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ID

44895

Description

Study ID: 104864-201 Clinical Study ID: 104864/A201 Study Title: A Phase III, Open-Label, Multicenter, Randomized, Comparative Study of Topotecan, Ara-C and G-CSF (TAG) versus Idarubicin, Ara-C and G-CSF (IDAG) in MDS Patients with RAEB (High-Risk), RAEB-t or in Patients with AML from a Preceding Phase of MDS Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: hycamtin Study Indication: Myelodysplastic Syndrome https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

Link

https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

Keywords

Versions (2)
  1. 4/24/18 4/24/18 - Halim Ugurlu
  2. 3/31/22 3/31/22 - Martin Dugas
Copyright Holder

GSK

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March 31, 2022

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Creative Commons BY-NC 4.0
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    GSK Study ID 104864-201-Laboratory (next Course)

    English

    Laboratory Tests

    1 forms  
    1. StudyEvent: GSK Study ID 104864-201-Laboratory (next Course)
      1. Laboratory Tests
    Identification Numbers
    Description

    Identification Numbers

    Alias
    UMLS CUI-1
    C1300638
    Patient Number
    Description

    Patient Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C1830427
    Patient Initials
    Description

    Patient Initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440
    Laboratory Tests-Hematology
    Description

    Laboratory Tests-Hematology

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0474523
    Sample Date
    Description

    Sample Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413
    Laboratory Name
    Description

    Laboratory Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C3258037
    Hemoglobin
    Description

    I.6

    Data type

    float

    Measurement units
    • g/dl
    Alias
    UMLS CUI [1]
    C0019046
    g/dl
    Hematocrit
    Description

    I.7

    Data type

    float

    Measurement units
    • %
    Alias
    UMLS CUI [1]
    C0518014
    %
    RBC
    Description

    I.8

    Data type

    float

    Alias
    UMLS CUI [1]
    C0014772
    WBC
    Description

    I.9

    Data type

    float

    Alias
    UMLS CUI [1]
    C0023508
    Neutrophils - segmented
    Description

    I.10

    Data type

    float

    Alias
    UMLS CUI [1]
    C0229640
    Bands
    Description

    Bands

    Data type

    text

    Alias
    UMLS CUI [1]
    C1882076
    Lymphocytes
    Description

    I.12

    Data type

    float

    Alias
    UMLS CUI [1]
    C0200635
    Monocytes
    Description

    I.13

    Data type

    float

    Alias
    UMLS CUI [1]
    C0026473
    Eosinophils
    Description

    I.14

    Data type

    float

    Alias
    UMLS CUI [1]
    C0857996
    Basophils
    Description

    I.15

    Data type

    float

    Alias
    UMLS CUI [1]
    C0200641
    Platelets
    Description

    I.16

    Data type

    float

    Alias
    UMLS CUI [1]
    C0005821
    Blast Cells
    Description

    I.17

    Data type

    float

    Measurement units
    • %
    Alias
    UMLS CUI [1]
    C0368761
    %
    Prothrombin Time (PT)
    Description

    I.18

    Data type

    float

    Alias
    UMLS CUI [1]
    C0033707
    Partial Thromboplastin Time
    Description

    I.19

    Data type

    float

    Alias
    UMLS CUI [1]
    C3525810
    Fibrinogen
    Description

    I.20

    Data type

    float

    Alias
    UMLS CUI [1]
    C0016006
    Laboratory Tests-Blood Chemistry
    Description

    Laboratory Tests-Blood Chemistry

    Alias
    UMLS CUI-1
    C1254595
    UMLS CUI-2
    C0005774
    Visit
    Description

    Screening, Day 1, Day 2.... Day 1 tests are required only if not performed within the previous 7 days or if abnormal at the Screening visit. Do not fill day 1 if not required NOTE: If the laboratory changes during the study, a new set of reference ranges must be completed.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0545082
    Sample Date
    Description

    Sample Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413
    Laboratory Name
    Description

    Laboratory Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C3258037
    Sodium
    Description

    I.24

    Data type

    float

    Measurement units
    • mmol/l
    Alias
    UMLS CUI [1]
    C0337443
    mmol/l
    Potassium
    Description

    I.25

    Data type

    float

    Measurement units
    • mmol/l
    Alias
    UMLS CUI [1]
    C0202194
    mmol/l
    Chloride
    Description

    I.26

    Data type

    float

    Measurement units
    • mmol/l
    Alias
    UMLS CUI [1]
    C0201952
    mmol/l
    Bicarbonate
    Description

    I.27

    Data type

    float

    Alias
    UMLS CUI [1]
    C0202059
    Calcium
    Description

    I.28

    Data type

    float

    Alias
    UMLS CUI [1]
    C0201925
    Phosphorus
    Description

    I.29

    Data type

    float

    Alias
    UMLS CUI [1]
    C0031705
    Magnesium
    Description

    I.30

    Data type

    float

    Alias
    UMLS CUI [1]
    C0373675
    BUN
    Description

    I.31

    Data type

    float

    Alias
    UMLS CUI [1]
    C0005845
    Urea
    Description

    I.32

    Data type

    float

    Alias
    UMLS CUI [1]
    C0523961
    Uric Acid
    Description

    I.33

    Data type

    float

    Alias
    UMLS CUI [1]
    C0202239
    Creatinine
    Description

    I.34

    Data type

    float

    Alias
    UMLS CUI [1]
    C0201976
    Alkaline Phosphatase
    Description

    I.35

    Data type

    float

    Alias
    UMLS CUI [1]
    C0201850
    LDH
    Description

    I.36

    Data type

    float

    Alias
    UMLS CUI [1]
    C0202113
    SGOT/AST
    Description

    I.37

    Data type

    float

    Alias
    UMLS CUI [1]
    C0201899
    SGPT/ALT
    Description

    I.38

    Data type

    float

    Alias
    UMLS CUI [1]
    C0201836
    Total Bilirubin
    Description

    I.39

    Data type

    float

    Alias
    UMLS CUI [1]
    C0201913
    Direct Bilirubin
    Description

    I.40

    Data type

    float

    Alias
    UMLS CUI [1]
    C0201916
    Total Protein
    Description

    I.41

    Data type

    float

    Alias
    UMLS CUI [1]
    C0555903
    Albumin
    Description

    I.42

    Data type

    float

    Alias
    UMLS CUI [1]
    C0201838
    Creatinine Clearance
    Description

    I.43

    Data type

    float

    Alias
    UMLS CUI [1]
    C0373595
    Serum Beta HCG
    Description

    I.44

    Data type

    float

    Alias
    UMLS CUI [1]
    C2348195
    Are there clinically significant abnormal laboratory values?
    Description

    Are there clinically significant abnormal laboratory values?

    Data type

    text

    Alias
    UMLS CUI [1]
    C0438215
    Laboratory Tests-Urinalysis
    Description

    Laboratory Tests-Urinalysis

    Alias
    UMLS CUI-1
    C0042014
    UMLS CUI-2
    C0587081
    Sample Date
    Description

    Sample Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413
    Laboratory Name
    Description

    Laboratory Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C3258037
    Protein
    Description

    Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0262923
    Glucose
    Description

    Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0004076
    Blood
    Description

    Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0202514
    Was microscopy performed?
    Description

    Complete microscopy if protein and/or blood results are positive Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0430397
    RBC/HPF
    Description

    Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.

    Data type

    text

    Alias
    UMLS CUI [1]
    C4039763
    WBC/HPF
    Description

    Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.

    Data type

    text

    Alias
    UMLS CUI [1]
    C4039553
    Casts/LPF
    Description

    Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0439356
    Crystals/LPF
    Description

    Microscopy Enter laboratory result or one of the following codes: ND = not done; LE = documented laboratory error.

    Data type

    text

    Alias
    UMLS CUI [1]
    C1287304
    Are there clinically significant abnormal laboratory values?
    Description

    If 'Yes', record the findings and/or diagnosis on page x for Screening, or in the Adverse Experience section

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0438215
    Laboratory Tests-Bone Marrow Examination
    Description

    Laboratory Tests-Bone Marrow Examination

    Alias
    UMLS CUI-1
    C0005957
    UMLS CUI-2
    C0022885
    Sample Date
    Description

    Sample Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413
    Laboratory Name
    Description

    Laboratory Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C3258037
    Pronormoblasts (%)
    Description

    Erythroid Series

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2350150
    UMLS CUI [1,2]
    C0005953
    Basophilic Normoblasts (%)
    Description

    Erythroid Series

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2238288
    UMLS CUI [1,2]
    C0005953
    Polychromatophilic Normoblasts (%)
    Description

    Erythroid Series

    Data type

    text

    Alias
    UMLS CUI [1]
    C2238289
    Orthochromatic Normoblasts (%)
    Description

    Erythroid Series

    Data type

    text

    Alias
    UMLS CUI [1]
    C2238290
    Myeloblasts (%)
    Description

    Myeloblasts (%)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0229633
    UMLS CUI [1,2]
    C0005953
    Promyelocytes (%)
    Description

    Promyelocytes (%)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0033416
    UMLS CUI [1,2]
    C0005953
    Myelocytes (%)
    Description

    Myelocytes (%)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0369715
    UMLS CUI [1,2]
    C0005953
    Metamyelocytes (%)
    Description

    Metamyelocytes (%)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0229635
    UMLS CUI [1,2]
    C0005953
    Bands (%)
    Description

    Bands (%)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1882076
    UMLS CUI [1,2]
    C0005953
    Basophils (%)
    Description

    Basophils (%)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0549791
    UMLS CUI [1,2]
    C0005953
    Eosinophils (%)
    Description

    Eosinophils (%)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1171399
    UMLS CUI [1,2]
    C0005953
    Neutrophils (%)
    Description

    Neutrophils (%)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C4028217
    UMLS CUI [1,2]
    C0005953
    Lymphocytes (%)
    Description

    Lymphocytes (%)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0200635
    UMLS CUI [1,2]
    C0005953
    Plasma Cells (%)
    Description

    Plasma Cells (%)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0032112
    UMLS CUI [1,2]
    C0005953
    Monocytes (%)
    Description

    Monocytes (%)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0026473
    UMLS CUI [1,2]
    C0005953
    Reticulum Cells (%)
    Description

    Reticulum Cells (%)

    Data type

    text

    Alias
    UMLS CUI [1]
    C2238294
    Megakaryocytes (%)
    Description

    Megakaryocytes (%)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0025166
    UMLS CUI [1,2]
    C0005953
    Myeloid Erythroid Ratio
    Description

    Myeloid Erythroid Ratio

    Data type

    text

    Alias
    UMLS CUI [1]
    C2238284
    Cellularity of Specimen
    Description

    Cellularity of Specimen

    Data type

    text

    Alias
    UMLS CUI [1]
    C1561532
    Biopsy
    Description

    Biopsy

    Data type

    text

    Alias
    UMLS CUI [1]
    C0005954
    Does the patient have splenomegaly?
    Description

    Splenomegaly

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0038002
    Does the patient have extramedullary disease or soft tissue involvement?
    Description

    Extramedullary disease or soft tissue involvement

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1515974
    UMLS CUI [1,2]
    C0012634
    UMLS CUI [1,3]
    C1314939
    UMLS CUI [1,4]
    C1517060
    UMLS CUI [2]
    C0225317
    If yes to Extramedullary disease or soft tissue involvement, please record the site(s)
    Description

    If yes to Extramedullary disease or soft tissue involvement

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1515974
    UMLS CUI [1,2]
    C0012634
    UMLS CUI [1,3]
    C1314939
    UMLS CUI [1,4]
    C1517060
    UMLS CUI [2]
    C0225317
    Cytogenetics
    Description

    Cytogenetics

    Alias
    UMLS CUI-1
    C0010802
    Sample Date
    Description

    Sample Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413
    Laboratory Name
    Description

    Laboratory Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C3258037
    Chromosome Abnormalities Present
    Description

    Chromosome Abnormalities Present

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C4015468
    UMLS CUI [1,2]
    C0150312
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    Laboratory Tests

