ID

37939

Descrição

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

Palavras-chave

Versões (1)
  1. 01/09/2019 01/09/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

1 de setembro de 2019

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

  • Os mais recentes
  • Os mais antigos
  • Preferidos
  • Os mais recentes
    • Os mais recentes
    • Os mais antigos
    • Preferidos

    Sem comentários

    Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

    Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308

    Inglês

    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

    1 Formulários  
    Administrative
    Descrição

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Center Number
    Descrição

    Center Number

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0600091
    Patient Number
    Descrição

    Patient Number

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1709561
    Patient ID
    Descrição

    Patient ID

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2348585
    Review of Disease Status
    Descrição

    Review of Disease Status

    Alias
    UMLS CUI-1
    C0699749
    UMLS CUI-2
    C0699752
    Date of Assessment
    Descrição

    Date of Assessment

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C2985720
    Assessment not done
    Descrição

    Assessment not done

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0220825
    UMLS CUI [1,2]
    C1272696
    Reason for assessment not done
    Descrição

    Mark only one

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0220825
    UMLS CUI [1,2]
    C2826287
    Date of Progression
    Descrição

    Date of Progression

    Tipo de dados

    date

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

    Mark one

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C1516048
    UMLS CUI [2]
    C4534461
    Therapeutic Interventions
    Descrição

    Therapeutic Interventions

    Alias
    UMLS CUI-1
    C0808232
    Were any therapeutic interventions administered during this course to ameliorate toxicities associated with study drug?
    Descrição

    If “Yes", complete Therapeutic Interventions log.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0808232
    UMLS CUI [2,1]
    C0013221
    UMLS CUI [2,2]
    C0304229
    End of Course Eligibility
    Descrição

    End of Course Eligibility

    Alias
    UMLS CUI-1
    C0013893
    UMLS CUI-2
    C0750729
    UMLS CUI-3
    C0444930
    Did the patient meet the following criteria by Day 28?
    Descrição

    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.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0013893
    Unscheduled Laboratory Tests - Hematology
    Descrição

    Unscheduled Laboratory Tests - Hematology

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C3854240
    UMLS CUI-3
    C0474523
    Hematology Sample Date
    Descrição

    Hematology Sample Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C1302413
    Hematology Laboratory Name
    Descrição

    Hematology Laboratory Name

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C3258037
    Unscheduled Laboratory Tests - Hematology
    Descrição

    Unscheduled Laboratory Tests - Hematology

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C3854240
    UMLS CUI-3
    C0474523
    Hematology Test
    Descrição

    Hematology Test

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0018941
    Hematology - No Result
    Descrição

    Hematology - No Result

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0018941
    UMLS CUI [1,2]
    C1274040
    Hematology - Value
    Descrição

    Hematology - Value

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0474523
    Hematology - Value out of range and NOT clinically significant
    Descrição

    Hematology - Value out of range and NOT clinically significant

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C0438215
    UMLS CUI [1,3]
    C2826293
    Hematology - Value out of range and clinically significant
    Descrição

    Hematology - Value out of range and clinically significant

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C0438215
    UMLS CUI [1,3]
    C2826293
    Therapeutic Interventions
    Descrição

    Therapeutic Interventions

    Alias
    UMLS CUI-1
    C0808232
    Line Number
    Descrição

    Line Number

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0449788
    Procedure
    Descrição

    Procedure

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2700391
    Procedure details
    Descrição

    Procedure details

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C2700391
    UMLS CUI [1,2]
    C1522508
    Procedure Time
    Descrição

    Procedure Time

    Tipo de dados

    time

    Alias
    UMLS CUI [1,1]
    C2700391
    UMLS CUI [1,2]
    C0040223
    Procedure Date
    Descrição

    Procedure Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C2700391
    UMLS CUI [1,2]
    C0011008
    Voltar ao início da página

    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

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    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])
    Assessment not done
    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])
    Reason for assessment not done
    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])
    Lesion Evaluation or Clinical Assessment
    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])
    Haematology Test
    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])
    Haematology - No Result
    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])
    Haematology - Value out of range and NOT clinically significant
    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])
    Haematology - Value out of range and clinically significant
    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])
    Voltar ao início da página 

    Ajuda

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial