ID

4591

Descrição

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

Palavras-chave

Versões (2)
  1. 16/12/2013 16/12/2013 -
  2. 17/09/2021 17/09/2021 -
Transferido a

16 de dezembro de 2013

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy
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Rezidiv / Tod EudraCT-Nr 2008-004583-40 Akute myeloische Leukämie(AML) AML alle außer FAB M3

Alemão Inglês

Rezidiv / Tod

1 Formulários  
  1. StudyEvent: Akute myeloische Leukämie(AML) AML alle außer FAB M3
    1. Rezidiv / Tod
Patient data
Descrição

Patient data

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

Pat.-Nr.

Tipo de dados

integer

Alias
UMLS CUI 2011AB
C1830427
LOINC Version 232
MTHU021361
Date of the relapse diagnosis:
Descrição

Datum der Rezidiv-Diagnose

Tipo de dados

date

Alias
Code-1
Date of diagnosis
UMLS CUI 2011AB
C2316983
SNOMEDCT_2012_01_31
432213005
LOINC Version 232
MTHU038128
Code-2
Relapse
UMLS CUI 2011AB
C0035020
SNOMEDCT_2012_01_31
263855007
Differential blood count
Descrição

Differential blood count

Alias
Code-1
Differential Leukocyte Count
UMLS CUI 2011AB
C0162401
SNOMEDCT_2012_01_31
165511009
MedDRA 14.1
10012784
If already documented in the CRF, please specify page number (further documentation not required):
Descrição

Falls bereits im CRF dokumentiert, bitte Seitenzahl angeben

Tipo de dados

integer

Alias
Code-1
CRF
UMLS CUI 2011AB
C1516308
Code-2
Page
UMLS CUI 2011AB
C1704732
Code-3
Documented
UMLS CUI 2011AB
C1301725
SNOMEDCT_2012_01_31
397934002
Code-4
Differential Leukocyte Count
UMLS CUI 2011AB
C0162401
SNOMEDCT_2012_01_31
165511009
MedDRA 14.1
10012784
Date:
Descrição

Datum

Tipo de dados

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
Descrição

Haemoglobin

Tipo de dados

integer

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

Haemoglobin

Tipo de dados

integer

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

Leukozyten

Tipo de dados

integer

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

Leukozyten

Tipo de dados

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
Descrição

Prozentanteil Neutrophile

Tipo de dados

integer

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

Prozentanteil Stabkernige

Tipo de dados

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
Descrição

[oder] Prozentanteil Segmentkernige

Tipo de dados

integer

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

Prozentanteil Lymphozyten

Tipo de dados

integer

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

Prozentanteil Monozyten

Tipo de dados

integer

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

Prozentanteil Eosinophile

Tipo de dados

integer

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

Prozentanteil Basophile

Tipo de dados

integer

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

Prozentanteil Blasten

Tipo de dados

integer

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

Prozentanteil Promyelozyten

Tipo de dados

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
Descrição

Prozentanteil Myelozyten

Tipo de dados

integer

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

Prozentanteil Metamyelozyten

Tipo de dados

integer

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

Prozentanteil sonstige Zellen

Tipo de dados

integer

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

Thrombozyten

Tipo de dados

integer

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

Thrombozyten

Tipo de dados

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
Descrição

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
Descrição

Datum - Knochenmarkuntersuchung

Tipo de dados

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
If already documented in the CRF, please specify page number (further documentation not required):
Descrição

Falls bereits im CRF dokumentiert, bitte Seitenzahl angeben

Tipo de dados

integer

Alias
Code-1
CRF
UMLS CUI 2011AB
C1516308
Code-2
Page
UMLS CUI 2011AB
C1704732
Code-3
Documented
UMLS CUI 2011AB
C1301725
SNOMEDCT_2012_01_31
397934002
Code-4
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:
Descrição

Obligater Materialversand

Tipo de dados

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
Descrição

kein Versand weil

Tipo de dados

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
Descrição

Cytology

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

Blastenanteil

Tipo de dados

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 [%]
Descrição

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

Tipo de dados

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:
Descrição

Zytogenetik

Tipo de dados

integer

Alias
UMLS CUI 2011AB
C0010802
Cytogenetic aberration detectable:
Descrição

Cytogenetic aberration detectable

Tipo de dados

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
Descrição

count of metaphases

Tipo de dados

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
Descrição

total count of metaphases

Tipo de dados

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
Descrição

% interphase FISH

Tipo de dados

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:
Descrição

New aberration detectable

Tipo de dados

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 (Please attach copy of findings!)
Descrição

Molecular Genetic Analysis (Please attach copy of findings!)

