)
CL Item
no shipping because (kein Versand weil)
Absent (Code-1)
C0332197 (UMLS CUI 2011AB)
2667000 (SNOMEDCT_2012_01_31)
Shipping (Code-2)
C1524049 (UMLS CUI 2011AB)
Reason (Code-3)
C0392360 (UMLS CUI 2011AB)
410666004 (SNOMEDCT_2012_01_31)
MTHU008862 (LOINC Version 232)
kein Versand weil
Item
no shipping because
string
Absent (Code-1)
C0332197 (UMLS CUI 2011AB)
2667000 (SNOMEDCT_2012_01_31)
Shipping (Code-2)
C1524049 (UMLS CUI 2011AB)
Reason (Code-3)
C0392360 (UMLS CUI 2011AB)
410666004 (SNOMEDCT_2012_01_31)
MTHU008862 (LOINC Version 232)
Materials (Code-4)
C0520510 (UMLS CUI 2011AB)
260769002 (SNOMEDCT_2012_01_31)
MTHU013790 (LOINC Version 232)
MAT (HL7 V3 2006_05)
Shipping (Code-5)
C1524049 (UMLS CUI 2011AB)
Item
Shipping of an iliac crest biopsy to:
integer
Shipping (Code-1)
C1524049 (UMLS CUI 2011AB)
Iliac crest (Code-2)
C0223651 (UMLS CUI 2011AB)
29850006 (SNOMEDCT_2012_01_31)
Biopsy (Code-3)
C0005558 (UMLS CUI 2011AB)
86273004 (SNOMEDCT_2012_01_31)
10004720 (MedDRA 14.1)
MTHU028106 (LOINC Version 232)
Versand einer Beckenkammbiopsie
Code List
Shipping of an iliac crest biopsy to:
CL Item
Munster (1)
C0454791 (UMLS CUI 2011AB)
223810004 (SNOMEDCT_2012_01_31)
CL Item
Dresden (2)
no_code (Code-1)
CL Item
Frankfurt (3)
no_code (Code-1)
CL Item
no shipping because (kein Versand weil)
Absent (Code-1)
C0332197 (UMLS CUI 2011AB)
2667000 (SNOMEDCT_2012_01_31)
Shipping (Code-2)
C1524049 (UMLS CUI 2011AB)
Reason (Code-3)
C0392360 (UMLS CUI 2011AB)
410666004 (SNOMEDCT_2012_01_31)
MTHU008862 (LOINC Version 232)
kein Versand weil
Item
no shipping because
string
Absent (Code-1)
C0332197 (UMLS CUI 2011AB)
2667000 (SNOMEDCT_2012_01_31)
Shipping (Code-2)
C1524049 (UMLS CUI 2011AB)
Reason (Code-3)
C0392360 (UMLS CUI 2011AB)
410666004 (SNOMEDCT_2012_01_31)
MTHU008862 (LOINC Version 232)
Iliac crest (Code-4)
C0223651 (UMLS CUI 2011AB)
29850006 (SNOMEDCT_2012_01_31)
Biopsy (Code-5)
C0005558 (UMLS CUI 2011AB)
86273004 (SNOMEDCT_2012_01_31)
10004720 (MedDRA 14.1)
MTHU028106 (LOINC Version 232)
Item Group
Cytology
C1305671 (UMLS CUI 2011AB)
10061804 (MedDRA 14.1)
MTHU000052 (LOINC Version 232)
Item
Blast percentage
integer
Blasts (Code-1)
C0368761 (UMLS CUI 2011AB)
312256009 (SNOMEDCT_2012_01_31)
MTHU005201 (LOINC Version 232)
Percentage (Code-2)
CL343029 (UMLS CUI 2011AB)
% (HL7 V3 2006_05)
Blastenanteil
Code List
Blast percentage
CL Item
<5% (1)
Less than (Code-1)
C0439092 (UMLS CUI 2011AB)
276139006 (SNOMEDCT_2012_01_31)
LT (HL7 V3 2006_05)
5 (Code-2)
C0205451 (UMLS CUI 2011AB)
34001005 (SNOMEDCT_2012_01_31)
Percent (Code-3)
C0439165 (UMLS CUI 2011AB)
118582008 (SNOMEDCT_2012_01_31)
CL Item
>=5% (2)
Not Less Than (Code-1)
C0439091 (UMLS CUI 2011AB)
276138003 (SNOMEDCT_2012_01_31)
GE (HL7 V3 2006_05)
5 (Code-2)
C0205451 (UMLS CUI 2011AB)
34001005 (SNOMEDCT_2012_01_31)
Percent (Code-3)
C0439165 (UMLS CUI 2011AB)
