ID

4595

Descripción

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

Palabras clave

Versiones (2)
  1. 16/12/13 16/12/13 -
  2. 16/12/13 16/12/13 -
Subido en

16 de diciembre de 2013

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0 Legacy
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Monat 1 Erhaltungstherapie / Nachbeobachtung EudraCT-Nr.: 2008-004583-40 Akute myeloische Leukämie(AML) AML alle außer FAB M3

Alemán Inglés

Monat 1 Erhaltungstherapie / Nachbeobachtung

1 formularios  
  1. StudyEvent: Akute myeloische Leukämie(AML) AML alle außer FAB M3
    1. Monat 1 Erhaltungstherapie / Nachbeobachtung
Patient data
Descripción

Patient data

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

Pat.-Nr.

Tipo de datos

integer

Alias
UMLS CUI 2011AB
C1830427
LOINC Version 232
MTHU021361
Treatment status
Descripción

Treatment status

Alias
Code-1
Treatment status
UMLS CUI 2011AB
C0749659
LOINC Version 232
MTHU036151
Number of received consolidation therapies:
Descripción

Anzahl der erhaltenen Konsolidierungstherapien

Tipo de datos

integer

Alias
Code-1
Number
UMLS CUI 2011AB
C0449788
SNOMEDCT_2012_01_31
410681005
Code-2
Received
UMLS CUI 2011AB
C1514756
Code-3
Consolidation Therapy
UMLS CUI 2011AB
C1511484
ECOG performance status finding
Descripción

ECOG performance status finding

Alias
UMLS CUI 2011AB
C1828127
SNOMEDCT_2012_01_31
424122007
Date:
Descripción

Datum

Tipo de datos

date

Alias
UMLS CUI 2011AB
C0011008
SNOMEDCT_2012_01_31
410671006
LOINC Version 232
MTHU021546
ECOG performance status finding
Descripción

ECOG-Status

Tipo de datos

integer

Alias
UMLS CUI 2011AB
C1828127
SNOMEDCT_2012_01_31
424122007
How many transfusions did the patient receive in the period between day 1 of last chemotherapy AND day 1 of the 1st month of maintenance therapy / follow-up*? *: Determination of the 1st day of the respective month: Maintenance therapy (Arm A): Day of the 1st administration of 5-azacytidine Follow-up (Arm B): Day of differential blood count
Descripción

Wieviel Transfusionen hat der Patient im Zeitraum zwischen: Tag 1 der letzten Chemotherapie UND Tag 1 des 1. Monats der Erhaltungstherapie / Nachbeobachtung* erhalten? *: Festlegung des 1. Tages des jeweiligen Monats: Erhaltungstherapie (Arm A): Tag der 1. Gabe von 5-Azacytidin Nachbeobachtung (Arm B): Tag des Differentialblutbildes

Tipo de datos

integer

Alias
Code-1
Number
UMLS CUI 2011AB
C0449788
SNOMEDCT_2012_01_31
410681005
Code-2
Transfusions
UMLS CUI 2011AB
C1879316
SNOMEDCT_2012_01_31
5447007
MedDRA 14.1
10066152
Code-3
Between
UMLS CUI 2011AB
CL426201
Code-4
Last
UMLS CUI 2011AB
C1517741
Code-5
Chemotherapy
UMLS CUI 2011AB
C0392920
SNOMEDCT_2012_01_31
150415003
Code-6
And
UMLS CUI 2011AB
C1515981
Number of transfused erythrocyte concentrates:
Descripción

Number of transfused erythrocyte concentrates

Tipo de datos

integer

Alias
Code-1
Number
UMLS CUI 2011AB
C0449788
SNOMEDCT_2012_01_31
410681005
Code-2
Erythrocyte Transfusion
UMLS CUI 2011AB
C0086252
SNOMEDCT_2012_01_31
116863004
Code-3
Concentrate
UMLS CUI 2011AB
C2003864
Number of transfused platelet concentrates:
Descripción

Number of transfused platelet concentrates

Tipo de datos

integer

Alias
Code-1
Number
UMLS CUI 2011AB
C0449788
SNOMEDCT_2012_01_31
410681005
Code-2
Platelet transfusion
UMLS CUI 2011AB
C0086818
SNOMEDCT_2012_01_31
12719002
MedDRA 14.1
10035543
ICD-9-CM Version 2011
99.05
Code-3
Concentrate
UMLS CUI 2011AB
C2003864
If AEs have occurred temporarily, please document these in the AE forms!
Descripción

Wenn zwischenzeitlich AEs aufgetreten sind, bitte diese auf den AE-Bögen dokumentieren!

