ID

13939

Beschrijving

A randomised comparison of daily 25 mg versus 5 mg lenalidomide as maintenance therapy after high-dose therapy and autologous stem cell transplantation in patients with multiple myeloma. Protocol-Code: RV-MM-PI-280 EudraCT-Number: 2007-003945-33 Author: Claus Schreiber Review: Gerd Felder Approval of CRF: Prof. Dr. med. G. Kobbe (LKP) Release for MDM: Prof. Gattermann, Düsseldorf (26.1.2016) Principal Investigator „LenaMain“-Studie: Prof. Roland Fenk, Düsseldorf Coordinating center for clinical trial Medical faculty of University Hospital Heinrich-Heine-University Scientific Director: Herr Dr. J. Grebe Moorenstrasse 5 40225 Düsseldorf Tel.: +49 (0) 211-81-19701 Fax: +49 (0) 211-81-19702

Trefwoorden

  1. 17-03-16 17-03-16 -
Geüploaded op

17 maart 2016

DOI

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Licentie

Creative Commons BY-NC 3.0

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    Eighth Maintenance Cycle LenaMain-Study

    Eighth Maintenance Cycle

    Monthly control visit with response evaluation
    Beschrijving

    Monthly control visit with response evaluation

    Date of visit
    Beschrijving

    Date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0011008
    Medication dosage of last cycle
    Beschrijving

    Cumulative dosage of trial substance during last cycle in mg

    Datatype

    float

    Maateenheden
    • mg
    Alias
    UMLS CUI [1]
    C3174092
    mg
    Prior trial substance dosage
    Beschrijving

    Trial substance dosage

    Datatype

    integer

    Maateenheden
    • mg
    Alias
    UMLS CUI [1,1]
    C0013230
    UMLS CUI [1,2]
    C0178602
    New trial substance dosage
    Beschrijving

    Trial substance dosage

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0013230
    UMLS CUI [1,2]
    C0178602
    Please specify reason for dose reduction
    Beschrijving

    Dosage reduction

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0547047
    Response after first consolidation cycle
    Beschrijving

    Response

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0521982
    External assessment of response
    Beschrijving

    External assessment of response

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0521982
    UMLS CUI [1,2]
    C0220825
    UMLS CUI [1,3]
    C0036524
    Did any Adverse Events occur?
    Beschrijving

    Adverse Events

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0877248
    Vital signs
    Beschrijving

    Vital signs

    Heart rate
    Beschrijving

    Heart rate

    Datatype

    integer

    Maateenheden
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Blood pressure, systolic
    Beschrijving

    Blood pressure

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823
    mmHg
    Blood pressure, diastolic
    Beschrijving

    Blood pressure

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823
    mmHg
    Body weight
    Beschrijving

    Body weight

    Datatype

    float

    Maateenheden
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Body Height
    Beschrijving

    Body Height

    Datatype

    integer

    Maateenheden
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Ecog performance status
    Beschrijving

    Ecog performance status

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1520224
    Laboratory:Protein electrophoresis
    Beschrijving

    Laboratory:Protein electrophoresis

    Albumin
    Beschrijving

    Albumin

    Datatype

    float

    Maateenheden
    • g/dL
    Alias
    UMLS CUI [1]
    C0201838
    g/dL
    Total Protein in 24h urine
    Beschrijving

    Total Protein

    Datatype

    float

    Maateenheden
    • mg/24h
    Alias
    UMLS CUI [1]
    C0428541
    mg/24h
    Total Serum Protein
    Beschrijving

    Total Serum Protein

    Datatype

    float

    Maateenheden
    • g/dl
    Alias
    UMLS CUI [1]
    C0036836
    g/dl
    Beta-globulin measurement
    Beschrijving

    Beta-globulin

    Datatype

    float

    Maateenheden
    • g/dL
    Alias
    UMLS CUI [1]
    C0005157
    g/dL
    Gamma-Globulin measurement
    Beschrijving

    Gamma-Globulin

    Datatype

    float

    Maateenheden
    • g/dL
    Alias
    UMLS CUI [1]
    C0860681
    g/dL
    Beta and gamma globulin total
    Beschrijving

    Please give the sum only, if stated in the lab sheet

    Datatype

    float

    Maateenheden
    • g/dL
    Alias
    UMLS CUI [1]
    C1717622
    g/dL
    Serum immunofixation
    Beschrijving

