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37640

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Study ID: 104864/612 Clinical Study ID: 104864/612 Study Title: A Prospective, Open Label Phase II Study to Evaluate the Efficacy and Safety of Topotecan (HycamtinTM) in Combination with Carboplatin as First-line Chemotherapy in Patients with Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: HycamtinTM Study Indication: Ovarian Cancer

Nyckelord

Versioner (1)
  1. 2019-08-12 2019-08-12 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

12 augusti 2019

DOI

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Creative Commons BY-NC 3.0
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    Topotecan (HycamtinTM) with Carboplatin as First-Line Chemotherapy in Patients with Ovarian Cancer; 104864/612

    Engelsk

    Cycle 1

    1 Formulär  
    1. StudyEvent: ODM
      1. Cycle 1
    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Patient Number
    Beskrivning

    Patient number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1830427
    Day 1
    Beskrivning

    Day 1

    Alias
    UMLS CUI-1
    C0011298
    Weight
    Beskrivning

    Body Weight

    Datatyp

    float

    Måttenheter
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Body surface area
    Beskrivning

    Body Surface Area

    Datatyp

    float

    Måttenheter
    • m2
    Alias
    UMLS CUI [1]
    C0005902
    m2
    Administration of study medication topotecan
    Beskrivning

    Administration of study medication topotecan

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C0146224
    UMLS CUI-3
    C3469597
    Day
    Beskrivning

    Experimental drug, Topotecan, Administration of medication, Day

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0146224
    UMLS CUI [1,3]
    C3469597
    UMLS CUI [1,4]
    C0439228
    Planned daily dose for this infusion
    Beskrivning

    Experimental drug, Topotecan, Daily Dose, Planned

    Datatyp

    text

    Måttenheter
    • mg/m2
    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0146224
    UMLS CUI [1,3]
    C2348070
    UMLS CUI [1,4]
    C1301732
    Administered total dose of the daily infusion
    Beskrivning

    Experimental drug, Topotecan, Daily Dose, Total

    Datatyp

    integer

    Måttenheter
    • mg
    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0146224
    UMLS CUI [1,3]
    C2348070
    UMLS CUI [1,4]
    C0439810
    mg
    Start date of the infusion
    Beskrivning

    Experimental drug, Topotecan, Administration of medication, Start Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0146224
    UMLS CUI [1,3]
    C3469597C0808070
    Start time of the infusion
    Beskrivning

    Experimental drug, Topotecan, Administration of medication, Start Time

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0146224
    UMLS CUI [1,3]
    C3469597
    UMLS CUI [1,4]
    C1301880
    Administration of study medication carboplatin AUC 5 (2 h after topotecan infusion)
    Beskrivning

    Administration of study medication carboplatin AUC 5 (2 h after topotecan infusion)

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C0079083
    UMLS CUI-3
    C3469597
    Day
    Beskrivning

    Experimental drug, Carboplatin, Administration of medication, Day

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0079083
    UMLS CUI [1,3]
    C3469597
    UMLS CUI [1,4]
    C0439228
    Planned daily dose for this infusion
    Beskrivning

    Experimental drug, Carboplatin, Daily Dose, Planned

    Datatyp

    text

    Måttenheter
    • mg/m2
    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0079083
    UMLS CUI [1,3]
    C2348070
    UMLS CUI [1,4]
    C1301732
    mg/m2
    Administered total dose of the daily infusion
    Beskrivning

    Experimental drug, Carboplatin, Daily Dose, Total

    Datatyp

    integer

    Måttenheter
    • mg
    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0079083
    UMLS CUI [1,3]
    C2348070
    UMLS CUI [1,4]
    C0439810
    mg
    Start date of the infusion
    Beskrivning

    Experimental drug, Carboplatin, Administration of medication, Start Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0079083
    UMLS CUI [1,3]
    C3469597C0808070
    Start time of the infusion
    Beskrivning

    Experimental drug, Carboplatin, Administration of medication, Start Time

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0079083
    UMLS CUI [1,3]
    C3469597
    UMLS CUI [1,4]
    C1301880
    Laboratory Values - Hematology
    Beskrivning

    Laboratory Values - Hematology

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0474523
    Visit
    Beskrivning

