0 Evaluaciones
ID

42278

Descripción

Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

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Versiones (3)
  1. 27/4/21 27/4/21 -
  2. 27/4/21 27/4/21 -
  3. 28/4/21 28/4/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

28 de abril de 2021

DOI

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Licencia

Creative Commons BY 4.0
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    Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410)

    Inglés

    Regimen 1 and Regimen 2: Days 1 - 5 - Weight/ Body Surface Area; Topotecan Study Medication Record; Pre-Cisplatin Hydration Record; Cisplatin Study Medication Record; Post-Cisplatin Hydration Record; Post-Cisplatin Dosing; Etoposide Study Medication Record; Vital Signs

    1 formularios  
    Administrative
    Descripción

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Centre Number
    Descripción

    Centre Number

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Patient Number
    Descripción

    Patient Number

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585
    Patient Initials
    Descripción

    Patient Initials

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2986440
    Day 1 Visit Date
    Descripción

    Day 1 Visit Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303
    Weight/Body Surface Area (Regimen 1, Regimen 2)
    Descripción

    Weight/Body Surface Area (Regimen 1, Regimen 2)

    Alias
    UMLS CUI-1
    C0005910
    UMLS CUI-2
    C0005902
    Weight
    Descripción

    Weight

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0005910
    Weight in kg or ibs
    Descripción

    Weight in kg or ibs

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0005910
    Body Surface Area
    Descripción

    Body Surface Area

    Tipo de datos

    float

    Unidades de medida
    • m^2
    Alias
    UMLS CUI [1]
    C0005902
    m^2
    Topotecan Study Medication Record (Regimen 1, Regimen 2)
    Descripción

    Topotecan Study Medication Record (Regimen 1, Regimen 2)

    Alias
    UMLS CUI-1
    C0146224
    UMLS CUI-2
    C2734539
    UMLS CUI-3
    C0008972
    Day (Topotecan)
    Descripción

    Day (Topotecan)

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0439228
    UMLS CUI [2]
    C0146224
    Scheduled Daily Dose for this Infusion (Topotecan)
    Descripción

    Scheduled Daily Dose for this Infusion (Topotecan)

    Tipo de datos

    float

    Unidades de medida
    • mg/m^2
    Alias
    UMLS CUI [1,1]
    C2348070
    UMLS CUI [1,2]
    C0205539
    UMLS CUI [2]
    C0574032
    UMLS CUI [3]
    C0146224
    mg/m^2
    Total Daily Dose for this Infusion (Topotecan)
    Descripción

    Total Daily Dose for this Infusion (Topotecan)

    Tipo de datos

    float

    Unidades de medida
    • mg
    Alias
    UMLS CUI [1]
    C2348070
    UMLS CUI [2]
    C0574032
    UMLS CUI [3]
    C0146224
    mg
    Infusion Start Date (Topotecan)
    Descripción

    Infusion Start Date (Topotecan)

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0574032
    UMLS CUI [1,2]
    C0808070
    UMLS CUI [2]
    C0146224
    Infusion Start Time (Topotecan)
    Descripción

    Infusion Start Time (Topotecan)

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0574032
    UMLS CUI [1,2]
    C1301880
    UMLS CUI [2]
    C0146224
    Infusion Stop Date (Topotecan)
    Descripción

    Infusion Stop Date (Topotecan)

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C0574032
    UMLS CUI [2]
    C0146224
    Infusion Stop Time (Topotecan)
    Descripción

    Infusion Stop Time (Topotecan)

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C1522314
    UMLS CUI [1,2]
    C0574032
    UMLS CUI [2]
    C0146224
    Day 5 Pre-Cisplatin Hydration Record (Regimen 1)
    Descripción

    Day 5 Pre-Cisplatin Hydration Record (Regimen 1)

    Alias
    UMLS CUI-1
    C0008838
    UMLS CUI-2
    C1321013
    UMLS CUI-3
    C0332152
    Hydration regimen (Pre-Cisplatin)
    Descripción

    Hydration regimen (Pre-Cisplatin)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1321013
    UMLS CUI [1,2]
    C1276413
    UMLS CUI [2,1]
    C0008838
    UMLS CUI [2,2]
    C0332152
    Date of Infusion (Pre-Cisplatin)
    Descripción