Tipo de datos

integer

Differential blood count
Descripción

Differential blood count

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

Datum

Tipo de datos

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
Descripción

Haemoglobin

Tipo de datos

integer

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

Haemoglobin

Tipo de datos

integer

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

Leukozyten

Tipo de datos

integer

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

Leukozyten

Tipo de datos

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
Descripción

Prozentanteil Neutrophile

Tipo de datos

integer

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

Prozentanteil Stabkernige

Tipo de datos

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
Descripción

[oder] Prozentanteil Segmentkernige

Tipo de datos

integer

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

Prozentanteil Lymphozyten

Tipo de datos

integer

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

Prozentanteil Monozyten

Tipo de datos

integer

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

Prozentanteil Eosinophile

Tipo de datos

integer

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

Prozentanteil Basophile

Tipo de datos

integer

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

Prozentanteil Blasten

Tipo de datos

integer

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

Prozentanteil Promyelozyten

Tipo de datos

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
Descripción

Prozentanteil Myelozyten

Tipo de datos

integer

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

Prozentanteil Metamyelozyten

Tipo de datos

integer

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

Prozentanteil sonstige Zellen

Tipo de datos

integer

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

Thrombozyten

Tipo de datos

integer

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

Thrombozyten

Tipo de datos

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
Clinical Chemistry
Descripción

Clinical Chemistry

Alias
UMLS CUI 2011AB
C0008000
Sodium [mmol/L]
Descripción

Natrium [mmol/l]

Tipo de datos

integer

Alias
Code-1
Sodium:SCnc:Pt:Bld:Qn
UMLS CUI 2011AB
C0365091
LOINC Version 232
2947-0
Potassium [mmol/L]
Descripción

Kalium [mmol/l]

Tipo de datos

integer

Alias
Code-1
Potassium:SCnc:Pt:Bld:Qn
UMLS CUI 2011AB
C0364961
LOINC Version 232
6298-4
Total protein
Descripción

Gesamteiweiß

Tipo de datos

integer

Alias
Code-1
Total Protein Measurement
UMLS CUI 2011AB
C0555903
SNOMEDCT_2012_01_31
304383000
MedDRA 14.1
10050537
Total protein
Descripción

Gesamteiweiß

Tipo de datos

integer

Alias
Code-1
Total Protein Measurement
UMLS CUI 2011AB
C0555903
SNOMEDCT_2012_01_31
304383000
MedDRA 14.1
10050537
Code-2
Unit of Measure
UMLS CUI 2011AB
C1519795
Uric acid
Descripción

Harnsäure

Tipo de datos

integer

Alias
Code-1
Urate [Mass/volume] in Serum or Plasma
UMLS CUI 2011AB
C0365228
LOINC Version 232
3084-1
Uric acid
Descripción

Harnsäure

Tipo de datos

integer

Alias
Code-1
Urate [Mass/volume] in Serum or Plasma
UMLS CUI 2011AB
C0365228
LOINC Version 232
3084-1
Code-2
Unit of Measure
UMLS CUI 2011AB
C1519795
Blood Urea Nitrogen
Descripción

Harnstoff-N

Tipo de datos

integer

Alias
Code-1
Blood urea nitrogen measurement
UMLS CUI 2011AB
C0005845
SNOMEDCT_2012_01_31
250623007
MedDRA 14.1
10005845
Blood Urea Nitrogen
Descripción

Harnstoff-N

Tipo de datos

integer

Alias
Code-1
Blood urea nitrogen measurement
UMLS CUI 2011AB
C0005845
SNOMEDCT_2012_01_31
250623007
MedDRA 14.1
10005845
Code-2
Unit of Measure
UMLS CUI 2011AB
C1519795
Urea
Descripción

[oder] Harnstoff

Tipo de datos

integer

Alias
Code-1
Urea Measurement
UMLS CUI 2011AB
C0523961
SNOMEDCT_2012_01_31
105010007
MedDRA 14.1
10046346
Urea
Descripción

[oder] Harnstoff

Tipo de datos

integer

Alias
Code-1
Urea Measurement
UMLS CUI 2011AB
C0523961
SNOMEDCT_2012_01_31
105010007
MedDRA 14.1
10046346
Code-2
Unit of Measure
UMLS CUI 2011AB
C1519795
Creatinine
Descripción

Kreatinin

Tipo de datos

integer

Alias
Code-1
Creatinine Measurement
UMLS CUI 2011AB
C0201975
SNOMEDCT_2012_01_31
70901006
MedDRA 14.1
10005480
Creatinine
Descripción

Kreatinin

Tipo de datos

integer

Alias
Code-1
Creatinine Measurement
UMLS CUI 2011AB
C0201975
SNOMEDCT_2012_01_31
70901006
MedDRA 14.1
10005480
Code-2
Unit of Measure
UMLS CUI 2011AB
C1519795
Bilirubin total
Descripción

Bilirubin (gesamt)

Tipo de datos

integer

Alias
Code-1
Total Bilirubin Measurement
UMLS CUI 2011AB
C0201913
SNOMEDCT_2012_01_31
359986008
MedDRA 14.1
10004696
Bilirubin total
Descripción

Bilirubin (gesamt)

Tipo de datos

integer

Alias
Code-1
Total Bilirubin Measurement
UMLS CUI 2011AB
C0201913
SNOMEDCT_2012_01_31
359986008
MedDRA 14.1
10004696
Code-2
Unit of Measure
UMLS CUI 2011AB
C1519795
GOT/AST
Descripción

GOT/AST

Tipo de datos

integer

Alias
Code-1
Aspartate transaminase level
UMLS CUI 2011AB
C0428339
SNOMEDCT_2012_01_31
373679006
GOT/AST
Descripción

GOT/AST

Tipo de datos

integer

Alias
Code-1
Aspartate transaminase level
UMLS CUI 2011AB
C0428339
SNOMEDCT_2012_01_31
373679006
Code-2
Unit of Measure
UMLS CUI 2011AB
C1519795
GPT/ALT
Descripción

GPT/ALT

Tipo de datos

integer

Alias
Code-1
Alanine Transaminase
UMLS CUI 2011AB
C0001899
SNOMEDCT_2012_01_31
56935002
LOINC Version 232
MTHU006766
GPT/ALT
Descripción

GPT/ALT

Tipo de datos

integer

Alias
Code-1
Alanine Transaminase
UMLS CUI 2011AB
C0001899
SNOMEDCT_2012_01_31
56935002
LOINC Version 232
MTHU006766
Code-2
Unit of Measure
UMLS CUI 2011AB
C1519795
AP
Descripción

AP

Tipo de datos

integer

Alias
Code-1
Alkaline phosphatase level - finding
UMLS CUI 2011AB
C0428332
SNOMEDCT_2012_01_31
365771003
AP
Descripción

AP

Tipo de datos

integer

Alias
Code-1
Alkaline phosphatase level - finding
UMLS CUI 2011AB
C0428332
SNOMEDCT_2012_01_31
365771003
Code-2
Unit of Measure
UMLS CUI 2011AB
C1519795
LDH
Descripción

LDH

Tipo de datos

integer

Alias
Code-1
Lactate Dehydrogenase
UMLS CUI 2011AB
C0022917
SNOMEDCT_2012_01_31
259319003
LOINC Version 232
MTHU002348
LDH
Descripción

LDH

Tipo de datos

integer

Alias
Code-1
Lactate Dehydrogenase
UMLS CUI 2011AB
C0022917
SNOMEDCT_2012_01_31
259319003
LOINC Version 232
MTHU002348
Code-2
Unit of Measure
UMLS CUI 2011AB
C1519795
CRP
Descripción

CRP

Tipo de datos

integer

Alias
Code-1
C-reactive protein
UMLS CUI 2011AB
C0006560
SNOMEDCT_2012_01_31
61425002
LOINC Version 232
MTHU002335
CRP
Descripción

CRP

Tipo de datos

integer

Alias
Code-1
C-reactive protein
UMLS CUI 2011AB
C0006560
SNOMEDCT_2012_01_31
61425002
LOINC Version 232
MTHU002335
Code-2
Unit of Measure
UMLS CUI 2011AB
C1519795
Quick's value (in percent)
Descripción

Quick-Wert (in Prozent)

Tipo de datos

integer

Alias
Code-1
Prothrombin time ratio
UMLS CUI 2011AB
C0483455
MedDRA 14.1
10037064
INR
Descripción

INR

Tipo de datos

integer

Alias
Code-1
International Normalized Ratio
UMLS CUI 2011AB
CL415281
PTT [sec]
Descripción

PTT [sek]

Tipo de datos

integer

Alias
Code-1
Activated Partial Thromboplastin Time measurement
UMLS CUI 2011AB
C0030605
SNOMEDCT_2012_01_31
42525009
MedDRA 14.1
10000630
Bone marrow examination
Descripción