Alias
UMLS CUI 2011AB
C1513380
AML1/ETO:
Descrição

AML1/ETO

Tipo de dados

integer

Alias
UMLS CUI 2011AB
C1851466
PML/RARa:
Descrição

PML/RARa

Tipo de dados

integer

Alias
UMLS CUI 2011AB
C1867259
CBFbeta/MYH11:
Descrição

CBFbeta/MYH11

Tipo de dados

integer

Alias
UMLS CUI 2011AB
CL435279
C/EBPalpha:
Descrição

C/EBPalpha

Tipo de dados

integer

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

NPM1-Mut

Tipo de dados

integer

Alias
UMLS CUI 2011AB
C2826175
IDH mutation:
Descrição

IDH-Mutation

Tipo de dados

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:
Descrição

Flt3-Punktmutation

Tipo de dados

integer

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

Flt3-ITD

Tipo de dados

integer

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

Sonstige

Tipo de dados

string

Alias
UMLS CUI 2011AB
C0205394
SNOMEDCT_2012_01_31
74964007
Code-2
Molecular Genetic Analysis
UMLS CUI 2011AB
C1513380
Extramedullary AML manifestation
Descrição

Extramedulläre AML-Manifestation

Tipo de dados

integer

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

Lokalisation

Tipo de dados

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:
Descrição

andere

Tipo de dados

string

Alias
UMLS CUI 2011AB
C0205394
SNOMEDCT_2012_01_31
74964007
Was the extramedullary AML manifestation confirmed by biopsy / puncture?
Descrição

Wurde die extramedulläre AML-Manifestation durch eine Biopsie / Punktion gesichert?

Tipo de dados

integer

Alias
Code-1
Leukaemic infiltration extramedullary
UMLS CUI 2011AB
C1868812
MedDRA 14.1
10067117
Code-2
Biopsy
UMLS CUI 2011AB
C0005558
SNOMEDCT_2012_01_31
86273004
MedDRA 14.1
10004720
LOINC Version 232
MTHU028106
Code-3
Puncture
UMLS CUI 2011AB
C0034117
SNOMEDCT_2012_01_31
85921004
Code-4
Confirmed
UMLS CUI 2011AB
C0750484
Date of biopsy / puncture:
Descrição

Datum der Biopsie / Punktion

Tipo de dados

date

Alias
Code-1
Date
UMLS CUI 2011AB
C0011008
SNOMEDCT_2012_01_31
410671006
LOINC Version 232
MTHU021546
Code-2
Biopsy
UMLS CUI 2011AB
C0005558
SNOMEDCT_2012_01_31
86273004
MedDRA 14.1
10004720
LOINC Version 232
MTHU028106
Code-3
Puncture
UMLS CUI 2011AB
C0034117
SNOMEDCT_2012_01_31
85921004
Signature
Descrição

Signature

Alias
UMLS CUI 2011AB
C1519316
Date:
Descrição

Datum

Tipo de dados

date

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

Name/Unterschrift Prüfarzt

Tipo de dados

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
Patient data
Descrição

Patient data

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

Pat. No.

Tipo de dados

integer

Alias
UMLS CUI 2011AB
C1830427
LOINC Version 232
MTHU021361
Date of death:
Descrição

Todesdatum

Tipo de dados

date

Alias
UMLS CUI 2011AB
C1148348
SNOMEDCT_2012_01_31
399753006
LOINC Version 232
MTHU014693
If death has occurred up to and including 42 days after last administration of 5-Azacytidine / Chemotherapy, please fill in AE and SAE forms!
Descrição

Falls der Tod bis einschließlich 42 Tage nach letzter Gabe von 5-Azacytidin / Chemotherapie eingetreten ist , bitte AE- und SAE-Bogen ausfüllen!

Tipo de dados

integer

Cause of death:
Descrição

Todesursache

Tipo de dados

integer

Alias
Code-1
Cause of death:
UMLS CUI 2011AB
C0007465
SNOMEDCT_2012_01_31
184305005
LOINC Version 232
MTHU010441
Please specify:
Descrição

Bitte spezifizieren

Tipo de dados

string

Alias
Code-1
Specify
UMLS CUI 2011AB
C1521902
Code-2
Cause of death:
UMLS CUI 2011AB
C0007465
SNOMEDCT_2012_01_31
184305005
LOINC Version 232
MTHU010441
Remission status at date of death
Descrição

Remissionsstatus zum Todeszeitpunkt

Tipo de dados

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
Code-3
Date of death
UMLS CUI 2011AB
C1148348
SNOMEDCT_2012_01_31
399753006
LOINC Version 232
MTHU014693
Autopsy performed?
Descrição

Obduktion durchgeführt?

