ID

10242

Descrizione

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

versioni (3)
  1. 07/11/13 07/11/13 -
  2. 16/12/13 16/12/13 -
  3. 20/05/15 20/05/15 - Martin Dugas
Caricato su

20 maggio 2015

DOI

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Licenza

Creative Commons BY-NC 3.0
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AML AZA NCT00915252

Tedesco Inglese

Remissionsstatus vor 1. Konsolidierung AML NCT00915252

1 moduli  
  1. StudyEvent: Akute myeloische Leukämie(AML) AML alle außer FAB M3
    1. Remissionsstatus vor 1. Konsolidierung AML NCT00915252
Patient data
Descrizione

Patient data

Alias
UMLS CUI 2011AB
C2707520
LOINC Version 232
MTHU031990
Pat. No.: -
Descrizione

Pat. No.

Tipo di dati

integer

Alias
UMLS CUI 2011AB
C1830427
LOINC Version 232
MTHU021361
Differential blood count
Descrizione

Differential blood count

Alias
Code-1
Differential Leukocyte Count
UMLS CUI 2011AB
C0162401
SNOMEDCT_2012_01_31
165511009
MedDRA 14.1
10012784
Date:
Descrizione

Datum

Tipo di dati

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
Descrizione

Haemoglobin

Tipo di dati

integer

Alias
Code-1
Hemoglobin
UMLS CUI 2011AB
C0518015
MedDRA 14.1
10018876
Hemoglobin
Descrizione

Haemoglobin

Tipo di dati

integer

Alias
Code-1
Hemoglobin
UMLS CUI 2011AB
C0518015
MedDRA 14.1
10018876
Code-2
Unit of Measure
UMLS CUI 2011AB
C1519795
Leukocytes
Descrizione

Leukozyten

Tipo di dati

integer

Alias
Code-1
Leukocytes:NCnc:Pt:Bld:Qn
UMLS CUI 2011AB
C0945357
LOINC Version 232
26464-8
Leukocytes
Descrizione

Leukozyten

Tipo di dati

integer

Alias
Code-1
Leukocytes:NCnc:Pt:Bld:Qn
UMLS CUI 2011AB
C0945357
LOINC Version 232
26464-8
Code-2
Unit of Measure
UMLS CUI 2011AB
C1519795
Neutrophil percentage
Descrizione

Prozentanteil Neutrophile

Tipo di dati

integer

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

Prozentanteil Stabkernige

Tipo di dati

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
Descrizione

[oder] Prozentanteil Segmentkernige

Tipo di dati

integer

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

Prozentanteil Lymphozyten

Tipo di dati

integer

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

Prozentanteil Monozyten

Tipo di dati

integer

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

Prozentanteil Eosinophile

Tipo di dati

integer

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

Prozentanteil Basophile

Tipo di dati

integer

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

Prozentanteil Blasten

Tipo di dati

integer

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

Prozentanteil Promyelozyten

Tipo di dati

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
Descrizione

Prozentanteil Myelozyten

Tipo di dati

integer

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

Prozentanteil Metamyelozyten

Tipo di dati

integer

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

Prozentanteil sonstige Zellen

Tipo di dati

integer

Alias
Code-1
Other cells/100 leukocytes
UMLS CUI 2011AB
C1978275
LOINC Version 232
MTHU026796
Platelets
Descrizione

Thrombozyten

Tipo di dati

integer

Alias
Code-1
Platelets:NCnc:Pt:Bld:Qn
UMLS CUI 2011AB
C0942474
LOINC Version 232
26515-7
Platelets
Descrizione

Thrombozyten

Tipo di dati

integer

Alias
Code-1
Platelets:NCnc:Pt:Bld:Qn
UMLS CUI 2011AB
C0942474
LOINC Version 232
26515-7
Code-2
Unit of Measure
UMLS CUI 2011AB
C1519795
Bone marrow examination
Descrizione

Bone marrow examination

Alias
Code-1
Bone marrow examination
UMLS CUI 2011AB
C0005957
SNOMEDCT_2012_01_31
167907006
MedDRA 14.1
10005988
Date - Bone marrow examination
Descrizione

Datum - Knochenmarkuntersuchung

Tipo di dati

date

Alias
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
Obligatory materials shipping (bone marrow + blood) for determination of methylation status to:
Descrizione