    Date of Infusion (Pre-Cisplatin)

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0574032
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [2,1]
    C0008838
    UMLS CUI [2,2]
    C0332152
    Time Infusion Started (Pre-Cisplatin)
    Descripción

    Time Infusion Started (Pre-Cisplatin)

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0574032
    UMLS CUI [1,2]
    C1301880
    UMLS CUI [2,1]
    C0008838
    UMLS CUI [2,2]
    C0332152
    Total Administered (Pre-Cisplatin)
    Descripción

    Total Administered (Pre-Cisplatin)

    Tipo de datos

    float

    Unidades de medida
    • mL
    Alias
    UMLS CUI [1,1]
    C1533734
    UMLS CUI [1,2]
    C0439810
    UMLS CUI [2,1]
    C0008838
    UMLS CUI [2,2]
    C0332152
    mL
    Time Infusion Ended (Pre-Cisplatin)
    Descripción

    Time Infusion Ended (Pre-Cisplatin)

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0574032
    UMLS CUI [1,2]
    C1522314
    UMLS CUI [2,1]
    C0008838
    UMLS CUI [2,2]
    C0332152
    Day 5 Cisplatin Study Medication Record (Regimen 1)
    Descripción

    Day 5 Cisplatin Study Medication Record (Regimen 1)

    Alias
    UMLS CUI-1
    C0008838
    UMLS CUI-2
    C0304229
    UMLS CUI-3
    C2734539
    Scheduled Dose For This Infusion (Cisplatin)
    Descripción

    Scheduled Dose For This Infusion (Cisplatin)

    Tipo de datos

    float

    Unidades de medida
    • mg/m^2
    Alias
    UMLS CUI [1]
    C0574032
    UMLS CUI [2,1]
    C3174092
    UMLS CUI [2,2]
    C0205539
    UMLS CUI [3]
    C0008838
    mg/m^2
    Date Infusion Started (Cisplatin)
    Descripción

    Date Infusion Started (Cisplatin)

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C3173309
    UMLS CUI [1,2]
    C0574032
    UMLS CUI [2]
    C0008838
    Time Infusion Started (Cisplatin)
    Descripción

    Time Infusion Started (Cisplatin)

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0574032
    UMLS CUI [1,2]
    C1301880
    UMLS CUI [2]
    C0008838
    Total Administered (Cisplatin)
    Descripción

    Total Administered (Cisplatin)

    Tipo de datos

    float

    Unidades de medida
    • mg
    Alias
    UMLS CUI [1,1]
    C1521801
    UMLS CUI [1,2]
    C0439810
    UMLS CUI [2]
    C0008838
    mg
    Date Infusion Ended (Cisplatin)
    Descripción

    Date Infusion Ended (Cisplatin)

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C0574032
    UMLS CUI [2]
    C0008838
    Time Infusion Ended (Cisplatin)
    Descripción

    Time Infusion Ended (Cisplatin)

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C1522314
    UMLS CUI [1,2]
    C0574032
    UMLS CUI [2]
    C0008838
    Day 5 Post-Cisplatin Hydration Record (Regimen 1)
    Descripción

    Day 5 Post-Cisplatin Hydration Record (Regimen 1)

    Alias
    UMLS CUI-1
    C0008838
    UMLS CUI-2
    C1321013
    UMLS CUI-3
    C0231290
    Hydration regimen (Post-Cisplatin)
    Descripción

    Hydration regimen (Post-Cisplatin)

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1321013
    UMLS CUI [2,1]
    C0008838
    UMLS CUI [2,2]
    C0231290
    Date of Infusion (Post-Cisplatin)
    Descripción

    Date of Infusion (Post-Cisplatin)

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0574032
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [2,1]
    C0008838
    UMLS CUI [2,2]
    C0231290
    Time Infusion Started (Post-Cisplatin)
    Descripción

    Time Infusion Started (Post-Cisplatin)

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0574032
    UMLS CUI [1,2]
    C1301880
    UMLS CUI [2,1]
    C0008838
    UMLS CUI [2,2]
    C0231290
    Total Administered (Post-Cisplatin)
    Descripción

    Total Administered (Post-Cisplatin)