Tipo de dados

boolean

Alias
Code-1
Autopsy
UMLS CUI 2011AB
C0004398
SNOMEDCT_2012_01_31
29240004
MedDRA 14.1
10050117
ICD-9-CM Version 2011
89.8
Code-2
performed:
UMLS CUI 2011AB
C0884358
SNOMEDCT_2012_01_31
398166005
If yes, please send autopsy report or details:
Descrição

Wenn ja, bitte Obduktionsbericht schicken oder nähere Angaben

Tipo de dados

string

Alias
Code-1
Autopsy report
UMLS CUI 2011AB
C1548372
SNOMEDCT_2012_01_31
270116006
LOINC Version 232
MTHU035945
Code-2
Details
UMLS CUI 2011AB
C1522508
LOINC Version 232
MTHU027859
Signature
Descrição

Signature

Alias
UMLS CUI 2011AB
C1519316
Date:
Descrição

Datum

Tipo de dados

date

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

Name/Unterschrift Prüfarzt

Tipo de dados

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

Rezidiv / Tod

1 Formulários
  1. StudyEvent: Akute myeloische Leukämie(AML) AML alle außer FAB M3
    1. Rezidiv / Tod
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Patient data
C2707520 (UMLS CUI 2011AB)
MTHU031990 (LOINC Version 232)
Pat.-Nr.
Item
Pat. No.: -
integer
C1830427 (UMLS CUI 2011AB)
MTHU021361 (LOINC Version 232)
Datum der Rezidiv-Diagnose
Item
Date of the relapse diagnosis:
date
Date of diagnosis (Code-1)
C2316983 (UMLS CUI 2011AB)
432213005 (SNOMEDCT_2012_01_31)
MTHU038128 (LOINC Version 232)
Relapse (Code-2)
C0035020 (UMLS CUI 2011AB)
263855007 (SNOMEDCT_2012_01_31)
Item Group
Differential blood count
Differential Leukocyte Count (Code-1)
C0162401 (UMLS CUI 2011AB)
165511009 (SNOMEDCT_2012_01_31)
10012784 (MedDRA 14.1)
Falls bereits im CRF dokumentiert, bitte Seitenzahl angeben
Item
If already documented in the CRF, please specify page number (further documentation not required):
integer
CRF (Code-1)
C1516308 (UMLS CUI 2011AB)
Page (Code-2)
C1704732 (UMLS CUI 2011AB)
Documented (Code-3)
C1301725 (UMLS CUI 2011AB)
397934002 (SNOMEDCT_2012_01_31)
Differential Leukocyte Count (Code-4)
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)
Falls bereits im CRF dokumentiert, bitte Seitenzahl angeben
Item
If already documented in the CRF, please specify page number (further documentation not required):
integer
CRF (Code-1)
C1516308 (UMLS CUI 2011AB)
Page (Code-2)
C1704732 (UMLS CUI 2011AB)
Documented (Code-3)
C1301725 (UMLS CUI 2011AB)
397934002 (SNOMEDCT_2012_01_31)
Bone marrow examination (Code-4)
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
Cytogenetics:
integer
C0010802 (UMLS CUI 2011AB)
Zytogenetik
Code List
Cytogenetics:
CL Item
performed (Please attach copy of findings!) (1)
Performed (Code-1)
C0884358 (UMLS CUI 2011AB)
398166005 (SNOMEDCT_2012_01_31)
CL Item
not performed (2)
Not performed (Code-1)
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 (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)
Sonstige
Item
Other:
string
C0205394 (UMLS CUI 2011AB)
74964007 (SNOMEDCT_2012_01_31)
Molecular Genetic Analysis (Code-2)
C1513380 (UMLS CUI 2011AB)
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
Was the extramedullary AML manifestation confirmed by biopsy / puncture?
integer
Leukaemic infiltration extramedullary (Code-1)
C1868812 (UMLS CUI 2011AB)
10067117 (MedDRA 14.1)
Biopsy (Code-2)
C0005558 (UMLS CUI 2011AB)
86273004 (SNOMEDCT_2012_01_31)
10004720 (MedDRA 14.1)
MTHU028106 (LOINC Version 232)
Puncture (Code-3)
C0034117 (UMLS CUI 2011AB)
85921004 (SNOMEDCT_2012_01_31)
Confirmed (Code-4)
C0750484 (UMLS CUI 2011AB)
Wurde die extramedulläre AML-Manifestation durch eine Biopsie / Punktion gesichert?
Code List
Was the extramedullary AML manifestation confirmed by biopsy / puncture?
CL Item
yes (please attach copy of findings!): (ja)