Obligater Materialversand

Tipo di dati

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
Descrizione

kein Versand weil

Tipo di dati

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
Cytology
Descrizione

Cytology

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

Blastenanteil

Tipo di dati

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 [%]
Descrizione

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

Tipo di dati

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
Cytogenetics
Descrizione

Cytogenetics

Alias
UMLS CUI 2011AB
C0010802
Cytogenetics:
Descrizione

Cytogenetics

Tipo di dati

integer

Alias
UMLS CUI 2011AB
C0010802
Cytogenetic aberration detectable:
Descrizione

Cytogenetic aberration detectable

Tipo di dati

integer

Alias
Code-1
Cytogenetic Aberration
UMLS CUI 2011AB
C0008625
Code-2
Identifiable
UMLS CUI 2011AB
C0205396
SNOMEDCT_2012_01_31
7882003
LOINC Version 232
MTHU014964
count of metaphases
Descrizione

count of metaphases

Tipo di dati

integer

Alias
Code-1
Number
UMLS CUI 2011AB
C0449788
SNOMEDCT_2012_01_31
410681005
Code-2
Total
UMLS CUI 2011AB
C0439810
SNOMEDCT_2012_01_31
255619001
Code-3
Metaphase
UMLS CUI 2011AB
C1621812
SNOMEDCT_2012_01_31
74399001
total count of metaphases
Descrizione

total count of metaphases

Tipo di dati

integer

Alias
Code-1
Number
UMLS CUI 2011AB
C0449788
SNOMEDCT_2012_01_31
410681005
Code-2
Total
UMLS CUI 2011AB
C0439810
SNOMEDCT_2012_01_31
255619001
Code-3
Metaphase
UMLS CUI 2011AB
C1621812
SNOMEDCT_2012_01_31
74399001
% Interphase FISH
Descrizione

% interphase FISH

Tipo di dati

integer

Alias
Code-1
Percent
UMLS CUI 2011AB
C0439165
SNOMEDCT_2012_01_31
118582008
Code-2
Fluorescent in situ hybridisation positive
UMLS CUI 2011AB
CL437650
MedDRA 14.1
10072468
New aberration detectable:
Descrizione

New aberration detectable

Tipo di dati

boolean

Alias
Code-1
New
UMLS CUI 2011AB
C0205314
SNOMEDCT_2012_01_31
7147002
Code-2
Aberration
UMLS CUI 2011AB
C0008625
Code-3
Identifiable
UMLS CUI 2011AB
C0205396
SNOMEDCT_2012_01_31
7882003
LOINC Version 232
MTHU014964
Molecular Genetic Analysis
Descrizione

Molecular Genetic Analysis

Alias
Code-1
Molecular Genetic Analysis
UMLS CUI 2011AB
C1513380
Molecular Genetic Analysis
Descrizione

Molekulargenetik

Tipo di dati

integer

Alias
UMLS CUI 2011AB
C1513380
AML1/ETO:
Descrizione

AML1/ETO

Tipo di dati

integer

Alias
UMLS CUI 2011AB
C1851466
PML/RARa:
Descrizione

PML/RARa

Tipo di dati

integer

Alias
UMLS CUI 2011AB
C1867259
CBFbeta/MYH11:
Descrizione

CBFbeta/MYH11

Tipo di dati

integer

Alias
UMLS CUI 2011AB
CL435279
C/EBPalpha:
Descrizione

C/EBPalpha

Tipo di dati

integer

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

NPM1-Mut

Tipo di dati

integer

Alias
UMLS CUI 2011AB
C2826175
IDH mutation:
Descrizione

IDH-Mutation

Tipo di dati

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:
Descrizione

Flt3-Punktmutation

Tipo di dati

integer

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

Flt3-ITD

Tipo di dati

integer

Alias
Code-1
FLT3 Internal Tandem Duplication
UMLS CUI 2011AB
C2348499
Other:
Descrizione

Sonstige

Tipo di dati

string

Alias
UMLS CUI 2011AB
C0205394
SNOMEDCT_2012_01_31
74964007
Code-2
Molecular Genetic Analysis
UMLS CUI 2011AB
C1513380
Remission status
Descrizione

Remission status

Alias
Code-1
Remission
UMLS CUI 2011AB
C0544452
SNOMEDCT_2012_01_31
277022003
Code-2
Status
UMLS CUI 2011AB
C0449438
SNOMEDCT_2012_01_31
263490005
LOINC Version 232
MTHU015827
Remission status
Descrizione