    Laboratory Procedures, Hematology finding, Visit

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C0545082
    Sampling Date
    Beskrivning

    Laboratory Procedures, Hematology finding, Sampling, Date in time

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0011008
    Time
    Beskrivning

    Laboratory Procedures, Hematology finding, Sampling, Time

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0040223
    Name of laboratory
    Beskrivning

    Laboratory Procedures, Hematology finding, Performing laboratory name

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C3258037
    Lab code
    Beskrivning

    Laboratory Procedures, Hematology finding, Laboratory, Code

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C0022877
    UMLS CUI [1,4]
    C0805701
    Parameter
    Beskrivning

    Laboratory Procedures, Hematology finding, Parameter Value

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C0549193
    Result
    Beskrivning

    Laboratory Procedures, Hematology finding, Result

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C1274040
    Any clinically significant abnormal laboratory values?
    Beskrivning

    Laboratory Procedures, Hematology finding, Result, Clinical Significance

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0474523
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C2826293
    Laboratory Values - Clinical Chemistry
    Beskrivning

    Laboratory Values - Clinical Chemistry

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0008000
    Visit
    Beskrivning

    Laboratory Procedures, Chemistry, Clinical, Visit

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C0545082
    Sampling Date
    Beskrivning

    Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0011008
    Time
    Beskrivning

    Laboratory Procedures, Chemistry, Clinical, Sampling, Time

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0040223
    Name of laboratory
    Beskrivning

    Laboratory Procedures, Chemistry, Clinical, Performing laboratory name

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C3258037
    Lab code
    Beskrivning

    Laboratory Procedures, Chemistry, Clinical, Laboratory, Code

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C0022877
    UMLS CUI [1,4]
    C0805701
    Parameter
    Beskrivning

    Laboratory Procedures, Chemistry, Clinical, Parameter Value

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C0549193
    Result
    Beskrivning

    Laboratory Procedures, Chemistry, Clinical, Result

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C1274040
    Any clinically significant abnormal laboratory values?
    Beskrivning

    Laboratory Procedures, Chemistry, Clinical, Result, Clinical Significance

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C2826293
    Urinalysis
    Beskrivning

    Urinalysis

    Alias
    UMLS CUI-1
    C0042014
    Visit
    Beskrivning

    Laboratory Procedures, Urinalysis, Visit

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0042014
    UMLS CUI [1,3]
    C0545082
    Sampling Date
    Beskrivning

    Laboratory Procedures, Urinalysis, Sampling, Date in time

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0042014
    UMLS CUI [1,3]
    C0870078
    UMLS CUI [1,4]
    C0011008
    Name of the laboratory
    Beskrivning

    Laboratory Procedures, Urinalysis, Performing laboratory name

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0042014
    UMLS CUI [1,3]
    C3258037
    Lab code
    Beskrivning

    Laboratory Procedures, Urinalysis, Laboratory, Code

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0042014
    UMLS CUI [1,3]
    C0022877
    UMLS CUI [1,4]
    C0805701
    Parameter
    Beskrivning

    Laboratory Procedures, Urinalysis, Parameter Value

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0042014
    UMLS CUI [1,3]
    C0549193
    Result
    Beskrivning

    Laboratory Procedures, Urinalysis, Result

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0042014
    UMLS CUI [1,3]
    C1274040
    Microscopy done?
    Beskrivning

    Laboratory Procedures, Urinalysis, Microscopic urinalysis

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0042014
    UMLS CUI [1,3]
    C0430397
    Any clinically significant abnormal laboratory values?
    Beskrivning

    Laboratory Procedures, Urinalysis, Result, Clinical Significance

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0042014
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C2826293
    Concomitant Medication
    Beskrivning

    Concomitant Medication

    Alias
    UMLS CUI-1
    C2347852
    Please document all concomitant medication administered to the patient during this cycle.
    Beskrivning

    Concomitant Agent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Medication (trade name)
    Beskrivning

    Concomitant Agent, Medication name

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2360065
    Total Daily dose
    Beskrivning

    Concomitant Medication Daily Dose, Total

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2826638
    UMLS CUI [1,2]
    C0439810
    Mode of application
    Beskrivning