    1 forms
    1. StudyEvent: GSK Study ID 104864-201-Laboratory (next Course)
      1. Laboratory Tests
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Identification Numbers
    C1300638 (UMLS CUI-1)
    Patient Number
    Item
    Patient Number
    text
    C1830427 (UMLS CUI [1])
    Patient Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Item Group
    Laboratory Tests-Hematology
    C0022885 (UMLS CUI-1)
    C0474523 (UMLS CUI-2)
    Sample Date
    Item
    Sample Date
    date
    C1302413 (UMLS CUI [1])
    Laboratory Name
    Item
    Laboratory Name
    text
    C3258037 (UMLS CUI [1])
    I.6
    Item
    Hemoglobin
    float
    C0019046 (UMLS CUI [1])
    I.7
    Item
    Hematocrit
    float
    C0518014 (UMLS CUI [1])
    I.8
    Item
    RBC
    float
    C0014772 (UMLS CUI [1])
    I.9
    Item
    WBC
    float
    C0023508 (UMLS CUI [1])
    I.10
    Item
    Neutrophils - segmented
    float
    C0229640 (UMLS CUI [1])
    Bands
    Item
    Bands
    text
    C1882076 (UMLS CUI [1])
    I.12
    Item
    Lymphocytes
    float
    C0200635 (UMLS CUI [1])
    I.13
    Item
    Monocytes
    float
    C0026473 (UMLS CUI [1])
    I.14
    Item
    Eosinophils
    float
    C0857996 (UMLS CUI [1])
    I.15
    Item
    Basophils
    float
    C0200641 (UMLS CUI [1])
    I.16
    Item
    Platelets
    float
    C0005821 (UMLS CUI [1])
    I.17
    Item
    Blast Cells
    float
    C0368761 (UMLS CUI [1])
    I.18
    Item
    Prothrombin Time (PT)
    float
    C0033707 (UMLS CUI [1])
    I.19
    Item
    Partial Thromboplastin Time
    float
    C3525810 (UMLS CUI [1])
    I.20
    Item
    Fibrinogen
    float
    C0016006 (UMLS CUI [1])
    Item Group
    Laboratory Tests-Blood Chemistry
    C1254595 (UMLS CUI-1)
    C0005774 (UMLS CUI-2)
    Visit
    Item
    Visit
    text
    C0545082 (UMLS CUI [1])
    Sample Date
    Item
    Sample Date
    date
    C1302413 (UMLS CUI [1])
    Laboratory Name
    Item
    Laboratory Name
    text
    C3258037 (UMLS CUI [1])
    I.24
    Item
    Sodium
    float
    C0337443 (UMLS CUI [1])
    I.25
    Item
    Potassium
    float
    C0202194 (UMLS CUI [1])
    I.26
    Item
    Chloride
    float
    C0201952 (UMLS CUI [1])
    I.27
    Item
    Bicarbonate
    float
    C0202059 (UMLS CUI [1])
    I.28
    Item
    Calcium
    float
    C0201925 (UMLS CUI [1])
    I.29
    Item
    Phosphorus
    float
    C0031705 (UMLS CUI [1])
    I.30
    Item
    Magnesium
    float
    C0373675 (UMLS CUI [1])
    I.31
    Item
    BUN
    float
    C0005845 (UMLS CUI [1])
    I.32
    Item
    Urea
    float
    C0523961 (UMLS CUI [1])
    I.33
    Item
    Uric Acid
    float
    C0202239 (UMLS CUI [1])
    I.34
    Item
    Creatinine
    float
    C0201976 (UMLS CUI [1])
    I.35
    Item
    Alkaline Phosphatase
    float
    C0201850 (UMLS CUI [1])
    I.36
    Item
    LDH
    float
    C0202113 (UMLS CUI [1])
    I.37
    Item
    SGOT/AST
    float
    C0201899 (UMLS CUI [1])
    I.38
    Item
    SGPT/ALT
    float
    C0201836 (UMLS CUI [1])
    I.39
    Item
    Total Bilirubin
    float
    C0201913 (UMLS CUI [1])
    I.40
    Item
    Direct Bilirubin
    float
    C0201916 (UMLS CUI [1])
    I.41
    Item
    Total Protein
    float
    C0555903 (UMLS CUI [1])
    I.42
    Item
    Albumin
    float
    C0201838 (UMLS CUI [1])
    I.43
    Item
    Creatinine Clearance
    float
    C0373595 (UMLS CUI [1])
    I.44
    Item
    Serum Beta HCG
    float
    C2348195 (UMLS CUI [1])
    Item
