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ID

37973

Description

Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

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Versions (1)
  1. 9/3/19 9/3/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 3, 2019

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Creative Commons BY-NC 3.0
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    Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308

    English

    Survival Information; Form D; Termination Record

    1 forms  
    Survival Information - Month of Report
    Description

    Survival Information - Month of Report

    Alias
    UMLS CUI-1
    C0038953
    UMLS CUI-2
    C0439231
    UMLS CUI-3
    C0684224
    Please mark the appropriate box to indicate month of report
    Description

    Please mark the appropriate box to indicate month of report

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439231
    UMLS CUI [1,2]
    C0684224
    If other month of report, specify
    Description

    If other month of report, specify

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439231
    UMLS CUI [1,2]
    C0684224
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    Survival Information - Review of disease status
    Description

    Survival Information - Review of disease status

    Alias
    UMLS CUI-1
    C0038953
    UMLS CUI-2
    C0012634
    UMLS CUI-3
    C0449438
    Date of Assessment
    Description

    Date of Assessment

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985720
    Disease status
    Description

    Mark only one.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0449438
    Date of Progression
    Description

    Date of Progression

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0242656
    UMLS CUI [1,2]
    C0011008
    Lesion Evaluation or Clinical Assessment
    Description

    Lesion Evaluation or Clinical Assessment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C0220825
    UMLS CUI [2]
    C4534461
    Survival Information - Outcome
    Description

    Survival Information - Outcome

    Alias
    UMLS CUI-1
    C0038953
    UMLS CUI-2
    C1547647
    Has the patient died?
    Description

    If "Yes", complete FORM D

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011065
    If patient did not die, Date of last contact
    Description

    If patient did not die, Date of last contact

    Data type

    date

    Alias
    UMLS CUI [1]
    C0805839
    Was the patient lost to follow-up?
    Description

    Was the patient lost to follow-up?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1302313
    Form D
    Description

    Form D

    Alias
    UMLS CUI-1
    C0011065
    Primary Cause of Death
    Description

    Primary Cause of Death

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0007465
    If Progressive Disease, specify details
    Description

    If Progressive Disease, specify details

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1335499
    UMLS CUI [1,2]
    C2348235
    UMLS CUI [1,3]
    C1522508
    If Toxicity, specify details
    Description

    If Toxicity, specify details

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0040539
    UMLS CUI [1,2]
    C2348235
    UMLS CUI [1,3]
    C1522508
    If other cause of Death, specify
    Description

    If other cause of Death, specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0007465
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    Date of Death
    Description

    Date of Death

    Data type

    date

    Alias
    UMLS CUI [1]
    C1148348
    Was an Autopsy performed?
    Description

    Was an Autopsy performed?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0004398
    UMLS CUI [1,2]
    C0884358
    If Autopsy was performed, please summarize findings
    Description

    Include diagnosis

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0004398
    UMLS CUI [1,2]
    C0243095
    Investigator's Signauture
    Description

    I certify that I have reviewed the follow-up data and that all information is complete and accurate

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date of Investigator's Signature
    Description

    Date of Investigator's Signature

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Termination Record
    Description

    Termination Record

    Alias
    UMLS CUI-1
    C0871548
    Date of last dose of study medication
    Description

    Date of last dose of study medication

    Data type

    date

    Alias
    UMLS CUI [1]
    C1762893
    Date of last visit
    Description

    Date of last visit

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1320303
    UMLS CUI [1,2]
    C1517741
    Termination Record - Review of Disease Status
    Description

    Termination Record - Review of Disease Status

    Alias
    UMLS CUI-1
    C0871548
    UMLS CUI-2
    C0012634
    UMLS CUI-3
    C0449438
    Date of Assessment
    Description

    Date of Assessment

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985720
    Disease status
    Description

    Mark only one.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0449438
    Date of Progression
    Description

    Date of Progression

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0242656
    UMLS CUI [1,2]
    C0011008
    Lesion Evaluation or Clinical Assessment
    Description

    Lesion Evaluation or Clinical Assessment

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C0220825
    UMLS CUI [2]
    C4534461
    Termination Record - Best Overall Response
    Description

    Termination Record - Best Overall Response

    Alias
    UMLS CUI-1
    C0871548
    UMLS CUI-2
    C2986560
    Please indicate Best Overall Response
    Description