    Concomitant Agent, Drug Administration Routes

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0013153
    Indication
    Beskrivning

    Concomitant Agent, Indication

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C3146298
    Start date
    Beskrivning

    Concomitant Medication Start Date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2826734
    Stop date
    Beskrivning

    Concomitant Medication End Date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2826744
    Mark if ongoing
    Beskrivning

    Concomitant Medication Ongoing

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2826666
    Tillbaka till toppen

    Similar models

    Cycle 1

    1 Formulär
    1. StudyEvent: ODM
      1. Cycle 1
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Patient number
    Item
    Patient Number
    integer
    C1830427 (UMLS CUI [1])
    Item Group
    Day 1
    C0011298 (UMLS CUI-1)
    Body Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Body Surface Area
    Item
    Body surface area
    float
    C0005902 (UMLS CUI [1])
    Item Group
    Administration of study medication topotecan
    C0304229 (UMLS CUI-1)
    C0146224 (UMLS CUI-2)
    C3469597 (UMLS CUI-3)
    Item
    Day
    text
    C0304229 (UMLS CUI [1,1])
    C0146224 (UMLS CUI [1,2])
    C3469597 (UMLS CUI [1,3])
    C0439228 (UMLS CUI [1,4])
    Experimental drug, Topotecan, Administration of medication, Day
    Code List
    Day
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    Item
    Planned daily dose for this infusion
    text
    C0304229 (UMLS CUI [1,1])
    C0146224 (UMLS CUI [1,2])
    C2348070 (UMLS CUI [1,3])
    C1301732 (UMLS CUI [1,4])
    Laboratory Procedures, Hematology finding, Visit
    Code List
    Planned daily dose for this infusion
    CL Item
    Baseline (1)
    CL Item
    Day 1 (2)
    CL Item
    Day 8 (3)
    CL Item
    Day 15 (4)
    Experimental drug, Topotecan, Daily Dose, Total
    Item
    Administered total dose of the daily infusion
    integer
    C0304229 (UMLS CUI [1,1])
    C0146224 (UMLS CUI [1,2])
    C2348070 (UMLS CUI [1,3])
    C0439810 (UMLS CUI [1,4])
    Experimental drug, Topotecan, Administration of medication, Start Date
    Item
    Start date of the infusion
    date
    C0304229 (UMLS CUI [1,1])
    C0146224 (UMLS CUI [1,2])
    C3469597C0808070 (UMLS CUI [1,3])
    Experimental drug, Topotecan, Administration of medication, Start Time
    Item
    Start time of the infusion
    time
    C0304229 (UMLS CUI [1,1])
    C0146224 (UMLS CUI [1,2])
    C3469597 (UMLS CUI [1,3])
    C1301880 (UMLS CUI [1,4])
    Item Group
    Administration of study medication carboplatin AUC 5 (2 h after topotecan infusion)
    C0304229 (UMLS CUI-1)
    C0079083 (UMLS CUI-2)
    C3469597 (UMLS CUI-3)
    Item
    Day
    text
    C0304229 (UMLS CUI [1,1])
    C0079083 (UMLS CUI [1,2])
    C3469597 (UMLS CUI [1,3])
    C0439228 (UMLS CUI [1,4])
    Experimental drug, Topotecan, Administration of medication, Day
    Code List
    Day
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    Experimental drug, Carboplatin, Daily Dose, Planned
    Item
    Planned daily dose for this infusion
    text
    C0304229 (UMLS CUI [1,1])
    C0079083 (UMLS CUI [1,2])
    C2348070 (UMLS CUI [1,3])
    C1301732 (UMLS CUI [1,4])
    Experimental drug, Carboplatin, Daily Dose, Total
    Item
    Administered total dose of the daily infusion
    integer
    C0304229 (UMLS CUI [1,1])
    C0079083 (UMLS CUI [1,2])
    C2348070 (UMLS CUI [1,3])
    C0439810 (UMLS CUI [1,4])
    Experimental drug, Carboplatin, Administration of medication, Start Date
    Item
    Start date of the infusion
    date
    C0304229 (UMLS CUI [1,1])
    C0079083 (UMLS CUI [1,2])
    C3469597C0808070 (UMLS CUI [1,3])
    Experimental drug, Carboplatin, Administration of medication, Start Time
    Item
    Start time of the infusion
    time
    C0304229 (UMLS CUI [1,1])
    C0079083 (UMLS CUI [1,2])
    C3469597 (UMLS CUI [1,3])
    C1301880 (UMLS CUI [1,4])
    Item Group
    Laboratory Values - Hematology
    C0022885 (UMLS CUI-1)
    C0474523 (UMLS CUI-2)
    Item
    Visit
    text
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C0545082 (UMLS CUI [1,3])
    Laboratory Procedures, Hematology finding, Visit
    Code List
    Visit
    CL Item
    Baseline (1)
    CL Item
    Day 1 (2)
    CL Item
    Day 8 (3)
    CL Item
    Day 15 (4)
    Laboratory Procedures, Hematology finding, Sampling, Date in time
    Item
    Sampling Date
    date
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Laboratory Procedures, Hematology finding, Sampling, Time
    Item
    Time
    time
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Laboratory Procedures, Hematology finding, Performing laboratory name
    Item
    Name of laboratory
    text
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C3258037 (UMLS CUI [1,3])
    Laboratory Procedures, Hematology finding, Laboratory, Code
    Item
    Lab code
    text
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C0022877 (UMLS CUI [1,3])
    C0805701 (UMLS CUI [1,4])
    Item
    Parameter
    text
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C0549193 (UMLS CUI [1,3])
    Laboratory Procedures, Hematology finding, Parameter Value
    Code List
    Parameter
    CL Item
    Hemoglobin (1)
    CL Item
    Hematocrit (2)
    CL Item
    Erythrocytes (3)
    CL Item
    Leukocytes (4)
    CL Item
    Neutrophiles (5)
    CL Item
    Lymphocytes (6)
    CL Item
    Monocytes (7)
    CL Item
    Eosinophiles (8)
    CL Item
    Basophils (9)
    CL Item
    Thrombocytes (Platelets) (10)
    Item
    Result
    text
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Hematology finding, Parameter Value
    Code List
    Result
    Laboratory Procedures, Hematology finding, Result, Clinical Significance
    Item
    Any clinically significant abnormal laboratory values?
    boolean
    C0022885 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C2826293 (UMLS CUI [1,4])
    Item Group
    Laboratory Values - Clinical Chemistry
    C0022885 (UMLS CUI-1)
    C0008000 (UMLS CUI-2)
    Item
    Visit
    text
    C0022885 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0545082 (UMLS CUI [1,3])
    Laboratory Procedures, Hematology finding, Visit
    Code List
    Visit
    CL Item
    Baseline (1)
    CL Item
    Day 1 (2)
    CL Item
    Day 8 (3)
    CL Item
    Day 15 (4)
    Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time
    Item
    Sampling Date
    date
    C0022885 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Laboratory Procedures, Chemistry, Clinical, Sampling, Time
    Item
    Time
    time
    C0022885 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Laboratory Procedures, Chemistry, Clinical, Performing laboratory name
    Item
    Name of laboratory
    text
    C0022885 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C3258037 (UMLS CUI [1,3])
    Laboratory Procedures, Chemistry, Clinical, Laboratory, Code
    Item
    Lab code
    text
    C0022885 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0022877 (UMLS CUI [1,3])
    C0805701 (UMLS CUI [1,4])
    Item
    Parameter
    text
    C0022885 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0549193 (UMLS CUI [1,3])
    Laboratory Procedures, Hematology finding, Parameter Value
    Code List
    Parameter
    CL Item
    Sodium (1)
    CL Item
    Potassium (2)
    CL Item
    Chloride (3)
    CL Item
    Bicarbonate (4)
    CL Item
    Calcium (5)
    CL Item
    Phosphorus (6)
    CL Item
    Magnesium (7)
    CL Item
    BUN or (8)
    CL Item
    Urea (9)
    CL Item
    Uric acid (10)
    CL Item
    Creatinine (11)
    CL Item
    alk. Phosphatase (12)
    CL Item
    LDH (13)
