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37771

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

Versioner (2)
  1. 2019-08-23 2019-08-23 -
  2. 2019-08-23 2019-08-23 -
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GlaxoSmithKline

Uppladdad den

23 augusti 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

    Engelsk

    Screening - Prior Ovarian Cancer Treatment; Laboratory Tests; Lesion Assessment Record

    1 Formulär  
    Administrative
    Beskrivning

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Center Number
    Beskrivning

    Center Number

    Datatyp

    text

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

    Patient Number

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1709561
    Patient ID
    Beskrivning

    Patient ID

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Prior Ovarian Cancer Treatment - Chemotherapy
    Beskrivning

    Prior Ovarian Cancer Treatment - Chemotherapy

    Alias
    UMLS CUI-1
    C0029925
    UMLS CUI-2
    C0920425
    UMLS CUI-3
    C0392920
    Line No.
    Beskrivning

    Line No.

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0750480
    Chemo Agent
    Beskrivning

    Chemo Agent

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0013216
    Chemotherapy Start Date
    Beskrivning

    Chemotherapy Start Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0392920
    UMLS CUI [1,2]
    C0808070
    Chemotherapy End Date
    Beskrivning

    Chemotherapy End Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0392920
    UMLS CUI [1,2]
    C0806020
    Overall response
    Beskrivning

    Overall response

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C3272903
    Has the patient received radiotherapy?
    Beskrivning

    Has the patient received radiotherapy?

    Alias
    UMLS CUI-1
    C1522449
    Has the patient received radiotherapy?
    Beskrivning

    If "Yes", please specify below.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1522449
    Prior Ovarian Cancer Treatment - Radiotherapy
    Beskrivning

    Prior Ovarian Cancer Treatment - Radiotherapy

    Alias
    UMLS CUI-1
    C0029925
    UMLS CUI-2
    C0920425
    UMLS CUI-3
    C1522449
    Line No.
    Beskrivning

    Line No.

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0750480
    Radiotherapy - Specify Area
    Beskrivning

    Radiotherapy - Specify Area

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1997599
    Radiotherapy - Dose Received
    Beskrivning

    Radiotherapy - Dose Received

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0392920
    UMLS CUI [1,2]
    C3174092
    Radiotherapy - Date
    Beskrivning

    Radiotherapy - Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0392920
    UMLS CUI [1,2]
    C0011008
    Has the patient received prior cancer-related surgery?
    Beskrivning

    Has the patient received prior cancer-related surgery?

    Alias
    UMLS CUI-1
    C0543467
    UMLS CUI-2
    C0205156
    UMLS CUI-3
    C2826292
    Has the patient received prior cancer-related surgery?
    Beskrivning

    If "Yes", please specify below.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0543467
    UMLS CUI [1,2]
    C0205156
    UMLS CUI [1,3]
    C2826292
    Prior Ovarian Cancer Treatment - Surgical Treatment
    Beskrivning

    Prior Ovarian Cancer Treatment - Surgical Treatment

    Alias
    UMLS CUI-1
    C0029925
    UMLS CUI-2
    C0920425
    UMLS CUI-3
    C0543467
    Line No.
    Beskrivning

    Line No.

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0750480
    Surgery Type
    Beskrivning

    Surgery Type

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0543467
    UMLS CUI [1,2]
    C0332307
    Surgery Date
    Beskrivning

    Surgery Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0543467
    UMLS CUI [1,2]
    C0011008
    Has the patient received other cancer-related treatments?
    Beskrivning

    Has the patient received other cancer-related treatments?

    Alias
    UMLS CUI-1
    C0920425
    UMLS CUI-2
    C0205394
    Has the patient received other cancer-related treatments?
    Beskrivning

    If "Yes", please specify below.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0920425
    UMLS CUI [1,2]
    C0205394
    Other Cancer Related Treatments
    Beskrivning

    Other Cancer Related Treatments

    Alias
    UMLS CUI-1
    C0920425
    UMLS CUI-2
    C0205394
    Line No.
    Beskrivning

    Line No.

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0750480
    Treatment
    Beskrivning

    Treatment

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0087111
    Treatment Start Date
    Beskrivning

    Treatment Start Date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C3173309
    Treatment End Date
    Beskrivning

    Treatment End Date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1531784
    Laboratory Tests (within 7 days prior to Day 1) - Haematology
    Beskrivning

    Laboratory Tests (within 7 days prior to Day 1) - Haematology

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

    Haematology - Sample Date

    Datatyp

    date

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

    Haematology - Laboratory Name

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C3258037
    UMLS CUI [1,2]
    C0018941
    Laboratory Tests (within 7 days prior to Day 1) - Haematology
    Beskrivning

    Laboratory Tests (within 7 days prior to Day 1) - Haematology

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

    Haematology Test

    Datatyp

    integer

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

    Haematology - No Result

    Datatyp

    integer

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

    Haematology - Value

    Datatyp

    text

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

    Haematology - Value out of range and NOT clinically significant

    Datatyp

    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
    Beskrivning

    Haematology - Value out of range and clinically significant

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C0438215
    UMLS CUI [1,3]
    C2826293
    Laboratory Tests (within 7 days prior to Day 1) - Chemistry
    Beskrivning

    Laboratory Tests (within 7 days prior to Day 1) - Chemistry

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

    Chemistry - Sample Date

    Datatyp

    date

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

    Chemistry - Laboratory Name

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C3258037
    UMLS CUI [1,2]
    C0008000
    Laboratory Tests (within 7 days prior to Day 1) - Chemistry
    Beskrivning

    Laboratory Tests (within 7 days prior to Day 1) - Chemistry

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

    Chemistry - Test

    Datatyp

    integer

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

    Chemistry - No Result

    Datatyp

    integer

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

    Chemistry - Value

    Datatyp

    text

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

    Chemistry - Value out of range and NOT clinically significant

    Datatyp

    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
    Beskrivning

    Chemistry - Value out of range and NOT clinically significant

    Datatyp

    integer

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

    Lesion Assessment Record

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

    Lesion No.