    Tipo de datos

    float

    Unidades de medida
    • mL
    Alias
    UMLS CUI [1,1]
    C1521801
    UMLS CUI [1,2]
    C0439810
    UMLS CUI [2,1]
    C0008838
    UMLS CUI [2,2]
    C0231290
    mL
    Time Infusion Ended (Post-Cisplatin)
    Descripción

    Time Infusion Ended (Post-Cisplatin)

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C1522314
    UMLS CUI [1,2]
    C0574032
    UMLS CUI [2,1]
    C0008838
    UMLS CUI [2,2]
    C0231290
    Day 5 Vital Signs, Post-Cisplatin Dosing (Regimen 1)
    Descripción

    Day 5 Vital Signs, Post-Cisplatin Dosing (Regimen 1)

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0008838
    UMLS CUI-3
    C0439568
    Date and time vital signs performed (Post-Cisplatin)
    Descripción

    Date and time vital signs performed (Post-Cisplatin)

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    UMLS CUI [2,1]
    C0008838
    UMLS CUI [2,2]
    C0231290
    Temperature (Post-Cisplatin)
    Descripción

    Temperature (Post-Cisplatin)

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0005903
    UMLS CUI [2,1]
    C0008838
    UMLS CUI [2,2]
    C0231290
    Temperature (Post-Cisplatin)
    Descripción

    Temperature (Post-Cisplatin)

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0005903
    UMLS CUI [2,1]
    C0008838
    UMLS CUI [2,2]
    C0231290
    Temperature measurement site (Post-Cisplatin)
    Descripción

    Temperature measurement site (Post-Cisplatin)

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0489453
    UMLS CUI [2,1]
    C0008838
    UMLS CUI [2,2]
    C0231290
    Sitting Systolic Blood Pressure (Post-Cisplatin)
    Descripción

    After 5 Minutes Sitting

    Tipo de datos

    integer

    Unidades de medida
    • mm[Hg]
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0277814
    UMLS CUI [2,1]
    C0008838
    UMLS CUI [2,2]
    C0231290
    mm[Hg]
    Diastolic Sitting Blood Pressure (Post-Cisplatin)
    Descripción

    After 5 Minutes Sitting

    Tipo de datos

    integer

    Unidades de medida
    • mm[Hg]
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0277814
    UMLS CUI [2,1]
    C0008838
    UMLS CUI [2,2]
    C0231290
    mm[Hg]
    Pulse (Post-Cisplatin)
    Descripción

    After 5 Minutes Sitting

    Tipo de datos

    integer

    Unidades de medida
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    UMLS CUI [2,1]
    C0008838
    UMLS CUI [2,2]
    C0231290
    beats/min
    Etoposide Study Medication Record (Regimen 1, Regimen 2)
    Descripción

    Etoposide Study Medication Record (Regimen 1, Regimen 2)

    Alias
    UMLS CUI-1
    C0015133
    UMLS CUI-2
    C0304229
    UMLS CUI-3
    C2734539
    Day (Etoposide)
    Descripción

    Day (Etoposide)

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0439228
    UMLS CUI [2]
    C0015133
    Scheduled Daily Dose for this Infusion (Etoposide)
    Descripción

    Scheduled Daily Dose for this Infusion (Etoposide)

    Tipo de datos

    float

    Unidades de medida
    • mg/m^2
    Alias
    UMLS CUI [1,1]
    C2348070
    UMLS CUI [1,2]
    C0205539
    UMLS CUI [2]
    C0574032
    UMLS CUI [3]
    C0015133
    mg/m^2
    Total Daily Dose for this Infusion (Etoposide)
    Descripción

    Total Daily Dose for this Infusion (Etoposide)

    Tipo de datos

    float

    Unidades de medida
    • mg
    Alias
    UMLS CUI [1,1]
    C2348070
    UMLS CUI [1,2]
    C0574032
    UMLS CUI [2]
    C0015133
    mg
    Infusion Start Date (Etoposide)
    Descripción

    Infusion Start Date (Etoposide)

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0574032
    UMLS CUI [1,2]
    C0808070
    UMLS CUI [2]
    C0015133
    Infusion Start Time (Etoposide)
    Descripción

    Infusion Start Time (Etoposide)

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0574032
    UMLS CUI [1,2]
    C1301880
    UMLS CUI [2]
    C0015133
    Infusion Stop Date (Etoposide)
    Descripción

