0 Ratings

ID

37128

Description

Study ID: 104864/502 Clinical Study ID: 104864/502 Study Title: An Open-Label, Multicenter, Randomized, Phase II Study of Oral Topotecan Daily x 5 Days vs. Oral Topotecan 5 Days On, 2 Days Off for 3 Weeks for Second-Line Treatment in Patients with Recurrent, Locally Advanced or Metastatic Cervical 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: N/A Study Indication: Cancer, Locally Advanced or Metastatic Cervical Cancer

Keywords

  1. 7/3/19 7/3/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 3, 2019

DOI

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License

Creative Commons BY-NC 3.0

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    Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502

    Concomitant Medication

    1. StudyEvent: ODM
      1. Concomitant Medication
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Center Number
    Description

    Institution name, Identifier

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0600091
    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
    Concomitant Medication
    Description

    Concomitant Medication

    Alias
    UMLS CUI-1
    C2347852
    Drug Name (Trade Name Preferred)
    Description

    Concomitant Agent, Medication name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2360065
    Unit Dose
    Description

    Concomitant Agent, Dosage, Unit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0439148
    Frequency
    Description

    Concomitant Agent, Frequencies

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0439603
    Route
    Description

    Concomitant Agent, Drug Administration Routes

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0013153
    Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
    Description

    Concomitant Agent, Disease

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0012634
    Start Date
    Description

    Concomitant Medication Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826734
    End Date
    Description

    Concomitant Medication End Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826744
    If Continuing mark box
    Description

    Concomitant Agent, Continuous

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0549178

    Similar models

    Concomitant Medication

    1. StudyEvent: ODM
      1. Concomitant Medication
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Institution name, Identifier
    Item
    Center Number
    integer
    C1301943 (UMLS CUI [1,1])
    C0600091 (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
    Concomitant Medication
    C2347852 (UMLS CUI-1)
    Concomitant Agent, Medication name
    Item
    Drug Name (Trade Name Preferred)
    text
    C2347852 (UMLS CUI [1,1])
    C2360065 (UMLS CUI [1,2])
    Concomitant Agent, Dosage, Unit
    Item
    Unit Dose
    text
    C2347852 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0439148 (UMLS CUI [1,3])
    Concomitant Agent, Frequencies
    Item
    Frequency
    text
    C2347852 (UMLS CUI [1,1])
    C0439603 (UMLS CUI [1,2])
    Concomitant Agent, Drug Administration Routes
    Item
    Route
    text
    C2347852 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    Concomitant Agent, Disease
    Item
    Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
    text
    C2347852 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    Concomitant Medication Start Date
    Item
    Start Date
    date
    C2826734 (UMLS CUI [1])
    Concomitant Medication End Date
    Item
    End Date
    date
    C2826744 (UMLS CUI [1])
    Concomitant Agent, Continuous
    Item
    If Continuing mark box
    boolean
    C2347852 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])

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