    CL Item
    GOT/AST (14)
    CL Item
    GPT/ALT (15)
    CL Item
    Total bilirubine (16)
    CL Item
    Direct bilirubine (17)
    CL Item
    Total protein (18)
    CL Item
    Albumin (19)
    CL Item
    Creatinine clearance (20)
    Laboratory Procedures, Chemistry, Clinical, Result
    Item
    Result
    text
    C0022885 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Chemistry, Clinical, Result, Clinical Significance
    Item
    Any clinically significant abnormal laboratory values?
    boolean
    C0022885 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C2826293 (UMLS CUI [1,4])
    Item Group
    Urinalysis
    C0042014 (UMLS CUI-1)
    Item
    Visit
    text
    C0022885 (UMLS CUI [1,1])
    C0042014 (UMLS CUI [1,2])
    C0545082 (UMLS CUI [1,3])
    Laboratory Procedures, Hematology finding, Visit
    Code List
    Visit
    CL Item
    Baseline (1)
    CL Item
    Day 1 (2)
    Laboratory Procedures, Urinalysis, Sampling, Date in time
    Item
    Sampling Date
    date
    C0022885 (UMLS CUI [1,1])
    C0042014 (UMLS CUI [1,2])
    C0870078 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Laboratory Procedures, Urinalysis, Performing laboratory name
    Item
    Name of the laboratory
    text
    C0022885 (UMLS CUI [1,1])
    C0042014 (UMLS CUI [1,2])
    C3258037 (UMLS CUI [1,3])
    Laboratory Procedures, Urinalysis, Laboratory, Code
    Item
    Lab code
    text
    C0022885 (UMLS CUI [1,1])
    C0042014 (UMLS CUI [1,2])
    C0022877 (UMLS CUI [1,3])
    C0805701 (UMLS CUI [1,4])
    Item
    Parameter
    text
    C0022885 (UMLS CUI [1,1])
    C0042014 (UMLS CUI [1,2])
    C0549193 (UMLS CUI [1,3])
    Laboratory Procedures, Hematology finding, Parameter Value
    Code List
    Parameter
    CL Item
    pH value (1)
    CL Item
    Glomerular filtration rate (2)
    CL Item
    Protein (3)
    CL Item
    Glucose (4)
    CL Item
    Blood protein (5)
    CL Item
    Red blood cells / HPF (6)
    CL Item
    White blood cells / HPF (7)
    CL Item
    Cylinders (casts) / LPF (8)
    CL Item
    Crystals /LPF (9)
    Laboratory Procedures, Urinalysis, Result
    Item
    Result
    text
    C0022885 (UMLS CUI [1,1])
    C0042014 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Laboratory Procedures, Urinalysis, Microscopic urinalysis
    Item
    Microscopy done?
    boolean
    C0022885 (UMLS CUI [1,1])
    C0042014 (UMLS CUI [1,2])
    C0430397 (UMLS CUI [1,3])
    Laboratory Procedures, Urinalysis, Result, Clinical Significance
    Item
    Any clinically significant abnormal laboratory values?
    boolean
    C0022885 (UMLS CUI [1,1])
    C0042014 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C2826293 (UMLS CUI [1,4])
    Item Group
    Concomitant Medication
    C2347852 (UMLS CUI-1)
    Concomitant Agent
    Item
    Please document all concomitant medication administered to the patient during this cycle.
    boolean
    C2347852 (UMLS CUI [1])
    Concomitant Agent, Medication name
    Item
    Medication (trade name)
    text
    C2347852 (UMLS CUI [1,1])
    C2360065 (UMLS CUI [1,2])
    Concomitant Medication Daily Dose, Total
    Item
    Total Daily dose
    text
    C2826638 (UMLS CUI [1,1])
    C0439810 (UMLS CUI [1,2])
    Concomitant Agent, Drug Administration Routes
    Item
    Mode of application
    text
    C2347852 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    Concomitant Agent, Indication
    Item
    Indication
    text
    C2347852 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    Concomitant Medication Start Date
    Item
    Start date
    date
    C2826734 (UMLS CUI [1])
    Concomitant Medication End Date
    Item
    Stop date
    date
    C2826744 (UMLS CUI [1])
    Concomitant Medication Ongoing
    Item
    Mark if ongoing
    boolean
    C2826666 (UMLS CUI [1])
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