Bone marrow examination

Alias
UMLS CUI 2011AB
C0005957
SNOMEDCT_2012_01_31
167907006
MedDRA 14.1
10005988
Bone marrow examination
Descripción

Knochenmarkuntersuchung

Tipo de datos

integer

Alias
Code-1
Date - Bone marrow examination
UMLS CUI 2011AB
C0011008
SNOMEDCT_2012_01_31
410671006
LOINC Version 232
MTHU021546
Date - Bone marrow examination
Descripción

Datum - Knochenmarkuntersuchung

Tipo de datos

date

Alias
Code-1
Date - Bone marrow examination
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:
Descripción

Obligater Materialversand

Tipo de datos

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
Descripción

kein Versand weil

Tipo de datos

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
Descripción

Cytology

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

Blastenanteil

Tipo de datos

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 [%]
Descripción

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

Tipo de datos

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:
Descripción

Zytogenetik

Tipo de datos

integer

Alias
UMLS CUI 2011AB
C0010802
Cytogenetic aberration detectable:
Descripción

Cytogenetic aberration detectable

Tipo de datos

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
Descripción

count of metaphases

Tipo de datos

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
Descripción

total count of metaphases

Tipo de datos

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
Descripción

% interphase FISH

Tipo de datos

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:
Descripción

New aberration detectable

Tipo de datos

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!)
Descripción

Molecular Genetic Analysis (Please attach copy of findings!)

Alias
UMLS CUI 2011AB
C1513380
AML1/ETO:
Descripción

AML1/ETO

Tipo de datos

integer

Alias
UMLS CUI 2011AB
C1851466
PML/RARa:
Descripción

PML/RARa

Tipo de datos

integer

Alias
UMLS CUI 2011AB
C1867259
CBFbeta/MYH11:
Descripción

CBFbeta/MYH11

Tipo de datos

integer

Alias
UMLS CUI 2011AB
CL435279
C/EBPalpha:
Descripción

C/EBPalpha

Tipo de datos

integer

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

NPM1-Mut

Tipo de datos

integer

Alias
UMLS CUI 2011AB
C2826175
IDH mutation:
Descripción

IDH-Mutation

Tipo de datos

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:
Descripción

Flt3-Punktmutation

Tipo de datos

integer

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

Flt3-ITD

Tipo de datos

integer

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

Sonstige

Tipo de datos

string

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

Remission status

Tipo de datos

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
At the regular end of the study (1 year after the start of the 1st induction therapy) please fill in form "Studienende/Studien-abbruch" page 82!)
Descripción

Bei regulärem Studienende (1 Jahr nach Beginn der 1. Induktions-therapie) bitte Bogen "Studienende/Studienabbruch" Seite 82 ausfüllen!