118582008 (SNOMEDCT_2012_01_31)
CL Item
cannot be assessed (3)
cannot be assessed (Code-1)
C1707258 (UMLS CUI 2011AB)
wenn >=5%, dann bitte angeben [%]
Item
If >=5%, please specify [%]
integer
if (Code-1)
C0750557 (UMLS CUI 2011AB)
Not Less Than (Code-2)
C0439091 (UMLS CUI 2011AB)
276138003 (SNOMEDCT_2012_01_31)
GE (HL7 V3 2006_05)
5 (Code-3)
C0205451 (UMLS CUI 2011AB)
34001005 (SNOMEDCT_2012_01_31)
Percent (Code-4)
C0439165 (UMLS CUI 2011AB)
118582008 (SNOMEDCT_2012_01_31)
Specify (Code-5)
C1521902 (UMLS CUI 2011AB)
Item
Dysplasia sign:
integer
Dysplasia (Code-1)
C0334044 (UMLS CUI 2011AB)
25723000 (SNOMEDCT_2012_01_31)
10058314 (MedDRA 14.1)
Sign (Code-2)
C0311392 (UMLS CUI 2011AB)
72670004 (SNOMEDCT_2012_01_31)
MTHU001426 (LOINC Version 232)
Dysplasiezeichen
Code List
Dysplasia sign:
CL Item
Unilineage Dysplasia Present (1)
Unilineage Dysplasia Present (Code-1)
C2826319 (UMLS CUI 2011AB)
CL Item
AML with Multilineage Dysplasia (2)
AML with Multilineage Dysplasia (Code-1)
C1292773 (UMLS CUI 2011AB)
128827005 (SNOMEDCT_2012_01_31)
C92.A (ICD-10-CM Version 2010)
CL Item
Absent (3)
Absent (Code-1)
C0332197 (UMLS CUI 2011AB)
2667000 (SNOMEDCT_2012_01_31)
CL Item
Not examined for (4)
Not examined for (Code-1)
C0332129 (UMLS CUI 2011AB)
75134009 (SNOMEDCT_2012_01_31)
CL Item
cannot be assessed (5)
cannot be assessed (Code-1)
C1707258 (UMLS CUI 2011AB)
Item Group
FAB
French-American-British Classification (Code-1)
C2984084 (UMLS CUI 2011AB)
Item
FAB:
integer
French-American-British Classification (Code-1)
C2984084 (UMLS CUI 2011AB)
FAB
Code List
FAB:
CL Item
FAB type M0 (1)
FAB type M0 (Code-1)
C0457327 (UMLS CUI 2011AB)
278163009 (SNOMEDCT_2012_01_31)
CL Item
FAB type M1 (2)
FAB type M1 (Code-1)
C0457328 (UMLS CUI 2011AB)
278164003 (SNOMEDCT_2012_01_31)
CL Item
FAB type M2 (3)
FAB type M2 (Code-1)
C0457352 (UMLS CUI 2011AB)
278186002 (SNOMEDCT_2012_01_31)
CL Item
FAB type M4 (4)
FAB type M4 (Code-1)
C0457331 (UMLS CUI 2011AB)
278167005 (SNOMEDCT_2012_01_31)
CL Item
FAB type M4eo (5)
FAB type M4eo (Code-1)
C0457332 (UMLS CUI 2011AB)
278168000 (SNOMEDCT_2012_01_31)
CL Item
FAB type M5 (6)
FAB type M5 (Code-1)
C0457333 (UMLS CUI 2011AB)
278169008 (SNOMEDCT_2012_01_31)
CL Item
FAB type M5a (6a)
FAB type M5a (Code-1)
CL370644 (UMLS CUI 2011AB)
CL Item
FAB type M5b (6b)
FAB type M5b (Code-1)
C0457335 (UMLS CUI 2011AB)
278171008 (SNOMEDCT_2012_01_31)
CL Item
FAB type M6 (7)
FAB type M6 (Code-1)
C0457336 (UMLS CUI 2011AB)
278172001 (SNOMEDCT_2012_01_31)
CL Item
FAB type M7 (8)
FAB type M7 (Code-1)
C0457337 (UMLS CUI 2011AB)
278173006 (SNOMEDCT_2012_01_31)
CL Item
unknown (9)
unknown (Code-1)
C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)
Item
Cytogenetics (Please attach copy of findings!)
integer
Cytogenetics (Code-1)
C0010802 (UMLS CUI 2011AB)
Zytogenetik
Code List
Cytogenetics (Please attach copy of findings!)
