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ID

37738

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

  1. 8/21/19 8/21/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 21, 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

    1. StudyEvent: ODM
      1. Form D
    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
    Form D
    Description

    Form D

    Alias
    UMLS CUI-1
    C0011065
    Cause of Death
    Description

    Cause of Death

    Data type

    text

    Alias
    UMLS CUI [1]
    C0007465
    Specify
    Description

    Cause of Death

    Data type

    text

    Alias
    UMLS CUI [1]
    C0007465
    Date of Death
    Description

    Date of death

    Data type

    date

    Alias
    UMLS CUI [1]
    C1148348
    Was a post-mortem done?
    Description

    Cessation of life, Autopsy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0011065
    UMLS CUI [1,2]
    C0004398
    If 'Yes' please summarize findings (include diagnosis)
    Description

    Cessation of life, Autopsy, Finding

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011065
    UMLS CUI [1,2]
    C0004398
    UMLS CUI [1,3]
    C0243095
    Physician's Signature
    Description

    Cessation of life, Signature of responsible attending physician on file

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011065
    UMLS CUI [1,2]
    C0807938
    Date
    Description

    Cessation of life, Signature of responsible attending physician on file, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011065
    UMLS CUI [1,2]
    C0807938
    UMLS CUI [1,3]
    C0011008

    Similar models

    Form D

    1. StudyEvent: ODM
      1. Form D
    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])
    Item Group
    Form D
    C0011065 (UMLS CUI-1)
    Item
    Cause of Death
    text
    C0007465 (UMLS CUI [1])
    Code List
    Cause of Death
    CL Item
    Progressive Disease (1)
    CL Item
    Toxicity: Hematologic (2)
    CL Item
    Toxicity: Non-Hematologic (3)
    CL Item
    Other, specify (4)
    Cause of Death
    Item
    Specify
    text
    C0007465 (UMLS CUI [1])
    Date of death
    Item
    Date of Death
    date
    C1148348 (UMLS CUI [1])
    Cessation of life, Autopsy
    Item
    Was a post-mortem done?
    boolean
    C0011065 (UMLS CUI [1,1])
    C0004398 (UMLS CUI [1,2])
    Cessation of life, Autopsy, Finding
    Item
    If 'Yes' please summarize findings (include diagnosis)
    text
    C0011065 (UMLS CUI [1,1])
    C0004398 (UMLS CUI [1,2])
    C0243095 (UMLS CUI [1,3])
    Cessation of life, Signature of responsible attending physician on file
    Item
    Physician's Signature
    text
    C0011065 (UMLS CUI [1,1])
    C0807938 (UMLS CUI [1,2])
    Cessation of life, Signature of responsible attending physician on file, Date in time
    Item
    Date
    date
    C0011065 (UMLS CUI [1,1])
    C0807938 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])

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