Tipo de datos

integer

Signature
Descripción

Signature

Alias
UMLS CUI 2011AB
C1519316
Date:
Descripción

Datum

Tipo de datos

date

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

Name/Unterschrift Prüfarzt

Tipo de datos

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

Monat 1 Erhaltungstherapie / Nachbeobachtung

1 formularios
  1. StudyEvent: Akute myeloische Leukämie(AML) AML alle außer FAB M3
    1. Monat 1 Erhaltungstherapie / Nachbeobachtung
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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)
Item Group
Treatment status
Treatment status (Code-1)
C0749659 (UMLS CUI 2011AB)
MTHU036151 (LOINC Version 232)
Item
Number of received consolidation therapies:
integer
Number (Code-1)
C0449788 (UMLS CUI 2011AB)
410681005 (SNOMEDCT_2012_01_31)
Received (Code-2)
C1514756 (UMLS CUI 2011AB)
Consolidation Therapy (Code-3)
C1511484 (UMLS CUI 2011AB)
Anzahl der erhaltenen Konsolidierungstherapien
Code List
Number of received consolidation therapies:
CL Item
1 consolidation therapy block (1)
1 (Code-1)
C0205447 (UMLS CUI 2011AB)
38112003 (SNOMEDCT_2012_01_31)
Consolidation Therapy (Code-2)
C1511484 (UMLS CUI 2011AB)
Block (Code-3)
C2828370 (UMLS CUI 2011AB)
CL Item
2 consolidation therapy blocks (2)
2 (Code-1)
C0205448 (UMLS CUI 2011AB)
19338005 (SNOMEDCT_2012_01_31)
Consolidation Therapy (Code-2)
C1511484 (UMLS CUI 2011AB)
Block (Code-3)
C2828370 (UMLS CUI 2011AB)
CL Item
No consolidation therapy (3)
Negation (Code-1)
C1518422 (UMLS CUI 2011AB)
Consolidation Therapy (Code-2)
C1511484 (UMLS CUI 2011AB)
Item Group
ECOG performance status finding
C1828127 (UMLS CUI 2011AB)
424122007 (SNOMEDCT_2012_01_31)
Datum
Item
Date:
date
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Item
ECOG performance status finding
integer
C1828127 (UMLS CUI 2011AB)
424122007 (SNOMEDCT_2012_01_31)
ECOG-Status
Code List
ECOG performance status finding
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)
Wieviel Transfusionen hat der Patient im Zeitraum zwischen: Tag 1 der letzten Chemotherapie UND Tag 1 des 1. Monats der Erhaltungstherapie / Nachbeobachtung* erhalten? *: Festlegung des 1. Tages des jeweiligen Monats: Erhaltungstherapie (Arm A): Tag der 1. Gabe von 5-Azacytidin Nachbeobachtung (Arm B): Tag des Differentialblutbildes
Item
How many transfusions did the patient receive in the period between day 1 of last chemotherapy AND day 1 of the 1st month of maintenance therapy / follow-up*? *: Determination of the 1st day of the respective month: Maintenance therapy (Arm A): Day of the 1st administration of 5-azacytidine Follow-up (Arm B): Day of differential blood count
integer
Number (Code-1)
C0449788 (UMLS CUI 2011AB)
410681005 (SNOMEDCT_2012_01_31)
Transfusions (Code-2)
C1879316 (UMLS CUI 2011AB)
5447007 (SNOMEDCT_2012_01_31)
10066152 (MedDRA 14.1)
Between (Code-3)
CL426201 (UMLS CUI 2011AB)
Last (Code-4)
C1517741 (UMLS CUI 2011AB)
Chemotherapy (Code-5)
C0392920 (UMLS CUI 2011AB)
150415003 (SNOMEDCT_2012_01_31)
And (Code-6)
C1515981 (UMLS CUI 2011AB)
Number of transfused erythrocyte concentrates
Item
Number of transfused erythrocyte concentrates:
integer
Number (Code-1)
C0449788 (UMLS CUI 2011AB)
410681005 (SNOMEDCT_2012_01_31)
Erythrocyte Transfusion (Code-2)
C0086252 (UMLS CUI 2011AB)
116863004 (SNOMEDCT_2012_01_31)
Concentrate (Code-3)