CL Item
Normal karyotype (1)
C0333684 (UMLS CUI 2011AB)
2232008 (SNOMEDCT_2012_01_31)
CL Item
t(8;21) (2)
C1515794 (UMLS CUI 2011AB)
CL Item
t(16;16) (3)
C2828339 (UMLS CUI 2011AB)
CL Item
-7/7q- (4)
-7 (Code-1)
C1513483 (UMLS CUI 2011AB)
7q- (Code-2)
C1517990 (UMLS CUI 2011AB)
CL Item
t(6;9) (5)
C1515781 (UMLS CUI 2011AB)
CL Item
+8 as single aberration (6)
Trisomy 8 (Code-1)
C0432412 (UMLS CUI 2011AB)
205649008 (SNOMEDCT_2012_01_31)
10053871 (MedDRA 14.1)
MTHU010203 (LOINC Version 232)
Single (Code-2)
C0205171 (UMLS CUI 2011AB)
50607009 (SNOMEDCT_2012_01_31)
Aberration, Chromosome (Code-3)
C0008625 (UMLS CUI 2011AB)
CL Item
+8 with an additional aberration (except t(9;11)) (7)
Trisomy 8 (Code-1)
C0432412 (UMLS CUI 2011AB)
205649008 (SNOMEDCT_2012_01_31)
10053871 (MedDRA 14.1)
MTHU010203 (LOINC Version 232)
Additional (Code-2)
C1524062 (UMLS CUI 2011AB)
MTHU013802 (LOINC Version 232)
Aberration, Chromosome (Code-3)
C0008625 (UMLS CUI 2011AB)
Excluded (Code-4)
CL411789 (UMLS CUI 2011AB)
t(9;11) (Code-5)
C1515800 (UMLS CUI 2011AB)
CL Item
Complex karyotype (>= 3 lesions) (8)
Complex karyotype (Code-1)
CL429691 (UMLS CUI 2011AB)
Not Less Than (Code-2)
C0439091 (UMLS CUI 2011AB)
276138003 (SNOMEDCT_2012_01_31)
GE (HL7 V3 2006_05)
3 (Code-3)
C0205449 (UMLS CUI 2011AB)
421291004 (SNOMEDCT_2012_01_31)
CL Item
inv(16) (9)
C1541333 (UMLS CUI 2011AB)
CL Item
-5/5q- (10)
-5 (Code-1)
C1513481 (UMLS CUI 2011AB)
5q- (Code-2)
C1521461 (UMLS CUI 2011AB)
CL Item
t(3;3) (11)
C1515764 (UMLS CUI 2011AB)
CL Item
11q23 - aberrations (12)
11q23 (Code-1)
C0796367 (UMLS CUI 2011AB)
Aberration, Chromosome (Code-2)
C0008625 (UMLS CUI 2011AB)
sonstige Aberrationen
Item
other aberrations:
string
Other (Code-1)
C0205394 (UMLS CUI 2011AB)
74964007 (SNOMEDCT_2012_01_31)
Aberration, Chromosome (Code-2)
C0008625 (UMLS CUI 2011AB)
Item Group
Molecular Genetic Analysis (Please attach copy of findings!)
