ID

43157

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

Versions (3)
  1. 12/14/13 12/14/13 -
  2. 12/22/14 12/22/14 - Martin Dugas
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

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

German English

1. Induktionstherapieblock

1 forms  
  1. StudyEvent: Akute myeloische Leukämie(AML) AML alle außer FAB M3
    1. 1. Induktionstherapieblock
Patient data
Description

Patient data

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

Pat. No.

Data type

integer

Alias
UMLS CUI 2011AB
C1830427
LOINC Version 232
MTHU021361
Patient randomization in study arm:
Description

Patient randomization in study arm

Data type

integer

Alias
Code-1
Protocol Treatment Arm
UMLS CUI 2011AB
C1522541
5-Azacytidine - Dose no. 1
Description

5-Azacytidine - Dose no. 1

Alias
Code-1
5-Azacytidine
UMLS CUI 2011AB
C0004475
SNOMEDCT_2012_01_31
412329008
Code-2
Administration procedure
UMLS CUI 2011AB
C1533734
SNOMEDCT_2012_01_31
416118004
Code-3
First
UMLS CUI 2011AB
C0205435
SNOMEDCT_2012_01_31
255216001
Date
Description

Date

Data type

date

Alias
Code-1
Date
UMLS CUI 2011AB
C0011008
SNOMEDCT_2012_01_31
410671006
LOINC Version 232
MTHU021546
Code-2
Administration procedure
UMLS CUI 2011AB
C1533734
SNOMEDCT_2012_01_31
416118004
Code-3
First
UMLS CUI 2011AB
C0205435
SNOMEDCT_2012_01_31
255216001
Dose absolute/day (mg)
Description

Dose absolute/day (mg)

Data type

string

Alias
Code-1
Dose
UMLS CUI 2011AB
C0178602
SNOMEDCT_2012_01_31
260911001
Code-2
absolute
UMLS CUI 2011AB
C0205344
SNOMEDCT_2012_01_31
56136002
Code-3
mg/day
UMLS CUI 2011AB
C0439423
SNOMEDCT_2012_01_31
258835005
Code-4
Administration procedure
UMLS CUI 2011AB
C1533734
SNOMEDCT_2012_01_31
416118004
Code-5
First
UMLS CUI 2011AB
C0205435
SNOMEDCT_2012_01_31
255216001
Route of administration
Description

Route of administration

Data type

integer

Alias
Code-1
Route of administration
SNOMEDCT_2012_01_31
410675002
LOINC Version 232
MTHU008438
Code-2
Dose
SNOMEDCT_2012_01_31
260911001
Code-3
First
SNOMEDCT_2012_01_31
255216001
Code-4
Administration procedure
SNOMEDCT_2012_01_31
416118004
Code-5
First
SNOMEDCT_2012_01_31
255216001
UMLS CUI-1
C0013153
Reason for not intravenous
Description

Reason for not intravenous

Data type

string

Alias
Code-1
Indication of (contextual qualifier)
UMLS CUI 2011AB
C0392360
SNOMEDCT_2012_01_31
410666004
LOINC Version 232
MTHU008862
Code-2
Medication administration: intravenous
UMLS CUI 2011AB
C0812149
SNOMEDCT_2012_01_31
386358000
Code-3
Negation
UMLS CUI 2011AB
C1518422
Code-4
Administration procedure
UMLS CUI 2011AB
C1533734
SNOMEDCT_2012_01_31
416118004
Code-5
First
UMLS CUI 2011AB
C0205435
SNOMEDCT_2012_01_31
255216001
5-Azacytidine - Dose no. 2
Description

5-Azacytidine - Dose no. 2

Alias
Code-1
5-Azacytidine
UMLS CUI 2011AB
C0004475
SNOMEDCT_2012_01_31
412329008
Code-2
Administration procedure
UMLS CUI 2011AB
C1533734
SNOMEDCT_2012_01_31
416118004
Code-3
Second
UMLS CUI 2011AB
C0205436
SNOMEDCT_2012_01_31
81170007
Date
Description

Date

Data type

date

Alias
Code-1
Date
UMLS CUI 2011AB
C0011008
SNOMEDCT_2012_01_31
410671006
LOINC Version 232
MTHU021546
Code-2
Administration procedure
UMLS CUI 2011AB
C1533734
SNOMEDCT_2012_01_31
416118004
Code-3
Second
UMLS CUI 2011AB
C0205436
SNOMEDCT_2012_01_31
81170007
Dose absolute/day (mg)
Description

Dose absolute/day (mg)

Data type

string

Alias
Code-1
Dose
UMLS CUI 2011AB
C0178602
SNOMEDCT_2012_01_31
260911001
Code-2
absolute
UMLS CUI 2011AB
C0205344
SNOMEDCT_2012_01_31
56136002
Code-3
mg/day
UMLS CUI 2011AB
C0439423
SNOMEDCT_2012_01_31
258835005
Code-4
Administration procedure
UMLS CUI 2011AB
C1533734
SNOMEDCT_2012_01_31
416118004
Code-5
Second
UMLS CUI 2011AB
C0205436
SNOMEDCT_2012_01_31
81170007
Route of administration
Description

Route of administration

Data type

integer

Alias
Code-1
Route of administration
UMLS CUI 2011AB
C0013153
SNOMEDCT_2012_01_31
410675002
LOINC Version 232
MTHU008438
Code-2
Dose
UMLS CUI 2011AB
C0178602
SNOMEDCT_2012_01_31
260911001
Code-3
Second
UMLS CUI 2011AB
C0205436
SNOMEDCT_2012_01_31
81170007
Code-4
Administration procedure
UMLS CUI 2011AB
C1533734
SNOMEDCT_2012_01_31
416118004
Code-5
Second
UMLS CUI 2011AB
C0205436
SNOMEDCT_2012_01_31
81170007
Reason for not intravenous
Description

Reason for not intravenous

Data type

string

Alias
Code-1
Indication of (contextual qualifier)
UMLS CUI 2011AB
C0392360
SNOMEDCT_2012_01_31
410666004
LOINC Version 232
MTHU008862
Code-2
Medication administration: intravenous
UMLS CUI 2011AB
C0812149
SNOMEDCT_2012_01_31
386358000
Code-3
Negation
UMLS CUI 2011AB
C1518422
Code-4
Administration procedure
UMLS CUI 2011AB
C1533734
SNOMEDCT_2012_01_31
416118004
Code-5
Second
UMLS CUI 2011AB
C0205436
SNOMEDCT_2012_01_31
81170007
5-Azacytidine - Dose no. 3
Description

5-Azacytidine - Dose no. 3

Alias
Code-1
5-Azacytidine
UMLS CUI 2011AB
C0004475
SNOMEDCT_2012_01_31
412329008
Code-2
Administration procedure
UMLS CUI 2011AB
C1533734
SNOMEDCT_2012_01_31
416118004
Code-3
Third
UMLS CUI 2011AB
C0205437
SNOMEDCT_2012_01_31
70905002
Date
Description

Date

Data type

date

Alias
Code-1
Date
UMLS CUI 2011AB
C0011008
SNOMEDCT_2012_01_31
410671006
LOINC Version 232
MTHU021546
Code-2
Administration procedure
UMLS CUI 2011AB
C1533734
SNOMEDCT_2012_01_31
416118004
Code-3
Third
UMLS CUI 2011AB
C0205437
SNOMEDCT_2012_01_31
70905002
Dose absolute/day (mg)
Description

Dose absolute/day (mg)

Data type

string

Alias
Code-1
Dose
UMLS CUI 2011AB
C0178602
SNOMEDCT_2012_01_31
260911001
Code-2
absolute
UMLS CUI 2011AB
C0205344
SNOMEDCT_2012_01_31
56136002
Code-3
mg/day
UMLS CUI 2011AB
C0439423
SNOMEDCT_2012_01_31
258835005
Code-4
Administration procedure
UMLS CUI 2011AB
C1533734
SNOMEDCT_2012_01_31
416118004
Code-5
Third
UMLS CUI 2011AB
C0205437
SNOMEDCT_2012_01_31
70905002
Route of administration
Description

Route of administration

Data type

integer

Alias
Code-1
Route of administration
UMLS CUI 2011AB
C0013153
SNOMEDCT_2012_01_31
410675002
LOINC Version 232
MTHU008438
Code-2
Dose
UMLS CUI 2011AB
C0178602
SNOMEDCT_2012_01_31
260911001
Code-3
Third
UMLS CUI 2011AB
C0205437
SNOMEDCT_2012_01_31
70905002
Code-4
Administration procedure
UMLS CUI 2011AB
C1533734
SNOMEDCT_2012_01_31
416118004
Code-5
Third
UMLS CUI 2011AB
C0205437
SNOMEDCT_2012_01_31
70905002
Reason for not intravenous
Description

