ID

4595

Description

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

Keywords

AML

Clinical Trial

Follow-Up Studies

12/16/13 12/16/13 -
12/16/13 12/16/13 -

Uploaded on

December 16, 2013

DOI

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License

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

model
Details

Monat 1 Erhaltungstherapie / Nachbeobachtung

1 forms

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

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

Patientendaten

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)

Therapie-Status

Item Group

Treatment status

Treatment status (Code-1)
C0749659 (UMLS CUI 2011AB)
MTHU036151 (LOINC Version 232)

Anzahl der erhaltenen Konsolidierungstherapien

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)

ECOG-Status

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)

ECOG-Status

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

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)

Klinische Chemie

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)

Gesamteiweiß

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)

Harnsäure

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)

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)
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)

[oder] Harnstoff

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)

Kreatinin

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)

Bilirubin (gesamt)

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)

GOT/AST

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)

GPT/ALT

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)

Item

integer

Alkaline phosphatase level - finding (Code-1)
C0428332 (UMLS CUI 2011AB)
365771003 (SNOMEDCT_2012_01_31)

Item

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)

Code List

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)

LDH

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)

CRP

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)

Knochenmarkuntersuchung

Item Group

Bone marrow examination

C0005957 (UMLS CUI 2011AB)
167907006 (SNOMEDCT_2012_01_31)
10005988 (MedDRA 14.1)

Knochenmarkuntersuchung

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)

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

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)

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)

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

% 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 (Please attach copy of findings!)

C1513380 (UMLS CUI 2011AB)

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

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

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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Monat 1 Erhaltungstherapie / Nachbeobachtung EudraCT-Nr.: 2008-004583-40 Akute myeloische Leukämie(AML) AML alle außer FAB M3

Monat 1 Erhaltungstherapie / Nachbeobachtung

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