0 Evaluaciones
ID

42250

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 (1)
  1. 18/4/21 18/4/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

18 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

    Screening - Prior an Concomitant Medication; Telephone Randomisation

    1 formularios  
    Administrative
    Descripción

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    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
    Prior and Concomitant Medication
    Descripción

    Prior and Concomitant Medication

    Alias
    UMLS CUI-1
    C2826257
    UMLS CUI-2
    C2347852
    Has the patient taken any medication in the past 30 years?
    Descripción

    If "Yes" please record details below. Where appropriate, medical conditions should be recorded in the Significant Medical/ Surgical History and Physical examination section, utilising the same terminology. Record PM for prophylactic treatment with the Medical Condition for prophylactically administered medications.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2826257
    Prior and Concomitant Medication
    Descripción

    Prior and Concomitant Medication

    Alias
    UMLS CUI-1
    C2826257
    UMLS CUI-2
    C2347852
    Drug Name
    Descripción

    Trade Name preferred

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0013227
    Total Daily Dose
    Descripción

    Total Daily Dose

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2348070
    UMLS CUI [1,2]
    C0013227
    Administration Route
    Descripción

    Administration Route

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0013153
    Medical Condition
    Descripción

    Medical Condition

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0012634
    Medication Start Date
    Descripción

    Medication Start Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2826734
    Medication End Date
    Descripción

    Medication End Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2826744
    Medication Continuing
    Descripción

    Medication Continuing

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0549178
    Telephone Randomisation
    Descripción

    Telephone Randomisation

    Alias
    UMLS CUI-1
    C0039457
    UMLS CUI-2
    C0034656
    Has the patient been registered and randomised using the centralised telephone system?
    Descripción

    If "Yes" please record the patient's randomisation number

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1514821
    UMLS CUI [2]
    C0034656
    UMLS CUI [3]
    C0039457
    Randomisation Number
    Descripción

    Randomisation Number

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0237753
    Patient's randomised treatment arm
    Descripción

    Patient's randomised treatment arm

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1522541
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    Similar models

    Screening - Prior an Concomitant Medication; Telephone Randomisation

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Patient Number
    Item
    Patient Number
    text
    C2348585 (UMLS CUI [1])
    Patient Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Item Group
    Prior and Concomitant Medication
    C2826257 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    Has the patient taken any medication in the past 30 years?
    Item
    Has the patient taken any medication in the past 30 years?
    boolean
    C2826257 (UMLS CUI [1])
    Item Group
    Prior and Concomitant Medication
    C2826257 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    Drug Name
    Item
    Drug Name
    text
    C0013227 (UMLS CUI [1])
    Total Daily Dose
    Item
    Total Daily Dose
    text
    C2348070 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Administration Route
    Item
    Administration Route
    text
    C0013153 (UMLS CUI [1])
    Medical Condition
    Item
    Medical Condition
    text
    C0012634 (UMLS CUI [1])
    Medication Start Date
    Item
    Medication Start Date
    date
    C2826734 (UMLS CUI [1])
    Medication End Date
    Item
    Medication End Date
    date
    C2826744 (UMLS CUI [1])
    Item
    Medication Continuing
    integer
    C0013227 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Medication Continuing
    Code List
    Medication Continuing
    CL Item
    Medication Continuing (1)
    Item Group
    Telephone Randomisation
    C0039457 (UMLS CUI-1)
    C0034656 (UMLS CUI-2)
    Has the patient been registered and randomised using the centralised telephone system?
    Item
    Has the patient been registered and randomised using the centralised telephone system?
    boolean
    C1514821 (UMLS CUI [1])
    C0034656 (UMLS CUI [2])
    C0039457 (UMLS CUI [3])
    Randomisation Number
    Item
    Randomisation Number
    text
    C0034656 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Item
    Patient's randomised treatment arm
    text
    C1522541 (UMLS CUI [1])
    Patient's randomised treatment arm
    Code List
    Patient's randomised treatment arm
    CL Item
    Regimen 1 - Topotecan for 5 Days and Cisplatin on Day 5 (TC)
    CL Item
    Regimen 2 - Topotecan for 5 Days and Etoposide for 5 Days (TE)
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