    Datatyp

    integer

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

    Lesion Site Code

    Datatyp

    integer

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

    Lesion Site Description

    Datatyp

    text

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

    Lesion Measurement - Method Code

    Datatyp

    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
    Beskrivning

    Lesion Measurement - Date Performed

    Datatyp

    date

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

    Measurable/ Non measurable Lesion Code

    Datatyp

    integer

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

    Lesion Size - 1. Diameter (cm)

    Datatyp

    float

    Måttenheter
    • cm
    Alias
    UMLS CUI [1,1]
    C0449453
    UMLS CUI [1,2]
    C1301886
    cm
    Lesion Size - 2. Diameter (cm)
    Beskrivning

    Lesion Size - 2. Diameter (cm)

    Datatyp

    float

    Måttenheter
    • cm
    Alias
    UMLS CUI [1,1]
    C0449453
    UMLS CUI [1,2]
    C1301886
    cm
    Lesion Non-Evaluable
    Beskrivning

    Lesion Non-Evaluable

    Datatyp

    integer

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

    Lesion Non-Evaluable - Lesion Measurement Method Code

    Datatyp

    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
    Beskrivning

    Lesion Non-Evaluable - Date Performed

    Datatyp

    date

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

    Lesion Non-Evaluable Status

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0221198
    UMLS CUI [1,2]
    C1883425
    UMLS CUI [1,3]
    C0449438
    Tillbaka till toppen

    Similar models

    Screening - Prior Ovarian Cancer Treatment; Laboratory Tests; Lesion Assessment Record

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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])
    Item Group
    Prior Ovarian Cancer Treatment - Chemotherapy
    C0029925 (UMLS CUI-1)
    C0920425 (UMLS CUI-2)
    C0392920 (UMLS CUI-3)
    Line No.
    Item
    Line No.
    integer
    C0750480 (UMLS CUI [1])
    Chemo Agent
    Item
    Chemo Agent
    text
    C0013216 (UMLS CUI [1])
    Chemotherapy Start Date
    Item
    Chemotherapy Start Date
    date
    C0392920 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Chemotherapy End Date
    Item
    Chemotherapy End Date
    date
    C0392920 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Item
    Overall response
    integer
    C3272903 (UMLS CUI [1])
    Overall response
    Code List
    Overall response
    CL Item
    None —> If “None", patient is not eligible for this study.  (1)
    CL Item
    Partial Response  (2)
    CL Item
    Complete Response (3)
    Item Group
    Has the patient received radiotherapy?
    C1522449 (UMLS CUI-1)
    Has the patient received radiotherapy?
    Item
    Has the patient received radiotherapy?
    boolean
    C1522449 (UMLS CUI [1])
    Item Group
    Prior Ovarian Cancer Treatment - Radiotherapy
    C0029925 (UMLS CUI-1)
    C0920425 (UMLS CUI-2)
    C1522449 (UMLS CUI-3)
    Line No.
    Item
    Line No.
    integer
    C0750480 (UMLS CUI [1])
    Radiotherapy - Specify Area
    Item
    Radiotherapy - Specify Area
    text
    C1997599 (UMLS CUI [1])
    Radiotherapy - Dose Received
    Item
    Radiotherapy - Dose Received
    text
    C0392920 (UMLS CUI [1,1])
    C3174092 (UMLS CUI [1,2])
    Radiotherapy - Date
    Item
    Radiotherapy - Date
    date
    C0392920 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Has the patient received prior cancer-related surgery?
    C0543467 (UMLS CUI-1)
    C0205156 (UMLS CUI-2)
    C2826292 (UMLS CUI-3)
    Has the patient received prior cancer-related surgery?
    Item
    Has the patient received prior cancer-related surgery?
    boolean
    C0543467 (UMLS CUI [1,1])
    C0205156 (UMLS CUI [1,2])
    C2826292 (UMLS CUI [1,3])
    Item Group
    Prior Ovarian Cancer Treatment - Surgical Treatment
    C0029925 (UMLS CUI-1)
    C0920425 (UMLS CUI-2)
    C0543467 (UMLS CUI-3)
    Line No.
    Item
    Line No.
    integer
    C0750480 (UMLS CUI [1])
    Surgery Type
    Item
    Surgery Type
    text
    C0543467 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Surgery Date
    Item
    Surgery Date
    date
    C0543467 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Has the patient received other cancer-related treatments?
    C0920425 (UMLS CUI-1)
    C0205394 (UMLS CUI-2)
    Has the patient received other cancer-related treatments?
    Item
    Has the patient received other cancer-related treatments?
    boolean
    C0920425 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Item Group
    Other Cancer Related Treatments
    C0920425 (UMLS CUI-1)
    C0205394 (UMLS CUI-2)
    Line No.
    Item
    Line No.
    integer
    C0750480 (UMLS CUI [1])
    Treatment
    Item
    Treatment
    text
    C0087111 (UMLS CUI [1])
    Treatment Start Date
    Item
    Treatment Start Date
    date
    C3173309 (UMLS CUI [1])
    Treatment End Date
    Item
    Treatment End Date
    date
    C1531784 (UMLS CUI [1])
    Item Group
    Laboratory Tests (within 7 days prior to Day 1) - 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 (within 7 days prior to Day 1) - 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 (within 7 days prior to Day 1) - 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 (within 7 days prior to Day 1) - 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 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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