ID

42250

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2021-04-18 2021-04-18 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

18 april 2021

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

  • Senaste
  • Äldsta
  • Önskad
  • Senaste
    • Senaste
    • Äldsta
    • Önskad

    Inga kommentarer

    Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

    Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410)

    Engelsk

    Screening - Prior an Concomitant Medication; Telephone Randomisation

    1 Formulär  
    Administrative
    Beskrivning

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Patient Number
    Beskrivning

    Patient Number

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Patient Initials
    Beskrivning

    Patient Initials

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2986440
    Prior and Concomitant Medication
    Beskrivning

    Prior and Concomitant Medication

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

    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.

    Datatyp

    boolean

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

    Prior and Concomitant Medication

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

    Trade Name preferred

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0013227
    Total Daily Dose
    Beskrivning

    Total Daily Dose

    Datatyp

    text

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

    Administration Route

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0013153
    Medical Condition
    Beskrivning

    Medical Condition

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0012634
    Medication Start Date
    Beskrivning

    Medication Start Date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2826734
    Medication End Date
    Beskrivning

    Medication End Date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2826744
    Medication Continuing
    Beskrivning

    Medication Continuing

    Datatyp

    integer

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

    Telephone Randomisation

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

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

    Datatyp

    boolean

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

    Randomisation Number

    Datatyp

    text

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

    Patient's randomised treatment arm

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1522541
    Tillbaka till toppen

    Similar models

    Screening - Prior an Concomitant Medication; Telephone Randomisation

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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)
    Tillbaka till toppen 

    Hjälp

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial