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ID

42278

Beschrijving

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

Trefwoorden

  1. 27-04-21 27-04-21 -
  2. 27-04-21 27-04-21 -
  3. 28-04-21 28-04-21 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

28 april 2021

DOI

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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)

    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

    Administrative
    Beschrijving

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Centre Number
    Beschrijving

    Centre Number

    Datatype

    text

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

    Patient Number

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2348585
    Patient Initials
    Beschrijving

    Patient Initials

    Datatype

    text

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

    Day 1 Visit Date

    Datatype

    date

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

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

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

    Weight

    Datatype

    float

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

    Weight in kg or ibs

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0005910
    Body Surface Area
    Beschrijving

    Body Surface Area

    Datatype

    float

    Maateenheden
    • m^2
    Alias
    UMLS CUI [1]
    C0005902
    m^2
    Topotecan Study Medication Record (Regimen 1, Regimen 2)
    Beschrijving

    Topotecan Study Medication Record (Regimen 1, Regimen 2)

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

    Day (Topotecan)

    Datatype

    integer

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

    Scheduled Daily Dose for this Infusion (Topotecan)

    Datatype

    float

    Maateenheden
    • 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)
    Beschrijving

    Total Daily Dose for this Infusion (Topotecan)

    Datatype

    float

    Maateenheden
    • mg
    Alias
    UMLS CUI [1]
    C2348070
    UMLS CUI [2]
    C0574032
    UMLS CUI [3]
    C0146224
    mg
    Infusion Start Date (Topotecan)
    Beschrijving

    Infusion Start Date (Topotecan)

    Datatype

    date

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

    Infusion Start Time (Topotecan)

    Datatype

    time

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

    Infusion Stop Date (Topotecan)

    Datatype

    date

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

    Infusion Stop Time (Topotecan)

    Datatype

    time

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

    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)
    Beschrijving

    Hydration regimen (Pre-Cisplatin)

    Datatype

    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)
    Beschrijving

    Date of Infusion (Pre-Cisplatin)

    Datatype

    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)
    Beschrijving

    Time Infusion Started (Pre-Cisplatin)

    Datatype

    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)
    Beschrijving

    Total Administered (Pre-Cisplatin)

    Datatype

    float

    Maateenheden
    • 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)
    Beschrijving

    Time Infusion Ended (Pre-Cisplatin)

    Datatype

    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)
    Beschrijving

    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)
    Beschrijving

    Scheduled Dose For This Infusion (Cisplatin)

    Datatype

    float

    Maateenheden
    • 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)
    Beschrijving

    Date Infusion Started (Cisplatin)

    Datatype

    date

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

    Time Infusion Started (Cisplatin)

    Datatype

    time

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

    Total Administered (Cisplatin)

    Datatype

    float

    Maateenheden
    • mg
    Alias
    UMLS CUI [1,1]
    C1521801
    UMLS CUI [1,2]
    C0439810
    UMLS CUI [2]
    C0008838
    mg
    Date Infusion Ended (Cisplatin)
    Beschrijving

    Date Infusion Ended (Cisplatin)

    Datatype

    date

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

    Time Infusion Ended (Cisplatin)

    Datatype

    time

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

    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)
    Beschrijving

    Hydration regimen (Post-Cisplatin)

    Datatype

    text

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

    Date of Infusion (Post-Cisplatin)

    Datatype

    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)
    Beschrijving

    Time Infusion Started (Post-Cisplatin)

    Datatype

    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)
    Beschrijving

    Total Administered (Post-Cisplatin)

    Datatype

    float

    Maateenheden
    • 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)
    Beschrijving

    Time Infusion Ended (Post-Cisplatin)

    Datatype

    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)
    Beschrijving

    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)
    Beschrijving

    Date and time vital signs performed (Post-Cisplatin)

    Datatype

    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)
    Beschrijving

    Temperature (Post-Cisplatin)

    Datatype

    float

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

    Temperature (Post-Cisplatin)

    Datatype

    integer

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

    Temperature measurement site (Post-Cisplatin)

    Datatype

    integer

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

    After 5 Minutes Sitting

    Datatype

    integer

    Maateenheden
    • 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)
    Beschrijving

    After 5 Minutes Sitting

    Datatype

    integer

    Maateenheden
    • 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)
    Beschrijving

    After 5 Minutes Sitting

    Datatype

    integer

    Maateenheden
    • 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)
    Beschrijving

    Etoposide Study Medication Record (Regimen 1, Regimen 2)

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

    Day (Etoposide)

    Datatype

    integer

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

    Scheduled Daily Dose for this Infusion (Etoposide)

    Datatype

    float

    Maateenheden
    • 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)
    Beschrijving

    Total Daily Dose for this Infusion (Etoposide)

    Datatype

    float

    Maateenheden
    • mg
    Alias
    UMLS CUI [1,1]
    C2348070
    UMLS CUI [1,2]
    C0574032
    UMLS CUI [2]
    C0015133
    mg
    Infusion Start Date (Etoposide)
    Beschrijving

    Infusion Start Date (Etoposide)

    Datatype

    date

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

    Infusion Start Time (Etoposide)

    Datatype

    time

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

    Infusion Stop Date (Etoposide)

    Datatype

    date

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

    Infusion Stop Time (Etoposide)

    Datatype

    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)
    Beschrijving

    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)
    Beschrijving

    Date and time vital signs performed (Post-Etoposide)

    Datatype

    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)
    Beschrijving

    Temperature (Post-Etoposide)

    Datatype

    float

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

    Temperature (Post-Etoposide)

    Datatype

    integer

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

    Temperature site (Post-Etoposide)

    Datatype

    integer

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

    After 5 Minutes Sitting

    Datatype

    integer

    Maateenheden
    • 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)
    Beschrijving

    After 5 Minutes Sitting

    Datatype

    integer

    Maateenheden
    • 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)
    Beschrijving

    After 5 Minutes Sitting

    Datatype

    integer

    Maateenheden
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    UMLS CUI [2,1]
    C0015133
    UMLS CUI [2,2]
    C0231290
    beats/min

    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

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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])
    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])
    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])
    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])
    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])
    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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