Remission status

Tipo di dati

integer

Alias
Code-1
Remission
UMLS CUI 2011AB
C0544452
SNOMEDCT_2012_01_31
277022003
Code-2
Status
UMLS CUI 2011AB
C0449438
SNOMEDCT_2012_01_31
263490005
LOINC Version 232
MTHU015827
Signature
Descrizione

Signature

Alias
UMLS CUI 2011AB
C1519316
Date:
Descrizione

Datum

Tipo di dati

date

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

Name/Unterschrift Prüfarzt

Tipo di dati

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

Remissionsstatus vor 1. Konsolidierung AML NCT00915252

1 moduli
  1. StudyEvent: Akute myeloische Leukämie(AML) AML alle außer FAB M3
    1. Remissionsstatus vor 1. Konsolidierung AML NCT00915252
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Patient data
C2707520 (UMLS CUI 2011AB)
MTHU031990 (LOINC Version 232)
Pat. No.
Item
Pat. No.: -
integer
C1830427 (UMLS CUI 2011AB)
MTHU021361 (LOINC Version 232)
Item Group
Differential blood count
Differential Leukocyte Count (Code-1)
C0162401 (UMLS CUI 2011AB)
165511009 (SNOMEDCT_2012_01_31)
10012784 (MedDRA 14.1)
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)
Haemoglobin
Item
Hemoglobin
integer
Hemoglobin (Code-1)
C0518015 (UMLS CUI 2011AB)
10018876 (MedDRA 14.1)
Item
Hemoglobin
integer
Hemoglobin (Code-1)
C0518015 (UMLS CUI 2011AB)
10018876 (MedDRA 14.1)
Unit of Measure (Code-2)
C1519795 (UMLS CUI 2011AB)
Haemoglobin
Code List
Hemoglobin
CL Item
[mmol/l] ([mmol/l])
Hemoglobin:SCnc:Pt:Bld:Qn (Code-1)
C2923664 (UMLS CUI 2011AB)
59260-0 (LOINC Version 232)
CL Item
[g/dl] ([g/dl])
Hemoglobin:MCnc:Pt:Bld:Qn (Code-1)
C0362923 (UMLS CUI 2011AB)
718-7 (LOINC Version 232)
Leukozyten
Item
Leukocytes
integer
Leukocytes:NCnc:Pt:Bld:Qn (Code-1)
C0945357 (UMLS CUI 2011AB)
26464-8 (LOINC Version 232)
Item
Leukocytes
integer
Leukocytes:NCnc:Pt:Bld:Qn (Code-1)
C0945357 (UMLS CUI 2011AB)
26464-8 (LOINC Version 232)
Unit of Measure (Code-2)
C1519795 (UMLS CUI 2011AB)
Leukozyten
Code List
Leukocytes
CL Item
[GPt/l] ([GPt/l])
Billion Cells per Liter (Code-1)
C0456524 (UMLS CUI 2011AB)
277199001 (SNOMEDCT_2012_01_31)
CL Item
[/µl] ( [/µl])
Cells per Microliter (Code-1)
C0439378 (UMLS CUI 2011AB)
258878000 (SNOMEDCT_2012_01_31)
CL Item
[10E3/µl] ([10E3/µl])
Thousand Cells per Microliter (Code-1)
C1883312 (UMLS CUI 2011AB)
CL Item
[/nl] ( [/nl])
Cells (Code-1)
C0007634 (UMLS CUI 2011AB)
4421005 (SNOMEDCT_2012_01_31)
MTHU001933 (LOINC Version 232)
Per (Code-3)
CL416189 (UMLS CUI 2011AB)
Nanoliter (Code-4)
C0560008 (UMLS CUI 2011AB)
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)
Thrombozyten
Item
Platelets
integer
Platelets:NCnc:Pt:Bld:Qn (Code-1)
C0942474 (UMLS CUI 2011AB)
26515-7 (LOINC Version 232)
Item
Platelets
integer
Platelets:NCnc:Pt:Bld:Qn (Code-1)
C0942474 (UMLS CUI 2011AB)
26515-7 (LOINC Version 232)
Unit of Measure (Code-2)
C1519795 (UMLS CUI 2011AB)
Thrombozyten
Code List
Platelets
CL Item
[GPt/l] ([GPt/l])
Billion Cells per Liter (Code-1)
C0456524 (UMLS CUI 2011AB)
277199001 (SNOMEDCT_2012_01_31)
CL Item
[/µl] ([/µl])
Cells per Microliter (Code-1)
C0439378 (UMLS CUI 2011AB)
258878000 (SNOMEDCT_2012_01_31)
CL Item
[10E3/µl] ([10E3/µl])
Thousand Cells per Microliter (Code-1)
C1883312 (UMLS CUI 2011AB)
CL Item
[/nl] ([/nl])
Cells (Code-1)
C0007634 (UMLS CUI 2011AB)
4421005 (SNOMEDCT_2012_01_31)
MTHU001933 (LOINC Version 232)
Per (Code-3)
CL416189 (UMLS CUI 2011AB)
Nanoliter (Code-4)
C0560008 (UMLS CUI 2011AB)
Item Group
Bone marrow examination
Bone marrow examination (Code-1)
C0005957 (UMLS CUI 2011AB)
167907006 (SNOMEDCT_2012_01_31)
10005988 (MedDRA 14.1)
Datum - Knochenmarkuntersuchung
Item
Date - Bone marrow examination
date
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
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 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 Group
Cytogenetics
C0010802 (UMLS CUI 2011AB)
Item
Cytogenetics:
integer
C0010802 (UMLS CUI 2011AB)
Cytogenetics
Code List
Cytogenetics:
CL Item
performed (Please attach copy of findings!) (1)
C0884358 (UMLS CUI 2011AB)
398166005 (SNOMEDCT_2012_01_31)
CL Item
not performed (2)
C0445106 (UMLS CUI 2011AB)
262008008 (SNOMEDCT_2012_01_31)
Item
Cytogenetic aberration detectable:
integer
Cytogenetic Aberration (Code-1)
C0008625 (UMLS CUI 2011AB)
Identifiable (Code-2)
C0205396 (UMLS CUI 2011AB)
7882003 (SNOMEDCT_2012_01_31)
MTHU014964 (LOINC Version 232)
Cytogenetic aberration detectable
Code List
Cytogenetic aberration detectable:
CL Item
yes, in / metaphases (yes, in metaphases)
yes (Code-1)
C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)
Metaphase (Code-2)
C1621812 (UMLS CUI 2011AB)
74399001 (SNOMEDCT_2012_01_31)
CL Item
yes, in % Interphase FISH (yes, in interphase FISH)
yes (Code-1)
C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)
Chromosome analysis.interphase:Imp:Pt:Bone mar:Nar:FISH (Code-2)
C1978637 (UMLS CUI 2011AB)
50659-2 (LOINC Version 232)
CL Item
no (no)
Negation (Code-1)
C1518422 (UMLS CUI 2011AB)
count of metaphases
Item
count of metaphases
integer
Number (Code-1)
C0449788 (UMLS CUI 2011AB)
410681005 (SNOMEDCT_2012_01_31)
Total (Code-2)
C0439810 (UMLS CUI 2011AB)
255619001 (SNOMEDCT_2012_01_31)
Metaphase (Code-3)
C1621812 (UMLS CUI 2011AB)
74399001 (SNOMEDCT_2012_01_31)
total count of metaphases
Item
total count of metaphases
integer
Number (Code-1)
C0449788 (UMLS CUI 2011AB)
410681005 (SNOMEDCT_2012_01_31)
Total (Code-2)
C0439810 (UMLS CUI 2011AB)
255619001 (SNOMEDCT_2012_01_31)
Metaphase (Code-3)
C1621812 (UMLS CUI 2011AB)
74399001 (SNOMEDCT_2012_01_31)
% interphase FISH
Item
% Interphase FISH
integer
Percent (Code-1)
C0439165 (UMLS CUI 2011AB)
118582008 (SNOMEDCT_2012_01_31)
Fluorescent in situ hybridisation positive (Code-2)
CL437650 (UMLS CUI 2011AB)
10072468 (MedDRA 14.1)
New aberration detectable
Item
New aberration detectable:
boolean
New (Code-1)
C0205314 (UMLS CUI 2011AB)
7147002 (SNOMEDCT_2012_01_31)
Aberration (Code-2)
C0008625 (UMLS CUI 2011AB)
Identifiable (Code-3)
C0205396 (UMLS CUI 2011AB)
