0 Beoordelingen
ID

37275

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

    Non-Serious Adverse Events (NSAE)

    1 Formulieren  
    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
    Non-Serious Adverse Events (NSAE)
    Beschrijving

    Non-Serious Adverse Events (NSAE)

    Alias
    UMLS CUI-1
    C1518404
    Did the subject experience any non-serious adverse events during the study?
    Beschrijving

    Non-serious Adverse Event, During, Clinical Trials

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0347984
    UMLS CUI [1,3]
    C0008976
    Event
    Beschrijving

    Non-serious Adverse Event

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1518404
    Start Date
    Beschrijving

    Non-serious Adverse Event, Start Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0808070
    Outcome
    Beschrijving

    Non-serious Adverse Event, Adverse Event Outcome

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C1705586
    End Date
    Beschrijving

    Non-serious Adverse Event, End Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0806020
    Maximum Toxicity
    Beschrijving

    Non-serious Adverse Event, Toxicity Grade

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C2826262
    Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
    Beschrijving

    Non-serious Adverse Event, Action Taken with Study Treatment

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C1704758
    Did the subject withdraw from study as a result of this AE?
    Beschrijving

    Non-serious Adverse Event, Withdraw

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C2349954
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Beschrijving

    Non-serious Adverse Event, Relationships, Experimental drug

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0439849
    UMLS CUI [1,3]
    C0304229
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    Similar models

    Non-Serious Adverse Events (NSAE)

    1 Formulieren
    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])
    Item Group
    Non-Serious Adverse Events (NSAE)
    C1518404 (UMLS CUI-1)
    Non-serious Adverse Event, During, Clinical Trials
    Item
    Did the subject experience any non-serious adverse events during the study?
    boolean
    C1518404 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    Non-serious Adverse Event
    Item
    Event
    text
    C1518404 (UMLS CUI [1])
    Non-serious Adverse Event, Start Date
    Item
    Start Date
    date
    C1518404 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Item
    Outcome
    text
    C1518404 (UMLS CUI [1,1])
    C1705586 (UMLS CUI [1,2])
    Non-serious Adverse Event, Adverse Event Outcome
    Code List
    Outcome
    CL Item
    Recovered/ Resolved  (1)
    CL Item
    Recovering/ Resolving (2)
    CL Item
    Not recovered/ Not resolved (3)
    CL Item
    Recovered/ Resolved with sequelae (4)
    Non-serious Adverse Event, End Date
    Item
    End Date
    date
    C1518404 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Item
    Maximum Toxicity
    text
    C1518404 (UMLS CUI [1,1])
    C2826262 (UMLS CUI [1,2])
    Non-serious Adverse Event, Toxicity Grade
    Code List
    Maximum Toxicity
    CL Item
    Grade 1  (1)
    CL Item
    Grade 2  (2)
    CL Item
    Grade 3  (3)
    CL Item
    Grade 4  (4)
    CL Item
    Grade 5  (5)
    CL Item
    Not applicable (6)
    Item
    Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
    text
    C1518404 (UMLS CUI [1,1])
    C1704758 (UMLS CUI [1,2])
    Non-serious Adverse Event, Action Taken with Study Treatment
    Code List
    Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
    CL Item
    Investigational product(s) withdrawn (1)
    CL Item
    Dose reduced  (2)
    CL Item
    Dose increased  (3)
    CL Item
    Dose not changed (4)
    CL Item
    Dose interrupted  (5)
    CL Item
    Not applicable (6)
    Non-serious Adverse Event, Withdraw
    Item
    Did the subject withdraw from study as a result of this AE?
    boolean
    C1518404 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    Non-serious Adverse Event, Relationships, Experimental drug
    Item
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    boolean
    C1518404 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    C0304229 (UMLS CUI [1,3])
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