Reason for not intravenous

Data type

string

Alias
Code-1
Indication of (contextual qualifier)
UMLS CUI 2011AB
C0392360
SNOMEDCT_2012_01_31
410666004
LOINC Version 232
MTHU008862
Code-2
Medication administration: intravenous
UMLS CUI 2011AB
C0812149
SNOMEDCT_2012_01_31
386358000
Code-3
Negation
UMLS CUI 2011AB
C1518422
Code-4
Administration procedure
UMLS CUI 2011AB
C1533734
SNOMEDCT_2012_01_31
416118004
Code-5
Third
UMLS CUI 2011AB
C0205437
SNOMEDCT_2012_01_31
70905002
5-Azacytidine - Dose no. 4
Description

5-Azacytidine - Dose no. 4

Alias
Code-1
5-Azacytidine
UMLS CUI 2011AB
C0004475
SNOMEDCT_2012_01_31
412329008
Code-2
Administration procedure
UMLS CUI 2011AB
C1533734
SNOMEDCT_2012_01_31
416118004
Code-3
Fourth
UMLS CUI 2011AB
C0205438
SNOMEDCT_2012_01_31
29970001
Date
Description

Date

Data type

date

Alias
Code-1
Date
UMLS CUI 2011AB
C0011008
SNOMEDCT_2012_01_31
410671006
LOINC Version 232
MTHU021546
Code-2
Administration procedure
UMLS CUI 2011AB
C1533734
SNOMEDCT_2012_01_31
416118004
Code-3
Fourth
UMLS CUI 2011AB
C0205438
SNOMEDCT_2012_01_31
29970001
Dose absolute/day (mg)
Description

Dose absolute/day (mg)

Data type

string

Alias
Code-1
Dose
UMLS CUI 2011AB
C0178602
SNOMEDCT_2012_01_31
260911001
Code-2
absolute
UMLS CUI 2011AB
C0205344
SNOMEDCT_2012_01_31
56136002
Code-3
mg/day
UMLS CUI 2011AB
C0439423
SNOMEDCT_2012_01_31
258835005
Code-4
Administration procedure
UMLS CUI 2011AB
C1533734
SNOMEDCT_2012_01_31
416118004
Code-5
Fourth
UMLS CUI 2011AB
C0205438
SNOMEDCT_2012_01_31
29970001
Route of administration
Description

Route of administration

Data type

integer

Alias
Code-1
Route of administration
UMLS CUI 2011AB
C0013153
SNOMEDCT_2012_01_31
410675002
LOINC Version 232
MTHU008438
Code-2
Dose
UMLS CUI 2011AB
C0178602
SNOMEDCT_2012_01_31
260911001
Code-3
Fourth
UMLS CUI 2011AB
C0205438
SNOMEDCT_2012_01_31
29970001
Code-4
Administration procedure
UMLS CUI 2011AB
C1533734
SNOMEDCT_2012_01_31
416118004
Code-5
Fourth
UMLS CUI 2011AB
C0205438
SNOMEDCT_2012_01_31
29970001
Reason for not intravenous
Description

Reason for not intravenous

Data type

string

Alias
Code-1
Indication of (contextual qualifier)
UMLS CUI 2011AB
C0392360
SNOMEDCT_2012_01_31
410666004
LOINC Version 232
MTHU008862
Code-2
Medication administration: intravenous
UMLS CUI 2011AB
C0812149
SNOMEDCT_2012_01_31
386358000
Code-3
Negation
UMLS CUI 2011AB
C1518422
Code-4
Administration procedure
UMLS CUI 2011AB
C1533734
SNOMEDCT_2012_01_31
416118004
Code-5
Fourth
UMLS CUI 2011AB
C0205438
SNOMEDCT_2012_01_31
29970001
5-Azacytidine - Dose no. 5
Description

5-Azacytidine - Dose no. 5

Alias
Code-1
5-Azacytidine
UMLS CUI 2011AB
C0004475
SNOMEDCT_2012_01_31
412329008
Code-2
Administration procedure
UMLS CUI 2011AB
C1533734
SNOMEDCT_2012_01_31
416118004
Code-3
Fifth
UMLS CUI 2011AB
C0205439
SNOMEDCT_2012_01_31
32088001
Date
Description

Date

Data type

date

Alias
Code-1
Date
UMLS CUI 2011AB
C0011008
SNOMEDCT_2012_01_31
410671006
LOINC Version 232
MTHU021546
Code-2
Administration procedure
UMLS CUI 2011AB
C1533734
SNOMEDCT_2012_01_31
416118004
Code-3
Fifth
UMLS CUI 2011AB
C0205439
SNOMEDCT_2012_01_31
32088001
Dose absolute/day (mg)
Description

Dose absolute/day (mg)

Data type

string

Alias
Code-1
Dose
UMLS CUI 2011AB
C0178602
SNOMEDCT_2012_01_31
260911001
Code-2
absolute
UMLS CUI 2011AB
C0205344
SNOMEDCT_2012_01_31
56136002
Code-3
mg/day
UMLS CUI 2011AB
C0439423
SNOMEDCT_2012_01_31
258835005
Code-4
Administration procedure
UMLS CUI 2011AB
C1533734
SNOMEDCT_2012_01_31
416118004
Code-5
Fifth
UMLS CUI 2011AB
C0205439
SNOMEDCT_2012_01_31
32088001
Route of administration
Description

Route of administration

Data type

integer

Alias
Code-1
Route of administration
UMLS CUI 2011AB
C0013153
SNOMEDCT_2012_01_31
410675002
LOINC Version 232
MTHU008438
Code-2
Dose
UMLS CUI 2011AB
C0178602
SNOMEDCT_2012_01_31
260911001
Code-3
Fifth
UMLS CUI 2011AB
C0205439
SNOMEDCT_2012_01_31
32088001
Code-4
Administration procedure
UMLS CUI 2011AB
C1533734
SNOMEDCT_2012_01_31
416118004
Code-5
Fifth
UMLS CUI 2011AB
C0205439
SNOMEDCT_2012_01_31
32088001
Reason for not intravenous
Description

Reason for not intravenous

Data type

string

Alias
Code-1
Indication of (contextual qualifier)
UMLS CUI 2011AB
C0392360
SNOMEDCT_2012_01_31
410666004
LOINC Version 232
MTHU008862
Code-2
Medication administration: intravenous
UMLS CUI 2011AB
C0812149
SNOMEDCT_2012_01_31
386358000
Code-3
Negation
UMLS CUI 2011AB
C1518422
Code-4
Administration procedure
UMLS CUI 2011AB
C1533734
SNOMEDCT_2012_01_31
416118004
Code-5
Fifth
UMLS CUI 2011AB
C0205439
SNOMEDCT_2012_01_31
32088001
5-Azacytidine dose reduction
Description

5-Azacytidine dose reduction

Alias
Code-1
Dose Reduced
UMLS CUI 2011AB
C1707814
Code-2
5-Azacytidine
UMLS CUI 2011AB
C0004475
SNOMEDCT_2012_01_31
412329008
5-Azacytidine dose reduction
Description

5-Azacytidine dose reduction

Data type

boolean

Alias
Code-1
Dose Reduced
UMLS CUI 2011AB
C1707814
Code-2
5-Azacytidine
UMLS CUI 2011AB
C0004475
SNOMEDCT_2012_01_31
412329008
yes, reason:
Description

yes, reason

Data type

integer

Alias
Code-1
Indication of (contextual qualifier)
UMLS CUI 2011AB
C0392360
SNOMEDCT_2012_01_31
410666004
LOINC Version 232
MTHU008862
Miscellaneous:
Description

Miscellaneous

Data type

string

Alias
UMLS CUI 2011AB
C0205395
SNOMEDCT_2012_01_31
49634009
LOINC Version 232
MTHU000097
Code-2
Free Text Format
UMLS CUI 2011AB
C2348713
AE-No:
Description

AE-No

Data type

integer

Alias
Code-1
Adverse event
UMLS CUI 2011AB
C0877248
MedDRA 14.1
10060933
LOINC Version 232
MTHU014542
Code-2
Number
UMLS CUI 2011AB
C0237753
SNOMEDCT_2012_01_31
260299005
LOINC Version 232
MTHU024869
Differential blood count
Description