7882003 (SNOMEDCT_2012_01_31)
MTHU014964 (LOINC Version 232)
Item Group
Molecular Genetic Analysis
Molecular Genetic Analysis (Code-1)
C1513380 (UMLS CUI 2011AB)
Item
Molecular Genetic Analysis
integer
C1513380 (UMLS CUI 2011AB)
Molekulargenetik
Code List
Molecular Genetic Analysis
CL Item
performed (Please attach copy of findings!) (1)
C0884358 (UMLS CUI 2011AB)
398166005 (SNOMEDCT_2012_01_31)
CL Item
not performed (2)
C0445106 (UMLS CUI 2011AB)
262008008 (SNOMEDCT_2012_01_31)
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)
Sonstige
Item
Other:
string
C0205394 (UMLS CUI 2011AB)
74964007 (SNOMEDCT_2012_01_31)
Molecular Genetic Analysis (Code-2)
C1513380 (UMLS CUI 2011AB)
Item Group
Remission status
Remission (Code-1)
C0544452 (UMLS CUI 2011AB)
277022003 (SNOMEDCT_2012_01_31)
Status (Code-2)
C0449438 (UMLS CUI 2011AB)
263490005 (SNOMEDCT_2012_01_31)
MTHU015827 (LOINC Version 232)
Item
Remission status
integer
Remission (Code-1)
C0544452 (UMLS CUI 2011AB)
277022003 (SNOMEDCT_2012_01_31)
Status (Code-2)
C0449438 (UMLS CUI 2011AB)
263490005 (SNOMEDCT_2012_01_31)
MTHU015827 (LOINC Version 232)
Remission status
Code List
Remission status
CL Item
Morphologic leukemia-free status (without achievement of peripheral CR criteria) (1)
Morphology (Code-1)
C0332437 (UMLS CUI 2011AB)
116676008 (SNOMEDCT_2012_01_31)
MTHU008051 (LOINC Version 232)
leukemia (Code-2)
C0023418 (UMLS CUI 2011AB)
93143009 (SNOMEDCT_2012_01_31)
10024288 (MedDRA 14.1)
C95.9 (ICD-10-CM Version 2010)
208.9 (ICD-9-CM Version 2011)
Free (Code-3)
C0332296 (UMLS CUI 2011AB)
37837009 (SNOMEDCT_2012_01_31)
Status (Code-4)
C0449438 (UMLS CUI 2011AB)
263490005 (SNOMEDCT_2012_01_31)
MTHU015827 (LOINC Version 232)
without (Code-5)
C0332288 (UMLS CUI 2011AB)
45169001 (SNOMEDCT_2012_01_31)
Achievement (Code-6)
C0001072 (UMLS CUI 2011AB)
CL Item
Morphologic complete remission (CR) (2)
Morphology (Code-1)
C0332437 (UMLS CUI 2011AB)
116676008 (SNOMEDCT_2012_01_31)
MTHU008051 (LOINC Version 232)
Complete Remission (CR) (Code-2)
C0677874 (UMLS CUI 2011AB)
103338009 (SNOMEDCT_2012_01_31)
CL Item
Cytogenetic complete remission (CRc) (3)
Cytogenetic Analysis (Code-1)
C0752095 (UMLS CUI 2011AB)
10059882 (MedDRA 14.1)
Complete Remission (CR) (Code-2)
C0677874 (UMLS CUI 2011AB)
103338009 (SNOMEDCT_2012_01_31)
CL Item
Molecular genetic complete remission (CRm) (4)
Molecular Genetic Analysis (Code-1)
C1513380 (UMLS CUI 2011AB)
Complete Remission (CR) (Code-2)
C0677874 (UMLS CUI 2011AB)
103338009 (SNOMEDCT_2012_01_31)
CL Item
Treatment failure (partial remission (PR), no response) (Please fill in form "Studienende/Studien-abbruch" page 82!) (5)
Treatment failure (Code-1)
C0162643 (UMLS CUI 2011AB)
10066901 (MedDRA 14.1)
PR (Code-2)
C1521726 (UMLS CUI 2011AB)
103337004 (SNOMEDCT_2012_01_31)
No response (Code-3)
C0438286 (UMLS CUI 2011AB)
266721009 (SNOMEDCT_2012_01_31)
10063670 (MedDRA 14.1)
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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