    Serum immunofixation

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1271678
    Comment on serum immunofixation
    Beschrijving

    Comment

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0947611
    Urine immunofixation
    Beschrijving

    Urine immunofixation

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1271641
    Comment on urine immunofixation
    Beschrijving

    Comment

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0947611
    IgA measurement
    Beschrijving

    IgA

    Datatype

    float

    Maateenheden
    • mg/dl
    Alias
    UMLS CUI [1]
    C0202083
    mg/dl
    IgD measurement
    Beschrijving

    IgD

    Datatype

    float

    Maateenheden
    • mg/dl
    Alias
    UMLS CUI [1]
    C0577612
    mg/dl
    IgG measurement
    Beschrijving

    IgG

    Datatype

    float

    Maateenheden
    • mg/dl
    Alias
    UMLS CUI [1]
    C0202087
    mg/dl
    Immunoglobulin M measurement
    Beschrijving

    IgM

    Datatype

    float

    Maateenheden
    • mg/dl
    Alias
    UMLS CUI [1]
    C0202084
    mg/dl
    FLC kappa measurement
    Beschrijving

    FLC kappa

    Datatype

    float

    Maateenheden
    • mg/l
    Alias
    UMLS CUI [1]
    C3274397
    mg/l
    Kappa
    Beschrijving

    Kappa

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0439099
    FLC lambda measurement
    Beschrijving

    FLC lambda

    Datatype

    float

    Maateenheden
    • mg/l
    Alias
    UMLS CUI [1]
    C3274399
    mg/l
    Lambda
    Beschrijving

    Lambda

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1706314
    Kappa/lambda quotient
    Beschrijving

    Kappa/lambda quotient

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1168398
    Laboratory:Hematology
    Beschrijving

    Laboratory:Hematology

    Erythrocytes
    Beschrijving

    Erythrocytes

    Datatype

    float

    Maateenheden
    • Mio/μl
    Alias
    UMLS CUI [1]
    C0014772
    Mio/μl
    Hemoglobin
    Beschrijving

    Hemoglobin

    Datatype

    float

    Maateenheden
    • g/dL
    Alias
    UMLS CUI [1]
    C0019046
    g/dL
    Hematocrit
    Beschrijving

    Hematocrit

    Datatype

    float

    Maateenheden
    • %
    Alias
    UMLS CUI [1]
    C0518014
    %
    Mean Corpuscular Volume
    Beschrijving

    MCV

    Datatype

    float

    Maateenheden
    • fl
    Alias
    UMLS CUI [1]
    C1948043
    fl
    MCH
    Beschrijving

    MCH

    Datatype

    float

    Maateenheden
    • pg
    Alias
    UMLS CUI [1]
    C0369183
    pg
    Mean corpuscular hemoglobin concentration
    Beschrijving

    MCHC

    Datatype

    float

    Maateenheden
    • g Hb/dL Ery
    Alias
    UMLS CUI [1]
    C0474535
    g Hb/dL Ery
    Leukocytes
    Beschrijving

    Leukocytes

    Datatype

    float

    Maateenheden
    • 1000/μl
    Alias
    UMLS CUI [1]
    C0023508
    1000/μl
    Leukocytes (total)
    Beschrijving

    Leukocytes

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1271681
    Platelet count
    Beschrijving

    Platelets

    Datatype

    float

    Maateenheden
    • 1000/uL
    Alias
    UMLS CUI [1]
    C0005821
    1000/uL
    Neutrophils percentage
    Beschrijving

    Neutrophils percentage

    Datatype

    float

    Maateenheden
    • %
    Alias
    UMLS CUI [1]
    C2238207
    %
    Neutrophils
    Beschrijving

    Neutrophils

    Datatype

    float

    Maateenheden
    • abs.
    Alias
    UMLS CUI [1]
    C0948762
    abs.
    Eosinophils percentage
    Beschrijving

    Eosinophils percentage

    Datatype

    float

    Maateenheden
    • %
    Alias
    UMLS CUI [1]
    C2228144
    %
    Basophils percentage
    Beschrijving

    Basophils percentage

    Datatype

    float

    Maateenheden
    • %
    Alias
    UMLS CUI [1]
    C2237945
    %
    Monocytes percentage
    Beschrijving

    Monocytes percentage

    Datatype

    float

    Maateenheden
    • %
    Alias
    UMLS CUI [1]
    C2237144
    %
    Lymphocytes percentage
    Beschrijving

