ID

37961

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

Keywords

Versions (1)
  1. 9/2/19 9/2/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 2, 2019

DOI

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License

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

    Course -- Prior to next Course (Day 25 - 28) - Vital Signs; Tumor Marker (CA-125); Laboratory Tests; Lesion Assessment Record

    1 forms  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Center Number
    Description

    Center Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Patient Number
    Description

    Patient Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C1709561
    Patient ID
    Description

    Patient ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Date of Visit
    Description

    Date of Visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Visit not done or Withdrawal from Study
    Description

    Visit not done or Withdrawal from Study

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1272696
    UMLS CUI [2]
    C0422727
    Course Number
    Description

    Course Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0237753
    UMLS CUI [1,2]
    C0750729
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Systolic Blood Pressure
    Description

    Sitting (after 5 mins.)

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0871470
    mm[Hg]
    Diastolic Blood Pressure
    Description

    Sitting after (5 mins.)

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0428883
    mm[Hg]
    Pulse
    Description

    Sitting (after 5 mins.)

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    beats/min
    Temperature
    Description

    Temperature

    Data type

    float

    Alias
    UMLS CUI [1]
    C0005903
    Temperature Unit
    Description

    Temperature Unit

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0005903
    UMLS CUI [1,2]
    C1519795
    Tumor Marker (CA-125)
    Description

    Tumor Marker (CA-125)

    Alias
    UMLS CUI-1
    C0041365
    UMLS CUI-2
    C0201549
    Tumor Marker Sample Date
    Description

    Tumor Marker Sample Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0041365
    UMLS CUI [1,2]
    C0201549
    UMLS CUI [1,3]
    C1302413
    Laboratory Name
    Description

    Laboratory Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C3258037
    Tumor Marker Value
    Description

    Tumor Marker Value

    Data type

    integer

    Measurement units
    • U/mL
    Alias
    UMLS CUI [1,1]
    C0041365
    UMLS CUI [1,2]
    C0201549
    U/mL
    Laboratory Tests - Haematology
    Description

    Laboratory Tests - Haematology

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0474523
    Haematology - Sample Date
    Description

    Haematology - Sample Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1302413
    UMLS CUI [1,2]
    C0018941
    Haematology - Laboratory Name
    Description

    Haematology - Laboratory Name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3258037
    UMLS CUI [1,2]
    C0018941
    Laboratory Tests - Haematology
    Description

    Laboratory Tests - Haematology

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0474523
    Haematology Test
    Description

    Haematology Test

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0018941
    Haematology - No Result
    Description

    Haematology - No Result

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0018941
    UMLS CUI [1,2]
    C1274040
    Haematology - Value
    Description

    Haematology - Value

    Data type

    text

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

    Haematology - Value out of range and NOT clinically significant

    Data type

    integer

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

    Haematology - Value out of range and clinically significant

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C0438215
    UMLS CUI [1,3]
    C2826293
    Laboratory Tests - Chemistry
    Description

    Laboratory Tests - Chemistry

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0008000
    Chemistry - Sample Date
    Description

    Chemistry - Sample Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1302413
    UMLS CUI [1,2]
    C0008000
    Chemistry - Laboratory Name
    Description

    Chemistry - Laboratory Name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3258037
    UMLS CUI [1,2]
    C0008000
    Laboratory Tests - Chemistry
    Description

    Laboratory Tests - Chemistry

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0008000
    Chemistry - Test
    Description

    Chemistry - Test

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0525044
    Chemistry - No Result
    Description

    Chemistry - No Result

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C1274040
    Chemistry - Value
    Description

    Chemistry - Value

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C1274040
    Chemistry - Value out of range and NOT clinically significant
    Description

    Chemistry - Value out of range and NOT clinically significant

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C1274040
    UMLS CUI [1,3]
    C0438215
    UMLS CUI [1,4]
    C2826293
    Chemistry - Value out of range and NOT clinically significant
    Description

    Chemistry - Value out of range and NOT clinically significant

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C1274040
    UMLS CUI [1,3]
    C0438215
    UMLS CUI [1,4]
    C2826293
    Lesion Assessment
    Description

    Lesion Assessment

    Alias
    UMLS CUI-1
    C0221198
    UMLS CUI-2
    C1516048
    Was Lesion Assessment done at this course?
    Description

    Was Lesion Assessment done at this course?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C1516048
    Lesion Assessment Record
    Description

    Lesion Assessment Record

    Alias
    UMLS CUI-1
    C0221198
    UMLS CUI-2
    C1516048
    Lesion No.
    Description

    Lesion No.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0237753
    UMLS CUI [1,2]
    C0221198
    Lesion Site Code
    Description

    Lesion Site Code

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0449695
    UMLS CUI [1,2]
    C0805701
    Lesion Site Description
    Description

    Lesion Site Description

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0449695
    UMLS CUI [1,2]
    C0678257
    Lesion Measurement - Method Code
    Description

    Lesion Measurement - Method Code

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1299991
    UMLS CUI [1,2]
    C0221198
    UMLS CUI [1,3]
    C2911685
    UMLS CUI [1,4]
    C0805701
    Lesion Measurement - Date Performed
    Description

    Lesion Measurement - Date Performed

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1299991
    UMLS CUI [1,2]
    C0221198
    UMLS CUI [1,3]
    C0011008
    Measurable/ Non measurable Lesion Code
    Description

    Measurable/ Non measurable Lesion Code

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C1513040
    UMLS CUI [2]
    C1334988
    Lesion Size - 1. Diameter (cm)
    Description

    Lesion Size - 1. Diameter (cm)

    Data type

    float

    Measurement units
    • cm
    Alias
    UMLS CUI [1,1]
    C0449453
    UMLS CUI [1,2]
    C1301886
    cm
    Lesion Size - 2. Diameter (cm)
    Description

    Lesion Size - 2. Diameter (cm)

    Data type

    float

    Measurement units
    • cm
    Alias
    UMLS CUI [1,1]
    C0449453
    UMLS CUI [1,2]
    C1301886
    cm
    Lesion Non-Evaluable
    Description

    Lesion Non-Evaluable

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C1883425
    Lesion Non-Evaluable - Lesion Measurement Method Code
    Description

    Lesion Non-Evaluable - Lesion Measurement Method Code

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C1883425
    UMLS CUI [1,3]
    C1299991
    UMLS CUI [1,4]
    C0805701
    Lesion Non-Evaluable - Date Performed
    Description

    Lesion Non-Evaluable - Date Performed

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C1883425
    UMLS CUI [1,3]
    C0011008
    Lesion Non-Evaluable Status
    Description

    Lesion Non-Evaluable Status

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C1883425
    UMLS CUI [1,3]
    C0449438
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    Course -- Prior to next Course (Day 25 - 28) - Vital Signs; Tumor Marker (CA-125); Laboratory Tests; Lesion Assessment Record