    Are there clinically significant abnormal laboratory values?
    text
    C0438215 (UMLS CUI [1])
    Are there clinically significant abnormal laboratory values?
    Code List
    Are there clinically significant abnormal laboratory values?
    CL Item
    No (1)
    CL Item
    Yes (If 'Yes', record findings and/or diagnosis on page for Screening or in the Adverse Experience section) (2)
    Item Group
    Laboratory Tests-Urinalysis
    C0042014 (UMLS CUI-1)
    C0587081 (UMLS CUI-2)
    Sample Date
    Item
    Sample Date
    date
    C1302413 (UMLS CUI [1])
    Laboratory Name
    Item
    Laboratory Name
    text
    C3258037 (UMLS CUI [1])
    Item
    Protein
    text
    C0262923 (UMLS CUI [1])
    Protein
    Code List
    Protein
    CL Item
    Negative (0)
    CL Item
    Trace (1)
    CL Item
    Positive (2)
    CL Item
    Not Done (3)
    Item
    Glucose
    text
    C0004076 (UMLS CUI [1])
    Glucose
    Code List
    Glucose
    CL Item
    Negative  (0)
    CL Item
    Trace  (1)
    CL Item
    Positive  (2)
    CL Item
    Not Done (3)
    Item
    Blood
    text
    C0202514 (UMLS CUI [1])
    Blood
    Code List
    Blood
    CL Item
    Negative  (0)
    CL Item
    Trace  (1)
    CL Item
    Positive  (2)
    CL Item
    Not Done (3)
    Microscopy of Urin
    Item
    Was microscopy performed?
    boolean
    C0430397 (UMLS CUI [1])
    Item
    RBC/HPF
    text
    C4039763 (UMLS CUI [1])
    RBC/HPF
    Code List
    RBC/HPF
    CL Item
    Negative (0)
    CL Item
    1-4 (Few) (1)
    CL Item
    >4(Many) (3)
    Item
    WBC/HPF
    text
    C4039553 (UMLS CUI [1])
    WBC/HPF
    Code List
    WBC/HPF
    CL Item
    Negative  (0)
    CL Item
    1-5 (Few) (1)
    CL Item
    >10 (Many) (3)
    CL Item
    6-10 (Moderate) (2)
    Item
    Casts/LPF
    text
    C0439356 (UMLS CUI [1])
    Casts/LPF
    Code List
    Casts/LPF
    CL Item
    Negative (0)
    CL Item
    1-5 (Few) (1)
    CL Item
    >5(Many) (3)
    Item
    Crystals/LPF
    text
    C1287304 (UMLS CUI [1])
    Crystals/LPF
    Code List
    Crystals/LPF
    CL Item
    Negative (0)
    CL Item
    1-2 (Few) (1)
    CL Item
    >2(Many) (3)
    Are there clinically significant abnormal laboratory values?
    Item
    Are there clinically significant abnormal laboratory values?
    boolean
    C0438215 (UMLS CUI [1])
    Item Group
    Laboratory Tests-Bone Marrow Examination
    C0005957 (UMLS CUI-1)
    C0022885 (UMLS CUI-2)
    Sample Date
    Item
    Sample Date
    date
    C1302413 (UMLS CUI [1])
    Laboratory Name
    Item
    Laboratory Name
    text
    C3258037 (UMLS CUI [1])
    Pronormoblasts (%)
    Item
    Pronormoblasts (%)
    text
    C2350150 (UMLS CUI [1,1])
    C0005953 (UMLS CUI [1,2])
    Basophilic Normoblasts (%)
    Item
    Basophilic Normoblasts (%)
    text
    C2238288 (UMLS CUI [1,1])
    C0005953 (UMLS CUI [1,2])
    Polychromatophilic Normoblasts (%)
    Item
    Polychromatophilic Normoblasts (%)
    text
    C2238289 (UMLS CUI [1])
    Orthochromatic Normoblasts (%)
    Item
    Orthochromatic Normoblasts (%)
    text
    C2238290 (UMLS CUI [1])
    Myeloblasts (%)
    Item
    Myeloblasts (%)
    text
    C0229633 (UMLS CUI [1,1])
    C0005953 (UMLS CUI [1,2])
    Promyelocytes (%)
    Item
    Promyelocytes (%)
    text
    C0033416 (UMLS CUI [1,1])
    C0005953 (UMLS CUI [1,2])
    Myelocytes (%)
    Item
    Myelocytes (%)
    text
    C0369715 (UMLS CUI [1,1])
    C0005953 (UMLS CUI [1,2])
    Metamyelocytes (%)
    Item
    Metamyelocytes (%)
    text
