0 Beoordelingen
ID

37263

Beschrijving

Study ID: 104864/902 Clinical Study ID: 104864/902 Study Title: An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00316173 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: CARBOPLATIN Study Indication: Ovarian Cancer; Neoplasms, Ovarian

Trefwoorden

Versies (1)
  1. 12-07-19 12-07-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

12 juli 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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    HYCAMTIN in Combination With Carboplatin in Subjects with Ovarian Cancer; NCT00316173

    Engels

    Cycle 4 Day 8

    1 Formulieren  
    1. StudyEvent: ODM
      1. Cycle 4 Day 8
    Administrative Data
    Beschrijving

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Beschrijving

    Clinical Trial Subject Unique Identifier

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Beschrijving

    Date of visit

    Datatype

    date

    Alias
    UMLS CUI [1]
    C1320303
    Vital Signs
    Beschrijving

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Blood pressure - Systolic
    Beschrijving

    Systolic Pressure

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Blood pressure - Diastolic
    Beschrijving

    Diastolic blood pressure

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart rate
    Beschrijving

    Heart rate

    Datatype

    integer

    Maateenheden
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Temperature
    Beschrijving

    Body Temperature

    Datatype

    float

    Maateenheden
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Treatment Confirmation
    Beschrijving

    Treatment Confirmation

    Alias
    UMLS CUI-1
    C0087111
    UMLS CUI-2
    C0750484
    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
    Beschrijving

    Therapeutic procedure, Confirmation

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0750484
    If No, record reason(s)
    Beschrijving

    Therapeutic procedure, Wrong, Reason and Justification

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C3827420
    UMLS CUI [1,3]
    C0566251
    Terug naar het begin van de pagina

    Similar models

    Cycle 4 Day 8

    1 Formulieren
    1. StudyEvent: ODM
      1. Cycle 4 Day 8
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Clinical Trial Subject Unique Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Date of visit
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Systolic Pressure
    Item
    Blood pressure - Systolic
    integer
    C0871470 (UMLS CUI [1])
    Diastolic blood pressure
    Item
    Blood pressure - Diastolic
    integer
    C0428883 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Body Temperature
    Item
    Temperature
    float
    C0005903 (UMLS CUI [1])
    Item Group
    Treatment Confirmation
    C0087111 (UMLS CUI-1)
    C0750484 (UMLS CUI-2)
    Therapeutic procedure, Confirmation
    Item
    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
    boolean
    C0087111 (UMLS CUI [1,1])
    C0750484 (UMLS CUI [1,2])
    Therapeutic procedure, Wrong, Reason and Justification
    Item
    If No, record reason(s)
    text
    C0087111 (UMLS CUI [1,1])
    C3827420 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Terug naar het begin van de pagina 

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