Differential blood count

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

Datum

Data type

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
Description

Haemoglobin

Data type

integer

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

Haemoglobin

Data type

integer

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

Leukozyten

Data type

integer

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

Leukozyten

Data type

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
Description

Prozentanteil Neutrophile

Data type

integer

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

Prozentanteil Stabkernige

Data type

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
Description

[oder] Prozentanteil Segmentkernige

Data type

integer

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

Prozentanteil Lymphozyten

Data type

integer

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

Prozentanteil Monozyten

Data type

integer

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

Prozentanteil Eosinophile

Data type

integer

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

Prozentanteil Basophile

Data type

integer

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

Prozentanteil Blasten

Data type

integer

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

Prozentanteil Promyelozyten

Data type

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
Description

Prozentanteil Myelozyten

Data type

integer

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

Prozentanteil Metamyelozyten

Data type

integer

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

Prozentanteil sonstige Zellen

Data type

integer

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

Thrombozyten

Data type

integer

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

Thrombozyten

Data type

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
Obligatory materials shipping (blood) for determination of methylation status to:
Description

Obligater Materialversand

Data type

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
Blood
UMLS CUI 2011AB
C0005767
SNOMEDCT_2012_01_31
87612001
LOINC Version 232
MTHU029981
HL7 V3 2006_05
Determination
Code-5
C1148554
Code-6
Human Methylation Status
UMLS CUI 2011AB
CL338687
no shipping because
Description

kein Versand weil

Data type

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
Chemotherapy
Description

Chemotherapy

Alias
UMLS CUI 2011AB
C0392920
SNOMEDCT_2012_01_31
150415003
Day 1:
Description

Day 1

Data type

date

Alias
Code-1
day
UMLS CUI 2011AB
C0439228
SNOMEDCT_2012_01_31
258703001
HL7 V3 2006_05
D
Code-2
1
UMLS CUI 2011AB
C0205447
SNOMEDCT_2012_01_31
38112003
Ara-C (100mg/sqm over 24 hrs intravenous day 1-7)
Description

Ara-C (100mg/sqm over 24 hrs intravenous day 1-7)

Alias
Code-1
Ara-C
UMLS CUI 2011AB
C0010711
SNOMEDCT_2012_01_31
89265009
Code-2
One Hundred
UMLS CUI 2011AB
CL447292
Code-3
mg/m2/24.h
UMLS CUI 2011AB
C1532575
SNOMEDCT_2012_01_31
414734008
Code-4
Intravenous
UMLS CUI 2011AB
C0348016
SNOMEDCT_2012_01_31
255560000
Code-5
day
UMLS CUI 2011AB
C0439228
SNOMEDCT_2012_01_31
258703001
HL7 V3 2006_05
D
Code-6
1
UMLS CUI 2011AB
C0205447
SNOMEDCT_2012_01_31
38112003
Ara-C - dose reduction
Description

Ara-C - dose reduction

Data type

boolean

Alias
Code-1
Ara-C
UMLS CUI 2011AB
C0010711
SNOMEDCT_2012_01_31
89265009
Code-2
Dose Reduced
UMLS CUI 2011AB
C1707814
(if yes:) a) Reason:
Description

Reason

Data type

string

Alias
Code-1
Reason
UMLS CUI 2011AB
C0392360
SNOMEDCT_2012_01_31
410666004
LOINC Version 232
MTHU008862
Code-2
Ara-C
UMLS CUI 2011AB
C0010711
SNOMEDCT_2012_01_31
89265009
Code-3
Dose Reduced
UMLS CUI 2011AB
C1707814
(if yes:) b) Absolute total dose in this therapy block (mg):
Description

Absolute total dose

Data type

integer

Alias
Code-1
Absolute
UMLS CUI 2011AB
C0205344
SNOMEDCT_2012_01_31
56136002
Code-2
Total Dose
UMLS CUI 2011AB
C2986497
Code-3
Therapy
UMLS CUI 2011AB
C0039798
Code-4
Block
UMLS CUI 2011AB
C2828370
Code-5
mg
UMLS CUI 2011AB
C0439210
SNOMEDCT_2012_01_31
258684004
Code-6
Ara-C
UMLS CUI 2011AB
C0010711
SNOMEDCT_2012_01_31
89265009
Daunorubicin (60mg/sqm over 1-2 hrs intravenous day 3-5)
Description

Daunorubicin (60mg/sqm over 1-2 hrs intravenous day 3-5)

Alias
Code-1
Daunorubicin
UMLS CUI 2011AB
C0011015
SNOMEDCT_2012_01_31
372715008
Code-2
Sixty
UMLS CUI 2011AB
CL447150
Code-3
mg/m2/24.h
UMLS CUI 2011AB
C1532575
SNOMEDCT_2012_01_31
414734008
Code-4
Intravenous
UMLS CUI 2011AB
C0348016
SNOMEDCT_2012_01_31
255560000
Code-5
day
UMLS CUI 2011AB
C0439228
SNOMEDCT_2012_01_31
258703001
HL7 V3 2006_05
D
Code-6
3
UMLS CUI 2011AB
C0205449
SNOMEDCT_2012_01_31
421291004
Daunorubicin (60mg/sqm over 1-2 hrs intravenous day 3-5) - dose reduction
Description

Daunorubicin - dose reduction

Data type

boolean

Alias
Code-1
Daunorubicin
UMLS CUI 2011AB
C0011015
SNOMEDCT_2012_01_31
372715008
Code-2
Dose Reduced
UMLS CUI 2011AB
C1707814
(if yes:) a) Reason:
Description

Reason

Data type

string

Alias
Code-1
Reason
UMLS CUI 2011AB
C0392360
SNOMEDCT_2012_01_31
410666004
LOINC Version 232
MTHU008862
Code-2
Daunorubicin
UMLS CUI 2011AB
C0011015
SNOMEDCT_2012_01_31
372715008
Code-3
Dose Reduced
UMLS CUI 2011AB
C1707814
(if yes:) b) Absolute total dose in this therapy block (mg):
Description

Absolute total dose

Data type

integer

Alias
Code-1
Absolute
UMLS CUI 2011AB
C0205344
SNOMEDCT_2012_01_31
56136002
Code-2
Total Dose
UMLS CUI 2011AB
C2986497
Code-3
Therapy
UMLS CUI 2011AB
C0039798
Code-4
Block
UMLS CUI 2011AB
C2828370
Code-5
mg
UMLS CUI 2011AB
C0439210
SNOMEDCT_2012_01_31
258684004
Code-6
Daunorubicin
UMLS CUI 2011AB
C0011015
SNOMEDCT_2012_01_31
372715008
G-CSF dose
Description

G-CSF dose

Alias
Code-1
G-CSF
UMLS CUI 2011AB
C0079459
SNOMEDCT_2012_01_31
80572003
LOINC Version 232
MTHU031847
Code-2
Administration procedure
UMLS CUI 2011AB
C1533734
SNOMEDCT_2012_01_31
416118004
Patient did receive G-CSF:
Description

Patient did receive G-CSF

Data type

boolean

Alias
Code-1
Patient
UMLS CUI 2011AB
C0030705
SNOMEDCT_2012_01_31
116154003
Code-2
Receive
UMLS CUI 2011AB
C1514756
Code-3
G-CSF
UMLS CUI 2011AB
C0079459
SNOMEDCT_2012_01_31
80572003
LOINC Version 232
MTHU031847
(if yes:) Start date:
Description

Begin

Data type

date

Alias
UMLS CUI 2011AB
C0808070
LOINC Version 232
MTHU008298
Code-2
G-CSF
UMLS CUI 2011AB
C0079459
SNOMEDCT_2012_01_31
80572003
LOINC Version 232
MTHU031847
(if yes:) End date:
Description

End

Data type

date

Alias
UMLS CUI 2011AB
C0806020
LOINC Version 232
MTHU008302
Code-2
G-CSF
UMLS CUI 2011AB
C0079459
SNOMEDCT_2012_01_31
80572003
LOINC Version 232
MTHU031847
(if yes:) Pharmaceutical Preparations:
Description

Medication

Data type

integer

Alias
UMLS CUI 2011AB
C0013227
LOINC Version 232
MTHU038481
Cytopenia duration
Description

Cytopenia duration

Alias
Code-1
Cytopenia
UMLS CUI 2011AB
C0010828
SNOMEDCT_2012_01_31
50820005
MedDRA 14.1
10066274
Code-2
Duration
UMLS CUI 2011AB
C0449238
SNOMEDCT_2012_01_31
103335007
LOINC Version 232
MTHU001938
leucocytes <1,0 GPt/l or <1000 /ul
Description

leucocytes <1,0 GPt/l or <1000 /ul

Alias
Code-1
Leukocytes
UMLS CUI 2011AB
C0023516
SNOMEDCT_2012_01_31
52501007
MedDRA 14.1
10047955
LOINC Version 232
MTHU001946
Code-2
Less Than
UMLS CUI 2011AB
C0439092
Code-3
Thousand Cells per Microliter
UMLS CUI 2011AB
C1883312
Code-4
One
UMLS CUI 2011AB
C0205447
SNOMEDCT_2012_01_31
421379005
Code-5
Billion Cells per Liter
UMLS CUI 2011AB
C0456524
SNOMEDCT_2012_01_31
277199001
Start date (leucocytes <1,0 GPt/l or <1000 /ul)
Description

start leukopenia

Data type

date

Alias
Code-1
Start Date
UMLS CUI 2011AB
C0808070
LOINC Version 232
MTHU008298
Code-2
Leukopenia
UMLS CUI 2011AB
C0023530
ICD-10-CM Version 2010
D72.81
ICD-9-CM Version 2011
288.5
End date (leucocytes >=1,0 GPt/l or >=1000 /ul)
Description

end leukopenia

Data type

date

Alias
Code-1
End Date
UMLS CUI 2011AB
C0806020
LOINC Version 232
MTHU008302
Code-2
Leukopenia
UMLS CUI 2011AB
C0023530
ICD-10-CM Version 2010
D72.81
ICD-9-CM Version 2011
288.5
(or) cytopenia ongoing [leucocytes <1,0 GPt/l or <1000 /ul] on:
Description