    C0229635 (UMLS CUI [1,1])
    C0005953 (UMLS CUI [1,2])
    Bands (%)
    Item
    Bands (%)
    text
    C1882076 (UMLS CUI [1,1])
    C0005953 (UMLS CUI [1,2])
    Basophils (%)
    Item
    Basophils (%)
    text
    C0549791 (UMLS CUI [1,1])
    C0005953 (UMLS CUI [1,2])
    Eosinophils (%)
    Item
    Eosinophils (%)
    text
    C1171399 (UMLS CUI [1,1])
    C0005953 (UMLS CUI [1,2])
    Neutrophils (%)
    Item
    Neutrophils (%)
    text
    C4028217 (UMLS CUI [1,1])
    C0005953 (UMLS CUI [1,2])
    Lymphocytes (%)
    Item
    Lymphocytes (%)
    text
    C0200635 (UMLS CUI [1,1])
    C0005953 (UMLS CUI [1,2])
    Plasma Cells (%)
    Item
    Plasma Cells (%)
    text
    C0032112 (UMLS CUI [1,1])
    C0005953 (UMLS CUI [1,2])
    Monocytes (%)
    Item
    Monocytes (%)
    text
    C0026473 (UMLS CUI [1,1])
    C0005953 (UMLS CUI [1,2])
    Reticulum Cells (%)
    Item
    Reticulum Cells (%)
    text
    C2238294 (UMLS CUI [1])
    Item
    Megakaryocytes (%)
    text
    C0025166 (UMLS CUI [1,1])
    C0005953 (UMLS CUI [1,2])
    Megakaryocytes (%)
    Code List
    Megakaryocytes (%)
    CL Item
    Normal (1)
    CL Item
    Increased (2)
    CL Item
    Decreased (3)
    Item
    Myeloid Erythroid Ratio
    text
    C2238284 (UMLS CUI [1])
    Myeloid Erythroid Ratio
    Code List
    Myeloid Erythroid Ratio
    CL Item
    Normal (1)
    CL Item
    Increased (2)
    CL Item
    Decreased (3)
    Item
    Cellularity of Specimen
    text
    C1561532 (UMLS CUI [1])
    Cellularity of Specimen
    Code List
    Cellularity of Specimen
    CL Item
    Aplastic (1)
    CL Item
    Hypocellular (2)
    CL Item
    Normacellular (3)
    CL Item
    Hypercellular (4)
    CL Item
    Packed (5)
    Item
    Biopsy
    text
    C0005954 (UMLS CUI [1])
    Biopsy
    Code List
    Biopsy
    CL Item
    Normal (1)
    CL Item
    Presence of blast cell clusters (2)
    CL Item
    ALIP (3)
    Splenomegaly
    Item
    Does the patient have splenomegaly?
    boolean
    C0038002 (UMLS CUI [1])
    Extramedullary disease or soft tissue involvement
    Item
    Does the patient have extramedullary disease or soft tissue involvement?
    boolean
    C1515974 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    C1314939 (UMLS CUI [1,3])
    C1517060 (UMLS CUI [1,4])
    C0225317 (UMLS CUI [2])
    If yes to Extramedullary disease or soft tissue involvement
    Item
    If yes to Extramedullary disease or soft tissue involvement, please record the site(s)
    text
    C1515974 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    C1314939 (UMLS CUI [1,3])
    C1517060 (UMLS CUI [1,4])
    C0225317 (UMLS CUI [2])
    Item Group
    Cytogenetics
    C0010802 (UMLS CUI-1)
    Sample Date
    Item
    Sample Date
    date
    C1302413 (UMLS CUI [1])
    Laboratory Name
    Item
    Laboratory Name
    text
    C3258037 (UMLS CUI [1])
    Item
    Chromosome Abnormalities Present
    text
    C4015468 (UMLS CUI [1,1])
    C0150312 (UMLS CUI [1,2])
    Chromosome Abnormalities Present
    Code List
    Chromosome Abnormalities Present
    CL Item
    None (0)
    CL Item
    -5/del (5q) (1)
    CL Item
    -7/del (7q) (2)
    CL Item
    +8 (3)
    CL Item
    +9 del(9q) (4)
    CL Item
    -11q (5)
    CL Item
    -12p (6)
    CL Item
    del(13q) (7)
    CL Item
    -18 (8)
    CL Item
    +19 (9)
    CL Item
    +21 (10)
    CL Item
    3q21-26 (11)
    CL Item
    t(1;7) (12)
    CL Item
    Other, Specify.... (13)
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