    Please indicate Best Overall Response

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2986560
    Termination Record - Study Conclusion
    Description

    Termination Record - Study Conclusion

    Alias
    UMLS CUI-1
    C0871548
    UMLS CUI-2
    C1707478
    UMLS CUI-3
    C0008972
    Mark the primary cause of study conclusion
    Description

    Mark the primary cause of study conclusion

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1707478
    UMLS CUI [1,2]
    C0008972
    UMLS CUI [1,3]
    C0085978
    If other cause of study conclusion, specify
    Description

    If other cause of study conclusion, specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0008972
    UMLS CUI [1,2]
    C0085978
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    Termination Record - Investigator Signature
    Description

    Termination Record - Investigator Signature

    Alias
    UMLS CUI-1
    C0871548
    UMLS CUI-2
    C2346576
    Investigator's Signature
    Description

    I certify that I have reviewed the data on the case report form, including laboratory data, and the Adverse Event and Serious Adverse Event sections, and that all information is complete and accurate.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Investigator's Signature - Date Signed
    Description

    Investigator's Signature - Date Signed

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
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    Similar models

    Survival Information; Form D; Termination Record

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Survival Information - Month of Report
    C0038953 (UMLS CUI-1)
    C0439231 (UMLS CUI-2)
    C0684224 (UMLS CUI-3)
    Item
    Please mark the appropriate box to indicate month of report
    integer
    C0439231 (UMLS CUI [1,1])
    C0684224 (UMLS CUI [1,2])
    Please mark the appropriate box to indicate month of report
    Code List
    Please mark the appropriate box to indicate month of report
    CL Item
    3 (1)
    CL Item
    6 (2)
    CL Item
    9 (3)
    CL Item
    12 (4)
    CL Item
    15 (5)
    CL Item
    18 (6)
    CL Item
    21 (7)
    CL Item
    24 (8)
    CL Item
    Other, specify (9)
    If other month of report, specify
    Item
    If other month of report, specify
    integer
    C0439231 (UMLS CUI [1,1])
    C0684224 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Item Group
    Survival Information - Review of disease status
    C0038953 (UMLS CUI-1)
    C0012634 (UMLS CUI-2)
    C0449438 (UMLS CUI-3)
    Date of Assessment
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1])
    Item
    Disease status
    integer
    C0012634 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Disease status
    Code List
    Disease status
    CL Item
    Not Applicable (disease progression previously established) (1)
    CL Item
    Non-evaluable (2)
    CL Item
    Complete Response (3)
    CL Item
    Partial Response (4)
    CL Item
    Stable Disease (5)
    CL Item
    Disease Progression (6)
    Date of Progression
    Item
    Date of Progression
    date
    C0242656 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Lesion Evaluation or Clinical Assessment
    text
    C0221198 (UMLS CUI [1,1])
    C0220825 (UMLS CUI [1,2])
    C4534461 (UMLS CUI [2])
    Lesion Evaluation or Clinical Assessment
    Code List
    Lesion Evaluation or Clinical Assessment
    CL Item
    Lesion Evaluation (1)
    CL Item
    Clinical Assessment (2)
    Item Group
    Survival Information - Outcome
    C0038953 (UMLS CUI-1)
    C1547647 (UMLS CUI-2)
    Has the patient died?
    Item
    Has the patient died?
    boolean
    C0011065 (UMLS CUI [1])
    If patient did not die, Date of last contact
    Item
    If patient did not die, Date of last contact
    date
    C0805839 (UMLS CUI [1])
    Was the patient lost to follow-up?
    Item
    Was the patient lost to follow-up?
    boolean
    C1302313 (UMLS CUI [1])
    Item Group
    Form D
    C0011065 (UMLS CUI-1)
    Item
    Primary Cause of Death
    integer
    C0007465 (UMLS CUI [1])
    Primary Cause of Death
    Code List
    Primary Cause of Death
    CL Item
    Progressive Disease, specify details (1)
    CL Item
    Toxicity, specify details (2)
    CL Item
    Other, specify (3)
    If Progressive Disease, specify details
    Item
    If Progressive Disease, specify details