    Lymphocytes percentage

    Datatype

    float

    Maateenheden
    • %
    Alias
    UMLS CUI [1]
    C2200256
    %
    Neutrophils
    Beschrijving

    Neutrophils

    Datatype

    float

    Maateenheden
    • 1000/μl
    Alias
    UMLS CUI [1]
    C0200633
    1000/μl
    Laboratory:serum chemistry
    Beschrijving

    Laboratory:serum chemistry

    Sodium
    Beschrijving

    Sodium

    Datatype

    float

    Maateenheden
    • mmol/L
    Alias
    UMLS CUI [1]
    C0337443
    mmol/L
    Potassium
    Beschrijving

    Potassium

    Datatype

    float

    Maateenheden
    • mmol/l
    Alias
    UMLS CUI [1]
    C0202194
    mmol/l
    Calcium
    Beschrijving

    Calcium

    Datatype

    float

    Maateenheden
    • mmol/l
    Alias
    UMLS CUI [1]
    C0201925
    mmol/l
    Glucose
    Beschrijving

    Glucose

    Datatype

    float

    Maateenheden
    • mg/dl
    Alias
    UMLS CUI [1]
    C0202042
    mg/dl
    Alkaline Phosphatase
    Beschrijving

    Alkaline Phosphatase

    Datatype

    float

    Maateenheden
    • U/L
    Alias
    UMLS CUI [1]
    C0201850
    U/L
    Bilirubin
    Beschrijving

    Bilirubin

    Datatype

    float

    Maateenheden
    • mg/dL
    Alias
    UMLS CUI [1]
    C0005437
    mg/dL
    AST (SGOT)
    Beschrijving

    AST

    Datatype

    float

    Maateenheden
    • U/L
    Alias
    UMLS CUI [1]
    C0201899
    U/L
    ALT
    Beschrijving

    ALT

    Datatype

    float

    Maateenheden
    • U/L
    Alias
    UMLS CUI [1]
    C0201836
    U/L
    Gamma GT
    Beschrijving

    Gamma GT

    Datatype

    float

    Maateenheden
    • U/l
    Alias
    UMLS CUI [1]
    C0202035
    U/l
    Lactate Dehydrogenase (LDH)
    Beschrijving

    LDH

    Datatype

    float

    Maateenheden
    • U/L
    Alias
    UMLS CUI [1]
    C0202113
    U/L
    Urea
    Beschrijving

    Urea

    Datatype

    float

    Maateenheden
    • mg/dl
    Alias
    UMLS CUI [1]
    C0523961
    mg/dl
    CRP
    Beschrijving

    CRP

    Datatype

    float

    Maateenheden
    • md/dl
    Alias
    UMLS CUI [1]
    C0201657
    md/dl
    Serum creatinine
    Beschrijving

    Creatinine, Serum

    Datatype

    float

    Maateenheden
    • mg/dL
    Alias
    UMLS CUI [1]
    C0201976
    mg/dL
    Creatinine Clearance
    Beschrijving

    Creatinine Clearance

    Datatype

    float

    Maateenheden
    • mL/min
    Alias
    UMLS CUI [1]
    C0373595
    mL/min
    Laboratory:pregnancy test
    Beschrijving

    Laboratory:pregnancy test

    Is the subject of childbearing potential?
    Beschrijving

    Childbearing potential

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C3831118
    Pregnancy test result
    Beschrijving

    Pregnancy test

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0032976
    Has the patient experienced irregularities with her menstrual period since her last pregnancy test?
    Beschrijving

    Menstruation

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0025344
    Quality of life
    Beschrijving

    Quality of life

    Total Score QoL
    Beschrijving

    Please answer questions 1-30 of the EORTC QIQ-C30 Quality of Life

    Datatype

    float

    Alias
    UMLS CUI [1]
    C3476431
    Hematotoxicity CTC
    Beschrijving

    Hematotoxicity CTC

    Hemoglobin CTC
    Beschrijving

    Hematotoxicity evaluation according to CTC during the last cycle (please document CTC grade of the lowest hemoglobin value)

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0019046
    UMLS CUI [1,2]
    C1516728
    Date of lowest hemoglobin value
    Beschrijving

    Date of lowest hemoglobin value

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0518015
    Hemoglobin: actions taken with study medication
    Beschrijving

