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ID

43230

Beschrijving

2. Konsolidierungstherapieblock EudraCT-Nr 2008-004583-40 Akute myeloische Leukämie(AML) AML alle außer FAB M3 consolidation therapy 2 AML in elderly patients AML-AZA NCT00915252 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

  1. 14-12-13 14-12-13 -
  2. 31-07-15 31-07-15 - Martin Dugas
  3. 20-09-21 20-09-21 -
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20 september 2021

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    consolidation therapy 2 AML in elderly patients AML-AZA NCT00915252

    consolidation therapy 2 AML in elderly patients AML-AZA NCT00915252

    1. StudyEvent: Akute myeloische Leukämie(AML) AML alle außer FAB M3
      1. consolidation therapy 2 AML in elderly patients AML-AZA NCT00915252
    Patient data
    Beschrijving

    Patient data

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

    Pat. No.

    Datatype

    integer

    Alias
    UMLS CUI 2011AB
    C1830427
    LOINC Version 232
    MTHU021361
    Clinical finding
    Beschrijving

    Clinical finding

    Alias
    UMLS CUI 2011AB
    C0037088
    SNOMEDCT_2012_01_31
    404684003
    Physical Examination Date:
    Beschrijving

    Physical Examination Date

    Datatype

    date

    Alias
    UMLS CUI 2011AB
    C2826643
    ECOG performance status finding:
    Beschrijving

    ECOG

    Datatype

    integer

    Alias
    UMLS CUI 2011AB
    C1828127
    SNOMEDCT_2012_01_31
    424122007
    Body weight
    Beschrijving

    Body weight

    Datatype

    float

    Maateenheden
    • kg
    Alias
    Code-1
    Body Weight
    SNOMEDCT_2012_01_31
    27113001
    LOINC Version 232
    MTHU001885
    UMLS CUI [1]
    C0005910
    kg
    Body surface area
    Beschrijving

    Body surface area

    Datatype

    float

    Maateenheden
    Alias
    Code-1
    Body Surface Area
    SNOMEDCT_2012_01_31
    301898006
    MedDRA 14.1
    10050311
    UMLS CUI [1]
    C0005902
    Differential blood count
    Beschrijving

    Differential blood count

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

    Datum

    Datatype

    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
    Beschrijving

    Hemoglobin

    Datatype

    float

    Maateenheden
    • g/dL
    Alias
    Code-1
    Hemoglobin
    MedDRA 14.1
    10018876
    UMLS CUI [1]
    C0019046
    g/dL
    Leukocytes
    Beschrijving

    Leukocytes

    Datatype

    float

    Maateenheden
    • /ul
    Alias
    Code-1
    Leukocytes:NCnc:Pt:Bld:Qn
    LOINC Version 232
    26464-8
    UMLS CUI [1]
    C0023516
    /ul
    Neutrophil percentage
    Beschrijving

    Prozentanteil Neutrophile

    Datatype

    integer

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

    Prozentanteil Stabkernige

    Datatype

    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
    Beschrijving

    [oder] Prozentanteil Segmentkernige

    Datatype

    integer

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

    Prozentanteil Lymphozyten

    Datatype

    integer

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

    Prozentanteil Monozyten

    Datatype

    integer

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

    Prozentanteil Eosinophile

    Datatype

    integer

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

    Prozentanteil Basophile

    Datatype

    integer

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

    Prozentanteil Blasten

    Datatype

    integer

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

    Prozentanteil Promyelozyten

    Datatype

    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
    Beschrijving

    Prozentanteil Myelozyten

    Datatype

    integer

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

    Prozentanteil Metamyelozyten

    Datatype

    integer

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

    Prozentanteil sonstige Zellen

    Datatype

    integer

    Alias
    Code-1
    Other cells/100 leukocytes
    UMLS CUI 2011AB
    C1978275
    LOINC Version 232
    MTHU026796
    Peripheral Platelet Count
    Beschrijving

    Peripheral Platelet Count

    Datatype

    float

    Maateenheden
    • 1000/uL
    Alias
    Code-1
    Platelets:NCnc:Pt:Bld:Qn
    LOINC Version 232
    26515-7
    UMLS CUI [1]
    C0005821
    1000/uL
    Clinical Chemistry
    Beschrijving

    Clinical Chemistry

    Alias
    UMLS CUI-1
    C0008000
    Sodium
    Beschrijving

    Sodium

    Datatype

    float

    Maateenheden
    • mmol/L
    Alias
    Code-1
    Sodium:SCnc:Pt:Bld:Qn
    LOINC Version 232
    2947-0
    UMLS CUI [1]
    C0337443
    mmol/L
    Potassium
    Beschrijving

    Potassium

    Datatype

    float

    Maateenheden
    • mmol/l
    Alias
    Code-1
    Potassium:SCnc:Pt:Bld:Qn
    LOINC Version 232
    6298-4
    UMLS CUI [1]
    C0202194
    mmol/l
    Total Protein
    Beschrijving

    Total Protein

    Datatype

    float

    Maateenheden
    • mg/dL
    Alias
    Code-1
    Total Protein Measurement
    SNOMEDCT_2012_01_31
    304383000
    MedDRA 14.1
    10050537
    UMLS CUI [1]
    C0036836
    mg/dL
    Uric acid
    Beschrijving

    Uric acid

    Datatype

    float

    Maateenheden
    • md/dl
    Alias
    Code-1
    Urate [Mass/volume] in Serum or Plasma
    LOINC Version 232
    3084-1
    UMLS CUI [1]
    C0041980
    md/dl
    BUN
    Beschrijving

    BUN

    Datatype

    float

    Maateenheden
    • mg/dL
    Alias
    Code-1
    Urea Measurement
    SNOMEDCT_2012_01_31
    105010007
    MedDRA 14.1
    10046346
    UMLS CUI [1]
    C0005845
    mg/dL
    Creatinine
    Beschrijving

    Creatinine

    Datatype

    float

    Maateenheden
    • mg/dL
    Alias
    Code-1
    Creatinine Measurement
    SNOMEDCT_2012_01_31
    70901006
    MedDRA 14.1
    10005480
    UMLS CUI [1]
    C0201976
    mg/dL
    Bilirubin, total
    Beschrijving

    Bilirubin, total

    Datatype

    float

    Maateenheden
    • mg/dL
    Alias
    Code-1
    Total Bilirubin Measurement
    SNOMEDCT_2012_01_31
    359986008
    MedDRA 14.1
    10004696
    UMLS CUI [1]
    C0201913
    mg/dL
    AST (SGOT)
    Beschrijving

    AST (SGOT)

    Datatype

    float

    Maateenheden
    • U/L
    Alias
    Code-1
    Aspartate transaminase level
    SNOMEDCT_2012_01_31
    373679006
    UMLS CUI [1]
    C0201899
    U/L
    ALT (SGPT)
    Beschrijving

    ALT (SGPT)

    Datatype

    float

    Maateenheden
    • U/L
    Alias
    Code-1
    Alanine Transaminase
    SNOMEDCT_2012_01_31
    56935002
    LOINC Version 232
    MTHU006766
    UMLS CUI [1]
    C0201836
    U/L
    Alkaline Phosphatase
    Beschrijving

    Alkaline Phosphatase

    Datatype

    float

    Maateenheden
    • U/L
    Alias
    Code-1
    Alkaline phosphatase level - finding
    SNOMEDCT_2012_01_31
    365771003
    UMLS CUI [1]
    C0201850
    U/L
    Lactate Dehydrogenase
    Beschrijving

    Lactate Dehydrogenase

    Datatype

    float

    Maateenheden
    • U/L
    Alias
    Code-1
    Lactate Dehydrogenase
    SNOMEDCT_2012_01_31
    259319003
    LOINC Version 232
    MTHU002348
    UMLS CUI [1]
    C0202113
    U/L
    CRP
    Beschrijving

    CRP

    Datatype

    float

    Maateenheden
    • md/dl
    Alias
    Code-1
    C-reactive protein
    SNOMEDCT_2012_01_31
    61425002
    LOINC Version 232
    MTHU002335
    UMLS CUI [1]
    C0201657
    md/dl
    Quick
    Beschrijving

    Quick

    Datatype

    float

    Maateenheden
    • %
    Alias
    Code-1
    Prothrombin time ratio
    MedDRA 14.1
    10037064
    UMLS CUI [1]
    C0483455
    %
    INR
    Beschrijving

    INR

    Datatype

    float

    Alias
    Code-1
    International Normalized Ratio
    UMLS CUI [1]
    C0525032
    PTT
    Beschrijving

    PTT

    Datatype

    float

    Maateenheden
    • seconds
    Alias
    Code-1
    Activated Partial Thromboplastin Time measurement
    SNOMEDCT_2012_01_31
    42525009
    MedDRA 14.1
    10000630
    UMLS CUI [1]
    C0030605
    seconds
    Patient randomization in study arm:
    Beschrijving

    Patient randomization in study arm

    Datatype

    integer

    Alias
    Code-1
    Protocol Treatment Arm
    UMLS CUI 2011AB
    C1522541
    5-Azacytidine
    Beschrijving

    5-Azacytidine

    Alias
    Code-1
    5-Azacytidine
    UMLS CUI 2011AB
    C0004475
    SNOMEDCT_2012_01_31
    412329008
    5-Azacytidine dose:
    Beschrijving

    5-Azacytidine dose

    Datatype

    integer

    Alias
    Code-1
    5-Azacytidine
    UMLS CUI 2011AB
    C0004475
    SNOMEDCT_2012_01_31
    412329008
    Code-2
    Dose
    UMLS CUI 2011AB
    C0178602
    SNOMEDCT_2012_01_31
    260911001
    5-Azacytidine
    Beschrijving

    5-Azacytidine

    Alias
    Code-1
    5-Azacytidine
    UMLS CUI 2011AB
    C0004475
    SNOMEDCT_2012_01_31
    412329008
    5-Azacytidine - Dose no. 1
    Beschrijving

    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
    Beschrijving

    Date

    Datatype

    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)
    Beschrijving

    Dose absolute/day (mg)

    Datatype

    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
    Beschrijving

    Route of administration

    Datatype

    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
    First
    UMLS CUI 2011AB
    C0205435
    SNOMEDCT_2012_01_31
    255216001
    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
    Reason for not subcutaneous
    Beschrijving

    Reason for not subcutaneous

    Datatype

    string

    Alias
    Code-1
    Indication of (contextual qualifier)
    UMLS CUI 2011AB
    C0392360
    SNOMEDCT_2012_01_31
    410666004
    LOINC Version 232
    MTHU008862
    Code-2
    Subcutaneous Route of Drug Administration
    UMLS CUI 2011AB
    C1522438
    SNOMEDCT_2012_01_31
    34206005
    HL7 V3 2006_05
    _SubcutaneousRoute
    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
    Beschrijving

    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
    Beschrijving

    Date

    Datatype

    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)
    Beschrijving

    Dose absolute/day (mg)

    Datatype

    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
    Beschrijving

    Route of administration

    Datatype

    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 subcutaneous
    Beschrijving

    Reason for not subcutaneous

    Datatype

    string

    Alias
    Code-1
    Indication of (contextual qualifier)
    UMLS CUI 2011AB
    C0392360
    SNOMEDCT_2012_01_31
    410666004
    LOINC Version 232
    MTHU008862
    Code-2
    Subcutaneous Route of Drug Administration
    UMLS CUI 2011AB
    C1522438
    SNOMEDCT_2012_01_31
    34206005
    HL7 V3 2006_05
    _SubcutaneousRoute
    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. 3
    Beschrijving

    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
    Beschrijving

    Date

    Datatype

    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)
    Beschrijving

    Dose absolute/day (mg)

    Datatype

    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
    Beschrijving

    Route of administration

    Datatype

    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 subcutaneous
    Beschrijving

    Reason for not subcutaneous

    Datatype

    string

    Alias
    Code-1
    Indication of (contextual qualifier)
    UMLS CUI 2011AB
    C0392360
    SNOMEDCT_2012_01_31
    410666004
    LOINC Version 232
    MTHU008862
    Code-2
    Subcutaneous Route of Drug Administration
    UMLS CUI 2011AB
    C1522438
    SNOMEDCT_2012_01_31
    34206005
    HL7 V3 2006_05
    _SubcutaneousRoute
    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. 4
    Beschrijving

    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
    Beschrijving

    Date

    Datatype

    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)
    Beschrijving

    Dose absolute/day (mg)

    Datatype

    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
    Beschrijving

    Route of administration

    Datatype

    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 subcutaneous
    Beschrijving

    Reason for not subcutaneous

    Datatype

    string

    Alias
    Code-1
    Indication of (contextual qualifier)
    UMLS CUI 2011AB
    C0392360
    SNOMEDCT_2012_01_31
    410666004
    LOINC Version 232
    MTHU008862
    Code-2
    Subcutaneous Route of Drug Administration
    UMLS CUI 2011AB
    C1522438
    SNOMEDCT_2012_01_31
    34206005
    HL7 V3 2006_05
    _SubcutaneousRoute
    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. 5
    Beschrijving

    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
    Beschrijving

    Date

    Datatype

    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)
    Beschrijving

    Dose absolute/day (mg)

    Datatype

    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
    Beschrijving

    Route of administration

    Datatype

    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 subcutaneous
    Beschrijving