Ongoing cytopenia

Data type

date

Alias
Code-1
Leukopenia
UMLS CUI 2011AB
C0023530
ICD-10-CM Version 2010
D72.81
ICD-9-CM Version 2011
288.5
Code-2
ongoing
UMLS CUI 2011AB
C0549178
neutrophils <0,5 GPt/l or <500 /ul
Description

neutrophils <0,5 GPt/l or <500 /ul

Alias
Code-1
Neutrophils
UMLS CUI 2011AB
C0027950
SNOMEDCT_2012_01_31
116712007
MedDRA 14.1
10029380
LOINC Version 232
MTHU006207
Code-2
Less Than
UMLS CUI 2011AB
C0439092
Code-3
Five
UMLS CUI 2011AB
C0205451
SNOMEDCT_2012_01_31
421820001
Code-4
One Hundred
UMLS CUI 2011AB
CL447292
Code-5
Thousand Cells per Microliter
UMLS CUI 2011AB
C1883312
Code-6
Half
UMLS CUI 2011AB
C2825407
Start date (neutrophils <0,5 GPt/l or <500 /ul)
Description

start neutropenia

Data type

date

Alias
Code-1
Start Date
UMLS CUI 2011AB
C0808070
LOINC Version 232
MTHU008298
Code-2
Neutropenia
UMLS CUI 2011AB
C0027947
SNOMEDCT_2012_01_31
165517008
MedDRA 14.1
10029354
ICD-10-CM Version 2010
D70.9
ICD-9-CM Version 2011
288
End date (neutrophils >=0,5 GPt/l or >=500 /ul)
Description

end neutropenia

Data type

date

Alias
Code-1
End Date
UMLS CUI 2011AB
C0806020
LOINC Version 232
MTHU008302
Code-2
Neutropenia
UMLS CUI 2011AB
C0027947
SNOMEDCT_2012_01_31
165517008
MedDRA 14.1
10029354
ICD-10-CM Version 2010
D70.9
ICD-9-CM Version 2011
288
(or) cytopenia ongoing [neutrophils <0,5 GPt/l or <500 /ul] on:
Description

Ongoing cytopenia

Data type

date

Alias
Code-1
Neutropenia
UMLS CUI 2011AB
C0027947
SNOMEDCT_2012_01_31
165517008
MedDRA 14.1
10029354
ICD-10-CM Version 2010
D70.9
ICD-9-CM Version 2011
288.00
Code-2
ongoing
UMLS CUI 2011AB
C0549178
Start date (platelets <25 GPt/l or <25000 /ul)
Description

Start date (platelets <25 GPt/l or <25000 /ul)

Alias
Code-1
platelets
UMLS CUI 2011AB
C0005821
SNOMEDCT_2012_01_31
16378004
LOINC Version 232
MTHU002432
Code-2
Less Than
UMLS CUI 2011AB
C0439092
Code-3
Twenty
UMLS CUI 2011AB
CL447287
Code-4
Five
UMLS CUI 2011AB
C0205451
SNOMEDCT_2012_01_31
421820001
Code-5
Thousand Cells per Microliter
UMLS CUI 2011AB
C1883312
Code-6
Twenty
UMLS CUI 2011AB
CL447287
Start date (platelets <25 GPt/l or <25000 /ul)
Description

start thrombopenia

Data type

date

Alias
Code-1
Start Date
UMLS CUI 2011AB
C0808070
LOINC Version 232
MTHU008298
Code-2
Thrombocytopenia
UMLS CUI 2011AB
C0040034
SNOMEDCT_2012_01_31
415116008
MedDRA 14.1
10043554
ICD-10-CM Version 2010
D69.6
ICD-9-CM Version 2011
287.5
End date (platelets >=25 GPt/l or >=25000 /ul - increasing, independent of substitution of platelets)
Description

end thrombopenia

Data type

date

Alias
Code-1
End Date
UMLS CUI 2011AB
C0806020
LOINC Version 232
MTHU008302
Code-2
Thrombocytopenia
UMLS CUI 2011AB
C0040034
SNOMEDCT_2012_01_31
415116008
MedDRA 14.1
10043554
ICD-10-CM Version 2010
D69.6
ICD-9-CM Version 2011
287.5
(or) cytopenia ongoing [platelets <25 GPt/l or <25000 /ul] on:
Description

Ongoing cytopenia

Data type

date

Alias
Code-1
Thrombocytopenia
UMLS CUI 2011AB
C0040034
SNOMEDCT_2012_01_31
415116008
MedDRA 14.1
10043554
ICD-10-CM Version 2010
D69.6
ICD-9-CM Version 2011
287.5
Code-2
ongoing
UMLS CUI 2011AB
C0549178
Signature
Description