Yes (Code-1)
C1298907 (UMLS CUI 2011AB)
373066001 (SNOMEDCT_2012_01_31)
CL Item
no (nein)
No (Code-1)
C1298908 (UMLS CUI 2011AB)
373067005 (SNOMEDCT_2012_01_31)
Datum der Biopsie / Punktion
Item
Date of biopsy / puncture:
date
Date (Code-1)
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Biopsy (Code-2)
C0005558 (UMLS CUI 2011AB)
86273004 (SNOMEDCT_2012_01_31)
10004720 (MedDRA 14.1)
MTHU028106 (LOINC Version 232)
Puncture (Code-3)
C0034117 (UMLS CUI 2011AB)
85921004 (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)
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)
Todesdatum
Item
Date of death:
date
C1148348 (UMLS CUI 2011AB)
399753006 (SNOMEDCT_2012_01_31)
MTHU014693 (LOINC Version 232)
Falls der Tod bis einschließlich 42 Tage nach letzter Gabe von 5-Azacytidin / Chemotherapie eingetreten ist , bitte AE- und SAE-Bogen ausfüllen!
Item
If death has occurred up to and including 42 days after last administration of 5-Azacytidine / Chemotherapy, please fill in AE and SAE forms!
integer
Item
Cause of death:
integer
Cause of death: (Code-1)
C0007465 (UMLS CUI 2011AB)
184305005 (SNOMEDCT_2012_01_31)
MTHU010441 (LOINC Version 232)
Todesursache
Code List
Cause of death:
CL Item
Infection (1)
C0021311 (UMLS CUI 2011AB)
257551009 (SNOMEDCT_2012_01_31)
10021789 (MedDRA 14.1)
CL Item
Hemorrhage (2)
C0019080 (UMLS CUI 2011AB)
50960005 (SNOMEDCT_2012_01_31)
10055798 (MedDRA 14.1)
R58 (ICD-10-CM Version 2010)
459.0 (ICD-9-CM Version 2011)
CL Item
Other cause (3)
other (Code-1)
C0205394 (UMLS CUI 2011AB)
74964007 (SNOMEDCT_2012_01_31)
Cause (Code-2)
C1314792 (UMLS CUI 2011AB)
134198009 (SNOMEDCT_2012_01_31)
Bitte spezifizieren
Item
Please specify:
string
Specify (Code-1)
C1521902 (UMLS CUI 2011AB)
Cause of death: (Code-2)
C0007465 (UMLS CUI 2011AB)
184305005 (SNOMEDCT_2012_01_31)
MTHU010441 (LOINC Version 232)
Item
Remission status at date of death
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)
Date of death (Code-3)
C1148348 (UMLS CUI 2011AB)
399753006 (SNOMEDCT_2012_01_31)
MTHU014693 (LOINC Version 232)
Remissionsstatus zum Todeszeitpunkt
Code List
Remission status at date of death
CL Item
CR or morphologic leukemia-free status (1)
CR (Code-1)
C0677874 (UMLS CUI 2011AB)
103338009 (SNOMEDCT_2012_01_31)
Morphology (Code-2)
C0332437 (UMLS CUI 2011AB)
116676008 (SNOMEDCT_2012_01_31)
MTHU008051 (LOINC Version 232)
leukemia (Code-3)
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-4)
C0332296 (UMLS CUI 2011AB)
37837009 (SNOMEDCT_2012_01_31)
Status (Code-5)
C0449438 (UMLS CUI 2011AB)
263490005 (SNOMEDCT_2012_01_31)
MTHU015827 (LOINC Version 232)
CL Item
Primary therapy failure / Relapse (2)
primary (Code-1)
CL414904 (UMLS CUI 2011AB)
Treatment failure (Code-2)
C0162643 (UMLS CUI 2011AB)
10066901 (MedDRA 14.1)
Relapse (Code-3)
C0035020 (UMLS CUI 2011AB)
263855007 (SNOMEDCT_2012_01_31)
CL Item
unknown (3)
C0439673 (UMLS CUI 2011AB)
261665006 (SNOMEDCT_2012_01_31)
Obduktion durchgeführt?
Item
Autopsy performed?
boolean
Autopsy (Code-1)
C0004398 (UMLS CUI 2011AB)
29240004 (SNOMEDCT_2012_01_31)
10050117 (MedDRA 14.1)
89.8 (ICD-9-CM Version 2011)
performed: (Code-2)
C0884358 (UMLS CUI 2011AB)
398166005 (SNOMEDCT_2012_01_31)
Wenn ja, bitte Obduktionsbericht schicken oder nähere Angaben
Item
If yes, please send autopsy report or details:
string
Autopsy report (Code-1)
C1548372 (UMLS CUI 2011AB)
270116006 (SNOMEDCT_2012_01_31)
MTHU035945 (LOINC Version 232)
Details (Code-2)
C1522508 (UMLS CUI 2011AB)
MTHU027859 (LOINC Version 232)
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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