    Reason for not subcutaneous

    Datatype

    string

    Alias
    Code-1
    Indication of (contextual qualifier)
    UMLS CUI 2011AB
    C0392360
    SNOMEDCT_2012_01_31
    410666004
    LOINC Version 232
    MTHU008862
    Code-2
    Subcutaneous Route of Drug Administration
    UMLS CUI 2011AB
    C1522438
    SNOMEDCT_2012_01_31
    34206005
    HL7 V3 2006_05
    _SubcutaneousRoute
    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 reduction
    Beschrijving

    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
    Beschrijving

    5-Azacytidine dose reduction

    Datatype

    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:
    Beschrijving

    yes, reason

    Datatype

    integer

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

    Miscellaneous

    Datatype

    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:
    Beschrijving

    AE-No

    Datatype

    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
    Code-3
    Actual
    UMLS CUI 2011AB
    C0237400
    Code-4
    Therapy
    UMLS CUI 2011AB
    C0039798
    Code-5
    Block
    UMLS CUI 2011AB
    C2828370
    AE-No:
    Beschrijving

    AE-No

    Datatype

    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
    Code-3
    Previous
    UMLS CUI 2011AB
    C0205156
    SNOMEDCT_2012_01_31
    9130008
    Code-4
    Therapy
    UMLS CUI 2011AB
    C0039798
    Code-5
    Block
    UMLS CUI 2011AB
    C2828370
    Transfusions
    Beschrijving

    Transfusions

    Alias
    UMLS CUI 2011AB
    C1879316
    SNOMEDCT_2012_01_31
    5447007
    MedDRA 14.1
    10066152
    How many transfusions did the patient receive in the period between day 1 of the 1st consolidation chemotherapy AND day 1 of the 2nd consolidation chemotherapy?
    Beschrijving

    Transfusions between day 1 of 1st consolidation chemotherapy and day 1 of 2nd consolidation chemotherapy

    Datatype

    integer

    Alias
    Code-1
    Number
    UMLS CUI 2011AB
    C0449788
    SNOMEDCT_2012_01_31
    410681005
    Code-2
    Transfusions
    UMLS CUI 2011AB
    C1879316
    SNOMEDCT_2012_01_31
    5447007
    MedDRA 14.1
    10066152
    Code-3
    Between
    UMLS CUI 2011AB
    CL426201
    Code-4
    day
    UMLS CUI 2011AB
    C0439228
    SNOMEDCT_2012_01_31
    258703001
    HL7 V3 2006_05
    D
    Code-5
    1
    UMLS CUI 2011AB
    C0205447
    SNOMEDCT_2012_01_31
    38112003
    Code-6
    1st
    UMLS CUI 2011AB
    C0205435
    SNOMEDCT_2012_01_31
    255216001
    Number of transfused erythrocyte concentrates:
    Beschrijving

    Number of transfused erythrocyte concentrates

    Datatype

    integer

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

    Number of transfused platelet concentrates

    Datatype

    integer

    Alias
    Code-1
    Number
    UMLS CUI 2011AB
    C0449788
    SNOMEDCT_2012_01_31
    410681005
    Code-2
    Platelet transfusion
    UMLS CUI 2011AB
    C0086818
    SNOMEDCT_2012_01_31
    12719002
    MedDRA 14.1
    10035543
    ICD-9-CM Version 2011
    99.05
    Code-3
    Concentrate
    UMLS CUI 2011AB
    C2003864
    Chemotherapy
    Beschrijving

    Chemotherapy

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

    Day 1

    Datatype

    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 (2 x 1g/sqm over 3 hrs intravenous day 1,3,5)
    Beschrijving

    Ara-C (2 x 1g/sqm over 3 hrs intravenous day 1,3,5)

    Alias
    Code-1
    Ara-C
    UMLS CUI 2011AB
    C0010711
    SNOMEDCT_2012_01_31
    89265009
    Code-2
    2 x
    UMLS CUI 2011AB
    C1948050
    Code-3
    1
    UMLS CUI 2011AB
    C0205447
    SNOMEDCT_2012_01_31
    38112003
    Code-4
    g/m2
    UMLS CUI 2011AB
    C1300564
    SNOMEDCT_2012_01_31
    396168004
    Code-5
    3
    UMLS CUI 2011AB
    C0205449
    SNOMEDCT_2012_01_31
    421291004
    Code-6
    h
    UMLS CUI 2011AB
    C0439227
    SNOMEDCT_2012_01_31
    258702006
    Ara-C - dose reduction
    Beschrijving

    Ara-C - dose reduction

    Datatype

    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:
    Beschrijving

    Reason

    Datatype

    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):
    Beschrijving

    Absolute total dose

    Datatype

    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
    G-CSF dose
    Beschrijving

    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:
    Beschrijving

    Patient did receive G-CSF

    Datatype

    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:
    Beschrijving

    Begin

    Datatype

    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:
    Beschrijving

    End

    Datatype

    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:
    Beschrijving

    Medication

    Datatype

    integer

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

    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
    Beschrijving

    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)
    Beschrijving

    start leukopenia

    Datatype

    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)
    Beschrijving

    end leukopenia

    Datatype

    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:
    Beschrijving

    Ongoing cytopenia

    Datatype

    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
    Beschrijving

    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)
    Beschrijving

    start neutropenia

    Datatype

    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)
    Beschrijving

    end neutropenia

    Datatype

    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:
    Beschrijving

    Ongoing cytopenia

    Datatype

    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)
    Beschrijving

    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)
    Beschrijving

    start thrombopenia

    Datatype

    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)
    Beschrijving

    end thrombopenia

    Datatype

    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:
    Beschrijving

    Ongoing cytopenia

    Datatype

    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
    Beschrijving

    Signature

    Alias
    UMLS CUI 2011AB
    C1519316
    Date:
    Beschrijving

    Datum

    Datatype

    date

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

    Name/Unterschrift Prüfarzt

    Datatype

    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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    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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 Group
    Clinical finding
    C0037088 (UMLS CUI 2011AB)
    404684003 (SNOMEDCT_2012_01_31)
    Physical Examination Date
    Item
    Physical Examination Date:
    date
    C2826643 (UMLS CUI 2011AB)
    Item
    ECOG performance status finding:
    integer
    C1828127 (UMLS CUI 2011AB)
    424122007 (SNOMEDCT_2012_01_31)
    Code List
    ECOG performance status finding:
    CL Item
    ECOG 0 (Normal physical fitness) (0)
    C1828078 (UMLS CUI 2011AB)
    425389002 (SNOMEDCT_2012_01_31)
    CL Item
    ECOG 1 (Outpatient care, easy work possible) (1)
    C1827388 (UMLS CUI 2011AB)
    422512005 (SNOMEDCT_2012_01_31)
    CL Item
    ECOG 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 3 (More than half day bed-ridden, limited self-sufficiency possible) (3)
    C1827126 (UMLS CUI 2011AB)
    423053003 (SNOMEDCT_2012_01_31)
    CL Item
    ECOG 4 (Permanent bed-ridden) (4)
    C1827528 (UMLS CUI 2011AB)
    423237006 (SNOMEDCT_2012_01_31)
    Weight
    Item
    Body weight
    float
    Body Weight (Code-1)
    27113001 (SNOMEDCT_2012_01_31)
    MTHU001885 (LOINC Version 232)
    C0005910 (UMLS CUI [1])
    BSA
    Item
    Body surface area
    float
    Body Surface Area (Code-1)
    301898006 (SNOMEDCT_2012_01_31)
    10050311 (MedDRA 14.1)
    C0005902 (UMLS CUI [1])
    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)
    Hemoglobin
    Item
    Hemoglobin
    float
    Hemoglobin (Code-1)
    10018876 (MedDRA 14.1)
    C0019046 (UMLS CUI [1])
    Leukocytes
    Item
    Leukocytes
    float
    Leukocytes:NCnc:Pt:Bld:Qn (Code-1)
    26464-8 (LOINC Version 232)
    C0023516 (UMLS CUI [1])
    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)
    Platelets
    Item
    Peripheral Platelet Count
    float
    Platelets:NCnc:Pt:Bld:Qn (Code-1)
    26515-7 (LOINC Version 232)
    C0005821 (UMLS CUI [1])
    Item Group
    Clinical Chemistry
    C0008000 (UMLS CUI-1)
    Sodium
    Item
    Sodium
    float
    Sodium:SCnc:Pt:Bld:Qn (Code-1)
    2947-0 (LOINC Version 232)
    C0337443 (UMLS CUI [1])
    Potassium
    Item
    Potassium
    float
    Potassium:SCnc:Pt:Bld:Qn (Code-1)
    6298-4 (LOINC Version 232)
    C0202194 (UMLS CUI [1])
    Total Protein
    Item
    Total Protein
    float
    Total Protein Measurement (Code-1)
    304383000 (SNOMEDCT_2012_01_31)
    10050537 (MedDRA 14.1)
    C0036836 (UMLS CUI [1])
    Uric acid
    Item
    Uric acid
    float
    Urate [Mass/volume] in Serum or Plasma (Code-1)
    3084-1 (LOINC Version 232)
    C0041980 (UMLS CUI [1])
    BUN
    Item
    BUN
    float
    Urea Measurement (Code-1)
    105010007 (SNOMEDCT_2012_01_31)
    10046346 (MedDRA 14.1)
    C0005845 (UMLS CUI [1])
    Creatinine, Serum
    Item
    Creatinine
    float
    Creatinine Measurement (Code-1)
    70901006 (SNOMEDCT_2012_01_31)
    10005480 (MedDRA 14.1)
    C0201976 (UMLS CUI [1])
    Bilirubin, total
    Item
    Bilirubin, total
    float
    Total Bilirubin Measurement (Code-1)
    359986008 (SNOMEDCT_2012_01_31)
    10004696 (MedDRA 14.1)
    C0201913 (UMLS CUI [1])
    AST
    Item
    AST (SGOT)
    float
    Aspartate transaminase level (Code-1)
    373679006 (SNOMEDCT_2012_01_31)
    C0201899 (UMLS CUI [1])
    ALT
    Item
    ALT (SGPT)
    float
    Alanine Transaminase (Code-1)
    56935002 (SNOMEDCT_2012_01_31)
    MTHU006766 (LOINC Version 232)
    C0201836 (UMLS CUI [1])
    Alkaline Phosphatase
    Item
    Alkaline Phosphatase
    float
    Alkaline phosphatase level - finding (Code-1)
    365771003 (SNOMEDCT_2012_01_31)
    C0201850 (UMLS CUI [1])
    LDH
    Item
    Lactate Dehydrogenase
    float
    Lactate Dehydrogenase (Code-1)
    259319003 (SNOMEDCT_2012_01_31)
    MTHU002348 (LOINC Version 232)
    C0202113 (UMLS CUI [1])
    CRP
    Item
    CRP
    float
    C-reactive protein (Code-1)
    61425002 (SNOMEDCT_2012_01_31)
    MTHU002335 (LOINC Version 232)
    C0201657 (UMLS CUI [1])
    Quick
    Item
    Quick
    float
    Prothrombin time ratio (Code-1)
    10037064 (MedDRA 14.1)
    C0483455 (UMLS CUI [1])
    INR
    Item
    INR
    float
    International Normalized Ratio (Code-1)
    C0525032 (UMLS CUI [1])
    PTT
    Item
    PTT
    float
    Activated Partial Thromboplastin Time measurement (Code-1)
    42525009 (SNOMEDCT_2012_01_31)
    10000630 (MedDRA 14.1)
    C0030605 (UMLS CUI [1])
    Item
    Patient randomization in study arm:
    integer
    Protocol Treatment Arm (Code-1)
    C1522541 (UMLS CUI 2011AB)
    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 31) (2)
    B (Code-1)
    C0439105 (UMLS CUI 2011AB)
    421151005 (SNOMEDCT_2012_01_31)
    Item Group
    5-Azacytidine
    5-Azacytidine (Code-1)
    C0004475 (UMLS CUI 2011AB)
    412329008 (SNOMEDCT_2012_01_31)
    Item
    5-Azacytidine dose:
    integer
    5-Azacytidine (Code-1)
    C0004475 (UMLS CUI 2011AB)
    412329008 (SNOMEDCT_2012_01_31)
    Dose (Code-2)
    C0178602 (UMLS CUI 2011AB)
    260911001 (SNOMEDCT_2012_01_31)
    Code List
    5-Azacytidine dose:
    CL Item
    DL 0: 18 mg/m2 (0)
    Dose (Code-1)
    C0178602 (UMLS CUI 2011AB)
    260911001 (SNOMEDCT_2012_01_31)
    Level (Code-2)
    C0456079 (UMLS CUI 2011AB)
    260911001 (SNOMEDCT_2012_01_31)
    Zero (Code-3)
    C0919414 (UMLS CUI 2011AB)
    258317007 (SNOMEDCT_2012_01_31)
    Eight (Code-4)
    C0205454 (UMLS CUI 2011AB)
    421825006 (SNOMEDCT_2012_01_31)
    Ten (Code-5)
    C0205456 (UMLS CUI 2011AB)