    Actions taken with study medication

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1704758
    Leukocytes CTC
    Beschrijving

    Hematotoxicity evaluation according to CTC during the last cycle (please document CTC grade of the lowest leukocytes value)

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C1516728
    UMLS CUI [1,2]
    C0023516
    Date of lowest leukocytes value
    Beschrijving

    Date of lowest leukocytes value

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0023508
    Actions taken with study medication:leukocytes
    Beschrijving

    Actions taken with study medication

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1704758
    Platelets CTC
    Beschrijving

    Hematotoxicity evaluation according to CTC during the last cycle (please document CTC grade of the lowest platelets value)

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C1516728
    UMLS CUI [1,2]
    C0032181
    Date of lowest platelets value
    Beschrijving

    Date of lowest platelets value

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0032181
    Actions taken with study medication:platelets
    Beschrijving

    Actions taken with study medication

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1704758
    Neutrophils CTC
    Beschrijving

    Hematotoxicity evaluation according to CTC during the last cycle (please document CTC grade of the lowest neutrophils value)

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C1516728
    UMLS CUI [1,2]
    C0948762
    Date of lowest neutrophils value
    Beschrijving

    Date of lowest neutrophils value

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0948762
    Actions taken with study medication:neutrophils
    Beschrijving

    Actions taken with study medication

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1704758

    Similar models

    Eighth Maintenance Cycle

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Monthly control visit with response evaluation
    Date
    Item
    Date of visit
    date
    C0011008 (UMLS CUI [1])
    Medication dosage
    Item
    Medication dosage of last cycle
    float
    C3174092 (UMLS CUI [1])
    Item
    Prior trial substance dosage
    integer
    C0013230 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    Code List
    Prior trial substance dosage
    CL Item
    25 mg (1)
    CL Item
    15 mg (2)
    CL Item
    10 mg (3)
    CL Item
    5 mg (4)
    CL Item
    20 mg (5)
    Item
    New trial substance dosage
    integer
    C0013230 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    Code List
    New trial substance dosage
    CL Item
    25 mg (1)
    CL Item
    15 mg (2)
    CL Item
    10 mg (3)
    CL Item
    5 mg (4)
    CL Item
    20 mg (5)
    Dosage reduction
    Item
    Please specify reason for dose reduction
    text
    C0178602 (UMLS CUI [1,1])
    C0547047 (UMLS CUI [1,2])
    Item
    Response after first consolidation cycle
    integer
    C0521982 (UMLS CUI [1])
    Code List
    Response after first consolidation cycle
    CL Item
    sCR (0)
    CL Item
    CR (1)
    CL Item
    vgPR (2)
    CL Item
    PR (3)
    CL Item
    SD (5)
    CL Item
    PD (6)
    External assessment of response
    Item
    External assessment of response
    boolean
    C0521982 (UMLS CUI [1,1])
    C0220825 (UMLS CUI [1,2])
    C0036524 (UMLS CUI [1,3])
    Adverse Events
    Item
    Did any Adverse Events occur?
    boolean
    C0877248 (UMLS CUI [1])
    Item Group
    Vital signs
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Blood pressure
    Item
    Blood pressure, systolic
    integer
    C0005823 (UMLS CUI [1])
    Blood pressure
    Item
    Blood pressure, diastolic
    integer
    C0005823 (UMLS CUI [1])
    Body weight
    Item
    Body weight
    float
    C0005910 (UMLS CUI [1])
    Body Height
    Item
    Body Height
    integer
    C0005890 (UMLS CUI [1])
    Item
    Ecog performance status
    integer
    C1520224 (UMLS CUI [1])
    Code List
    Ecog performance status
    CL Item
    Score 0 (0)
    CL Item
