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ID

37279

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

    Study Conclusion

    1 Formulieren  
    1. StudyEvent: ODM
      1. Study Conclusion
    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
    Study Conclusion
    Beschrijving

    Study Conclusion

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008972
    Date of subject completion or withdrawal
    Beschrijving

    Completion Status, Date in time; Withdraw, Date in time

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0805732
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [2,1]
    C2349954
    UMLS CUI [2,2]
    C0011008
    Was the subject withdrawn from the study?
    Beschrijving

    Withdraw

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2349954
    If Yes, check the primary reason for withdrawal
    Beschrijving

    Withdraw, Reason and justification

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0566251
    Specify
    Beschrijving

    Withdraw, Reason and justification

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0566251
    Terug naar het begin van de pagina

    Similar models

    Study Conclusion

    1 Formulieren
    1. StudyEvent: ODM
      1. Study Conclusion
    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
    Study Conclusion
    C1707478 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    Completion Status, Date in time; Withdraw, Date in time
    Item
    Date of subject completion or withdrawal
    date
    C0805732 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C2349954 (UMLS CUI [2,1])
    C0011008 (UMLS CUI [2,2])
    Withdraw
    Item
    Was the subject withdrawn from the study?
    boolean
    C2349954 (UMLS CUI [1])
    Item
    If Yes, check the primary reason for withdrawal
    text
    C2349954 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    Withdraw, Reason and justification
    Code List
    If Yes, check the primary reason for withdrawal
    CL Item
    Adverse event  (1)
    CL Item
    Lost to follow-up (2)
    CL Item
    Protocol violation (3)
    CL Item
    Subject decided to withdraw from the study  (4)
    CL Item
    Lack of efficacy (5)
    CL Item
    Sponsor terminated study (6)
    CL Item
    Disease progression (7)
    CL Item
    Other, specify (8)
    Withdraw, Reason and justification
    Item
    Specify
    text
    C2349954 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    Terug naar het begin van de pagina 

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