Signature

Alias
UMLS CUI 2011AB
C1519316
Date:
Description

Datum

Data type

date

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

Name/Unterschrift Prüfarzt

Data type

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

1. Induktionstherapieblock

1 forms
  1. StudyEvent: Akute myeloische Leukämie(AML) AML alle außer FAB M3
    1. 1. Induktionstherapieblock
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient data
C2707520 (UMLS CUI 2011AB)
MTHU031990 (LOINC Version 232)
Pat. No.
Item
Pat. No.: -
integer
C1830427 (UMLS CUI 2011AB)
MTHU021361 (LOINC Version 232)
Item
Patient randomization in study arm:
integer
Protocol Treatment Arm (Code-1)
C1522541 (UMLS CUI 2011AB)
Patient randomization in study arm
Code List
Patient randomization in study arm:
CL Item
A (5-Azacytidine) (1)
A (Code-1)
C1706281 (UMLS CUI 2011AB)
422097006 (SNOMEDCT_2012_01_31)
5-Azacytidine (Code-2)
C0004475 (UMLS CUI 2011AB)
412329008 (SNOMEDCT_2012_01_31)
CL Item
B (Documentation continued on page 11) (2)
B (Code-1)
C0439105 (UMLS CUI 2011AB)
421151005 (SNOMEDCT_2012_01_31)
Item Group
5-Azacytidine - Dose no. 1
5-Azacytidine (Code-1)
C0004475 (UMLS CUI 2011AB)
412329008 (SNOMEDCT_2012_01_31)
Administration procedure (Code-2)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
First (Code-3)
C0205435 (UMLS CUI 2011AB)
255216001 (SNOMEDCT_2012_01_31)
Date
Item
Date
date
Date (Code-1)
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Administration procedure (Code-2)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
First (Code-3)
C0205435 (UMLS CUI 2011AB)
255216001 (SNOMEDCT_2012_01_31)
Dose absolute/day (mg)
Item
Dose absolute/day (mg)
string
Dose (Code-1)
C0178602 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
absolute (Code-2)
C0205344 (UMLS CUI 2011AB)
56136002 (SNOMEDCT_2012_01_31)
mg/day (Code-3)
C0439423 (UMLS CUI 2011AB)
258835005 (SNOMEDCT_2012_01_31)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
First (Code-5)
C0205435 (UMLS CUI 2011AB)
255216001 (SNOMEDCT_2012_01_31)
Item
Route of administration
integer
Route of administration (Code-1)
410675002 (SNOMEDCT_2012_01_31)
MTHU008438 (LOINC Version 232)
Dose (Code-2)
260911001 (SNOMEDCT_2012_01_31)
First (Code-3)
255216001 (SNOMEDCT_2012_01_31)
Administration procedure (Code-4)
416118004 (SNOMEDCT_2012_01_31)
First (Code-5)
255216001 (SNOMEDCT_2012_01_31)
C0013153 (UMLS CUI-1)
Route of administration
Code List
Route of administration
CL Item
Bolus Infusion (1)
Bolus Infusion Procedure (Code-1)
C1511237 (UMLS CUI 2011AB)
CL Item
not intravenous (2)
Medication administration: intravenous (Code-1)
C0812149 (UMLS CUI 2011AB)
386358000 (SNOMEDCT_2012_01_31)
Negation (Code-2)
C1518422 (UMLS CUI 2011AB)
Reason for not intravenous
Item
Reason for not intravenous
string
Indication of (contextual qualifier) (Code-1)
C0392360 (UMLS CUI 2011AB)
410666004 (SNOMEDCT_2012_01_31)
MTHU008862 (LOINC Version 232)
Medication administration: intravenous (Code-2)
C0812149 (UMLS CUI 2011AB)
386358000 (SNOMEDCT_2012_01_31)
Negation (Code-3)
C1518422 (UMLS CUI 2011AB)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
First (Code-5)
C0205435 (UMLS CUI 2011AB)
255216001 (SNOMEDCT_2012_01_31)
Item Group
5-Azacytidine - Dose no. 2
5-Azacytidine (Code-1)
C0004475 (UMLS CUI 2011AB)
412329008 (SNOMEDCT_2012_01_31)
Administration procedure (Code-2)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Second (Code-3)
C0205436 (UMLS CUI 2011AB)
81170007 (SNOMEDCT_2012_01_31)
Date
Item
Date
date
Date (Code-1)
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Administration procedure (Code-2)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Second (Code-3)
C0205436 (UMLS CUI 2011AB)
81170007 (SNOMEDCT_2012_01_31)
Dose absolute/day (mg)
Item
Dose absolute/day (mg)
string
Dose (Code-1)
C0178602 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
absolute (Code-2)
C0205344 (UMLS CUI 2011AB)
56136002 (SNOMEDCT_2012_01_31)
mg/day (Code-3)
C0439423 (UMLS CUI 2011AB)
258835005 (SNOMEDCT_2012_01_31)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Second (Code-5)
C0205436 (UMLS CUI 2011AB)
81170007 (SNOMEDCT_2012_01_31)
Item
Route of administration
integer
Route of administration (Code-1)
C0013153 (UMLS CUI 2011AB)
410675002 (SNOMEDCT_2012_01_31)
MTHU008438 (LOINC Version 232)
Dose (Code-2)
C0178602 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
Second (Code-3)
C0205436 (UMLS CUI 2011AB)
81170007 (SNOMEDCT_2012_01_31)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Second (Code-5)
C0205436 (UMLS CUI 2011AB)
81170007 (SNOMEDCT_2012_01_31)
Route of administration
Code List
Route of administration
CL Item
Bolus Infusion (1)
Bolus Infusion Procedure (Code-1)
C1511237 (UMLS CUI 2011AB)
CL Item
not intravenous (2)
Medication administration: intravenous (Code-1)
C0812149 (UMLS CUI 2011AB)
386358000 (SNOMEDCT_2012_01_31)
Negation (Code-2)
C1518422 (UMLS CUI 2011AB)
Reason for not intravenous
Item
Reason for not intravenous
string
Indication of (contextual qualifier) (Code-1)
C0392360 (UMLS CUI 2011AB)
410666004 (SNOMEDCT_2012_01_31)
MTHU008862 (LOINC Version 232)
Medication administration: intravenous (Code-2)
C0812149 (UMLS CUI 2011AB)
386358000 (SNOMEDCT_2012_01_31)
Negation (Code-3)
C1518422 (UMLS CUI 2011AB)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Second (Code-5)
C0205436 (UMLS CUI 2011AB)
81170007 (SNOMEDCT_2012_01_31)
Item Group
5-Azacytidine - Dose no. 3
5-Azacytidine (Code-1)
C0004475 (UMLS CUI 2011AB)
412329008 (SNOMEDCT_2012_01_31)
Administration procedure (Code-2)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Third (Code-3)
C0205437 (UMLS CUI 2011AB)
70905002 (SNOMEDCT_2012_01_31)
Date
Item
Date
date
Date (Code-1)
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Administration procedure (Code-2)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Third (Code-3)
C0205437 (UMLS CUI 2011AB)
70905002 (SNOMEDCT_2012_01_31)
Dose absolute/day (mg)
Item
Dose absolute/day (mg)
string
Dose (Code-1)
C0178602 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
absolute (Code-2)
C0205344 (UMLS CUI 2011AB)
56136002 (SNOMEDCT_2012_01_31)
mg/day (Code-3)
C0439423 (UMLS CUI 2011AB)
258835005 (SNOMEDCT_2012_01_31)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Third (Code-5)
C0205437 (UMLS CUI 2011AB)
70905002 (SNOMEDCT_2012_01_31)
Item
Route of administration
integer
Route of administration (Code-1)
C0013153 (UMLS CUI 2011AB)
410675002 (SNOMEDCT_2012_01_31)
MTHU008438 (LOINC Version 232)
Dose (Code-2)
C0178602 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
Third (Code-3)
C0205437 (UMLS CUI 2011AB)
70905002 (SNOMEDCT_2012_01_31)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Third (Code-5)
C0205437 (UMLS CUI 2011AB)
70905002 (SNOMEDCT_2012_01_31)
Route of administration
Code List
Route of administration
CL Item
Bolus Infusion (1)
Bolus Infusion Procedure (Code-1)
C1511237 (UMLS CUI 2011AB)
CL Item
not intravenous (2)
Medication administration: intravenous (Code-1)