    text
    C1335499 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    C1522508 (UMLS CUI [1,3])
    If Toxicity, specify details
    Item
    If Toxicity, specify details
    text
    C0040539 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    C1522508 (UMLS CUI [1,3])
    If other cause of Death, specify
    Item
    If other cause of Death, specify
    text
    C0007465 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Date of Death
    Item
    Date of Death
    date
    C1148348 (UMLS CUI [1])
    Was an Autopsy performed?
    Item
    Was an Autopsy performed?
    boolean
    C0004398 (UMLS CUI [1,1])
    C0884358 (UMLS CUI [1,2])
    If Autopsy was performed, please summarize findings
    Item
    If Autopsy was performed, please summarize findings
    text
    C0004398 (UMLS CUI [1,1])
    C0243095 (UMLS CUI [1,2])
    Investigator's Signauture
    Item
    Investigator's Signauture
    text
    C2346576 (UMLS CUI [1])
    Date of Investigator's Signature
    Item
    Date of Investigator's Signature
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Termination Record
    C0871548 (UMLS CUI-1)
    Date of last dose of study medication
    Item
    Date of last dose of study medication
    date
    C1762893 (UMLS CUI [1])
    Date of last visit
    Item
    Date of last visit
    date
    C1320303 (UMLS CUI [1,1])
    C1517741 (UMLS CUI [1,2])
    Item Group
    Termination Record - Review of Disease Status
    C0871548 (UMLS CUI-1)
    C0012634 (UMLS CUI-2)
    C0449438 (UMLS CUI-3)
    Date of Assessment
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1])
    Item
    Disease status
    integer
    C0012634 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Disease status
    Code List
    Disease status
    CL Item
    Non-evaluable  (1)
    CL Item
    Complete Response  (2)
    CL Item
    Partial Response  (3)
    CL Item
    Stable Disease  (4)
    CL Item
    Disease Progression (5)
    Date of Progression
    Item
    Date of Progression
    date
    C0242656 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Lesion Evaluation or Clinical Assessment
    integer
    C0221198 (UMLS CUI [1,1])
    C0220825 (UMLS CUI [1,2])
    C4534461 (UMLS CUI [2])
    Lesion Evaluation or Clinical Assessment
    Code List
    Lesion Evaluation or Clinical Assessment
    CL Item
    Lesion Evaluation  (1)
    CL Item
    Clinical Assessment (2)
    Item Group
    Termination Record - Best Overall Response
    C0871548 (UMLS CUI-1)
    C2986560 (UMLS CUI-2)
    Item
    Please indicate Best Overall Response
    integer
    C2986560 (UMLS CUI [1])
    Please indicate Best Overall Response
    Code List
    Please indicate Best Overall Response
    CL Item
    Complete Response (1)
    CL Item
    Partial Response (2)
    CL Item
    Stable Disease (3)
    CL Item
    Progressive Disease (4)
    CL Item
    Non-evaluable for response (5)
    Item Group
    Termination Record - Study Conclusion
    C0871548 (UMLS CUI-1)
    C1707478 (UMLS CUI-2)
    C0008972 (UMLS CUI-3)
    Item
    Mark the primary cause of study conclusion
    integer
    C1707478 (UMLS CUI [1,1])
    C0008972 (UMLS CUI [1,2])
    C0085978 (UMLS CUI [1,3])
    Mark the primary cause of study conclusion
    Code List
    Mark the primary cause of study conclusion
    CL Item
    Adverse Event (complete Adverse Event Case Report Form.)  (1)
    CL Item
    Progressive Disease (ie Lack of Efficacy)  (2)
    CL Item
    Protocol deviation (including non-compliance)  (3)
    CL Item
    Lost to follow-up  (4)
    CL Item
    Death - Please complete the Death Report form (Form D).  (5)
    CL Item
    Patient withdrawn at her own request, for reasons other that those above.  (6)
    CL Item
    Other, specify (7)
    If other cause of study conclusion, specify
    Item
    If other cause of study conclusion, specify
    text
    C0008972 (UMLS CUI [1,1])
    C0085978 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Item Group
    Termination Record - Investigator Signature
    C0871548 (UMLS CUI-1)
    C2346576 (UMLS CUI-2)
    Investigator's Signature
    Item
    Investigator's Signature
    text
    C2346576 (UMLS CUI [1])
    Investigator's Signature - Date Signed
    Item
    Investigator's Signature - Date Signed
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
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