    420258001 (SNOMEDCT_2012_01_31)
    mg/m2 (Code-6)
    C1319266 (UMLS CUI 2011AB)
    396174004 (SNOMEDCT_2012_01_31)
    CL Item
    DL 1: 37,5 mg/m2 (1)
    Dose (Code-1)
    C0178602 (UMLS CUI 2011AB)
    260911001 (SNOMEDCT_2012_01_31)
    Level (Code-2)
    C0456079 (UMLS CUI 2011AB)
    260911001 (SNOMEDCT_2012_01_31)
    One (Code-3)
    C0205447 (UMLS CUI 2011AB)
    421379005 (SNOMEDCT_2012_01_31)
    Thirty (Code-4)
    CL447153 (UMLS CUI 2011AB)
    Seven (Code-5)
    C0205453 (UMLS CUI 2011AB)
    420359007 (SNOMEDCT_2012_01_31)
    Point (Code-6)
    CL415149 (UMLS CUI 2011AB)
    CL Item
    DL 2: 75 mg/m2 (2)
    Dose (Code-1)
    C0178602 (UMLS CUI 2011AB)
    260911001 (SNOMEDCT_2012_01_31)
    Level (Code-2)
    C0456079 (UMLS CUI 2011AB)
    260911001 (SNOMEDCT_2012_01_31)
    Seventy (Code-4)
    CL447148 (UMLS CUI 2011AB)
    Five (Code-5)
    C0205451 (UMLS CUI 2011AB)
    421820001 (SNOMEDCT_2012_01_31)
    mg/m2 (Code-6)
    C1319266 (UMLS CUI 2011AB)
    396174004 (SNOMEDCT_2012_01_31)
    Item Group
    5-Azacytidine
    5-Azacytidine (Code-1)
    C0004475 (UMLS CUI 2011AB)
    412329008 (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)
    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)
    First (Code-3)
    C0205435 (UMLS CUI 2011AB)
    255216001 (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)
    Code List
    Route of administration
    CL Item
    subcutaneous (1)
    Subcutaneous Route of Drug Administration (Code-1)
    C1522438 (UMLS CUI 2011AB)
    34206005 (SNOMEDCT_2012_01_31)
    _SubcutaneousRoute (HL7 V3 2006_05)
    Reason for not subcutaneous
    Item
    Reason for not subcutaneous
    string
    Indication of (contextual qualifier) (Code-1)
    C0392360 (UMLS CUI 2011AB)
    410666004 (SNOMEDCT_2012_01_31)
    MTHU008862 (LOINC Version 232)
    Subcutaneous Route of Drug Administration (Code-2)
    C1522438 (UMLS CUI 2011AB)
    34206005 (SNOMEDCT_2012_01_31)
    _SubcutaneousRoute (HL7 V3 2006_05)
    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)
    Code List
    Route of administration
    CL Item
    subcutaneous (1)
    Subcutaneous Route of Drug Administration (Code-1)
    C1522438 (UMLS CUI 2011AB)
    34206005 (SNOMEDCT_2012_01_31)
    _SubcutaneousRoute (HL7 V3 2006_05)
    Reason for not subcutaneous
    Item
    Reason for not subcutaneous
    string
    Indication of (contextual qualifier) (Code-1)
    C0392360 (UMLS CUI 2011AB)
    410666004 (SNOMEDCT_2012_01_31)
    MTHU008862 (LOINC Version 232)
    Subcutaneous Route of Drug Administration (Code-2)
    C1522438 (UMLS CUI 2011AB)
    34206005 (SNOMEDCT_2012_01_31)
    _SubcutaneousRoute (HL7 V3 2006_05)
    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. 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)
    Code List
    Route of administration
    CL Item
    subcutaneous (1)
    Subcutaneous Route of Drug Administration (Code-1)
    C1522438 (UMLS CUI 2011AB)
    34206005 (SNOMEDCT_2012_01_31)
    _SubcutaneousRoute (HL7 V3 2006_05)
    Reason for not subcutaneous
    Item
    Reason for not subcutaneous
    string
    Indication of (contextual qualifier) (Code-1)
    C0392360 (UMLS CUI 2011AB)
    410666004 (SNOMEDCT_2012_01_31)
    MTHU008862 (LOINC Version 232)
    Subcutaneous Route of Drug Administration (Code-2)
    C1522438 (UMLS CUI 2011AB)
    34206005 (SNOMEDCT_2012_01_31)
    _SubcutaneousRoute (HL7 V3 2006_05)
    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. 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)
    Code List
    Route of administration
    CL Item
    subcutaneous (1)
    Subcutaneous Route of Drug Administration (Code-1)
    C1522438 (UMLS CUI 2011AB)
    34206005 (SNOMEDCT_2012_01_31)
    _SubcutaneousRoute (HL7 V3 2006_05)
    Reason for not subcutaneous
    Item
    Reason for not subcutaneous
    string
