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ID

37649

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2019-08-13 2019-08-13 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

13 augusti 2019

DOI

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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

    Engelsk

    Study End

    1 Formulär  
    1. StudyEvent: ODM
      1. Study End
    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Patient Number
    Beskrivning

    Patient number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1830427 (undefined)
    Study End
    Beskrivning

    Study End

    Alias
    UMLS CUI-1
    C0008972 (Clinical Research)
    UMLS CUI-2
    C0444930 (End)
    SNOMED
    261782000
    Did the patient prematurely terminate the study or was she prematurely withdrawn?
    Beskrivning

    Clinical Trials, Withdraw

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,2]
    C2349954 (Withdraw (activity))
    If "yes", please document the date
    Beskrivning

    Clinical Trials, Withdraw, Date in time

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,2]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    If "yes", please provide the primary reason for withdrawal
    Beskrivning

    Clinical Trials, Withdraw, Reason and justification

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,2]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,3]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    Please specify
    Beskrivning

    Clinical Trials, Withdraw, Reason and justification

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,2]
    C2349954 (Withdraw (activity))
    UMLS CUI [1,3]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    Confirmation of the investigator
    Beskrivning

    Confirmation of the investigator

    Alias
    UMLS CUI-1
    C2346576 (Investigator Signature)
    UMLS CUI-2
    C0750484 (Confirmation)
    LOINC
    LA15290-2
    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.
    Beskrivning

    Investigator Signature

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2346576 (Investigator Signature)
    Date
    Beskrivning

    Investigator Signature, Date in time

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C2346576 (Investigator Signature)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Name in printed letters or practice stamp
    Beskrivning

    Investigator Name

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2826892 (Investigator Name)
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    Similar models

    Study End

    1 Formulär
    1. StudyEvent: ODM
      1. Study End
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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])
    Tillbaka till toppen 

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