    Score 1 (1)
    CL Item
    Score 2 (2)
    CL Item
    Score 3 (3)
    CL Item
    Score 4 (4)
    CL Item
    Score 5 (5)
    Item Group
    Laboratory:Protein electrophoresis
    Albumin
    Item
    Albumin
    float
    C0201838 (UMLS CUI [1])
    Total Protein
    Item
    Total Protein in 24h urine
    float
    C0428541 (UMLS CUI [1])
    Total Serum Protein
    Item
    Total Serum Protein
    float
    C0036836 (UMLS CUI [1])
    Beta-globulin
    Item
    Beta-globulin measurement
    float
    C0005157 (UMLS CUI [1])
    Gamma-Globulin
    Item
    Gamma-Globulin measurement
    float
    C0860681 (UMLS CUI [1])
    Beta and gamma globulin total
    Item
    Beta and gamma globulin total
    float
    C1717622 (UMLS CUI [1])
    Item
    Serum immunofixation
    integer
    C1271678 (UMLS CUI [1])
    Code List
    Serum immunofixation
    CL Item
    positive (1)
    CL Item
    negative (2)
    Comment
    Item
    Comment on serum immunofixation
    text
    C0947611 (UMLS CUI [1])
    Item
    Urine immunofixation
    integer
    C1271641 (UMLS CUI [1])
    Code List
    Urine immunofixation
    CL Item
    positive (1)
    CL Item
    negative (2)
    Comment
    Item
    Comment on urine immunofixation
    text
    C0947611 (UMLS CUI [1])
    IgA
    Item
    IgA measurement
    float
    C0202083 (UMLS CUI [1])
    IgD
    Item
    IgD measurement
    float
    C0577612 (UMLS CUI [1])
    IgG
    Item
    IgG measurement
    float
    C0202087 (UMLS CUI [1])
    IgM
    Item
    Immunoglobulin M measurement
    float
    C0202084 (UMLS CUI [1])
    FLC kappa
    Item
    FLC kappa measurement
    float
    C3274397 (UMLS CUI [1])
    Kappa
    Item
    Kappa
    integer
    C0439099 (UMLS CUI [1])
    FLC lambda
    Item
    FLC lambda measurement
    float
    C3274399 (UMLS CUI [1])
    Lambda
    Item
    Lambda
    integer
    C1706314 (UMLS CUI [1])
    Kappa/lambda quotient
    Item
    Kappa/lambda quotient
    integer
    C1168398 (UMLS CUI [1])
    Item Group
    Laboratory:Hematology
    Erythrocytes
    Item
    Erythrocytes
    float
    C0014772 (UMLS CUI [1])
    Hemoglobin
    Item
    Hemoglobin
    float
    C0019046 (UMLS CUI [1])
    Hematocrit
    Item
    Hematocrit
    float
    C0518014 (UMLS CUI [1])
    MCV
    Item
    Mean Corpuscular Volume
    float
    C1948043 (UMLS CUI [1])
    MCH
    Item
    MCH
    float
    C0369183 (UMLS CUI [1])
    MCHC
    Item
    Mean corpuscular hemoglobin concentration
    float
    C0474535 (UMLS CUI [1])
    Leukocytes
    Item
    Leukocytes
    float
    C0023508 (UMLS CUI [1])
    Leukocytes
    Item
    Leukocytes (total)
    integer
    C1271681 (UMLS CUI [1])
    Platelets
    Item
    Platelet count
    float
    C0005821 (UMLS CUI [1])
    Neutrophils percentage
    Item
    Neutrophils percentage
    float
    C2238207 (UMLS CUI [1])
    Neutrophils
    Item
    Neutrophils
    float
    C0948762 (UMLS CUI [1])
    Eosinophils percentage
    Item
    Eosinophils percentage
    float
    C2228144 (UMLS CUI [1])
    Basophils percentage
    Item
    Basophils percentage
    float
    C2237945 (UMLS CUI [1])
    Monocytes percentage
    Item
    Monocytes percentage
    float
    C2237144 (UMLS CUI [1])
    Lymphocytes percentage
    Item
    Lymphocytes percentage
    float
    C2200256 (UMLS CUI [1])
    Neutrophils
    Item
    Neutrophils
    float
    C0200633 (UMLS CUI [1])
    Item Group
    Laboratory:serum chemistry
    Sodium
    Item
    Sodium
    float
    C0337443 (UMLS CUI [1])
    Potassium
    Item
    Potassium
    float
    C0202194 (UMLS CUI [1])
    Calcium
    Item
    Calcium
    float
    C0201925 (UMLS CUI [1])
    Glucose
    Item
    Glucose
    float
    C0202042 (UMLS CUI [1])
    Alkaline Phosphatase
    Item
    Alkaline Phosphatase
    float
    C0201850 (UMLS CUI [1])
    Bilirubin
    Item
    Bilirubin
    float
    C0005437 (UMLS CUI [1])
    AST
    Item
    AST (SGOT)
    float
    C0201899 (UMLS CUI [1])
    ALT
    Item
    ALT
    float
    C0201836 (UMLS CUI [1])
    Gamma GT