C0812149 (UMLS CUI 2011AB)
386358000 (SNOMEDCT_2012_01_31)
Negation (Code-2)
C1518422 (UMLS CUI 2011AB)
Reason for not intravenous
Item
Reason for not intravenous
string
Indication of (contextual qualifier) (Code-1)
C0392360 (UMLS CUI 2011AB)
410666004 (SNOMEDCT_2012_01_31)
MTHU008862 (LOINC Version 232)
Medication administration: intravenous (Code-2)
C0812149 (UMLS CUI 2011AB)
386358000 (SNOMEDCT_2012_01_31)
Negation (Code-3)
C1518422 (UMLS CUI 2011AB)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Third (Code-5)
C0205437 (UMLS CUI 2011AB)
70905002 (SNOMEDCT_2012_01_31)
Item Group
5-Azacytidine - Dose no. 4
5-Azacytidine (Code-1)
C0004475 (UMLS CUI 2011AB)
412329008 (SNOMEDCT_2012_01_31)
Administration procedure (Code-2)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Fourth (Code-3)
C0205438 (UMLS CUI 2011AB)
29970001 (SNOMEDCT_2012_01_31)
Date
Item
Date
date
Date (Code-1)
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Administration procedure (Code-2)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Fourth (Code-3)
C0205438 (UMLS CUI 2011AB)
29970001 (SNOMEDCT_2012_01_31)
Dose absolute/day (mg)
Item
Dose absolute/day (mg)
string
Dose (Code-1)
C0178602 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
absolute (Code-2)
C0205344 (UMLS CUI 2011AB)
56136002 (SNOMEDCT_2012_01_31)
mg/day (Code-3)
C0439423 (UMLS CUI 2011AB)
258835005 (SNOMEDCT_2012_01_31)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Fourth (Code-5)
C0205438 (UMLS CUI 2011AB)
29970001 (SNOMEDCT_2012_01_31)
Item
Route of administration
integer
Route of administration (Code-1)
C0013153 (UMLS CUI 2011AB)
410675002 (SNOMEDCT_2012_01_31)
MTHU008438 (LOINC Version 232)
Dose (Code-2)
C0178602 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
Fourth (Code-3)
C0205438 (UMLS CUI 2011AB)
29970001 (SNOMEDCT_2012_01_31)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Fourth (Code-5)
C0205438 (UMLS CUI 2011AB)
29970001 (SNOMEDCT_2012_01_31)
Route of administration
Code List
Route of administration
CL Item
Bolus Infusion (1)
Bolus Infusion Procedure (Code-1)
C1511237 (UMLS CUI 2011AB)
CL Item
not intravenous (2)
Medication administration: intravenous (Code-1)
C0812149 (UMLS CUI 2011AB)
386358000 (SNOMEDCT_2012_01_31)
Negation (Code-2)
C1518422 (UMLS CUI 2011AB)
Reason for not intravenous
Item
Reason for not intravenous
string
Indication of (contextual qualifier) (Code-1)
C0392360 (UMLS CUI 2011AB)
410666004 (SNOMEDCT_2012_01_31)
MTHU008862 (LOINC Version 232)
Medication administration: intravenous (Code-2)
C0812149 (UMLS CUI 2011AB)
386358000 (SNOMEDCT_2012_01_31)
Negation (Code-3)
C1518422 (UMLS CUI 2011AB)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Fourth (Code-5)
C0205438 (UMLS CUI 2011AB)
29970001 (SNOMEDCT_2012_01_31)
Item Group
5-Azacytidine - Dose no. 5
5-Azacytidine (Code-1)
C0004475 (UMLS CUI 2011AB)
412329008 (SNOMEDCT_2012_01_31)
Administration procedure (Code-2)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Fifth (Code-3)
C0205439 (UMLS CUI 2011AB)
32088001 (SNOMEDCT_2012_01_31)
Date
Item
Date
date
Date (Code-1)
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Administration procedure (Code-2)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Fifth (Code-3)
C0205439 (UMLS CUI 2011AB)
32088001 (SNOMEDCT_2012_01_31)
Dose absolute/day (mg)
Item
Dose absolute/day (mg)
string
Dose (Code-1)
C0178602 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
absolute (Code-2)
C0205344 (UMLS CUI 2011AB)
56136002 (SNOMEDCT_2012_01_31)
mg/day (Code-3)
C0439423 (UMLS CUI 2011AB)
258835005 (SNOMEDCT_2012_01_31)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Fifth (Code-5)
C0205439 (UMLS CUI 2011AB)
32088001 (SNOMEDCT_2012_01_31)
Item
Route of administration
integer
Route of administration (Code-1)
C0013153 (UMLS CUI 2011AB)
410675002 (SNOMEDCT_2012_01_31)
MTHU008438 (LOINC Version 232)
Dose (Code-2)
C0178602 (UMLS CUI 2011AB)
260911001 (SNOMEDCT_2012_01_31)
Fifth (Code-3)
C0205439 (UMLS CUI 2011AB)
32088001 (SNOMEDCT_2012_01_31)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Fifth (Code-5)
C0205439 (UMLS CUI 2011AB)
32088001 (SNOMEDCT_2012_01_31)
Route of administration
Code List
Route of administration
CL Item
Bolus Infusion (1)
Bolus Infusion Procedure (Code-1)
C1511237 (UMLS CUI 2011AB)
CL Item
not intravenous (2)
Medication administration: intravenous (Code-1)
C0812149 (UMLS CUI 2011AB)
386358000 (SNOMEDCT_2012_01_31)
Negation (Code-2)
C1518422 (UMLS CUI 2011AB)
Reason for not intravenous
Item
Reason for not intravenous
string
Indication of (contextual qualifier) (Code-1)
C0392360 (UMLS CUI 2011AB)
410666004 (SNOMEDCT_2012_01_31)
MTHU008862 (LOINC Version 232)
Medication administration: intravenous (Code-2)
C0812149 (UMLS CUI 2011AB)
386358000 (SNOMEDCT_2012_01_31)
Negation (Code-3)
C1518422 (UMLS CUI 2011AB)
Administration procedure (Code-4)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Fifth (Code-5)
C0205439 (UMLS CUI 2011AB)
32088001 (SNOMEDCT_2012_01_31)
Item Group
5-Azacytidine dose reduction
Dose Reduced (Code-1)
C1707814 (UMLS CUI 2011AB)
5-Azacytidine (Code-2)
C0004475 (UMLS CUI 2011AB)
412329008 (SNOMEDCT_2012_01_31)
5-Azacytidine dose reduction
Item
5-Azacytidine dose reduction
boolean
Dose Reduced (Code-1)
C1707814 (UMLS CUI 2011AB)
5-Azacytidine (Code-2)
C0004475 (UMLS CUI 2011AB)
412329008 (SNOMEDCT_2012_01_31)
Item
yes, reason:
integer
Indication of (contextual qualifier) (Code-1)
C0392360 (UMLS CUI 2011AB)
410666004 (SNOMEDCT_2012_01_31)
MTHU008862 (LOINC Version 232)
yes, reason
Code List
yes, reason:
CL Item
AE(s) (1)
Adverse event (Code-1)
C0877248 (UMLS CUI 2011AB)
10060933 (MedDRA 14.1)
MTHU014542 (LOINC Version 232)
CL Item
Occurrence of leukocytosis > 50.000 /microl (2)
Leukocytosis (Code-1)
C0023518 (UMLS CUI 2011AB)
111583006 (SNOMEDCT_2012_01_31)
10024378 (MedDRA 14.1)
D72.829 (ICD-10-CM Version 2010)
288.60 (ICD-9-CM Version 2011)
Greater Than (Code-2)
C0439093 (UMLS CUI 2011AB)
276140008 (SNOMEDCT_2012_01_31)
GT (HL7 V3 2006_05)
Fifty (Code-3)
CL447144 (UMLS CUI 2011AB)
Thousand Cells per Microliter (Code-4)
C1883312 (UMLS CUI 2011AB)
CL Item
treatment error (3)
treatment error (Code-1)
C0679862 (UMLS CUI 2011AB)
CL Item
Miscellaneous (4)
C0205395 (UMLS CUI 2011AB)
49634009 (SNOMEDCT_2012_01_31)
MTHU000097 (LOINC Version 232)
Miscellaneous
Item
Miscellaneous:
string
C0205395 (UMLS CUI 2011AB)
49634009 (SNOMEDCT_2012_01_31)
MTHU000097 (LOINC Version 232)
Free Text Format (Code-2)
C2348713 (UMLS CUI 2011AB)
AE-No
Item
AE-No:
integer
Adverse event (Code-1)
C0877248 (UMLS CUI 2011AB)
10060933 (MedDRA 14.1)
MTHU014542 (LOINC Version 232)
Number (Code-2)
C0237753 (UMLS CUI 2011AB)
260299005 (SNOMEDCT_2012_01_31)
MTHU024869 (LOINC Version 232)
Item Group
Differential blood count
Differential Leukocyte Count (Code-1)
C0162401 (UMLS CUI 2011AB)
165511009 (SNOMEDCT_2012_01_31)
10012784 (MedDRA 14.1)
Datum
Item
Date:
date
C0011008 (UMLS CUI 2011AB)
410671006 (SNOMEDCT_2012_01_31)
