ID

4171

Beschrijving

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

Trefwoorden

Geüploaded op

7 november 2013

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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Remissionsstatus vor 1. Konsolidierung (bei fehlender hämatolog. Regeneration am Tag 35 nach letzter Induktion: zwischen Tag 35 und 42!) EudraCT-Nr 2008-004583-40 Akute myeloische Leukämie(AML) AML alle außer FAB M3

model
Details

Remissionsstatus vor 1. Konsolidierung (bei fehlender hämatolog. Regeneration am Tag 35 nach letzter Induktion: zwischen Tag 35 und 42!)

1 Formulieren

StudyEvent: Akute myeloische Leukämie(AML) AML alle außer FAB M3
1. Remissionsstatus vor 1. Konsolidierung (bei fehlender hämatolog. Regeneration am Tag 35 nach letzter Induktion: zwischen Tag 35 und 42!)

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Patientendaten

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)

Differentialblutbild

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)

Haemoglobin

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)

Leukozyten

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)

Thrombozyten

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)

Knochenmarkuntersuchung

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)

Obligater Materialversand

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)

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)

Zytologie

Item Group

Cytology

C1305671 (UMLS CUI 2011AB)
10061804 (MedDRA 14.1)
MTHU000052 (LOINC Version 232)

Blastenanteil

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)

Zytogenetik

Item Group

Cytogenetics

C0010802 (UMLS CUI 2011AB)

Cytogenetics

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)

Cytogenetic aberration detectable

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)

yes, in interphase FISH

Item

yes, in % Interphase FISH

float

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)
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)
Percent (Code-1)
C0439165 (UMLS CUI 2011AB)
118582008 (SNOMEDCT_2012_01_31)
Interphase (Code-2)
C0021798 (UMLS CUI 2011AB)
5741007 (SNOMEDCT_2012_01_31)
Interphase (Code-1)
C0021798 (UMLS CUI 2011AB)
5741007 (SNOMEDCT_2012_01_31)
FISH (Code-2)
C0162789 (UMLS CUI 2011AB)
426329006 (SNOMEDCT_2012_01_31)
10066931 (MedDRA 14.1)
FISH (Code-1)
C0162789 (UMLS CUI 2011AB)
426329006 (SNOMEDCT_2012_01_31)
10066931 (MedDRA 14.1)

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

% 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)

Molekulargenetik

Item Group

Molecular Genetic Analysis

Molecular Genetic Analysis (Code-1)
C1513380 (UMLS CUI 2011AB)

Molekulargenetik

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)

AML1/ETO

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)

PML/RARa

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)

CBFbeta/MYH11

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)

C/EBPalpha

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)

NPM1-Mut

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)

IDH-Mutation

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)

Flt3-Punktmutation

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)

Flt3-ITD

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)

Remission status

Item Group

Remission status

C0544452 (UMLS CUI 2011AB)
277022003 (SNOMEDCT_2012_01_31)
C0449438 (UMLS CUI 2011AB)
263490005 (SNOMEDCT_2012_01_31)
MTHU015827 (LOINC Version 232)

Remission status

Item

Remission status

integer

C0544452 (UMLS CUI 2011AB)
277022003 (SNOMEDCT_2012_01_31)
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)

Unterschrift

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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Remissionsstatus vor 1. Konsolidierung (bei fehlender hämatolog. Regeneration am Tag 35 nach letzter Induktion: zwischen Tag 35 und 42!) EudraCT-Nr 2008-004583-40 Akute myeloische Leukämie(AML) AML alle außer FAB M3

Remissionsstatus vor 1. Konsolidierung (bei fehlender hämatolog. Regeneration am Tag 35 nach letzter Induktion: zwischen Tag 35 und 42!)

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