    Infusion Stop Date (Etoposide)

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C0574032
    UMLS CUI [2]
    C0015133
    Infusion Stop Time (Etoposide)
    Descripción

    Infusion Stop Time (Etoposide)

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C1522314
    UMLS CUI [1,2]
    C0574032
    UMLS CUI [2]
    C0015133
    Day 5 Vital Signs, Post-Etoposide Dosing (Regimen 2)
    Descripción

    Day 5 Vital Signs, Post-Etoposide Dosing (Regimen 2)

    Alias
    UMLS CUI-1
    C0015133
    UMLS CUI-2
    C0008838
    UMLS CUI-3
    C0439568
    Date and time vital signs performed (Post-Etoposide)
    Descripción

    Date and time vital signs performed (Post-Etoposide)

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    UMLS CUI [2,1]
    C0015133
    UMLS CUI [2,2]
    C0231290
    Temperature (Post-Etoposide)
    Descripción

    Temperature (Post-Etoposide)

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0005903
    UMLS CUI [2,1]
    C0015133
    UMLS CUI [2,2]
    C0231290
    Temperature (Post-Etoposide)
    Descripción

    Temperature (Post-Etoposide)

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0005903
    UMLS CUI [2,1]
    C0015133
    UMLS CUI [2,2]
    C0231290
    Temperature site (Post-Etoposide)
    Descripción

    Temperature site (Post-Etoposide)

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0489453
    UMLS CUI [2,1]
    C0015133
    UMLS CUI [2,2]
    C0231290
    Sitting Systolic Blood Pressure (Post-Etoposide)
    Descripción

    After 5 Minutes Sitting

    Tipo de datos

    integer

    Unidades de medida
    • mm[Hg]
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0277814
    UMLS CUI [2,1]
    C0015133
    UMLS CUI [2,2]
    C0231290
    mm[Hg]
    Diastolic Sitting Blood Pressure (Post-Etoposide)
    Descripción

    After 5 Minutes Sitting

    Tipo de datos

    integer

    Unidades de medida
    • mm[Hg]
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0277814
    UMLS CUI [2,1]
    C0015133
    UMLS CUI [2,2]
    C0231290
    mm[Hg]
    Pulse (Post-Etoposide)
    Descripción

    After 5 Minutes Sitting

    Tipo de datos

    integer

    Unidades de medida
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    UMLS CUI [2,1]
    C0015133
    UMLS CUI [2,2]
    C0231290
    beats/min
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    Similar models

    Regimen 1 and Regimen 2: Days 1 - 5 - Weight/ Body Surface Area; Topotecan Study Medication Record; Pre-Cisplatin Hydration Record; Cisplatin Study Medication Record; Post-Cisplatin Hydration Record; Post-Cisplatin Dosing; Etoposide Study Medication Record; Vital Signs