MTHU021546 (LOINC Version 232)
Differential Leukocyte Count (Code-2)
C0162401 (UMLS CUI 2011AB)
165511009 (SNOMEDCT_2012_01_31)
10012784 (MedDRA 14.1)
Haemoglobin
Item
Hemoglobin
integer
Hemoglobin (Code-1)
C0518015 (UMLS CUI 2011AB)
10018876 (MedDRA 14.1)
Item
Hemoglobin
integer
Hemoglobin (Code-1)
C0518015 (UMLS CUI 2011AB)
10018876 (MedDRA 14.1)
Unit of Measure (Code-2)
C1519795 (UMLS CUI 2011AB)
Haemoglobin
Code List
Hemoglobin
CL Item
[mmol/l] ([mmol/l])
Hemoglobin:SCnc:Pt:Bld:Qn (Code-1)
C2923664 (UMLS CUI 2011AB)
59260-0 (LOINC Version 232)
CL Item
[g/dl] ([g/dl])
Hemoglobin:MCnc:Pt:Bld:Qn (Code-1)
C0362923 (UMLS CUI 2011AB)
718-7 (LOINC Version 232)
Leukozyten
Item
Leukocytes
integer
Leukocytes:NCnc:Pt:Bld:Qn (Code-1)
C0945357 (UMLS CUI 2011AB)
26464-8 (LOINC Version 232)
Item
Leukocytes
integer
Leukocytes:NCnc:Pt:Bld:Qn (Code-1)
C0945357 (UMLS CUI 2011AB)
26464-8 (LOINC Version 232)
Unit of Measure (Code-2)
C1519795 (UMLS CUI 2011AB)
Leukozyten
Code List
Leukocytes
CL Item
[GPt/l] ([GPt/l])
Billion Cells per Liter (Code-1)
C0456524 (UMLS CUI 2011AB)
277199001 (SNOMEDCT_2012_01_31)
CL Item
[/µl] ( [/µl])
Cells per Microliter (Code-1)
C0439378 (UMLS CUI 2011AB)
258878000 (SNOMEDCT_2012_01_31)
CL Item
[10E3/µl] ([10E3/µl])
Thousand Cells per Microliter (Code-1)
C1883312 (UMLS CUI 2011AB)
CL Item
[/nl] ( [/nl])
Cells (Code-1)
C0007634 (UMLS CUI 2011AB)
4421005 (SNOMEDCT_2012_01_31)
MTHU001933 (LOINC Version 232)
Per (Code-3)
CL416189 (UMLS CUI 2011AB)
Nanoliter (Code-4)
C0560008 (UMLS CUI 2011AB)
Prozentanteil Neutrophile
Item
Neutrophil percentage
integer
Neutrophils/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0942471 (UMLS CUI 2011AB)
26511-6 (LOINC Version 232)
Prozentanteil Stabkernige
Item
Band neutrophil percentage
integer
Neutrophils.band form/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0942468 (UMLS CUI 2011AB)
26508-2 (LOINC Version 232)
[oder] Prozentanteil Segmentkernige
Item
[or] Segmented neutrophil percentage
integer
Neutrophils.segmented/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0942466 (UMLS CUI 2011AB)
26505-8 (LOINC Version 232)
Prozentanteil Lymphozyten
Item
Lymphocyte percentage
integer
Lymphocytes/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0942440 (UMLS CUI 2011AB)
26478-8 (LOINC Version 232)
Prozentanteil Monozyten
Item
Monocyte percentage
integer
Monocytes/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0942447 (UMLS CUI 2011AB)
26485-3 (LOINC Version 232)
Prozentanteil Eosinophile
Item
Eosinophil percentage
integer
Eosinophils/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0945354 (UMLS CUI 2011AB)
26450-7  (LOINC Version 232)
Prozentanteil Basophile
Item
Basophil percentage
integer
Basophils/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C1114065 (UMLS CUI 2011AB)
30180-4  (LOINC Version 232)
Prozentanteil Blasten
Item
Blast cell percentage
integer
Blasts/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0942416 (UMLS CUI 2011AB)
26446-5  (LOINC Version 232)
Prozentanteil Promyelozyten
Item
Promyelocyte percentage
integer
Promyelocytes/100 leukocytes:Number Fraction:Point in time:Whole blood:Quantitative (Code-1)
C1114906 (UMLS CUI 2011AB)
26524-9  (LOINC Version 232)
Prozentanteil Myelozyten
Item
Myelocyte percentage
integer
Myelocytes/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0942460 (UMLS CUI 2011AB)
26498-6  (LOINC Version 232)
Prozentanteil Metamyelozyten
Item
Metamyelocyte percentage
integer
Metamyelocytes/100 leukocytes:NFr:Pt:Bld:Qn (Code-1)
C0944135 (UMLS CUI 2011AB)
28541-1  (LOINC Version 232)
Prozentanteil sonstige Zellen
Item
Percentage of other cells
integer
Other cells/100 leukocytes (Code-1)
C1978275 (UMLS CUI 2011AB)
MTHU026796 (LOINC Version 232)
Thrombozyten
Item
Platelets
integer
Platelets:NCnc:Pt:Bld:Qn (Code-1)
C0942474 (UMLS CUI 2011AB)
26515-7 (LOINC Version 232)
Item
Platelets
integer
Platelets:NCnc:Pt:Bld:Qn (Code-1)
C0942474 (UMLS CUI 2011AB)
26515-7 (LOINC Version 232)
Unit of Measure (Code-2)
C1519795 (UMLS CUI 2011AB)
Thrombozyten
Code List
Platelets
CL Item
[GPt/l] ([GPt/l])
Billion Cells per Liter (Code-1)
C0456524 (UMLS CUI 2011AB)
277199001 (SNOMEDCT_2012_01_31)
CL Item
[/µl] ([/µl])
Cells per Microliter (Code-1)
C0439378 (UMLS CUI 2011AB)
258878000 (SNOMEDCT_2012_01_31)
CL Item
[10E3/µl] ([10E3/µl])
Thousand Cells per Microliter (Code-1)
C1883312 (UMLS CUI 2011AB)
CL Item
[/nl] ([/nl])
Cells (Code-1)
C0007634 (UMLS CUI 2011AB)
4421005 (SNOMEDCT_2012_01_31)
MTHU001933 (LOINC Version 232)
Per (Code-3)
CL416189 (UMLS CUI 2011AB)
Nanoliter (Code-4)
C0560008 (UMLS CUI 2011AB)
Item
Obligatory materials shipping (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)
Blood (Code-4)
C0005767 (UMLS CUI 2011AB)
87612001 (SNOMEDCT_2012_01_31)
MTHU029981 (LOINC Version 232)
Determination (HL7 V3 2006_05)
C1148554 (Code-5)
Human Methylation Status (Code-6)
CL338687 (UMLS CUI 2011AB)
Obligater Materialversand
Code List
Obligatory materials shipping (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
Chemotherapy
C0392920 (UMLS CUI 2011AB)
150415003 (SNOMEDCT_2012_01_31)
Day 1
Item
Day 1:
date
day (Code-1)
C0439228 (UMLS CUI 2011AB)
258703001 (SNOMEDCT_2012_01_31)
D (HL7 V3 2006_05)
1 (Code-2)
C0205447 (UMLS CUI 2011AB)
38112003 (SNOMEDCT_2012_01_31)
Item Group
Ara-C (100mg/sqm over 24 hrs intravenous day 1-7)
Ara-C (Code-1)
C0010711 (UMLS CUI 2011AB)
89265009 (SNOMEDCT_2012_01_31)
One Hundred (Code-2)
CL447292 (UMLS CUI 2011AB)
mg/m2/24.h (Code-3)
C1532575 (UMLS CUI 2011AB)
414734008 (SNOMEDCT_2012_01_31)
Intravenous (Code-4)
C0348016 (UMLS CUI 2011AB)
255560000 (SNOMEDCT_2012_01_31)
day (Code-5)
C0439228 (UMLS CUI 2011AB)
258703001 (SNOMEDCT_2012_01_31)
D (HL7 V3 2006_05)
1 (Code-6)
C0205447 (UMLS CUI 2011AB)
38112003 (SNOMEDCT_2012_01_31)
Ara-C - dose reduction
Item
Ara-C - dose reduction
boolean
Ara-C (Code-1)
C0010711 (UMLS CUI 2011AB)
89265009 (SNOMEDCT_2012_01_31)
Dose Reduced (Code-2)
C1707814 (UMLS CUI 2011AB)
Reason
Item
(if yes:) a) Reason:
string
Reason (Code-1)
C0392360 (UMLS CUI 2011AB)
410666004 (SNOMEDCT_2012_01_31)
MTHU008862 (LOINC Version 232)
Ara-C (Code-2)
C0010711 (UMLS CUI 2011AB)
89265009 (SNOMEDCT_2012_01_31)
Dose Reduced (Code-3)
C1707814 (UMLS CUI 2011AB)
Absolute total dose
Item
(if yes:) b) Absolute total dose in this therapy block (mg):
integer
Absolute (Code-1)
C0205344 (UMLS CUI 2011AB)
56136002 (SNOMEDCT_2012_01_31)
Total Dose (Code-2)
C2986497 (UMLS CUI 2011AB)
Therapy (Code-3)
C0039798 (UMLS CUI 2011AB)
Block (Code-4)
C2828370 (UMLS CUI 2011AB)
mg (Code-5)
C0439210 (UMLS CUI 2011AB)
258684004 (SNOMEDCT_2012_01_31)
Ara-C (Code-6)
C0010711 (UMLS CUI 2011AB)
89265009 (SNOMEDCT_2012_01_31)
Item Group
Daunorubicin (60mg/sqm over 1-2 hrs intravenous day 3-5)
Daunorubicin (Code-1)
C0011015 (UMLS CUI 2011AB)
372715008 (SNOMEDCT_2012_01_31)
Sixty (Code-2)
CL447150 (UMLS CUI 2011AB)
mg/m2/24.h (Code-3)
C1532575 (UMLS CUI 2011AB)
414734008 (SNOMEDCT_2012_01_31)
Intravenous (Code-4)