C2003864 (UMLS CUI 2011AB)
Number of transfused platelet concentrates
Item
Number of transfused platelet concentrates:
integer
Number (Code-1)
C0449788 (UMLS CUI 2011AB)
410681005 (SNOMEDCT_2012_01_31)
Platelet transfusion (Code-2)
C0086818 (UMLS CUI 2011AB)
12719002 (SNOMEDCT_2012_01_31)
10035543 (MedDRA 14.1)
99.05 (ICD-9-CM Version 2011)
Concentrate (Code-3)
C2003864 (UMLS CUI 2011AB)
Wenn zwischenzeitlich AEs aufgetreten sind, bitte diese auf den AE-Bögen dokumentieren!
Item
If AEs have occurred temporarily, please document these in the AE forms!
integer
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
Clinical Chemistry
C0008000 (UMLS CUI 2011AB)
Natrium [mmol/l]
Item
Sodium [mmol/L]
integer
Sodium:SCnc:Pt:Bld:Qn (Code-1)
C0365091 (UMLS CUI 2011AB)
2947-0 (LOINC Version 232)
Kalium [mmol/l]
Item
Potassium [mmol/L]
integer
Potassium:SCnc:Pt:Bld:Qn (Code-1)
C0364961 (UMLS CUI 2011AB)
6298-4 (LOINC Version 232)
Gesamteiweiß
Item
Total protein
integer
Total Protein Measurement (Code-1)
C0555903 (UMLS CUI 2011AB)
304383000 (SNOMEDCT_2012_01_31)
10050537 (MedDRA 14.1)
Item
Total protein
integer
Total Protein Measurement (Code-1)
C0555903 (UMLS CUI 2011AB)
304383000 (SNOMEDCT_2012_01_31)
10050537 (MedDRA 14.1)
Unit of Measure (Code-2)
C1519795 (UMLS CUI 2011AB)
Gesamteiweiß
Code List
Total protein
CL Item
[g/l] ([g/l])
g/L (Code-1)
C0439294 (UMLS CUI 2011AB)
258794004 (SNOMEDCT_2012_01_31)
CL Item
[g/dl] ([g/dl])
g/dL (Code-1)
C0439267 (UMLS CUI 2011AB)
258795003 (SNOMEDCT_2012_01_31)
Harnsäure
Item
Uric acid
integer
Urate [Mass/volume] in Serum or Plasma (Code-1)
C0365228 (UMLS CUI 2011AB)
3084-1 (LOINC Version 232)
Item
Uric acid
integer
Urate [Mass/volume] in Serum or Plasma (Code-1)
C0365228 (UMLS CUI 2011AB)
3084-1 (LOINC Version 232)
Unit of Measure (Code-2)
C1519795 (UMLS CUI 2011AB)
Harnsäure
Code List
Uric acid
CL Item
[mg/dl] ([mg/dl])
mg/dl (Code-1)
C0439269 (UMLS CUI 2011AB)
258797006 (SNOMEDCT_2012_01_31)
3084-1 (LOINC Version 232)
CL Item
[µmol/L] ([µmol/l])
µmol/l (Code-1)
C0439300 (UMLS CUI 2011AB)
258814008 (SNOMEDCT_2012_01_31)
Harnstoff-N
Item
Blood Urea Nitrogen
integer
Blood urea nitrogen measurement (Code-1)
C0005845 (UMLS CUI 2011AB)
250623007 (SNOMEDCT_2012_01_31)
10005845 (MedDRA 14.1)
Item
Blood Urea Nitrogen
integer
Blood urea nitrogen measurement (Code-1)
C0005845 (UMLS CUI 2011AB)
250623007 (SNOMEDCT_2012_01_31)
10005845 (MedDRA 14.1)
Unit of Measure (Code-2)
C1519795 (UMLS CUI 2011AB)
Harnstoff-N
Code List
Blood Urea Nitrogen
CL Item
[mg/dl] ([mg/dl])
Urea nitrogen:MCnc:Pt:Bld:Qn (Code-1)
C0365237 (UMLS CUI 2011AB)
6299-2 (LOINC Version 232)
CL Item
[mmol/l] ([mmol/l])
Urea nitrogen:SCnc:Pt:Bld:Qn (Code-1)
C2923863 (UMLS CUI 2011AB)
59570-2 (LOINC Version 232)
[oder] Harnstoff
Item
Urea
integer
Urea Measurement (Code-1)
C0523961 (UMLS CUI 2011AB)
105010007 (SNOMEDCT_2012_01_31)
10046346 (MedDRA 14.1)
Item
Urea
integer
Urea Measurement (Code-1)
C0523961 (UMLS CUI 2011AB)
105010007 (SNOMEDCT_2012_01_31)
10046346 (MedDRA 14.1)
Unit of Measure (Code-2)
C1519795 (UMLS CUI 2011AB)
[oder] Harnstoff
Code List
Urea
CL Item
[mg/dl] ([mg/dl])
Urea:MCnc:Pt:Bld:Qn (Code-1)
C0803775 (UMLS CUI 2011AB)
20977-5  (LOINC Version 232)
CL Item
[mmol/l] ([mmol/l])
Urea [Moles/​volume] in Blood (Code-1)
72903-8  (LOINC Version 232)
Kreatinin
Item
Creatinine