    Item
    Gamma GT
    float
    C0202035 (UMLS CUI [1])
    LDH
    Item
    Lactate Dehydrogenase (LDH)
    float
    C0202113 (UMLS CUI [1])
    Urea
    Item
    Urea
    float
    C0523961 (UMLS CUI [1])
    CRP
    Item
    CRP
    float
    C0201657 (UMLS CUI [1])
    Creatinine, Serum
    Item
    Serum creatinine
    float
    C0201976 (UMLS CUI [1])
    Creatinine Clearance
    Item
    Creatinine Clearance
    float
    C0373595 (UMLS CUI [1])
    Item Group
    Laboratory:pregnancy test
    Childbearing potential
    Item
    Is the subject of childbearing potential?
    boolean
    C3831118 (UMLS CUI [1])
    Item
    Pregnancy test result
    integer
    C0032976 (UMLS CUI [1])
    Code List
    Pregnancy test result
    CL Item
    positive (1)
    CL Item
    negative (2)
    Item
    Has the patient experienced irregularities with her menstrual period since her last pregnancy test?
    integer
    C0025344 (UMLS CUI [1])
    Code List
    Has the patient experienced irregularities with her menstrual period since her last pregnancy test?
    CL Item
    No menstruation (0)
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item Group
    Quality of life
    Quality of life score
    Item
    Total Score QoL
    float
    C3476431 (UMLS CUI [1])
    Item Group
    Hematotoxicity CTC
    Item
    Hemoglobin CTC
    integer
    C0019046 (UMLS CUI [1,1])
    C1516728 (UMLS CUI [1,2])
    Code List
    Hemoglobin CTC
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    Date of lowest hemoglobin value
    Item
    Date of lowest hemoglobin value
    date
    C0011008 (UMLS CUI [1,1])
    C0518015 (UMLS CUI [1,2])
    Item
    Hemoglobin: actions taken with study medication
    integer
    C1704758 (UMLS CUI [1])
    Code List
    Hemoglobin: actions taken with study medication
    CL Item
    No change required (0)
    CL Item
    Interruption/ prolongation without dose reduction (1)
    CL Item
    Interruption/ prolongation with dose reduction (2)
    Item
    Leukocytes CTC
    integer
    C1516728 (UMLS CUI [1,1])
    C0023516 (UMLS CUI [1,2])
    Code List
    Leukocytes CTC
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    Date of lowest leukocytes value
    Item
    Date of lowest leukocytes value
    date
    C0011008 (UMLS CUI [1,1])
    C0023508 (UMLS CUI [1,2])
    Item
    Actions taken with study medication:leukocytes
    integer
    C1704758 (UMLS CUI [1])
    Code List
    Actions taken with study medication:leukocytes
    CL Item
    No change required (0)
    CL Item
    Interruption/ prolongation without dose reduction (1)
    CL Item
    Interruption/ prolongation with dose reduction (2)
    Item
    Platelets CTC
    integer
    C1516728 (UMLS CUI [1,1])
    C0032181 (UMLS CUI [1,2])
    Code List
    Platelets CTC
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    Date of lowest platelets value
    Item
    Date of lowest platelets value
    date
    C0011008 (UMLS CUI [1,1])
    C0032181 (UMLS CUI [1,2])
    Item
    Actions taken with study medication:platelets
    integer
    C1704758 (UMLS CUI [1])
    Code List
    Actions taken with study medication:platelets
    CL Item
    No change required (0)
    CL Item
    Interruption/ prolongation without dose reduction (1)
    CL Item
    Interruption/ prolongation with dose reduction (2)
    Item
    Neutrophils CTC
    integer
    C1516728 (UMLS CUI [1,1])
    C0948762 (UMLS CUI [1,2])
    Code List
    Neutrophils CTC
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    Date of lowest neutrophils value
    Item
    Date of lowest neutrophils value
    date
    C0011008 (UMLS CUI [1,1])
    C0948762 (UMLS CUI [1,2])
    Item
    Actions taken with study medication:neutrophils
    integer
    C1704758 (UMLS CUI [1])
    Code List
    Actions taken with study medication:neutrophils
    CL Item
    No change required (0)
    CL Item
    Interruption/ prolongation without dose reduction (1)
    CL Item
    Interruption/ prolongation with dose reduction (2)

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