    Indication of (contextual qualifier) (Code-1)
    C0392360 (UMLS CUI 2011AB)
    410666004 (SNOMEDCT_2012_01_31)
    MTHU008862 (LOINC Version 232)
    Subcutaneous Route of Drug Administration (Code-2)
    C1522438 (UMLS CUI 2011AB)
    34206005 (SNOMEDCT_2012_01_31)
    _SubcutaneousRoute (HL7 V3 2006_05)
    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. 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)
    Code List
    Route of administration
    CL Item
    subcutaneous (1)
    Subcutaneous Route of Drug Administration (Code-1)
    C1522438 (UMLS CUI 2011AB)
    34206005 (SNOMEDCT_2012_01_31)
    _SubcutaneousRoute (HL7 V3 2006_05)
    Reason for not subcutaneous
    Item
    Reason for not subcutaneous
    string
    Indication of (contextual qualifier) (Code-1)
    C0392360 (UMLS CUI 2011AB)
    410666004 (SNOMEDCT_2012_01_31)
    MTHU008862 (LOINC Version 232)
    Subcutaneous Route of Drug Administration (Code-2)
    C1522438 (UMLS CUI 2011AB)
    34206005 (SNOMEDCT_2012_01_31)
    _SubcutaneousRoute (HL7 V3 2006_05)
    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 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)
    Code List
    yes, reason:
    CL Item
    AE(s) in actual therapy block (1)
    Adverse event (Code-1)
    C0877248 (UMLS CUI 2011AB)
    10060933 (MedDRA 14.1)
    MTHU014542 (LOINC Version 232)
    Actual (Code-2)
    C0237400 (UMLS CUI 2011AB)
    Therapy (Code-3)
    C0039798 (UMLS CUI 2011AB)
    Block (Code-4)
    C2828370 (UMLS CUI 2011AB)
    CL Item
    AE(s) in a previous therapy block (2)
    Adverse event (Code-1)
    C0877248 (UMLS CUI 2011AB)
    10060933 (MedDRA 14.1)
    MTHU014542 (LOINC Version 232)
    Previous (Code-2)
    C0205156 (UMLS CUI 2011AB)
    9130008 (SNOMEDCT_2012_01_31)
    Therapy (Code-3)
    C0039798 (UMLS CUI 2011AB)
    Block (Code-4)
    C2828370 (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)
    Actual (Code-3)
    C0237400 (UMLS CUI 2011AB)
    Therapy (Code-4)
    C0039798 (UMLS CUI 2011AB)
    Block (Code-5)
    C2828370 (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)
    Previous (Code-3)
    C0205156 (UMLS CUI 2011AB)
    9130008 (SNOMEDCT_2012_01_31)
    Therapy (Code-4)
    C0039798 (UMLS CUI 2011AB)
    Block (Code-5)
    C2828370 (UMLS CUI 2011AB)
    Item Group
    Transfusions
    C1879316 (UMLS CUI 2011AB)
    5447007 (SNOMEDCT_2012_01_31)
    10066152 (MedDRA 14.1)
    Transfusions between day 1 of 1st consolidation chemotherapy and day 1 of 2nd consolidation chemotherapy
    Item
    How many transfusions did the patient receive in the period between day 1 of the 1st consolidation chemotherapy AND day 1 of the 2nd consolidation chemotherapy?
    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)
    day (Code-4)
    C0439228 (UMLS CUI 2011AB)
    258703001 (SNOMEDCT_2012_01_31)
    D (HL7 V3 2006_05)
    1 (Code-5)
    C0205447 (UMLS CUI 2011AB)
    38112003 (SNOMEDCT_2012_01_31)
    1st (Code-6)
    C0205435 (UMLS CUI 2011AB)
    255216001 (SNOMEDCT_2012_01_31)
    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)
    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 (2 x 1g/sqm over 3 hrs intravenous day 1,3,5)
    Ara-C (Code-1)
    C0010711 (UMLS CUI 2011AB)
    89265009 (SNOMEDCT_2012_01_31)
    2 x (Code-2)
    C1948050 (UMLS CUI 2011AB)
    1 (Code-3)
    C0205447 (UMLS CUI 2011AB)
    38112003 (SNOMEDCT_2012_01_31)
    g/m2 (Code-4)
    C1300564 (UMLS CUI 2011AB)
    396168004 (SNOMEDCT_2012_01_31)
    3 (Code-5)
    C0205449 (UMLS CUI 2011AB)
    421291004 (SNOMEDCT_2012_01_31)
    h (Code-6)
    C0439227 (UMLS CUI 2011AB)
    258702006 (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
    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)
    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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