ID

37689

Description

Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Keywords

Versions (1)
  1. 8/16/19 8/16/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 16, 2019

DOI

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License

Creative Commons BY-NC 3.0
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    Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886

    English

    Study Medication

    1 forms  
    1. StudyEvent: ODM
      1. Study Medication
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Center number
    Description

    Study Coordinating Center, Identification number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2825181
    UMLS CUI [1,2]
    C1300638
    Patient Number
    Description

    Patient number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1830427
    Patient Initials
    Description

    Person Initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440
    Visit Date
    Description

    Date of visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Weight/Body Surface Area
    Description

    Weight/Body Surface Area

    Alias
    UMLS CUI-1
    C0005910
    UMLS CUI-2
    C0005902
    Weight - Unit
    Description

    Body Weight, Unit of Measure

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0005910
    UMLS CUI [1,2]
    C1519795
    Weight
    Description

    Body Weight

    Data type

    float

    Body Surface Area
    Description

    Body Surface Area

    Data type

    float

    Measurement units
    • m2
    Alias
    UMLS CUI [1]
    C0005902
    m2
    Topotecan Study Medication/Radiation Record
    Description

    Topotecan Study Medication/Radiation Record

    Alias
    UMLS CUI-1
    C0146224
    UMLS CUI-2
    C1522449
    Treatment Day
    Description

    Topotecan, Therapeutic radiology procedure, Day

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0146224
    UMLS CUI [1,2]
    C1522449
    UMLS CUI [1,3]
    C0439228
    Date
    Description

    Topotecan; Therapeutic radiology procedure, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0146224
    UMLS CUI [1,2]
    C1522449
    UMLS CUI [1,3]
    C0011008
    Scheduled Daily Dose
    Description

    Topotecan; Therapeutic radiology procedure, Daily Dose, Scheduled

    Data type

    integer

    Measurement units
    • mg
    Alias
    UMLS CUI [1,1]
    C0146224
    UMLS CUI [1,2]
    C1522449
    UMLS CUI [1,3]
    C2348070
    UMLS CUI [1,4]
    C0205539
    mg
    Actual Daily Dose
    Description

    Topotecan; Therapeutic radiology procedure, Daily Dose, Actual

    Data type

    integer

    Measurement units
    • mg
    Alias
    UMLS CUI [1,1]
    C0146224
    UMLS CUI [1,2]
    C1522449
    UMLS CUI [1,3]
    C2348070
    UMLS CUI [1,4]
    C0237400
    mg
    RT Daily Dose
    Description

    Therapeutic radiology procedure, Daily Dose

    Data type

    integer

    Measurement units
    • x 100Gy
    Alias
    UMLS CUI [1,1]
    C0146224
    UMLS CUI [1,2]
    C1522449
    UMLS CUI [1,3]
    C2348070
    UMLS CUI [1,4]
    C0237400
    x 100Gy
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    Similar models

    Study Medication

    1 forms
    1. StudyEvent: ODM
      1. Study Medication
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Study Coordinating Center, Identification number
    Item
    Center number
    integer
    C2825181 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    Patient number
    Item
    Patient Number
    integer
    C1830427 (UMLS CUI [1])
    Person Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Date of visit
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Weight/Body Surface Area
    C0005910 (UMLS CUI-1)
    C0005902 (UMLS CUI-2)
    Item
    Weight - Unit
    text
    C0005910 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    Body Weight, Unit of Measure
    Code List
    Weight - Unit
    CL Item
    kg (1)
    CL Item
    lb (2)
    Body Weight
    Item
    Weight
    float
    Body Surface Area
    Item
    Body Surface Area
    float
    C0005902 (UMLS CUI [1])
    Item Group
    Topotecan Study Medication/Radiation Record
    C0146224 (UMLS CUI-1)
    C1522449 (UMLS CUI-2)
    Item
    Treatment Day
    text
    C0146224 (UMLS CUI [1,1])
    C1522449 (UMLS CUI [1,2])
    C0439228 (UMLS CUI [1,3])
    Topotecan, Therapeutic radiology procedure, Day
    Code List
    Treatment Day
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    CL Item
    8 (8)
    CL Item
    9 (9)
    CL Item
    10 (10)
    CL Item
    11 (11)
    CL Item
    12 (12)
    CL Item
    13 (13)
    CL Item
    14 (14)
    CL Item
    15 (15)
    CL Item
    16 (16)
    CL Item
    17 (17)
    CL Item
    18 (18)
    CL Item
    19 (19)
    CL Item
    20 (20)
    CL Item
    21 (21)
    CL Item
    22 (22)
    CL Item
    23 (23)
    CL Item
    24 (24)
    CL Item
    25 (25)
    Topotecan; Therapeutic radiology procedure, Date in time
    Item
    Date
    date
    C0146224 (UMLS CUI [1,1])
    C1522449 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Topotecan; Therapeutic radiology procedure, Daily Dose, Scheduled
    Item
    Scheduled Daily Dose
    integer
    C0146224 (UMLS CUI [1,1])
    C1522449 (UMLS CUI [1,2])
    C2348070 (UMLS CUI [1,3])
    C0205539 (UMLS CUI [1,4])
    Topotecan; Therapeutic radiology procedure, Daily Dose, Actual
    Item
    Actual Daily Dose
    integer
    C0146224 (UMLS CUI [1,1])
    C1522449 (UMLS CUI [1,2])
    C2348070 (UMLS CUI [1,3])
    C0237400 (UMLS CUI [1,4])
    Therapeutic radiology procedure, Daily Dose
    Item
    RT Daily Dose
    integer
    C0146224 (UMLS CUI [1,1])
    C1522449 (UMLS CUI [1,2])
    C2348070 (UMLS CUI [1,3])
    C0237400 (UMLS CUI [1,4])
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