integer
Creatinine Measurement (Code-1)
C0201975 (UMLS CUI 2011AB)
70901006 (SNOMEDCT_2012_01_31)
10005480 (MedDRA 14.1)
Item
Creatinine
integer
Creatinine Measurement (Code-1)
C0201975 (UMLS CUI 2011AB)
70901006 (SNOMEDCT_2012_01_31)
10005480 (MedDRA 14.1)
Unit of Measure (Code-2)
C1519795 (UMLS CUI 2011AB)
Kreatinin
Code List
Creatinine
CL Item
[mg/dl] ([mg/dl])
Creatinine:MCnc:Pt:Bld:Qn (Code-1)
C1526484 (UMLS CUI 2011AB)
38483-4  (LOINC Version 232)
CL Item
[µmol/l] ([µmol/l])
Creatinine:SCnc:Pt:Bld:Qn (Code-1)
C2924074 (UMLS CUI 2011AB)
59826-8  (LOINC Version 232)
Bilirubin (gesamt)
Item
Bilirubin total
integer
Total Bilirubin Measurement (Code-1)
C0201913 (UMLS CUI 2011AB)
359986008 (SNOMEDCT_2012_01_31)
10004696 (MedDRA 14.1)
Item
Bilirubin total
integer
Total Bilirubin Measurement (Code-1)
C0201913 (UMLS CUI 2011AB)
359986008 (SNOMEDCT_2012_01_31)
10004696 (MedDRA 14.1)
Unit of Measure (Code-2)
C1519795 (UMLS CUI 2011AB)
Bilirubin (gesamt)
Code List
Bilirubin total
CL Item
[mg/dl] ([mg/dl])
Bilirubin:MCnc:Pt:Bld:Qn (Code-1)
C1623600 (UMLS CUI 2011AB)
42719-5  (LOINC Version 232)
CL Item
[µmol/l] ([µmol/l])
Bilirubin.total [Moles/​volume] in Blood (Code-1)
54363-7  (LOINC Version 232)
GOT/AST
Item
GOT/AST
integer
Aspartate transaminase level (Code-1)
C0428339 (UMLS CUI 2011AB)
373679006 (SNOMEDCT_2012_01_31)
Item
GOT/AST
integer
Aspartate transaminase level (Code-1)
C0428339 (UMLS CUI 2011AB)
373679006 (SNOMEDCT_2012_01_31)
Unit of Measure (Code-2)
C1519795 (UMLS CUI 2011AB)
GOT/AST
Code List
GOT/AST
CL Item
[U/l] ([U/l])
Aspartate aminotransferase:CCnc:Pt:Ser/Plas:Qn (Code-1)
C0364055 (UMLS CUI 2011AB)
1920-8  (LOINC Version 232)
CL Item
[µmol/s*l] ([µmol/s*l])
Aspartate transaminase level (Code-1)
C0428339 (UMLS CUI 2011AB)
373679006 (SNOMEDCT_2012_01_31)
Liter per Micromole per Second (Code-2)
C2827845 (UMLS CUI 2011AB)
GPT/ALT
Item
GPT/ALT
integer
Alanine Transaminase (Code-1)
C0001899 (UMLS CUI 2011AB)
56935002 (SNOMEDCT_2012_01_31)
MTHU006766 (LOINC Version 232)
Item
GPT/ALT
integer
Alanine Transaminase (Code-1)
C0001899 (UMLS CUI 2011AB)
56935002 (SNOMEDCT_2012_01_31)
MTHU006766 (LOINC Version 232)
Unit of Measure (Code-2)
C1519795 (UMLS CUI 2011AB)
GPT/ALT
Code List
GPT/ALT
CL Item
[U/l] ([U/l])
Alanine aminotransferase:CCnc:Pt:Ser/Plas:Qn (Code-1)
C0363876 (UMLS CUI 2011AB)
1742-6  (LOINC Version 232)
CL Item
[µmol/s*l] ([µmol/s*l])
Alanine Transaminase (Code-1)
C0001899 (UMLS CUI 2011AB)
56935002 (SNOMEDCT_2012_01_31)
MTHU006766 (LOINC Version 232)
Liter per Micromole per Second (Code-2)
C2827845 (UMLS CUI 2011AB)
AP
Item
AP
integer
Alkaline phosphatase level - finding (Code-1)
C0428332 (UMLS CUI 2011AB)
365771003 (SNOMEDCT_2012_01_31)
Item
AP
integer
Alkaline phosphatase level - finding (Code-1)
C0428332 (UMLS CUI 2011AB)
365771003 (SNOMEDCT_2012_01_31)
Unit of Measure (Code-2)
C1519795 (UMLS CUI 2011AB)
AP
Code List
AP
CL Item
[U/l] ([U/l])
Alkaline phosphatase:CCnc:Pt:Bld:Qn (Code-1)
C0363917 (UMLS CUI 2011AB)
1783-0  (LOINC Version 232)
CL Item
[µmol/s*l] ([µmol/s*l])
Alkaline phosphatase level - finding (Code-1)
C0428332 (UMLS CUI 2011AB)
365771003 (SNOMEDCT_2012_01_31)
Liter per Micromole per Second (Code-2)
C2827845 (UMLS CUI 2011AB)
LDH
Item
LDH
integer
Lactate Dehydrogenase (Code-1)
C0022917 (UMLS CUI 2011AB)
259319003 (SNOMEDCT_2012_01_31)