C0348016 (UMLS CUI 2011AB)
255560000 (SNOMEDCT_2012_01_31)
day (Code-5)
C0439228 (UMLS CUI 2011AB)
258703001 (SNOMEDCT_2012_01_31)
D (HL7 V3 2006_05)
3 (Code-6)
C0205449 (UMLS CUI 2011AB)
421291004 (SNOMEDCT_2012_01_31)
Daunorubicin - dose reduction
Item
Daunorubicin (60mg/sqm over 1-2 hrs intravenous day 3-5) - dose reduction
boolean
Daunorubicin (Code-1)
C0011015 (UMLS CUI 2011AB)
372715008 (SNOMEDCT_2012_01_31)
Dose Reduced (Code-2)
C1707814 (UMLS CUI 2011AB)
Reason
Item
(if yes:) a) Reason:
string
Reason (Code-1)
C0392360 (UMLS CUI 2011AB)
410666004 (SNOMEDCT_2012_01_31)
MTHU008862 (LOINC Version 232)
Daunorubicin (Code-2)
C0011015 (UMLS CUI 2011AB)
372715008 (SNOMEDCT_2012_01_31)
Dose Reduced (Code-3)
C1707814 (UMLS CUI 2011AB)
Absolute total dose
Item
(if yes:) b) Absolute total dose in this therapy block (mg):
integer
Absolute (Code-1)
C0205344 (UMLS CUI 2011AB)
56136002 (SNOMEDCT_2012_01_31)
Total Dose (Code-2)
C2986497 (UMLS CUI 2011AB)
Therapy (Code-3)
C0039798 (UMLS CUI 2011AB)
Block (Code-4)
C2828370 (UMLS CUI 2011AB)
mg (Code-5)
C0439210 (UMLS CUI 2011AB)
258684004 (SNOMEDCT_2012_01_31)
Daunorubicin (Code-6)
C0011015 (UMLS CUI 2011AB)
372715008 (SNOMEDCT_2012_01_31)
Item Group
G-CSF dose
G-CSF (Code-1)
C0079459 (UMLS CUI 2011AB)
80572003 (SNOMEDCT_2012_01_31)
MTHU031847 (LOINC Version 232)
Administration procedure (Code-2)
C1533734 (UMLS CUI 2011AB)
416118004 (SNOMEDCT_2012_01_31)
Patient did receive G-CSF
Item
Patient did receive G-CSF:
boolean
Patient (Code-1)
C0030705 (UMLS CUI 2011AB)
116154003 (SNOMEDCT_2012_01_31)
Receive (Code-2)
C1514756 (UMLS CUI 2011AB)
G-CSF (Code-3)
C0079459 (UMLS CUI 2011AB)
80572003 (SNOMEDCT_2012_01_31)
MTHU031847 (LOINC Version 232)
Begin
Item
(if yes:) Start date:
date
C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)
G-CSF (Code-2)
C0079459 (UMLS CUI 2011AB)
80572003 (SNOMEDCT_2012_01_31)
MTHU031847 (LOINC Version 232)
End
Item
(if yes:) End date:
date
C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)
G-CSF (Code-2)
C0079459 (UMLS CUI 2011AB)
80572003 (SNOMEDCT_2012_01_31)
MTHU031847 (LOINC Version 232)
Item
(if yes:) Pharmaceutical Preparations:
integer
C0013227 (UMLS CUI 2011AB)
MTHU038481 (LOINC Version 232)
Medication
Code List
(if yes:) Pharmaceutical Preparations:
CL Item
Neulasta (1)
C1171279 (UMLS CUI 2011AB)
388379009 (SNOMEDCT_2012_01_31)
CL Item
Neupogen (2)
C0210630 (UMLS CUI 2011AB)
108965009 (SNOMEDCT_2012_01_31)
CL Item
Granocyte (3)
C0218640 (UMLS CUI 2011AB)
327123007 (SNOMEDCT_2012_01_31)
CL Item
other (4)
C0205394 (UMLS CUI 2011AB)
74964007 (SNOMEDCT_2012_01_31)
Item Group
Cytopenia duration
Cytopenia (Code-1)
C0010828 (UMLS CUI 2011AB)
50820005 (SNOMEDCT_2012_01_31)
10066274 (MedDRA 14.1)
Duration (Code-2)
C0449238 (UMLS CUI 2011AB)
103335007 (SNOMEDCT_2012_01_31)
MTHU001938 (LOINC Version 232)
Item Group
leucocytes <1,0 GPt/l or <1000 /ul
Leukocytes (Code-1)
C0023516 (UMLS CUI 2011AB)
52501007 (SNOMEDCT_2012_01_31)
10047955 (MedDRA 14.1)
MTHU001946 (LOINC Version 232)
Less Than (Code-2)
C0439092 (UMLS CUI 2011AB)
Thousand Cells per Microliter (Code-3)
C1883312 (UMLS CUI 2011AB)
One (Code-4)
C0205447 (UMLS CUI 2011AB)
421379005 (SNOMEDCT_2012_01_31)
Billion Cells per Liter (Code-5)
C0456524 (UMLS CUI 2011AB)
277199001 (SNOMEDCT_2012_01_31)
start leukopenia
Item
Start date (leucocytes <1,0 GPt/l or <1000 /ul)
date
Start Date (Code-1)
C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)
Leukopenia (Code-2)
C0023530 (UMLS CUI 2011AB)
D72.81 (ICD-10-CM Version 2010)
288.5 (ICD-9-CM Version 2011)
end leukopenia
Item
End date (leucocytes >=1,0 GPt/l or >=1000 /ul)
date
End Date (Code-1)
C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)
Leukopenia (Code-2)
C0023530 (UMLS CUI 2011AB)
D72.81 (ICD-10-CM Version 2010)
288.5 (ICD-9-CM Version 2011)
Ongoing cytopenia
Item
(or) cytopenia ongoing [leucocytes <1,0 GPt/l or <1000 /ul] on:
date
Leukopenia (Code-1)
C0023530 (UMLS CUI 2011AB)
D72.81 (ICD-10-CM Version 2010)
288.5 (ICD-9-CM Version 2011)
ongoing (Code-2)
C0549178 (UMLS CUI 2011AB)
Item Group
neutrophils <0,5 GPt/l or <500 /ul
Neutrophils (Code-1)
C0027950 (UMLS CUI 2011AB)
116712007 (SNOMEDCT_2012_01_31)
10029380 (MedDRA 14.1)
MTHU006207 (LOINC Version 232)
Less Than (Code-2)
C0439092 (UMLS CUI 2011AB)
Five (Code-3)
C0205451 (UMLS CUI 2011AB)
421820001 (SNOMEDCT_2012_01_31)
One Hundred (Code-4)
CL447292 (UMLS CUI 2011AB)
Thousand Cells per Microliter (Code-5)
C1883312 (UMLS CUI 2011AB)
Half (Code-6)
C2825407 (UMLS CUI 2011AB)
start neutropenia
Item
Start date (neutrophils <0,5 GPt/l or <500 /ul)
date
Start Date (Code-1)
C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)
Neutropenia (Code-2)
C0027947 (UMLS CUI 2011AB)
165517008 (SNOMEDCT_2012_01_31)
10029354 (MedDRA 14.1)
D70.9 (ICD-10-CM Version 2010)
288 (ICD-9-CM Version 2011)
end neutropenia
Item
End date (neutrophils >=0,5 GPt/l or >=500 /ul)
date
End Date (Code-1)
C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)
Neutropenia (Code-2)
C0027947 (UMLS CUI 2011AB)
165517008 (SNOMEDCT_2012_01_31)
10029354 (MedDRA 14.1)
D70.9 (ICD-10-CM Version 2010)
288 (ICD-9-CM Version 2011)
Ongoing cytopenia
Item
(or) cytopenia ongoing [neutrophils <0,5 GPt/l or <500 /ul] on:
date
Neutropenia (Code-1)
C0027947 (UMLS CUI 2011AB)
165517008 (SNOMEDCT_2012_01_31)
10029354 (MedDRA 14.1)
D70.9 (ICD-10-CM Version 2010)
288.00 (ICD-9-CM Version 2011)
ongoing (Code-2)
C0549178 (UMLS CUI 2011AB)
Item Group
Start date (platelets <25 GPt/l or <25000 /ul)
platelets (Code-1)
C0005821 (UMLS CUI 2011AB)
16378004 (SNOMEDCT_2012_01_31)
MTHU002432 (LOINC Version 232)
Less Than (Code-2)
C0439092 (UMLS CUI 2011AB)
Twenty (Code-3)
CL447287 (UMLS CUI 2011AB)
Five (Code-4)
C0205451 (UMLS CUI 2011AB)
421820001 (SNOMEDCT_2012_01_31)
Thousand Cells per Microliter (Code-5)
C1883312 (UMLS CUI 2011AB)
Twenty (Code-6)
CL447287 (UMLS CUI 2011AB)
start thrombopenia
Item
Start date (platelets <25 GPt/l or <25000 /ul)
date
Start Date (Code-1)
C0808070 (UMLS CUI 2011AB)
MTHU008298 (LOINC Version 232)
Thrombocytopenia (Code-2)
C0040034 (UMLS CUI 2011AB)
415116008 (SNOMEDCT_2012_01_31)
10043554 (MedDRA 14.1)
D69.6 (ICD-10-CM Version 2010)
287.5 (ICD-9-CM Version 2011)
end thrombopenia
Item
End date (platelets >=25 GPt/l or >=25000 /ul - increasing, independent of substitution of platelets)
date
End Date (Code-1)
C0806020 (UMLS CUI 2011AB)
MTHU008302 (LOINC Version 232)
Thrombocytopenia (Code-2)
C0040034 (UMLS CUI 2011AB)
415116008 (SNOMEDCT_2012_01_31)
10043554 (MedDRA 14.1)
D69.6 (ICD-10-CM Version 2010)
287.5 (ICD-9-CM Version 2011)
Ongoing cytopenia
Item
(or) cytopenia ongoing [platelets <25 GPt/l or <25000 /ul] on:
date
Thrombocytopenia (Code-1)
C0040034 (UMLS CUI 2011AB)
415116008 (SNOMEDCT_2012_01_31)
10043554 (MedDRA 14.1)
D69.6 (ICD-10-CM Version 2010)
287.5 (ICD-9-CM Version 2011)
ongoing (Code-2)
C0549178 (UMLS CUI 2011AB)
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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