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37939

Beskrivning

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

Nyckelord

  1. 2019-09-01 2019-09-01 -
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GlaxoSmithKline

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1 september 2019

DOI

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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

    Course 3 Prior to next Course (Day 25 - 28) - Review of Disease Status; Therapeutic Interventions; End of Course Eligibility; Unscheduled Laboratory Tests; Therapeutic Interventions Log

    Administrative
    Beskrivning

    Administrative

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

    Center Number

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1301943 (Institution name)
    SNOMED
    398321007
    UMLS CUI [1,2]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Patient Number
    Beskrivning

    Patient Number

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1709561 (Planned Subject Number)
    Patient ID
    Beskrivning

    Patient ID

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Review of Disease Status
    Beskrivning

    Review of Disease Status

    Alias
    UMLS CUI-1
    C0699749 (disease stage)
    UMLS CUI-2
    C0699752 (Review of)
    SNOMED
    55210009
    Date of Assessment
    Beskrivning

    Date of Assessment

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2985720 (Assessment Date)
    Assessment not done
    Beskrivning

    Assessment not done

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0220825 (Evaluation)
    LOINC
    LP36377-7
    UMLS CUI [1,2]
    C1272696 (Not Done)
    SNOMED
    385660001
    Reason for assessment not done
    Beskrivning

    Mark only one

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0220825 (Evaluation)
    LOINC
    LP36377-7
    UMLS CUI [1,2]
    C2826287 (Not-Done Reason)
    Date of Progression
    Beskrivning

    Date of Progression

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0242656 (Disease Progression)
    SNOMED
    246453008
    LOINC
    LP121764-7
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Lesion Evaluation or Clinical Assessment
    Beskrivning

    Mark one

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0221198 (Lesion)
    SNOMED
    52988006
    UMLS CUI [1,2]
    C1516048 (Assessed)
    UMLS CUI [2]
    C4534461 (Clinical assessment)
    LOINC
    LA27942-4
    Therapeutic Interventions
    Beskrivning

    Therapeutic Interventions

    Alias
    UMLS CUI-1
    C0808232 (Therapeutic Intervention)
    Were any therapeutic interventions administered during this course to ameliorate toxicities associated with study drug?
    Beskrivning

    If “Yes", complete Therapeutic Interventions log.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0808232 (Therapeutic Intervention)
    UMLS CUI [2,1]
    C0013221 (Drug toxicity)
    SNOMED
    7895008
    UMLS CUI [2,2]
    C0304229 (Experimental drug)
    End of Course Eligibility
    Beskrivning

    End of Course Eligibility

    Alias
    UMLS CUI-1
    C0013893 (Eligibility Determination)
    UMLS CUI-2
    C0750729 (Course)
    SNOMED
    288524001
    UMLS CUI-3
    C0444930 (End)
    SNOMED
    261782000
    Did the patient meet the following criteria by Day 28?
    Beskrivning

    Hemoglobin >= 9.0 g/dL [90 g/L] Neutrophils >= 1000 cells/mm3 [>= 1.0 x 10*9 /L] Platelets >= 100,000/mm3 [>= 100.0 x 10*9 /L] No clinically significant non-hematologic drug related toxicity If "Yes“, proceed to next course. If "No”, complete Unscheduled Laboratory Tests.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0013893 (Eligibility Determination)
    Unscheduled Laboratory Tests - Hematology
    Beskrivning

    Unscheduled Laboratory Tests - Hematology

    Alias
    UMLS CUI-1
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    UMLS CUI-2
    C3854240 (Unscheduled)
    SNOMED
    2341000175109
    LOINC
    LA22869-4
    UMLS CUI-3
    C0474523 (Hematology finding)
    SNOMED
    250207003
    Hematology Sample Date
    Beskrivning

    Hematology Sample Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0474523 (Hematology finding)
    SNOMED
    250207003
    UMLS CUI [1,2]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    Hematology Laboratory Name
    Beskrivning

    Hematology Laboratory Name

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0474523 (Hematology finding)
    SNOMED
    250207003
    UMLS CUI [1,2]
    C3258037 (Performing laboratory name)
    LOINC
    LP135668-4
    Unscheduled Laboratory Tests - Hematology
    Beskrivning

    Unscheduled Laboratory Tests - Hematology

    Alias
    UMLS CUI-1
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    UMLS CUI-2
    C3854240 (Unscheduled)
    SNOMED
    2341000175109
    LOINC
    LA22869-4
    UMLS CUI-3
    C0474523 (Hematology finding)
    SNOMED
    250207003
    Hematology Test
    Beskrivning

    Hematology Test

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0018941 (Hematologic Tests)
    SNOMED
    252275004
    Hematology - No Result
    Beskrivning

    Hematology - No Result

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0018941 (Hematologic Tests)
    SNOMED
    252275004
    UMLS CUI [1,2]
    C1274040 (Result)
    SNOMED
    394617004
    Hematology - Value
    Beskrivning

    Hematology - Value

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0474523 (Hematology finding)
    SNOMED
    250207003
    Hematology - Value out of range and NOT clinically significant
    Beskrivning

    Hematology - Value out of range and NOT clinically significant

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0474523 (Hematology finding)
    SNOMED
    250207003
    UMLS CUI [1,2]
    C0438215 (Laboratory test result abnormal)
    SNOMED
    165346000
    UMLS CUI [1,3]
    C2826293 (Clinical Significance)
    Hematology - Value out of range and clinically significant
    Beskrivning

    Hematology - Value out of range and clinically significant

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0474523 (Hematology finding)
    SNOMED
    250207003
    UMLS CUI [1,2]
    C0438215 (Laboratory test result abnormal)
    SNOMED
    165346000
    UMLS CUI [1,3]
    C2826293 (Clinical Significance)
    Therapeutic Interventions
    Beskrivning

    Therapeutic Interventions

    Alias
    UMLS CUI-1
    C0808232 (Therapeutic Intervention)
    Line Number
    Beskrivning

    Line Number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0449788 (Count of entities)
    SNOMED
    410681005
    Procedure
    Beskrivning

    Procedure

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2700391 (Procedure (set of actions))
    Procedure details
    Beskrivning

    Procedure details

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2700391 (Procedure (set of actions))
    UMLS CUI [1,2]
    C1522508 (Details)
    LOINC
    MTHU027859
    Procedure Time
    Beskrivning

    Procedure Time

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C2700391 (Procedure (set of actions))
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Procedure Date
    Beskrivning

    Procedure Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C2700391 (Procedure (set of actions))
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006

    Similar models

    Course 3 Prior to next Course (Day 25 - 28) - Review of Disease Status; Therapeutic Interventions; End of Course Eligibility; Unscheduled Laboratory Tests; Therapeutic Interventions Log

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Center Number
    Item
    Center Number
    text
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Patient Number
    Item
    Patient Number
    text
    C1709561 (UMLS CUI [1])
    Patient ID
    Item
    Patient ID
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Review of Disease Status
    C0699749 (UMLS CUI-1)
    C0699752 (UMLS CUI-2)
    Date of Assessment
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1])
    Item
    Assessment not done
    integer
    C0220825 (UMLS CUI [1,1])
    C1272696 (UMLS CUI [1,2])
    Code List
    Assessment not done
    CL Item
    Not Done (1)
    Item
    Reason for assessment not done
    integer
    C0220825 (UMLS CUI [1,1])
    C2826287 (UMLS CUI [1,2])
    Code List
    Reason for assessment not done
    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])
    C1516048 (UMLS CUI [1,2])
    C4534461 (UMLS CUI [2])
    Code List
    Lesion Evaluation or Clinical Assessment
    CL Item
    Lesion Evaluation (1)
    CL Item
    Clinical Assessment (2)
    Item Group
    Therapeutic Interventions
    C0808232 (UMLS CUI-1)
    Were any therapeutic interventions administered during this course to ameliorate toxicities associated with study drug?
    Item
    Were any therapeutic interventions administered during this course to ameliorate toxicities associated with study drug?
    boolean
    C0808232 (UMLS CUI [1])
    C0013221 (UMLS CUI [2,1])
    C0304229 (UMLS CUI [2,2])
    Item Group
    End of Course Eligibility
    C0013893 (UMLS CUI-1)
    C0750729 (UMLS CUI-2)
    C0444930 (UMLS CUI-3)
    Did the patient meet the following criteria by Day 28?
    Item
    Did the patient meet the following criteria by Day 28?
    boolean
    C0013893 (UMLS CUI [1])
    Item Group
    Unscheduled Laboratory Tests - Hematology
    C0022885 (UMLS CUI-1)
    C3854240 (UMLS CUI-2)
    C0474523 (UMLS CUI-3)
    Hematology Sample Date
    Item
    Hematology Sample Date
    date
    C0474523 (UMLS CUI [1,1])
    C1302413 (UMLS CUI [1,2])
    Hematology Laboratory Name
    Item
    Hematology Laboratory Name
    text
    C0474523 (UMLS CUI [1,1])
    C3258037 (UMLS CUI [1,2])
    Item Group
    Unscheduled Laboratory Tests - Hematology
    C0022885 (UMLS CUI-1)
    C3854240 (UMLS CUI-2)
    C0474523 (UMLS CUI-3)
    Item
    Hematology Test
    integer
    C0018941 (UMLS CUI [1])
    Code List
    Hematology Test
    CL Item
    Hemoglobin  (1)
    CL Item
    Hematocrit  (2)
    CL Item
    RBC  (3)
    CL Item
    WBC  (4)
    CL Item
    Neutrophils  (5)
    CL Item
    Bands  (6)
    CL Item
    Lymphocytes  (7)
    CL Item
    Monocytes  (8)
    CL Item
    Eosinophils  (9)
    CL Item
    Basophils  (10)
    CL Item
    Platelets  (11)
    CL Item
    Granulocytes (12)
    Item
    Hematology - No Result
    integer
    C0018941 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Code List
    Hematology - No Result
    CL Item
    No Result (1)
    Hematology - Value
    Item
    Hematology - Value
    text
    C0474523 (UMLS CUI [1])
    Item
    Hematology - Value out of range and NOT clinically significant
    integer
    C0474523 (UMLS CUI [1,1])
    C0438215 (UMLS CUI [1,2])
    C2826293 (UMLS CUI [1,3])
    Code List
    Hematology - Value out of range and NOT clinically significant
    CL Item
    Value out of range and NOT clinically significant (2)
    Item
    Hematology - Value out of range and clinically significant
    integer
    C0474523 (UMLS CUI [1,1])
    C0438215 (UMLS CUI [1,2])
    C2826293 (UMLS CUI [1,3])
    Code List
    Hematology - Value out of range and clinically significant
    CL Item
    Value out of range and clinically significant (3)
    Item Group
    Therapeutic Interventions
    C0808232 (UMLS CUI-1)
    Line Number
    Item
    Line Number
    integer
    C0449788 (UMLS CUI [1])
    Procedure
    Item
    Procedure
    text
    C2700391 (UMLS CUI [1])
    Procedure details
    Item
    Procedure details
    text
    C2700391 (UMLS CUI [1,1])
    C1522508 (UMLS CUI [1,2])
    Procedure Time
    Item
    Procedure Time
    time
    C2700391 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Procedure Date
    Item
    Procedure Date
    date
    C2700391 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])

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