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ID

37255

Description

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

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Versions (1)
  1. 7/12/19 7/12/19 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

July 12, 2019

DOI

Pour une demande vous connecter.

Licence

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

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    Cycle 2 Day 1

    1 Formulaires  
    1. StudyEvent: ODM
      1. Cycle 2 Day 1
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Clinical Trial Subject Unique Identifier

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Description

    Date of visit

    Type de données

    date

    Alias
    UMLS CUI [1]
    C1320303
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Weight
    Description

    Body Weight

    Type de données

    float

    Unités de mesure
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Body surface area
    Description

    Body Surface Area

    Type de données

    float

    Unités de mesure
    • m2
    Alias
    UMLS CUI [1]
    C0005902
    m2
    Blood pressure - Systolic
    Description

    Systolic Pressure

    Type de données

    integer

    Unités de mesure
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Blood pressure - Diastolic
    Description

    Diastolic blood pressure

    Type de données

    integer

    Unités de mesure
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart rate
    Description

    Heart rate

    Type de données

    integer

    Unités de mesure
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Temperature
    Description

    Body Temperature

    Type de données

    float

    Unités de mesure
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Treatment Confirmation
    Description

    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?
    Description

    Therapeutic procedure, Confirmation

    Type de données

    boolean

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

    Therapeutic procedure, Wrong, Reason and Justification

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C3827420
    UMLS CUI [1,3]
    C0566251
    Retour au début de la page

    Similar models

    Cycle 2 Day 1

    1 Formulaires
    1. StudyEvent: ODM
      1. Cycle 2 Day 1
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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)
    Body Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Body Surface Area
    Item
    Body surface area
    float
    C0005902 (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])
    Retour au début de la page 

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