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ID

37649

Description

Study ID: 104864/612 Clinical Study ID: 104864/612 Study Title: A Prospective, Open Label Phase II Study to Evaluate the Efficacy and Safety of Topotecan (HycamtinTM) in Combination with Carboplatin as First-line Chemotherapy in Patients with Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: HycamtinTM Study Indication: Ovarian Cancer

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Versions (1)
  1. 8/13/19 8/13/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 13, 2019

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License

Creative Commons BY-NC 3.0
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    Topotecan (HycamtinTM) with Carboplatin as First-Line Chemotherapy in Patients with Ovarian Cancer; 104864/612

    English

    Study End

    1 forms  
    1. StudyEvent: ODM
      1. Study End
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Patient Number
    Description

    Patient number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1830427
    Study End
    Description

    Study End

    Alias
    UMLS CUI-1
    C0008972
    UMLS CUI-2
    C0444930
    Did the patient prematurely terminate the study or was she prematurely withdrawn?
    Description

    Clinical Trials, Withdraw

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0008976
    UMLS CUI [1,2]
    C2349954
    If "yes", please document the date
    Description

    Clinical Trials, Withdraw, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0008976
    UMLS CUI [1,2]
    C2349954
    UMLS CUI [1,3]
    C0011008
    If "yes", please provide the primary reason for withdrawal
    Description

    Clinical Trials, Withdraw, Reason and justification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0008976
    UMLS CUI [1,2]
    C2349954
    UMLS CUI [1,3]
    C0566251
    Please specify
    Description

    Clinical Trials, Withdraw, Reason and justification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0008976
    UMLS CUI [1,2]
    C2349954
    UMLS CUI [1,3]
    C0566251
    Confirmation of the investigator
    Description

    Confirmation of the investigator

    Alias
    UMLS CUI-1
    C2346576
    UMLS CUI-2
    C0750484
    Signature of the responsible investigator I hereby declare that the data documented in his case report form are an exact and correct repetition of the patient's findings, that the trial was conducted according to protocol, and that the patient's consent for the study participation has been obtained.
    Description

    Investigator Signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date
    Description

    Investigator Signature, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Name in printed letters or practice stamp
    Description

    Investigator Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
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    Similar models

    Study End

    1 forms
    1. StudyEvent: ODM
      1. Study End
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Patient number
    Item
    Patient Number
    integer
    C1830427 (UMLS CUI [1])
    Item Group
    Study End
    C0008972 (UMLS CUI-1)
    C0444930 (UMLS CUI-2)
    Clinical Trials, Withdraw
    Item
    Did the patient prematurely terminate the study or was she prematurely withdrawn?
    boolean
    C0008976 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    Clinical Trials, Withdraw, Date in time
    Item
    If "yes", please document the date
    date
    C0008976 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    If "yes", please provide the primary reason for withdrawal
    text
    C0008976 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Clinical Trials, Withdraw, Reason and justification
    Code List
    If "yes", please provide the primary reason for withdrawal
    CL Item
    Adverse event (1)
    CL Item
    Insufficient therapeutic effect (2)
    CL Item
    Protocol violation (incl. non-compliance) (3)
    CL Item
    Patient is lost to follow-up (4)
    CL Item
    Other, please specify (5)
    Clinical Trials, Withdraw, Reason and justification
    Item
    Please specify
    text
    C0008976 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Item Group
    Confirmation of the investigator
    C2346576 (UMLS CUI-1)
    C0750484 (UMLS CUI-2)
    Investigator Signature
    Item
    Signature of the responsible investigator I hereby declare that the data documented in his case report form are an exact and correct repetition of the patient's findings, that the trial was conducted according to protocol, and that the patient's consent for the study participation has been obtained.
    text
    C2346576 (UMLS CUI [1])
    Investigator Signature, Date in time
    Item
    Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Investigator Name
    Item
    Name in printed letters or practice stamp
    text
    C2826892 (UMLS CUI [1])
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