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Centre Number
    Item
    Centre Number
    text
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Patient Number
    Item
    Patient Number
    text
    C2348585 (UMLS CUI [1])
    Patient Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Day 1 Visit Date
    Item
    Day 1 Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Weight/Body Surface Area (Regimen 1, Regimen 2)
    C0005910 (UMLS CUI-1)
    C0005902 (UMLS CUI-2)
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Item
    Weight in kg or ibs
    integer
    C0005910 (UMLS CUI [1])
    Weight in kg or ibs
    Code List
    Weight in kg or ibs
    CL Item
    kg (1)
    CL Item
    ibs (2)
    Body Surface Area
    Item
    Body Surface Area
    float
    C0005902 (UMLS CUI [1])
    Item Group
    Topotecan Study Medication Record (Regimen 1, Regimen 2)
    C0146224 (UMLS CUI-1)
    C2734539 (UMLS CUI-2)
    C0008972 (UMLS CUI-3)
    Day (Topotecan)
    Item
    Day (Topotecan)
    integer
    C0439228 (UMLS CUI [1])
    C0146224 (UMLS CUI [2])
    Scheduled Daily Dose for this Infusion (Topotecan)
    Item
    Scheduled Daily Dose for this Infusion (Topotecan)
    float
    C2348070 (UMLS CUI [1,1])
    C0205539 (UMLS CUI [1,2])
    C0574032 (UMLS CUI [2])
    C0146224 (UMLS CUI [3])
    Total Daily Dose for this Infusion (Topotecan)
    Item
    Total Daily Dose for this Infusion (Topotecan)
    float
    C2348070 (UMLS CUI [1])
    C0574032 (UMLS CUI [2])
    C0146224 (UMLS CUI [3])
    Infusion Start Date (Topotecan)
    Item
    Infusion Start Date (Topotecan)
    date
    C0574032 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    C0146224 (UMLS CUI [2])
    Infusion Start Time (Topotecan)
    Item
    Infusion Start Time (Topotecan)
    time
    C0574032 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    C0146224 (UMLS CUI [2])
    Infusion Stop Date (Topotecan)
    Item
    Infusion Stop Date (Topotecan)
    date
    C0806020 (UMLS CUI [1,1])
    C0574032 (UMLS CUI [1,2])
    C0146224 (UMLS CUI [2])
    Infusion Stop Time (Topotecan)
    Item
    Infusion Stop Time (Topotecan)
    time
    C1522314 (UMLS CUI [1,1])
    C0574032 (UMLS CUI [1,2])
    C0146224 (UMLS CUI [2])
    Item Group
    Day 5 Pre-Cisplatin Hydration Record (Regimen 1)
    C0008838 (UMLS CUI-1)
    C1321013 (UMLS CUI-2)
    C0332152 (UMLS CUI-3)
    Hydration regimen (Pre-Cisplatin)
    Item
    Hydration regimen (Pre-Cisplatin)
    text
    C1321013 (UMLS CUI [1,1])
    C1276413 (UMLS CUI [1,2])
    C0008838 (UMLS CUI [2,1])
    C0332152 (UMLS CUI [2,2])
    Date of Infusion (Pre-Cisplatin)
    Item
    Date of Infusion (Pre-Cisplatin)
    date
    C0574032 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0008838 (UMLS CUI [2,1])
    C0332152 (UMLS CUI [2,2])
    Time Infusion Started (Pre-Cisplatin)
    Item
    Time Infusion Started (Pre-Cisplatin)
    time
    C0574032 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    C0008838 (UMLS CUI [2,1])
    C0332152 (UMLS CUI [2,2])
    Total Administered (Pre-Cisplatin)
    Item
    Total Administered (Pre-Cisplatin)
    float
    C1533734 (UMLS CUI [1,1])
    C0439810 (UMLS CUI [1,2])
    C0008838 (UMLS CUI [2,1])
    C0332152 (UMLS CUI [2,2])
    Time Infusion Ended (Pre-Cisplatin)
    Item
    Time Infusion Ended (Pre-Cisplatin)
    time
    C0574032 (UMLS CUI [1,1])
    C1522314 (UMLS CUI [1,2])
    C0008838 (UMLS CUI [2,1])
    C0332152 (UMLS CUI [2,2])
    Item Group
    Day 5 Cisplatin Study Medication Record (Regimen 1)
    C0008838 (UMLS CUI-1)
    C0304229 (UMLS CUI-2)
    C2734539 (UMLS CUI-3)
    Scheduled Dose For This Infusion (Cisplatin)
    Item
    Scheduled Dose For This Infusion (Cisplatin)