C1513380 (UMLS CUI 2011AB)
Item
AML1/ETO:
integer
C1851466 (UMLS CUI 2011AB)
AML1/ETO
Code List
AML1/ETO:
CL Item
yes (1)
Yes (Code-1)
C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)
CL Item
no (2)
No (Code-1)
C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)
CL Item
Not examined for (3)
C0332129 (UMLS CUI 2011AB)
75134009 (SNOMEDCT_2012_01_31)
Item
PML/RARa:
integer
C1867259 (UMLS CUI 2011AB)
PML/RARa
Code List
PML/RARa:
CL Item
yes (1)
Yes (Code-1)
C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)
CL Item
no (2)
No (Code-1)
C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)
CL Item
Not examined for (3)
C0332129 (UMLS CUI 2011AB)
75134009 (SNOMEDCT_2012_01_31)
Item
CBFbeta/MYH11:
integer
CL435279 (UMLS CUI 2011AB)
CBFbeta/MYH11
Code List
CBFbeta/MYH11:
CL Item
yes (1)
Yes (Code-1)
C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)
CL Item
no (2)
No (Code-1)
C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)
CL Item
Not examined for (3)
C0332129 (UMLS CUI 2011AB)
75134009 (SNOMEDCT_2012_01_31)
Item
C/EBPalpha:
integer
C1413322 (UMLS CUI 2011AB)
C/EBPalpha
Code List
C/EBPalpha:
CL Item
yes (1)
Yes (Code-1)
C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)
CL Item
no (2)
No (Code-1)
C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)
CL Item
Not examined for (3)
C0332129 (UMLS CUI 2011AB)
75134009 (SNOMEDCT_2012_01_31)
Item
NPM1(mut):
integer
C2826175 (UMLS CUI 2011AB)
NPM1-Mut
Code List
NPM1(mut):
CL Item
yes (1)
Yes (Code-1)
C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)
CL Item
no (2)
No (Code-1)
C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)
CL Item
Not examined for (3)
C0332129 (UMLS CUI 2011AB)
75134009 (SNOMEDCT_2012_01_31)
CL Item
Not examined for (1)
C0332129 (UMLS CUI 2011AB)
75134009 (SNOMEDCT_2012_01_31)
Item
IDH mutation:
integer
Isocitrate Dehydrogenase (NAD+) (Code-1)
C0022157 (UMLS CUI 2011AB)
259318006 (SNOMEDCT_2012_01_31)
MTHU012138 (LOINC Version 232)
Mutation (Code-2)
C0026882 (UMLS CUI 2011AB)
55446002 (SNOMEDCT_2012_01_31)
IDH-Mutation
Code List
IDH mutation:
CL Item
yes (1)
Yes (Code-1)
C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)
CL Item
no (2)
No (Code-1)
C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)
CL Item
Not examined for (3)
C0332129 (UMLS CUI 2011AB)
75134009 (SNOMEDCT_2012_01_31)
Item
FLT3 point mutation:
integer
FLT3 Tyrosine Kinase Domain Point Mutation (Code-1)
C2348501 (UMLS CUI 2011AB)
Flt3-Punktmutation
Code List
FLT3 point mutation:
CL Item
yes (1)
Yes (Code-1)
C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)
CL Item
no (2)
No (Code-1)
C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)
CL Item
Not examined for (3)
C0332129 (UMLS CUI 2011AB)
75134009 (SNOMEDCT_2012_01_31)
Item
FLT3-ITD:
integer
FLT3 Internal Tandem Duplication (Code-1)
C2348499 (UMLS CUI 2011AB)
Flt3-ITD
Code List
FLT3-ITD:
CL Item
yes (1)
Yes (Code-1)
C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)
CL Item
no (2)
No (Code-1)
C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)
CL Item
Not examined for (3)
C0332129 (UMLS CUI 2011AB)
75134009 (SNOMEDCT_2012_01_31)
Flt3-ITD-ratio
Item
Flt3-ITD-ratio
integer
FLT3 Internal Tandem Duplication (Code-1)
C2348499 (UMLS CUI 2011AB)
Ratio (Code-2)
C0456603 (UMLS CUI 2011AB)
118586006 (SNOMEDCT_2012_01_31)
Flt3-ITD Prozentsatz
Item
Flt3-ITD Percentage
integer
FLT3 Internal Tandem Duplication (Code-1)
C2348499 (UMLS CUI 2011AB)
Percentage (Code-2)
CL343029 (UMLS CUI 2011AB)
% (HL7 V3 2006_05)
Sonstige
Item
Other:
string
C0205394 (UMLS CUI 2011AB)
74964007 (SNOMEDCT_2012_01_31)
Item Group
Signature
C1519316 (UMLS CUI 2011AB)
Datum
Item
Date:
date
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Name/Unterschrift Prüfarzt
Item
Name/Signature study physician
string
Name (Code-1)
C0027365 (UMLS CUI 2011AB)
MTHU008539 (LOINC Version 232)
Signature (Code-2)
C1519316 (UMLS CUI 2011AB)
Study (Code-3)
C0008976 (UMLS CUI 2011AB)
110465008 (SNOMEDCT_2012_01_31)
Physician (Code-4)
C0031831 (UMLS CUI 2011AB)
309343006 (SNOMEDCT_2012_01_31)
MTHU010489 (LOINC Version 232)
PHYS (HL7 V3 2006_05)
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