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Center Number
    Item
    Center Number
    text
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Patient Number
    Item
    Patient Number
    text
    C1709561 (UMLS CUI [1])
    Patient ID
    Item
    Patient ID
    text
    C2348585 (UMLS CUI [1])
    Date of Visit
    Item
    Date of Visit
    date
    C1320303 (UMLS CUI [1])
    Item
    Visit not done or Withdrawal from Study
    text
    C0545082 (UMLS CUI [1,1])
    C1272696 (UMLS CUI [1,2])
    C0422727 (UMLS CUI [2])
    Visit not done or Withdrawal from Study
    Code List
    Visit not done or Withdrawal from Study
    CL Item
    Visit Not Done (1)
    CL Item
    Withdrawal from study (2)
    Course Number
    Item
    Course Number
    integer
    C0237753 (UMLS CUI [1,1])
    C0750729 (UMLS CUI [1,2])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Systolic Blood Pressure
    Item
    Systolic Blood Pressure
    integer
    C0871470 (UMLS CUI [1])
    Diastolic Blood Pressure
    Item
    Diastolic Blood Pressure
    integer
    C0428883 (UMLS CUI [1])
    Pulse
    Item
    Pulse
    integer
    C0232117 (UMLS CUI [1])
    Temperature
    Item
    Temperature
    float
    C0005903 (UMLS CUI [1])
    Item
    Temperature Unit
    integer
    C0005903 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    Temperature Unit
    Code List
    Temperature Unit
    CL Item
    °C (1)
    CL Item
    °F (2)
    Item Group
    Tumor Marker (CA-125)
    C0041365 (UMLS CUI-1)
    C0201549 (UMLS CUI-2)
    Tumor Marker Sample Date
    Item
    Tumor Marker Sample Date
    date
    C0041365 (UMLS CUI [1,1])
    C0201549 (UMLS CUI [1,2])
    C1302413 (UMLS CUI [1,3])
    Laboratory Name
    Item
    Laboratory Name
    text
    C3258037 (UMLS CUI [1])
    Tumor Marker Value
    Item
    Tumor Marker Value
    integer
    C0041365 (UMLS CUI [1,1])
    C0201549 (UMLS CUI [1,2])
    Item Group
    Laboratory Tests - Haematology
    C0022885 (UMLS CUI-1)
    C0474523 (UMLS CUI-2)
    Haematology - Sample Date
    Item
    Haematology - Sample Date
    date
    C1302413 (UMLS CUI [1,1])
    C0018941 (UMLS CUI [1,2])
    Haematology - Laboratory Name
    Item
    Haematology - Laboratory Name
    text
    C3258037 (UMLS CUI [1,1])
    C0018941 (UMLS CUI [1,2])
    Item Group
    Laboratory Tests - Haematology
    C0022885 (UMLS CUI-1)
    C0474523 (UMLS CUI-2)
    Item
    Haematology Test
    integer
    C0018941 (UMLS CUI [1])
    Haematology Test
    Code List
    Haematology 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
    Haematology - No Result
    integer
    C0018941 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Haematology - No Result
    Code List
    Haematology - No Result
    CL Item
    No Result (1)
    Haematology - Value
    Item
    Haematology - Value
    text
    C0474523 (UMLS CUI [1])
    Item
    Haematology - 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
    Haematology - Value out of range and NOT clinically significant
    CL Item
    Value out of range and NOT clinically significant (2)
    Item
    Haematology - 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
    Haematology - Value out of range and clinically significant
    CL Item
    Value out of range and clinically significant (3)
    Item Group
    Laboratory Tests - Chemistry
    C0022885 (UMLS CUI-1)
    C0008000 (UMLS CUI-2)
    Chemistry - Sample Date
    Item
    Chemistry - Sample Date
    date
    C1302413 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    Chemistry - Laboratory Name
    Item
    Chemistry - Laboratory Name
    text
    C3258037 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    Item Group
    Laboratory Tests - Chemistry
    C0022885 (UMLS CUI-1)
    C0008000 (UMLS CUI-2)
    Item
    Chemistry - Test
    integer
    C0525044 (UMLS CUI [1])
    Chemistry - Test
    Code List
    Chemistry - Test
    CL Item
    Total Protein  (1)
    CL Item
    Albumin  (2)
    CL Item
    Total Bilirubin  (3)
    CL Item
    SGPT (ALT)  (4)
    CL Item
    SGOT (AST)  (5)
    CL Item
    Alkaline Phosphatase  (6)
    CL Item
    Glucose  (7)
    CL Item
    LDH  (8)
    CL Item
    BUN  (9)
    CL Item
    Serum Creatinine  (10)
    CL Item
    Uric Acid  (11)
    CL Item
    Calcium  (12)
    CL Item
    Phosphorus  (13)
    CL Item
    Sodium  (14)
    CL Item
    Potassium  (15)
    CL Item
    Chloride  (16)
    CL Item
    Bicarbonate (17)
    Item
    Chemistry - No Result
    integer
    C0008000 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Chemistry - No Result
    Code List