    float
    C0574032 (UMLS CUI [1])
    C3174092 (UMLS CUI [2,1])
    C0205539 (UMLS CUI [2,2])
    C0008838 (UMLS CUI [3])
    Date Infusion Started (Cisplatin)
    Item
    Date Infusion Started (Cisplatin)
    date
    C3173309 (UMLS CUI [1,1])
    C0574032 (UMLS CUI [1,2])
    C0008838 (UMLS CUI [2])
    Time Infusion Started (Cisplatin)
    Item
    Time Infusion Started (Cisplatin)
    time
    C0574032 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    C0008838 (UMLS CUI [2])
    Total Administered (Cisplatin)
    Item
    Total Administered (Cisplatin)
    float
    C1521801 (UMLS CUI [1,1])
    C0439810 (UMLS CUI [1,2])
    C0008838 (UMLS CUI [2])
    Date Infusion Ended (Cisplatin)
    Item
    Date Infusion Ended (Cisplatin)
    date
    C0806020 (UMLS CUI [1,1])
    C0574032 (UMLS CUI [1,2])
    C0008838 (UMLS CUI [2])
    Time Infusion Ended (Cisplatin)
    Item
    Time Infusion Ended (Cisplatin)
    time
    C1522314 (UMLS CUI [1,1])
    C0574032 (UMLS CUI [1,2])
    C0008838 (UMLS CUI [2])
    Item Group
    Day 5 Post-Cisplatin Hydration Record (Regimen 1)
    C0008838 (UMLS CUI-1)
    C1321013 (UMLS CUI-2)
    C0231290 (UMLS CUI-3)
    Hydration regimen (Post-Cisplatin)
    Item
    Hydration regimen (Post-Cisplatin)
    text
    C1321013 (UMLS CUI [1])
    C0008838 (UMLS CUI [2,1])
    C0231290 (UMLS CUI [2,2])
    Date of Infusion (Post-Cisplatin)
    Item
    Date of Infusion (Post-Cisplatin)
    date
    C0574032 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0008838 (UMLS CUI [2,1])
    C0231290 (UMLS CUI [2,2])
    Time Infusion Started (Post-Cisplatin)
    Item
    Time Infusion Started (Post-Cisplatin)
    time
    C0574032 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    C0008838 (UMLS CUI [2,1])
    C0231290 (UMLS CUI [2,2])
    Total Administered (Post-Cisplatin)
    Item
    Total Administered (Post-Cisplatin)
    float
    C1521801 (UMLS CUI [1,1])
    C0439810 (UMLS CUI [1,2])
    C0008838 (UMLS CUI [2,1])
    C0231290 (UMLS CUI [2,2])
    Time Infusion Ended (Post-Cisplatin)
    Item
    Time Infusion Ended (Post-Cisplatin)
    time
    C1522314 (UMLS CUI [1,1])
    C0574032 (UMLS CUI [1,2])
    C0008838 (UMLS CUI [2,1])
    C0231290 (UMLS CUI [2,2])
    Item Group
    Day 5 Vital Signs, Post-Cisplatin Dosing (Regimen 1)
    C0518766 (UMLS CUI-1)
    C0008838 (UMLS CUI-2)
    C0439568 (UMLS CUI-3)
    Date and time vital signs performed (Post-Cisplatin)
    Item
    Date and time vital signs performed (Post-Cisplatin)
    datetime
    C0518766 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    C0008838 (UMLS CUI [2,1])
    C0231290 (UMLS CUI [2,2])
    Temperature (Post-Cisplatin)
    Item
    Temperature (Post-Cisplatin)
    float
    C0005903 (UMLS CUI [1])
    C0008838 (UMLS CUI [2,1])
    C0231290 (UMLS CUI [2,2])
    Item
    Temperature (Post-Cisplatin)
    integer
    C0005903 (UMLS CUI [1])
    C0008838 (UMLS CUI [2,1])
    C0231290 (UMLS CUI [2,2])
    Temperature
    Code List
    Temperature (Post-Cisplatin)
    CL Item
    °C (1)
    CL Item
    °F (2)
    Item
    Temperature measurement site (Post-Cisplatin)
    integer
    C0489453 (UMLS CUI [1])
    C0008838 (UMLS CUI [2,1])
    C0231290 (UMLS CUI [2,2])
    Temperature site
    Code List
    Temperature measurement site (Post-Cisplatin)
    CL Item
    Oral (1)
    CL Item
    Axillary (2)
    CL Item
    Tympanic (3)
    CL Item
    Rectal (4)
    Sitting Systolic Blood Pressure (Post-Cisplatin)
    Item
    Sitting Systolic Blood Pressure (Post-Cisplatin)
    integer
    C0871470 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    C0008838 (UMLS CUI [2,1])
    C0231290 (UMLS CUI [2,2])
    Diastolic Sitting Blood Pressure (Post-Cisplatin)