MTHU002348 (LOINC Version 232)
Item
LDH
integer
Lactate Dehydrogenase (Code-1)
C0022917 (UMLS CUI 2011AB)
259319003 (SNOMEDCT_2012_01_31)
MTHU002348 (LOINC Version 232)
Unit of Measure (Code-2)
C1519795 (UMLS CUI 2011AB)
LDH
Code List
LDH
CL Item
[U/l] ([U/l])
Lactate Dehydrogenase (Code-1)
C0022917 (UMLS CUI 2011AB)
259319003 (SNOMEDCT_2012_01_31)
MTHU002348 (LOINC Version 232)
Unit per Liter (Code-2)
C0439339 (UMLS CUI 2011AB)
258947003 (SNOMEDCT_2012_01_31)
CL Item
[µmol/s*l] ([µmol/s*l])
Lactate Dehydrogenase (Code-1)
C0022917 (UMLS CUI 2011AB)
259319003 (SNOMEDCT_2012_01_31)
MTHU002348 (LOINC Version 232)
Liter per Micromole per Second (Code-2)
C2827845 (UMLS CUI 2011AB)
CRP
Item
CRP
integer
C-reactive protein (Code-1)
C0006560 (UMLS CUI 2011AB)
61425002 (SNOMEDCT_2012_01_31)
MTHU002335 (LOINC Version 232)
Item
CRP
integer
C-reactive protein (Code-1)
C0006560 (UMLS CUI 2011AB)
61425002 (SNOMEDCT_2012_01_31)
MTHU002335 (LOINC Version 232)
Unit of Measure (Code-2)
C1519795 (UMLS CUI 2011AB)
CRP
Code List
CRP
CL Item
[mg/l] ([mg/l])
C reactive protein:MCnc:Pt:Ser/Plas:Qn (Code-1)
C0364121 (UMLS CUI 2011AB)
1988-5  (LOINC Version 232)
mg/l (Code-2)
C0439268 (UMLS CUI 2011AB)
258796002 (SNOMEDCT_2012_01_31)
CL Item
[mg/dl] ([mg/dl])
C reactive protein:MCnc:Pt:Ser/Plas:Qn (Code-1)
C0364121 (UMLS CUI 2011AB)
1988-5  (LOINC Version 232)
mg/dl (Code-2)
C0439269 (UMLS CUI 2011AB)
258797006 (SNOMEDCT_2012_01_31)
Quick-Wert (in Prozent)
Item
Quick's value (in percent)
integer
Prothrombin time ratio (Code-1)
C0483455 (UMLS CUI 2011AB)
10037064 (MedDRA 14.1)
INR
Item
INR
integer
International Normalized Ratio (Code-1)
CL415281 (UMLS CUI 2011AB)
PTT [sek]
Item
PTT [sec]
integer
Activated Partial Thromboplastin Time measurement (Code-1)
C0030605 (UMLS CUI 2011AB)
42525009 (SNOMEDCT_2012_01_31)
10000630 (MedDRA 14.1)
Item Group
Bone marrow examination
C0005957 (UMLS CUI 2011AB)
167907006 (SNOMEDCT_2012_01_31)
10005988 (MedDRA 14.1)
Item
Bone marrow examination
integer
Date - Bone marrow examination (Code-1)
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Knochenmarkuntersuchung
Code List
Bone marrow examination
CL Item
Performed (durchgeführt)
Performed (Code-1)
C0884358 (UMLS CUI 2011AB)
398166005 (SNOMEDCT_2012_01_31)
CL Item
Not performed (nicht durchgeführt)
Not performed (Code-1)
C0445106 (UMLS CUI 2011AB)
262008008 (SNOMEDCT_2012_01_31)
Datum - Knochenmarkuntersuchung
Item
Date - Bone marrow examination
date
Date - Bone marrow examination (Code-1)
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Bone marrow examination (Code-2)
C0005957 (UMLS CUI 2011AB)
167907006 (SNOMEDCT_2012_01_31)
10005988 (MedDRA 14.1)
Item
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
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
Relapse (Please fill in form "Rezidiv" page 83+84 and form "Studienende/Stu-dienabbruch page 82!) (3)
Relapse (Code-1)
C0035020 (UMLS CUI 2011AB)
263855007 (SNOMEDCT_2012_01_31)
Bei regulärem Studienende (1 Jahr nach Beginn der 1. Induktions-therapie) bitte Bogen "Studienende/Studienabbruch" Seite 82 ausfüllen!
Item
At the regular end of the study (1 year after the start of the 1st induction therapy) please fill in form "Studienende/Studien-abbruch" page 82!)
integer
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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