    Chemistry - No Result
    CL Item
    No Result (1)
    Chemistry - Value
    Item
    Chemistry - Value
    text
    C0008000 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Item
    Chemistry - Value out of range and NOT clinically significant
    integer
    C0008000 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    C0438215 (UMLS CUI [1,3])
    C2826293 (UMLS CUI [1,4])
    Chemistry - Value out of range and NOT clinically significant
    Code List
    Chemistry - Value out of range and NOT clinically significant
    CL Item
    Value out of range and NOT clinically significant (2)
    Item
    Chemistry - Value out of range and NOT clinically significant
    integer
    C0008000 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    C0438215 (UMLS CUI [1,3])
    C2826293 (UMLS CUI [1,4])
    Chemistry - Value out of range and NOT clinically significant
    Code List
    Chemistry - Value out of range and NOT clinically significant
    CL Item
    Value out of range and clinically significant (3)
    Item Group
    Lesion Assessment
    C0221198 (UMLS CUI-1)
    C1516048 (UMLS CUI-2)
    Was Lesion Assessment done at this course?
    Item
    Was Lesion Assessment done at this course?
    boolean
    C0221198 (UMLS CUI [1,1])
    C1516048 (UMLS CUI [1,2])
    Item Group
    Lesion Assessment Record
    C0221198 (UMLS CUI-1)
    C1516048 (UMLS CUI-2)
    Lesion No.
    Item
    Lesion No.
    integer
    C0237753 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    Item
    Lesion Site Code
    integer
    C0449695 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    Lesion Site Code
    Code List
    Lesion Site Code
    CL Item
    Abdominal/Pelvic  (01)
    CL Item
    Hepatic  (02)
    CL Item
    Pulmonary  (03)
    CL Item
    Lymph Node  (04)
    CL Item
    Chest Wall  (05)
    CL Item
    Other (99)
    Lesion Site Description
    Item
    Lesion Site Description
    text
    C0449695 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    Item
    Lesion Measurement - Method Code
    integer
    C1299991 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    C2911685 (UMLS CUI [1,3])
    C0805701 (UMLS CUI [1,4])
    Method Code
    Code List
    Lesion Measurement - Method Code
    CL Item
    Physical Measurement  (01)
    CL Item
    CT scan  (02)
    CL Item
    MRI scan  (03)
    CL Item
    Radiography  (04)
    CL Item
    Chest X-Ray  (05)
    CL Item
    Radionuclide scan  (06)
    CL Item
    Other (99)
    Lesion Measurement - Date Performed
    Item
    Lesion Measurement - Date Performed
    date
    C1299991 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Measurable/ Non measurable Lesion Code
    integer
    C0221198 (UMLS CUI [1,1])
    C1513040 (UMLS CUI [1,2])
    C1334988 (UMLS CUI [2])
    Measurable/ Non measurable Lesion Code
    Code List
    Measurable/ Non measurable Lesion Code
    CL Item
    Measurable (1)
    CL Item
    Non-measurable (2)
    Lesion Size - 1. Diameter (cm)
    Item
    Lesion Size - 1. Diameter (cm)
    float
    C0449453 (UMLS CUI [1,1])
    C1301886 (UMLS CUI [1,2])
    Lesion Size - 2. Diameter (cm)
    Item
    Lesion Size - 2. Diameter (cm)
    float
    C0449453 (UMLS CUI [1,1])
    C1301886 (UMLS CUI [1,2])
    Item
    Lesion Non-Evaluable
    integer
    C0221198 (UMLS CUI [1,1])
    C1883425 (UMLS CUI [1,2])
    Lesion Non-Evaluable
    Code List
    Lesion Non-Evaluable
    CL Item
    Ascites (1)
    CL Item
    Bone Metastases (2)
    CL Item
    Pleural Effusion (3)
    Item
    Lesion Non-Evaluable - Lesion Measurement Method Code
    integer
    C0221198 (UMLS CUI [1,1])
    C1883425 (UMLS CUI [1,2])
    C1299991 (UMLS CUI [1,3])
    C0805701 (UMLS CUI [1,4])
    Lesion Non-Evaluable - Lesion Measurement Method Code
    Code List
    Lesion Non-Evaluable - Lesion Measurement Method Code
    CL Item
    Physical Measurement  (01)
    CL Item
    CT scan  (02)
    CL Item
    MRI scan (03)
    CL Item
    Radiography (04)
    CL Item
    Chest X-Ray  (05)
    CL Item
    Radionuclide scan  (06)
    CL Item
    Other (99)
    Lesion Non-Evaluable - Date Performed
    Item
    Lesion Non-Evaluable - Date Performed
    date
    C0221198 (UMLS CUI [1,1])
    C1883425 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Lesion Non-Evaluable Status
    integer
    C0221198 (UMLS CUI [1,1])
    C1883425 (UMLS CUI [1,2])
    C0449438 (UMLS CUI [1,3])
    Lesion Non-Evaluable Status
    Code List
    Lesion Non-Evaluable Status
    CL Item
    Not Done (1)
    CL Item
    Present (2)
    CL Item
    Absent (3)
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