    Item
    Diastolic Sitting Blood Pressure (Post-Cisplatin)
    integer
    C0428883 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    C0008838 (UMLS CUI [2,1])
    C0231290 (UMLS CUI [2,2])
    Pulse (Post-Cisplatin)
    Item
    Pulse (Post-Cisplatin)
    integer
    C0232117 (UMLS CUI [1])
    C0008838 (UMLS CUI [2,1])
    C0231290 (UMLS CUI [2,2])
    Item Group
    Etoposide Study Medication Record (Regimen 1, Regimen 2)
    C0015133 (UMLS CUI-1)
    C0304229 (UMLS CUI-2)
    C2734539 (UMLS CUI-3)
    Day (Etoposide)
    Item
    Day (Etoposide)
    integer
    C0439228 (UMLS CUI [1])
    C0015133 (UMLS CUI [2])
    Scheduled Daily Dose for this Infusion (Etoposide)
    Item
    Scheduled Daily Dose for this Infusion (Etoposide)
    float
    C2348070 (UMLS CUI [1,1])
    C0205539 (UMLS CUI [1,2])
    C0574032 (UMLS CUI [2])
    C0015133 (UMLS CUI [3])
    Total Daily Dose for this Infusion (Etoposide)
    Item
    Total Daily Dose for this Infusion (Etoposide)
    float
    C2348070 (UMLS CUI [1,1])
    C0574032 (UMLS CUI [1,2])
    C0015133 (UMLS CUI [2])
    Infusion Start Date (Etoposide)
    Item
    Infusion Start Date (Etoposide)
    date
    C0574032 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    C0015133 (UMLS CUI [2])
    Infusion Start Time (Etoposide)
    Item
    Infusion Start Time (Etoposide)
    time
    C0574032 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    C0015133 (UMLS CUI [2])
    Infusion Stop Date (Etoposide)
    Item
    Infusion Stop Date (Etoposide)
    date
    C0806020 (UMLS CUI [1,1])
    C0574032 (UMLS CUI [1,2])
    C0015133 (UMLS CUI [2])
    Infusion Stop Time (Etoposide)
    Item
    Infusion Stop Time (Etoposide)
    time
    C1522314 (UMLS CUI [1,1])
    C0574032 (UMLS CUI [1,2])
    C0015133 (UMLS CUI [2])
    Item Group
    Day 5 Vital Signs, Post-Etoposide Dosing (Regimen 2)
    C0015133 (UMLS CUI-1)
    C0008838 (UMLS CUI-2)
    C0439568 (UMLS CUI-3)
    Date and time vital signs performed (Post-Etoposide)
    Item
    Date and time vital signs performed (Post-Etoposide)
    datetime
    C0518766 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    C0015133 (UMLS CUI [2,1])
    C0231290 (UMLS CUI [2,2])
    Temperature (Post-Etoposide)
    Item
    Temperature (Post-Etoposide)
    float
    C0005903 (UMLS CUI [1])
    C0015133 (UMLS CUI [2,1])
    C0231290 (UMLS CUI [2,2])
    Item
    Temperature (Post-Etoposide)
    integer
    C0005903 (UMLS CUI [1])
    C0015133 (UMLS CUI [2,1])
    C0231290 (UMLS CUI [2,2])
    Temperature
    Code List
    Temperature (Post-Etoposide)
    CL Item
    °C  (1)
    CL Item
    °F (2)
    Item
    Temperature site (Post-Etoposide)
    integer
    C0489453 (UMLS CUI [1])
    C0015133 (UMLS CUI [2,1])
    C0231290 (UMLS CUI [2,2])
    Temperature site
    Code List
    Temperature site (Post-Etoposide)
    CL Item
    Oral  (1)
    CL Item
    Axillary  (2)
    CL Item
    Tympanic  (3)
    CL Item
    Rectal (4)
    Sitting Systolic Blood Pressure (Post-Etoposide)
    Item
    Sitting Systolic Blood Pressure (Post-Etoposide)
    integer
    C0871470 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    C0015133 (UMLS CUI [2,1])
    C0231290 (UMLS CUI [2,2])
    Diastolic Sitting Blood Pressure (Post-Etoposide)
    Item
    Diastolic Sitting Blood Pressure (Post-Etoposide)
    integer
    C0428883 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    C0015133 (UMLS CUI [2,1])
    C0231290 (UMLS CUI [2,2])
    Pulse (Post-Etoposide)
    Item
    Pulse (Post-Etoposide)
    integer
    C0232117 (UMLS CUI [1])
    C0015133 (UMLS CUI [2,1])
    C0231290 (UMLS CUI [2,2])
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